EnSite Precision Cardiac Mapping System EE3000 Instructions for Use SW ver 2.0

State: Released Date: 2016.01.12 15:46 GMT

EnSite Precision™ Cardiac Mapping System Instructions for Use ARTEN100141615 Rev.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 Bard-Clearsign recording system

Ablation Cable Kit, IBI, T9 Cable to Bard-Stamp recording system 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

Catalog Number

ACT

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

Amplifier

Amplifier Accessory Kit

CIM Certificate

CIM

Catheter Input Module (for the recording system in use)

Catheter Input Module Cable Connector

Amplifier and Display Workstation Catheter Input Module Cable Connector

Amplifier Cart

Amplifier Cart

Amplifier Kit

Amplifier Kit

Catheter Input Module Cable Connector

Bedrail Mount Kit 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

State: Released Date: 2016.01.12 15:46 GMT

EnSite Precision™ Cardiac Mapping System Instructions for Use ARTEN100141615 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

Data Module Connector

ECG cable connector

Data Network Connection

ECG or RecordConnect ECG Cable Connector

Date of Manufacture

ECG Surface Electrode

Defibrillator-proof Type BF applied part

ELDI Field Upgrade Kit

ELDI Field Upgrade Kit

Defibrillator-proof Type CF Applied Part EnSiteTM ArrayTM Catheter cable connector Dispersive Patch Cable Connector

Dispersive Patch Cable Connector

EnSite VelocityTM Amplifier

EnSiteTM VelocityTM Cardiac Mapping System Amplifier

Equipotential Cable

Equipotential Cable

Dispersive Patch Cable Connector Equipotential jack Dispersive Patch Cable Connector

State: Released Date: 2016.01.12 15:46 GMT

EnSite Precision™ Cardiac Mapping System Instructions for Use ARTEN100141615 Rev.A

4

Symbol

Description

Symbol

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

Humidity Limitation

In Metro Mark - Brazil

European Customer Service

Includes

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

Input Voltage, Input Frequency and Replacement fuse information

EXP

Interface between Biosense Webster Stockert ablation generator and the EnSiteTM Amplifier

Field Interface between diagnostic catheters and the EnSiteTM Amplifier Field Frame Bracket Interface between EnSite™ NavX™ Navigation and Visualization Technology patches / system reference and the EnSiteTM Amplifier

Field Frame Cable

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

Follow Instructions For Use

For Use With Interface between EPT ablation generator and the EnSiteTM Amplifier Fragile

Interface between manufacturerspecific generators and the EnSiteTM Amplifier

Fragile

Interface between manufacturerspecific recording systems and the EnSiteTM Amplifier

Fuse

Interface between Medtronic Atakr ablation generator and the EnSiteTM Amplifier

GenConnect

Interface between Siemens-Sensis recording system and the EnSiteTM Amplifier

GenConnect Cable Connector, to EnSiteTM Amplifier

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

Hardware

HN

Hospital Network Connection

Intl Power Kit

International Power Kit

Intl Rail Clamp

International Rail Clamp

State: Released Date: 2016.01.12 15:46 GMT

EnSite Precision™ Cardiac Mapping System Instructions for Use ARTEN100141615 Rev.A

Symbol

Description

5

Symbol

Description Link

Keep Dry

Not for direct patient contact Keep Dry

Notified Body CE Mark

Kit Kit, CoHesion 3D Visualization Module

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

Kit, WetLab

Laptop Review Station

Laptop Review Station On ArrayLink™ cable: ArrayLink™ Data Module cable connector

Link +55 C

Local Monitor Connection -25 C

On carton: Transport/storage temperature limitation

Lot number On carton: Transport/storage temperature limitation Made in U.S.A.

Made in U.S.A. Patient Reference Sensor

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

Field Frame On the EnSiteTM Amplifier: ArrayLink Data Module cable connector EnSite Precision™ Field Frame Patient Orientation

Manufactured By

MODEL

Monitor Arm

Mounting Kit

Multi-electrode Diagnostic Catheter

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

Model Number

Module

Monitor Arm

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

On the EnSiteTM Amplifier: ECG or RecordConnect ECG cable connector

On the EnSiteTM Amplifier: Fiber optic Cable Connector

On the EnSiteTM Amplifier: GenConnect cable connector

Multi-electrode Diagnostic Catheter

Non Sterile

On the EnSiteTM Amplifier: NavLink™ Module cable connector

State: Released Date: 2016.01.12 15:46 GMT

EnSite Precision™ Cardiac Mapping System Instructions for Use ARTEN100141615 Rev.A

6

Symbol

Description

Symbol

On GenConnect: GenConnect cable connector

Description Research Switch Research Workstation

On NavLink™ Module: NavLink™ Module cable connector RF Filter +27 C

RF Filter Trap for Stockert

Operating Temperature +18 C

Serial Number Power Plug Small Surface Electrode Kit

Small Surface Electrode Kit

Power Switch Software

Printed Circuit Assembly

Printer

Printer

Software Installation

Software Upgrade Kit

Software Upgrade Kit

Port 1 Standby Power Port 2 Status Port 3

STERILE EO

Sterilized Using Ethylene Oxide

Port 4 Surface Electrode Kit

Surface Electrode Kit

Power System Reference Patch Connector Atmospheric Pressure Limits Training Media

Universal RecordConnect

Quantity US Customer Service

US Customer Service

US Power Kit

US Power Kit

US Rail Clamp

US Rail Clamp

RecordConnect

Recorder Interconnect Kit, EPMED V5.0

Remote Monitor Connection Use By Date Remote Monitor Stand

Remote Monitor Stand Utility Upgrade Kit

State: Released Date: 2016.01.12 15:46 GMT

EnSite Precision™ Cardiac Mapping System Instructions for Use ARTEN100141615 Rev.A

Symbol

Description

Weight

Workstation

Workstation

Workstation Accessory Kit

Workstation Accessory Kit

Workstation Cart

Workstation Cart

7

State: Released Date: 2016.01.12 15:46 GMT

8

EnSite Precision™ Cardiac Mapping System Instructions for Use ARTEN100141615 Rev.A

State: Released Date: 2016.01.12 15:46 GMT

EnSite Precision™ Cardiac Mapping System Instructions for Use ARTEN100141615 Rev.A

9

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 Precision™ Cardiac Mapping System Lab Setup 19 Signal and Power Connections 20 Warnings and Cautions 21 Best Practices and Recommendations 25

Chapter 2. Using the Graphical User Interface 27 Operating Modes 27 Main Workspace 28 Common Controls 29 Menu Bar 29 Tool Palette 32 Using the Mouse 33 Common Interface Elements 35 Mapping Control Panel Settings 36 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 EnSite Precision™ Link, Sensor Enabled™ Connections 50 EnSite Precision™ Field Frame Connections 50 NavLink™ Module Connections 51 ArrayLink™ Module Connections 51 CathLink™ Module Connections 52 SJM ECG Cable Connections 52 RecordConnect Connections 53 GenConnect Connections 54

Connecting the EnSite™ Amplifier to the DWS 54 Connecting the Local Monitor to the DWS 54 Connecting the Remote Monitor to the DWS 55 Opticis Video Extender 56 Avenview Video Extender 57 Using the Remote Monitor Configuration Tool 59 Connecting Cables to the EnSite™ Amplifier 60 Color-Coded Connections 60 Connecting a System Reference Surface Electrode 61 Connecting the EnSite Precision™ Patient Reference Sensors (PRS) 62 Patient Reference Sensors 62 Patient Reference Sensor and Patch Placement 62 Patch Removal 62 Connecting the EnSite Precision™ Field Frame 64 EnSite Precision™ Field Frame Assembly 64 Assemble the Field Frame 65 Attach the Bracket to the Table 65 Attach the EnSite Precision™ Field Frame to the Bracket 66 Performing an EnSite Precision™ Module Functional Check 68 Connecting EnSite™Surface Electrodes 69 Surface Electrode Description 69 Placement Considerations 69 Surface Electrode Placement 70 Connecting ECG Surface Electrodes 72 Connecting ECG Surface Electrodes When Using a RecordConnect 73 Connecting ECG Surface Electrodes When Not Using a RecordConnect 74 Connecting an RF Ablation Catheter and Generator 75 Connecting Diagnostic Catheters 76 Connecting the EnSite™ Array™ Catheter 77 Connecting an Auxiliary Unipolar Reference 78 Using a Recording System 79 Connecting Diagnostic Catheters When Using a RecordConnect 80 Connecting Diagnostic Catheters When Not Using a RecordConnect 81

Chapter 4. Preparing for a Study 83 Preparing for an EnSite™ NavX™ Navigation and Visualization Technology Study 83 EnSite™ NavX™ Navigation and Visualization Technology Study with RecordConnect 83 EnSite™ NavX™ Navigation and Visualization Technology Study without RecordConnect 86 EnSite™ NavX™ Navigation and Visualization Technology, Sensor Enabled™ Study with RecordConnect 89 EnSite™ NavX™ Navigation and Visualization Technology, Sensor Enabled™ Study without RecordConnect 93 Preparing for an EnSite™ Array™ Catheter Study 97

State: Released Date: 2016.01.12 15:46 GMT

10

Table of Contents

EnSite™ Array™ Catheter Study with RecordConnect 97 EnSite™ Array™ Catheter Study without RecordConnect 100

Chapter 5. Starting a Study 103 Starting the System 103 Keyboard and Screen Languages 104 Selecting a Keyboard Language 104 Selecting a Screen Language 104 Logging In 105 Title Screen 105 Getting Started 105 Starting a New Study 107 New Patient 107 Existing Patient 108 Past Studies 109 Resuming a Study 109

Chapter 6. Setup 111 Checking ECG Signals 111 Verifying ECG Signal Quality 112 Validation 112 EP Catheter Setup 113 Adding a Catheter to a Study 114 Catheter Signal Settings 116 Catheter Input Settings 117 Catheter Catalog 118 Adding a Catheter to the Catheter Catalog 118 Sorting the Catheter Catalog 118 Deleting a Catheter from the Catheter Catalog 118 Catheter Presets 119 Loading a Catheter Preset 120 Saving a Catheter Preset 120 Deleting or Renaming a Catheter Preset 120 EnSite™ Array™ Catheter Setup 121 EnSite™ NavX™ Navigation and Visualization Technology, Sensor Enabled™ Setup 123 Positional Reference Tool 123 Setting Up the Positional Reference Tool 124 Positional Reference Catheter Dislodgement 125 Respiration Compensation 127 Collecting Respiration Data 127 Respiration Rejection 128 Respiration Meter 129 EnGuide Stability Monitor 129 Metal Distortion and Distortion Meter 129 Metal Distortion Meter 129 Baseline Distortion Measurement 130 EnGuide Alignment 130 Saturation Recovery 131 Signal Filters 131

Chapter 7. Model 133 The EnGuide Navigation System 133 Setting up EnGuide Navigation 133 EnGuide Navigation Indicators 135 Modeling 136 Model Presets 136 Loading a Model Preset 136 Saving a New Model Preset 136 Deleting or Renaming a Model Preset 137 Model Control Panel 138 Color Chart and Visibility Selector 139 Collecting Surface Points 139 OneModel Tool 141 Using the Surface List 142

EnSite Precision™ Cardiac Mapping System Instructions for Use ARTEN100141615 Rev.A

Field Scaling 143 EnSite™ NavX™ Navigation and Visualization Technology Field Scaling (NavX) 143 EnSite™ NavX™ Navigation and Visualization Technology, Sensor Enabled™ Field Scaling (NavX SE) 144 Digital Image Fusion (DIF) 145 Creating a Model to Import 145 Importing a Digital Image 145 Additional Options for DIF Files 146 Viewing a DIF Image for Reference 147

Chapter 8. Waveforms 149 Using the Waveform Display 149 Selecting and Adjusting Waveforms 150 Displaying and Filtering Traces 151 Calipers 151 How to Create a Caliper 151 Using Calipers 151

Chapter 9. Recording and Playing Segments 153 Recording Segments 153 Automatically Recorded Segments 153 Accessing Recorded Segments 154 Playing Recorded Segments 154

Chapter 10. Adjusting and Labeling Maps 155 Map Settings Properties 157 EnGuide Display Settings 158 Information Display Settings 159 Views and the Orientation Reference 160 Orientation Toolbar 160 Creating and Saving Map Views 161 Additional Map Controls 162 Labels 162 Placing a Map Label 163 Selecting and Modifying Labels 164 Label Colors 165 Anatomic Markers 165 Placing Anatomic Markers 166 Selecting and Modifying Anatomic Markers 167 EnGuide Shadows 168 Placing EnGuide Shadows 169 Selecting and Modifying EnGuide Shadows 170 Verifying Catheter Stability 171 Tape Measures 172 Placing a Tape Measure 173 Selecting and Modifying Tape Measures 174

Chapter 11. Mapping – Noncontact 175 Types of Noncontact Maps 175 Interpreting Isopotential Maps 176 Virtuals 177 Setting Virtual Waveform Parameters 177 Placing Virtuals 178 Using Global Virtuals 178 Interpreting Isopotential Color 179 Using Manual Color Controls 180 Using AutoFocus Color Controls 180 Using the Tracking Virtual 182 Substrate Mapping 182 Creating a Substrate Map 184 Isochronal Mapping 185 Creating an Isochronal Map 186

State: Released Date: 2016.01.12 15:46 GMT

EnSite Precision™ Cardiac Mapping System Instructions for Use ARTEN100141615 Rev.A

Chapter 12. Mapping – Contact 187 Types of Contact Maps 188 Cardiac Triggered Maps 188 Non-Cardiac Triggered Maps 188 Signals Collection 189 Reference Signal Source 189 Multiple ECGs 189 Roving Signal Source 189 Detection Algorithm 189 Additional Signals 190 Considerations 190 Non-Cardiac Triggered CFE Maps 190 Reentrant Maps 191 Propagation Maps 191 SparkleMap 191 Mapping Control Panel 192 Cardiac Triggered Mapping Settings 192 Non-Cardiac Triggered Mapping Settings 195 Collecting Points 196 Points Display 199 The OneMap Tool 201 Creating a Map 202 Setting up a New Map 202 Collecting Points 202 To Map from a Segment 203 Managing Maps 204 Mapping Controls 204

Chapter 13. Therapy 205 Lesion Markers 206 Placing Lesion Markers 207 Selecting and Modifying Lesion Markers 208 Lesion Control Panel 209

Table of Contents

11

Saving an Image 222 Accessing an Image 222 Creating Animations 223 Creating an MPEG movie 223 Creating a JPEG image sequence 223 Data Export 224 Waveform Data 224 Directory Name 224 Export Interval Options 224 Exporting 225 Presets 225 Archiving Studies 226 Copying Study Records to CD/DVD 227 Archiving Media 227 Importing Studies 229 Importing Patient and Study Records 230 Accessing a Saved Study from CD/DVD 230

Appendix A. Troubleshooting 233 Contacting Technical Support 233 Troubleshooting Tools 233 Using SJM™ Connect 234 If You Need SJM™ Technical Support 234 Sending Files with SJM™ Connect 235 Uploading Logs with SJM™ Connect 236 Uploading Studies 236 Proxy Configuration 237 Notifying SJM 237 Troubleshooting Common Problems 238 System Hardware Problems 238 Patient Signal Problems 240 Software Interface Problems 241

Appendix B. Care and Service 243 Chapter 14. RealReview 211 Reviewing Segments 212 Reviewing Bookmarks 212 Reviewing Images 212 Reviewing Annotations 212

Chapter 15. Reviewing and Editing Past Studies 213 Past Studies 213 Reviewing Past Studies 214 Editing Past Studies 214 Offline Review 215 Offline Review – Model 215 Offline Review – Mapping 216 Offline Review – Therapy 216 Offline Review – Review 216 Managing Patient and Study Records 216 Searching for Patient Records 216 Modifying Patient Information 216 Removing Patient Records 217 Modifying Study Records 217 Deleting Studies 217

Chapter 16. Ending a Study 219 Ending a Study 219

Chapter 17. Capturing, Exporting, and Importing Information 221 Exporting Data to External Devices 221 Selecting an Area for Capture 221 Saving and Accessing Individual Images 222

Service and Technical Support 243 Setting Environmental Information 244 Setting the System Clock 244 Setting the Powerline Frequency 244 Setting the Owner Information 244 Customer-Performed Maintenance 245 EnSite™ Amplifier 245 EnSite Precision™ Link, Sensor Enabled™ 246 EnSite Precision™ Patient Reference Sensors (PRS) 247 Field Service Representative Performed Maintenance 248 Replacement Parts 248 Moving the System 249 Installing EnSite™ Cardiac Mapping System Software Licenses 249 Preparing to Install 249 Retrieve License(s) and Create Media 250 Verify the Contents of a License File 253 Install Licenses 254 Verify Installed Licenses 254 Re-Creating Licenses 255 Manage Licenses 256 Installation Report 256 Velocity license has not been installed 256 Installing a base license 257 Warranty Policy 257 General Notices 257

Appendix C. Technical Specifications 259 Specifications 259 Electromagnetic Emissions – Declaration 261

State: Released Date: 2016.01.12 15:46 GMT

12

Table of Contents

Appendix D. Glossary 265 Appendix E. Index 273 Appendix F. EnSite™ Fusion™ Registration Module 279 Indications for Use 279 Warnings, Cautions, and Disclaimers 279 Introduction 279 Performing Registration 280 Importing a DIF Model 280 Scaling the EnSite™ NavX™ Navigation and Visualization Technology, Sensor Enabled™ Navigation Field 281 Placing Fiducial Point Pairs 282 Display Options 285 The EnSite™ Fusion™ Registration Module Control Panel Display Options 285 Map Settings Menu 286

Appendix G. EnSite™ Derexi™ Module 289 Indications for Use 289 Introduction 289 Minimum System Requirements 289 EnSite™ Cardiac Mapping System / EP-WorkMate™ System Signal Connections 290 Connecting to the EnSite™ Cardiac Mapping System 291 HP xw6400 291 HP xw6400 or HP Z600 291 Connection States 292 Maps and Integration 293 Number of Maps / Map Points 293 Map Point Analysis 293 Mapping Constraints 293 Patient Connections 293 Dual System Start-up Procedure using the EnSite™ Derexi™ Module 294 Interface Features & Descriptions 295 EP-WorkMate™ Recording System Mapping Controls 296

Appendix H. EnSite™ Verismo™ Segmentation Tool 297

EnSite Precision™ Cardiac Mapping System Instructions for Use ARTEN100141615 Rev.A

State: Released Date: 2016.01.12 15:46 GMT

EnSite Precision™ Cardiac Mapping System Instructions for Use ARTEN100141615 Rev.A

Introduction

13

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™ NavX™ 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 13) 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).

State: Released Date: 2016.01.12 15:46 GMT

14

Chapter 1. Introduction Key System Features

EnSite Precision™ Cardiac Mapping System Instructions for Use ARTEN100141615 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 Precision™ Cardiac Mapping System computer.

■

The study images can be printed using a color printer.

DEMRI – Delayed Enhancement Magnetic Resonance Imaging. 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.

■

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 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.

State: Released Date: 2016.01.12 15:46 GMT

EnSite Precision™ Cardiac Mapping System Instructions for Use ARTEN100141615 Rev.A

Chapter 1. Introduction Key System Features

15

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 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.

■

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 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, Sensor Enabled™ 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.

State: Released Date: 2016.01.12 15:46 GMT

16

Chapter 1. Introduction Key System Features

EnSite Precision™ Cardiac Mapping System Instructions for Use ARTEN100141615 Rev.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. Score Map – Provides a method to visualize areas of map points matching the morphology of the selected ECG signal. 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

■

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 10x’s real-time speed. As an example, if the original mapping time were 10 minutes, the user can generate a second map in only 1 additional minute. This same concept could be employed for map3, map4, etc. 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.

State: Released Date: 2016.01.12 15:46 GMT

EnSite Precision™ Cardiac Mapping System Instructions for Use ARTEN100141615 Rev.A

Chapter 1. Introduction System Components

17

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 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.

State: Released Date: 2016.01.12 15:46 GMT

18

EnSite Precision™ Cardiac Mapping System Instructions for Use ARTEN100141615 Rev.A

Chapter 1. Introduction System Components

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, Sensor Enabled™ 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 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.

State: Released Date: 2016.01.12 15:46 GMT

EnSite Precision™ Cardiac Mapping System Instructions for Use ARTEN100141615 Rev.A

Chapter 1. Introduction EnSite™ Cardiac Mapping System Diagram

19

EnSite™ Cardiac Mapping System Diagram Typical EnSite Precision™ Cardiac Mapping System Lab Setup

Figure 3. EnSite Precision™ System Setup. Table 1. Figure 3. EnSite Precision™ System Setup. 1

Remote Monitor Stand

7

EnSite Precision™ Link, Sensor Enabled™, CathLink™ Module, NavLink™ Module

2

Monitor Boom (Patient Monitors)

8

Field Frame cable to the EnSite Precision™ Link, Sensor Enabled™, routed under the patient table

3

EnSite™ Amplifier

9

Patient Table

4

Fiber Optic Cables

10

Workstation

5

C Arm

11

Monitor

6

EnSite Precision™ Field Frame and bracket

12

Keyboard and Mouse

State: Released Date: 2016.01.12 15:46 GMT

20

Chapter 1. Introduction EnSite™ Cardiac Mapping System Diagram

EnSite Precision™ Cardiac Mapping System Instructions for Use ARTEN100141615 Rev.A

Signal and Power Connections EnSite Precision™ Display WorkStation (DWS) Connections

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