1

EnSite Precision™ Cardiac INSTRUCTIONS FOR USE

INTERNATIONAL EDITION
Mapping System
Model EE3000
Software Version
2.2

You are not here this morning

WARNING: The use of this device in conjunction with radio frequency ablation, as a © Copyright 2017
St. Jude Medical
part of the diagnosis and treatment of cardiac arrhythmias, may pose an
increased risk of adverse events such as cardiac perforation, myocardial Unless otherwise noted, ™ indicates that the name
infarction, air embolism, and hematoma requiring surgical repair and/or is a trademark of, or licensed to, St. Jude Medical or
one of its subsidiaries. ST. JUDE MEDICAL and
blood transfusion. the nine-squares symbol are trademarks and
services marks of St. Jude Medical, Inc. and its
related companies.
Pat. http://patents.sjm.com
© 2017 St. Jude Medical, Inc. All Rights Reserved.
This software includes a custom version of the
AVW Toolkit:
Copyright (c) 1995-2017 Biomedical Imaging
Resource, Mayo Clinic/Foundation.
This software includes the DST Digital
Segmentation Tool:
Copyright (c) 2004-2017 Biomedical Imaging
Resource, Mayo Clinic/Foundation.
Valleylab is a trademark of Covidien AG.
DICOM is a trademark of National Electrical
Manufacturers Association
St. Jude Medical CIDEX and CIDEX OPA are trademarks of Johnson
One St. Jude Medical Drive & Johnson Corporation.
St. Paul, MN SANI-CLOTH is a trademark of Professional
Disposables International, Inc.
55117-9913 USA
+1 855 478 5833
+1 651 756 5833
sjm.com

St. Jude Medical

Coordination Center BVBA
The Corporate Village
Da Vincilaan 11 Box F1
1935 Zaventem
Belgium
+32 2 774 68 11
sjm.com

Australian Sponsor:
St. Jude Medical Australia Pty Limited
17 Orion Rd.,
Lane Cove NSW 2066
AUSTRALIA

*600004505*
+61 (02) 9936 1200
ARTEN600004505 Rev. B
2017-01
 EnSite Precision™ Cardiac Mapping System Instructions for Use
2 ARTEN600004505 Rev. B

Symbol Description Symbol Description

Cable Accessory Kit

21” Monitor 21” Monitor

Cable from RecordConnect to EnSiteTM

24” Monitor 24” Monitor 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

Cable to GE-Cardiolab recording

Ablation Cable Kit, JLL
system

Cable to St. Jude Medical EP-

Ablation catheter cable connector
Workmate recording system

Cardiac Mapping System

Ablation catheter cable connector

ACT Catalog Number

AC Power
Catheter

Adapter Assembly, ECG/NavX

Catheter Catalog Installation

Amplifier Network Connection

Catheter Impedance Checker

Amp and Chassis Amp and Chassis CIM Certificate

Catheter Input Module (for the recording

Amplifier Amplifier CIM system in use)

Amplifier Accessory Kit Amplifier Accessory Kit 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
Catheter Interface Module cable
Auxiliary Reference Cable Connector connection for catheter inputs 1-56
EnSite Precision™ Cardiac Mapping System Instructions for Use
ARTEN600004505 Rev. B 3

Symbol Description 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

ELDI Field Upgrade Kit ELDI Field Upgrade Kit

Defibrillator-proof Type BF applied part

Defibrillator-proof Type CF Applied Part

EnSiteTM ArrayTM Catheter cable
connector

Dispersive Patch Cable Connector

EnSiteTM VelocityTM Cardiac Mapping

EnSiteTM VelocityTM Amplifier System Amplifier
Dispersive Patch Cable Connector

Equipotential Cable Equipotential Cable

Dispersive Patch Cable Connector

Equipotential jack

Dispersive Patch Cable Connector

 EnSite Precision™ Cardiac Mapping System Instructions for Use
4 ARTEN600004505 Rev. B

Symbol Description Symbol Description

Consult Instructions for Use on Website Humidity Limitation

Intertek Safety Agency Certification In Metro Mark - Brazil

European Customer Service European Customer Service Includes

Federal law (USA) restricts this device Input Voltage, Input Frequency and
to sale by or on the order of a physician. 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
Field Frame Cable Technology patches / system reference
and the EnSiteTM Amplifier

Follow Instructions For Use Interface between EnSite Precision™

Cardiac Mapping System EnSiteTM
ArrayTM catheter / data module and the
EnSiteTM Amplifier
For Use With
Interface between EPT ablation
generator and the EnSiteTM Amplifier
Fragile
Interface between manufacturer-
specific generators and the EnSiteTM
Amplifier

Fragile Interface between manufacturer-

specific 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
GenConnect Cable Connector, to Amplifier
EnSiteTM Amplifier
Interface between SJM-T Series
(formerly IBI-T Series) ablation
generator and the EnSiteTM Amplifier
Hardware

Intl Power Kit International Power Kit

HN

Hospital Network Connection Intl Rail Clamp International Rail Clamp

EnSite Precision™ Cardiac Mapping System Instructions for Use
ARTEN600004505 Rev. B 5

Symbol Description Symbol Description

Link
Keep Dry

Not for direct patient contact

Keep Dry

Kit Notified Body CE Mark

Kit, WetLab On ArrayLink™ cable: ArrayLink™

cable connector
or
Laptop Review Station Laptop Review Station CathLink™, or RecordConnect catheter
channels 65 to 128 cable connector

Link
On ArrayLink™ cable: ArrayLink™ Data
Module cable connector
Local Monitor Connection

On carton: Transport/storage
Lot number temperature limitation

Made in U.S.A. On CathLink™ or RecordConnect

Made in U.S.A. cable: CathLink™ or RecordConnect
catheter channels 1 to 64 cable
Patient Reference Sensor connector

Field Frame On the EnSiteTM Amplifier: ArrayLink

Data Module cable connector

On the EnSiteTM Amplifier: ArrayLink,

EnSite Precision™ Field Frame Patient CathLink, or RecordConnect catheter
Orientation channels 65 to 128 cable connector

On the EnSiteTM Amplifier: CathLink or

RecordConnect catheter channels 1 to
Manufactured By 64 cable connector

Medical Electrical Equipment On the EnSiteTM Amplifier: ECG or

RecordConnect ECG cable connector

MODEL Model Number

On the EnSiteTM Amplifier: Fiber optic
Cable Connector
Module

On the EnSiteTM Amplifier: GenConnect

Monitor Arm Monitor Arm cable connector

Mounting Kit
On the EnSiteTM Amplifier: NavLink™
Module cable connector
Multi-electrode Diagnostic Catheter Multi-electrode Diagnostic Catheter
On GenConnect: GenConnect cable
connector
Non Sterile
 EnSite Precision™ Cardiac Mapping System Instructions for Use
6 ARTEN600004505 Rev. B

Symbol Description Symbol Description

On NavLink™ Module: NavLink™ Research Workstation

Module cable connector

RF Filter

Operating Temperature
RF Filter Trap for Stockert

Serial Number
Power Plug

Small Surface Electrode Kit Small Surface Electrode Kit

Power Switch

Software

Printed Circuit Assembly

Software Installation

Printer Printer
Software Upgrade Kit Software Upgrade Kit

Port 1

Standby Power
Port 2

Status
Port 3

STERILE EO Sterilized Using Ethylene Oxide

Port 4

Power Surface Electrode Kit Surface Electrode Kit

System Reference Patch Connector

Atmospheric Pressure Limits

Training Media

Quantity Universal RecordConnect

RecordConnect US Customer Service US Customer Service

Recorder Interconnect Kit, EPMED US Power Kit US Power Kit

V5.0

US Rail Clamp US Rail Clamp

Remote Monitor Connection

Remote Monitor Stand Use By Date

Remote Monitor Stand

Research Switch Utility Upgrade Kit

EnSite Precision™ Cardiac Mapping System Instructions for Use
ARTEN600004505 Rev. B 7

Symbol Description

Weight

Workstation Workstation

Workstation Accessory Kit Workstation Accessory Kit

Workstation Cart Workstation Cart

 EnSite Precision™ Cardiac Mapping System Instructions for Use
8 ARTEN600004505 Rev. B
EnSite Precision™ Cardiac Mapping System Instructions for Use
ARTEN600004505 Rev. B 9

Table of Contents

Chapter 1. Introduction 15 Connecting the EnSite™ Amplifier to the DWS 56

Indications for Use 15 Connecting the Local Monitor to the DWS 56
System Description 15 Connecting the Remote Monitor to the DWS 57
Key System Features 16 Opticis Video Extender 57
System Components 19 Avenview Video Extender 59
EnSite™ Amplifier 19 Using the Remote Monitor Configuration Tool 61
Display Workstation (DWS) 19 Connecting Cables to the EnSite™ Amplifier 62
Components Not Included 20 Color-Coded Connections 62
EnSite™ Cardiac Mapping System Diagram 21 Connecting a System Reference Surface Electrode 63
Typical EnSite Precision™ Cardiac Mapping System Lab Connecting the EnSite Precision™ Patient Reference Sensors
Setup 21 (PRS) 64
Signal and Power Connections 22 Patient Reference Sensors 64
Warnings and Cautions 23 Patient Reference Sensor and Patch Placement 64
Best Practices and Recommendations 27 Patch Removal 64
Connecting the EnSite Precision™ Field Frame 66
EnSite Precision™ Field Frame Assembly 66
Chapter 2. Using the Graphical User Interface 29 Assemble the Field Frame 67
Operating Modes 29
Attach the Bracket to the Table 67
Main Workspace 30
Attach the EnSite Precision™ Field Frame to the Bracket 68
Common Controls 31
Performing an EnSite Precision™ Module Functional Check 70
Menu Bar 31
Connecting EnSite™ Surface Electrodes 72
Tool Palette 33
Surface Electrode Description 72
Using the Mouse 34
Placement Considerations 72
Common Interface Elements 36
Surface Electrode Placement 73
Mapping Control Panel Settings 37
Connecting ECG Surface Electrodes 75
Dual View 39
Connecting ECG Surface Electrodes When Using a
Split Screen 40
RecordConnect 76
Screen Layout Controls 42
Connecting ECG Surface Electrodes When Not Using a
Screen Layout Presets 43
RecordConnect 77
System Messages 46
Connecting an RF Ablation Catheter and Generator 78
Information Message 46
Connecting Diagnostic Catheters 79
Advisory Message 46
Connecting the EnSite™ Array™ Catheter 80
System Busy Message 46
Connecting an Auxiliary Unipolar Reference 81
Warning Message 46
Using a Recording System 82
Notebook 47
Connecting Diagnostic Catheters When Using a
Saving an Event 48
RecordConnect 83
Saving a Bookmark 48
Connecting Diagnostic Catheters When Not Using a
Presets 49
RecordConnect 84
Load a preset 49
Save a preset 49
Chapter 4. Preparing for a Study 87
Preparing for an EnSite™ NavX™ Navigation and Visualization
Chapter 3. External Connections 51 Technology Study 87
EnSite™ Amplifier Connections 51
EnSite™ NavX™ Navigation and Visualization Technology
EnSite Precision™ Link, Sensor Enabled™ Connections 52 Study with RecordConnect 87
EnSite Precision™ Field Frame Connections 52
EnSite™ NavX™ Navigation and Visualization Technology
NavLink™ Module Connections 53
Study without RecordConnect 90
ArrayLink™ Module Connections 53 EnSite™ NavX™ Navigation and Visualization Technology,
CathLink™ Module Connections 54
Sensor Enabled™ Study with RecordConnect 93
SJM ECG Cable Connections 54
EnSite™ NavX™ Navigation and Visualization Technology,
RecordConnect Connections 55 Sensor Enabled™ Study without RecordConnect 97
GenConnect Connections 56
Preparing for an EnSite™ Array™ Catheter Study 101
 Table of Contents EnSite Precision™ Cardiac Mapping System Instructions for Use
10 ARTEN600004505 Rev. B

EnSite™ Array™ Catheter Study with RecordConnect 101 Deleting or Renaming a Model Preset 149
EnSite™ Array™ Catheter Study without RecordConnect 104 Model Control Panel 150
Color Chart and Visibility Selector 151
Chapter 5. Starting a Study 107 Collecting Surface Points 151
Flexible Workflow Options 151
Starting the System 107
Collect Points 152
Keyboard and Screen Languages 108
Selecting a Keyboard Language 108 Edit Points 152
OneModel Tool 154
Selecting a Screen Language 108
Using the Surface List 155
Logging In 109
Title Screen 109 Field Scaling 156
EnSite™ NavX™ Navigation and Visualization Technology,
Getting Started 110
Sensor Enabled™ Field Scaling (NavX SE) 157
Starting a New Study 113
New Patient 113 EnSite™ NavX™ Navigation and Visualization Technology
Field Scaling (NavX) 158
Existing Patient 114
Digital Image Fusion (DIF) 159
Past Studies 115
Resuming a Study 115 Creating a Model to Import 159
Importing a Digital Image 159
Additional Options for DIF Files 160
Chapter 6. Setup 117 Viewing a DIF Image for Reference 160
Checking ECG Signals 117 DEMRI (Delayed Enhancement MRI) Image Integration 161
Verifying ECG Signal Quality 118
Validation 118
EP Catheter Setup 119
Chapter 8. Waveforms 163
Using the Waveform Display 163
Adding a Catheter to a Study 121
Selecting and Adjusting Waveforms 164
EnSite Precision™ System Data Quality Indicators 123
Catheter Signal Settings 124 Displaying and Filtering Traces 165
Calipers 165
Catheter Input Settings 125
How to Create a Caliper 165
Catheter Catalog 125
Adding a Catheter to the Catheter Catalog 126 Using Calipers 165
Sorting the Catheter Catalog 126
Deleting a Catheter from the Catheter Catalog 126 Chapter 9. Recording and Playing Segments 167
Catheter Presets 126 Recording Segments 167
Loading a Catheter Preset 127 Automatically Recorded Segments 167
Saving a Catheter Preset 127 Accessing Recorded Segments 168
Deleting or Renaming a Catheter Preset 127 Playing Recorded Segments 168
Sheath Filter Setup 128
Description 128 Chapter 10. Adjusting and Labeling Maps 169
Enable and Baseline the Catheter 128
Map Settings Properties 171
EnSite™ Array™ Catheter Setup 130
EnGuide Display Settings 172
EnSite™ NavX™ Navigation and Visualization Technology, Information Display Settings 173
Sensor Enabled™ Setup 132
Views and the Orientation Reference 174
Positional Reference Tool 132
Orientation Toolbar 174
Setting Up the Positional Reference Tool 134 Creating and Saving Map Views 175
Positional Reference Catheter Dislodgement 135
Additional Map Controls 176
Respiration Compensation 137
Labels 177
Collecting Respiration Data 137 Placing a Map Label 177
Respiration Rejection 138
Selecting and Modifying Labels 178
Respiration Meter 139
Label Colors 179
EnGuide Stability Monitor 139 Anatomic Markers 179
Metal Distortion and Distortion Meter 139
Placing Anatomic Markers 180
Metal Distortion Meter 140
Selecting and Modifying Anatomic Markers 181
Baseline Distortion Measurement 140 EnGuide Shadows 182
EnGuide Alignment 140
Placing EnGuide Shadows 183
Saturation Recovery 140
Selecting and Modifying EnGuide Shadows 184
Signal Filters 141 Verifying Catheter Stability 185
Tape Measures 186
Chapter 7. Model 143 Placing a Tape Measure 187
The EnGuide Navigation System 143 Selecting and Modifying Tape Measures 188
Setting up EnGuide Navigation 143
EnGuide Navigation Indicators 145 Chapter 11. Mapping – Noncontact 189
Modeling 146
Types of Noncontact Maps 189
Impedance and Magnetic Data 146
Interpreting Isopotential Maps 190
EnSite™ NavX™ SE Points 146 Virtuals 191
Model Presets 148
Setting Virtual Waveform Parameters 191
Loading a Model Preset 148
Placing Virtuals 192
Saving a New Model Preset 149 Using Global Virtuals 192
EnSite Precision™ Cardiac Mapping System Instructions for Use Table of Contents
ARTEN600004505 Rev. B 11

Interpreting Isopotential Color 193 Chapter 16. Ending a Study 233

Using Manual Color Controls 194 Ending a Study 233
Using AutoFocus Color Controls 194
Using the Tracking Virtual 196
Substrate Mapping 196
Chapter 17. Capturing, Exporting, and Importing
Creating a Substrate Map 198 Information 235
Isochronal Mapping 199 Exporting Data to External Devices 235
Creating an Isochronal Map 200 Selecting an Area for Capture 235
Saving and Accessing Individual Images 236
Saving an Image 236
Chapter 12. Mapping – Contact 201 Accessing an Image 236
Types of Contact Maps 202
Creating Animations 237
Cardiac Triggered Maps 202 Creating an MPEG movie 237
Non-Cardiac Triggered Maps 202
Creating a JPEG image sequence 237
Signals Collection 203
Data Export 238
Reference Signal Source 203 Waveform Data 238
Roving Signal Source 203
Directory Name 238
Detection Algorithm 203
Export Interval Options 238
Additional Signals 204 Exporting 239
Considerations 204
Presets 239
Non-Cardiac Triggered CFE Maps 204
Archiving Studies 240
Reentrant Maps 205 Archiving Media 241
Propagation Maps 205
Importing Studies 242
SparkleMap 205
Mapping Control Panel 206
Cardiac Triggered Mapping Settings 206 Appendix A. Troubleshooting 245
Non-Cardiac Triggered Mapping Settings 209 Contacting Technical Support 245
Collecting Points 210 Troubleshooting Tools 245
Points Display 213 Using SJM™ Connect 246
The OneMap Tool 215 If You Need SJM™ Technical Support 246
Creating a Map 216 Sending Files with SJM™ Connect 247
Setting up a New Map 216 Uploading Logs with SJM™ Connect 248
Collecting Points 216 Uploading Studies 248
To Map from a Segment 217 Proxy Configuration 249
Managing Maps 218 Notifying SJM 249
Mapping Controls 218 Troubleshooting Common Problems 250
System Hardware Problems 250
Patient Signal Problems 252
Chapter 13. Therapy 219 EnGuide Stability Problems 253
Lesion Markers 220
Magnetic Tracking Problems 255
Placing Lesion Markersf 221 Software Interface Problems 255
Selecting and Modifying Lesion Markers 222
Lesion Control Panel 223
Appendix B. Care and Service 257
Service and Technical Support 257
Chapter 14. RealReview 225 Setting Environmental Information 258
Reviewing Segments 226 Setting the System Clock 258
Reviewing Bookmarks 226
Setting the Powerline Frequency 258
Reviewing Images 226
Setting the Owner Information 258
Reviewing Annotations 226 Customer-Performed Maintenance 259
EnSite™ Amplifier 259
Chapter 15. Reviewing and Editing Past Studies 227 EnSite™ DWS 260
Past Studies 227 EnSite Precision™ Link, Sensor Enabled™ 260
Reviewing Past Studies 228 EnSite Precision™ Patient Reference Sensors (PRS) 261
Editing Past Studies 228 Field Service Representative Performed Maintenance 262
Offline Review 229 Replacement Parts 262
Offline Review – Model 229 Moving the System 263
Offline Review – Mapping 230 Installing EnSite™ Cardiac Mapping System Software Licenses
Offline Review – Therapy 230 263
Offline Review – Review 230 Preparing to Install 263
Managing Patient and Study Records 230 Retrieve License(s) and Create Media 264
Searching for Patient Records 230 Verify the Contents of a License File 267
Modifying Patient Information 230 Install Licenses 268
Removing Patient Records 231 Verify Installed Licenses 268
Modifying Study Records 231 Re-Creating Licenses 269
Deleting Studies 231 Manage Licenses 270
Installation Report 270
Velocity license has not been installed 270
 Table of Contents EnSite Precision™ Cardiac Mapping System Instructions for Use
12 ARTEN600004505 Rev. B

Installing a base license 271 Loading the Series for Segmentation 302
Warranty Policy 271 Using the Segmentation Interface 303
General Notices 271 Introduction to the Segmentation Screen 303
Menu Bar Summary 304
Appendix C. Technical Specifications 273 Using Basic Interface Controls 304
Specifications 273 Navigating in Slice Views 305
Electromagnetic Emissions – Declaration 275 Using the Zoom Control 305
Using the Pan Control 305
Using the Intensity (W/L) Controls 306
Appendix D. EnSite™ Fusion™ Registration Module Rotating the 3D Model 306
279 Using Templates 306
Indications for Use 279 Performing Segmentation 307
Warnings, Cautions, and Disclaimers 279 Overview of Segmentation Tools 307
Introduction 279 Additional Controls: Delete, Undo, Cancel 307
Performing Registration 280 Using the Structure List 308
Importing a DIF Model 280 Structure Attributes 308
Scaling the EnSite™ NavX™ Navigation and Visualization Modifying Structures 308
Technology Navigation Field 281 Using the Region Grow Tool 309
Placing Fiducial Point Pairs 282 Using the Chamber Tool 311
Display Options 285 Using the Vessel Tool 312
The EnSite™ Fusion™ Registration Module Control Panel Using the Separator Tool 313
Display Options 285 Using the Trace Tool 314
Map Settings Menu 286 Using Trace in a Slice View 314
Using Trace in the 3D View 314
Appendix E. EnSite™ Derexi™ Module 289 Using the Barrier Tool 315
Indications for Use 289 Using the Reassign Tool 316
Introduction 289 Reassigning a Structure 316
Minimum System Requirements 289 Placing Labels 317
EnSite™ Cardiac Mapping System / EP-WorkMate™ System Using the Measurement Tools 317
Signal Connections 290 Measuring Distances 318
Connecting to the EnSite™ Cardiac Mapping System 291 Measuring Volumes 318
HP xw6400 291 Saving and Exporting 319
HP xw6400 or HP Z600 291 Key Points About Saving Models 319
Connection States 292 Saving the Model to the Hard Drive 319
Maps and Integration 293 Exporting Models to CD or DVD 319
Number of Maps / Map Points 293 Saving Work in Progress 320
Map Point Analysis 293 Reviewing the Final Model 320
Mapping Constraints 293 Using the DIF Viewer 320
Patient Connections 293 Viewing Segmentation Contours 321
Dual System Start-up Procedure using the EnSite™ Derexi™ Printing Images 322
Module 294 Troubleshooting 322
Interface Features & Descriptions 295 Contacting Technical Support 322
EP-WorkMate™ Recording System Mapping Controls 296 Troubleshooting Tools 322
Troubleshooting Common Problems 323

Appendix F. EnSite™ Verismo™ Segmentation Tool

Appendix G. Courier™ PACS Module Appendix 325
Module 297 Introduction 325
Indications for Use 297
Operator Requirements 325
Description 297
Requirements 325
Contraindications 298 Connections 325
Warnings and Precautions 298
Configuring the EnSite™ Courier PACS Module 326
Operator Requirements 298
Configure DWS Network Settings 327
System Requirements and Considerations 298 Connect the DWS to the Network 327
Overview of Segmentation 298
Configure the IP Address 327
Optimal Characteristics for the EnSite™ Verismo™
Configure the EnSite™ Courier™ PACS Module 333
Segmentation Tool Image Files 299 Configure PACS Server Settings 333
Loading Files for Segmentation 300
Description of PACS Server Settings 334
Starting the EnSite™ Verismo™ Segmentation Tool 300
Configure the EnSite™ Courier™ PACS Module Application
Verismo Cleanup 300 Entity Settings 335
Loading DICOM Files 300
Description of EnSite™ Courier™ PACS Module Settings 335
Using DICOM Files from Saved Data 300
Storage Attributes 336
Using the Wizard 301 History Management 336
Introduction to the Patient Screen 301
Query Configuration 336
Selecting a Series for Segmentation 301
Register the EnSite™ Courier™ PACS Module on the PACS
Viewing Options 302 Server 338
Subregioning the Series 302
Import Image Data into the EnSite™ Verismo™ Segmentation
EnSite Precision™ Cardiac Mapping System Instructions for Use Table of Contents
ARTEN600004505 Rev. B 13

Tool for Segmentation 338

Launch the EnSite™ Courier™ PACS Module 338
Perform a Query 338
Import a Study 339
Receive Study or CT/MR Scans 340
Archive Segmented 3D Model/Map to PACS Server 340
Delete Study after Archiving 341
Import Pre-segmented 3D Models for Use in the EnSite™
Cardiac Mapping System 341
Retrieve Pre-segmented 3D Models from the PACS Server 341
Receive Pre-Segmented 3D Models 341
Store EnSite™ Cardiac Mapping System Studies on PACS
Server 342
Import EnSite™ Cardiac Mapping System Studies from a PACS
Server 343
Display EnSite™ Cardiac Mapping System Study Screenshots
344
Troubleshooting 344
Courier Log 344
Query Failed 345
Retrieve Failed 345
Image Incompatibility 345
Receive Failed 346
Storage Failed 346
Storage Commitment Failed 346

Appendix H. Glossary 347

Appendix I. Index 357

 Table of Contents EnSite Precision™ Cardiac Mapping System Instructions for Use
14 ARTEN600004505 Rev. B
EnSite Precision™ Cardiac Mapping System Instructions for Use
ARTEN600004505 Rev. B 15

Introduction 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).
 Chapter 1. Introduction EnSite Precision™ Cardiac Mapping System Instructions for Use
16 Key System Features ARTEN600004505 Rev. B

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.

Delayed Enhancement Magnetic Resonance Imaging. – (DEMRI) See “DEMRI (Delayed Enhancement MRI) Image Integration”
on page 161.

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 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 Chapter 1. Introduction
ARTEN600004505 Rev. B Key System Features
17

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.
■ 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 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.

 Chapter 1. Introduction EnSite Precision™ Cardiac Mapping System Instructions for Use
18 Key System Features ARTEN600004505 Rev. B

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
■ 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 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 Chapter 1. Introduction
ARTEN600004505 Rev. B System Components
19

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.
 Chapter 1. Introduction EnSite Precision™ Cardiac Mapping System Instructions for Use
20 System Components ARTEN600004505 Rev. B

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 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.
EnSite Precision™ Cardiac Mapping System Instructions for Use Chapter 1. Introduction
ARTEN600004505 Rev. B EnSite™ Cardiac Mapping System Diagram
21

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

 Chapter 1. Introduction EnSite Precision™ Cardiac Mapping System Instructions for Use
22 EnSite™ Cardiac Mapping System Diagram ARTEN600004505 Rev. B

Signal and Power Connections

EnSite Precision™ Display WorkStation (DWS) Connections

Figure 4. Signal and power connections for an EnSite Precision™ 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 Precision™ Cardiac Mapping System Instructions for Use Chapter 1. Introduction
ARTEN600004505 Rev. B Warnings and Cautions
23

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 Precision™ Cardiac Mapping System.

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

Operator Requirements. The EnSite Precision™ Cardiac Mapping System must be operated by, or under the supervision of, an
electrophysiologist trained in the operation of the EnSite Precision™ 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 Precision™ Cardiac Mapping System is not intended for use as a primary ECG monitor. During
EnSite Precision™ 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 Precision™ 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 Precision™ Cardiac Mapping System, other than those described
in this manual.
■ Do not connect the system to multiple portable socket outlets or extension cords.

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

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

Patient Safety. Observe the following:

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

WARNING: When using the EnSite Precision™ Module full protection against the effects of cardiac defibrillator discharge and other
leakage currents is dependent upon the use of appropriate cables.

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.
 Chapter 1. Introduction EnSite Precision™ Cardiac Mapping System Instructions for Use
24 Warnings and Cautions ARTEN600004505 Rev. B

CAUTION: Patients with any implantable device might undergo the procedure provided that the implantable device complies with
ANSI/AAMI PC69 and the implantable device manufacturer’s recommendations regarding the type of invasive
procedure and exposure to electromagnetic interference (EMI) are strictly followed. In addition, it is recommended to
turn off the magnetic field generated by the EnSite Precision Field Frame during telemetry or communication between
an external programmer and the implanted device.

In any case of abnormal behavior of the implanted device, turn the system’s magnetic field off.

Whenever device programming has been performed before or during the procedure, it is recommended, following the
procedure, to:
– Program the device back to its original pre-procedure settings or other settings according to the patient’s clinical
indications.
– Perform a routine device evaluation.
– In any case of uncertainty regarding device programming, please consult with a relevant device expert.

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 Precision™ Surface Electrode Kit, Sensor Enabled™ 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.

Validating EnSite™ NavX™ Navigation and Visualization Technology, Sensor Enabled™. Before validating EnSite™ NavX™
Navigation and Visualization Technology, Sensor Enabled™, 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
Precision™ 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.
EnSite Precision™ Cardiac Mapping System Instructions for Use Chapter 1. Introduction
ARTEN600004505 Rev. B Warnings and Cautions
25

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

NOTE: Using location information from non-functional electrodes may yield unexpected Field Scaling results. This cannot be
reversed. However, the use of Field scaling is optional and can be unapplied if unexpected results are seen.
■ Check for and disable non-functional electrodes or electrodes in a sheath before creating a model. Collecting points from non-
functioning electrodes or electrodes in a sheath can result in unexpected field scaling results. See “Field Scaling” on page 156 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.

Shutting Down the Workstation. To shut down the workstation, always follow the instructions in “Ending a Study” on page 233.

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

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

Surface Electrodes and Patient Reference Sensor (PRS) Patches. Use care in applying and removing surface electrodes (ECG,
system reference, EnSite Precision™ surface electrodes) and PRS patches:

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

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

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

CAUTION: When removing the system reference surface electrode from the patient’s abdomen, disconnect the patch from the patient
before disconnecting its jack from the EnSite™ NavLink™ Module.
 Chapter 1. Introduction EnSite Precision™ Cardiac Mapping System Instructions for Use
26 Warnings and Cautions ARTEN600004505 Rev. B

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

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

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

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

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

WARNING: Before applying the System Reference surface electrode, ensure that the application site is hair-free, clean, and dry.
Dryness is particularly important if the preparation agent is flammable or a potential skin irritant.
Liquids . System components are susceptible to damage from liquids. Keep liquids away from this equipment.

Sterilization and Cleaning. Keep this in mind:

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

CAUTION: Do not clean system components with bleach.

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

CAUTION: Do not sterilize system components.

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

CAUTION: Do not immerse system components in liquid.

CAUTION: Do not operate the EnSite Precision™ Field Frame within 10 m of another operating Field Frame.

CAUTION: Do not place the EnSite Precision™ Field Frame cable inside the measurement volume or wrap it around the Field Frame,
as it may create a magnetic interference.

CAUTION: Do not coil the EnSite Precision™ Field Frame cable. The cable carries enough electric current that a magnetic field will
be created when the cable is placed in a circular formation. This magnetic field may disturb the Field Frame's magnetic
field.

CAUTION: Do not place the EnSite Precision™ Link, Sensor Enabled™ within 1 m of the EnSite Precision™ Field Frame.

CAUTION: Metallic equipment used in close proximity to the magnetic field during the procedure, such as a sterile drape holder,
may affect SE points and SE field scaling accuracy.

CAUTION: Do not place tool cables within 30 mm of the EnSite Precision™ Field Frame cable. If placed this close-particularly if
the cables are parallel to each other-the tool cable may become subject to electromagnetic interference.

CAUTION: Do not use the EnSite Precision™ Cardiac Mapping System in the presence of other magnetic fields.

CAUTION: Do not drop the EnSite Precision™ Field Frame or subject it to impact. Physical damage to the Field Frame may alter
the Field Frame's factory calibration.

CAUTION: Do not disconnect the EnSite Precision™ Field Frame from the system while tracking. Disconnecting the Field Frame
while in tracking mode may result in sparks being generated.

CAUTION: Do not expose or immerse the EnSite Precision™ system to liquids, or allow fluid to enter the equipment in any way.
Exposing the EnSite Precision™ system to liquids may result in equipment damage, produce a fire or shock hazard, and
result in possible personal injury.

CAUTION: Keep EnSite Precision™ Field Frame approximately 75cm away from any exposed ground planes to prevent interference
which may affect SE points and SE field scaling accuracy.
EnSite Precision™ Cardiac Mapping System Instructions for Use Chapter 1. Introduction
ARTEN600004505 Rev. B Best Practices and Recommendations
27

CAUTION: Disconnect power to the EnSite Precision™ system before cleaning it.

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

CAUTION: Do not autoclave any Precision system component. Autoclaving may damage the system.

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

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

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

Best Practices and Recommendations

Operating Environment. Ensure that the following requirements are maintained:

■ To protect the privacy and security of sensitive information, including protected health information (PHI), the system should be
located in a secured environment.
■ All system connections are in place, securely fastened, and functional.
■ Proper grounding and patient isolation standards are maintained.
■ Cables from catheters connected directly to the patient are placed to avoid inadvertent damage or unintentional movement.
■ Proper support equipment (e.g., defibrillation unit, ECG monitor, etc.) is on site for immediate response to patient distress.
■ Proper ventilation is present. The system components are not suitable for use in the presence of flammable gases, including
flammable anesthetic mixtures. Do not block the vents on the rear of the EnSite Precision™ Link, Sensor Enabled™ with drapes
or other materials.

NOTE: Refer to “Technical Specifications” on page 273 for specific environmental electromagnetic specifications and
recommendations.

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

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

■ Use properly grounded power outlets with appropriate circuit breaker ratings:
– Workstation and monitors: at least 8.0A at 110V , at least 4.0A at 230V .
– EnSite™ Amplifier: at least 4.0A at 110V , at least 2.0A at 230V .
■ The EnSite™ Amplifier should be turned on and allowed to run for at least 30 minutes before beginning a study.
 Chapter 1. Introduction EnSite Precision™ Cardiac Mapping System Instructions for Use
28 Best Practices and Recommendations ARTEN600004505 Rev. B

Compatible Components. The EnSite Precision™ Cardiac Mapping System has been tested to meet the safety requirements of IEC
60601-1 (refer to Table 40 on page 274). Use of components other than those specified by St. Jude Medical cannot be guaranteed to
perform as intended. These components have been tested to meet safety requirements:
■ EnSite Precision™ Display WorkStation (DWS)
■ EnSite™ Amplifier
■ Hospital grade power cord
■ RecordConnect
■ GenConnect
■ CathLink™ Module
■ ArrayLink™ Module
■ NavLink™ Module
■ SJM ECG Cable
■ EnSite™ Array™ Catheter
■ Fiber optic cable
■ EP WorkMate™ System 4.3.x
■ WorkMate Claris™ System 1.x
■ GE CardioLab
■ Bard ClearSign
■ Siemens AXIOM Sensis XP
■ EnSite Precision™ Module, Sensor Enabled™
■ EnSite Precision™ Surface Electrode Kit

Compatible Modules. The EnSite Precision™ Cardiac Mapping System is compatible with the following software modules:
■ AutoMark Module
■ EnSite™ AutoMap Module
■ EnSite™ Contact Force Module
EnSite Precision™ Cardiac Mapping System Instructions for Use
ARTEN600004505 Rev. B 29

Using the Graphical User CHAPTER 2

Interface

Operating Modes

The EnSite Precision™ Cardiac Mapping System can operate in two modes: Realtime and Offline Review. The operating mode
determines which system functions are available.
■ Realtime mode allows data to be gathered, displayed, and recorded simultaneously while a patient is being studied. Patient
connections to the EnSite Precision™ Cardiac Mapping System Amplifier are required, and the EnSite™ Amplifier must be
powered on.
■ Offline Review mode allows data from a previous study to be viewed and edited. The EnSite™ Amplifier does not need to be
connected or powered on.

The functions available in Offline Review mode are more limited than those available in Realtime mode. Table 2 on page 29 describes
the functions that are available in Realtime mode and Offline Review mode.

Table 2. Functions available in Realtime mode and Offline Review mode.

Task Realtime Offline Review

Setup All • Shows a historical view of the study setup.

• If viewing a segment or bookmark, shows the setup at the time
of capture.
• If viewing the static items (Model View, Images, or
Animations), shows the final state of the setup.
• Review the ECG signals and adjust the controls.
• Shows the catheters and traces used during the study.
• Select which catheters are visible.

Model All • Change surface colors, names, and visibility.

• Surface editing functions are not available.

Mapping Primary & Secondary View: Left Primary pane shows the • Open maps.
realtime study. Right Secondary pane shows either Realtime or • Review map points.
Review. (When Split Screen is active.)
• Collect points from the recorded catheter signal.

Therapy All • Review therapy data.

• Modify lesions.

Real • In Realtime mode, the Real Review task allows recorded data • In Offline Review mode, the Review task allows recorded data
Review from the study to be viewed. from a past study to be viewed and edited.
• Primary & Secondary View: Left Primary pane shows the • Primary & Secondary View: Left pane shows recorded data
realtime study. Right Secondary pane also shows the realtime from the past study selected in the Title screen. Right pane
study. You can switch between realtime and recorded shows a different view of the recorded data from the same past
information. study.

Status Bar Blue Brown

 Chapter 2. Using the Graphical User Interface EnSite Precision™ Cardiac Mapping System Instructions for Use
30 Main Workspace ARTEN600004505 Rev. B

Main Workspace
G Q
A F B
C
D E
H

I
K

J
L
N

O P

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

Table 3. Horizontal Split Screen Mode Elements

Callout Item Description

A Menu Bar Provides access to system-level controls. For more information, refer to “Menu Bar” on page 31.

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

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

D Active EnGuide Select the Active EnGuide.

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

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

G Split Screen View Switches between single and split screen views. Display two maps, each generated with a different set of mapping
points. The primary display contains the live map, while the secondary can display the same map, a second live map
generated with different mapping points, or a Review map. See “Split Screen” on page 40 for more information.

H Single/Dual View Toggles between single and dual map views. Refer to “Dual View” on page 39 for more information.
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Table 3. Horizontal Split Screen Mode Elements

Callout Item Description

I Orientation Shows the orientation of the map/model DIF.

Reference

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

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

L Tool Palette The tools that are available depend on the task that is enabled and the state of the procedure. Only one tool can be
selected at a time from the palette. For more information, refer to “Tool Palette” on page 33.

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

N Waveform Display The waveform display area.

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

P Bedside View Depending on the system setup, this control adjusts the bedside monitor display, so that different parts of the
workspace may be brought into view. This control will be present only if a remote monitor with a display of 1600 x
1200 (21inch) or less is part of the system setup.
An abbreviated view of the EnSite Precision™ Cardiac Mapping System displays because the lower resolution of the
21-inch bedside monitor can display only a portion of the higher resolution primary monitor.
• By default, the left portion of the primary monitor containing the model/mapping workspace displays on the bedside
monitor.
• The Bedside View button enables you to toggle the bedside monitor to display the left side (model/mapping) or the
right side (control panel) of the primary monitor screen.
• The Bedside View button can only be controlled in the lab or control room where the lab technician has access to
the mouse.

Q Control Panel Show/Hide Control Panel Toggle.

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

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

The EnSite Precision™ Cardiac Mapping System uses a video extender to transmit a video signal from the DWS to the remote monitor
over a fiber-optic cable. Refer to “Connecting the Remote Monitor to the DWS” on page 57 about how to connect the remote monitor
to the DWS.

Common Controls

Menu Bar
The menu bar provides access to system-level controls. All active menu bar and menu
options for the current operating mode are displayed in white lettering. Options not
available for the current operating mode are shown in gray lettering. Selecting a menu will Figure 6. The menu bar.
display a column of additional options. Menu options followed by three periods “...” will
display a window when selected.

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

NOTE: The underlined letters in the menu bar will be different, dependent on the translated language.
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The menu bar contents are described in Table 4 on page 32.

Table 4. Menu bar description.

Menu Submenu Function

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

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

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

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

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

Load DIF Import a three-dimensional model created from digital images collected from Spiral CT or
MRI for display in the EnSite Precision™ Cardiac Mapping System for display. See “Digital
Image Fusion (DIF)” on page 159 for more details.

Eject External Media Eject the CD/DVD.

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

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

Amplifier Settings... Access EnSite™ Amplifier controls:

• Saturation Recovery
• Power Line
• RecordConnect
• References

Log... Access the EnSite™ Amplifier log.

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

Reset Amplifier Reset and test the EnSite™ Amplifier.

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

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

Record <F4> Record/Stop recording.

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

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

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

Saturation recovery <F8> Initiate saturation recovery.

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

Cancel <F12> Discard the collect point.

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

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

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

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

The tool palette is shown in Figure 7. The available tools depends on the active task. The properties for a selected
tool display in the toolbar.
Table 5. Tool Palette

Callout Item Description

A
A Layout Preset Recall setting preferences for layout presets (see “Screen Layout Presets” on page 43).

B Magnifying Centers the model back into view, if it is beyond the borders of the screen. B
Glass
C
C Rotate/Pan The Rotate/Pan (hand) tool is used to rotate the model or map.

D Arrow Used for selection. D

E Label Used to annotate a model or map. For more information, refer to “Labels” on page 177. E
NOTE: The labels have no intrinsic meaning to the EnSite Precision™ Cardiac Mapping System.
Users can assign their own meaning to labels. F
F Anatomic Used to create anatomic markers. For more information, refer to “Anatomic Markers” on page 179.
Marker G

G Tape Measure Used to create tape measures. For more information, refer to “Tape Measures” on page 186. H
H Lesion Used to create lesions. For more information, refer to “Lesion Markers” on page 220.
I
I Virtuals (EnSite™ Array™ Catheter studies only) Used to place virtual electrodes on noncontact maps. For
more information, refer to “Virtuals” on page 191.
J
J EnGuide Used to place a shadow on the selected EnGuide. For more information, refer to “EnGuide
Shadow Shadows” on page 182. K
K Add a Caliper Add a timing caliper. L
L Cleanup Toggle: Show/Hide meters and controls in the Model/Map display area.
Display M
M Meter Clicking this icon displays a list of checkboxes that control the display of:
Displays • Velocity Meter (EnSite™ NavX™ Navigation and Visualization Technology only)
N
• Velocity Filter (EnSite™ NavX™ Navigation and Visualization Technology only)
• Respiration Meter (EnSite™ NavX™ Navigation and Visualization Technology) O
• Metal Distortion Meter (EnSite™ NavX™ Navigation and Visualization Technology, Sensor
Enabled™ only) P
• Voltage Caliper
• Tracking Virtual (ArrayLink™ Module only, RealReview)
• Electrode Spacing (EnSite™ NavX™ Navigation and Visualization Technology, Sensor Q
Enabled™ only)
• Proximity to Surface (realtime only) Figure 7. Tool
• Velocity Lockout Slider (EnSite™ NavX™ Navigation and Visualization Technology, Sensor palette.
Enabled™ only)
• Collect Respiration Data (EnSite™ NavX™ Navigation and Visualization Technology, Sensor
Enabled™ only).
For more information, refer to “Information Display Settings” on page 173.
NOTE: In an EnSite™ Array™ Catheter study, Velocity Filters, Meter Threshold, and Lockout
Settings are not available.

N EnGuide Displays a list of checkboxes that control the EnGuide Display options, including Show EnGuides,
Displays Electrode Numbers, Active EnGuide Silhouette, Stabilize ABL, and a slider control for EnGuide
Responsiveness. For more information, refer to “EnGuide Display Settings” on page 172.

O Display Map Settings Properties (see “Map Settings Properties” on page 171)
Settings
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Table 5. Tool Palette

Callout Item Description

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

Q Detection Configure signal detection settings (see “Signals Collection” on page 203).
Settings

Selecting Map Tags on the Model or Map

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

To select Map Tags in the Tool Palette:

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

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

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

To select Map Tags in a list:

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

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

Using the Mouse

Basic Mouse Actions
The following terms are used to describe ways to use the mouse:
■ Click – Move the mouse pointer over a specified feature and press the left mouse button once and release.
■ Right-click – Move the mouse pointer over a specified feature and press the right mouse button once and release to display a
context-sensitive menu.
■ Double click – Move the mouse pointer over a specified feature and quickly press and release the left mouse button twice.
■ Drag – Press and hold a mouse button, move the mouse, and release the button.
■ Select – “Select” is a generic term for selecting a specified feature by using the mouse. “Select” could refer to a single click on
an object, such as an on-screen button, choosing text from a list of options, or it could refer to clicking on an item in the menu bar,
highlighting a selection in the menu and clicking again.
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Rotating, Panning, and Zooming

Use the mouse to rotate, pan, and zoom a model/map:
■ To rotate the model/map in any direction, use the middle mouse button to click and drag in any direction. Alternatively, select the
Hand tool on the Tool Palette and then left click and drag in any direction.
■ To rotate the model/map clockwise or counterclockwise, hold down <Ctrl> or <Alt> and middle-click and drag clockwise or
counterclockwise. Alternatively, select the Hand tool on the Tool Palette, hold down <Ctrl> and click and drag clockwise or
counterclockwise.
■ To pan (move vertically and horizontally) the model/map, hold <Shift>, middle-click, and drag. Alternatively, select the Hand tool
on the Tool Palette, hold down <Shift>, and then click and drag. In Dual View, panning works independently for each model/map.
■ To zoom the model/map in and out at the mouse pointer position, hold down <Shift> and rotate the mouse middle wheel or select
the menu item in the Map Settings menu. In Dual View, zooming works independently for each model/map, unless synced/F3 is
active.

Use keyboard keys

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

Selecting and Adjusting Waveforms

Use the mouse to select and adjust waveforms:

NOTE: This does not apply to waveforms while in the Mapping task.
■ To add a temporary isoelectric line, left-click and hold on the waveform.
■ To add a permanent isoelectric line to a waveform, select the waveform, hold down <Shift> and left-click on the waveform.
■ To move a waveform, left-click on the waveform and drag up or down.
■ To remove a waveform from the waveform display, left-click on the waveform and drag it off the left edge of the screen.
■ Waveforms of a specific signal type are ganged so the amplitude for all will be adjusted. To adjust the amplitude of all waveforms,
middle-click on the waveform and drag up or down to increase or decrease the amplitude.
■ To adjust the amplitude of a single waveform, hold down <Shift> then middle-click and drag the waveform up or down.
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Common Interface Elements

A
The interface is controlled by using the mouse and keyboard to manipulate the
information that appears on the display. Figure 8 on page 36 shows examples of the
types of controls that are common throughout the interface.

A. Button. Click a button to initiate the action described by the button’s label. B C
Buttons are referred to in the text with the button’s label in brackets, such as “Click
[OK] to continue.” Some labels on buttons will change to reflect the buttons role in a
process. For example, in the Mapping control panel, clicking the propagation map
E
[Play] button changes the button to [Stop]. When the [Stop] button is clicked, it
changes to [Play]. The following buttons commonly appear at the bottom of
D
windows:
■ [OK] – When clicked, all the settings in the window are accepted, the required E
actions are performed, and the window closes.
■ [Apply] – When clicked, all the settings in the window are accepted, the required
actions are performed, and the window remains open.
E
■ [Cancel] – When clicked, settings that have not been applied are ignored, and
the window closes, without implementing changes.
■ [Close] – This button appears in windows with controls that take effect as soon E
as they are selected. When clicked, the window closes.
F
B. Checkbox. The item is selected when either a white check mark ✓
or ✕ is shown in the box. When the box is empty, the item is not selected. Click the
checkbox to select or unselect the item.

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

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

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

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

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

Lists. Lists display information that can be selected by clicking with the mouse. If a
list contains more information than will fit in the list, scrollbars appear on the right
or bottom edge of the list. Click and drag the scrollbars to move the information in
the list.
■ Select contiguous multiple items from a list by clicking and dragging in the list
or by clicking one item, pressing <Shift>, and then clicking another item to
select all items in between.
■ Select multiple individual items from a list by hold down <Shift> while clicking
on items in the list.
Figure 8. Common Controls.
Text areas. Text areas are for typing text using the keyboard. To use a text area, click
on the text area to display a cursor. Then, use the keyboard to type information into the text area.

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

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

NOTE: Refer to chapters “Mapping – Contact” on page 201 and “Mapping – Noncontact” on page 189 for information about
map types.

When the Mapping task is selected, the Mapping Settings appear in the control panel on
the right side of the main workspace. You can save these settings as “Presets” when you
anticipate using a particular setting often for future setups. A
B
When Split Screen is active, the settings apply to the display that has focus, which is
highlighted with a yellow border.

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

B. (Cardiac Triggered map settings)

■ Unipole/Bipole display. Only available if peak-to-peak or peak negative voltage maps
are selected.
■ Cardiac Triggered Reference ( (on) for LAT)
■ Current Map (LAT, Peak-to-Peak, Peak-Negative, CFE Mean, CFE Std. Dev)
■ Project Map to: Select the surface group you want to project the map to. D

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

C. Settings
– Low-V ID slider
– Map Display (Standard LAT, Reentrant Map, Propagation Map, [Play])
■ Map Display (Standard LAT, Reentrant Map, Propagation Map)

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

Interpolation)
■ Use Last Duplicate
■ Use Best Duplicate
■ Points/Labels (Show Selected Points Only, 3D Points, 3D Labels, 3D Annotations,
Surface Points, 3D Annotations, Flash New Points)
■ Appearance (Auto Color, Show HR/CL)

Complex Fractionated Electrograms (CFE) map settings

B. (Non Cardiac Triggered map settings)
■ Cardiac Triggered Reference ( (off) for CFE) Figure 9. Mapping control panel
– Current Map (CFE Mean, CFE Std Dev) for non-cardiac triggered map
settings.
C. Settings
– Low-V ID slider
– Fractionation Threshold checkbox
– Width slider
– Refractory slider
– Segment Length slider
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D. Map Appearance slider controls (Interior Projection, Exterior Projection, Interpolation)

– Use Last Duplicate/Use Best Duplicate radio buttons
■ Points/Labels (Show Selected Points Only, 3D Points, 3D Labels, 3D Annotations, Surface Points, Flash New Points)
■ Appearance (Auto Color, Show Mapping Metrics)
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Dual View
Dual View allows you to display two views of the same map. Using Dual View with Split Screen mode you can display two views of
the same map in either the primary or secondary display, or in both displays.

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

The following features are available only for the highlighted, active view:
■ Using the mouse to rotate the model
■ Adjusting the clipping plane
■ Adjusting the view scale
■ Saving or loading a Map View

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

C
A B

Figure 10. Dual View Mode

Table 6. Dual View Mode

Callout Description

A Primary View

B Secondary View

C Active View (framed with green brackets)

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Split Screen
(Available in all tasks except Setup.)

Split Screen mode allows you to display combinations of Realtime and Review maps, generated with the same or different mapping
points. You can:
■ Display the same map side-by-side in Realtime and Review workflows
■ Display two different maps, each generated with the same or different mapping points
■ Display one Realtime map (primary display) and one Realtime or Review map (secondary display)

NOTE: To visualize different screen arrangements, try a different screen layout preset (see “Screen Layout Presets” on page 43).

F
I E
G

A B

Figure 11. Split Screen

Manipulating the Windows:

■ The primary map displays on the left and the secondary map displays on the right
■ A yellow border highlights the active display
■ The Control Panel information and controls relate to the active display (the active map name displays at the Control Panel top)
■ Click within the inactive display to make it active
■ Change the size of the displays by dragging the adjustment bar (C) left or right.
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Window Elements
Table 7. Horizontal Split Screen Mode Elements

Callout Description

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

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

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

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

E Name of the active map.

F Toggle between single and split screen mode

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

H Mapping waveform display.

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

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

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

Choose from available content

■ Click the button in the desired empty window to place that content in the window (Figure 12: A).
■ When the content is placed, the button is removed. You can still select different content using the right-click menu of that window.
■ Only one type of content can exist within each display group.
■ If you choose content that exists in a different window, that content is swapped into the selected window.

Split existing windows

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

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

Close extra windows

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

B C

B C

B C

Figure 12. Default Window Layout

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Screen Layout Presets

■ The system provides basic display configuration presets that are accessed from the Layout Presets menu. These built-in presets
contain a map display and several blank windows to populate as desired.
■ You can also save a custom preset, as well as rename and delete the custom presets

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

C
D

Figure 13. Screen Layout Presets (Closeup View)

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Display Options
The following options are available from the right-click menu in the respective window:
■ Size, location, and content type of each window
■ Stack Waveform Display
– Font Size
– Sweep Speed
– Wave Thickness
■ Acquisition Waveform Display
– Font Size
– High/Low Lines setting (“Show All”, “Show Distal”, or “Hide All”)
– Sweep Speed
– Wave Thickness
■ Map Display
– Active EnGuide Silhouette (Off, Normal, Enhanced)
– CL/Metric display
– Visibility
– Flash for new points on/off
– Electrode spacing visibility
– Font Size
– Proximity Indicator
– Visibility
– Fixed on/off
– Proximity to Surface visibility (text display)
– Respiration Meter visibility
– Tracking Virtual visibility
– Velocity Meter visibility
– Voltage Caliper visibility

Load a Screen Layout Preset

1. Click the Screen Layout Preset button (Figure 13A).
2. Click a pre-defined blank layout, or a saved preset name (if available) (Figure 13 B).
■ The selected screen layout loads.
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3. Add or change content in the window:

■ Click a content button (D), in a blank window, or;
■ Right-click in the window and select the desired content from the Window menu selection (Figure 14).

Figure 14. Window Content Right-Click Menu

Save a Custom Preset

1. Configure the screen layout as desired, using the “Screen Layout Controls” on page 42.
2. Click the Screen Layout Preset button (Figure 13A).
3. Select Save Preset option.
4. Enter the name and click OK.

Manage a Custom Preset

This option allows you to rename a preset, as well as add notes or delete the preset.
1. Click the Screen Layout Preset button (Figure 13A).
2. Select the Manage Presets option.
3. Highlight the preset name, and click Rename, Delete, or enter text into the Notes field.
4. Click Close when finished.
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System Messages

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

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

NOTE: Access a list of Information and Advisory messages displayed during the study
by clicking on the Message Log icon in the status tray in the lower right portion
of the screen of Realtime and live studies only.
Figure 15. Information message.

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

NOTE: Access a list of Information and Advisory messages displayed during the study by
clicking on the Message Log icon in the status tray in the lower right portion of
the screen of Realtime and live studies only.
Figure 16. Advisory message.

System Busy Message

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

Figure 17. System Busy message.

Warning Message
Warning messages alert the user of an action that is going to occur and asks the user to verify
the action. The message must be acted upon before any other action can be taken on the system.
Figure 18. Warning message.
NOTE: Some warning messages can be disabled by checking the “Do not show this
message again” box; once this box is checked and the user clicks OK, the message
will no longer display for the remainder of the study session.
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Notebook

The Notebook feature is accessible in Realtime and Review.

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

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

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

▼ Order by Type
■ Animation
■ Bookmark
■ Mapping
■ Image Sequence
■ Segment
■ Stop Time
■ Auto Segment (System automatically adds)
■ Comment
■ Image
■ Model
■ StartTime

 Order by Time

For example:
– Autosegments (#)

B
– Events (#)
– Segments (#)
– Images (#)
– Bookmarks (#)
– Mapping (#)
– and others....

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

Figure 19. The Notebook control panel.

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Saving an Event
(Realtime mode and RealReview mode only)

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

NOTE: The key sequence for saving an event is <Ctrl> + <E>. The time is stamped
when the key sequence is executed.
1. From the menu bar, select File > Save Event. The Save Event window will appear
(Figure 20 on page 48).
2. Type the text of the annotation in the text area, and then click [Save].
Figure 20. The Save Event window.
Saving a Bookmark
(RealReview mode and Offline Review mode only)

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

NOTE: The key sequence for saving a bookmark is <Ctrl> + <B>. The time is stamped when the key sequence is executed.
1. If the segment is playing, pause it by clicking [ll].
2. From the menu bar, select File > Save Bookmark. The Save Bookmark window will appear.
3. Type the annotation for the bookmark in the text area, and then click [Save].
EnSite Precision™ Cardiac Mapping System Instructions for Use Chapter 2. Using the Graphical User Interface
ARTEN600004505 Rev. B Presets
49

Presets

Presets can be used in the Setup (Catheters), Model (Surfaces),

and Mapping (Controls) tasks to load a predefined set of:
■ EP catheters
■ Model surfaces
■ Mapping controls
■ Screen layouts

Although there are some differences in the use of presets in these

three areas, the basic ideas in their use are the same. See Figure 21
on page 49 for examples of model presets.

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

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

Rename or delete the current physician’s presets

■ Open the Preset menu and select Manage Presets.
■ To rename a preset, select the preset in the list then click the
[Rename] button (or double-click on the current preset
name) and type a new name in the [Name] text area.
■ Alternatively, double-click on the name in the list and type a
new name. A note can also be written in the Note text area.
■ To delete a preset, select a preset in the list then click
[Delete]. When renaming or deleting are complete, click
[Close].

Figure 21. Using presets.

 Chapter 2. Using the Graphical User Interface EnSite Precision™ Cardiac Mapping System Instructions for Use
50 Presets ARTEN600004505 Rev. B
EnSite Precision™ Cardiac Mapping System Instructions for Use
ARTEN600004505 Rev. B 51

External Connections CHAPTER 3

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

EnSite™ Amplifier Connections

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

Description

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

A. Status lights.

B. GenConnect connector.

C. EnSite™ NavLink™ Module connector.

D. EnSite™ CathLink™ Module OR RecordConnect connector.

E. SJM ECG Cable OR RecordConnect ECG cable connector.

F. ArrayLink™ Data Module connector.

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

RecordConnect connector.

H. Fiber-optic cable connectors.

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

I. Power switch.

J. AC power module with fuse holder.

K. Equipotential ground.

Figure 22. EnSite™ Amplifier connections.

 Chapter 3. External Connections EnSite Precision™ Cardiac Mapping System Instructions for Use
52 EnSite Precision™ Link, Sensor Enabled™ Connections ARTEN600004505 Rev. B

EnSite Precision™ Link, Sensor Enabled™ Connections

Description

The EnSite Precision™ Link, Sensor Enabled™ is used to

connect the EnSite Precision™ Field Frame, the patient
reference sensors (PRS), and catheters, to the EnSite™
Amplifier.
NOTE: When catheters or reference sensors are plugged or
unplugged from the Precision link, all catheters and reference
sensors will briefly reset to amber and metal distortion will be red
while the EnSite Precision™ link recognizes the new
configuration.

A. EnSite Precision™ Field Frame connector

B. EnSite Precision™ Patient Reference Sensor connectors

C. Catheter connectors

D. Input power connector

E. Fiber optic connector, to the EnSite™ Amplifier (connector

“H” Figure 22 on page 51)

Figure 23. EnSite Precision™ Link, Sensor Enabled™ connections.

EnSite Precision™ Field Frame Connections

Description

The EnSite Precision™ Field Frame connects to the EnSite

Precision™ Link, Sensor Enabled™.

A. Cable to the EnSite Precision™ Link, Sensor Enabled™.

Figure 24. EnSite Precision™ Field Frame connections.

EnSite Precision™ Cardiac Mapping System Instructions for Use Chapter 3. External Connections
ARTEN600004505 Rev. B NavLink™ Module Connections
53

NavLink™ Module Connections

Description

The NavLink™ Module is used to connect EnSite Precision™

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

A. System reference surface electrode connector.

B. EnSite Precision™ surface electrode connectors.

C. EnSite Precision™ left leg surface electrode with integrated

Data chip connector.

D. Auxiliary unipolar reference connector.

E. NavLink™ Module Cable to EnSite™ Amplifier.

Figure 25. NavLink™ Module connections.

ArrayLink™ Module Connections

Description

The ArrayLink™ Module is used to connect the EnSite™ Array™

Catheter and Data Module to the EnSite™ Amplifier.

A. Data Module connector from EnSite™ Array™ Catheter

cable.

B. EnSite™ Array™ Catheter cable connector.

C. Cable to EnSite™ Amplifier.

Figure 26. ArrayLink™ Module connections.

 Chapter 3. External Connections EnSite Precision™ Cardiac Mapping System Instructions for Use
54 CathLink™ Module Connections ARTEN600004505 Rev. B

CathLink™ Module Connections

Description

The CathLink™ Module is used to connect diagnostic catheters to

the EnSite™ Amplifier. The CathLink Module cannot be used if a
RecordConnect is used.

A. Catheter connectors.

B. Cable to EnSite™ Amplifier.

Figure 27. CathLink™ Module connections.

SJM ECG Cable Connections

Description

The SJM ECG Cable is used to connect standard ECG electrodes

to the EnSite™ Amplifier. Except for Bard Recording Systems, the
C ECG cable cannot be used if a Record Connect is used.

A. Chest & Limb leads.

B. ECG patch snap connectors.

A
B
C. EnSite™ Amplifier Connection.

Figure 28. SJM ECG Cable connections.

EnSite Precision™ Cardiac Mapping System Instructions for Use Chapter 3. External Connections
ARTEN600004505 Rev. B RecordConnect Connections
55

RecordConnect Connections

Description

RecordConnect is used to connect a recording system to the

EnSite™ Amplifier. When RecordConnect is used, the CathLink™
Module and the SJM ECG Cable are normally not used.

A different RecordConnect model is required for each make of

recording system. The RecordConnect for a particular make of
recording system is fitted with the correct number and type of
connectors.

A. Cables to the EnSite™ Amplifier.

B. CIM cable connectors. The number and type of connectors

depends on the make of the recording system.

C. ECG cable connector.

D. Cables to the recording system. The number of cables and

type of connectors on the cables depends on the make of the
recording system.

Figure 29. RecordConnect connections.

 Chapter 3. External Connections EnSite Precision™ Cardiac Mapping System Instructions for Use
56 GenConnect Connections ARTEN600004505 Rev. B

GenConnect Connections

Description

GenConnect is used to connect the ablation catheter and

dispersive surface electrodes to the EnSite™ Amplifier. It isolates
the EnSite Precision™ Cardiac Mapping System location signal
from the ablation generator.

A different GenConnect model is required for each make of

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

A. Dispersive patches IN connectors. The type of connector

depends on the make of the ablation system.

B. Ablation catheter IN connector. The type of connector

depends on the make of the ablation catheter.

C. Ablation catheter OUT connector.

D. Dispersive patches OUT connector.

E. Cable to the EnSite™ Amplifier.

Figure 30. GenConnect connections.

Connecting the EnSite™ Amplifier to the DWS

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

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

Connecting the Local Monitor to the DWS

The local monitor is connected to the DWS using a digital video connector cable Connect one end of the cable to the digital video
connector on the back of the DWS, and connect the other end to the connector on the rear of the monitor. Hand-tighten the connector
thumb screws at each end.
EnSite Precision™ Cardiac Mapping System Instructions for Use Chapter 3. External Connections
ARTEN600004505 Rev. B Connecting the Remote Monitor to the DWS
57

Connecting the Remote Monitor to the DWS

The remote monitor is connected to the DWS by means of a video extender. Two type of video extenders available: Opticis and
Avenview. The procedure used to connect the remote monitor to the DWS depends on the video extender being used. Refer to one of
these procedures:
■ “Opticis Video Extender” on page 57.
■ “Avenview Video Extender” on page 59.

Opticis Video Extender

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

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

1. Connect the MONITOR(Rx) video extender to the remote monitor (see Figure
31 on page 57):
a. Connect one end of the fiber optic cable to the MONITOR(Rx) video
extender, and the other end to the COMPUTER(Tx) video extender.
b. Plug the 5VDC Power Adapter into a power source and then into the video
extender. The blue LED will illuminate.
c. Connect the MONITOR(Rx) video extender to the remote monitor’s DVI
input connector. (See Figure 31.)

Table 8. Remote Monitor Connections

A DVI Input

B Video Extender — MONITOR (Rx)

C Fiber Optic Cable

D 5V DC Power Cable Figure 31. Remote Monitor Connections.

 Chapter 3. External Connections EnSite Precision™ Cardiac Mapping System Instructions for Use
58 Connecting the Remote Monitor to the DWS ARTEN600004505 Rev. B

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

a. Plug the 5VDC Power Adapter into a power source and then into the video extender. The blue LED (C) will blink twice, then
remain lit.
– Connect the DVI converter cable to the COMPUTER(Tx) video extender, then connect the DVI converter cable (E) to
the display port on the workstation (F).

A B
C
D
F

Figure 32. Opticis Video Extender and Workstation Remote Monitor Connection.

Table 9.

Figure 32. Workstation Remote Monitor Connections.

A 5V DC Power Cable

B Fiber Optic Cable

C Blue LED

D Opticis Video Extender

E DVI Converter Cable

• Plug into the Display Port labeled “REM”, next to the arrow symbol

F Display Port

3. Start the workstation. The same video should display on both the Primary Monitor and on the Remote Monitor.
4. Follow the steps in “Using the Remote Monitor Configuration Tool” on page 61 to configure the remote monitor.

NOTE: Avoid wear and tear on the fiber optic video cable connections by only handling the (Opticis) video extenders by the
black chassis. Avoid repeatedly disconnecting and re-connecting the fiber optic video cable connectors.
EnSite Precision™ Cardiac Mapping System Instructions for Use Chapter 3. External Connections
ARTEN600004505 Rev. B Connecting the Remote Monitor to the DWS
59

Avenview Video Extender

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

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

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

1. Configure the COMPUTER video extender:
A
a. Power on the Remote Monitor.
b. Connect the COMPUTER video extender to the Remote Monitor’s DVI input.
c. Plug the 5VDC Power Adapter into the COMPUTER video extender. (See Figure 33).
C
d. Observe the red LED on the Video Extender. It should turn on immediately after the
5VDC Power Adapter is connected, turn off momentarily, then turn back on. This B
sequence indicates that the Video Extender has read the data that it needs from the
Remote Monitor to allow the Workstation to correctly identify the Remote Monitor’s
characteristics.
e. Disconnect the 5VDC Power Adapter from the COMPUTER video extender, and
then remove the video extender from the Remote Monitor. E D
Table 10.

Figure 33. Configuring the COMPUTER Video Extender.

A DVI Input Figure 33. Configuring the

COMPUTER Video Extender.
B Video Extender — COMPUTER

C Red LED

D 5V DC Power Cable

E Fiber Optic Cable

2. Connect the MONITOR video extender to the remote monitor (see Figure 34):
a. Plug the 5VDC Power Adapter into a power source and then into the video extender.
b. Connect the video extender to the remote monitor’s DVI input connector.
Table 11.

Figure 34. Remote Monitor Connections.

A DVI Input

B Video Extender — MONITOR

C Red LED

D 5V DC Power Cable

E Fiber Optic Cable

3. Connect the DVI converter cable to the COMPUTER video extender, then connect the
DVI converter cable (D) to the workstation display port (E). (See Figure 35 on page 60.) Figure 34. Remote Monitor
Connections.
4. Connect one end of the fiber optic cable to the MONITOR video extender, and the other
end to the COMPUTER video extender.
 Chapter 3. External Connections EnSite Precision™ Cardiac Mapping System Instructions for Use
60 Connecting the Remote Monitor to the DWS ARTEN600004505 Rev. B

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

A B

C E

Figure 35. Avenview Video Extender and Workstation Remote Monitor Connection.

Table 12.

Figure 35 Workstation Remote Monitor Connections.

A 5V DC Power Cable

B Fiber Optic Cable

C Avenview Video Extender

D DVI Converter Cable

• Plug into the Display Port labeled “REM”, next to the arrow symbol

E Display Port

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

NOTE: If the Remote monitor fails to display properly after the reboot, refer to “Using the Remote Monitor Configuration Tool”
on page 61.
EnSite Precision™ Cardiac Mapping System Instructions for Use Chapter 3. External Connections
ARTEN600004505 Rev. B Using the Remote Monitor Configuration Tool
61

Using the Remote Monitor Configuration Tool

Follow these steps to configure the Remote Monitor:

1. Login as the EnSite Precision™ Cardiac Mapping System user.
2. Click the [Services] button.
3. On the Services tab, click the [Configure Remote Monitor button].
4. Select the remote monitor from the {Select a Monitor] drop-down menu, and click [OK].

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

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

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

NOTE: The DWS detects monitors and video extenders that are connected to it during the boot process. Any monitors or video
extenders that are not connected during the boot process will not have their video signals enabled by the DWS (i.e. you
will not see anything on the monitor.)
 Chapter 3. External Connections EnSite Precision™ Cardiac Mapping System Instructions for Use
62 Connecting Cables to the EnSite™ Amplifier ARTEN600004505 Rev. B

Connecting Cables to the EnSite™ Amplifier

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

Figure 36. Connecting a cable to and disconnecting a cable from the EnSite™ Amplifier.
■ To connect a cable to the EnSite™ Amplifier (Figure 36 above), align the dot on the cable connector with the arrow on the
EnSite™ Amplifier connector and push the cable connector onto the EnSite™ Amplifier connector until a click is heard.
■ To disconnect a cable from the EnSite™ Amplifier (Figure 36 above), turn the locking ring on the cable connector
counterclockwise and pull the cable connector off of the EnSite™ Amplifier connector.

Color-Coded Connections
The cable connectors and the EnSite™ Amplifier connections are color coded and labeled with identical icons on each, for easy
identification. The icons and color codes are described in Table 13 below.

Table 13. EnSite Amplifier cable connector icons and colors.

Icon Connector Color Function

Black GenConnect

Green NavLink™ Module

Yellow CathLink™ or RecordConnect catheter

Blue ECG or RecordConnect ECG

White ArrayLink™ Data Module

Yellow ArrayLink™ Module, CathLink™ Module, or

RecordConnect Catheter

Figure 37. The EnSite™ Amplifier Panel Connectors

EnSite Precision™ Cardiac Mapping System Instructions for Use Chapter 3. External Connections
ARTEN600004505 Rev. B Connecting a System Reference Surface Electrode
63

Connecting a System Reference Surface Electrode

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

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

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

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

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

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

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

The numbered steps in the following procedure correspond to the numbered callouts in Figure 38 on page 63.
1. Place the system reference surface electrode on the patient’s abdomen (Figure 38 on page 63).
2. Connect the system reference surface electrode lead to the Sys-Ref connector on the NavLink™ Module.
3. Connect the NavLink™ Module cable to the green NavLink™ Module connector on the EnSite™ Amplifier.

Figure 38. Connecting the system reference surface electrode.

 Chapter 3. External Connections EnSite Precision™ Cardiac Mapping System Instructions for Use
64 Connecting the EnSite Precision™ Patient Reference Sensors (PRS) ARTEN600004505 Rev. B

Connecting the EnSite Precision™ Patient Reference Sensors (PRS)

Patient Reference Sensors

The EnSite Precision™ Module includes two (2) Patient Reference Sensors that are held in place on the body with disposable, self-
adhesive patches, which are supplied in the EnSite Precision™ Surface Electrode Kit.

PRS Locations
■ The patch must be placed with the PRS wire channel pointed toward the patient’s head.
■ Center one patch and PRS on the patient’s chest above the pectorals. Once a procedure begins, this PRS becomes the PRS-A (PRS-
Anterior).
■ Center one patch and PRS on the patient’s upper back, between the shoulder blades. Once a procedure begins, this PRS becomes
the PRS-P (PRS-Posterior).
■ Route both PRS cables up to the patient’s shoulder, then down along the patient’s side, to the location of the EnSite Precision™
Link, Sensor Enabled™.

Patient Reference Sensor and Patch Placement

Perform this procedure to place both the front (PRS-A) and the back (PRS-P) sensors and patches. The numbered steps in the procedure
correspond to the numbered callouts in Figure 39 on page 65.
1. Prepare and clean the patient.
2. Remove the large white liner from the underside of the patch, exposing the adhesive.
3. Place a front and a back patch on the patient, as described above and shown in Figure 39 on page 65.

NOTE: Avoid removing and repositioning the patch.

4. For each of the two patches, remove the gold liner from the front of the patch, exposing the adhesive. This is where the electrode
will be placed.
5. For each of the two sensors, place one on each patch’s adhesive area.

NOTE: Avoid removing and repositioning the PRS.

6. Connect each PRS lead to a REF connector on the EnSite Precision™ Link, Sensor Enabled™.

Patch Removal
7. Peel off each patch from the body, leaving the PRS attached, using the white foam pull tab.
8. Release the PRS from the patch by grasping the white foam pull tab and the colored pull tab, and pulling the two tabs in opposite
directions.
– The sensor will release from the patch. Dispose of the patch and clean the PRS according to the instructions in “EnSite
Precision™ Patient Reference Sensors (PRS)” on page 261.
EnSite Precision™ Cardiac Mapping System Instructions for Use Chapter 3. External Connections
ARTEN600004505 Rev. B Connecting the EnSite Precision™ Patient Reference Sensors (PRS)
65

Figure 39. Patient Reference Sensor and Patch Placement

 Chapter 3. External Connections EnSite Precision™ Cardiac Mapping System Instructions for Use
66 Connecting the EnSite Precision™ Field Frame ARTEN600004505 Rev. B

Connecting the EnSite Precision™ Field Frame

EnSite Precision™ Field Frame Assembly

The EnSite Precision™ Module includes one Field Frame assembly, which must be assembled before first use, and one bracket, which
attaches the Field Frame to the edges of the table. The Field Frame placement is adjustable and allows for side-to-side as well as head-
to-toe movement. Two levers on the side of the Frame lock it into position after alignment.

Figure 40. EnSite Precision™ Field Frame Assembly

EnSite Precision™ Field Frame Parts List

The EnSite Precision™ Field Frame assembly box includes the following parts:

Table 14.

Number Quantity Part

1 8 M8 Nylon Screws

2 1 Left Side Rail

3 1 EnSite Precision™ Field Frame

4 1 Right Side Rail

5 2 Lock Levers

6 2 Safety Stop Lever

n/a 1 #8 Metric Hex Wrench

EnSite Precision™ Cardiac Mapping System Instructions for Use Chapter 3. External Connections
ARTEN600004505 Rev. B Connecting the EnSite Precision™ Field Frame
67

Assemble the Field Frame

NOTE: This assembly procedure takes approximately 15 minutes. A #8 metric hex wrench, included, is also needed to assemble
the Field Frame.
1. Use 4 M8 nylon screws (1) to attach the left side rail (2) to the end of the Frame that does not include a cable connector.

NOTE: The left and right side rails will not properly fit onto the Frame if reversed. The right side rail accommodates the
connector on the right side of the Frame, and also includes two locking levers.

CAUTION: Snugly hand-tighten the screws with the hex wrench. Do not over-tighten, as the screw may break off inside the Frame.
2. Use the remaining 4 M8 nylon screws to attach the right side rail to the end of the Frame that includes the Precision™ Link,
Sensor Enabled™ cable connector (4).
3. Place the Field Frame assembly in a safe location while attaching the bracket to the table, below.

Attach the Bracket to the Table

The Field Frame Bracket spreads apart and clamps to the sides of the table, using tension created by stretching the O-rings that hold
the bracket together. No tools are needed to attach the bracket.

NOTE: Center the bracket under the patient’s heart for best results. To reposition the bracket when the EnSite Precision™ Frame
is attached, first unlock the frame, then move the bracket as described below. Lock the Field Frame after repositioning
the bracket (see “Attach the EnSite Precision™ Field Frame to the Bracket” on page 68).

Figure 41. Field Frame Table Bracket Attachment

1. Grasp one end of the bracket with two hands.
2. Hook the end of the bracket onto the opposite edge of the table.
3. Pull the end of the bracket toward you and release and hook the other end of the bracket onto the closest edge of the table.
■ The bracket is spring-tensioned and clamps onto the table edges when carefully released.

NOTE: It is possible to spread the bracket apart so that the two halves separate, causing the alignment rods to become unseated.
If this happens, place the bracket on the floor and lightly hold one end on the floor with your feet. Pull the other half up
and re-seat the rods into the holes.
 Chapter 3. External Connections EnSite Precision™ Cardiac Mapping System Instructions for Use
68 Connecting the EnSite Precision™ Field Frame ARTEN600004505 Rev. B

Attach the EnSite Precision™ Field Frame to the Bracket

Figure 42. Slide the EnSite Precision™ Field Frame Into the Bracket
1. Turn the two lock levers on the side of the Field Frame assembly down (Figure 42), to the unlocked position (see the Lock icon
next to the levers).
2. Grasp the Field Frame with two hands and align to the runners on the underside of the bracket (Figure 42), orienting the Frame
toward the patient’s head, as shown on the Patient Orientation label attached to the Field Frame (see Figure 42). The cable
connector end of the Field Frame must be positioned toward the patient’s feet.
3. Slide the Field Frame into the brackets until it stops at the safety stop (Figure 42 & Figure 41).
4. Slide the safety stop levers (one on each end) down and slide the Field Frame into position (Figure 43).

Figure 43. Safety Stop Lever

5. Turn the two lock levers up to lock the Field Frame into position (Figure 43).
EnSite Precision™ Cardiac Mapping System Instructions for Use Chapter 3. External Connections
ARTEN600004505 Rev. B Connecting the EnSite Precision™ Field Frame
69

NOTE: The EnSite Precision™ Field Frame must be locked into place before use

Figure 44. EnSite Precision™ Field Frame Connected to the EnSite Precision™ Link., Sensor Enabled™
6. Attach one end of the cable to the Field Frame connector (Figure 44).
7. Route the cable beneath the table and attach the free end to the connector on the left side of the EnSite Precision™ Link, Sensor
Enabled™.

CAUTION: Do not coil the EnSite Precision™ Field Frame cable. The cable carries enough electric current that a magnetic field will
be created when the cable is placed in a circular formation. This magnetic field may disturb the Field Frame's magnetic
field.

CAUTION: Do not place the EnSite Precision™ Link, Sensor Enabled™ within 1 m of the EnSite Precision™ Field Frame.

CAUTION: Metallic equipment used in close proximity to the magnetic field during the procedure, such as a sterile drape holder,
may affect SE points and SE field scaling accuracy.

CAUTION: Do not place tool cables within 30 mm of the EnSite Precision™ Field Frame cable. If placed this close — particularly
if the cables are parallel to each other — the tool cable may become subject to electromagnetic interference.

CAUTION: Keep the EnSite Precision™ Field Frame approximately 75cm away from any exposed ground planes to prevent
interference that may affect SE points and SE field scaling accuracy.
 Chapter 3. External Connections EnSite Precision™ Cardiac Mapping System Instructions for Use
70 Performing an EnSite Precision™ Module Functional Check ARTEN600004505 Rev. B

8. Connect the external power supply provided with the EnSite Precision™ Link to the back of the Link.
9. Connect the power supply to a power outlet.

Figure 45. EnSite Precision™ Link., Sensor Enabled™ Power Supply Connections

Performing an EnSite Precision™ Module Functional Check

After connecting the EnSite Precision™ Link, Sensor Enabled™

and attaching the EnSite Precision™ Field Frame to the table,
perform this check to confirm that the system is properly
functioning.
1. Connect a PRS (Patient Reference Sensor) to each of the
two REF ports on the Precision Link.

Figure 46. EnSite Precision™ Link, Sensor Enabled™, Showing

PRS Connections
EnSite Precision™ Cardiac Mapping System Instructions for Use Chapter 3. External Connections
ARTEN600004505 Rev. B Performing an EnSite Precision™ Module Functional Check
71

2. Turn on the DWS.

3. Log in to the EnSite™ Cardiac Mapping System (see
“Logging In” on page 109).
4. Start a new study.
5. Select or create a placeholder patient and click Next.
6. In the NavX SE drop-down menu, select NavX SE, and
click Begin Study.
7. Select the NavX SE Source tab.
8. Position each PRS above the EnSite Precision™ Field
Frame at two separate heights.
■ The Indicators turn green to confirm that the PRS is inside
the detection area of the Field Frame.

Figure 47. Functional check showing Patient Reference Sensors

inside the detection area and the Indicators green
9. Position each PRS outside the Field Frame to confirm that
the Indicators turn amber.
■ The Indicators turn amber to confirm that the PRS is outside
the detection area of the EnSite Precision™ Field Frame.

NOTE: If the Indicators display as described above, the

functional check is successful. Contact SJM
Customer Service if the check failed.

Figure 48. Functional check showing Patient Reference Sensors

outside the detection area and the Indicators amber
 Chapter 3. External Connections EnSite Precision™ Cardiac Mapping System Instructions for Use
72 Connecting EnSite™ Surface Electrodes ARTEN600004505 Rev. B

Connecting EnSite™ Surface Electrodes

Surface Electrode Description

■ The shape of the electrode may vary depending on which kit you have; all electrode shapes are functionally equivalent.
■ The electrodes are color-coded and have a placement diagram printed on the surface.

Placement Considerations
When placing the EnSite™ surface electrodes on the patient, it is important to place them in the correct position, not only in
relationship to each other, but also in relationship to other surface electrodes placed for other purposes (see Figure 49).

Skin preparation
Good skin preparation is essential to all electrophysiology studies. Adhering to the steps below helps minimize the noise related to
surface patch placement during EnSite Velocity System procedures.
1. Trim excess hair from all locations where surface electrodes and patches will be used.
2. Prepare the skin surface where ECG and surface electrodes will be placed using the following technique:
a. Gently abrade the skin using a gauze pad or like material, or using a gel prep (such as Omni Prep) that contains small particles
of gritty material. Make sure that all the gel material is removed from the skin.
b. Clean the surface with soap and water after the skin has been abraded.

NOTE: Avoid cleaning with isopropyl alcohol unless the skin is excessively oily or covered with lotion.
c. Ensure that the skin is completely dry and that all alcohol has evaporated before placing any surface patches.

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

Anterior (Chest) and Posterior (Back) Electrodes

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

Right and Left Electrodes

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

Neck and Left Leg Electrodes

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

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

NOTE: The rectangular version front surface electrode has cutouts to allow ECG surface electrode positioning. The V2 ECG
surface electrode should be placed before the front surface electrode is placed. Refer to “Connecting ECG Surface
Electrodes” on page 75 for more information.
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ARTEN600004505 Rev. B Connecting EnSite™ Surface Electrodes
73

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

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

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

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

Surface Electrode Placement

“X” indicates the location of the surface electrode.

Correct Placement

Caudal Views of Thorax

Incorrect Placement

Figure 49. Placement of Surface Electrodes.

 Chapter 3. External Connections EnSite Precision™ Cardiac Mapping System Instructions for Use
74 Connecting EnSite™ Surface Electrodes ARTEN600004505 Rev. B

Surface Electrode Placement Order

The numbered steps in the following procedure correspond to the numbered callouts in Figure 50.
1. Position the ECG surface electrodes on the patient. Proper placement of the V2 ECG surface electrode is important. For more
information about placing ECG electrodes, refer to “Connecting ECG Surface Electrodes” on page 75.
2. Place each surface electrode on the patient as per the illustration printed on the back of the surface electrode. Proper surface
electrode placement is important. See Figure 49 on page 73 for proper placement. The orientation of the surface electrode leads
is not important.
3. Connect each surface electrode lead to its matching color-coded connector on the NavLink™ Module.
4. Connect the NavLink™ Module cable to the green NavLink™ Module connector on the EnSite™ Amplifier.

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

Figure 50. surface electrode placement order. The dashed lines indicate electrode fields.
EnSite Precision™ Cardiac Mapping System Instructions for Use Chapter 3. External Connections
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75

Connecting ECG Surface Electrodes

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

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

NOTE: For EnSite™ NavX™ Navigation and Visualization Technology studies, a set of ten ECG surface electrodes is included
in the EnSite Precision™ Surface Electrode Kit. Place ECG surface electrodes within the front EnSite Precision™
surface electrode (Figure 51 on page 75). Placing the ECG surface electrodes on the patient in the following order may
prove to be the most efficient:
1. Place the V2 ECG surface electrode at the 4th intercostal space, left sternal edge.3
2. Place the front surface electrode.
3. Place the remaining ECG surface electrodes.

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

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

Figure 51. ECG Surface Electrode Placement .

3. “Guidelines For Recording A 12 Lead Electrocardiogram (ECG),” South Durham Health Care NHS Trust.
 Chapter 3. External Connections EnSite Precision™ Cardiac Mapping System Instructions for Use
76 Connecting ECG Surface Electrodes ARTEN600004505 Rev. B

Connecting ECG Surface Electrodes When Using a RecordConnect

The numbered steps in this procedure correspond to the numbered callouts in Figure 52.
1. Connect the standard ECG surface electrodes to the patient in the typical 12-lead configuration.
2. Connect the ECG surface electrodes to the recording manufacturer’s ECG cable.
3. Connect the recording manufacturer’s ECG cable to the ECG connector on the RecordConnect.
4. Connect the ECG interconnect on the RecordConnect to the recording system.
5. Connect the ECG cable on the RecordConnect to the blue connector on the EnSite™ Amplifier.

Figure 52. ECG surface electrode connections when using a RecordConnect.

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ARTEN600004505 Rev. B Connecting ECG Surface Electrodes
77

Connecting ECG Surface Electrodes When Not Using a RecordConnect

The numbered steps in this procedure correspond to the numbered callouts in Figure 53.
1. Connect the standard ECG surface electrodes to the patient in the typical 12-lead configuration.
2. Labels identify the proper connections for each surface electrode: RL – right leg, LL – left leg, RA – right arm, LA – left arm,
V1: right-most chest surface electrode, through V6: left-most chest surface electrode.

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

Figure 53. ECG surface electrode connections when not using a RecordConnect.
 Chapter 3. External Connections EnSite Precision™ Cardiac Mapping System Instructions for Use
78 Connecting an RF Ablation Catheter and Generator ARTEN600004505 Rev. B

Connecting an RF Ablation Catheter and Generator

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

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

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

NOTE: The procedure described here and the accompanying diagram (Figure 54) are generic. The specific connections required
to connect an ablation system depend on the brand of ablation system being used.

Figure 54. Basic connections when using the GenConnect.

The numbered steps in the following procedure correspond to the numbered callouts in Figure 54.
1. Connect the ablation catheter extension cable to the Ablation Catheter cable connector IN on the GenConnect.
2. Connect the dispersive patches cable to the Dispersive Patches cable connector IN on the GenConnect.
3. Connect one end of the St Jude Medical (SJM™) catheter interconnect cable to the Ablation Catheter cable OUT connector on
the GenConnect and the other end to the RF ablation generator.
4. Connect one end of the SJM™ dispersive interconnect cable to the GenConnect Dispersive cable OUT connector on the
GenConnect and the other end to the RF ablation generator.
5. Connect one end of the SJM™ interconnect cable to the EnSite™ Amplifier connection on the GenConnect module and the
other end to the EnSite™ Amplifier.
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ARTEN600004505 Rev. B Connecting Diagnostic Catheters
79

Connecting Diagnostic Catheters

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

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

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

NOTE: Catheter polarity and waveform display are controlled in the software. See “EP Catheter Setup” on page 119.”

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

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

Figure 55. CathLink™ Module - In an EnSite™ Array™ Catheter Study only the first 28 channels can
be used for locating electrodes.
 Chapter 3. External Connections EnSite Precision™ Cardiac Mapping System Instructions for Use
80 Connecting the EnSite™ Array™ Catheter ARTEN600004505 Rev. B

Connecting the EnSite™ Array™ Catheter

(EnSite™ Array™ Catheter studies only)

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

Figure 56. The ArrayLink™ Module clamping position

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

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

The numbered steps in the following procedure correspond to the numbered callouts in Figure 57 on page 80.
1. Align the EnSite™ Array™ Catheter connector so that the plastic chain connecting the Data Module is facing to the left and
gently press the connector into the EnSite™ ArrayLink™ Module connector on the ArrayLink™ Module. The latch on the
ArrayLink™ Module will lock the connection in place.

2. Connect the Data Module to the Data Module connector on the ArrayLink™ Module. The Data Module is tethered to the
EnSite™ ArrayLink™ Module connector.
3. Connect the large yellow connector on the ArrayLink™ Module to the yellow ArrayLink™ Module connection on the far right
side of EnSite™ Amplifier.
4. Connect the small white connector on the ArrayLink™ Module cable to the white Data Module connection on the EnSite™
Amplifier.

Figure 57. An EnSite™ Array™ Catheter connector and Data Module connected to the ArrayLink™ Module.
EnSite Precision™ Cardiac Mapping System Instructions for Use Chapter 3. External Connections
ARTEN600004505 Rev. B Connecting an Auxiliary Unipolar Reference
81

Connecting an Auxiliary Unipolar Reference

The unipolar reference is the zero potential reference for unipolar diagnostic catheters and EnSite™ Array™ Catheter signals.
■ For EnSite™ Array™ Catheter studies, the default unipolar reference is the most proximal ring electrode (E3) on the EnSite™
Array™ Catheter.
■ For EnSite™ NavX™ Navigation and Visualization Technology, Sensor Enabled™ studies, the default unipolar reference is the
System Reference.

To use an Auxiliary Unipolar Reference:

NOTE: The Auxiliary Unipolar Reference electrode needs to be stationary throughout the study.
1. Place the electrode of the diagnostic catheter to be used as the unipolar reference within the blood pool, but outside of all
chambers of interest. Connect the lead of this electrode to the Aux Ref connector on the NavLink™ Module.
2. From the menu bar, select Amplifier > Settings > References, and check the Auxiliary checkbox.

Figure 58. Connecting a diagnostic catheter electrode being used as a unipolar reference.
 Chapter 3. External Connections EnSite Precision™ Cardiac Mapping System Instructions for Use
82 Using a Recording System ARTEN600004505 Rev. B

Using a Recording System

There are two methods of using the EnSite Precision™ Cardiac Mapping System with a conventional recording system. The first
method offers a convenient means of making patient connections, but is dependent on the type of recording system. The second method
offers a universal means of using any recording system, but requires more manual connections. These methods are described here and
illustrated in Figure 61 on page 85.

Method 1 uses a recording system RecordConnect, which routes the ECG and EP catheter signals from the patient to both the EnSite™
Amplifier and the recording system, thereby eliminating the need for a second set of ECG surface electrodes and the use of jumper
cables to share intracardiac signals.
■ The ECG surface electrode leads are connected to the recording system ECG cable, and the ECG cable is normally connected to
the RecordConnect. The RecordConnect routes the ECG signals from the patient to the EnSite™ Amplifier and the recording
system.
■ The EP catheters are connected to the recording system CIM, and the CIM is connected to the RecordConnect. The
RecordConnect routes the EP catheter signals from the patient to the EnSite™ Amplifier and the recording system.

Method 2 uses a CathLink™ Module catheter input module, an SJM ECG Cable, a second set of ECG surface electrodes, and jumper
cables.
■ One set of ECG surface electrode leads is connected to the SJM ECG Cable, and the SJM ECG Cable is connected to the EnSite™
Amplifier. The second set of ECG surface electrode leads is connected to the recording system.
■ The EP catheters are connected to the recording system and jumpered to a CathLink™ Module. The CathLink™ Module routes
the EP catheter signals from the recording system to the EnSite™ Amplifier.
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ARTEN600004505 Rev. B Using a Recording System
83

Connecting Diagnostic Catheters When Using a RecordConnect

NOTE: The procedure described here and the accompanying diagram (Figure 59 on page 83) are for a generic RecordConnect.
The actual connections required to connect a RecordConnect depend on the brand of recording system being used.
Contact SJM for a list of available RecordConnect modules.

The numbered steps in the following procedure correspond to the numbered callouts in Figure 59 on page 83.
1. Connect the diagnostic catheter electrode leads to the recording system manufacturer’s CIM.
2. Connect the recording system manufacturer’s CIMs to the CIM input connectors on the RecordConnect.
3. Connect the CIM interconnect cables on the RecordConnect to the recording system.
4. Connect the CIM cables on the RecordConnect to the yellow RecordConnect connectors on the EnSite™ Amplifier.

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

Figure 59. Diagnostic catheter connections when using a RecordConnect.

 Chapter 3. External Connections EnSite Precision™ Cardiac Mapping System Instructions for Use
84 Using a Recording System ARTEN600004505 Rev. B

Connecting Diagnostic Catheters When Not Using a RecordConnect

The numbered steps in the following procedure correspond to the numbered callouts in Figure 60 on page 84.
1. Connect the diagnostic catheter leads to the CathLink™ Module.
2. Connect the CathLink™ Module cable to the yellow CathLink™ Module connector on the EnSite™ Amplifier.

Figure 60. Diagnostic catheter connections when not using a RecordConnect.

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ARTEN600004505 Rev. B Using a Recording System
85

Figure 61. Using a recording system with and without RecordConnect.

 Chapter 3. External Connections EnSite Precision™ Cardiac Mapping System Instructions for Use
86 Using a Recording System ARTEN600004505 Rev. B
EnSite Precision™ Cardiac Mapping System Instructions for Use
ARTEN600004505 Rev. B 87

Preparing for a Study CHAPTER 4

Preparing for an EnSite™ NavX™ Navigation and Visualization Technology

Study

Refer to “Using a Recording System” on page 82 for more information.

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

EnSite™ NavX™ Navigation and Visualization Technology Study with RecordConnect

An EnSite™ NavX™ Navigation and Visualization Technology study that uses RecordConnect requires the following:
■ EnSite Precision™ surface electrodes
■ System reference surface electrode
■ NavLink™ Module
■ Diagnostic catheters
■ ECG surface electrodes
■ RecordConnect
■ Ablation catheter and generator
■ Dispersive surface electrodes
■ GenConnect

Figure 62 on page 88 illustrates the basic components and connections required for an EnSite™ NavX™ Navigation and Visualization
Technology study that uses RecordConnect.

Table 15 on page 89 describes the basic tasks required in an EnSite™ NavX™ Navigation and Visualization Technology study.
 Chapter 4. Preparing for a Study EnSite Precision™ Cardiac Mapping System Instructions for Use
88 Preparing for an EnSite™ NavX™ Navigation and Visualization ARTEN600004505 Rev. B

Figure 62. The basic components and connections for an EnSite™ NavX™ Navigation and Visualization Technology study when

* The physical location of the fiber optic cable connections, on the front panel of the EnSite™ Amplifier, may be located on the right
side of the panel (as shown) or may be located on the left side of the panel, depending on the hardware configuration installed.
EnSite Precision™ Cardiac Mapping System Instructions for Use Chapter 4. Preparing for a Study
ARTEN600004505 Rev. B Preparing for an EnSite™ NavX™ Navigation and Visualization
89

Table 15. EnSite™ NavX™ Navigation and Visualization Technology study with RecordConnect.

1. Turn on the EnSite™ Amplifier and allow it to warm up for 30 minutes before beginning a “Starting the System” on page 107
study.

2. Connect the EnSite Precision™ Cardiac Mapping System component cables to the EnSite™ “Using the Remote Monitor Configuration
Amplifier. Tool” on page 61

3. Place the system reference surface electrode on the patient, and then connect the electrode “Connecting a System Reference Surface
leads to the NavLink™ Module. Electrode” on page 63

4. Place the V2 ECG surface electrode on the patient. “Connecting ECG Surface Electrodes” on
page 75

5. Place the EnSite Precision™ surface electrodes on the patient, and then connect the “Connecting EnSite™ Surface Electrodes” on
electrode leads to the NavLink™ Module. page 72

6. Place the remaining ECG surface electrodes on the patient, and then connect all electrode “Connecting ECG Surface Electrodes” on
leads to the recording system’s ECG cable. page 75

7. Connect the recording system’s ECG cable to the RecordConnect. “Connecting ECG Surface Electrodes When
Using a RecordConnect” on page 76

8. Connect EP catheters to the recording system’s CIMs, and then connect the CIMs to the “Connecting Diagnostic Catheters When
RecordConnect. Using a RecordConnect” on page 83

9. Connect the ablation catheter and dispersive patches to the GenConnect, and then connect “Connecting an RF Ablation Catheter and
the GenConnect to the ablation generator and the EnSite Precision™ Cardiac Mapping Generator” on page 78
System.

10. Turn on the DWS. “Starting the System” on page 107

11. Log in to the EnSite Precision™ Cardiac Mapping System. “Logging In” on page 109

12. Start a new EnSite™ NavX™ Navigation and Visualization Technology study. “Starting a New Study” on page 113

13. Enter the Setup task. “Setup” on page 117

14. Check ECG signal quality and turn on signal filters if necessary. “Checking ECG Signals” on page 117

15. Perform validation. “Validation” on page 118

16. Add EP catheters to the study. “EP Catheter Setup” on page 119

17. Perform EnSite™ NavX™ Navigation and Visualization Technology setup. “EnSite™ NavX™ Navigation and
Visualization Technology, Sensor Enabled™
Setup” on page 132

18. Create a model. “Model” on page 143

19. Create maps. “Mapping – Contact” on page 201

20. Deliver therapy, if indicated. “Therapy” on page 219

21. End the study. “Ending a Study” on page 233

 Chapter 4. Preparing for a Study EnSite Precision™ Cardiac Mapping System Instructions for Use
90 Preparing for an EnSite™ NavX™ Navigation and Visualization ARTEN600004505 Rev. B

EnSite™ NavX™ Navigation and Visualization Technology Study without RecordConnect

An EnSite™ NavX™ Navigation and Visualization Technology study that does not use RecordConnect requires the following:
■ EnSite Precision™ surface electrodes
■ System reference surface electrode
■ NavLink™ Module
■ Diagnostic catheters
■ Jumper cables for diagnostic catheters
■ CathLink™ Module (one or two, depending on the recording system)
■ ECG surface electrodes (two sets)
■ SJM ECG Cable
■ Ablation catheter and generator
■ Dispersive surface electrodes
■ GenConnect

Figure 63 on page 91 illustrates the basic components and connections required for an EnSite™ NavX™ Navigation and Visualization
Technology study that does not use RecordConnect.

Table 16 on page 92 describes the basic tasks required in an EnSite™ NavX™ Navigation and Visualization Technology study.
EnSite Precision™ Cardiac Mapping System Instructions for Use Chapter 4. Preparing for a Study
ARTEN600004505 Rev. B Preparing for an EnSite™ NavX™ Navigation and Visualization
91

Figure 63. The basic components and connections for an EnSite™ NavX™ Navigation and Visualization Technology study when
a RecordConnect is not used.

* The physical location of the fiber optic cable connections, on the front panel of the EnSite™ Amplifier, may be located on the right
side of the panel (as shown) or may be located on the left side of the panel, depending on the hardware configuration installed.
 Chapter 4. Preparing for a Study EnSite Precision™ Cardiac Mapping System Instructions for Use
92 Preparing for an EnSite™ NavX™ Navigation and Visualization ARTEN600004505 Rev. B

Table 16. EnSite™ NavX™ Navigation and Visualization Technology study without RecordConnect.

1. Turn on the EnSite™ Amplifier and allow it to warm up for 30 minutes before beginning a “Starting the System” on page 107
study.

2. Connect the EnSite Precision™ Cardiac Mapping System component cables to the EnSite™ “Using the Remote Monitor Configuration
Amplifier. Tool” on page 61

3. Place the system reference surface electrode on the patient, and then connect the electrode “Connecting a System Reference Surface
leads to the NavLink™ Module. Electrode” on page 63

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

4. Place the Set 1 V2 ECG surface electrode on the patient. “Connecting ECG Surface Electrodes” on
page 75

5. Place the EnSite Precision™ surface electrodes on the patient, and then connect the “Connecting EnSite™ Surface Electrodes” on
electrode leads to the NavLink™ Module. page 72

6. Place the remaining Set 1 ECG surface electrodes on the patient, and then connect all “Connecting ECG Surface Electrodes When
electrode leads to the SJM ECG Cable. Not Using a RecordConnect” on page 77

7. Place the Set 2 ECG surface electrodes on the patient, and then connect all electrode leads “Connecting ECG Surface Electrodes When
to the recording system’s ECG cable. Not Using a RecordConnect” on page 77

8. Connect EP catheters to the recording system’s CIMs, as per the recording system’s “Connecting Diagnostic Catheters When Not
instructions, and then jumper the EP catheters from the recording system’s CIMs to the Using a RecordConnect” on page 84
CathLink™ Module.

9. Connect the ablation catheter and dispersive patches to the GenConnect, and then connect “Connecting an RF Ablation Catheter and
the GenConnect to the ablation generator and the EnSite Precision™ Cardiac Mapping Generator” on page 78
System.

10. Turn on the DWS. “Starting the System” on page 107

11. Log in to the EnSite Precision™ Cardiac Mapping System. “Logging In” on page 109

12. Start a new EnSite™ NavX™ Navigation and Visualization Technology study. “Starting a New Study” on page 113

13. Enter the Setup task “Setup” on page 117

14. Check ECG signal quality and turn on signal filters if necessary. “Checking ECG Signals” on page 117

15. Perform validation. “Validation” on page 118

16. Add EP catheters to the study. “EP Catheter Setup” on page 119

17. Perform EnSite™ NavX™ Navigation and Visualization Technology setup. “EnSite™ NavX™ Navigation and
Visualization Technology, Sensor Enabled™
Setup” on page 132

18. Create a model. “Model” on page 143

19. Create maps. “Mapping – Contact” on page 201

20. Deliver therapy, if indicated. “Therapy” on page 219

21. End the study. “Ending a Study” on page 233

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ARTEN600004505 Rev. B Preparing for an EnSite™ NavX™ Navigation and Visualization
93

EnSite™ NavX™ Navigation and Visualization Technology, Sensor Enabled™ Study with
RecordConnect
NOTE: For information on NavX SE studies not using the EnSite Precision™ Field Frame, Refer to the MediGuide™ System
Interface Module Instructions for Use.

An EnSite™ NavX™ Navigation and Visualization Technology, Sensor Enabled™ study that uses RecordConnect requires the
following:
■ EnSite™ NavX™ Navigation and Visualization Technology surface electrodes
■ System reference surface electrode
■ NavLink™ Module
■ Diagnostic catheters
■ ECG surface electrodes
■ RecordConnect
■ Ablation catheter and generator
■ Dispersive surface electrodes
■ GenConnect
■ EnSite Precision™ Link, Sensor Enabled™
■ Patient Reference Sensors (PRS)
■ EnSite Precision™ Field Frame

Figure 64 on page 94 illustrates the basic components and connections required for an EnSite™ NavX™ Navigation and Visualization
Technology, Sensor Enabled™ study that uses RecordConnect.

Table 17 on page 95 describes the basic tasks required in an EnSite™ NavX™ Navigation and Visualization Technology, Sensor
Enabled™ study.
 Chapter 4. Preparing for a Study EnSite Precision™ Cardiac Mapping System Instructions for Use
94 Preparing for an EnSite™ NavX™ Navigation and Visualization ARTEN600004505 Rev. B

Figure 64. The basic components and connections for an EnSite™ NavX™ Navigation and Visualization Technology, Sensor
Enabled™ study when a RecordConnect is used.

* The physical location of the fiber optic cable connections, on the front panel of the EnSite™ Amplifier, may be located on the right
side of the panel (as shown) or may be located on the left side of the panel, depending on the hardware configuration installed.
EnSite Precision™ Cardiac Mapping System Instructions for Use Chapter 4. Preparing for a Study
ARTEN600004505 Rev. B Preparing for an EnSite™ NavX™ Navigation and Visualization
95

Table 17. EnSite™ NavX™ Navigation and Visualization Technology, Sensor Enabled™ study with RecordConnect.

1. Turn on the EnSite™ Amplifier and allow it to warm up for 30 minutes before beginning a “Starting the System” on page 107
study.

2. Connect the EnSite Precision™ Cardiac Mapping System component cables to the EnSite™ “Using the Remote Monitor Configuration
Amplifier. Tool” on page 61

3. Place the system reference surface electrode on the patient, and then connect the electrode “Connecting a System Reference Surface
leads to the NavLink™ Module. Electrode” on page 63

4. Place the V2 ECG surface electrode on the patient. “Connecting ECG Surface Electrodes” on
page 75

5. Place the EnSite Precision™ surface electrodes on the patient, and then connect the “Connecting EnSite™ Surface Electrodes” on
electrode leads to the NavLink™ Module. page 72

6. Place the PRS patches and sensors on the patient. “Connecting the EnSite Precision™ Patient
Reference Sensors (PRS)” on page 64

7. Connect the EnSite Precision™ Link, Sensor Enabled™ to the EnSite™ Amplifier. “Patient Reference Sensor and Patch
Placement” on page 65

8. Connect the EnSite Precision™ Field Frame to the EnSite Precision™ Link, Sensor “Connecting the EnSite Precision™ Field
Enabled™. Frame” on page 66

9. Connect the PRS to the EnSite Precision™ Link, Sensor Enabled™. “Patient Reference Sensor and Patch
Placement” on page 65

10. Place the remaining ECG surface electrodes on the patient, and connect all electrode leads “Connecting ECG Surface Electrodes” on
to the recording system’s ECG cable. page 75

11. Position the EnSite Precision™ Field Frame under the patient’s torso, centered under the “Connecting the EnSite Precision™ Field
heart. Frame” on page 66

12. Connect the recording system’s ECG cable to the RecordConnect. “Connecting ECG Surface Electrodes When
Using a RecordConnect” on page 76

13. Connect EP catheters to the recording system’s CIMs, and then connect the CIMs to the “Connecting Diagnostic Catheters When
RecordConnect. Using a RecordConnect” on page 83

14. Connect the ablation catheter and dispersive patches to the GenConnect, and then connect “Connecting an RF Ablation Catheter and
the GenConnect to the ablation generator and the EnSite Precision™ Cardiac Mapping Generator” on page 78
System.

15. Turn on the DWS. “Starting the System” on page 107

16. Log in to the EnSite Precision™ Cardiac Mapping System. “Logging In” on page 109

17. Start a new EnSite™ NavX™ Navigation and Visualization Technology, Sensor Enabled™ “Starting a New Study” on page 113
study.

18. Enter the Setup task. “Setup” on page 117

19. Check ECG signal quality and turn on signal filters if necessary. “Checking ECG Signals” on page 117

20. Perform validation. “Validation” on page 118

21. Perform an EnSite Precision™ Module functional check to verify proper operation. “Performing an EnSite Precision™ Module
Functional Check” on page 70

22. Add EP catheters to the study. “EP Catheter Setup” on page 119

23. Perform EnSite™ NavX™ Navigation and Visualization Technology, Sensor Enabled™ “EnSite™ NavX™ Navigation and
setup. Visualization Technology, Sensor Enabled™
Setup” on page 132
 Chapter 4. Preparing for a Study EnSite Precision™ Cardiac Mapping System Instructions for Use
96 Preparing for an EnSite™ NavX™ Navigation and Visualization ARTEN600004505 Rev. B

24. Create a model. “Model” on page 143

25. Create maps. “Mapping – Contact” on page 201

26. Deliver therapy, if indicated. “Therapy” on page 219

27. End the study. “Ending a Study” on page 233

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97

EnSite™ NavX™ Navigation and Visualization Technology, Sensor Enabled™ Study without
RecordConnect
NOTE: For information on NavX SE studies not using the EnSite Precision™ Field Frame, Refer to the MediGuide System
Interface Module Instructions for Use.

An EnSite™ NavX™ Navigation and Visualization Technology, Sensor Enabled™ study that does not use RecordConnect requires
the following:
■ EnSite Precision™ surface electrodes
■ System reference surface electrode
■ NavLink™ Module
■ Diagnostic catheters
■ Jumper cables for diagnostic catheters
■ CathLink™ Module (one or two, depending on the recording system)
■ ECG surface electrodes (two sets)
■ SJM™ ECG Cable
■ Ablation catheter and generator
■ Dispersive surface electrodes
■ GenConnect
■ EnSite Precision™ Link, Sensor Enabled™
■ Patient Reference Sensors (PRS)
■ EnSite Precision™ Field Frame

Figure 65 on page 98 illustrates the basic components and connections required for an EnSite™ NavX™ Navigation and Visualization
Technology, Sensor Enabled™ study that does not use RecordConnect.

Table 18 on page 99 describes the basic tasks required in an EnSite™ NavX™ Navigation and Visualization Technology, Sensor
Enabled™ study, without RecordConnect.
 Chapter 4. Preparing for a Study EnSite Precision™ Cardiac Mapping System Instructions for Use
98 Preparing for an EnSite™ NavX™ Navigation and Visualization ARTEN600004505 Rev. B

Figure 65. The basic components and connections for an EnSite™ NavX™ Navigation and Visualization Technology, Sensor
Enabled™ study when a RecordConnect is not used.

* The physical location of the fiber optic cable connections, on the front panel of the EnSite™ Amplifier, may be located on the right
side of the panel (as shown) or may be located on the left side of the panel, depending on the hardware configuration installed.
EnSite Precision™ Cardiac Mapping System Instructions for Use Chapter 4. Preparing for a Study
ARTEN600004505 Rev. B Preparing for an EnSite™ NavX™ Navigation and Visualization
99

Table 18. EnSite™ NavX™ Navigation and Visualization Technology, Sensor Enabled™ study without RecordConnect.

1. Turn on the EnSite™ Amplifier and allow it to warm up for 30 minutes before beginning a “Starting the System” on page 107
study.

2. Connect the EnSite Precision™ Cardiac Mapping System component cables to the EnSite™ “Using the Remote Monitor Configuration
Amplifier. Tool” on page 61

3. Place the system reference surface electrode on the patient, and then connect the electrode “Connecting a System Reference Surface
leads to the NavLink™ Module. Electrode” on page 63

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

4. Place the Set 1 V2 ECG surface electrode on the patient. “Connecting ECG Surface Electrodes” on
page 75

5. Place the EnSite Precision™ surface electrodes on the patient, and then connect the “Connecting EnSite™ Surface Electrodes” on
electrode leads to the NavLink™ Module. page 72

6. Place the PRS patches and sensors on the patient. “Connecting the EnSite Precision™ Patient
Reference Sensors (PRS)” on page 64

7. Connect the EnSite Precision™ Link, Sensor Enabled™ to the EnSite™ Amplifier. “Patient Reference Sensor and Patch
Placement” on page 65

8. Connect the EnSite Precision™ Field Frame to the EnSite Precision™ Link, Sensor “Connecting the EnSite Precision™ Field
Enabled™. Frame” on page 66

9. Connect the PRS to the EnSite Precision™ Link, Sensor Enabled™. “Patient Reference Sensor and Patch
Placement” on page 65

10. Place the remaining Set 1 ECG surface electrodes on the patient and connect all electrode “Connecting ECG Surface Electrodes When
leads to the SJM ECG Cable. Not Using a RecordConnect” on page 77

11. Place the Set 2 ECG surface electrodes on the patient, and then connect all electrode leads “Connecting ECG Surface Electrodes When
to the recording system’s ECG cable. Not Using a RecordConnect” on page 77

12. Position the EnSite Precision™ Field Frame under the patient’s torso, centered under the “Connecting the EnSite Precision™ Field
heart. Frame” on page 66

13. Connect EP catheters to the recording system’s CIMs, as per the recording system’s “Connecting Diagnostic Catheters When Not
instructions, and then jumper the EP catheters from the recording system’s CIMs to the Using a RecordConnect” on page 84
CathLink™ Module.

14. Connect the ablation catheter and dispersive patches to the GenConnect, and then connect “Connecting an RF Ablation Catheter and
the GenConnect to the ablation generator and the EnSite Precision™ Cardiac Mapping Generator” on page 78
System.

15. Turn on the DWS. “Starting the System” on page 107

16. Log in to the EnSite Precision™ Cardiac Mapping System. “Logging In” on page 109

17. Start a new EnSite™ NavX™ Navigation and Visualization Technology, Sensor Enabled™ “Starting a New Study” on page 113
study.

18. Enter the Setup task “Setup” on page 117

19. Check ECG signal quality and turn on signal filters if necessary. “Checking ECG Signals” on page 117

20. Perform validation. “Validation” on page 118

21. Perform an EnSite Precision™ Module functional check to verify proper operation. “Performing an EnSite Precision™ Module
Functional Check” on page 70

22. Add EP catheters to the study. “EP Catheter Setup” on page 119
 Chapter 4. Preparing for a Study EnSite Precision™ Cardiac Mapping System Instructions for Use
100 Preparing for an EnSite™ NavX™ Navigation and Visualization ARTEN600004505 Rev. B

23. Perform EnSite™ NavX™ Navigation and Visualization Technology, Sensor Enabled™ “EnSite™ NavX™ Navigation and
setup. Visualization Technology, Sensor Enabled™
Setup” on page 132

24. Create a model. “Model” on page 143

25. Create maps. “Mapping – Contact” on page 201

26. Deliver therapy, if indicated. “Therapy” on page 219

27. End the study. “Ending a Study” on page 233

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ARTEN600004505 Rev. B Preparing for an EnSite™ Array™ Catheter Study
101

Preparing for an EnSite™ Array™ Catheter Study

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

Refer to “Using a Recording System” on page 82 for more information.

EnSite™ Array™ Catheter Study with RecordConnect

An EnSite™ Array™ Catheter study that uses a RecordConnect requires the following:
■ EnSite™ Array™ Catheter
■ ArrayLink™ Module
■ System reference surface electrode
■ NavLink™ Module
■ Diagnostic catheters
■ ECG surface electrodes
■ RecordConnect
■ Ablation catheter and generator
■ Dispersive surface electrodes
■ GenConnect

Figure 66 on page 102 illustrates the basic components and connections required for an EnSite™ Array™ Catheter study that uses
RecordConnect.

Table 19 on page 103 describes the basic tasks required in an EnSite™ Array™ Catheter study.
 Chapter 4. Preparing for a Study EnSite Precision™ Cardiac Mapping System Instructions for Use
102 Preparing for an EnSite™ Array™ Catheter Study ARTEN600004505 Rev. B

Figure 66. The basic components and connections for an EnSite™ Array™ Catheter study when RecordConnect is used.

* The physical location of the fiber optic cable connections, on the front panel of the EnSite™ Amplifier, may be located on the right
side of the panel (as shown) or may be located on the left side of the panel, depending on the hardware configuration installed.
EnSite Precision™ Cardiac Mapping System Instructions for Use Chapter 4. Preparing for a Study
ARTEN600004505 Rev. B Preparing for an EnSite™ Array™ Catheter Study
103

Table 19. EnSite™ Array™ Catheter study with RecordConnect.

1. Turn on the EnSite™ Amplifier and allow it to warm up for 30 minutes before beginning a “Starting the System” on page 107
study.

2. Connect the EnSite Precision™ Cardiac Mapping System component cables to the EnSite™ “Using the Remote Monitor Configuration
Amplifier. Tool” on page 61

3. Place the system reference surface electrode on the patient, and then connect the electrode “Connecting a System Reference Surface
leads to the NavLink™ Module. Electrode” on page 63

4. Place the ECG surface electrodes on the patient, and then connect the electrode leads to “Connecting ECG Surface Electrodes” on
the recording system ECG cable. page 75

5. Connect the recording system’s ECG cable to the RecordConnect. “Connecting ECG Surface Electrodes When
Using a RecordConnect” on page 76

6. Connect EP catheters to the recording system’s CIMs, and then connect the CIMs to the “Connecting Diagnostic Catheters When
RecordConnect. Using a RecordConnect” on page 83

7. Connect the ablation catheter and dispersive patches to the GenConnect, and then connect “Connecting an RF Ablation Catheter and
the GenConnect to the ablation generator and the EnSite Precision™ Cardiac Mapping Generator” on page 78
System.

8. Connect the EnSite™ Array™ Catheter cable and Data Module to the EnSite™ Array™ “ArrayLink™ Module Connections” on page
Catheter. 53

9. Turn on the DWS. “Starting the System” on page 107

10. Log in to the EnSite Precision™ Cardiac Mapping System. “Logging In” on page 109

11. Start a new EnSite™ Array™ Catheter study. “Starting a New Study” on page 113

12. Enter the Setup task. “Setup” on page 117

13. Check ECG signal quality and turn on signal filters if necessary. “Checking ECG Signals” on page 117

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

15. Perform validation. “Validation” on page 118

16. Add EP catheters to the study. “EP Catheter Setup” on page 119

17. Perform EnSite™ Array™ Catheter setup. “Catheter Presets” on page 126

18. Create a model. “Model” on page 143

19. Create maps. “Mapping – Noncontact” on page 189 or

“Mapping – Contact” on page 201

20. Deliver therapy, if indicated. “Therapy” on page 219

21. End the study. “Ending a Study” on page 233

 Chapter 4. Preparing for a Study EnSite Precision™ Cardiac Mapping System Instructions for Use
104 Preparing for an EnSite™ Array™ Catheter Study ARTEN600004505 Rev. B

EnSite™ Array™ Catheter Study without RecordConnect

An EnSite™ Array™ Catheter study that does not use RecordConnect requires the following:
■ EnSite™ Array™ Catheter
■ ArrayLink™ Module
■ System reference surface electrode
■ NavLink™ Module
■ Diagnostic catheters
■ Jumper cables for diagnostic catheters
■ CathLink™ Module
■ ECG surface electrodes (two sets)
■ SJM ECG Cable
■ Ablation catheter and generator
■ Dispersive surface electrodes
■ GenConnect

Figure 67 on page 105 illustrates the basic components and connections required for an EnSite™ Array™ Catheter study that does not
use RecordConnect.

Table 20 on page 106 describes the basic tasks required in an EnSite™ Array™ Catheter study.
EnSite Precision™ Cardiac Mapping System Instructions for Use Chapter 4. Preparing for a Study
ARTEN600004505 Rev. B Preparing for an EnSite™ Array™ Catheter Study
105

Figure 67. The basic components and connections for an EnSite™ Array™ Catheter study when RecordConnect is not used.

* The physical location of the fiber optic cable connections, on the front panel of the EnSite™ Amplifier, may be located on the right
side of the panel (as shown) or may be located on the left side of the panel, depending on the hardware configuration installed.
 Chapter 4. Preparing for a Study EnSite Precision™ Cardiac Mapping System Instructions for Use
106 Preparing for an EnSite™ Array™ Catheter Study ARTEN600004505 Rev. B

Table 20. EnSite™ Array™ study without RecordConnect.

1. Turn on the EnSite™ Amplifier and allow it to warm up for 30 minutes before beginning a “Starting the System” on page 107
study.

2. Connect the EnSite Precision™ Cardiac Mapping System component cables to the EnSite™ “Using the Remote Monitor Configuration
Amplifier. Tool” on page 61

3. Place the system reference surface electrode on the patient, and then connect the electrode “Connecting a System Reference Surface
lead to the NavLink™ Module. Electrode” on page 63

4. Place the Set 1 ECG surface electrodes on the patient, and then connect the electrode leads “Connecting ECG Surface Electrodes” on
to the SJM ECG Cable. page 75

5. Place the Set 2 ECG surface electrodes on the patient, and then connect all electrode leads “Connecting ECG Surface Electrodes When
to the recording system, as per the recording system’s instructions. Not Using a RecordConnect” on page 77

6. Connect EP catheters to the recording system’s CIMs, as per the recording system’s “Connecting Diagnostic Catheters When Not
instructions, and then jumper the EP catheters from the recording system’s CIMs to the Using a RecordConnect” on page 84
CathLink™ Module.

7. Connect the ablation catheter and dispersive patches to the GenConnect, and then connect “Connecting an RF Ablation Catheter and
the GenConnect to the ablation generator and the EnSite Precision™ Cardiac Mapping Generator” on page 78
System.

8. Turn on the DWS. “Starting the System” on page 107

9. Log in to the EnSite Precision™ Cardiac Mapping System. “Logging In” on page 109

10. Start a new EnSite™ Array™ Catheter study. “Starting a New Study” on page 113

11. Enter the Setup task “Setup” on page 117

12. Check ECG signal quality and turn on signal filters if necessary. “Checking ECG Signals” on page 117

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

14. Connect the EnSite™ Array™ Catheter cable and Data Module to the ArrayLink™ Module. “ArrayLink™ Module Connections” on page
53

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

15. Perform validation. “Validation” on page 118

16. Add EP catheters to the study. “EP Catheter Setup” on page 119

17. Perform the EnSite™ Array™ Catheter setup. “Catheter Presets” on page 126

18. Create a model. “Model” on page 143

19. Create maps. “Mapping – Noncontact” on page 189 or

“Mapping – Contact” on page 201

20. Deliver therapy, if indicated. “Therapy” on page 219

21. End the study. “Ending a Study” on page 233

EnSite Precision™ Cardiac Mapping System Instructions for Use
ARTEN600004505 Rev. B 107

Starting a Study CHAPTER 5

Starting the System

Before starting the system, verify the following:

■ The ArrayLink™ Module, if it is being used, is securely fastened to a rail on the patient table.
■ The EnSite Precision™ Link, Sensor Enabled™, if it is being used, is securely fastened to a rail on the patient table. The unit
powers-on when plugged-in.
■ The CathLink™ Module, if it is being used, is securely fastened to a rail on the patient table.
■ All cable connections to the EnSite™ Amplifier are secure.
■ The fiber-optic cable connection between the DWS and the EnSite™ Amplifier is secure.

Use the following procedure to start the system:

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

NOTE: If the EnSite™ Amplifier is already powered on when setting up the system for a new study, power cycle the EnSite™
Amplifier before starting a new study. The EnSite™ Amplifier self-test provides important information about the status
of the EnSite™ Amplifier components that may not be available unless the EnSite™ Amplifier is power cycled.
1. Press the EnSite™ Amplifier power switch to the ON position.
2. When the system is powered on, the status lights may change state for approximately two minutes while the system performs
self-testing. After two minutes, check the EnSite™ Amplifier status lights. The green light should illuminate and remain lit. If
the amber light flashes or is steadily illuminated, there is a problem. To resolve the problem, refer to “Troubleshooting” on page
245 or contact EnSite Precision™ Cardiac Mapping System Technical Support before proceeding.
3. Power on the power conditioner.
4. Press and release the workstation power switch (located on the front of the workstation) to power on the workstation. When
powered on, the workstation begins automated self-testing. When self-testing is complete, the system login screen appears on the
monitor.
 Chapter 5. Starting a Study EnSite Precision™ Cardiac Mapping System Instructions for Use
108 Keyboard and Screen Languages ARTEN600004505 Rev. B

Keyboard and Screen Languages

Languages can be selected for the keyboard and the screens. The default keyboard language and screen language is U.S. English. If a
different keyboard language is to be used, follow the steps in “Selecting a Keyboard Language” on page 108 to select the keyboard
language. If a different screen language is to be used, follow the steps in “Selecting a Screen Language” on page 108 to select the
screen language.

Selecting a Keyboard Language

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

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

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

Selecting a Screen Language

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

NOTE: The Login screen is always in English.

NOTE: If the screen language selected is Chinese or Japanese, the user can toggle between English characters and Chinese
characters, or between English characters and Japanese characters, by holding down the Ctrl key and pressing the space
bar.
1. Log in to the system (see “Logging In” on page 109).

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

NOTE: The user must log out and log back in to the system for the change to take effect.
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ARTEN600004505 Rev. B Logging In
109

Logging In

NOTE: The login name and password must be entered as

lowercase letters with no spaces.
1. Type the login name in the Username: text box and press
Enter. The default login name is all lower-case “ensite”
and is case-sensitive. After the login name has been
entered, the text box text changes to Password.
2. Type the password in the Password text box and press
Enter. The password is sjm3000. In a few seconds the
Title Screen appears.

NOTE: The Training Database can be used to review

practice cases. The login name is training and
the password is sjm3000.

NOTE: If the password is changed from the initial

password above, the Login screen will not Figure 68. The Login Screen.
display. Contact your system administrator for
the current password.

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

■ Select system language , view system information , and access SJM Connect from the tool bar at the bottom
of the screen.
■ Click the Back button to return to the previous menu.
■ Click to log out of the session.
 Chapter 5. Starting a Study EnSite Precision™ Cardiac Mapping System Instructions for Use
110 Getting Started ARTEN600004505 Rev. B

Getting Started

After logging in, access the desired menu:

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

Figure 69. The Title Screen.

EnSite Precision™ Cardiac Mapping System Instructions for Use Chapter 5. Starting a Study
ARTEN600004505 Rev. B Getting Started
111

Clinical Menu

Figure 70. The Clinical Menu.

■ New Study, to start a new study (go to “Starting a New Study” on page 113).
■ Last Study, to access the last study (go to “Past Studies” on page 115).
■ Past Studies, to access a previously-recorded study in Offline Review model (go to “Offline Review” on page 229).
■ Archive
■ Import
■ Verismo, to access the EnSite™ Verismo™ Segmentation Tool, if the tool has been installed.
■ EnSite™ Courier™ PACS Module, if it has been installed.
 Chapter 5. Starting a Study EnSite Precision™ Cardiac Mapping System Instructions for Use
112 Getting Started ARTEN600004505 Rev. B

Services Menu

Figure 71. The Services Menu.

■ Collect Logs: to export logs to CD/DVD or USB device.
■ Verismo Cleanup: to cleanup unneeded files.
■ Install License From Media: to install product licenses on the DWS. Administrator access.
■ Upgrade Software: to upgrade DWS system software. Administrator access.
■ Manage License: to add or remove product licenses. Administrator access.

■ [About the System] to display a variety of system information, including the software release notes, controls for setting the
system clock, controls for establishing the hospital name, utilities for advanced technical support, and notices. See
“Troubleshooting” on page 245 and “Setting Environmental Information” on page 258 for further information.

■ [Logout] to log off the system.

EnSite Precision™ Cardiac Mapping System Instructions for Use Chapter 5. Starting a Study
ARTEN600004505 Rev. B Starting a New Study
113

Starting a New Study

New Patient
To begin a new study for a new patient:
1. Click [New Study] from the Clinical Menu (Figure 70 on page
111) to display the Study Setup screen.
2. Click [New Patient]. (Default)
3. Fill in the patient information: Last Name, First Name, M.I., 2
Patient ID, Date of Birth, Gender, Weight.

NOTE: Weight (in kilograms) is the minimum required field

to proceed. However, you will need to enter the 3
remainder of the required information before you can
end the study. See “Ending a Study” on page 233.
4. Click [Next] to display the next Study Setup screen.
4
5. Select a study type: EnSite NavX or EnSite Array. (Default is
NavX).
6. Enter the study information: Diagnosis, Procedure, and
Physician.
5
7. Select the appropriate Recording System.
8. Click [Begin Study] to begin the study.

NOTE: After starting a new study, signal parameters need to

6
be set, as described in “Setup” on page 117.

Figure 72. Study Start up for a New Patient.

 Chapter 5. Starting a Study EnSite Precision™ Cardiac Mapping System Instructions for Use
114 Starting a New Study ARTEN600004505 Rev. B

Existing Patient
To begin a new study for an existing patient:
1. Click [New Study] from the Title Screen to display the New
Study Patient Information screen.
2. Click [Existing Patient].
3. Select a patient from the list. A summary of patient
2
information and a list of past studies are displayed on the 3
screen.
4. Click [Next] to display the Study Setup screen.
5. Select a study type: EnSite NavX or EnSite Array.
6. Enter the study information: Diagnosis, Procedure, and
Physician.
4
7. Click [Begin Study] to begin the study.

NOTE: After starting a new study, signal parameters need to

be set, as described in “Setup” on page 117.
5

Figure 73. Study Setup for an Existing Patient.

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ARTEN600004505 Rev. B Past Studies
115

Past Studies

Resuming a Study
NOTE: Studies may only be continued using the same data module.

NOTE: When a study is resumed, all settings will be loaded from the cursor position in the segment being reviewed.

NOTE: A study can be resumed even after a system has been shut down, either intentionally or unintentionally.

To resume a study, follow these steps:

1. Return to the Login Screen and Log in.
2. Click on the Clinical icon to access the Clinical Menu (Figure 70 on page 111).
3. Click on the Past Studies icon to display the list of studies.
4. Select the Patient Name and the study date that are associated with the data module that was used during that study; ensure that
the data module is still viable (does not exceed the 18-hour time stamp [from initial validation]).
5. Click Open Study. The study will be opened
in the Model task and the last recorded
segment will begin to play. To play a
different segment, select the segment from
the Segment drop-down menu at the bottom
of the screen (Figure 74 on page 115).
6. Verify that the EnGuides and model are
displayed, and that the catheter is properly
aligned with the model. If they are not, it
may be necessary to load a different segment
or move the cursor to a different location in
the segment.
7. Select File > Resume Study.
8. Click [Yes] in the dialog box (Figure 75 on
page 115) to continue.

Figure 74. Load Segment Window for RealTime Review.

Figure 75. Resume Study dialog box

 Chapter 5. Starting a Study EnSite Precision™ Cardiac Mapping System Instructions for Use
116 Past Studies ARTEN600004505 Rev. B
EnSite Precision™ Cardiac Mapping System Instructions for Use
ARTEN600004505 Rev. B 117

Setup CHAPTER 6

Checking ECG Signals

D E

Figure 76. ECG Signals Display.

A: Trace name; B: ECG waveform; C: Data type; D: Amplitude control; E: Filter controls.
 Chapter 6. Setup EnSite Precision™ Cardiac Mapping System Instructions for Use
118 Validation ARTEN600004505 Rev. B

Verifying ECG Signal Quality

(All studies)
1. Verify ECG signal quality by examining the traces (Figure 76 on page 117). Traces should be smooth lines that are free of
excessive noise. If traces contain excessive noise, check all electrode and cable connections between the patient and the EnSite™
Amplifier.
2. If signal filtering is desired, verify that the Display Filter Data checkbox has the Noise, High Pass, and Low Pass filters set
accordingly.
3. Use the Amplitude slider to adjust the waveform as desired.

Validation

(All studies)

The Data Module must be validated before catheter navigation can begin. Validation should be performed as close as possible to
creating the first model, map or 3D point.

NOTE: It is recommended to validate again just prior to model or map creation. Validation can be performed more than once.

CAUTION: The EnSite™ Array™ and the EnSite Precision™ Surface Electrode Kits are intended for single use only. Device
integrity will be compromised by any reuse, which may compromise patient safety and system performance.

Prior to validating the Data Module:

■ For EnSite™ Array™ Catheter studies, the EnSite™ Array™ catheter and data module must be connected to the ArrayLink™
Module, and the catheter must be deployed in the chamber of interest. The Data Module is tethered to the EnSite™ Array™
catheter.
■ For EnSite™ NavX™ Navigation and Visualization Technology, Sensor Enabled™ studies, the EnSite Precision™ surface
electrodes, the System Reference patch, the Patient Reference Sensors must be properly positioned on the patient and connected
to the NavLink and the EnSite Precision™ Link, Sensor Enabled™. The Data Module is incorporated in the EnSite Precision™
left leg patch.

Once the above actions have been completed, validate the Data Module as follows:
1. Insert the Data Module into the Data Module connection on either the ArrayLink™ or NavLink™ modules, as appropriate.
Note: The Data Module cable connectors and their corresponding connections for the ArrayLink™ or NavLink™ module look
completely different from one another.
2. Click on the Catheter Setup subtask in order to see the yellow Validation window. The yellow Validation window will appear in
the upper left corner of the screen.
3. Click on [Validate], in the yellow message window, to begin the validation process. When validation is complete, a message
appears in the lower right side of the screen. Set up the catheters.
Note: Because the default position for located catheters may be outside the model display, right-click in the model display
background, select Center Model At:, and then select one of the following from the submenu:
■ Center of Surface(s)
■ Surface Point
■ Active Electrode
■ Catheter Tip (brings up submenu of the chosen catheters from list)
4. If validation fails, check that the ArrayLink™ or NavLink™ Module connections are correct. To attempt to revalidate, from the
menu bar, select Amplifier > Validate (re-validation can be done as many times as necessary, within the 18-hour Data Module
time frame).
EnSite Precision™ Cardiac Mapping System Instructions for Use Chapter 6. Setup
ARTEN600004505 Rev. B EP Catheter Setup
119

EP Catheter Setup

(All studies)

1 3456

7 8

9
10 11

12
13 14 15

Figure 77. The Catheter Setup Screen.

1. CIM – Graphic representation of the catheter input modules (CIMs) used to connect catheters to the EnSite Precision™ Cardiac
Mapping System. Shown is the CathLink, which is connected directly to the EnSite™ Amplifier. Also available are CIMS that match
some recording systems, and are connected to the EnSite Precision™ Cardiac Mapping System with specific RecordConnects.

2. Catheter List – List of the catheters included in this study. Click on a line item in the catheter list to select that catheter. The selected
catheter’s properties will be displayed below the list.

3. Catheter Visibility – Show or hide a catheter in the navigation area.

4. Catheter Color – Click the colored box to change the color of the catheter.

5. Sheath Filer – Detects and provides visual feedback when all or part of a catheter is in the sheath. When an electrode is detected to
be within the sheath, both visibility and data collection from the electrode will suspend. See “Sheath Filter Setup” on page 128.

6. Electrode Numbers Checkbox – Requires Show Electrode Numbers to be selected from the Display Settings menu.

7. Electrode Spacing – The electrode spacing of the selected catheter is displayed here. Electrode spacing is calculated from the edges
of the electrodes, not the center.

NOTE: Enter proper spacing prior to collecting model points.

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120 EP Catheter Setup ARTEN600004505 Rev. B

8. Catheter Representation – This is a representation of the selected catheter. It shows the electrodes and how they map to the input
channels.
■ To show/hide the mapping lines, right-click and turn the Show Lines checkbox On or Off.
■ To show/hide the catheter representation, right-click and turn the Show Catheter checkbox On or Off.

9. Filter Controls – The Noise Filter can be turned on or off and the High Pass and Low Pass filters can be adjusted as needed for
bipolar and unipolar signals. Separate controls are available for ECG, and the EnSite™ Array™ Catheter under the model workflow.
In addition, the EnSite™ Array™ Catheter has a Spatial filter.

10. Waveforms – The waveforms of the selected catheter are displayed here.

11. Catheter Properties – Catheter properties are Name, Brand Name, Type, Manufacturer, Model Number, Number of Electrodes,
Diameter, Distal Length, Electrode Length, Type, and Electrode Spacing.

12. Signal Order – These checkboxes dictate the order in which the waveforms are displayed.
(Distal to Proximal or Proximal to Distal).

NOTE: This does not apply to the Mapping Waveforms.

13. Polarity – This drop-down menu is used to set the selected catheter’s polarity: Paired Bipolar, All Bipolar, or All Unipolar.

14. Add a Trace – Clicking the [+] button will add a trace. By default, it will be a unipolar electrogram configured with the Distal
electrode set as positive (left column), with the reference set as the System Reference (or Aux Ref, if chosen) (right column).
■ You can also configure this trace as a bipole by changing the electrode configuration to any combination of electrodes on the same
catheter.
■ To remove a trace, left-click and drag the trace to the left of the window.

NOTE: Cryo Ablation connections can be made through the CIM or RecordConnect.

15. GenConnect Panel – This panel serves as the software connection for the ablation catheter. When adding an RF catheter, this
panel must be used rather than the CIM representation shown above it. Note that the ablation catheter should only be visualized using
these inputs. If the EGM output from the generator is input to the CIM to see cardiac signals on the recording system, those channels
should not be used to visualize a catheter in the EnSite System.
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Adding a Catheter to a Study

Before adding catheters to the study, ensure that the
appropriate RecordConnect has been specified for the study.
This is important because the CIM that is displayed in
Catheter Setup is determined by the RecordConnect.

NOTE: If any catheters have been defined, the

RecordConnect (and therefore the CIM)
cannot be changed unless the catheters are
first undefined by clicking the [-] button in the
Catheter Setup or loading the Nominal Preset.
Figure 78. The Amplifier Settings RecordConnect window.
To select a different CIM for the study, from the menu bar
select Amplifier > Settings > RecordConnect. Ensure that
the corresponding checkbox is checked for the recording
system being used for the study.

There are multiple ways to add a catheter to a study:

■ “Defining a Catheter” on page 122.
■ “Selecting a Catheter from the Catheter Catalog” on page 122.
■ “Loading a Catheter Preset” on page 123.
■ “Automatically Adding a Sensor Enabled™ Catheter” on page 123.
 Chapter 6. Setup EnSite Precision™ Cardiac Mapping System Instructions for Use
122 EP Catheter Setup ARTEN600004505 Rev. B

Defining a Catheter
1. Click the + button beneath the Catheter List.
2. Enter a catheter name (up to four alphanumeric characters) or choose a system default name from the drop-down menu.

NOTE: When typing in the text area for Name, Manufacturer, Model Number, Brand Name, and Electrode Spacing, the text
area turns yellow. Text entry is not complete and accepted until the <Enter> key has been pressed and the text area returns
to blue. To return to the previously accepted data, press the <ESC> key.
3. Select a color for the catheter body. The color of the waveforms for the catheter defaults to the color selected for the catheter
body.
4. Specify the catheter properties: number of electrodes, catheter diameter, distal length, electrode length, electrode spacing.
When specifying the number of electrodes, the electrodes will be assigned to consecutive Input Channels starting with the distal
electrode assigned to the first available channel.

NOTE: Electrode spacing is calculated from the edges of the electrodes, not the centers of the electrodes.

NOTE: If the catheter is to be used as an ablation catheter, move it to the GenConnect panel by right-clicking on the first
GenConnect input channel and then selecting Set Distal.

NOTE: If a catheter is to be used to collect Model points, and Field Scaling is to be applied, the electrode size and spacing
information entered into the catheter description must match the information provided by the catheter manufacturer.
Model points collected with catheters that are inappropriately described may yield unexpected Field Scaling results. This
cannot be corrected by re-entering correct information after the fact. However, Field Scaling is an option which can be
unapplied if unexpected results occur.
5. From the Polarity drop-down menu, specify whether signals should be collected from paired bipoles, all possible bipoles, or all
possible unipoles.
6. Set the filters using the filter controls.
7. (Optional) To add the catheter to the Catheter Catalog, click [Add to Catalog]..

Selecting a Catheter from the Catheter Catalog

To add a catheter to the Catheter List from the Catheter Catalog:
1. Click the [Catheter Catalog] button. The catalog window opens.
2. Choose the desired catheter from the catalog list.
3. Click the [Add New] at the lower right of the catalog window.
4. Choose more catheters or close the catalog window with the [Close] button at the lower right corner of the catalog window.
– The selected catheter's attributes will populate the applicable property setting fields, and the catheter's distal electrode will be
automatically assigned to the first available input. Subsequent electrodes will be placed in consecutive inputs, if available.

To redefine a catheter already in the Catheter List using the Catheter Catalog:
1. Highlight the catheter to be redefined in the Catheter List.
2. Click the [Catheter Catalog] button. The catalog window opens.
3. Select the desired catheter in the catalog list.
4. Click [Apply to Current] at the lower right corner of the catalog window.
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5. Choose more catheters or close the catalog window with the [Close] button at the lower right corner of the catalog window.
– The selected catheter's attributes will populate the applicable property setting fields, and the catheter's distal electrode will be
automatically assigned to the first available input. Subsequent electrodes will be placed in consecutive inputs, if available.
■ The catheter name can be modified by double clicking on the name in the Catheter List or in the Name field (four character limit).
The name can also be modified by selecting a system default name from the drop down list in the Name field.
■ Modify any editable properties, if necessary. (Note: only diagnostic catheters added via the catalog can be modified.)
■ Reassign any input channels, if necessary.

For more information about using the Catheter Catalog, refer to “Catheter Catalog” on page 125.

Loading a Catheter Preset

To load a preset for the current physician, open the Preset menu in the upper-right corner of the control panel and select a preset from
the list. The menu lists all of the presets for the current physician.

To load a preset belonging to another physician, open the Preset menu in the upper-right corner of the control panel and select Load
Preset... The Load Preset window lists the presets for all physicians on the system. Select the desired preset and then click [OK].

For more information about using catheter presets, refer to “Catheter Presets” on page 126.

Automatically Adding a Sensor Enabled™ Catheter

NOTE: Available only with an EnSite™ NavX™ Navigation and Visualization Technology, Sensor Enabled™ study.

When a Sensor Enabled catheter is connected, the system automatically adds its attributes. The user must setup the pin jacks.

NOTE: If needed, check the magnetic port settings from the Attributes tab, then
select the desired Sensor Enabled port.

EnSite Precision™ System Data Quality Indicators

Once realtime EnSite Precision™ system data has been received, Data Quality Indicator(s) display in the bottom right corner of the
map display. The Indicators correspond to the status of connected Sensor Enabled™ devices and the Patient Reference Sensors (PRS-
A and PRS-P).

The EnSite Precision™ Cardiac Mapping System Indicator label denotes the specific
Precision Link port Sensor Enabled™ devices) are configured in. A
■ The Data Quality indicators show gray while connecting.
■ When devices or the PRS are valid, the EnSite Precision™ Cardiac Mapping System
Data Quality Indicator color is green.
■ If this data becomes invalid, the EnSite Precision™ Cardiac Mapping System Data B
Quality Indicator color turns amber.
■ Use these indicators to troubleshoot the Sensor Enabled™ catheter or PRS connection
problems. Refer to the “Troubleshooting” on page 245 for more information when
device field status is invalid.

Figure 79. (A) Devices are

connecting; (B) Devices are valid; and
(C) Devices are invalid
 Chapter 6. Setup EnSite Precision™ Cardiac Mapping System Instructions for Use
124 EP Catheter Setup ARTEN600004505 Rev. B

Catheter Signal Settings

The Setup task workflow must be selected to access catheter signals. In addition, the Catheter Setup icon, in the upper right side of
the screen must be selected. Signals from the selected catheters in the Catheter List appear in the waveform display. Next to each trace
are the electrodes that comprise the signal. In the instance of a bipolar signal, two numbers will appear. The number in the left column
is the positive pole, and the right column is the negative pole. A trace can be configured as unipolar by setting the right electrode to
the dash. The unipolar reference is the System Reference by default, but can be set to the Auxiliary Reference in the
[Amplifier>Settings>References>Unipolar References] Menu.

One or more waveforms can be selected for trace height adjustment. Traces should be smooth lines that are free of excessive noise. If
traces contain excessive noise, check all electrode and cable connections between the patient and the EnSite™ Amplifier. Also, try the
Noise Filter (see “Signal Filters” on page 141 and “Patient Signal Problems” on page 252).

NOTE: Saturated waveforms appear purple in the waveform display. Should this occur, it is advisable to initiate Saturation
Recovery. Refer to “Saturation Recovery” on page 140 for instruction.
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Catheter Input Settings

Catheter Input Settings can only be accessed and displayed in the Setup task workflow with the Catheter
Setup icon selected.

Right click on an electrode input channel in the CIM to display the options for the catheter representation:
■ The Visible checkbox shows/hides the selected electrode.

NOTE: Making an electrode not visible will cause the system to not use the electrode's location
information for EnGuide related functions such as collecting model points, making map tags, or
3D mapping information. Electrograms from the electrode will be available for viewing and
measurement with calipers, but the electrograms will have “No Location” if displayed in
Figure 80. Catheter
Mapping Waveforms. Mapping points will not be taken from electrodes with “no Location.”
settings right-click
NOTE: The visibility of non-functional electrodes on any catheter should be turned off. menu.
■ The Connected checkbox connects/disconnects the selected electrode. When an electrode is
disconnected, its channel becomes available. To reconnect a disconnected electrode, click on the electrode on the catheter image
in the CIM.
■ The Set Distal checkbox moves all electrodes on a selected catheter to new input channels. To move the electrodes, select the
catheter in the Catheter List, position the mouse over the new distal input channel of choice, right-click and check the Set Distal
checkbox. The input channel positions can also be manually moved by clicking and dragging the displayed electrode lines.
■ The Show Lines checkbox shows the mapping lines between the input channels and the electrodes on the catheter representation.
■ The Show Catheter checkbox shows/hides the display representation of the catheter in the CIM.
■ By right-clicking on an electrode in the CIM, it can be checked/unchecked to be Visible or not. An electrode can also be chosen
(checkbox) to be Connected (available) or not.

Catheter Catalog

Figure 81. Catheter Catalog.

The Catheter Catalog contains the most commonly-used SJM catheters. These catheters can be selected from the catalog, or additional
catheters can be added to the Catheter Catalog, for use in a study. See “Selecting a Catheter from the Catheter Catalog” on page 122.
 Chapter 6. Setup EnSite Precision™ Cardiac Mapping System Instructions for Use
126 Catheter Presets ARTEN600004505 Rev. B

Adding a Catheter to the Catheter Catalog

Any catheter in the Catheter List can be added to the Catheter Catalog.
1. Click the appropriate catheter from the catheter list, in the control panel, to add to the Catheter Catalog.
2. Click [Add to Catalog] in the catheter control panel.
3. To manually add a catheter to the Catheter Catalog, follow Steps 1-7 of “Defining a Catheter” on page 122.

Sorting the Catheter Catalog

The Catheter Catalog may contain a large number of catheters, making it difficult to easily locate a desired catheter. The catalog can
be sorted by column headings, or searched for specific text in specific column.
■ To sort the catalog by a column heading, click on the column heading.
■ To search for specific text, select the column heading from the Add Filter drop-down menu then type the desired search text in
the text box.
■ To find the most recently used catheters in the list, click on Last 20 Used.

Deleting a Catheter from the Catheter Catalog

NOTE: Default catheters cannot be deleted from the Catalog. Only user-defined or added catheters can be deleted.
1. Select the catheter to delete from the Catheter Catalog.
2. Click the [ - ] button, and the catheter will be deleted from the Catheter Catalog list.

Catheter Presets

Catheter presets allow for the quick recall of routinely used catheter definition and setups. Certain types of studies may consistently
use the same catheter setup, or defined catheters of the same type. Catheter presets allow for a one time setup of these parameters for
use in multiple studies.

A catheter preset stores all the information needed for each catheter defined in the setup. This information includes:
■ Catheter List
■ Input and Channel Configuration
■ Catheter Signal Settings

The Catheter Presets include catalog or user definitions for each catheter in the list including:

■ Name ■ Type
■ Color ■ Diameter (display in either mm or french size)
■ Number of Electrodes ■ Distal Length
■ Manufacturer ■ Electrode Length
■ Model Number ■ Electrode Spacing
■ Brand Name

NOTE: Waveform height (amplitude) is stored with a preset.

The preset input channel configuration includes corresponding channel numbers to catheter electrodes. A message is displayed if a
preset is loaded after Catheter Setup.
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Loading a Catheter Preset

(Realtime Only)

To load a preset, open the Preset menu in the upper-right corner of the control panel
and select a preset from the list. The menu lists all of the presets in the system.

After the preset is loaded the Catheter List is populated with the catheter names. To
modify a catheter in the list, select the catheter.

Figure 82. Loading a catheter preset.

Saving a Catheter Preset

To save the current catheter setup as a preset, open the Preset menu in the upper-
right corner of the control panel and select Save Preset. In the Save Preset window,
type a name for the preset, and then click [OK].

Figure 83. Saving a catheter preset.

Deleting or Renaming a Catheter Preset

To delete or rename a preset for the current physician, open the Preset menu in the
upper-right corner of the control panel and select Manage Presets. In the Manage
Presets window, select a preset from the list. To delete the preset, click [Delete]. To
rename the preset, double-click on the name then type the new name, or select the
preset to be renamed then click on [Rename]. To add a note for the preset, type in
the Note text area. When renaming is complete, click [Close].

Figure 84. Managing catheter presets.

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128 Sheath Filter Setup ARTEN600004505 Rev. B

Sheath Filter Setup

Description
The Sheath Filter detects and provides visual feedback when all or part of a catheter is in the sheath. When an electrode is detected to
be within the sheath, both visibility and data collection from the electrode will suspend.

A sheath graphic is drawn around the proximal catheter shaft to indicate that the sheath filter is active. The Sheath Filter has three
states:

Table 21. Sheath Filter States

Disabled Enabled Configured

Inactive. Amber colored sheath graphic. A baseline Blue colored sheath graphic. Sheath Filter is
procedure for the selected catheter is active; both enabled and baselined.
required.

Enable and Baseline the Catheter

NOTE: The Sheath Filter is automatically baselined for enabled catheters when model creation begins from that catheter.

To use the Sheath Filter with a traditional catheter:

1. Enable the Sheath Filter by:
■ Selecting the checkbox in Catheter Setup (Figure 85)

OR
■ Selecting the catheter from the Sheath Filter option in the Display Settings right-click menu (Figure 85).

Figure 85. Enable Sheath Filter: from right-click Display menu (left) or Catheter Setup (right)

NOTE: This procedure does not require a contact vs. non-contact position as when using a TactiCath™ Quartz ablation catheter,
but rather requires that all electrodes be out of the sheath.
2. Perform the baseline procedure by first positioning the catheter with all electrodes out of the sheath.
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3. Begin the baselining procedure by:

■ Selecting Set Baseline from the right-click Display Menu (Figure 86)

OR
■ Right-clicking on the Sheath Filter icon in the catheter list item and selecting Set Baseline (Figure 86).

Figure 86. Set Baseline: from right-click Display menu (left) or Catheter Setup (right)
– During the baselining process, a progress bar display in the lower-right area of the window.

NOTE: The baselining procedure may fail if the system determines that electrodes
are in the sheath. This automatic determination can be overridden by
clicking Ignore if it is confirmed by other means that all of the electrodes
are out of the sheath during the baselining process (Figure 87).
Figure 87. Baseline Fail Message

NOTE: The baselining procedure may also fail if there is an impedance error
condition in the incoming data (Figure 88). There is no user override for
this condition.

NOTE: If the Sheath Filter is falsely triggering, a new baseline may be required.

Figure 88. Baseline Impedance Error

Fail Message
 Chapter 6. Setup EnSite Precision™ Cardiac Mapping System Instructions for Use
130 EnSite™ Array™ Catheter Setup ARTEN600004505 Rev. B

EnSite™ Array™ Catheter Setup

(EnSite™ Array™ Catheter studies only)

Fly-Eye

Bar Chart

Figure 89. The EnSite™ Array™ Catheter Setup screen.

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

NOTE: A connected EnSite™ Array™ Catheter must be deployed in the chamber of interest and validated before it can be used
to gather data. Refer to “Validation” on page 118.
1. Use the Amplitude slider to adjust trace height as desired. Evaluate the signals in the fly-eye display. Traces should be smooth
lines that are free of excessive noise. If traces contain excessive noise, check the EnSite™ Array™ Catheter and system
reference patch connections between the patient and the EnSite™ Amplifier.
The Fly-Eye is divided into 64 labeled frames containing EnSite™ Array™ Catheter traces. The A1-A8 column on the left side
of the display has electrodes that progress from the proximal to the distal end of the electrode array. Each of the other columns, B
through H, are arranged in the same manner.
Note: For EnSite™ Array™ Catheter signals, saturated data is also indicated by magenta traces for those signals which are
saturated. Should this occur, it is advisable to initiate Saturation Recovery.
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2. In the fly-eye, evaluate the electrode status and deselect any noisy electrodes. Click on a frame in the fly-eye display to manually
activate or inactivate electrodes. The catheter may have a maximum of eight inactive electrodes. Signals that are either
excessively noisy or display an excessively low signal should typically be turned off. The frame border and label color in each
frame indicates the electrode status:
■ Blue indicates an active electrode.
■ Pink indicates an inactive electrode that was automatically disabled by the system. The EnSite Precision™ Cardiac
Mapping System employs an automatic detection scheme for determining when an electrode on the EnSite™ Array™
Catheter is not functioning properly. The automatic detection scheme can inactivate or activate EnSite™ Array™ Catheter
electrodes as the signal quality changes. If a number of electrodes are automatically disabled, verify that the system
reference electrode is properly connected to the patient’s abdomen and to the NavLink™ Module. Also verify that the
EnSite™ Array™ Catheter is properly connected to the ArrayLink™ Module.
■ Red indicates an inactive electrode that has been manually disabled.
■ Magenta indicates an electrode that has been disabled during the manufacturing process. Up to three electrodes may be
disabled during the manufacturing of a valid catheter. These electrodes cannot be activated.

The EnSite™ Array™ Catheter Bar Chart is a second

method of evaluating electrode status. The chart displays the
signals A1 through H8 as a progression of resistance
measurements. For example, the electrodes on column A of
the EnSite™ Array™ Catheter appear in red; the electrodes
A1 to A8 (proximal to distal) appear in the chart from left to
right.

Figure 90. The EnSite™ Array Catheter bar chart.

The values (displayed with the mean subtracted) start at a high positive value, for the proximal electrodes,
and progress to lower resistances until they become high negative values for the distal electrodes (Figure 90
on page 131).

Each column of electrodes on the EnSite™ Array™ Catheter should form a smooth step-like pattern.
1. Visualize a line that intersects the value of each column, similar to the green line shown in Figure 91 on
page 131. Adjust the Amplitude slider as necessary to visualize the pattern.
2. Identify inappropriate values. Typically, an inappropriate value is represented by any column that
deviates from the expected pattern by over 2 Ohms or over 50% of the column height, whichever is
greater.
3. Use the EnSite™ Array™ Catheter fly-eye display to inactivate electrodes with inappropriate values.

Figure 91. The

EnSite™ Array
Catheter bar chart for
EnSite Array electrode
column A. A green line
intersects each
column; this is an
appropriate pattern.
 Chapter 6. Setup EnSite Precision™ Cardiac Mapping System Instructions for Use
132 EnSite™ NavX™ Navigation and Visualization Technology, Sensor ARTEN600004505 Rev. B

EnSite™ NavX™ Navigation and Visualization Technology, Sensor

Enabled™ Setup

CAUTION: The EnSite Precision™ Surface Electrode Kit is intended for single use only. Device integrity will be compromised by
any reuse, which may compromise patient safety and system performance.
1. Click [Collect Respiration Data] to collect Respiration Compensation
data. When respiration data has been collected, Apply Respiration
Compensation and Apply Respiration Rejection are automatically
turned on. Refer to “Respiration Compensation” on page 137 for more
information.
2. During EnSite™ NavX™ Navigation and Visualization Technology, 1
Sensor Enabled™ studies, the displayed position of all electrodes is
relative to the location of the positional reference.

Click on the System Reference drop-down menu to select an in vivo

electrode that will remain stable during a study.

Choosing the Positional Reference

System Reference- Use of an in vivo electrode as the positional reference

is not required for an EnSite NavX Navigation and Visualization study. The 2
default setting of System Reference may be used. System Reference is best
used when a controlled and regular respiration pattern and minimal patient
movement is expected such as when general anesthesia is used for patient
sedation.

Intracardiac Electrode- When available, an electrode on a stable catheter

such as a Coronary Sinus catheter, may be chosen to serve as the positional
reference. Because an intracardiac electrode moves with the heart during
respiration and patient movement, it is best used when there is the potential
for irregular respiration or patient movement such as when conscious
sedation is used.
Note: The positional reference electrode must remain in a stable position.
A shadow may be placed to help determine stability. The positional
reference electrode should not be used for pacing.

Positional Reference Tool

The Positional Reference Tool is a software feature available during EnSite™

NavX™ Navigation and Visualization Technology, Sensor Enabled™
procedures that alerts the user when there has been acute movement of the
positional reference catheter. It is designed to detect sudden movement of the
positional reference catheter along its long axis that exceeds a preset distance
threshold of 4mm.

Figure 92. The EnSite™ NavX™ Navigation and

Visualization Technology, Sensor Enabled™ setup
window.
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133

This feature requires that the positional reference catheter be located in a stable location throughout the procedure. It is recommended
that the coronary sinus (CS) catheter be used for this purpose. The Positional Reference Tool is intended to be used with a multi-
electrode positional reference catheter, and requires that the positional reference catheter consist of at least 4 electrodes. The Positional
Reference Tool detects positional reference catheter movement by comparing the current position of the positional reference electrode
to its past position. The Positional Reference Tool examines all the electrodes on the positional reference catheter to confirm that the
detected movement is due to actual physical catheter dislodgement.

By default, this feature is not enabled; however, the user can enable or disable this feature at any time during the procedure. If
positional reference catheter movement is detected, the user is provided with several methods to manage the repositioning of the
catheter.

NOTE: The Positional Reference Tool can only be enabled if the positional reference catheter has at least 4 electrodes. If fewer
than 4 visible electrodes are defined, the Positional Reference Tool will not activate, even if the user attempts to set up
and enable the feature.
 Chapter 6. Setup EnSite Precision™ Cardiac Mapping System Instructions for Use
134 Positional Reference Tool ARTEN600004505 Rev. B

Setting Up the Positional Reference Tool

NOTE: The Positional Reference Tool requires that the positional reference
catheter be located in a stable location. It is recommended that the A
coronary sinus (CS) catheter be used for this purpose.

The Positional Reference Tool requires a minimum of 4 visible electrodes on the

positional reference catheter. The visibility of bad electrodes on the positional
reference catheter should be turned off. Refer to the EnSite Precision™ Cardiac
Mapping System Instructions for Use for information about changing the visibility
of electrodes.

Follow these steps to set up the Positional Reference Tool:

1. Select the positional reference catheter and positional reference electrode
from the Positional Reference drop-down menu (Figure 93, right).
2. Check the Catheter in desired location box. B
3. Check the Enable Positional Reference Tool box.
The system will display a message (Figure 95, below) and a progress bar while

Figure 94. Progress bar monitors percent completion of

catheter repositioning

the Positional Reference Tool is being enabled, and another message when the
Positional Reference Tool is enabled (Figure 95, below). The catheter must be
kept in a stable position and not disturbed for the duration of the Positional
Reference Tool’s initialization.

NOTE: Initializing the Positional Reference Tool takes approximately 10

seconds from the time that the [Accept] button is clicked.

Figure 95. The message on the left appears when Positional Reference
Tool is being enabled. The message on the right appears after the
Positional Reference Tool is enabled.

Figure 93. A: These controls are used to set

up the Positional Reference Tool. B: These
controls are used to correct dislodgement.
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135

Positional Reference Catheter Dislodgement

When the Positional Reference Tool detects that the positional
reference catheter has moved at least 4mm from its previous
location, a message will be displayed (see Figure 96, right).

CAUTION: Model points, mapping points, and map tags (labels,

lesions, shadows, etc.) placed at EnGuide within
approximately 15 seconds prior to notification of Figure 96. This message is displayed when the positional
dislodgement may not be based on the previous reference electrode becomes dislodged.
location of the positional reference catheter. The user
should confirm whether these points are valid.
After a dislodgement has been detected, the Positional Reference Tool gives users the option to take immediate action
(click [Adjust Now]) or to take action later (click [Adjust Later]).

CAUTION: If the [Adjust Later] button is selected, the user must be aware that any tasks that rely on the positional reference
catheter’s location may be affected. These tasks include collecting model points, collecting mapping points, placing
labels, placing lesions, etc.

CAUTION: The Positional Reference Tool will not monitor positional reference catheter dislodgements if [Adjust Later] is selected.
To re-enable the Positional Reference Tool and accept the new location of the positional reference electrode after a
dislodgement has been detected, click on [Accept] (see Figure 93 on page 134).

NOTE: If the user wants to reset the Positional Reference Tool and not accept the new location, they should uncheck then recheck
the Positional Reference Tool enabled checkbox shown in Figure 93 on page 134.

CAUTION: In the event that the system notifies the user of both an EnSite Precision™ patch error and a Positional Reference Tool
dislodgement message, the EnSite Precision™ patch error should be addressed first.

CAUTION: In the event that the system notifies the user of both an EnSite Precision™ patch error and a Positional Reference Tool
dislodgement message, the user should verify that the positional reference catheter has physically moved.

CAUTION: Sudden impedance changes of the body or catheter electrodes caused by the connection of other devices (e.g., stimulator,
defibrillator, and other devices) may trigger the Positional Reference Tool. The user should verify the movement before
accepting the adjustment.

How to Verify Positional Reference Catheter Dislodgement

The user should assess the validity of the positional reference catheter dislodgement prior to clicking the [Accept] button in the
Positional Reference Tool window. Once the Positional Reference Tool window is open (see Figure 93 on page 134), the map display
will show a preview of the catheter locations as if the [Accept] button was clicked. If the user wants to reset the Positional Reference
Tool and not accept the new locations, the user should uncheck and recheck the Positional Reference Tool via the check box shown in
Figure 93 on page 134.

The steps below discuss how to assess the validity of the dislodgement prior to accepting the new positional reference electrode
location. With the Positional Reference Tool window open:
1. Assess the position of all the catheters within the EnSite™ NavX™ Navigation and Visualization Technology, Sensor Enabled™
field relative to the created geometry and other known landmarks.
2. Validate against fluoro (if needed).
3. If the catheters are shown in appropriate positions, the user should click [Accept] and the Positional Reference Tool will adjust
and re-initialize. If the user does not think the catheters are shown in the appropriate locations, the user can disable and then re-
enable the Positional Reference Tool by using the check box shown in Figure 93 on page 134. This will disregard the notification
and will not update the position of the catheters.

NOTE: Whenever the user clicks [Accept] the positional reference must be kept in a stable position and not be disturbed for the
duration of the Positional Reference Tool’s re-initialization.
 Chapter 6. Setup EnSite Precision™ Cardiac Mapping System Instructions for Use
136 Positional Reference Tool ARTEN600004505 Rev. B

Managing Positional Reference Catheter Dislodgement

Managing the dislodgement of the positional reference catheter is done in the EnSite™ NavX™ Navigation and Visualization
Technology, Sensor Enabled™ Setup task. If [Adjust Now] was clicked at the time of dislodgement notification, the system will
immediately enter the EnSite™ NavX™ Navigation and Visualization Technology, Sensor Enabled™ Setup task. If [Adjust Later]
was clicked at the time of dislodgement notification, the user will need to manually enter the EnSite™ NavX™ Navigation and
Visualization Technology, Sensor Enabled™ Setup task. When the EnSite™ NavX™ Navigation and Visualization Technology,
Sensor Enabled™ Setup task is entered (either by selecting [Adjust Now] or manually selecting the EnSite™ NavX™ Navigation and
Visualization Technology, Sensor Enabled™ Setup task in the Setup Workflow section) the display will show the current location of
the positional reference catheter as well as a preview of where the other catheters will be located if the adjustment is accepted. A yellow
sphere will surround the previous location of the selected electrode on the positional reference catheter and a dashed line will connect
the current location of the selected electrode with the previous location of that same electrode (see Figure 97 below).

The user can choose to manually reposition the positional reference electrode using the yellow sphere and dashed line as a guide
(catheter movement will appear damped). To return the positional reference electrode to its previous position, move the positional
reference catheter until the positional reference electrode moves into the yellow sphere and the sphere turns green (see Figure 97
below). The yellow sphere will turn green once the selected electrode is within 4mm of the previous location. When satisfied with the
readjusted position, click [Accept]. This will reset the Positional Reference Tool with the new coordinates of the selected electrode.
When the user selects [Accept] the new location of the positional reference catheter is set. All other catheters will be displayed relative
to this new position.

The user can also choose to click [Accept] without manually repositioning the positional reference catheter. This will also reset the
Positional Reference Tool with the new coordinates of the selected electrode. When the user selects [Accept] the new location of the
positional reference catheter is set. All other catheters will be displayed relative to this new position. The user should ensure that the
positional reference catheter is in a clinically appropriate, stable location before clicking [Accept].

C B E

Figure 97. A and B show the previous position of the positional reference catheter and electrode. C and D show the current position
of the positional reference catheter and electrode.To return the positional reference electrode to its previous position, move catheter
C until electrode D is within the yellow sphere, in which case the yellow sphere will turn green. E shows the positional reference
electrode properly adjusted.

A progress bar (beneath the control panel) can be seen while the re-
initialization is in progress (see Figure 98, right). When complete, the
system will be ready for continued operation. During that time, some
catheters may temporarily appear to have shifted. Figure 98. Progress bar monitors percent completion of
catheter repositioning
Re-initializing the Positional Reference Tool takes approximately 10
seconds from the time that the [Accept] button is selected.
EnSite Precision™ Cardiac Mapping System Instructions for Use Chapter 6. Setup
ARTEN600004505 Rev. B Respiration Compensation
137

Respiration Compensation

(All studies)

The Respiration Compensation feature is used to compensate for catheter movement caused by a patient’s breathing. It may facilitate
more consistent model creation and lesion marking, and improve navigation stability while placing lesions.

Before Respiration Compensation can be used, the system needs to briefly monitor the patient’s respiration in order to collect
respiration data and calculate a respiration range.

During respiration data collection, all catheters must be in stable positions; then, over a period of 12 seconds, the system collects the
x-y-z coordinate of all located electrodes and the impedance values of all EnSite Precision™ surface electrodes. The system identifies
respiration by a gradual rise in intrathoracic impedance of the EnSite Precision™ surface electrodes. The lowest and highest
impedance values sampled during data collection define the respiration range. This range is referred to as the Respiration
Compensation range.

When respiration data collection is complete, an automatic segment is recorded and Respiration Compensation monitors the EnSite
Precision™ surface electrodes for the impedance pattern of respiration; when respiration occurs, navigation on each electrode is
gradually compensated in correlation with the degree of the impedance change.

When respiration compensation is applied, the system will continually monitor the respiration motion of the catheters and gradually
update the compensation values throughout the study when the individual catheters are in a stable position.

NOTE: If a new electrode or catheter is defined after respiration data collection completes, the user should manually recollect
respiration compensation data.

NOTE: Visibility of bad electrodes on a catheter should be turned off in order to have Respiration Compensation applied to a
catheter. Refer to “Catheter Input Settings” on page 125 for instruction).

NOTE: Respiration Compensation is not applied to the Positional Reference electrode.

NOTE: Respiration Compensation can be turned on and off. If it is turned off and then turned on, it uses the previously collected
respiration data.

NOTE: Respiration Compensation data can be manually collected at any time during a study.

Collecting Respiration Data

(All studies)

The [Collect Respiration Data] button appears on the NavX Utilities subtask on the Setup Task or in the Meters Display in the Tool Bar.

To collect Respiration Compensation data:

1. Be sure that the patient is in a stable respiration pattern and that all catheters are in stable positions.
2. Click [Collect Respiration Data]. Data collection takes
approximately 12 seconds. During this time, a progress box is
displayed (see Figure 99, right). When data collection is complete,
Respiration Compensation is applied and Apply Respiration
Compensation and Apply Respiration Rejection are turned on.

To disable Respiration Compensation, turn off the Apply Respiration

Compensation checkbox. Compensation values are saved, and can be
re-applied at any time.

Figure 99. Respiration Compensation progress bar.

 Chapter 6. Setup EnSite Precision™ Cardiac Mapping System Instructions for Use
138 Respiration Compensation ARTEN600004505 Rev. B

To cancel Respiration Compensation Data collection. click the Cancel button on the progress box (see Figure 99, right). When
Respiration Compensation Data collection is canceled, Apply Respiration Compensation and Apply Respiration Rejection are
turned off.

NOTE: If desired, a respiratory waveform computed from surface electrode impedances can be displayed in the Waveform
Display.

Respiration data can be re-collected at any time during a study. To do so, click on the Meter Displays icon on the tool palette and then
click the Collect Respiration Compensation button, or click the Collect Respiration Compensation button on the control panel in
the EnSite™ NavX™ Navigation and Visualization Technology Setup task. The re-computed Respiration Compensation values
replace all previous Respiration Compensation values.

Re-collecting respiration data is recommended in all of the following situations:

■ After adding electrodes that were not present during Respiration Compensation data collection.
■ After significantly moving a catheter within the heart (e.g., left atrium to right atrium).
■ After significant changes in respiration, such as moving the patient onto or off of a ventilator.
■ Any time that respiratory motion is visible on EnGuide navigation.
■ After the user resolves any EnSite Precision™ surface electrode errors.

Adaptive Respiration Compensation

Select the Update Respiration Compensation check box to enable. Once enabled, Respiration Compensation will continue to monitor
respiration and adapt the compensation applied to any slow changes in the respiratory pattern. Deselect this feature to unapply the
update of Respiration Compensation if desired, making Respiration Compensation static rather than adaptive.

Adaptive Respiration compensation is best used when a controlled and regular respiration pattern is expected such as when general
anesthesia is used for patient sedation.

Adaptive Respiration should be disabled when there is the potential for irregular respiration such as coughing or sleep apnea such as
when conscious sedation is used.

Respiration Rejection
(All studies)

NOTE: Respiration data must be collected to use the Respiration Rejection feature.

The Respiration Rejection feature is used to suspend model point collection and labeling functions when the patient’s respiration falls
outside of a percentage of the Respiration Compensation range.

When the Respiration Rejection criteria is met, the Respiration Meter outline flashes red, and all displayed electrodes flash yellow,
and the following functions are suspended:
■ Model point collection
■ Map labels at the Active Electrode
■ Lesion markers at the Active Electrode
■ Shadow at selected EnGuide
■ Map points

When patient respiration returns to within the Respiratory Rejection threshold, the Respiration Meter outline and displayed electrodes
return to their normal color and the suspended functions resume.

To set the Respiration Rejection threshold, drag the purple bar in the Respiration Meter up or down.

To turn off Respiration Rejection, uncheck the Apply Respiration Rejection checkbox.
EnSite Precision™ Cardiac Mapping System Instructions for Use Chapter 6. Setup
ARTEN600004505 Rev. B EnGuide Stability Monitor
139

Respiration Meter
(EnSite™ NavX™ Navigation and Visualization Technology, Sensor Enabled™ studies, Realtime only)

The Respiration Meter (Figure 100, right) shows the current level of respiration, as computed by the
relative impedance on the EnSite™ NavX™ Navigation and Visualization Technology, Sensor Enabled™
surface electrodes. The data in this display is identical to the respiration waveform available in the
Waveform Display. The units on the meter are a percentage of the Respiration Compensation range based
on the Respiration Rejection sensitivity setting. The Respiration Meter is turned on by selecting the Meter
Displays icon on the Tool Palette and checking the Respiration Meter checkbox. The Respiration Meter
will display by default when Respiration Data has been collected.

If Respiration Rejection is turned on, when the Respiration Rejection criteria is met, the Respiration Meter
outline flashes red, all displayed electrodes flash yellow, model point collection stops, and labeling is Figure 100. Respiration
disabled. When patient respiration returns to within the Respiratory Rejection threshold, the Respiration Meter.
Meter outline and displayed electrode return to their normal color and the suspended functions resume.

EnGuide Stability Monitor

The EnSite Precision™ Cardiac Mapping System has the ability to check for unexpected changes in sensor enabled EnGuide locations.
If the system provides a message that instability has been detected, check for rate or rhythm changes, respiratory changes, or patient
movement. If required, use EnGuide Alignment to adjust the alignment of EnGuides relative to the model. Also, check the status of
the Metal Distortion Meter. If the distortion threshold is exceeded, there could potentially be a shift in the magnetic sensor positions
caused by the presence of metal in the area of the EnSite Precision™ Field Frame.

NOTE: Sensor enabled catheter required, with Field Scaling applied. The EnGuide Stability Monitor only works when actively
tracking sensor enabled EnGuide locations.

Metal Distortion and Distortion Meter

(EnSite™ NavX™ Navigation and Visualization Technology, Sensor Enabled™

studies, Realtime only)

The EnSite Precision™ Cardiac Mapping System has the ability to check for
changes in the distortion of the magnetic field used to locate sensor enabled
catheters. A baseline distortion measurement is taken; then, changes in the
distortion larger than a defined threshold will disable the use of magnetic
location data.
■ This feature is enabled with the checkbox in the Metal Distortion section on
the EnSite™ NavX™ Navigation and Visualization Technology, Sensor
Enabled™ setup tab (Figure 102 on page 140, #1).
■ The visibility of the Distortion Meter can be controlled by selecting the
1 2 3
Meter Displays icon on the Tool Palette and checking the Distortion Meter Figure 101. Metal Distortion Meter.
checkbox.
 Chapter 6. Setup EnSite Precision™ Cardiac Mapping System Instructions for Use
140 EnGuide Alignment ARTEN600004505 Rev. B

Metal Distortion Meter

A Distortion Meter is available that displays the current level of relative magnetic field distortion. The units on the meter have no
physical meaning but correlate to the estimated shift of magnetic sensor positions. The distortion threshold is shown as two dashed
purple lines, which can be adjusted by clicking and dragging on the meter (Figure 101).
■ Before a baseline measurement is made, the meter outline is red (Figure 101, “1”).
■ After a baseline measurement is made, the meter outline is white and the current level of relative distortion is shown as a green
bar (Figure 101, “2”). If the relative distortion exceeds the threshold, the meter outline will be red (Figure 101, “3”).

Baseline Distortion Measurement

A baseline measurement can be taken by clicking the Set Reference State button
(Figure 102-2) on the EnSite™ NavX™ Navigation and Visualization Technology,
Sensor Enabled™ setup tab. A baseline measurement will be automatically taken
when model collection begins if one has not been taken.

Figure 102. EnSite™ NavX™ SE Setup Tab

EnGuide Alignment

(EnSite™ NavX™ Navigation and Visualization Technology, Sensor Enabled™ studies only)

In the control panel, click [Show EnGuide Alignment] to initiate EnGuide Alignment. If there are changes in catheter location that
cannot be adapted by navigating the positional reference electrode, EnGuide Alignment allows for visually realigning the catheter to
the model along the x-y-z- axes.

EnGuide Alignment is used to visually adjust the alignment of EnGuides relative to the model. To align the EnGuides in the workspace,
hold down the <Shift> key and the middle mouse button, and drag the mouse. While dragging the mouse, the EnGuides will move,
but the model remains stationary. Use the middle mouse button to rotate the model. Use the [Apply] checkbox to switch between the
aligned (checkbox on) and unaligned (checkbox off) states. When satisfied with the alignment, click [Accept].

Saturation Recovery

(All studies)
EnSite Precision™ Cardiac Mapping System Instructions for Use Chapter 6. Setup
ARTEN600004505 Rev. B Signal Filters
141

Signals may become saturated by high energy sources such

as a defibrillation pulse. Saturation Recovery allows the
quick recovery of signals to facilitate identification of post-
therapy complexes.
1. From the menu bar, select Amplifier > Settings >
Saturation Recovery.
2. Use the Duration in Seconds slider bar to set the
duration of the recovery period from 0.2 to 2.0 seconds.
3. Click [Recover Now] to Start Saturation Recovery.
Figure 103. Saturation Recovery controls.
Hot key: <F8> starts Saturation Recovery.

NOTE: Signals in the Waveforms Display turn purple during Saturation Recovery.

Signal Filters

Table 22. Signal filter descriptions and default settings.

Filter Description Settings Default Setting

ECG EP Catheter EnSite™

Array™
Bipolar Unipolar Unipolar
NavX Array

Noise Noise filters are 50 - 60 Hz notch filters that reduce OFF, ON OFF OFF OFF OFF OFF
powerline noise. Available settings are On/Off. To
adjust the powerline frequency and filter, see
“Setting the Powerline Frequency” on page 258.

Highpass Highpass filters reduce low-frequency signals (i.e., 0.05, 0.5, 0.5 Hz 30 Hz 2 Hz 2 Hz 2 Hz
repolarization signals) and baseline drift. 1, 2, 5, 10,
20, 30, 40
Hz

Lowpass Lowpass filters reduce high-frequency signals 500, 400, 50 Hz 300 Hz 300 Hz 100 Hz 100 Hz
commonly caused by electronic interference. 300, 200,
100, 60,
50, 40, 30,
20, 10 Hz

Spatial (EnSite™ Array™ signals only) Spatial Filters OFF, ON — — — ON

optimize signals based on the placement of the
EnSite™ Array™. For right atrial placements, the
spatial filter should be turned on.
 Chapter 6. Setup EnSite Precision™ Cardiac Mapping System Instructions for Use
142 Signal Filters ARTEN600004505 Rev. B
EnSite Precision™ Cardiac Mapping System Instructions for Use
ARTEN600004505 Rev. B 143

Model CHAPTER 7

The EnGuide Navigation System

The EnGuide navigation system is used to display catheters and electrodes. The display of an EP catheter in the model window display
is called an EnGuide.

NOTE: The maximum catheter Navigation Accuracy error is 2.0mm in an EnSite™ NavX™ SE field scaled model.

The EnGuide navigation system is turned on and off with the Active EnGuide control. See Figure 104 on page 143.
■ To turn the EnGuide navigation system on, set the Active EnGuide control to any catheter.
■ To turn the EnGuide navigation system off, set the Active EnGuide to None. When the EnGuide navigation system is off, no
EnGuides are displayed. Turning off the EnGuide navigation system can remove the appearance of the EnGuide signal on
recording systems. The EnGuide signal may appear on the other recording systems on the located catheter when using the Array
application and on the surface ECG when using the NavX application.
Hot key: <Shift>+<F5> switches the EnGuide signal between off and the most recently used active catheter. In NavX, using this
Hot key toggles all located and visible catheters.

Setting up EnGuide Navigation

(Realtime mode only)

The EnGuide navigation system can be used to locate one or more conventional EP catheters. The maximum number of electrodes that
can be located varies by study type. For EnSite™ NavX™ Navigation and Visualization Technology studies, the maximum number
of electrodes that can be located is 132, and the maximum number of electrodes per catheter is 32. For EnSite Array studies, the
maximum number of electrodes that can be located is 4, and the maximum number of electrodes per catheter is 32. See “Connecting
Diagnostic Catheters” on page 79 for information about which catheter inputs can be located in Array studies.EnGuide setup is
typically done as a part of the Setup task at the beginning of a study. Refer to “EP Catheter Setup” on page 119 for more information.

If an EnGuide is displaying fewer electrodes than expected (based on catheter settings), the electrodes may be too close to one another
for the EnGuide to display different electrodes, or there may be a problem with an electrode, such as a short.

Active EnGuide and Active Electrode

The Active EnGuide and Active Electrode are the catheter and electrode
that are used for creating surfaces, placing labels, placing lesions, and
collecting points for maps.

The controls for selecting the Active EnGuide and Active Electrode are Figure 104. The Active EnGuide and Active Electrode
located at the left side of the Tool Bar. Use the drop-down menus to controls. The Active Electrode is green.
change these values. The Active Electrode is green; all other electrodes
are silver (Figure 104 on page 143).
 Chapter 7. Model EnSite Precision™ Cardiac Mapping System Instructions for Use
144 The EnGuide Navigation System ARTEN600004505 Rev. B

EnGuide Responsiveness
The response speed between catheter motion and the EnGuide navigation display
is adjustable using the EnGuide Responsiveness slider on the EnGuide Displays
on the Tool Palette, as shown in Figure 105 on page 144.

Faster response settings show all catheter motion, while more stable settings may
reduce the influence of respiration and cardiac motion. The default setting for
EnSite™ NavX™ Navigation and Visualization Technology is mid-range. For
EnSite Array™ Catheter studies, the default setting is “Fast”.

Figure 105. The EnGuide Displays settings

menu.
EnGuide Proximity Indicator
The EnGuide proximity indicator represents the position of the Active Electrode.
The position of the indicator is size scaled based upon the distance from the Active
Electrode to the closest model surface. The proximity indicator is drawn on the
surface as a colored translucent spot, matching the color of the Active Electrode
(Figure 106 on page 144). The maximum diameter of the proximity indicator can Figure 106. The proximity indicator is a green
be displayed based on either the current lesion size or by checking the Fixed spot on the surface nearest the Active Electrode.
Proximity Indicator box, located under the drop-down menu in the map display
under the eyeball. See “Map Settings Properties” on page 171 for more
information on the Fixed Proximity Indicator.

NOTE: The Proximity Indicator only displays on finished surfaces.

Surface Proximity
The surface proximity distance is the distance from the Active Electrode to the model or DIF surface (Fusion must be applied). To
display this measurement on an EnSite™ NavX™ Navigation and Visualization Technology model, field scaling must be applied. The
proximity distance is displayed at the bottom of the map display in the following fashion: the current value, followed by the average
calculated value over 12 seconds, shown in parentheses. A negative value indicates that the electrode is inside the model surface, while
a positive value indicates the electrode is outside the model surface. The surface distance can be disabled by unchecking the Proximity
to Surface checkbox, located under the Meter Displays menu on the Tool Palette.

NOTE: The surface distance is displayed even if the EnGuide proximity indicator is not displayed.

R Value and Z Value

(EnSite™ Array™ Catheter studies only)

When the EnGuide navigation system is on, R values and Z values appear at the bottom of the
map display. (Refer to labels A and B in Figure 107 on page 144).
■ R Value (label A) - is the distance in millimeters from the center of the electrode array on
the EnSite Array to the Active Electrode.

NOTE: For the most accurate electrogram reconstruction, the R Value should be within 40 A
mm.
■ Z Value (label B) - is the distance in millimeters of the Active Electrode above or below the B
equator of the electrode array on the EnSite Array. When the Active Electrode is nearer to
the distal end of the EnSite™ Array™ Catheter, the Z value is negative. When the Active
Electrode is nearer to the proximal end of the electrode array, the Z value is positive.
Figure 107. A: R value; B: Z value.
EnSite Precision™ Cardiac Mapping System Instructions for Use Chapter 7. Model
ARTEN600004505 Rev. B The EnGuide Navigation System
145

EnGuide Navigation Indicators

EnGuide electrodes change color to indicate various conditions.
■ Green or silver – Conditions are normal.
■ Blinking Yellow/Green – (EnSite Array studies only) This condition only occurs if a problem is indicated in the Active Electrode.
■ Yellow – (EnSite™ Array™ Catheter studies only) The preselected EP catheter electrode is more than 6 cm from the EnSite™
Array™ Catheter, or the EnGuide signal is weak. If electrodes within 6 cm of the array appear in yellow, there may be a problem
with the catheter. A new catheter or connecting cable may display better results.
■ Yellow – (All studies) The Respiratory Rejection threshold has been met when the Active Electrode is blinking yellow and the
electrodes on all EnGuides are colored yellow.
■ Yellow – (All studies) The Velocity Filter threshold has been exceeded when electrodes on any catheter are colored yellow.
■ Blinking red – There is a significant error. The location may be unreliable and 3D graphics (labels, lesions) cannot be placed at
the Active EnGuide.
– EnSite™ Array™ Catheter studies: If the Active Electrode is red, the locator points straight out of the end of the array.
– EnSite™ NavX™ Navigation and Visualization Technology studies: If the EnGuide electrodes turn red and point upward,
there is a problem with one of the following: A surface electrode, the Active Electrode, a Non-Active EnGuide at the distal
electrode. A warning appears indicating which electrode is causing the problem. See “Troubleshooting” on page 245.

Velocity Filter and Velocity Meter

(All studies)

The Velocity Filter prevents model point collection during rapid catheter
movements. When the velocity of any electrode used to collect model points
exceeds a user-specified percentage of the electrode’s velocity (the velocity
threshold), model point collection is suspended only for those electrodes exceeding
the threshold for a user-specified period of time.

Model point collection resumes after the lockout period only if the velocity of all
electrodes has returned to a value below the velocity threshold. Velocity Filter
settings are active only during model creation.

The Velocity Meter shows the relative velocity of the Active Electrode (green bar)
and the velocity threshold (purple bar). The meter’s border, normally white, flashes
red if the velocity exceeds the velocity threshold during model edit or OneMap.

To display the Velocity Filter controls, click on the Meter Display icon in the Tool
Palette. Put a check in the Velocity Filter checkbox to turn the Velocity Filter on.
Uncheck the box to turn the filter off. Use the Filter Lockout in Seconds slider to
set the collection lockout period. The Velocity threshold value can be set by
dragging the purple threshold line, in the Velocity meter, to the desired location.

Figure 108. Velocity Meter and Velocity Filter

controls.
 Chapter 7. Model EnSite Precision™ Cardiac Mapping System Instructions for Use
146 Modeling ARTEN600004505 Rev. B

Modeling

The EnSite Precision™ Cardiac Mapping System displays contoured, three-dimensional surface models of the patient’s cardiac
anatomy. The purpose of creating a model is to collect and label the anatomic locations within the chamber. The software does not
assume a specific chamber shape; therefore, it is important to collect enough points to provide sufficient chamber definition. A single
model may consist of multiple surfaces.

A surface is created by dragging a selected catheter to locations within a cardiac structure. As the catheter moves, points are collected
at and between all electrodes on the catheter. A surface is wrapped around the outermost points. This process can be repeated to create
multiple surfaces. If surfaces in the same group overlap, the surfaces combine and the overlapping section is clipped away.

WARNING: The EnSite Precision™ Cardiac Mapping System model display should be used in conjunction with conventional EP
techniques to confirm catheter location.

NOTE: A model is not required for EnSite™ NavX™ Navigation and Visualization Technology, Sensor Enabled™ studies, but
is required in order to use Field Scaling. Field Scaling is based on model points collected and requires that model points
collected include representations of all 3 axes in all areas of the model. Known interelectrode spacing used to create the
model is used to adjust the dimensions of the navigation field.

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

Impedance and Magnetic Data

The EnSite Precision™ Cardiac Mapping System will collect impedance-based (NavX) points and magnetic-based (NavX SE) points.
During model collection, both NavX points and NavX SE points are collected from a Sensor Enabled™ tool. Field Scaling can then
be applied using either data set to optimize the model.

NOTE: The maximum allowable Tracking Accuracy error in an EnSite™ NavX™ SE field scaled model is 10%.

NOTE: NavX SE field scaling adjusts the dimensions of the navigation field based on both the position and orientation of
magnetically located sensors and the electrodes on Sensor Enabled™ tools.
■ EnSite™ NavX™: Scale field based on entered interelectrode spacing
■ EnSite™ NavX™ SE: Scale field based on magnetically-located sensor location

EnSite™ NavX™ SE Points

During the model creation process, magnetic data is represented in the system by orange EnSite™ NavX™ SE points. Select the
EnSite™ NavX™ SE checkbox to display these points in addition to the green impedance based model points.
■ Collect EnSite™ NavX™ SE points globally throughout the model to ensure an accurate distribution of sensor data within the
field.
EnSite Precision™ Cardiac Mapping System Instructions for Use Chapter 7. Model
ARTEN600004505 Rev. B Modeling
147
Respiration Gating
In order to reduce the effects of respiration on the quality and consistency of EnSite™ NavX™
Navigation and Visualization Technology, Sensor Enabled™ points, the system is designed to
collect points only during the end expiration period when the lungs are nearly empty. This process
is referred to as Respiration Gating.

The location of the PRS-A, as determined by the magnetics tracking system, is used to detect end
expiration. The system can be configured to display a gating signal that indicates when it is
collecting EnSite™ NavX™ Navigation and Visualization Technology, Sensor Enabled™ points, Figure 109. Respiration Gating
corresponding to when it has detected end expiration. The signal will alternate between high and Display
low values when actively gating, indicating periods of end expiration and inspiration / expiration.
If the gating signal is not alternating between high and low values, this indicates that the system
is unable to detect end expiration. In addition to the Respiration Gating signal, the system will display an indication of the Respiration
Gating status in the Data Quality indicators area (Figure 110). This Data Quality indicator will display once respiration compensation
has been performed and the EnSite Precision™ system hardware is connected. When the Respiration Gating status is unknown to the
respiration compensation algorithm, the Data Quality indicator will display gray.

When the system is able to produce a valid Respiration Gating signal (alternating between high
and low values corresponding to observed patient respiration), the respiration compensation
algorithm will adjust electrode locations to their end expiration locations. The Data Quality
indicator will display green when the Respiration Gating is valid and used for respiration
A
compensation. If a valid Respiration Gating signal cannot be achieved, the respiration
compensation will adjust electrode locations to the locations corresponding to the midpoint of
respiration as detected by the impedance-based respiration waveform. The Data Quality indicator
will display amber when the Respiration Gating is invalid and not being used for respiration
compensation.

In an EnSite™ NavX™ Navigation and Visualization Technology, Sensor Enabled™ study, it is B

important to have a valid Respiration Gating signal prior to collecting respiration compensation.
Figure 110. Respiration Gating
status is (A) Valid and (B) Invalid
There is an option to view the gating waveform in the Respiration section of the Waveform
Display menu (Figure 109).

Figure 111. Respiration Gating Signals

 Chapter 7. Model EnSite Precision™ Cardiac Mapping System Instructions for Use
148 Modeling ARTEN600004505 Rev. B

Point Display
With the enhanced point density of impedance based model points, it may be difficult to visualize
the orange EnSite™ NavX™ SE points within the dense cloud of green. Turn off visualization of
the green impedance points by selecting None from the Points drop-down menu. This in
combination with the selected EnSite™ NavX™ SE checkbox, and shown here with edge
enhancement, will allow visualization of only the Sensor Enabled™ data which can help direct the
operator to areas that may be underrepresented with sensor data.

Figure 112. Points Display

Point Pairs
Looking closely at the EnSite™ NavX™ SE point pairs, the points are made up of two components:
■ The orange sphere, which corresponds to the location of the electrode located within the EnSite™ NavX™ impedance field
■ The tail of the point pair, which points toward the corresponding sensor location

Model Presets
Model presets are used to initialize a model using a predefined list of surfaces. When a model preset
is loaded, the surfaces don't exist, but they have properties such as names and colors. This list can
serve as a starting point for which surfaces to collect points. Model presets tend to fall into two
categories. A study-type model preset is for surfaces that are appropriate for a specific study type.
An anatomy study-type model preset is for surfaces that refer to a specific anatomical group.

The following attributes are included in model preset: color, name, grid type, show, detail level
(surface type), fill level, group.

Loading a Model Preset

(Realtime Only)

To load a Model Preset, open the Preset menu in the upper-right corner of the control panel and
select a preset from the list.

After the preset is loaded, the Surface List is populated with surface names saved in the model
Figure 113. Model Preset
preset. To modify a surface in the list, select the surface.
Menu.
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Saving a New Model Preset

To save the current model setup as a preset, open the Preset menu in the upper-right corner of the
control panel and select Save Preset. In the Save Preset window, type a name for the preset, and
then click [OK].
Figure 114. Save Preset.
Deleting or Renaming a Model Preset
To delete or rename a preset for the current physician, open the Preset menu in the upper-right corner
of the control panel and select Manage Presets. In the Manage Presets window, select a preset from
the list. To delete the preset, click [Delete]. To rename the preset, double-click on the name then type
the new name, or select the preset to be renamed then click on [Rename]. To add a note for the preset,
type in the Note text area. When renaming is complete, click [Close].

Figure 115. Manage

Presets.
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Model Control Panel

From. Points can be collected using the active electrode, all electrodes on the active
EnGuide, or all electrodes on all EnGuides. Select from the drop-down menu.

Collect Points. Clicking on this button allows the user to continually collect points to create
a surface model.

Name. The name of the surface. Select a name from the drop-down menu, or type a name.

Group. The Group drop-down menu allows a surface to be associated, generally in terms of
blood pool. Selections are Left, Right, and Other. Overlapping surfaces from the same group
are automatically cut away. Overlapping surfaces from different groups are not cut away.

Type. These radio buttons control the level of surface detail. Select High or Low when not
creating the model with the OneModel tool. Select OneModel when using the OneModel tool
to create the model.

Center. (For Type set to High or Low only) Controls how the center of the model is defined.
■ Auto – The center of the model is based on the average location of the points collected.
Auto is the default setting.
■ EnGuide – The center of a model is at the Active Electrode.
■ Fixed – In EnSite Array studies, the first surface uses the Fixed setting and cannot be
changed. The surface uses the EnSite Array as the center point.

Fill. Controls the level of surface detail. As the slider is dragged to the right, the surface detail
smooths.

Points. This dropdown menu shows/hides the collected points. Hiding points is useful if they
begin to obscure navigation. Showing points is useful for evaluating areas requiring further
collection.

Edit Surface – When selected, the currently selected surface can be edited.

Edit Points – When selected, point editing is active. To select points in the
selected surface, click and drag to create a closed loop around the desired points.
Once the loop is closed the selected points will be highlighted. These points can
then be deleted, assigned to another surface, or copied to another surface.

The delete operation can be undone by clicking [Undo].

Color Picker – Next to the surface Name drop-down menu, there is a colored Figure 116. Model control panel.
square. Click this button to bring up a menu of color options for the surface.

[Delete Points]. When enabled, the [Delete Points] function allows the user to use the
mouse to erase selected points from the model.

[Discard Changes]. Discards model point editing on the selected surface except for a reassigned or copied point.

CAUTION: Discard Changes will delete all surfaces if the model has not been finished at least once.

Show/Hide Field Scaling. Field Scaling can be computed and applied if point collection is not in progress and catheter electrode
spacing has been specified.
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Color Chart and Visibility Selector

A. Group. The name of the group to which the surfaces belong.

B. Color Chart. Use the color chart to select a color for the item. Click on the colored square
to open the color chart, and then click on the desired color.

C. Grid. The number of clicks (1, 2, or 3) on cylinder will determine where a surface grid is
placed on the model. Clicking once, places the grid on the interior of the model, clicking twice,
places the grid on the exterior of the surface. Clicking a third time turns the grid off.

D. Include/Exclude. This checkbox controls whether a surface is displayed in the model.

When the check mark is visible, the surface is displayed for labeling, intersecting, and
overlapping surfaces. When the checkbox is unchecked, the entire surface is excluded from
view.

E. Show/Hide. Use the visibility icon to show or hide the item. When the icon is showing, the
item is visible. To hide the item, click on the icon. Hiding an item does not delete the item. Figure 117. Color Chart & Visibility
Selector.

Collecting Surface Points

(Realtime mode only and requires that the EnGuide navigation system be enabled.)

NOTE: For studies where Field Scaling is used, be sure that appropriate interelectrode spacing and size are specified for any
catheter that is used for collecting points.

NOTE: If a catheter is to be used to collect Model points, and Field Scaling is to be applied, the electrode size and spacing
information entered into the catheter description must match the information provided by the catheter manufacturer.
Model points collected with catheters that are inappropriately described may yield unexpected Field Scaling results. This
cannot be corrected by re-entering correct information after the fact. However, Field Scaling is an option which can be
unapplied if unexpected results occur.

NOTE: For optimal use of the Field Scaling feature, the points collected should represent all 3 axes (x-y-z) in all areas of the
model.

Flexible Workflow Options

You can choose the point collection workflow to accommodate patient needs: begin with a Sensor Enabled™ tool or begin with a non-
Sensor Enabled™ tools. Using either of these workflows will result in the same model with an added level of dimensional accuracy
provided by the addition of magnetic data.

NOTE: Using a Sensor Enabled™ tool will allow you to collect magnetic and impedance points simultaneously.

Begin with a Sensor Enabled™ Tool

Begin model creation using a Sensor Enabled™ tool such as the Advisor™ FL Circular Mapping Catheter, Sensor Enabled™. After
model creation begins, initiate and compute EnSite™ NavX™ SE Field Scaling. As more model data is collected, the Field Scaling
algorithm will automatically update. Display the orange EnSite NavX™ SE points to verify global distribution of data. Once 1sensor
data has been collected, you can enter a non-Sensor Enabled™ tool, such as the TactiCath™ Quartz Contact Force Ablation Catheter,
for additional model creation or model touch up. No updates will be made to EnSite™ NavX™ SE Field Scaling since the additional
tool does not contain a sensor.
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Begin with a non-Sensor Enabled™ Tool

The other option is to begin model creation as always using any tool, such as the Inquiry™ Afocus II™ double loop electrophysiology
catheter. Then introduce a Sensor Enabled™ tool, such as the FlexAbility™ Ablation Catheter, Sensor Enabled™, to move throughout
the chamber and collect a global distribution of sensor data. Again, visualize the EnSite™ NavX™ SE points to verify that sensor data
has been collected in all areas. Then apply and compute EnSite™ NavX™ SE Field Scaling.

Collect Points
1. Set the Active EnGuide that is to be used to collect points.
2. Click the [+] button in the control panel to create a new surface.
3. Use the Name drop-down to select an existing surface name, or type the name of the new surface.
4. Use the Group drop-down to associate the surface with a group: Left, Right, or Other.
5. Click [Collect Points] to begin collecting points on and between electrodes of the Active EnGuide. Drag the catheter along the
chamber walls and throughout the interior to create a surface.
A surface appears:
■ For an EnSite™ Array™ Catheter study, the first surface appears around the wireframe of the EnSite™ Array™ Catheter.
■ For subsequent surfaces of EnSite™ Array™ Catheter and all EnSite™ NavX™ Navigation and Visualization Technology
studies, the surface begins at the center of the Active EnGuide. This does not apply to surfaces created with the OneModel
tool.
6. Click [Stop Collecting Points] to stop collecting points.
7. Click [Finish Model] when model creation is complete. Otherwise, repeat steps 1-6 for all additional surfaces.

Edit Points
As the model is created, use the following controls in the control panel to inspect and adjust the model.
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NOTE: Edit EnSite™ NavX™ SE points the same as you would geometry points.
■ To delete points, click the [Delete Points] button (which then changes to [Stop Deleting]). The mouse pointer becomes a square
eraser. Move the eraser over the points to be deleted, and click the left-mouse button to delete. Clicking and holding the mouse
button erases points by dragging. To return recently deleted points to the surface, click [Undo Delete]. To stop deleting points,
click the [Stop Deleting] button; once this is done, [Undo Delete] is not possible.
■ Use the Edit Points tool to move or copy points from the current
surface to another surface, or to delete a large group of points. Click
the Edit Points icon, and then click on the map display to form a
closed shape around the group of points to be reassigned. The
points on the interior of the closed shape turn red. The map can then
be rotated to confirm appropriate selection. Use the Assign to
drop-down menu to move the points, or the Copy to drop-down
menu to copy the points, to one of the available options:
– New assigns the points to a new surface.
– Delete removes the points.
– Existing surface. Selecting the name of an existing surface
assigns the points to that surface.

NOTE: Reassigned and copied points cannot be undone by the

[Discard Changes] function.

Figure 118. The Reassign tool can be used to move

points from one surface to another.
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OneModel Tool

(All studies)

The OneModel tool is a cardiac model creation tool that wraps the model surface tightly around collected points without tying it back
to a center point. It provides enhanced anatomic detail of the cardiac model when creating a single surface model, and reduces the time
required to create a finished model without requiring the user to change the point collection techniques.

Type. These checkboxes determine the method used by the system to create a model with the
collected points. Select the OneModel checkbox to use the OneModel Tool to create the
model.

NOTE: When creating the model, the user can switch back and forth between definition
Types: High, Low, and OneModel. Items projected onto the surface may adjust
their positions based on the surface generated by each type.

Fill. (with OneModel) When using the OneModel Tool, a higher Fill value (shown in the box
to the right of the slider) results in more space between collected points being filled in, but
with less detail. A lower Fill value has less space filled in, but with finer detail. More points
may need to be collected to fill in the gaps.

NOTE: When OneModel is selected, the Center options are grayed out because they are
not applicable to the OneModel Tool.

NOTE: Moving surfaces to separate surface groups can help in situations where visible
separation between surfaces is desired.

Figure 119. Model control panel

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Using the Surface List

After creating a model and/or importing a DIF model, the name of each available structure appears in the control panel surface list.
The list can contain one model with up to 16 created surfaces and one DIF model with up to 16 surfaces.

NOTE: See EnSite™ Verismo™ Segmentation Tool Instructions For Use for further information on creating multiple-structure DIF
models. Structures from DIF models are identified with “DIF.” If the DIF icon is selected, only the DIF control displays.

You can adjust and edit surfaces independently of one another. To adjust a surface attribute, follow these actions:

A B

A B C D E

Figure 120. A: The LSPV is included and shown; B: The LSPV is included, but not shown. The result is a hole in the left atrial body
at the points of intersection.

Table 23. Points Display

Callout Item Description

A Show Surface Click the eyeball icon to show or hide a surface.

Note: A created surface can be included, but not shown. This combination leaves a hole at the intersection between
surfaces. See Figure 120 on page 155.

B Surface Color Double-click the color and select a color from the color picker.

C Grid (Created surfaces only) Click the grid icon to toggle through the display states:
1. Grid off (default)
2. Display the Grid on the inside of the surface
3. Display the Grid on the outside of the surface

D Name Double-click a surface name and type in the field.

E Include (Created surfaces only)

Surface • Select a checkbox to include a surface.
• Deselect a checkbox to not include a surface.
• A surface that is not included is not displayed, used for labeling, or intersecting overlapping surfaces.
Note: Excluding unnecessary surfaces optimizes performance.

F + Add a surface.

- Delete the selected surface.

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Field Scaling

(EnSite™ NavX™ Navigation and Visualization Technology, Sensor Enabled™ only and requires a model.)

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

There are two field scaling options:

■ EnSite™ NavX™ Navigation and Visualization Technology, Sensor Enabled™ (NavX SE): Known offsets between the position
and orientation of magnetic sensor(s) and electrodes on St Jude Medical Sensor Enabled catheters are used to adjust the
dimensions of the navigation field.
■ 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™ Field Scaling
(NavX SE)
Field Scaling is based on points collected in continuous mode by catheters during model
creation. Depending on the location system being used (EnSite™ NavX™ Navigation and
Visualization Technology or NavX™ SE), points are either electrode locations with
measured interelectrode spacing or EnSite™ NavX™ Navigation and Visualization
Technology/NavX™ SE point pairs. Adjustments to the dimensions of the navigation field
are made to match the known points of the catheters to create the NavX™ SE points. In the
case of NavX™ SE Field Scaling, showing NavX™ SE points (see Figure 121 below) will
help ensure good coverage of the chamber, resulting in better NavX™ SE Field Scaling
results.
As the catheter is moved during model creation, the system records the location and
spacing of the sensors on the active catheter. Field Scaling allows tape measure lengths and
closed anatomic marker areas to be computed and displayed.

NOTE: NavX™ SE point pairs can be collected using either NavX™ SE or

MediGuide™ Technology as the NavX™ SE source.
NOTE: After initial connection to the MediGuide Technology™/NavX™ SE system,
the user may notice that MediGuide Technology™/NavX SE Fiducials do not
collect until after approximately 30 seconds has passed, and then start
collecting.

Applying Field Scaling

The process setup for applying Field Scaling is identical for both EnSite™ NavX™
Navigation and Visualization Technology and for NavX™ SE, as follows.
To display NavX™ SE points for Field Scaling, check the NavX™ SE checkbox
(Figure 121).

NOTE: Field Scaling is optional and reversible.

To apply Field Scaling:
1. Click the gear icon at the lower-right corner of the controls.
2. Select the type of Field Scaling to be computed by checking either the NavX or the
NavX SE checkbox from the Field Scaling Options popup.
NOTE: Checking a Field Scaling type different from the one currently applied will
automatically unapply Field Scaling.
3. Click [Compute] to compute Field Scaling. If there are not enough points collected,
an error message will appear, and Field Scaling will not be applied.
4. The Apply check box is automatically checked. To unapply Field Scaling, uncheck
the Apply box. Figure 121. Field Scaling controls
5. (Optional) Select the [Auto] checkbox to enable automatic Field Scaling updates.
When sufficient new NavX™ points are collected, Field Scaling is automatically updated.

NavX™ SE points are not collected under the following conditions:

■ When NavX™ SE locations are invalid
■ When the Active EnGuide is not a sensor enabled catheter
■ When the EnGuide has Stabilize ABL enabled
■ When the Sheath Filter feature has detected that the catheter has been retracted into the catheter sheath
■ When the Metal Distortion is out of range
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158 Field Scaling ARTEN600004505 Rev. B

NOTE: You must have the distal electrode and at least one of electrodes 2, 3, or 4 enabled to collect NavX SE points.

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

Field Scaling is based on model points collected in continuous mode by catheters with
defined interelectrode spacing.

Average measured interelectrode spacing is collected for all locations within the Figure 122. NavX Field Scaling controls.
model. Adjustments to the dimensions of the navigation field are made to match the
known interelectrode spacing of the catheters used to create the model.

As the catheter is moved during model creation, the system records the location of the electrodes on the active catheter, as well as the
relative change in displayed interelectrode locations.

Field Scaling allows for straight line and surface tape measures in EnSite™ NavX™ Navigation and Visualization Technology. If Field
Scaling is not applied, the EnSite™ NavX™ Navigation and Visualization Technology tape measure length is not displayed in the
marker area.

NOTE: For studies where Field Scaling is used, be sure that appropriate interelectrode spacing and size are specified for any
catheter that is used for collecting points.

NOTE: If a catheter is to be used to collect Model points, and Field Scaling is to be applied, the electrode size and spacing
information entered into the catheter description must match the information provided by the catheter manufacturer.
Model points collected with catheters that are inappropriately described may yield unexpected Field Scaling results. This
cannot be corrected by re-entering correct information after the fact. However, Field Scaling is an option which can be
unapplied if unexpected results occur.

NOTE: For optimal use of the Field Scaling feature, the points collected should represent all 3 axes (x-y-z) in all areas of the
model.

To apply Field Scaling:

1. Click [Compute] to compute field scaling.
2. The Apply checkbox is automatically checked. To unapply Field Scaling, uncheck the Apply box.
3. (Optional) Select the [Auto] checkbox to enable automatic Field Scaling updates. When sufficient new NavX points are
collected, Field Scaling is automatically updated.

Model points are not used for Field Scaling under the following conditions:
■ Electrodes having spacing greater than 11.25 mm (center to center)
■ Collecting with a single electrode
■ Catheters without defined interelectrode spacing or electrode length
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Digital Image Fusion (DIF)

Three-dimensional models created from digital images collected from Spiral CT, MRI, and DEMRI (Delayed Enhancement MRI) can
be imported into the EnSite Precision™ Cardiac Mapping System for display.

Creating a Model to Import

Models for import into the EnSite Precision™ Cardiac Mapping System can
be created using segmentation tools such as the EnSite™ Verismo™
Segmentation Tool. Refer to “EnSite™ Verismo™ Segmentation Tool
Module” on page 297 for information on using Verismo.

When using the EnSite™ Verismo™ Segmentation Tool, the creation of a

model involves the following steps.
■ The patient is scanned. See the EnSite™ Verismo™ Segmentation Tool
Instructions for Use for the optimal EnSite™ Verismo™ Segmentation
Tool scan file characteristics.
■ The scanned image is exported to a CD/DVD in DICOM3 format.
■ The CD/DVD is imported into an EnSite Precision™ Cardiac Mapping
System workstation with the EnSite™ Verismo™ Segmentation Tool,
and the segmentation process is used to create a DIF file according to the Figure 123. An imported DIF left atrium.
EnSite™ Verismo™ Segmentation Tool Instructions for Use.
■ If the DIF file is created on the same EnSite Precision™ Cardiac Mapping System DWS that will be used during the clinical study,
the DIF file can be accessed from the hard drive. If the DIF file will be used on a separate EnSite Precision™ Cardiac Mapping
System, the DIF file can be exported to a USB device or CD/DVD for import into the clinical EnSite Precision™ Cardiac Mapping
System.

In addition to the DIF file format, the EnSite Precision™ Cardiac Mapping System also supports CardEP file format for digital images,
as well as Siemens, Phillips, Toshiba (Vital Images), and Terra Recon formats; however, formats other than DIF may not be able to
use all DIF-related functions, such as the ability to show or hide individual chamber surfaces.

Importing a Digital Image

1. Click the DIF icon at the top of the Model control panel.
2. From the DIF control panel, click [Load DIF...]. The Import DIF window appears (Figure 124 on page 159).

NOTE: For loading DIF files before validation, select File > Load DIF...

3. From the Load DIF window, select a DIF file for import. Select
a source, either HardDrive or DVD/CD, for import from the
drop-down menu at the top left corner of the window.
■ HardDrive – DIF files created by the EnSite™ Verismo™
Segmentation Tool on the same EnSite Precision™ Cardiac
Mapping System DWS are stored on the workstation’s hard
drive. As additional models are added, the oldest models
are deleted first. Models can also be manually deleted by
selecting a model from the list and clicking [Delete].
(Figure 124 ).

Figure 124. The Import Digital Images window, Hard Drive.

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160 Digital Image Fusion (DIF) ARTEN600004505 Rev. B

■ DVD/CD – Digital image models can be imported via DVD

and CD. Models can be formatted as Digital Image Fusion
(.xml), or GE DICOM3 models processed using CardEP
software. For GE CardEP models, the original CD/DVD
from the GE workstation is required for import, not just the
file of the model itself. Select an image type to display the
appropriate models. (Figure 125 ).
4. Select [Load] to load the model.

NOTE: The colors applied to the DIF model are the EnSite
Precision™ Cardiac Mapping System software model
colors, not the colors that were used during
segmentation. Figure 125. The Import Digital Images window, DVD/CD.

Additional Options for DIF Files

Models created by the EnSite™ Verismo™ Segmentation Tool have additional features:

Patient information. In the Import Digital Image window, models are displayed with information from the patient, scan, and saved
model name. Clicking on the category name at the top of a column sorts the data by that column.

DIF viewer – A viewer is available for previewing DIF models. Select [View] to display the selected DIF model. The following
controls are available in the viewer:
■ Rotate – Hold down the middle mouse button and drag.
■ Zoom – Use the roller wheel on the mouse.
■ Wireframe – Options > Wireframe.
■ Bounding box display – Options > Bounding Box.
■ Default views – Views > AP/PA/LL/RL/CRA/CAU.

Viewing a DIF Image for Reference

DIF models can be shown or hidden by clicking on the Show DIF Model checkbox in Map Settings.
■ The digital image appears in the map display.
■ To compare the two models, select Dual View. The EnSite Precision™ Cardiac Mapping System model appears on the left side
of the screen, and the DIF model appears on the right side of the screen.

Digital images are saved with rotational information included. The orientation reference will automatically appear for the digital
image.
■ In an EnSite™ Array™ Catheter study, the EnSite Precision™ Cardiac Mapping System model and DIF model rotate together
when an AP view is saved for the map display.
■ In an EnSite™ NavX™ Navigation and Visualization Technology study, the EnSite Precision™ Cardiac Mapping System model
and DIF model rotate together when EnSite™ NavX™ Navigation and Visualization Technology is validated.

NOTE: Clipping, Map Scale, rotation, spin, Edge Enhancement, and panning can be used to change the appearance of the model.
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DEMRI (Delayed Enhancement MRI) Image Integration

The use of delayed enhancement MRI is sometimes used to analyze areas of
electrically nonviable tissues such as areas of fibrosis, scar, or ischemia. The
import of this model type into the EnSite Precision™ System may provide a
faster, higher resolution of substrate over traditional voltage mapping. The
system can now accept Visualization Tool Kit files, or VTK files, and
Visualization Toolkit Polygons, or VTP files. These files are created from a
third-party application rather than through the EnSite™ Verismo™
Segmentation Tool.

Once imported, interaction is similar to a DIF file, with options to view or use
with the EnSite™ Fusion™ Registration module. The DIF list (Figure 127 - 1)
shows both surfaces and associated maps as defined in the third party
application. The color spectrum bar on the left (Figure 127 - 2) is displayed just
as it is for timing and voltage maps within the system. One map tool data set
(Figure 127 - 3) can be displayed on the surface at a time.

NOTE: If using this model in the EnSite™ Fusion™ Registration

process, in single map display, you’ll be able to either visualize Figure 126. DEMRI Image
the associated imported map or project a contact map on the
surface, but not both.

In Split Screen mode, you can display an EnSite model in one screen and the DEMRI in the other.

3
Figure 127. Imported DEMRI Image

File limitations for VTK or VTP files include:

■ Total number of vertices cannot exceed 1,000,000
■ Total number of polygons cannot exceed 2,000,000
■ Polygons are limited to only containing three points (triangles)
■ Only one occurrence of the <Piece> tag is supported
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Waveforms CHAPTER 8

Using the Waveform Display

A typical waveform display that is used in the Model, Therapy, and RealReview tasks is shown in Figure 128 below.

B D D

Figure 128. Waveform display for Model, Therapy, and RealReview tasks.

A. Waveforms – Signals can be simultaneously displayed as waveforms. Each waveform consists of a label and a trace. The label
identifies the source of the signal, and includes whether the signal is unfiltered, whether contact catheters are unipolar, the signal label,
and the signal amplitude. If the traces turn purple, then the data should not be used. Purple signal traces are also used to indicate a
blanking period and saturation recovery.

B. Time cursor – The time cursor is a vertical yellow line in the waveform display that indicates the time represented by the map
display. The specific time represented by the time cursor appears in the lower right corner of the waveform display. The following
controls are available for the time cursor in review mode:
■ Left-clicking in the waveform display background (not on a trace) makes the time cursor appear at the mouse pointer.
■ Dragging the time cursor moves the cursor across the waveform display.

NOTE: In Realtime, the cursor is not shown when one or more waves are visible.

C. Time scale – The time scale (in milliseconds) appears at the top edge of the waveform display. Right-click between waveforms in
the window to display a menu for setting the sweep speed, font size, and waveform thickness.

D. Calipers – Calipers are used to measure timing between signal features in the waveform display during review mode. See “Using
Calipers” on page 165 for information about using calipers.
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Selecting and Adjusting Waveforms

Waveforms can be selected and adjusted by clicking on the waveform in the waveform display.

Selecting waveforms – Shift-left-clicking on a waveform makes the selected

trace bold and displays a dotted white line at 0 mV. Selecting a virtual
waveform trace highlights the virtual electrode for that trace in the map
display and displays the color calipers (Figure 129 on page 164). The color
calipers are rail lines indicating the current Color High and Color Low values.
Shift-left-click on a waveform again to remove the rail lines and color calipers.

Moving waveforms – To move a waveform, left-click on the waveform and

drag up or down.

Adding waveforms – To add a waveform to the waveform display, turn on the

waveform’s checkbox in the Traces control panel.

Removing waveforms – To remove a waveform from the waveform display,

turn off the waveform’s checkbox in the Traces control panel, or left-click on
the waveform and drag it off the left edge of the screen. Figure 129. Rails on virtual waveforms correspond to
current color bar settings.
Adjusting amplitude – To adjust the waveform amplitude, middle-click the
waveform and drag up or down to increase or decrease the amplitude for all
waveforms of that signal type. To adjust the amplitude for a single waveform,
hold <Shift> + middle-click and drag up or down.

Right click in the black background for waveform options menu:

Sweep Speed – Adjusts the number of mm/sec. in the waveform display (time scale).

Reset Offsets – Evenly spaces all visible waveforms vertically in the waveform display, without changing the order of the display.

Reorder Waveforms – Rearranges the waveforms according to the trace number and types as defined by the order in the Traces
control panel (Figure 130 on page 165).

Font Size – Used to select a font size for the label text in the waveform display.

Thickness – Used to adjust the thickness of all waveforms in the waveform display.

Hi/Lo Lines – Doing a shift-left-click on a selected virtual waveform, causes the waveform to bold and for color calipers to display.
The color calipers are horizontal rail lines that indicate the current Color High and the current Color Low values of the selected
waveform. Doing a shift-left-click again will remove them.
EnSite Precision™ Cardiac Mapping System Instructions for Use Chapter 8. Waveforms
ARTEN600004505 Rev. B Displaying and Filtering Traces
165

Displaying and Filtering Traces

Use the Traces tab (Figure 130 a.) to select the signals
to display and the Filters tab (Figure 130 b.) to select
the filtering options for the displayed traces. Signals
are listed in a tree-like structure and can be checked to
be visible or hidden in the Waveform display. The
settings for each signal, including the color, d/dt, and
filtering can be adjusted. Filters can be turned on or off
for individual signals. If the filter settings are changed,
the filter settings for all signals in that group are
changed. By default, ECG signals, EP catheters, and
(for EnSite™ Array™ Catheter studies) Virtuals are
included in the Signals List.

(EnSite™ Array™ Catheter studies only) Use the

Virtuals control panel to set the properties for virtual
electrodes. (For more information refer to “Virtuals”
on page 191).
A B
Figure 130. A: Waves Control Tab; B: Filters Control Tab
Calipers

How to Create a Caliper

In RealReview or Offline Review, while playing a segment of interest, select the [ll] pause button beneath the waveforms. Then select
the  caliper button and select the beat of interest in the waveform display. The cursor will change to a plus sign and ”H”.

Using Calipers
Calipers are used to measure timing between signal features in the waveform display during review mode.
■ The caliper is a set of two vertical lines with a horizontal line between them. The time between the vertical lines is displayed above
the horizontal line in milliseconds. The frequency is displayed beneath the caliper measurement is greater than 1m Sec.
■ Ten calipers can be placed in a recorded segment, and ten per mapping point in the Mapping Task. The calipers in the Mapping
points are saved with the points. Calipers placed in a recorded segment are not saved.
■ To move vertical caliper lines, click on the lines to move that side of the caliper.
■ To move the entire caliper without changing the distance between the vertical lines, middle-click the caliper and drag left or right.
■ To move a horizontal caliper line, left-click and drag the horizontal line up or down.
■ To add a caliper, click the  caliper button, next to the [Show/Hide Wave Controls] button.
■ To remove a caliper, left-click and drag the horizontal line past the top or the bottom of the waveform display.
■ Calipers move with the waveform display. When a vertical line or caliper moves outside of the display area, a small arrow appears
at the edge of the screen. This arrow can be left-clicked to select the vertical caliper line then dragged to bring the caliper back
into the waveform display. The relative caliper position also appears in the segment overview.
 Chapter 8. Waveforms EnSite Precision™ Cardiac Mapping System Instructions for Use
166 Calipers ARTEN600004505 Rev. B

Figure 131. Waveform display for Model, Therapy, and RealReview tasks.

Figure 132. Waveform display for Mapping task.

Figure 133. Waveform display for Setup task.

EnSite Precision™ Cardiac Mapping System Instructions for Use
ARTEN600004505 Rev. B 167

Recording and Playing CHAPTER 9

Segments

Recording Segments

Segment recording is used to save a segment of information to the Notebook for future review. The recording controls are available in
Realtime mode and RealReview mode.
1. From the control bar, click the green [Record] button to begin recording. The [Record] button will change to a orange [Stop]
button. The recorded segment begins approximately 10 seconds before the [Record] button was clicked. The length of the
segment being recorded and the number of segments recorded during the study appear at the top of the Notebook.
Hot key: <F4> key can be used in place of [Record] and [Stop].
2. Click [Stop] to stop recording.
3. An annotation can be added to the segment by typing in the text area on the control bar. Annotations can be added or modified at
a later time from the Notebook.

Automatically Recorded Segments

The system automatically records segments. These automatically recorded segments are added to the Notebook where they are
identified as Auto Segments. Automatic recording occurs under the following circumstances:
■ After validating
■ When the positional reference is changed
■ When positional reference dislodgement is detected
■ When positional reference dislodgement is adjusted and accepted
■ When the user collects Respiration Compensation data
■ Right-click and select Sheath Filter Baseline
■ When the model is finished
■ Before and after EnGuide Alignment
■ Every 15 minutes
■ At the end of a study

NOTE: Auto segments do not appear in the segment drop down menu.
 Chapter 9. Recording and Playing Segments EnSite Precision™ Cardiac Mapping System Instructions for Use
168 Accessing Recorded Segments ARTEN600004505 Rev. B

Accessing Recorded Segments

The purpose of the RealReview task and Offline Review mode is to review data recorded during Realtime mode.

To access a recorded segment (RealReview or Offline Review modes) from the same study, use the notebook:
1. From the list, select a recorded segment or bookmark.
2. Select [Load] or double click on the segment or bookmark name, if doing it from the Notebook in Realtime.

A recorded segment can also be accessed from the Segment drop-down menu in the control bar.

Playing Recorded Segments

Figure 134. Play Bar

[] / []. By default, when RealReview mode is first entered, the system waits for the user to select a segment in that study.
■[] starts the time cursor moving to the right. When the cursor reaches the right edge of the waveform display, segment
playback starts over again. After clicking [], the label on the button changes to [].
■[] pauses playback. After clicking [], the label on the button changes to [].
Time cursor. The time cursor is a vertical yellow line in the waveform display that indicates the time represented by the map display.
The specific time represented by the time cursor appears in the lower right corner of the waveform display.
■ Clicking in the waveform display background (not on a trace) makes the time cursor appear at the mouse pointer.
■ Dragging the time cursor moves the cursor across the waveform display.
■ Moving the time cursor in the waveform display also affects the time represented by the map display.

Arrow buttons. While the waveform display is frozen, the left and right arrow buttons move the time cursor one sample to the left or
right, respectively. Holding down an arrow button causes the time cursor to scroll. To set a sample (in 1, 10, or 100ms), right click on
the right or left arrow keys and make a selection from the windows.

Hot key: The arrow keys on the keyboard can be used to scroll the time cursor left or right.

Review Speed. In Review modes, the Review Speed drop-down menu controls the speed of the time cursor as it moves to the right,
which controls how fast the waveforms scroll across the screen. To choose a speed, click on the drop-down menu button and select a
speed from the available list: 1:1 (real time speed), 1:2 (half speed), 1:4 (quarter speed), 1:10, 1:25, 1:50, 1:100, 1:200, 1:500, 1:1000,
2:1 (double speed), TurboMap (maximum speed).

Overview – The segment overview shows the length of the entire recorded segment in black. The portion of the entire recorded
segment that is shown in the waveform display appears in gray in the Overview.
■ Click and drag the gray area of the Overview to display that area in the waveform display.
■ The time cursor and any placed calipers also appear in the Overview.
EnSite Precision™ Cardiac Mapping System Instructions for Use
ARTEN600004505 Rev. B 169

Adjusting and Labeling CHAPTER 10

Maps

A B D
C
E
F H
I
G
J
K

L M

Figure 135. A Noncontact Isopotential map (left) and (right). Refer to chapters 11 & 12.

Table 24. Map Features

Caption Item Description

A Active EnGuide and The catheter and electrode to use for creating a model, placing labels, and placing lesions.
Active Electrode

B Map Selection (Applies to contact maps only, not shown above) Click button to display the list of map names created during a
study.

C Dual Views/Single Click on this button to select a dual view map/model display or a single view map/model display. The default
View setting is a single view display.

D Map Settings Click to display a list of checkboxes that control how information is displayed in the map display area.

E Orientation Reference This torso-shaped icon indicates the current orientation of the model by rotating as the model rotates. Select
different map views by right-clicking the torso, then selecting from a menu. Refer to “Views and the Orientation
Reference” on page 174.

F Color Controls The color bar depicts how the map display translates numerical data into color. The data varies by map type.
Refer to “Mapping – Noncontact” on page 189 and “Mapping – Contact” on page 201.
• Color High and Color Low handles allow adjustment of current color bar settings.
• Double-click numeric values to directly enter values.
By right-clicking on the color controls the user is able to change to a Grey Scale.
 Chapter 10. Adjusting and Labeling Maps EnSite Precision™ Cardiac Mapping System Instructions for Use
170 ARTEN600004505 Rev. B

Table 24. Map Features

Caption Item Description

G Model The model is the representation of the patient’s cardiac chamber. There are several options for adjusting the
features of the model. A map can be displayed on the model surface.

H Translucency Slider Adjust the translucency of the image for optimal visualization of objects behind other surfaces.

I Edge Enhancement When enabled, provides a rendering of the model where the body can be translucent but the edge remains
distinctly defined.

J Clipping Plane Clipping planes allow for a view of the interior and rear of the closed model by cutting a plane away from the
viewing space. The slider provides a smooth, controlled way of adjusting the clipping plane. Unlocking the
Clipping Plane deletes it.

K Plane Lock Clipping planes can be locked in the model/map display window. When locked, the orientation remains fixed
relative to the model. When unlocked, the orientation is parallel to the screen. To change the orientation of a
locked clipping plane, unlock it, rotate, and lock it again.

L Tracking Virtual (EnSite™ Array™ Catheter studies only) The Tracking Virtual indicates the Peak-Negative location on an
isopotential map. The tracking virtual waveform displays 100 milliseconds of data, based on the location of the
Tracking Virtual. The waveform display can be adjusted by middle-clicking the waveform and dragging up or
down.

M Voltage Caliper The Voltage Caliper displays the measured potential at the selected signal of the Active Electrode. To select the
signal displayed, right click on the Voltage Caliper and select Select Signal.
Select Auto Adjust and the caliper automatically adjusts to the peak to peak value of the waveform.

N Map Highlight When Split Screen is activated, the active view is outlined with a yellow border. To make the other view active,
click once on the black background of the non-highlighted view. The following features are available only for the
highlighted, active view:
• Using the mouse to rotate the model
• Hold <Shift> and rotate the mouse wheel to zoom at the pointer position
• Adjusting the clipping plane
• Adjusting the view scale
• Edge Enhancement
• Saving or loading a Map View
• Using the mouse to delete surface points or place map labels, lesion markers, anatomic markers, tape
measures, or virtual electrodes can only be done in the highlighted view; however, the result of these actions
appear in both views.
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171

Map Settings Properties

Label Text On. This checkbox shows/hides the label text for all map labels, anatomic markers,
tape measures, lesions, virtuals, and EnGuide Shadows.

Label Show Through. This checkbox allows or prevents label text for all map labels, anatomic
markers, tape measures, lesion markers, virtuals, and EnGuide Shadows from showing through
other objects.

Show EnSite Model. This checkbox enables/disables the display of the contoured, three-
dimensional surface model(s) of a patient’s cardiac anatomy.

Show DIF Model. This checkbox allows the DIF model (i.e., CT scan or MRI) to either be
hidden or displayed.

Project on DIF. (After EnSite™ Fusion™ Registration has been performed) Enabling this
checkbox allows the user to project or unproject 3D Labels and/or Lesions (referred to as 3DP),
and map data onto the DIF surface rather than onto the EnSite Precision™ Cardiac Mapping
System model surface.

Show Mapping. Causes surfaces to be colored using the current map color.

Hide Non-Map Surface Groups – Hide surfaces that have no maps projected on them.

Map Transparency On – Check this box to display map colors with values greater than Color
Figure 136. Map settings menu.
High as transparent instead of purple, or (in EnSite™ Array™ Catheter only) charcoal gray in
the gray scale scheme. Areas of the contact map that are not colored will be hidden.

NOTE: Do not check the Map Transparency On box unless a map is currently displayed.

Confidence Region – (EnSite™ Array™ Catheter studies only) This checkbox enables or disables a red highlight on areas of the grid
that are more than 4cm from the center of the EnSite™ Array™ Catheter. Signal and tape measure accuracy can be decreased in these
areas.

Show Proximity Indicator – (EnSite™ NavX™ Navigation and Visualization Technology, Sensor Enabled™ studies only) This
checkbox enables the proximity indicator.

Fixed Proximity Indicator – Enabling this checkbox allows the diameter of the proximity indicator to be set to a maximum of 10mm,
regardless of the current lesion size.

Show EnSite Array – (EnSite™ Array™ Catheter studies only) This checkbox shows the EnSite™ Array™ Catheter.

Zoom – Increases/decreases the size of the model in the display window. The middle mouse / scroll wheel can also be used to zoom.

Color Contour – This slider adjusts the gradation between colors on the map. At low Color Contour values, colors appear as distinct
bands. At high Color Contour values, there is a smooth transition between colors.
 Chapter 10. Adjusting and Labeling Maps EnSite Precision™ Cardiac Mapping System Instructions for Use
172 EnGuide Display Settings ARTEN600004505 Rev. B

EnGuide Display Settings

Show EnGuides – Select this checkbox to show EnGuides in the map display. It does
not disable the EnGuide navigation system. To disable the EnGuide navigation system,
set the Active EnGuide to None, or use the <Ctrl>+<F5> Hot Key. The EnGuide
navigation system must be enabled in order to display EnGuides.

Electrode Numbers – Select this checkbox to show catheter electrode numbers on the
map display to facilitate navigating the ablation catheter to specific electrodes. You can
show electrode numbers on all, some, or none. In Dual View, Split Screen, and
RealReview, this checkbox affects each view independently.

Stabilize ABL – Select this checkbox to enable Stabilize ABL; default setting is off, or
unselected. Stabilize ABL is applied to Ablation catheters or catheters placed in
GenConnect.

NOTE: If Stabilize ABL is enabled for the catheter, NavX points cannot be
collected.

Stabilize ABL corrects the location of the distal electrode based on the properties of the
catheter. ABL electrodes 2, 3, and 4 need to be displayed for Stabilize ABL to be
enabled.

WARNING: Do not use Stabilize ABL in situations where electrodes 2, 3, or 4, on the

ablation catheter, are covered by a sheath.
Active
NOTE: If Stabilize ABL is enabled and the display of electrodes 2, 3, or 4 is EnGuide
turned off, Stabilize ABL is disabled and a message displays to alert the Silhouette
user.

NOTE: If multiple ablation catheters are setup, Stabilize ABL is applied to each
catheter independently and only when appropriate.

Active EnGuide Silhouette – Select this checkbox to produce an outline of the Active
EnGuide, which displays over the model, showing where it resides inside the chamber. Figure 137. Active EnGuide silhouette
The silhouette is displayed in the color selected for the Active EnGuide. Select “Off”, feature.
“Normal”, or “Enhanced”.

EnGuide Responsiveness – This slider controls the response speed between catheter motion and EnGuide navigation.
EnSite Precision™ Cardiac Mapping System Instructions for Use Chapter 10. Adjusting and Labeling Maps
ARTEN600004505 Rev. B Information Display Settings
173

Information Display Settings

Velocity Meter. Displays a meter that shows the relative velocity of catheter movement
as calculated by the Velocity Filter during model creation.

Filter Lockout in Seconds. Adjusts the time in which point collection is suspended
(collection lockout period), in the event that the velocity of the catheter exceeds the
velocity threshold and point collection is disabled. Once the Filter Lockout time is met,
point collection will resume.

Velocity Filter. Calculates the velocity of a catheter as it collects points during model
creation.

Respiration Meter. Displays a meter that shows the current level of respiration, as
computed by the relative impedance on the EnSite™ NavX™ Navigation and
Visualization Technology, Sensor Enabled™ surface electrodes.

Voltage Caliper. This checkbox enables/disables the display of the waveform from the
Active Electrode, located in a window within the lower right corner of the map display.

Tracking Virtual. (EnSite™ Array™ Catheter studies only) This checkbox

enables/disables the display of the red Tracking Virtual icon on the map and the Figure 138. Information display settings
Tracking Virtual waveform window in the lower right corner of the map display. right-click menu.
Electrode Spacing. When this checkbox is enabled, the spacing of electrode locations,
both nominal and measured, (during model creation) are displayed.

Proximity to Surface. This checkbox enables/disables the display of the distance from the Active Electrode to the closest surface. The
distance information is displayed in text at the bottom of the Map Display. A positive number expresses locations outside the chamber,
and a negative number expresses locations inside the chamber.
 Chapter 10. Adjusting and Labeling Maps EnSite Precision™ Cardiac Mapping System Instructions for Use
174 Views and the Orientation Reference ARTEN600004505 Rev. B

Views and the Orientation Reference

(Any mode)

A view is a saved orientation of a model or map (rotation and panning) that is accessible by
clicking a button. The current rotation of the display is indicated by the orientation reference icon
in the upper right of the model or map display (Figure 139 on page 174).

Four predefined views and up to three custom views are available. The predefined views are AP,
LAO, RAO, and PA. The three custom views are user-named.

To access the view controls and the orientation reference settings, right-click on the orientation
reference icon (see Figure 140).

NOTE: In Array mode, the orientation reference icon is gray, until the AP view is defined.
Figure 139. The orientation
Orientation Toolbar reference icon.

The Orientation Toolbar provides one-click access to several model/map views:

Table 25. Orientation Toolbar

Icon Name

Center on surface. Double-click to follow.

Center on Active Electrode. Double-click to follow.

AP view.

LOA view.

RAO view.

PA view.
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ARTEN600004505 Rev. B Views and the Orientation Reference
175

Creating and Saving Map Views

NOTE: If a DIF model is highlighted, map views cannot be saved unless EnSite™ Fusion™
Registration is applied.

To save the current view and settings as the AP view, select Save New AP View from the right-
click menu. Saving the AP view automatically saves the LAO, RAO, and PA views. In the default
settings, LAO is set at -45 degrees from AP, and RAO is set at 30 degrees from AP. These angles
can be adjusted using the LAO Angle Setting and RAO Angle Setting slider bars under the “View
Angles” tab, or the up and down arrows on the keyboard or my manual text entry.
■ For EnSite Array studies, saving an AP, LAO, RAO, or PA map view automatically
establishes the other three views and enables the orientation reference.
■ For EnSite™ NavX™ Navigation and Visualization Technology studies, the orientation
reference and AP view are automatically established at the time of system validation. If a
model is created, and LAO and RAO are undefined, the LAO and RAO views are
automatically established when the model is completed. Saving AP, LAO, RAO, or PA views
also adjusts the orientation reference. The system does not overwrite custom views.

Figure 140. The Views and

orientation reference settings
right-click menu.
To save the current view and settings as a custom view, select Save Views from the right-click
menu. In the Save View window, select View1, View2, or View3, and then rename the view if
desired. The custom view name will be added to the right-click menu.Up to three custom views
can be created. The custom views are independent and do not compute automatically.

To access a view, select AP, LAO, RAO, PA, or a custom view from the right-click menu.

Figure 141. The Save View

window.
 Chapter 10. Adjusting and Labeling Maps EnSite Precision™ Cardiac Mapping System Instructions for Use
176 Views and the Orientation Reference ARTEN600004505 Rev. B

Additional Map Controls

Perspective On. Perspective View displays distant objects appearing smaller than close objects, thereby enabling improved
visualization of the 3D image with a clearer representation of the catheter positions. When Perspective On is selected, zooming in on
the map view transforms a view of the outside surface to that of the inside surface of a chamber. When zooming out, the view of the
inside surface, likewise, changes back to a view of the outside surface of the chamber. In Dual View, Perspective On works
independently for each map.

Show Torso. Shows/hides the orientation reference icon.

Synchronize Dualviews. When in Dual View, turn this checkbox on to synchronize the orientation of the two views and allow both
models or maps to be rotated at the same time.

Centering – A view can be established by centering. Right click on the main display space (on the model). A menu will come up that
includes Center Model At. Selecting this option will display a submenu with 4 options for recentering.
■ Center of Surface(s) – Centers the model within the view. In Dual View,
it works independently for each model.
■ Surface Point – Centers the model at a selected point. When Surface
Point is selected, the cursor changes to a red box with a dot in the center.
With a left mouse click, select the point of interest on the model. The
view is recentered to this point, and a small marker appears at this point.
Exit this mode by selecting off the model surface.
■ Active Electrode – Centers the map display to the active electrode. Figure 142. Center Model menu.
■ Catheter Tip – Centers the model on the desired EnGuide.

Translucence – To support the image integration of co-located models, surface translucency can be applied independently to each
surface. Translucency is applied to All Surfaces as the default setting.

Select the Translucence menu item, then select one or more options:
■ All Surfaces
■ Per EnSite Surface
■ Per EnSite Group
■ All EnSite Surfaces
■ Per DIF Surface
■ All DIF Surfaces

NOTE: When one of these modes is selected, adjustment of the

translucency slider in the map display will apply to the Figure 143. Translucence menu
surface, DIF, or Group currently selected within the Model
or DIF list.
EnSite Precision™ Cardiac Mapping System Instructions for Use Chapter 10. Adjusting and Labeling Maps
ARTEN600004505 Rev. B Labels
177

Labels

Labels (Figure 144 on page 177) are used to identify points on the model. Up to 1024 labels
can be placed during a study.

NOTE: The labels have no intrinsic meaning to the EnSite Precision™ Cardiac Mapping
System. Users can assign their own meaning to labels.

Figure 144. A model with labels.

Placing a Map Label

A
B C D

Figure 145. Label controls. A: Label Name; B: Projection Slider and Spin Box; C: Label at EnGuide button; D: 3D Label at
EnGuide buttonE: Right-click in black background for menu.

1. Select the Label tool on the Tool Palette.

2. Type the label’s name in the Name text area on the Tool Bar or select a name from the drop-down menu. By selecting the drop-
down menu after a name appears in the text area, commonly used names can be added or removed from the drop-down menu.
Note that once a label name is automatically added to the list, it cannot be manually removed.

NOTE: The list in the drop down is cleared at the end of each study.
3. Use the Projection slider (or spin box) to set the projection distance if the label is to be projected.
4. Place the label using one of the following methods:
■ Click on the map or DIF surface to place the label at the pointer location. Clicking repeatedly places multiple labels.
Note: When placing labels with the mouse, labels can be placed on either the DIF model or the created model surface. For
multiple-surface models, the label appears on the surface beneath the pointer.
■ Click [Label at EnGuide] to place a label at a point on the surface nearest to the Active Electrode. For multiple-surface
models, the label appears on the nearest included surface. Label location is projected from the 3D center of the Active
Electrode to the nearest surface. If the surface is edited and the projection distance is exceeded, the label re-projects from the
original 3D catheter location, because the original 3D catheter location is preserved.
■ Click [3D Label at EnGuide] to place a label at the Active Electrode location. This label is not connected to the surface of
the map, but rotates with the model. This function is useful for labeling the location of catheters outside of the chamber.
Note: When a label is placed, it is also added to the Label List in the RealReview task.
 Chapter 10. Adjusting and Labeling Maps EnSite Precision™ Cardiac Mapping System Instructions for Use
178 Labels ARTEN600004505 Rev. B

Selecting and Modifying Labels

Labels can be modified after a model is created by using the Tool Palette and Tool Bar
controls, the Label List and control panel in the RealReview task, or the Label right-click
menu.

NOTE: Labels can only be modified once they have been created.

■ To select a single Label, click on the Label tool in the Tool Palette, hold down
<Shift>, and then click on the item’s name.
■ To select multiple Labels, click the Label tool in the Tool Palette, hold down <Ctrl>,
and then click on each item. Alternatively, click on the Label tool in the Tool Palette,
hold down <Shift> or <Ctrl>, hold down the left mouse button, and then drag a box
around the Labels.
■ To deselect a Label, hold down <Shift> and click away from the Label’s name.

NOTE: When Label is selected, the color of its name changes to white in the
model/map display area.
Figure 146. The Label List is available in
■ To select Labels in a list: the Review task. Use it to modify labels.
– To select a single Label in the list, click on the Label in the list. Use the Tool Palette and Tool Bar controls
– To select multiple Labels in the list, hold down <Ctrl> and click on each label to create labels.
– To select multiple consecutive Labels in the list, hod down <Shift>, click on a
Label, and then click on another Label. Alternatively, click on a Label and drag
to select additional consecutive Labels.

NOTE: When a Label is selected, the color of its name changes to white in the model/map display area.
■ To modify a label using the Tool Palette and Tool Bar, select the Label tool on the Tool Palette, select the label, and then use the
Tool Bar controls to change the label’s name and projection.
■ To modify a label using the Label List and control panel in the Review task, select the Label icon in the control panel, select the
label in the Label List, and then use the control panel controls to modify the label’s visibility, or click [Delete] to delete the label
from the map and the Label List.
■ To show/hide, delete, move, or project a label using the Label right-click menu, select the Label tool on the Tool Palette, select
the label, right-click in the display area to display the Label menu, and then select one of the following:
– Show All Labels shows all labels.
– Hide Selected Labels hides/shows the selected labels. The labels are only hidden, not deleted.
– Delete Selected Labels deletes the selected labels from the map and the Label List.
– Move Selected Label moves the selected mouse placed label only. To move a label, select the label, click Move Selected
Label, and then click on the map at the desired location. Only mouse placed labels can be moved.
– Project Selected Labels changes a label’s projection. A label placed with [Label at EnGuide] is already projected. To move
the label to the original 3D location where the label was placed, turn off Project Selected Labels. A label placed with [3D
Label at EnGuide] is placed at the Active Electrode. To project the label onto the closest surface, turn on Project Selected
Labels.
– Show Labels Through Map makes labels visible regardless of the map orientation.

NOTE: Displayed 3D (D3D) labels can be renamed, deleted, and hidden, but the changes are not saved when the study is ended.
EnSite Precision™ Cardiac Mapping System Instructions for Use Chapter 10. Adjusting and Labeling Maps
ARTEN600004505 Rev. B Anatomic Markers
179

Label Colors
The color of a label indicates the label’s relationship to the surface (Figure 147 on page 179).
■ Green indicates that the label is on the nearest surface.
■ Amber indicates that the label is on the surface, but something is obstructing the label. This could
indicate that the label is on the far side of the model or behind an object such as an EnGuide
electrode.
■ Blue indicates that the label is not tied to the surface (such as 3D labels and EnGuide Shadows).
■ White indicates that the label is selected.
Figure 147. Map label
Anatomic Markers colors.

Anatomic markers connect points on the surface of the model with lines. Closed anatomic markers are useful for drawing valve or
vessel openings on the model; these circular markers can be cut out of the map to show these openings. Up to 256 anatomic markers
can be placed on the map.

Marker display is dependent upon the surfaces that it crosses.

■ If a surface that the marker crosses is deleted, the marker is deleted.
■ If a surface that the marker crosses is not included, the marker is hidden.

The method of calculating the area differs depending on whether or not the marker is cut out.
■ For markers that have not been cut out, the area is calculated for the entire surface encompassed by the marker.
■ For markers that have been cut out, the area is calculated for an averaged plane across the open marker.

Value Display for Markers

■ Shown in the map display next to the marker and in the table. Values are in cm2.

NOTE: Field Scaling must be applied for values to be displayed (EnSite™ NavX™ Navigation and Visualization Technology,
Sensor Enabled™ only).

The Marker List in the RealReview and Review tasks includes the name of every anatomic marker in use.
 Chapter 10. Adjusting and Labeling Maps EnSite Precision™ Cardiac Mapping System Instructions for Use
180 Anatomic Markers ARTEN600004505 Rev. B

Placing Anatomic Markers

A B C D

Figure 148. Anatomic marker controls. A: color control; B: thickness control; C: marker name; D: cutout checkbox; E: right-click
menu.

To place an anatomic marker:

1. Select the Anatomic Marker tool on the Tool Palette.
2. Create the marker by clicking at desired locations on the surface. The marker will be formed by connecting consecutive points.
3. Complete the marker.
■ For closed markers, click near the first point in the marker to close and complete the marker. To remove the center of the
closed marker, turn on the Cutout checkbox.
Note: If the marker encompasses the center of the model, the wrong portion of the model may be cut out.
■ For open markers, right-click in the display area to display the Marker menu, and then select Complete Open Marker or
deselect the Anatomic Marker tool
4. Set the marker’s color and thickness with the Color and Thickness controls on the Tool Bar.
5. Type a name for the marker in the Name text area, or select a name from the drop-down list.
Note: When an anatomic marker is placed on the map, it is also added to the Marker List in the RealReview task.
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181

Selecting and Modifying Anatomic Markers

Anatomic markers can be modified using the Tool Palette and Tool Bar controls, the Marker List in the RealReview and Review tasks,
and the Marker right-click menu.
■ To select a single Anatomic Marker, click on the Anatomic Marker tool in the Tool Palette, hold down <Shift>, and then click on
the Anatomic Marker’s name.
■ To select multiple Anatomic Markers, click on the Anatomic Marker tool in the Tool Palette, hold down <Ctrl>, and then click on
the Anatomic Marker. Alternatively, click on the Anatomic Marker tool in the Tool Palette, hold down <Shift> or <Ctrl>, hold
down the left mouse button, and then drag a box around the Anatomic Markers.
■ To deselect an Anatomic Marker, hold down <Shift> and click away from the Anatomic Marker’s name.

NOTE: When Anatomic Marker is selected, the color of its name changes to white in the model/map display area.
■ To select Anatomic Markers in a list:
– To select a single Anatomic Marker in the list, click on the Anatomic Marker in the list.
– To select multiple Anatomic Markers in the list, hold down <Ctrl> and click on each Anatomic Marker.
– To select multiple consecutive Anatomic Markers in the list, hold down <Shift>, click on an Anatomic Marker, and then click
on another Anatomic Marker, Alternatively, click on an Anatomic Marker and drag to select additional consecutive Anatomic
Markers.

NOTE: When an Anatomic Marker is selected, the color of its name changes to white in the model/map display area.
■ To modify a marker using the Tool Palette and Tool Bar: select the Anatomic Marker tool on the Tool Palette, select the marker,
and then use the Tool Bar controls to modify the marker’s color, thickness, name, and cutout.
■ To modify a marker using the Marker List and control panel in the RealReview task: select the Marker icon in the control panel,
select the marker in the Marker List, and then use the control panel controls to modify the marker’s visibility, or click [Delete] to
delete the marker.
■ To modify a marker using the right-click menu, select the Marker tool on the Tool Palette, select the marker, right-click in the
display area to display the Marker menu, and then select one of the following:
– Show All Markers shows/hides all markers. The markers are only hidden, not deleted.
– Hide Selected Markers hides/shows the selected markers. The markers are only hidden, not deleted.
– Delete Selected Markers deletes the selected markers from the map and the Marker List.
– Move Selected Marker moves the selected marker. Click on one of the displayed marker points to select the marker point to
move, then click the location on the map where the selected marker point is to be moved.
– Complete Open Marker completes the open marker being created.
 Chapter 10. Adjusting and Labeling Maps EnSite Precision™ Cardiac Mapping System Instructions for Use
182 EnGuide Shadows ARTEN600004505 Rev. B

Figure 149. Anatomic markers list and Tool Bar.

EnGuide Shadows

(Any mode)

EnGuide Shadows display a three-dimensional historic image of an EnGuide

catheter position. EnGuide Shadows can be useful in returning a catheter to a
previous position or for confirming that a catheter has remained in position (Figure
150 on page 182). Up to 256 EnGuide Shadows can be placed in the map display.

Figure 150. An EnGuide Shadow.

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ARTEN600004505 Rev. B EnGuide Shadows
183

Placing EnGuide Shadows

Figure 151. Shadow controls. A: shadow name; B: right-click menu.

1. Select the EnGuide Shadows tool on the Tool Palette.
2. Select a catheter from the Catheter drop-down menu on the Tool Bar.
Note: EnGuide Shadow keeps the color of the displayed catheter.

3. Right-click in the display area to display the EnGuide Shadows menu, and then select Add Shadow to place an EnGuide
Shadow at the location of the selected catheter, or select Add Shadow At All EnGuides to place an EnGuide Shadow at the
locations of all catheters.
4. Type a name for the EnGuide shadow in the Name text area or select a name from the drop-down menu. Names appear at the
middle of the EnGuide Shadow display.
Note: When a shadow is placed on the map, it also appears in the EnGuide Shadow List in the RealReview task.
 Chapter 10. Adjusting and Labeling Maps EnSite Precision™ Cardiac Mapping System Instructions for Use
184 EnGuide Shadows ARTEN600004505 Rev. B

Selecting and Modifying EnGuide Shadows

An EnGuide Shadow can be modified using the Tool Palette and Tool Bar controls, the right-click menu, or the EnGuide Shadows
control panel in the RealReview and Review tasks.

For information about selecting EnGuide shadows, refer to “Common Interface Elements” on page 36.
■ To select a single EnGuide Shadow, click on the EnGuide Shadow tool in the Tool Palette, hold down <Shift>, and then click on
the EnGuide Shadow’s name.
■ To select multiple EnGuide Shadows, click on the EnGuide Shadow tool in the Tool Palette, hold down <Ctrl>, and then click on
the EnGuide Shadow. Alternatively, click on the EnGuide Shadow tool in the Tool Palette, hold down <Shift> or <Ctrl>, hold
down the left mouse button, and then drag a box around the EnGuide Shadows.
■ To deselect an EnGuide Shadow, hold down <Shift> and click away from the EnGuide Shadow’s name.

NOTE: When EnGuide Shadow is selected, the color of its name changes to white in the model/map display area.
■ To select EnGuide Shadows in a list:
– To select a single EnGuide Shadow in the list, click on the Anatomic Marker in the list.
– To select multiple EnGuide Shadows in the list, hold down <Ctrl> and click on each EnGuide Shadow.
– To select multiple consecutive EnGuide Shadows in the list, hold down <Shift>, click on an EnGuide Shadow, and then click
on another EnGuide Shadow, Alternatively, click on an EnGuide Shadow and drag to select additional consecutive EnGuide
Shadows.
■ When an EnGuide Shadow is selected, the color of its name changes to white in the model/map display area.To modify an
EnGuide Shadow using the Tool Palette and Tool Bar: select the EnGuide Shadow tool on the Tool Palette, select the EnGuide
Shadow, and then use the Name text area on the Tool Bar to change the name.
■ To modify an EnGuide Shadow using the EnGuide Shadow List and control panel in the Review task: select the EnGuide Shadow
in the EnGuide Shadow List, and then use the checkbox to control visibility or the Delete button to delete the EnGuide Shadow.
■ To show, hide, and delete a shadow using the EnGuide Shadow right-click menu, select the EnGuide Shadow tool on the Tool
Palette, select the shadow, right-click in the display area to display the EnGuide Shadow menu, and then select one of the
following:
– Show All Shadows shows/hides all shadows.
– Hide Selected Shadows hides/shows the selected shadows. The shadows are only hidden, not deleted.
– Delete Selected Shadows deletes the selected shadows from the map and the EnGuide Shadow List.

Figure 152. The EnGuide Shadow list and Tool Bar.

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ARTEN600004505 Rev. B EnGuide Shadows
185

Verifying Catheter Stability

EnSite™ Array™ Catheter. EnSite™ Array™ Catheter stability can be verified using a catheter (such as a CS catheter) that has been
placed in a stable position.
1. Early in the study, use the EnGuide navigation system to display one or more electrodes on a stable catheter.
2. Place an EnGuide Shadow on the stable catheter.
3. Periodically check the position of the EnGuide electrodes and the EnGuide Shadow for the stable catheter. If the EnGuide
electrodes move away from the EnGuide Shadow, suspect that either the EnSite Array or the stable catheter has moved. Use
conventional techniques to determine if the stable catheter has moved.

EnSite™ NavX™ Navigation and Visualization Technology. The stability of diagnostic

catheters can be verified using EnGuide Shadows.
1. Use the EnGuide navigation system to display one or more electrodes on a stable catheter.
2. Early in the study, place an EnGuide Shadow on the stable catheter electrodes.
3. If the catheter moves away from the Shadows, suspect catheter movement (Figure 153 on
page 185).
Note: A shadow placed on an intracardiac positional reference does not move away from
the positional reference electrode. In the event of a positional reference dislodgement, all
other electrodes move from previous shadows.
Figure 153. An example of a
catheter that has moved in an
EnSite™ NavX™ study. The arrow
points to the EnGuide Shadow.
 Chapter 10. Adjusting and Labeling Maps EnSite Precision™ Cardiac Mapping System Instructions for Use
186 Tape Measures ARTEN600004505 Rev. B

Tape Measures

(EnSite™ Array™ Catheter, EnSite™ NavX™ Navigation and Visualization Technology, Sensor Enabled™ with field scaling
applied, DIF surfaces)

Tape measures are used to measure the distance (in mm) between points
on the model of the endocardial surface (Figure 154 on page 186). Up
to 12 tape measures can be placed on the map.

NOTE: Tape measure values can only be as accurate as the

contoured chamber model that they measure.

Figure 154. This map shows two tape measure lines across
the endocardial surface.
EnSite Precision™ Cardiac Mapping System Instructions for Use Chapter 10. Adjusting and Labeling Maps
ARTEN600004505 Rev. B Tape Measures
187

Placing a Tape Measure

A B

Figure 155. Tape measure controls. A: color control; B: type buttons; C: right-click menu.

1. Select the Tape Measure tool on the Tool Palette.

2. Set the tape measure’s color with the Color control on the Tool Bar.
3. Click the desired Type button:
■ [Surface] – connects two selected points on the map with the shortest possible line along the endocardial surface.
■ [Straight Line] – connects two selected points on the map with a straight line.
■ [Radial (RL)] – (EnSite™ Array™ Catheter only) connects a single selected point on the endocardium with the center of the
EnSite Array.
4. Place the tape measure:
■ For surface or straight measures: click on the map at the point to begin measuring, and then drag the mouse to position the
other end of the tape measure.
■ For radial measures: click on the map once to place a tape measure between the selected point and the center of the EnSite™
Array™ Catheter.

The tape measure appears on the map as a colored line. The tape measure’s type and the distance between the points in mm, appear at
the beginning of the tape measure. Up to 12 tape measures (yellow, green, cyan, orange, red, and magenta) can be used.

NOTE: In an EnSite™ NavX™ Navigation and Visualization Technology study, measurements will not be shown if Field
Scaling is not enabled (the line will still show through).
 Chapter 10. Adjusting and Labeling Maps EnSite Precision™ Cardiac Mapping System Instructions for Use
188 Tape Measures ARTEN600004505 Rev. B

Selecting and Modifying Tape Measures

Tape measures can be modified using the Tool Palette and Tool Bar controls, the Tape Measure List and control panel in the
RealReview task, and the Tape Measure right-click menu.
■ To select a single Tape Measure, click on the Tape Measure tool in the Tool Palette, hold down <Shift>, and then click on the Tape
Measure’s name.
■ To select multiple Tape Measures, click on the Tape Measure tool in the Tool Palette, hold down <Ctrl>, and then click on the
Tape Measure. Alternatively, click on the Tape Measure tool in the Tool Palette, hold down <Shift> or <Ctrl>, hold down the left
mouse button, and then drag a box around the Tape Measures.
■ To deselect a Tape Measure, hold down <Shift> and click away from the EnGuide Shadow’s name.

NOTE: When Tape Measure is selected, the color of its name changes to white in the model/map display area.
■ To select Tape Measures in a list:
– To select a single Tape Measure in the list, click on the Tape Measure in the list.
– To select multiple Tape Measures in the list, hold down <Ctrl> and click on each Tape Measure.
– To select multiple consecutive Tape Measures in the list, hold down <Shift>, click on a Tape Measure, and then click on
another Tape Measure, Alternatively, click on a Tape Measure and drag to select additional consecutive Tape Measures.

NOTE: When a Tape Measure is selected, the color of its name changes to white in the model/map display area.
■ To modify a tape measure using the Tool Palette and Tool Bar: select the Tape Measure tool on the Tool Palette, select the tape
measure, and then use the Tool Bar controls to modify the tape measure’s color and type.
■ To modify a tape measure using the Tape Measure control panel in the RealReview task: select the Tape Measure icon in the
control panel, select the tape measure in the Tape Measure List, and then use the control panel controls to modify the tape
measure’s visibility, or click [Delete] to delete the tape measure
■ To modify a tape measure using the Tape Measure right-click menu, select the Tape Measure tool on the Tool Palette, select the
tape measure, right-click in the display area to display the Tape Measure menu, and then select one of the following:
– Show All Tape Measures shows/hides all tape measures. The tape measures are only hidden, not deleted.
– Hide Selected Tape Measures hides/shows the selected tape measures.
– Delete Selected Tape Measures deletes the selected tape measures from the map and the Tape Measure List.
– Move Selected Tape Measure moves the selected tape measure. To move a tape measure, select the tape measure, click Move
Selected Tape Measure, and then click on the map at the desired location.

Figure 156. Tape measures list and Tool Bar.

EnSite Precision™ Cardiac Mapping System Instructions for Use
ARTEN600004505 Rev. B 189

Mapping – Noncontact CHAPTER 11

Types of Noncontact Maps

The EnSite™ Array™ Catheter study Mapping task is used to create noncontact maps. Three types of noncontact maps are available:
isopotential, substrate, and isochronal.
■ An Isopotential map shows voltages sensed by the EnSite™ Array™ Catheter as a three-dimensional map that uses color to
represent a range of electrical potentials across the surface of the heart chamber’s endocardium. This type of map contains the
electrical potentials at thousands of sites on the endocardial surface. As dynamic cardiac signals are viewed in the waveform
display, the same information is animated in the display of the isopotential map.
■ A Substrate map shows relative peak-negative unipolar voltage over a user-specified beat, throughout the chamber. Color in a
substrate map represents relative unipolar voltage levels at each location on the first surface.
■ An Isochronal map shows the progression of activation through the first surface. This type of map is especially useful in locating
functional block or lines of block created by ablation. Color in an isochronal map represents activation time (in milliseconds)
rather than voltage measurements.
 Chapter 11. Mapping – Noncontact EnSite Precision™ Cardiac Mapping System Instructions for Use
190 Interpreting Isopotential Maps ARTEN600004505 Rev. B

Interpreting Isopotential Maps

Figure 157. The noncontact mapping screen.

The EnSite™ Array™ Catheter study uses the dynamic isopotential map and the unipolar electrogram interpretation, in combination,
to identify the earliest activation sites. Map color is used to identify the areas of interest; virtual waveforms are used for confirmation.

NOTE: For multiple surface models, non-contact mapping can only be performed on the first surface.
1. Place virtual electrodes across an area of interest.
2. Locate a beat of interest in the waveform display. Reposition the virtual electrodes on the map if necessary.
3. Place the time cursor within the beat of interest.
4. Use the left arrow button to step the time cursor backward one frame at a time.
5. Adjust the High Pass filter (if necessary) to reduce baseline drift and low-frequency repolarization. Raise the filter as little as
possible, to preserve slow conduction sensitivity.
6. Adjust the color controls to identify isopotential color in the map display and reposition virtual electrodes within the color.
Review the virtual waveform traces to confirm activation.
7. Follow activation through the beat of interest, using color to identify general areas of interest and unipolar electrograms for
diagnosis. Label sites of interest.
8. Use conventional methodologies to confirm diagnosis.
EnSite Precision™ Cardiac Mapping System Instructions for Use Chapter 11. Mapping – Noncontact
ARTEN600004505 Rev. B Virtuals
191

Virtuals

(EnSite™ Array™ Catheter studies only)

By using the mouse to select a pattern of virtual electrodes on the map, virtual waveforms can be displayed based on signals from the
EnSite™ Array™ Catheter. Virtual waveforms are analogous to contact electrograms from conventional EP catheter electrodes.

Virtual waveform parameters can be adjusted as described below. Two sets of parameters for virtual electrograms are available,
Virtuals 1 and Virtuals 2.

A single virtual waveform, called the EnGuide Virtual, can be created from the site on the map surface where a vector going from the
center of the model through the distal tip of the Active EnGuide intersects the first map surface. As the EP catheter moves, so does the
signal location.

Setting Virtual Waveform Parameters

1. Select the Virtuals 1 or Virtuals 2 tab in the Virtuals control panel.
2. Use the Number spin box to select the total number of traces. The total number of
traces is the number of virtual electrodes that appear in the pattern. The number of
waveforms to display can be selected in the Virtuals control panel. A maximum of
16 traces can be used per trace pattern, for a total of 32 for Virtuals 1 and 2.
3. Use the Polarity drop-down menu to select the polarity for the virtual electrogram
signal:
■ Unipolar is a unipolar computation that simulates a signal between the selected
point and the unipolar reference.
■ Longitudinal is a bipolar computation that simulates a conventional EP
catheter (5 mm spacing) aligned with the long axis of the balloon.
■ Latitudinal is a bipolar computation that simulates a conventional EP catheter
(5 mm spacing) aligned with the short axis of the balloon.
■ Laplacian is an omnidirectional computation that simulates a bipolar catheter
pointing directly into the endocardial surface. Laplacian subtracts the
surrounding potentials from the selected point. It has excellent far-field
rejection. Amplitude in Laplacian waveform traces may vary significantly from
conventional bipolar computations.
4. Use the Pattern drop-down menu to select the pattern of virtual electrodes that is to
Figure 158. The Virtuals waveform
appear on the map: control panel.
■ To place a line of virtual electrodes (to simulate an EP catheter), select Line.
■ To place a block of virtual electrodes (to simulate a plaque) select Block.
■ To distribute the virtual electrodes over the entire chamber surface, select
Global. Recommended for use with 10 or more virtual electrodes, this pattern
facilitates searching for an area of interest on the map by evaluating waveform
traces for the first surface.
 Chapter 11. Mapping – Noncontact EnSite Precision™ Cardiac Mapping System Instructions for Use
192 Virtuals ARTEN600004505 Rev. B

Placing Virtuals
1. Set the virtual parameters as described in “Setting Virtual Waveform Parameters” on page 191.
2. Select the Virtuals tool on the Tool Palette.
3. Select Virtuals 1 or Virtuals 2 on the Tool Bar.
4. Use the mouse to place the virtual electrodes on the first surface. Each virtual electrode on the map is labeled with a number.
This number corresponds to the trace number in the waveform display.
■ To place a line of virtual electrodes, click, hold down the left mouse button and drag the mouse from the location where
virtuals will begin to where virtuals will end. Release the left mouse button. Virtual electrodes will be evenly distributed
along the entire path between the start and end points.
■ To place a block of virtual electrodes, click, hold down the left mouse button and drag the mouse from the location where
virtuals will begin to where virtuals will end. Release the left mouse button. Virtual electrodes will be evenly distributed in a
rectangle with the corners determined by the start and end points.
■ To distribute the virtual electrodes over the entire chamber surface (Global Virtuals - see below), click on the map to place
the first virtual electrode. Virtual electrodes are distributed across the first surface.

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

Using Global Virtuals

(EnSite™ Array™ Catheter studies only)

The global virtuals technique offers an approach to localizing areas of electrical interest, by creating virtual electrograms throughout
the first surface, simulating numerous multipolar catheters.
1. After recording a segment of focal arrhythmia, set up Global Virtuals.
2. Use global virtuals to identify a region of focal activation on the map.
a. Select Pattern: Global.
b. Adjust the number of virtual waveforms to be displayed.
c. Click on the first surface to distribute the global virtuals.
3. After identifying several points that display unipolar activation, use block virtuals to locate early activation.
a. Select Pattern: Block and swipe a block of virtual electrodes to encompass the area of interest.
b. Evaluate virtual traces to locate the earliest activation.
4. Confirm the early activation site using isopotential analysis.
5. Use conventional methodologies to confirm diagnosis.
EnSite Precision™ Cardiac Mapping System Instructions for Use Chapter 11. Mapping – Noncontact
ARTEN600004505 Rev. B Interpreting Isopotential Color
193

Interpreting Isopotential Color

Isopotential maps use color to represent voltage. Color on the surface of the map is interpreted by
using the color bar to the left of the main workspace, or the Color High and Color Low controls on
top of the workspace.

The color bar (Figure 159 on page 193) appears as a scale, ranging from +5 mV to
Higher than
-5 mV. Color in the color bar represents the progression of color values in the map
Color High
display. In the default color scheme, colors on an isopotential map’s surface and in
the color bar indicate the following:
■ The Color High value appears on the Color Bar and is represented on the color
bar by the purple caliper.
Color High
■ The Color Low value appears on the Color Bar and is represented on the color
bar by the white caliper.
■ Other colors represent the range of voltages between the Color High and Color
Low values. Color Low

NOTE: Right-click on the Color Bar to invert the color spectrum.

Lower than
Color Low

Figure 159. Color values in the map display.

Color adjustments do not change the underlying data, only the sensitivity of the
display. In Dual View, color controls affect both maps simultaneously.

See Figure 160 on page 193, for the color bar representations (1-3, in yellow) 1 2 3
described below (from left to right):
1. Color bar representing data collected for either an isopotential Local
Activation Time (LAT) or a Voltage Map.
A - Purple caliper - indicates color high
B - White caliper - indicates color low
C - Green caliper - midpoint between high and low
D - Shows the unit of measure (millivolts in this case) A
2. Color bar showing an isochronal LAT based color scale (in milliseconds)
3. Color bar shows a color scale, using a Low-V ID, P-P setting where gray C
shows the areas where voltage is below the set value.
B

Figure 160. Interpreting the color bars.

 Chapter 11. Mapping – Noncontact EnSite Precision™ Cardiac Mapping System Instructions for Use
194 Interpreting Isopotential Color ARTEN600004505 Rev. B

Using Manual Color Controls

Manual color controls provide the greatest amount of control in adjusting
map color.

Color bar calipers – The color bar calipers are used to adjust the map
color. Use the mouse to drag the calipers:
■ The top caliper (purple) adjusts the Color High value.
■ The bottom caliper (white) adjusts the Color Low value.
■ The middle caliper (green) adjusts both the Color High and Color Low
values while preserving the difference between these values.

Color bar scale – The scale of the color bar can be adjusted by selecting
the gray triangular arrows above and below the color bar (Figure 161 on
page 194).

NOTE: By right-clicking on the color controls the use is able to

change to a Gray Scale.

Using AutoFocus Color Controls

(EnSite™ Array™ Cather studies only)
Figure 161. An adjusted color bar scale.
The AutoFocus color controls are designed to automate the
adjustment of the Color High and Color Low values to
highlight early focal activation or small diastolic or pre-
systolic potentials.

The AutoFocus algorithm computes Color High and Color

Low values for each time cursor location. First, the
algorithm detects the Peak-Negative voltage on the map.
Then, the algorithm adjusts the color bar calipers to
percentages from the Upper Limit to the Peak-Negative,
the percentages are based on the AutoFocus sensitivity
setting (Figure 162 on page 194). The effect of AutoFocus
settings on the map display can be seen in Figure 163 on
page 195.

Figure 162. This diagram shows how the AutoFocus algorithm adjusts
EnSite Precision™ Cardiac Mapping System Instructions for Use Chapter 11. Mapping – Noncontact
ARTEN600004505 Rev. B Interpreting Isopotential Color
195

NOTE: Because the AutoFocus algorithm adjusts the

color controls for each sample, it is important
to observe the behavior of the calipers on the
color bar. AutoFocus may occasionally focus
on areas of the isopotential map that are not
relevant to the diagnostic process. These
areas represent electrical signals that are
farther below the Color High setting than the
area of physiologic interest. Such areas may
be generated by repolarization, baseline
drift, EnSite™ Amplifier recovery, etc., and
are differentiated by examining virtual
electrograms at this location. When this Figure 163. These maps show the same timepoint with different
occurs, either adjust the Upper Limit to AutoFocus settings.
display the area of interest, switch to manual
color control, or adjust the High Pass filter.

Enabling AutoFocus color controls – In the control panel, select a sensitivity level from the AutoFocus drop-down menu:
■ Off – AutoFocus is disabled and manual controls are active.
■ Discrete – The discrete setting may be useful for fine localization of early activation sites or highlighting a gap in a line of block.
■ Nominal – The nominal setting provides a balance between finding sites of earliest activation and tracking activation through the
cycle.
■ Broad – The broad setting may be useful for tracking chamber activation through the entire cardiac cycle.

NOTE: The AutoFocus color controls adjust the color bar pointers; however, AutoFocus does not adjust the High Pass Filter.

Adjusting the Upper Limit – The Upper Limit is the highest voltage that the AutoFocus algorithm will consider. The range is 1.00 to
-0.20 mV (default -0.03). Use the Upper Limit slider in the control panel to make fine adjustments to the AutoFocus algorithm.

Adjusting the high pass filter – During isopotential analysis, the high pass filter can be useful for reducing low-frequency signals
(such as repolarization signals) and baseline drift in waveform traces based on EnSite™ Array™ Catheter signals (such as virtual
waveforms). Use the High Pass Filter drop-down menu in the control panel to adjust the highpass filter settings.

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

To disable AutoFocus and use the manual controls, select [Off] from the AutoFocus drop-down menu in the control panel.
 Chapter 11. Mapping – Noncontact EnSite Precision™ Cardiac Mapping System Instructions for Use
196 Using the Tracking Virtual ARTEN600004505 Rev. B

Using the Tracking Virtual

(EnSite™ Array™ Catheter studies, RealReview, and Offline Review modes only)

The Tracking Virtual tool is used to locate and interpret the Peak-Negative
location in the chamber of interest. The Tracking Virtual appears on the map as
a small red icon comprised of eight short lines converging at the Peak-Negative
position. The unipolar virtual waveform from this location appears in a window
in the lower right side of the map display. The window is sized to display 100
milliseconds of data, and the amplitude can be adjusted by middle-clicking the
waveform and dragging up or down.

NOTE: In Review mode, the Tracking Virtual and Voltage calipers can be
displayed simultaneously.

NOTE: Tracking Virtual is displayed only on the first surface.

Labels can be placed at the tracking virtual location by selecting [Label at

Tracking Virtual] in the control panel. Labels are placed as surface labels with
the default text being “Label,” which will appear in the label list in Review task Figure 164. The Tracking Virtual (left) and
(see “Labels” on page 177). Tracking Virtual Waveform.

Substrate Mapping

(EnSite™ Array™ Catheter studies only)

Substrate maps display voltages from noncontact electrograms as ratiometric maps.

A substrate ratiometric map is a single color map that displays relative peak-negative
unipolar voltage over a user-specified beat, throughout the chamber. Color in a
substrate map represents relative unipolar voltage levels at each first surface location.

Figure 165. A substrate ratiometric map of

right atrial sinus rhythm, with substrate map
markers applied.
EnSite Precision™ Cardiac Mapping System Instructions for Use Chapter 11. Mapping – Noncontact
ARTEN600004505 Rev. B Substrate Mapping
197

To understand the substrate mapping algorithm, it is important to remember that every point on the surface represents a virtual
electrogram, each of which could be represented by a waveform trace. For each noncontact electrogram, the substrate mapping
algorithm locates the most negative signal within a user-defined caliper range. The system displays the relative voltages as a
ratiometric map of voltage in one of two ways (Figure 166 on page 197):
■ Global – In a Global substrate map, the system displays
relative color, from 0% (0mV) to 100% of the peak-
negative map value, throughout the first surface.
■ Absolute – In an Absolute substrate map, the system
displays relative color, from 0% (0mV) to 100% of a
user-defined threshold, throughout the first surface.

Figure 166. Definition of Global and Absolute ratiometric substrate

map scales.
 Chapter 11. Mapping – Noncontact EnSite Precision™ Cardiac Mapping System Instructions for Use
198 Substrate Mapping ARTEN600004505 Rev. B

Creating a Substrate Map

1. Select the Substrate tab.
2. If the segment is playing, click [Freeze].
3. Adjust the green caliper to select a single activation sequence.
Note: In the caliper measurement, do not use saturated data, or portions of the waveform
display that have a purple virtual waveform.
4. Use the Type drop-down menu to select Global or Absolute. When using an absolute
setting, use the Absolute Peak Negative mV slider to adjust the threshold.
5. Click the [Apply] button to display a substrate map.
■ A substrate map is a ratiometric voltage map which displays relative voltage values,
based on noncontact electrograms. Color on the first surface represents relative
voltage. The scale of the color bar represents a relative (percentage) voltage range
between the smallest voltage deflection in the chamber and either the (global) Peak-
Negative voltage deflection or a user-specified (absolute) negative value of interest.
Virtual electrograms may be useful in identifying local morphology changes, such as
fractionation. The map can be modified by adjusting the caliper range or
absolute/global map type.

NOTE: Click Apply after adjusting the calipers to update the map.
■ To add a substrate map marker:
a. Adjust the Peak Negative% slider to a percentage of interest.
b. Click [+]. A marker appears at all map locations that match the selected voltage.
Markers appear as a double line. Identifying the high-voltage side of the marker
is a thick line in the selected color. Identifying the low-voltage side of the marker
is a thinner darker line.
c. (Optional) Adjust the marker’s visibility, color, and name using the controls in
the marker list. Adjust the marker’s thickness using the Thickness slider. Names
for substrate map markers only appear in the marker list, not in the map display.
Note: The model surface must be stable before adding a substrate map marker. If the
model is modified after a substrate map marker is added, the marker keeps its 3-
dimensional position, which may not be on the revised model surface.
6. Use conventional methodologies to confirm diagnosis from substrate mapping.

Figure 167. The Substrate Mapping

control panel.
EnSite Precision™ Cardiac Mapping System Instructions for Use Chapter 11. Mapping – Noncontact
ARTEN600004505 Rev. B Isochronal Mapping
199

Isochronal Mapping

(EnSite™ Array™ Catheter studies only; RealReview and Offline modes only)

An isochronal map is a map that represents the progression of activation

through the first surface. This type of map is especially useful in locating
functional block or lines of block created by ablation. In an isochronal map,
color represents activation time (in milliseconds) rather than voltage
measurements.

To understand the isochrone algorithm, it is important to remember that every

point (2048 points in isochrone maps) on the first surface represents a virtual
electrogram, each of which could be represented as a waveform trace. The
isochrone algorithm maps the activation time for each point on the model.
■ Based on a user-defined caliper range, the isochrone algorithm defines the
baseline as the average value (mean) within the caliper range. The calipers
should encompass a single activation sequence.
■ The isochrone algorithm locates Peak-Negative, which is the lowest
negative signal within the caliper range.
■ The isochrone algorithm uses the multiple event sensitivity to locate the Figure 168. A noncontact isochronal map.
event that is used to display activation time.
– An event is defined as a negative deflection in the waveform trace, from the point where the trace crosses below baseline to
the point where the trace crosses above the baseline.
– Multiple event sensitivity is a user-adjustable value representing a percentage between baseline and Peak-Negative (default
40%). The isochrone map displays the first event with a negative deflection that is larger than the multiple event sensitivity.
– Activation time is defined at the midpoint voltage between the baseline and the Peak-Negative of the event. In virtual
waveform traces, this point is displayed as a white tick mark.
■ For each point on the first surface, the activation time is displayed as a color value representing time on the color bar.

Figure 169. Example of a virtual waveform trace used in an isochrone algorithm. Events 1 and 2 are defined by the
points where the trace crosses the baseline. Event 1 is used to display activation, because it is the first event that crosses
the multiple event sensitivity level.
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200 Isochronal Mapping ARTEN600004505 Rev. B

Creating an Isochronal Map

1. Select the Isochronal tab.
2. If the segment is playing, click [Freeze].
3. Place virtual electrodes on the map (“Placing Virtuals” on page 192).
4. Adjust the caliper to select a single activation sequence in a virtual waveform. Best
results are obtained by including flat baseline portions at the ends of the chosen data
selection.
Caution: In the caliper measurements for noncontact isochronal maps and Substrate
Mapping, do not use portions of the waveform display that have purple waveforms.
5. Use the Multiple Event Sensitivity slider to adjust the event size that qualifies as
activation.
6. Click [Apply] to display the isochronal map.
Note: On virtual waveforms, green tick marks in the virtual waveform traces
indicate where the isochrone algorithm declares an activation, if waveform d/dt is
enabled
7. Adjust the color settings to highlight the relevant range of activation times on the
map.

The map can be modified by adjusting the caliper range, or the Multiple Event
Sensitivity slider. Adjusting either the caliper range or the Multiple Event Sensitivity
slider requires that the [Apply] button be clicked again.

NOTE: When reviewing maps or virtuals created using the EnSite™ Array™
Catheter, be sure that the distance between the catheter and the location of
interest is within the desired distances. Figure 170. The isochronal map control
panel.
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Mapping – Contact CHAPTER 12

Figure 171. The contact mapping screen.

 Chapter 12. Mapping – Contact EnSite Precision™ Cardiac Mapping System Instructions for Use
202 Types of Contact Maps ARTEN600004505 Rev. B

Types of Contact Maps

The mapping tool organizes data collected during conventional electrophysiology procedures and displays the data in three-
dimensional maps. During mapping, the clinician samples various heart locations (points) in a stable rhythm using EnGuide-located
conventional catheters. The 3D location of each sampled location (point) is saved along with voltage and activation data, which can
be displayed on the nearest surface as color. A single set of collected data can be used to display several types of maps.

Cardiac Triggered Maps

Cardiac triggered maps use a surface electrocardiogram or an intra-cardiac electrogram as the reference to which collected points are
measured. There are four types of cardiac triggered maps:
■ Local Activation Time (LAT) isochronal maps display color-coded activation times for each collected location (or nearest
surface). The local activation time is the difference in milliseconds between detected activation on the roving waveform and the
reference waveform. Colors range from white (early) to purple (late).
■ Peak-to-Peak (P-P) voltage maps display color-coded voltage values for each collected location (or nearest surface). The P-P
voltage is the difference in millivolts between the peak positive and Peak-Negative components of the detected activation complex
on the roving waveform. Colors range from gray (low voltage) to purple (high voltage).
■ Peak Negative (P-Neg) voltage maps display color-coded voltage values for each collected location (or nearest surface). The P-
Neg voltage is the difference in millivolts between baseline and the Peak-Negative component of the detected activation complex
on the roving waveform. Colors range from gray (low voltage) to purple (high voltage).
■ CFE Mean maps provide a fractionation index based on the cycle length between multiple, discrete, local activations in an
electrogram. Collected points with a lower value are mapped toward the white end of the color spectrum.
■ CFE Standard Deviation maps provide a fractionation index based on the cycle length between multiple, discrete, local activations
in an electrogram. The CFE standard deviation calculates the standard deviation between activations. Collected points with a
lower value are mapped toward the white end of the color spectrum.
■ Fractionation map, indicates the number of CFE detections.
■ Point Count map. Indicates the number of points co-located with that point on the map.

NOTE: For Peak-to-Peak and Peak Negative, the user can select the Unipole box to display unipole maps. Unipole waveforms
display on the right. Deselect the Unipole box to display bipole maps.

NOTE: At least one LAT point must be mapped and saved in order for Peak-to-Peak and Peak-Negative, and CFE Mean options
to become available. Prior to this action, these options are grayed out.

Non-Cardiac Triggered Maps

Non-cardiac triggered maps collect points at one second intervals.
■ CFE Mean maps provide a fractionation index based on the cycle length between multiple, discrete, local activations in an
electrogram. Collected points with a lower value are mapped toward the white end of the color spectrum.
■ CFE Standard Deviation maps provide a fractionation index based on the cycle length between multiple, discrete, local activations
in an electrogram. The CFE standard deviation calculates the standard deviation between activations. Collected points with a
lower value are mapped toward the white end of the color spectrum.
■ Fractionation map, indicates the number of CFE detections.
■ Point Count map. Indicates the number of points co-located with that point on the map.
EnSite Precision™ Cardiac Mapping System Instructions for Use Chapter 12. Mapping – Contact
ARTEN600004505 Rev. B Signals Collection
203

Signals Collection

Reference Signal Source

Cardiac triggered maps require a reference signal. The reference signal is provided by a surface
electrocardiogram or an intra-cardiac electrogram. Multiple ECGs can be selected. The
electrodes that provide the reference signal must remain in a stable position throughout the
mapping procedure. The reference signal is set once before beginning a mapping procedure, and
is used for timing of the roving signals.

Non-cardiac triggered maps do not use any part of the cardiac signal as a reference. Instead, the
waveform window refreshes once each second.

Roving Signal Source

Both cardiac triggered and non-cardiac triggered maps require a roving signal. The roving signal
is used for sampling local activation times and voltages from various locations in the heart. The
roving signal source can be any intracardiac electrode; it can be changed during a procedure,
and data can be sampled from one or from multiple electrodes.
Figure 172. Collection tab.
Detection Algorithm
Both reference signals and roving signals require a detection algorithm. Detection algorithms
locate the best point on the waveform signal to use to identify activation. The detection algorithm first uses a P-P sensitivity to identify
activation complexes in the signal. A detection marker is then placed on the activation complex according to the Detection Marker
Placement.

P-P Sensitivity – (Applies to the map that has focus when in Split Screen mode.) The minimum peak-to-peak voltage required for the
detection algorithm to operate. Incoming signal complexes must be larger in amplitude than the P-P Sensitivity in order to be
considered activations by the system. While changing the P-P Sensitivity, red amplitude lines will appear on the related signal in the
acquisition panel to indicate the current setting. Set this sensitivity to just above the noise floor. If 1.5 seconds has elapsed since the
last reference signal detection, the algorithm will identify an optimal activation complex, even if it does not meet the P-P Sensitivity.

NOTE: For the Reference Signal, there is auto sensitivity. Auto Sensitivity is used Roving only for first and last deflection.

Detection Marker Placement – The available selections are:

■ -dVdt – Sharpest negative slope
■ +dV/dt – Sharpest positive slope
■ abs dVdt – Sharpest slope, regardless of positive or negative
■ Max – Peak positive
■ Min – Peak negative
■ abs Peak – Largest peak (difference from baseline) regardless of positive or negative
■ First Deflection – First deflection from baseline
■ Last Deflection – Last deflection from baseline

Setting up the Detection Method

1. Select a reference signal.
2. Set the P-P sensitivity slightly above the noise floor.
3. Select the appropriate detection parameter.
4. Repeat for the roving signal.
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204 Considerations ARTEN600004505 Rev. B

NOTE: The user can drag the green Reference Offset line to the desired position, and the system calculates the timing
automatically from that position. The aqua-colored line is the reference line placed by the detection algorithm and cannot
be moved.

NOTE: Do not change the reference offset after saving the first beat when using Score Map. Changing of the reference offset
after the first beat may lead to an incorrect mapping display.

NOTE: Cardiac triggered CFE maps use the same detection algorithm as LAT, P-P, and P-Neg. Non-cardiac CFE maps use the
one second window refresh signal as a trigger. The detection algorithm is not selectable.

NOTE: Detection on the roving waveform takes place within the Roving Activation Interval (“Roving Activation Interval (RAI)”
on page 210).

Additional Signals
Additional ECG or intracardiac signals can be selected to facilitate confirmation of rhythm
stability. These signals are only for visualization and are not involved in detection.

Figure 173. Signals control panel.

Considerations

Non-Cardiac Triggered CFE Maps

■ Multiple detections are possible in a single sample.
■ Tick marks in CFE maps are not individually adjustable.
■ In CFE maps, some detection settings can be adjusted retrospectively and affect all points in the current map, including
P-P Sensitivity, Width, Refractory, the RAI, and Segment Length.
■ P-P Sensitivity is set independently for CFE maps and other map types.
■ The Width slider controls the minimum complex width to consider for activation.
■ The Refractory slider controls the minimum amount of time between detections.
■ The Segment Length slider controls the number of seconds per sample.
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ARTEN600004505 Rev. B Considerations
205

Reentrant Maps
■ Reentrant maps present the mapping of reentrant arrhythmias and are displayed in a manner similar to activation maps. The color
displayed within the map is linked to the cardiac cycle length (CL) and allows the adjacent display of “early” (white) and “late”
(purple) activation times.
■ The CL of a Reentrant LAT map is determined by the spacing between the curtains. Adjustment of the CL can be made by clicking
and dragging the edge of the curtains to the desired location. The CL will not take effect until the Reentrant checkbox is turned on.

NOTE: Adjusting the CL and then collecting points may invalidate the map.

Propagation Maps
■ These maps display areas of activation times that fall within a specific time interval. The interval, represented by a white band on
a purple background, can be moved forward through one heart cycle either automatically or by user control.
■ A button beneath the Propagation checkbox controls automatic motion of the activation interval with [Play] and [Freeze] options.
These options are available in Review mode only.
■ [Play] loops over the user-selected cycle length.
■ Propagation maps can be played in Realtime or RealReview but recordings can only be exported in Offline Review.
■ When Propagation is enabled, the colors of the map change to purple and white only. The leading edge of the white stripe is
brighter than the trailing edge of the stripe to indicate the direction of travel activation.
■ Using the side color bar, the stripe can be widened (increasing the interval in milliseconds [ms]), by clicking and dragging above
the white stripe. This action can also be accomplished by clicking to the right of the stripe in the color bar at the top of the window.

SparkleMap
■ The SparkleMap feature allows you to view the activation sequence on top of another map (ex. Voltage map) which allows the
physician to simultaneously view multiple datasets on the same anatomic model. The SparkleMap shows the propagation
sequence via a series of circular flashes.
■ Click the SparkleMap button in the Mapping Control Panel (“Mapping Control Panel” on page 206) to activate.
 Chapter 12. Mapping – Contact EnSite Precision™ Cardiac Mapping System Instructions for Use
206 Mapping Control Panel ARTEN600004505 Rev. B

Mapping Control Panel

Cardiac Triggered Mapping Settings

Table 26. Cardiac Triggered Map Settings

Callout Item Description

A
A Map Name Name of the map that has focus. Edit the map name by double- B
clicking in the name and typing a new name.
C
B Cardiac Determines which map types are available for use. D
Triggered
Reference

C Current Map Checkboxes control the type of data displayed on the map that E
Type has focus. When the checkbox is changed, the scale, values,
and colors on the color bar will change in the map display. The
F
G
numeric display type for the waveforms under the Points tab will
also change to the current map type. The following display types
are available:
• LAT: Local Activation Time isochrone
• Peak-to-Peak: Peak-to-Peak voltage
• Peak-Negative: Peak-negative voltage
• CFE Mean: Complex Fractionated Electrogram Mean
activation between complexes H
CFE Std. Dev.: Complex Fractionated Electrogram Standard
Deviation between complexes. (Available only if Cardiac
Triggered Reference is unchecked).

D Project Map to Project the map to the desired surface group in the list. Closest
projects the map to the surface closest to the point(s).

E Low-V ID (Applies to the map that has focus when in Split Screen mode.)
Identifies low-voltage zones in LAT or CFE maps (see Figure
174). If a collected point’s P-P value is lower than the specified I
Low-V ID value, then that point will display a gray area instead of
the color-coded scale for the current map type. Grey points do
not interpolate with color points. The Low-V ID control and the
Color Low value of a P-P map are linked, and adjusting one will
adjust the other to the same value.

F Fractionation Renders points that are fractionated as larger spheres. Default J

Threshold value=3 (renders points with a fractionation value of >= 3

G Map Display (LAT maps only) The type of LAT map: Standard LAT, Reentrant
Map, or Propagation Map.
Sparkle Map: When any map type other than Propagation Map is
selected, the Play button is marked SparkleMap and activates
the SparkleMap feature.

Figure 174. Cardiac Triggered Mapping

control panel.
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ARTEN600004505 Rev. B Mapping Control Panel
207

Table 26. Cardiac Triggered Map Settings

Callout Item Description

H Map Appearance: Includes slider controls that modify various features of the map.

Interior Projection
(Applies to both maps when Split Screen mode is active.) This slider controls the
maximum distance that an interior 3D Point (represented as a triangle) can project to
a location on the surface (represented by a square). For multiple-surface models,
points will project to the nearest surface.

Exterior Projection
(Applies to both maps when Split Screen mode is active.) This slider controls the
maximum distance that an exterior 3D Point (represented as a triangle) can project
to a location on the surface (represented by a square). For multiple-surface models,
points will project to the nearest surface.

Interpolation
(Applies to the map that has focus when in Split Screen mode.) This slider controls
the minimum distance between surface points necessary for the system to
interpolate color. For multiple surface models, points will interpolate between
surfaces in the same group.

Use Last Duplicate

Uses the most recent duplicate.

Use Best Duplicate

Uses duplicate with the best combined timing and voltage. Favors points with large
voltages that are close to the average timing.

I Points/Labels: Includes controls to hide or display points and labels.

Show Selected Points Only

When selected, the system draws only the selected points in the 3D display.

3D Points
(Applies to the map that has focus when in Split Screen mode.) Enables/disables the
display of collected points as triangular markers. The triangular markers are placed
on the positive electrode of the roving signal channel (Figure 175 on page 208).

3D Labels
(Applies to the map that has focus when in Split Screen mode.) Allows data to be
numerically displayed adjacent to the triangular 3D points. 3D Points must be
enabled in order to show 3D labels (Figure 175 on page 208).

3D Annotation
(Applies to the map that has focus when in Split Screen mode.) Displays or hides the
user-defined annotations associated with 3D points.

Surface Points
(Applies to the map that has focus when in Split Screen mode.) Enables/disables the
display of small square points on the surface. These squares represent the point on
the surface closest to a collected 3D point (Figure 175 on page 208).

Flash New Points

New points flash as collected.
 Chapter 12. Mapping – Contact EnSite Precision™ Cardiac Mapping System Instructions for Use
208 Mapping Control Panel ARTEN600004505 Rev. B

Table 26. Cardiac Triggered Map Settings

Callout Item Description

J Appearance

Show Mapping Metric

(Applies to the map that has focus when in Split Screen mode.) Enables/disables the
display of the reference cycle length in mm (CL), and the measurement of the current
roving point (LAT) in a box in the lower right corner of the map display. The reference
rate and cycle length are computed from detections on the reference catheter.
• CL and LAT display in yellow when points are frozen
The live heart rate (HR) displays in the lower-left status bar and is calculated on the
reference you are using

Auto Color
• (Applies to the map that has focus when in Split Screen mode.) Controls whether
the system automatically controls the pointers on the color bar during mapping. If
Auto Color is enabled, the pointers will adjust to the minimum and maximum data
values for all points in the current map. Auto Color applies separately for each
display type. Auto Color will be disabled if any color is manually adjusted.

A B

Figure 175. A: An LAT isochrone with Low-V ID; B:A collected point displayed as A: surface point; B: 3D point; C: 3D label.
EnSite Precision™ Cardiac Mapping System Instructions for Use Chapter 12. Mapping – Contact
ARTEN600004505 Rev. B Mapping Control Panel
209

Non-Cardiac Triggered Mapping Settings

Notice that in the Mapping Settings control panel (see Figure 176) the available settings
have changed slightly from those shown in Figure 174 on page 206. The Map Display
controls have been replaced with the following slider controls:
■ The Width slider (CFE maps only) determines the minimum complex width to
consider for activation. Applies to the map that has focus when in Split Screen mode.
■ The Refractory slider (CFE maps only) determines the minimum amount of time
between detections. Applies to the map that has focus when in Split Screen mode.
■ The Segment Length slider (CFE maps only) determines the duration of the selected
segment length. Applies to the map that has focus when in Split Screen mode.

Figure 176. Non Cardiac Triggered

Mapping control panel.
 Chapter 12. Mapping – Contact EnSite Precision™ Cardiac Mapping System Instructions for Use
210 Collecting Points ARTEN600004505 Rev. B

Collecting Points

The waveform display is used to evaluate waveforms and collect points.

N
G E
D

O PQ RS
C
I

H
F
J
A
M L K

Figure 177. The waveform display for contact maps.

Table 27. Horizontal Split Screen Mode Elements

Callout Item Description

A Time scale The time scale (in milliseconds) at the top edge of the waveform display. The detected timing reference appears at 0
msec. Right-click on the Time Scale to display a menu to set the sweep speed, font size, and waveform thickness.

B Color bar (LAT maps only) When collecting or displaying LAT isochronal data, the color bar displays above the waveform
display. The function of the color bar duplicates the color bar in the map display. Dragging the pointers on the color
bar will adjust the range.

C Roving Activation The Roving Activation Interval is a timing parameter that is used in the detection of roving catheter activation. The
Interval (RAI) RAI is defined by the black area between the curtains. The curtains appear as shaded areas on either side of the
RAI. Roving catheter activation will not be reliably detected unless the beat falls within the black-background portion
of the waveform display. To adjust the RAI, click and drag the edge of the shaded background. The current RAI value
appears in the lower right of the waveform display. For non-cardiac CFE maps, the RAI is equivalent to the segment
length, and appears as a left curtain only. For cardiac triggered CFE maps, the RAI is set independently for CFE
maps and other contact map types.

D RAI Curtain Click and drag the curtain to adjust the RAI.

E Reference Reference catheter activation as defined by the selected reference detection algorithm. The reference caliper will
Activation Tic Mark always appear at 0 msec on the time scale.

NOTE: If the current rhythm does not meet the reference detection settings, this caliper will be magenta.
Points can still be collected and adjusted.
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ARTEN600004505 Rev. B Collecting Points
211

Table 27. Horizontal Split Screen Mode Elements

Callout Item Description

F Reference Offset Drag to place the Reference Offset Caliper to the desired point in the waveform. Waveform timing calculations will be
Caliper (Green) based upon the offset location.

G Roving Activation Roving catheter activation as defined by the selected roving detection algorithm, within the Roving Activation
Tic Mark Interval. When adjusting this caliper, the associated location in the map display will move to reflect the roving
position at the time of the caliper measurement.

NOTE: If the current rhythm does not meet the roving detection settings, this caliper will be magenta. Points
can still be collected and adjusted. If a time is adjusted and there are error conditions in the signal and
the reference caliper is not purple, the caliper will turn yellow.

NOTE: For CFE maps, multiple tick marks may appear on the roving waveform. Activation tick marks for CFE
maps are not adjustable.

H Voltage Low Roving catheter low voltage. This voltage caliper is set to the lowest voltage within 100 msec of detected roving
Caliper activation, within the RAI. This caliper is used in determining peak-to-peak (P-P) voltage and peak-negative voltage.

I Voltage High Roving catheter high voltage. This voltage caliper is set to the highest voltage within 100 msec of detected roving
Caliper activation, within the RAI. This caliper is used in determining peak-to-peak (P-P) voltage.

J Time Interval The RAI time interval.

K [Freeze]/[Save] When data is being collected (gated to detection of the timing reference), click the [Freeze] button to stop the
display and review data.
• After pressing [Freeze], the label on the button changes to [Save]. Clicking [Save] allows you to save the
current point and point display to the current map, a different map, or a new map using the pulldown menu.
• The following data is saved with each collected beat: electrode position, current waveforms (reference, roving,
signal1, signal2, signal3), buffered waveforms and related roving electrode locations, timing, and voltage.
Performance may begin to slow after 1000 points.
• When mapping is used in Review mode, [Freeze] will also freeze the waveform display and [Save] will cause the
waveform display to play.
Hot key: <F11> duplicates the function of the [Freeze] and [Save] buttons.

L [Cancel]/[Resume] When the waveform display is frozen, [Cancel] will remove the currently displayed beat and resume gated data
collection without adding information to the map. [Resume] will resume gated data collection.
Hot key: <F12> duplicates the function of the [Cancel] button.

M Collected point As data is collected, each detected beat is temporarily saved in a buffer. When the waveform display is frozen,
buffer buffered data can be accessed using the buffer controls below the waveform display (Figure 177 on page 210). The
beat that was present at the time that [Freeze] was selected is represented by [0]. Previous beats can be accessed
by selecting the buttons for [-1], [-2], etc. When reviewing beats in the buffer, the associated location in the map
display will change to reflect the roving location at each selected beat.
Hot key: The left and right arrow buttons in the beat buffer are duplicated by the left and right arrow keys on the
keyboard.

N Points list This is a list of the points that have been collected for the map.
See the Help Menu for the Points List keyboard shortcut list.

O Timing Caliper Click the icon to place a Timing Caliper on the waveform. Up to ten calipers can be placed for each collected point.

P Home Scrolls the list to the selected point.

Q Scope Locates the selected point in 3D space.

R Duplicates Show duplicates of the selected point.

S Points Show all points or only the used points.

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212 Collecting Points ARTEN600004505 Rev. B

Waveform Shadows
Shadows behind the waveform indicate morphology of previous beats.

NOTE: Shadows will be stored for all 12 surface ECG leads even if not displayed when the first point is collected.

Figure 178. Waveform Shadows Checkboxes

Table 28. Cardiac Triggered Map Settings

Item Description

Reference Shadows The first point saved in a map will store the displayed Reference and “extra” waveforms as gray shadows, and will be
displayed in the RAI behind subsequent detected beats. If the first saved point is deleted, the next point saved will
generate the shadows.
NOTE: Changing the reference signal of the waveform will remove the shadow.

NOTE: Shadows will be stored for all 12 surface ECG leads even if not displayed when the first point is collected.

Roving Shadows A dark red shadow appears behind the current waveform for the roving catheter. This waveform indicates the morphology
of the previous beat for this catheter. This shadow is used to confirm beat-to-beat stability.

NOTE: If data does not exist for the previous beat (earliest beat in the buffer, etc.), then the dark red shadow will
not appear.

All Roving Waves Select/deselect to display all roving waves.

Unipole Waves Select to display unipolar waves (this selection must be made to display unipolar electrograms in the Waveform Display).

Amplitude – The amplitude for ganged waveforms can be adjusted by middle-clicking the waveform and dragging up or down. To
adjust the amplitude of an individual waveform, Shift + middle-click on the waveform.

Sweep Speed – To adjust the sweep speed for waveforms, right-click in the waveform area and then select the sweep speed from the
pop-up menu.
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ARTEN600004505 Rev. B Points Display
213

Points Display
Click the Points tab to display the collected points. The display is a combined
waveform segment, synchronized in time, of every roving catheter waveform
incorporated into the map. Each waveform includes a tick mark indicating the
activation point and a numeric metric that is determined by the current map type.

Selecting a waveform in the Points display shows the original data for that heartbeat
in the waveform display including all saved waveforms, up to ten timing calipers per
point (timing calipers can be adjusted), voltage calipers, and all buffered data. The A B C
beat of interest and voltage caliper settings can be adjusted. All changes are saved
automatically. The point in the map display that is related to the highlighted D
waveform will flash red.
F
NOTE: The first point(s) in the map are highlighted green to indicate that they
are the template beat for the map. These points, while first E
chronologically, may appear at different places in the list with other
sort orders. These template beats are colored green so they are not
inadvertently deleted, as doing so would change the map.
Table 29. Points Display
I
CALLOUT ITEM Description

A Home Scroll list to the selected point.

B Scope Locates the selected point in 3D space.

C Sort Sort waveforms by order of collection, current map type, and cycle
length.(After making timing adjustments, the user must select sort
by LAT again.)
G
D Time scale • The time scale, in milliseconds (msec), displays at the top edge
of the waveform display. The timing reference of all waveforms is
synchronized to 0 msec. H
• Adjust the Sweep Speed by right-clicking in the black K
background and selecting Sweep Speed. The available options
are 40, 50, 100, 200, and 400 mm/sec. J

E Waveform Indicates the order of waveform collection. When multiple points

number are acquired simultaneously, all of the related points have the
same waveform number.

F Electrode Polarity of the electrodes on the catheter.Unipolar is indicated with N

Polarity the single electrode preceded by a “+” sign.

G Hide point When checked, this checkbox indicates that this point on the map
checkbox may show. Clear the check mark to hide this point. When
unchecked, the point is hidden, and a red circle displays.

H Duplicate A star above the check box indicates a duplicate point. There are L
M N
Points 3 types of duplicate points:
• Blue outline star - duplicate point, but not used
• Solid blue star - point has duplicates, but this point is used by the O
system
• Solid gold start - point has duplicates, but the user chose to use Figure 179. The Points display.
this point

Dashed line A dashed waveform line indicates that a point is not used to color
the map (not shown). The following types of points are drawn as
dashed: hidden points, duplicate points, points outside the
projection distances, and points with no locations.
 Chapter 12. Mapping – Contact EnSite Precision™ Cardiac Mapping System Instructions for Use
214 Points Display ARTEN600004505 Rev. B

Table 29. Points Display

CALLOUT ITEM Description

Solid line Indicates a point that is used in the map (not shown).

I Blue Indicates the selected waveform. The data for the waveform is
background shown in the waveform display. If the corresponding point is used
in the map, the 3D point, its projection on the map surface, and its
text, flash red.

J Timing caliper Indicates the roving activation time.

K Map point The Timing (in ms) or Voltage (in mV) of the map point.
measurement

L Number of The number of points that have been used/collected. The list may
points have to be scrolled to see all of the waveforms.

M Delete To delete a waveform from the Points display and its

corresponding point from the map, select the waveform and click
[Delete].

N Delete Group Removes the selected group of points.

O Delete last Removes the selected group of point(s) last saved.

Amplitude – Waveform amplitude can be adjusted by middle-clicking the waveform and dragging up or down. For the Points display,
amplitudes are ganged for all waveforms.

Panning – The Points display will default to centering on the timing reference. The display can be panned by <Shift> + middle-
clicking in the background and dragging left or right.

Waveform indicators – The type of line used in the waveform indicates the effect of the waveform on the map.
■ Solid, bold with blue background – The waveform is selected. The original data for this waveform is currently displayed in the
waveform display. If displayed in the map display, the 3D point, 3D text, and surface point for this waveform flash red.
■ Solid – The waveform is used by the map.
■ Dashed – The point is a duplicate or is degraded.

Delete Hidden Points – To delete points that were hidden using the Show checkbox, right-click in the waveform display or Points
display and select Delete Hidden Points.

Delete Unused Points – To delete all points that are not displayed due to the current projection settings, right-click in the waveform
display or Points display and select Delete Unused Points.

NOTE: Due to the potential collection of duplicate points, the action to “Delete Unused Points” may cause more unused points
to appear. To delete duplicates, sort by point status, then select and delete all of the unused duplicates.

Scroll bar – Use this control to scroll through all activation points.

Hot key: When the Points display is open, the up and down arrow keys select the previous or next point, respectively.

When the Points display is open, [Delete] will remove the current beat in the waveform display.
EnSite Precision™ Cardiac Mapping System Instructions for Use Chapter 12. Mapping – Contact
ARTEN600004505 Rev. B The OneMap Tool
215

The OneMap Tool

The OneMap Tool is used to simultaneously create a model and a map. By default,
the OneMap Tool is disabled. To use the OneMap Tool, click the [OneMap] button at
the top of the Mapping control panel.

If no model surfaces have been created, a default surface will be created. If model
surfaces have already been created, the currently selected surface is chosen by
default.

To create a new map, click on the drop-down menu in the top right of the control panel
or choose No Map Selected in the Mapping Window. Click on [New Map]. Enter a
name for the new map and click [OK]. Refer to “Creating a Map” on page 216.

There are three tabs located above the catheter selections (Settings, Points, and
Model). The Model tab is only available when [One Map] is selected. The Model tab
displays the entire menu that is available under the Model task, including Show/Hide
Field Scaling. This permits the user to easily edit the model without the need to return
to the Model task.

There is no need to click on the [Finish Model] button. When exiting the OneMap
Tool, the model finishes automatically.

NOTE: When [OneMap] is enabled, model surfaces may appear to be modified

because intersecting surfaces are no longer being calculated.

NOTE: In the OneMap Tool mode, the Active EnGuide is automatically

changed to be the same as the Roving catheter. The Active EnGuide
control is not selectable in the OneMap Tool mode.

Figure 180. The OneMap Tool - Model control

panel.
 Chapter 12. Mapping – Contact EnSite Precision™ Cardiac Mapping System Instructions for Use
216 Creating a Map ARTEN600004505 Rev. B

Creating a Map

Setting up a New Map

1. Select the Mapping task from the tool bar. The Mapping screen displays.
2. Select New Map from the drop-down menu, in the upper right of the Mapping control panel or choose No Map Selected in the
Mapping Window.
3. Name the map, and click [OK].
4. Select the reference timing signal. In the Collection control panel (lower left corner) Reference section:
a. Select a timing reference source from the drop-down menu.
b. Select a detection algorithm from the Detection drop-down men.
c. Adjust the Sensitivity to a level just outside of baseline noise.
After the timing reference and detection algorithms have been selected, waveforms will begin to refresh in the waveform display,
gated to detected activation on the timing reference.
5. Adjust the Roving Activation Interval by clicking and dragging the edge of the shaded boundary. Generally, the Roving
Activation Interval should be set to encompass one activation sequence on the roving catheter.
6. Select an initial roving catheter signal. The roving catheter can be any intracardiac electrogram that is actively being located
(hidden electrodes cannot be used as Roving). In the Collection control panel Roving section:
a. Select a roving source from the drop-down menu. The roving signal can be changed during mapping, allowing any
intracardiac electrode to be used as part of the mapping process.
b. Select a detection algorithm from the Detection drop-down men.
c. Adjust the Sensitivity to a level just outside of baseline noise. Sensitivity is set independently for CFE and other map types.
7. (OneMap Tool only) Select the source for collecting model points from the From drop-down menu: select Active EnGuide to
use the Active EnGuide to collect points, or Active Electrode to use the active electrode to collect points.

Collecting Points
In the OneMap Tool mode, the Active EnGuide is automatically changed to be the same as the Roving catheter. The Active EnGuide
control is not selectable in the OneMap Tool mode.
1. With the patient in the clinical rhythm, place the roving catheter to collect data. When a beat of interest appears in the RAI, select
[Freeze].

NOTE: (OneMap Tool only) Selecting [Freeze] will automatically enable [Collect Points] when model type is set to OneModel.
2. In the frozen mapping window, review the morphology of the beat and placement of the caliper lines. If necessary, select an
optimal beat from the collected point buffer and/or adjust calipers.
3. Click [Save] or select a New Map or an existing map from the pulldown menu to save the point; otherwise, select [Cancel]. The
waveform display will return to acquisition mode.
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ARTEN600004505 Rev. B Creating a Map
217

Figure 181. Map from Segment (example).

To Map from a Segment

1. Click the Split Screen Mode button in the upper right corner of the Mapping screen.

NOTE: You will need to switch the secondary screen from Live to Review mode (see Table 7 on page 41 for details).
2. Select the appropriate segment from the drop-down list at the bottom of the right display.
3. If necessary, use the Waveform control panel in the right display to set the roving catheter and electrode.
4. Reference K through N under “Collecting Points” on page 210. (Refer to Figure 177 on page 210).

NOTE: Points can be added to either the left or right display and will be applied to both displays. Offline Review only.
 Chapter 12. Mapping – Contact EnSite Precision™ Cardiac Mapping System Instructions for Use
218 Managing Maps ARTEN600004505 Rev. B

Managing Maps

New Map – New Map can be selected from the drop-down menu in the upper right corner of the Mapping control panel. Select New
Map; the Map Name window comes up with a prompt to name the map. Type a name in the Name field and click [OK].

Copy Open Map - Copy Open Map can be selected from the drop-down menu in the upper right corner of the Mapping control panel.
Select Copy Open Map; the Map Name window comes up with a prompt to name the map. Type a name in the Name field and click
[OK].

NOTE: You can rename a map by double-clicking in the Map Name field at the top of the Control Panel and typing in the new
name.

Mapping Controls
Access these Mapping controls by clicking on the eye ball icon in the upper right of the map
workspace.

Label Text On – Turns Label text on and off.

Label Show Through – Projects the labels through surfaces that may be obscuring them.

Show EnSite Model – Turns the entire model on and off during mapping.

Show DIF Model – This checkbox allows the DIF model (i.e., CT scan or MRI) to either be
hidden or displayed.

Project on DIF – (After EnSite™ Fusion™ Registration has been performed) Enabling this
checkbox allows the user to project or unproject 3D Labels and/or Lesions (referred to as 3DP),
and map data onto the DIF surface rather than onto the EnSite model surface.

Show Mapping – Causes surfaces to be colored using the current map color.

Hide Non-Map Surfaces – When turned on, hides surfaces that are not assigned to a map.

Map Transparency On – Turn the map Transparency on and off.

Figure 182. Map Displays.
NOTE: Do not turn on Transparency unless a map is currently displayed.

Show Proximity Indicator – This checkbox enables the proximity indicator.

Fixed Proximity Indicator – Turning this checkbox on sets the diameter of the Proximity Indicator to a maximum of 10mm, regardless
of the current lesion size.
EnSite Precision™ Cardiac Mapping System Instructions for Use
ARTEN600004505 Rev. B 219

Therapy CHAPTER 13

The Therapy task is used to place lesion markers on the map and perform ablation therapy. The Therapy control panel contains a list
of lesion markers and controls for modifying their appearance. When using the Lesion Marker tool, you can place lesion markers with
the mouse or use the tool bar to place surface and 3D lesions at the Active Electrode.

B C D E F
G
A

Figure 183. Therapy Screen.

A. Lesion Marker Tool – Use this tool to place lesion markers on the model.

B. Color – Use this color picker to set a lesion marker’s color.

C. Diameter – Use this spin box to set a lesion marker’s diameter.

D. Projection – Use this slider to set a lesion marker’s projection.

 Chapter 13. Therapy EnSite Precision™ Cardiac Mapping System Instructions for Use
220 Lesion Markers ARTEN600004505 Rev. B

E. Lesion at EnGuide – Click this button to place a lesion marker on the surface at the Active Electrode.

F. 3D Lesion Marker at EnGuide – Click this button to place a 3D lesion marker at the Active Electrode.

G. Lesion List – This is a list of all the lesion markers that have been placed.

H. Properties – Use these controls to modify a lesion marker’s color, diameter, 3D projection, or to show/hide lesion markers.

I. Therapy Display – Use to show/hide lesion marker text.

Lesion Markers

(Any mode)

Lesion markers (Figure 184 on page 220) are used to identify ablation lesion
marker sites. Up to 1024 lesions can be placed in the map display.

Lesion markers are projected from the 3D center of the Active Electrode to
the nearest surface. The original 3D catheter location is preserved. If the
surface is edited, the lesion is re-projected from the original 3D catheter
location.

An adjustable distance control allows you to edit the distance allowed for
projection. Lesion markers that are present and do not meet the 3D distance
requirement are displayed as 3D objects (without being tied to a surface).
You have the option to project, or not to project the lesion.

Each lesion marker has a numeric name that is displayed in a list. This
number increments each time a lesion marker is placed on the map. If a
lesion marker is deleted, the numeric list is updated to keep numbers
consecutive.

Figure 184. A map with lesion markers on the

surface.
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221

Placing Lesion Markersf

A B C D E E

Figure 185. Lesion marker controls. A: lesion tool; B: color control; C: size control; D: projection control; E: placement buttons;
F: right-click menu.

To place a lesion marker:

1. Select the Lesion Marker tool on the Tool Palette.
2. Set the lesion marker’s color and diameter with the Color and Diameter controls on the Tool Bar.

NOTE: The diameter control also adjusts the maximum diameter of the proximity indicator on the EnGuide electrode (refer to
“EnGuide Proximity Indicator” on page 144 for more information).
3. Place the lesion marker using one of the following methods:
■ Click on the map to place the lesion marker at the mouse pointer. Clicking repeatedly places multiple lesion markers. For
multiple-surface models, the lesion marker appears on the surface beneath the pointer.
■ Click [Lesion at EnGuide] to place the lesion marker on the point on the endocardial surface that is highlighted by the
EnGuide proximity indicator. For multiple-surface models, the lesion marker appears on the nearest included surface. A
lesion marker placed with [Lesion at EnGuide] is already projected. To move the lesion marker to the Active Electrode,
turn off the Project Selected Lesions checkbox from the right-click menu.
Hot key: <F6> places a lesion marker at the Active Electrode.
■ Click [3D Lesion at EnGuide] to place the lesion marker at the Active Electrode. This lesion marker appears as a sphere and
is not connected to the surface of the map, but rotates with the model. To project the lesion marker onto the closest surface,
turn on the Project Selected Lesions checkbox from the right-click menu.
Hot key: <Shift>+<F6> places a 3D lesion marker at the Active Electrode.

NOTE: The last lesion marker placed is outlined in yellow. If this lesion marker is deleted, the next to last lesion marker is
outlined.

NOTE: When a lesion marker is placed on the map, it is added to the Lesion List.
 Chapter 13. Therapy EnSite Precision™ Cardiac Mapping System Instructions for Use
222 Lesion Markers ARTEN600004505 Rev. B

Selecting and Modifying Lesion Markers

Lesion markers can be modified using the Tool Palette and Tool Bar controls, the
Lesion Markers control panel in the RealReview task, or the right-click menu.

For information about selecting lesion markers, refer to “Common Interface Elements”
on page 36.
■ To select a single Lesion Marker, click on the Lesion Marker tool in the Tool
Palette, hold down <Shift>, and then click on the Lesion Marker’s label.
■ To select multiple Lesion Markers, click on the Lesion Marker tool in the Tool
Palette, hold down <Ctrl>, and then click on the each Lesion Marker.
Alternatively, click on the Lesion Marker tool in the Tool Palette, hold down
<Shift> or <Ctrl>, hold down the left mouse button, and then drag a box around
the Lesion Markers.
Figure 186. Lesion Marker list control panel.
■ To deselect a Lesion Marker, hold down <Shift> and click away from the Lesion
Use this control panel to modify lesion
Marker's label.
markers.
To select Lesion Markers in a list:
■ To select a single Lesion Marker in the list, click on the Lesion Marker in the list.
■ To select multiple Lesion Markers in the list, hold down <Ctrl> and click on each Lesion Marker.
■ To select multiple consecutive Lesion Markers in the list, hold down <Shift>, click on a Lesion Marker and then click on another
Lesion Marker. Alternatively, click on a Lesion Marker and drag to select additional consecutive Lesion Markers.

NOTE: When a Lesion Marker is selected, the color of its label changes to white in the model/map display area.
■ To modify a lesion using the Tool Palette and Tool Bar: select the Lesion Marker tool on the Tool Palette, shift and click on the
lesion marker’s label, and then use the Tool Bar controls to modify the lesion marker’s color and size.
■ To modify a lesion marker using the Lesion Marker control panel in the RealReview task: select the lesion in the Lesion Marker
List, and then use the control panel controls to modify the lesion’s color, size, and projection.
■ To modify a lesion marker using the right-click menu, click on the lesion marker, right-click in the display area to display the
Lesion Marker menu, and then select one of the following:
– Show All Lesions shows all lesion markers.
– Hide Selected Lesions hides the selected lesion markers. The lesion markers are only hidden, not deleted.
– Delete Selected Lesions deletes the selected lesion markers from the map and the Lesion Markers List.
– Move Selected Lesion moves the selected lesion marker. To move a lesion marker, select the lesion marker, click Move
Selected Lesion, and then click on the map at the desired location. Moving a lesion marker changes it to a mouse-placed
lesion.
– Project Selected Lesions A lesion marker placed with [Lesion at EnGuide] is already projected. Project Selected Lesions
moves the lesion to the Active Electrode. A lesion marker placed with [3D Lesion at EnGuide] is placed at the Active
Electrode. Project Selected Lesions projects the lesion marker onto the closest surface.
– Show Lesion Text shows/hides the name of all lesion markers.
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ARTEN600004505 Rev. B Lesion Markers
223

Lesion Control Panel

A. Lesion Marker Visibility – When the box is checked this lesion marker is visible

B. Color – Clicking on this icon allows you to select a color for the lesion marker.

C. Lesion Number – The lesions are numbered in order of placement.

AB C D E
■ Time Stamp: When the lesion marker is placed, a time stamp is recorded. Hover over
to display the time stamp.

D. Annotation – Double-click on an annotation item to annotate.

E. 3D Lesion Marker – Clicking on the box icon changes the lesion from projected to 3D.

Lesion markers created in Review mode will have a brown background.

Figure 187. Lesion control panel.

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EnSite Precision™ Cardiac Mapping System Instructions for Use
ARTEN600004505 Rev. B 225

RealReview CHAPTER 14

RealReview is the task that allows the user to review study notebook recorded in the current study.

The RealReview screen can be divided into two display areas via the Split Screen icon (Figure 188 on page 225). The control panel
displays a Notebook (A) that contains recorded data that can be listed by Time or Type (Segments, Bookmarks, Images, Animations,
and Events).

Below the saved study content is a collection of annotation lists (B). While direct manipulation of annotations on the model will be
the most common way of interacting with annotations, these lists provide redundant access to labels, markers, measurements, lesion
markers, and shadows. To display the list for labels, tape measure, lesion markers or shadow for the specific display, select the
corresponding icon in the tool palette.

Figure 188. RealReview screen. A: Notebook listings; B: Annotation lists.

A. Notebook Listings – Refer to “Notebook” on page 47.

B. Annotation Listings – Displays a list of map tags corresponding to the selected icon on the tool palette. Refer to “Tool Palette” on
page 33.
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226 ARTEN600004505 Rev. B

Reviewing Segments
Selecting a segment from the notebook (by double clicking it
with the left mouse button) will display it in the right pane.
Playback controls become enabled beneath the view.

Reviewing Bookmarks
Selecting a bookmark from the control panel list (by double
clicking it with the left mouse button) opens the recorded
segment with the time cursor frozen at the bookmarked location.
This point is marked by a yellow line in the waveform display
and segment overview.

Reviewing Images Figure 189. Reviewing a segment in the right pane of dual view.

By double clicking on an image listed in the control panel, the

image is displayed in the middle of the display. The image size
can be adjusted by dragging the lower right corner of the
window.

Reviewing Annotations
The annotation list area can be used to view and modify the
annotations (labels, anatomic markers, tape measures, lesion
markers, and EnGuide shadows). Select a type icon from the
Tool Palette. Annotations created in Offline Review will have a
brown background in the control panel. To modify an
annotation, select the annotation in the list (it will be selected in
the model) then use the controls to show/hide, delete, and change
the appearance of the annotation.

Figure 191 on page 226 shows the individual lists and controls.

Figure 190. Reviewing a dual view segment with waveforms

turned on.

Figure 191. Annotation lists and controls. A: labels; B: anatomic markers; C: tape measures; D: lesion annotations; E: EnGuide
shadows.
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ARTEN600004505 Rev. B 227

Reviewing and Editing Past CHAPTER 15

Studies

Past Studies

Figure 192. Offline Review screen. A: Notebook listings; B: Annotation lists.

 Chapter 15. Reviewing and Editing Past Studies EnSite Precision™ Cardiac Mapping System Instructions for Use
228 Past Studies ARTEN600004505 Rev. B

Reviewing Past Studies

To review a past study:
1. Click [Past Studies] from the Clinical Menu (1) to display the
Offline Review screen, which provides a list of all studies
saved on the system.
2. Select a row in the list (2) to display a summary of the study,
which includes high-level information, saved content, and a
list of the equipment used in the study. The Past Studies list is
searchable by all fields or by individual fields.
3. Click [Open Study] (3) to open the study in Offline Review
mode.
1
Editing Past Studies
To edit a past study:
■ Click [Edit] (4) to change the Diagnosis, Procedure Type, or
Physician information.
■ Click [Edit Patient] (5) to update patient information.
■ Click [Delete] (6) to delete the study. 4

5 6 3

Figure 193. Reviewing a past study.

EnSite Precision™ Cardiac Mapping System Instructions for Use Chapter 15. Reviewing and Editing Past Studies
ARTEN600004505 Rev. B Offline Review
229

Offline Review

Opening a study from the Past Studies screen opens the study in the Model task. The last recorded segment will automatically be
played. The brown status bars indicate Offline Review mode (Figure 194 on page 229).

Figure 194. Offline Review screen. Note the brown status bars.

Offline Review – Setup

The setup section shows a historical view of the study setup. This section is largely read-only.

When viewing a segment or bookmark, the setup section will display:

■ The final model for the study
■ Catheter locations at time of recording

Other displays will display as they appeared at the time of recording

Offline Review – Model

Users can perform basic operations in the Model section such as changing surface colors, names, and visibility. However, surface
editing functions are unavailable.
 Chapter 15. Reviewing and Editing Past Studies EnSite Precision™ Cardiac Mapping System Instructions for Use
230 Managing Patient and Study Records ARTEN600004505 Rev. B

Offline Review – Mapping

The Mapping section in review mode offers the full set of controls as a realtime study. Users can open maps, review map points, and
collect points from the recorded catheter locations. Switching to Split Screen mode allows side-by-side comparison of the Review
items.

Offline Review – Therapy

The Therapy section in review mode allows users to modify lesion markers.

NOTE: Lesion markers added in offline review will be given a brown background in the list.

Offline Review – Review

When in the Review task, the study’s saved content is listed in the control panel. Switching to Split Screen mode allows side-by-side
comparison of the Review items.

Managing Patient and Study Records

Searching for Patient Records

The Past Studies list in the Offline Review screen can be searched by column headings: Patient, ID, Date, Weight, Physician, or
Diagnosis. This text-based search is not case sensitive. Partial spellings are supported by using a partial beginning of the unknown
text. For example, in a search by last name, typing the letters “An” would list all patients with last names that begin with “An,”
including names such as “Anton” or “Andersen.”

To search the Past Studies list:

1. Select the column heading from the Search By drop-down menu.
2. Type the text to search for in the text box. As text is typed, records that do not match the search text are eliminated from the list.
3. When the desired record appears, click on the record to select it.

Modifying Patient Information

1. Select a patient.
2. Click [Edit Patient...]. The Edit Patient window will appear with the information for the selected patient in the text areas.
3. Modify the text areas for the patient record.

NOTE: The Patient ID cannot be modified.

4. Click [OK] to store the modified patient record.

NOTE: If the patient has more than one study and the user wants the change to apply to only the selected study, check the Apply
Changes box for the selected study only.
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ARTEN600004505 Rev. B Managing Patient and Study Records
231

Removing Patient Records

A patient and all related study data can be removed from the database.
1. Select a patient.
2. Click [Edit Patient].
3. Click [Delete] to remove. A confirmation will appear.
4. Click [Yes] to remove the patient record.

Modifying Study Records

NOTE: Only records on the hard drive can be modified.
1. From the Study Review screen, select Source > Hard Disk.
2. Select a study.
3. Click [Edit] in the upper right corner of the screen. The Diagnosis Type, Procedure, and Physician Name display.
4. Modify this text by typing into the text area or using the adjacent drop-down menu buttons. Click [Save] to save changes.

Deleting Studies
Removing study information from the DWS hard drive will make more drive space available for future studies.

NOTE: If the hard drive becomes full during a study, the system will delete the oldest backed up studies first.

NOTE: Studies that have been removed from the hard drive can still be loaded from removable media for future reference.

NOTE: Multiple studies can be deleted.

1. From the Study Review screen, select Source > Hard Disk.
2. Select a study.
3. Click [Delete]. A confirmation window will appear.
4. Click [Yes] to delete the study.
 Chapter 15. Reviewing and Editing Past Studies EnSite Precision™ Cardiac Mapping System Instructions for Use
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EnSite Precision™ Cardiac Mapping System Instructions for Use
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Ending a Study CHAPTER 16

Ending a Study

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

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

Use the following procedure to end a study:

1. From the menu bar, select File > End Study. The system will prompt the user with “End the current study? Yes/No.” Click Yes.
If study and patient information has already been specified, go to step 3.
2. If study and patient information has not been specified, the system
will prompt the user with “Cannot end study without entering study
and patient information. Enter study and patient information?
Yes/No.” Click Yes. The system will display the Study and Patient
Information screen (Figure 195 on page 233). Fill in the required
information and click OK.
3. The system will prompt the user with ”Remember to backup study
information”.
4. Click OK to continue.

NOTE:
5. The system will return to the Login screen.

NOTE: To backup, or archive, the study, see “Archiving Studies” on

page 240.

Figure 195. Study and Patient Information screen.

 Chapter 16. Ending a Study EnSite Precision™ Cardiac Mapping System Instructions for Use
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ARTEN600004505 Rev. B 235

Capturing, Exporting, and CHAPTER 17

Importing Information

Exporting Data to External Devices

Images and study data can be stored to a USB device, a network drive, or CD/DVD for reuse on PC or Macintosh computers with a
compatible CD or DVD drive. Compatible CD/DVD formats are: CD-R, CD+R, CD-RW, CD+RW, DVD-R, DVD+R, DVD+RW, and
DVD-R Dual Layer.

NOTE: CD/DVDs must be handled with care. Do not allow a CD/DVD to fall on a hard surface. To label a CD/DVD, never use
a paper label, always write directly onto the CD/DVD using a permanent marker.

NOTE: Information can only be exported to a CD/DVD from outside of a study.

NOTE: A CD/DVD may contain multiple images, but only one study.

NOTE: If export to a USB device fails, try an alternate external storage device, a network location, or CD/DVD.

NOTE: Network File System (NFS) versions prior to NFSv3 may experience limitations to the addressable file system size to
less than 4.2GB. (This is a protocol limitation.)

NOTE: File system access errors may be experienced when using Server Message Block (SMB) versions prior to 2.0. Some files
may become inaccessible.

NOTE: USB devices having FAT32 file systems may be unable to store Velocity studies, due to the number of files, file name
length, or file size limitations of FAT32. NTFS or ext3 file systems are recommended to be used.

When images are stored to external media, they are listed by their annotation and an index number to differentiate duplicate
annotations. Images are stored as JPEG files.

Selecting an Area for Capture

When capturing images or creating animations, the entire screen or a selected area of the screen can be captured. In addition, the images
and animations can be captured with a white background. The user specifies what is to be captured in the Capture Image, Record
Movie, and Capture Images windows.
■ To capture the entire screen, select Full Screen.
■ To define the area of the screen to be captured, select Selected Area. To define the area to be captured, Click and hold down the
left mouse button and drag a box around the desired area of the screen. Adjust the box if necessary.
■ To capture the entire screen or selected area with a white background, select White Background. A white background is beneficial
if the images are going to be printed on a printer.

When the desired area has been selected, click [Capture Image] to capture an individual image, or click [Start] to capture an animation.
The captured image or animation is stored in the Notebook.
 Chapter 17. Capturing, Exporting, and Importing Information EnSite Precision™ Cardiac Mapping System Instructions for Use
236 Saving and Accessing Individual Images ARTEN600004505 Rev. B

NOTE: Individual images can be captured at any time during a study.

NOTE: MPEG and JPEG animations can only be captured in Offline Review.

Saving and Accessing Individual Images

Images of entire screens can be saved. These images can also be viewed.

Saving an Image
To save an individual image:
1. Select File > Save Image to display the Capture Image window.
2. Type a description of the image in the text area.
3. Indicate the screen area to be captured:
■ Select Full Screen to capture the entire screen.
■ Select Selected Area to manually select the screen area to
capture. Refer to “Selecting an Area for Capture” on page 235 Figure 196. The Capture Image dialog is used to capture
for more information about selecting the screen area. individual JPEG images.
4. Select White Background if a white background is desired.
5. Click [Capture Image]. The image is captured and saved as a part of the patient study, and is added to the Notebook.

Accessing an Image
NOTE: Images are saved with their appropriate study. If a study containing images created in Offline Review mode is removed
from the workstation hard drive, the images are removed as well. Be sure to backup studies so the images are saved.
1. Access the Notebook in RealReview.
2. Select an annotation from the list. Use the buttons described below to view or manage image files:
■ [Load] displays the image.

NOTE:This is the only location where printing can be done.

■ [Delete] erases the selected image.
■ [Edit] allows the user to edit the annotation of the image
3. Click [Close] to exit the window.
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Creating Animations

(Offline Review mode only)

A series of continuous images of the entire screen can be exported from the system as either an mpeg movie file or a sequence of jpeg
images.

Creating an MPEG movie

To start recording an MPEG movie:
1. Select File > Save Animation > Start Capturing MPEG Movie to display the
Record Movie window.
2. Indicate the screen area to be captured:
■ Select Full Screen to capture the entire screen.
Figure 197. The Record Movie window is used to
■ Select Selected Area to manually select the screen area to capture. Refer
record an MPEG movie.
to “Selecting an Area for Capture” on page 235 for more information
about selecting the screen area.
3. Select White Background if a white background is desired.
4. Click Start to start recording a movie.

To stop recording an MPEG movie:

1. Click the Animation Recording icon located in the bottom right corner of the screen.
or
Select File > Stop Capturing Animation.
2. A dialog box will appear in the center of the screen. Enter a description for the movie in Description field.
3. Click [Create Movie] to create the movie or [Cancel] to cancel the operation.

Creating a JPEG image sequence

To start recording a JPEG image sequence:
1. Select File > Save Animation > Start Capturing JPEG Images to display the
Capture Images window.
2. Indicate the screen area to be captured:
Figure 198. The Capture Images window is used
■ Select Full Screen to capture the entire screen.
to capture a series of individual JPEG images.
■ Select Selected Area to manually select the screen area to capture. Refer
to “Selecting an Area for Capture” on page 235 for more information about selecting the screen area.
3. Select White Background if a white background is desired.
4. Click Start to start recording a movie.

To stop recording a JPEG movie:

1. Click the Animation Recording icon located in the bottom right corner of the screen.
or
Select File > Stop Capturing Animation.
2. Enter a description for the movie in Description field.
3. Click [OK] to save the images or [Discard Images] to discard the captured images.
 Chapter 17. Capturing, Exporting, and Importing Information EnSite Precision™ Cardiac Mapping System Instructions for Use
238 Data Export ARTEN600004505 Rev. B

Data Export
(Offline Review only)

NOTE: This option exports data only to the DWS hard

drive.

To begin Data Export, select File > Export to bring up the Data
Export window (Figure 199 on page 238).
A
Waveform Data
Near the top of the window is a list of the types of data that can
be exported (A). Any or all of them can be selected using the
check boxes, and each will be written to its own file. When the B
user selects any type of data that changes over time (e.g.
Waveforms, or Electrode Locations), the Export Interval options
become available (C) to choose the time interval for the export. C
The Displayed Waveforms option is a special shortcut selection
that exports only those waveforms (of any type) that are
currently displayed, over the current span of the waveform
window. The Export Data and Export Interval options do not D
apply to this selection.

If Use System Reference at the top of the window is checked,

the Positional Reference will be set to System Reference before E
the export begins, regardless of its setting during the study. This
can standardize the positions of electrodes and labels, but also Figure 199. Data Export window. List of options (A); Directory
export them in positions different than how they appear on the Name (B); Export Interval options (C); Comments (D); Export
screen. If this option is checked, the user must revert the button (E)
Positional Reference manually after the export is complete.

Directory Name
A directory prefix is assigned in the Directory Name field of the Data Export window (see Figure 199, B). Each time the Export button
is clicked, a folder is created using this name and the current date and time of the button click, and the exported data files are saved
into this folder.

Export Interval Options

NOTE: The caliper and the cursor are only available in the following workflows: Model, Therapy, RealReview, or Non-Contact
Mapping.

Caliper. Select this option to use the green calipers in the waveform display to capture the time interval desired.

Displayed Window. Selecting this option captures the visible time interval in the waveform display.

Cursor Location . Selecting this option exports the segment beginning at the cursor. This option requires that one of two sub-options
also be selected:
■ Export until segment end, which will continue exporting data until the segment ends.
■ Duration (in seconds), in which the exact segment interval is determined by the user and is manually entered in the field supplied.

NOTE: Selecting [Clear Selections], at the top of the Data Export window, will clear all Export Option check marks. De-
selecting items can be done anytime prior to Export.
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ARTEN600004505 Rev. B Data Export
239

Exporting
When [Export] is clicked, a progress bar is displayed for each option selected. If Export Data: All is selected (see Figure 199, A), all
available data for the selected type(s) will be exported from the study (e.g., all EP Catheter Unipole Waveform channels). In contrast,
when Export Data: Displayed is selected, only those channels currently displayed in the waveform window will be exported.

Once an Export begins:

■ All graphical user interface objects are disabled, except [Cancel]
■ A progress bar is displayed for each option selected
■ Application configuration changes recorded as part of the segment are inhibited
■ The configuration at the start of the Export will be maintained for the duration of the Export

NOTE: When the progress bar(s) is displayed, [Cancel] can be selected to stop the Export. The Export may not stop immediately;
a slight delay can be expected.

Export is not available if Segment: None is selected

When exporting EnSite™ NavX™ Navigation and Visualization Technology data, the segment playback speed is automatically set to
1:4. This ratio allows for internal processing and the Export of data. When exporting non-contact data, if the Virtuals Grid option is
chosen, the playback speed is automatically set to 1:10; this ratio allows for the additional processing requirements.

Presets
The user can choose to save a Preset for application configurations that will be used in more than one
Export.

Once all the desired parameters are set, click on the Preset icon located in the upper right of the Data Save Preset…
Export window. Click on Save Preset to bring up the Save Preset window. Type in a name for the
Manage Presets...
preset and click [OK].

To reapply a Preset, click on the Preset icon and click on the appropriate Preset name. Figure 200. Preset icon
and Preset menu selections
NOTE: Export Presets can be applied to any segment in the study in which they are defined.
However, Export Presets cannot be applied to a different study.
 Chapter 17. Capturing, Exporting, and Importing Information EnSite Precision™ Cardiac Mapping System Instructions for Use
240 Archiving Studies ARTEN600004505 Rev. B

Archiving Studies

This option allows the user to archive entire studies to a USB

device, a network drive, CD/DVD, or to the DWS to remove later
via SJM Connect.
1. Click Archive from the Clinical Menu (1).

Figure 201. Clinical Menu.

2. Select the Archive Study tab.

2
3

4 5

7
6

Figure 202. Archive Study Window.

3. Highlight the desired study (3).
4. Insert the desired media, and select the Archive Destination (USB, CD/DVD, network drive,DICOM Server, or SJM Connect)
(4).
5. Select the Identifier (name of the USB device or enter the name of the CD/DVD) (5),
6. Select one or both options (6):
■ “Delete the selected studies from the local drive after successful archiving”
■ “Overwrite the previous archive on the selected destinations” (does not apply to CD/DVD media)
7. Click Archive (7).
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ARTEN600004505 Rev. B Archiving Media
241

8. The system prompts the user to anonymize the archived patient data. Click Yes or No.
■ A progress bar displays “Store in Progress.”
■ The study is archived on the selected media when the progress bar finishes.

Archiving Media

This option allows the user to archive individual images and

animations from a study, rather than the entire study.
1. Click Archive from the Clinical Menu (1).

2. Select the Archive Media tab (2). Figure 203. Clinical Menu.

3. Highlight the study that contains the desired images and

animations (3)

2
3 4
4b

5 6

Figure 204. Archive Media Window.

4. Select a File Name in the right section of the screen (4).
■ The selected image or animation displays below (4b).
5. Insert the desired media, and select the Archive Destination (USB, CD/DVD, network drive, or DICOM Server) (5).
 Chapter 17. Capturing, Exporting, and Importing Information EnSite Precision™ Cardiac Mapping System Instructions for Use
242 Importing Studies ARTEN600004505 Rev. B

6. Select the Identifier (name of the USB device or enter the name of the CD/DVD) (6),
7. Click [Archive] (7).
8. The system prompts the user to anonymize the archived patient data. Click Yes or No.
■ A progress bar displays “Store in Progress.”
■ The images and animations are archived on the selected media when the progress bar finishes.

Importing Studies

The user can import studies to the DWS from a USB device, a
network drive, or CD/DVD.
1. Click Import from the Clinical Menu (1).

Figure 205. Clinical Menu.

2. Select a source from the Import From: pulldown menu

2
3

Figure 206. Import Study Window.

■ If importing from USB or CD/DVD, make sure the media is present in the USB port or CD/DVD drive.
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ARTEN600004505 Rev. B Importing Studies
243

3. Click the [Query] or [Browse] button.

■ For CD/DVD, only [Browse] is available
■ The list of studies on the media displays:

Figure 207. Import Study Window Contents List.

4. Select a study from the list (4) and click the [Import Study] button.
5. The system prompts the user to anonymize the archived patient data. Click Yes or No.
■ A progress bar displays “Store in Progress.”
■ The study is imported to the DWS when the progress bar finishes.
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EnSite Precision™ Cardiac Mapping System Instructions for Use
ARTEN600004505 Rev. B 245

Troubleshooting APPENDIX A

Contacting Technical Support

The following troubleshooting guide is intended to help resolve problems with the system. If problems cannot be resolved by using
the suggestions presented here, contact your EnSite Precision™ Cardiac Mapping System field representative or distributor.

WARNING: Service and Technical Support

651-756-6985
Toll Free: 800-374-8038, Option 1

Troubleshooting Tools

Technical Support may ask that the user access one or more of the following software resources:

EnSite™ Connect – Technical Support is able to electronically access your EnSite Precision™ Cardiac Mapping System to perform
troubleshooting. See “Using SJM™ Connect” on page 246.

About the EnSite Precision™ Cardiac Mapping System – This information provides your EnSite Precision™ Cardiac Mapping
System Technical Support representative with general information about your DWS and EnSite™ Amplifier. There are two ways to
access this information:
■ During a study, from the menu bar, select Help > About.
■ From the title screen, Select [About EnSite Velocity].

Amplifier Logs – This function displays messages from the EnSite™ Amplifier during a study. From the menu bar, select Amplifier >
Log. A window appears that displays all of the collected logs.

Collect Log Files – This function collects all the log files from the DWS and exports them to external media. From the title screen,
select [Services], then [Collect Logs] from the Services menu. [Follow the on-screen prompts to complete the process. This operation
can take several minutes to complete.

Viewing recorded settings – Some settings used in Realtime mode can be viewed (but not changed) in Offline Review mode.
■ Hardware settings can be viewed by selecting Amplifier > Settings from the menu bar.
■ Catheter settings can be viewed in the Setup task.
■ EnSite™ NavX™ Navigation and Visualization Technology settings can be viewed in the Setup task.

Run external program – This function allows utilities to be accessed. From the title screen, select [About EnSite Velocity] > Utilities
> [Run External Program]. Follow the on-screen prompts to complete the process.

Study Files – Record a segment that shows relevant information (if possible) and save the study using the anonymize option to
extrenal media.
 Troubleshooting EnSite Precision™ Cardiac Mapping System Instructions for Use
246 Using SJM™ Connect ARTEN600004505 Rev. B

Using SJM™ Connect

SJM™ Connect is a feature that is available on the EnSite Precision™ Cardiac Mapping System. It allows an EnSite Precision™
Cardiac Mapping System Technical Support representative to connect to your DWS through a broadband Internet connection. When
connected to your DWS, the EnSite Precision™ Cardiac Mapping System Technical Support representative is able to see the interface.
You will also be able to chat with the Technical Support Representative through a chat window.

NOTE: SJM™ Connect is intended for troubleshooting purposes. SJM™ Connect is not intended to be used in lieu of an on-site
system operator.

NOTE: Personal patient information is automatically deleted from uploaded studies. The Technical Support representative uses
these anonymous studies to research any technical issues. When possible, record and annotate segments of any unusual
behavior for analysis.

If You Need SJM™ Technical Support

1. Call SJM™ Technical Support (see “Contacting Technical Support” on page 245).
2. SJM™ Technical Support will assess the issue over the phone and may need additional information from Collect Logs or remote
access to the DWS.
3. If SJM™ Technical Support requires remote access to the DWS, click the SJM™ Connect icon on the EnSite™ Cardiac
Mapping System’s tool bar.

Figure 208. The SJM™ Connect Icon

NOTE: An Ethernet cable with Internet access must be plugged into the hospital network port on the back of the DWS. This is
an encrypted, secure connection used by SJM™ Technical Support.

NOTE: Only enable SJM™ Connect if instructed to do so by SJM™ Technical Support.

4. The SJM™ Connect window displays. Select the timeout from drop down list and click the [Enable]. The SJM™ Connect icon
will turn bronze.

NOTE: SJM™ Connect will be enabled for the selected amount of time, ranging from 0.1 hour (6 minutes), 1 hour, 2 hours, 24
hours, and 48 hours. The default timeout is 0.1 hour (6 minutes). The timeout determines how long the session can remain
idle before being terminated. The session will not timeout at any time during a study.

Figure 209. SJM™ Connect Window

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247

5. If Technical Support initiates a remote connection to the DWS, a prompt displays requesting to view and control your computer
(Figure 210).

Figure 210. SJM™ Technical Support Access Request Example

6. Click [Allow]. If nothing is selected after 15 seconds, Technical Support will automatically connect. The SJM™ Connect icon
will turn green.
7. Technical Support will now have access to the system to troubleshoot the problem. A chat window will display if Technical
Support initiates a chat session (Figure 211).

Figure 211. SJM™ Technical Support Chat Window

8. If necessary, drag this window to the side of the monitor or click on the SJM Connect icon (Figure 205) and select “Show / Hide
Chat” in the SJM Connect dialog (Figure 208 on page 246) Figure 211. The minimized chat window will pop up if Technical
Support initiates a chat. Click [Show Chat] to bring window back on the display.
9. If Tech Support requests any logs, click [Upload Logs] from the SJM™ Connect window (Figure 209).
10. After the Technical Support session has ended, click the SJM™ Connect icon on the EnSite™ Mapping System’s tool bar and
click [Disable] button in the SJM™ Connect window. The SJM™ Connect icon will turn gray.

NOTE: The default status of SJM™ Connect on system startup is disabled. SJM™ Connect should only be enabled when a
Technical Support session is necessary.

If not disabled manually, SJM™ Connect will stay enabled until the specified timeout irrespective of user logouts or system shutdown.
It will disable automatically after the specified timeout if no Technical Support is connected at that time. If a Technical Support is
connected and the timeout expires, the SJM™ Connect session will stay enabled until Technical Support terminates the connection.

Whenever SJM™ Connect window is not active window on the screen, it will close itself. It can always be launched by clicking the
SJM™ Connect icon on the EnSite™ Mapping System’s tool bar.

Sending Files with SJM™ Connect

The chat function allows you to send files from the DWS to SJM™ Technical Support.
 Troubleshooting EnSite Precision™ Cardiac Mapping System Instructions for Use
248 Using SJM™ Connect ARTEN600004505 Rev. B

1. Click [Send File] from the chat window:

Figure 212. SJM™ Connect Chat Window

2. Browse the folders and select the desired file to send, and click [OK].

Figure 213. SJM™ Connect File Browser

NOTE: Do not click [Close] (Red X) button from the chat window, it will terminate the ongoing session with Tech Support. Do
not click any buttons from the chat window until Technical Support instructs you to.

Uploading Logs with SJM™ Connect

If SJM™ Technical Support requests that you upload logs:
1. Click [Upload Logs] from the SJM™ Connect window (Figure 209).
2. Select the logs to upload.

NOTE: The logs will not be uploaded automatically. They will remain on the DWS until SJM™ Technical Support connects to
the DWS to collect them.

Uploading Studies
If SJM™ Technical Support requests that you upload patient studies:
1. Click the [Clinical] button, then the [Archive] button from the EnSite™ Cardiac Mapping System main page.
2. Select the study or studies to upload.
3. Select the [SJM Connect] checkbox and click [Archive].
EnSite Precision™ Cardiac Mapping System Instructions for Use Troubleshooting
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249

4. Click [Close].

NOTE: The studies will not be uploaded automatically. They will remain on the DWS until SJM™ Technical Support connects
to the DWS to collect them.

Proxy Configuration
SJM™ Technical Support may request that you configure the proxy server in order to establish a connection to the DWS:
1. Click [Configure Proxy] in the SJM™ Connect window (Figure 209).

NOTE: The [Configure Proxy] button will be inactive if SJM™ Connect is enabled.

Figure 214. The SJM™ Connect Proxy Configuration Window

2. Click the [Enable Proxy] checkbox and enter the proxy server and proxy port information.
3. If the proxy server requires authentication, click the [Authorization Required] checkbox and enter the authorized user name and
password.
4. Click [Save] to save the proxy configuration.

NOTE: Do not configure a proxy if the hospital network does not require a proxy for Internet access. By default, no proxy is
configured and all the fields from the Proxy Configuration window will be inactive.

Notifying SJM
When system logs or patient studies have been prepared for uploading, contact SJM by telephone or e-mail.

To contact SJM by telephone:

Toll free: 1-800-374-8038; option 1

In Europe: 32-2-774-68-11
■ To contact SJM by email: [email protected]
 Troubleshooting EnSite Precision™ Cardiac Mapping System Instructions for Use
250 Troubleshooting Common Problems ARTEN600004505 Rev. B

Troubleshooting Common Problems

When a problem occurs perform the following steps:

1. Identify the problem source and use the guides below:
■ “System Hardware Problems” on page 250
■ “Patient Signal Problems” on page 252
■ “Software Interface Problems” on page 255
2. If the problem cannot be resolved, contact EnSite Precision™ Cardiac Mapping System Technical Support (“Contacting
Technical Support” on page 245).

System Hardware Problems

In general: Many Check all status lights
hardware problems can • EnSite™ Amplifier: When the system is powered on, the status lights may change state for approximately two
be identified/resolved by minutes while the system performs self-testing. If after the two minute power on self-test, the amber light flashes or
checking status lights and illuminates steadily, the EnSite™ Amplifier has detected a problem. The EnSite™ Amplifier status and any fault
cable connections. information can be uploaded by the workstation after the EnSite™ Amplifier connects to the workstation.
• EnSite Precision™ Cardiac Mapping System Workstation: The power LED on the front of the workstation should be
on.
Verify proper cable connections:
• Turn the system power off.
• Unplug the system components from power outlets.
• Check all connections for damage (such as bent or broken pins).
• Verify there are no loose connections.
• Check the integrity of the wall power outlet.
• Power the system on according to “Starting the System” on page 107.

Power Failures: A power If there is reason to believe that some type of power failure has occurred, turn the EnSite™ Amplifier power switch to
blackout will cause a total OFF immediately. Try to end the study and shutdown the workstation, as described in “Ending a Study” on page 233. If
system shutdown. In the the normal shutdown procedure is unsuccessful:
case of a brownout, the • Try Ctrl-Alt-Delete
system may totally
• Try Alt-F10 > [Exit EnSite Velocity] > [Exit]
shutdown or may show
signs of abnormal system • Try momentarily pressing the power button on the front of the DWS
behavior. • As a last resort, press and hold the power button on the front of the DWS.
When the power resumes and appears to be stable, power up the system as described in “Starting the System” on page
107. Monitor the automated system check during the power-up procedure. If any system problems occur, contact SJM
Technical Support immediately. To continue the study, see “Past Studies” on page 115.

There is a problem with • A solid amber LED indicates a self-test problem in the EnSite™ Amplifier.
the EnSite™ amplifier, • A flashing amber LED indicates an error in the EnSite™ Amplifier.
indicated by an amber
• Contact EnSite™ System Tech Support.
LED on the amplifier front
panel after the two-
minute power on self-test.

The EnSite™ Amplifier The EnSite™ Amplifier is unresponsive or is not collecting data in Realtime mode or RealReview mode. Try to re-
is not communicating with establish communication with the EnSite™ Amplifier by selecting Amplifier > Reconnect. If communication is not
the workstation. reestablished, do the following:
• Check the fiber-optic cable connection at the EnSite™ Amplifier and at the workstation.
• Power on the EnSite™ Amplifier and all peripherals.
• Power on the workstation.
• Check the 3 indicator lights on the Media Converter (inside the back door of the DWS).
- Fiber - green - Media Converter is receiving the signal from the EnSite™ Amplifier
- via the Fiber- Optic cable.
- Power (Pwr) - green - Media Converter is receiving power from the Workstation.
- Copper - green - Media converter is receiving the signal from the DWS
EnSite Precision™ Cardiac Mapping System Instructions for Use Troubleshooting
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251

There is a problem with The workstation displays a yellow warning dialog: “Amplifier Error.”
the EnSite™ Amplifier The user should Contact EnSite™ System Technical Support.
indicated by the
workstation.

The workstation will not • Verify that the power conditioner switch is on.
turn on, will not boot, or • Verify that the power cable is properly connected between the workstation and the power conditioner.
turns off unexpectedly.
• If the system should cease to function due to a power outage or other failure, turn off all power switches. Then restart
the system as described in “Starting the System” on page 107. System recovery may take up to 6 minutes.
• Try momentarily pressing the power button on the front of the DWS
• As a last resort, press and hold the power button on the front of the DWS.
• To continue the study, refer to “Past Studies” on page 115.

Hard drive has run out of If there is insufficient space on the hard drive to load a study from the external media, delete studies from the hard drive,
space. then load the study.

There is a broken Contact EnSite™ System Technical Support or Customer Service.

connector pin.

The printer does not • Ensure the printer is enabled. To do this, go to the Services menu and select [Select Printer]. Select the desired printer
print images. and click “Apply.”
• Ensure that printer ink cartridges are not depleted; replace depleted cartridges. Ensure that there is paper in the
printer.
 Troubleshooting EnSite Precision™ Cardiac Mapping System Instructions for Use
252 Troubleshooting Common Problems ARTEN600004505 Rev. B

Patient Signal Problems

There is a problem with If noise levels are excessive on EnSite Precision™ Cardiac Mapping System signals or the “Too many inactive
EnSite™ Array™ Catheter electrodes” message appears, check the following:
validation or signal check • Verify cable connections.
(including “too many bad
• Ensure that the EnSite™ Array™ Catheter connector and data module are firmly inserted into the ArrayLink™
electrodes”).
Module.
• Ensure that the System Reference Patch is properly connected to the NavLink™ Module and the patient. After
verifying cable connections, wait for 10 seconds and then verify signal fidelity from the EnSite™ Array™ Catheter
bar chart Setup mode.
• Verify that none of the ring electrodes on either the EnSite™ Array™ Catheter or the roving catheter are covered
by an insulator (such as a sheath) or obstructed by tissue.

There is a need to validate If the validity of a virtual electrogram signal or a map is in question, compare the EnGuide virtual electrogram to the
virtual electrogram EP catheter electrode in contact with the endocardium at the same site. Similarity between these signals suggests
morphology to contact validity of the virtual electrogram or map at the same site. This can be done in any mode. However, in review mode
electrograms the EnGuide locator must have been enabled before the segment was recorded.
• Set an electrode on an EP catheter to Active EnGuide.
• Under model controls, display the EnGuide locator as a vector with a single electrode.
• Under catheter setup / waveform controls, set EnGuide virtual polarity to Unipolar.
• In Waveform, set up two traces. Set one trace source to EP catheter and set the second trace source as EnGuide.
Use the electrode that is selected for EnGuide on both traces.The d/dt checkbox and Amplitude filtering should be
identical between the EP catheter and EnGuide traces.
• Verify that the EP catheter electrode is in contact with the chamber wall. Use the EnGuide locator to determine the
location of the EP catheter electrode.
Caution: If the EP catheter electrode is not in contact with the endocardium, the comparison between the
EnGuide virtual electrogram and the EP catheter electrode may not accurately reflect the relationship between
these signals.
• Compare the traces in the waveform display. Similarity between the signals indicates validity of the virtual
electrogram.

Interference between This equipment has been tested and found to comply with the limits for medical devices to EN 60601-1-2: 2001. This
devices is evident. testing shows the device provides reasonable protection against harmful interference in a typical medical
installation. However, there is no guarantee that interference will not occur in a particular installation. If this
equipment does cause harmful interference to other devices or is negatively impacted by other devices, try to
correct the interference by one or more of the following measures:
• Reorient or relocate the devices.
• Increase the separation between the devices.
• Connect the equipment to an outlet on a different circuit.
• Contact Technical Support for further assistance (“Contacting Technical Support” on page 245).

There is excessive If noise levels are excessive in general, check the following:
waveform noise. • Under catheter setup / waveform controls, evaluate signals with noise filters enabled and disabled.
• Ideally, the power source for the EnSite™ Amplifier should be a properly grounded, dedicated 15 amp circuit.
Avoid using hospital emergency power for either the workstation or EnSite™ Amplifier.

An EnSite™ NavX™ • Verify that all cable connections between the surface electrodes and the NavLink™ Module are secure.
Navigation and • Verify that none of the surface electrodes have come loose. If a surface electrode has come loose from the patient,
Visualization Technology re-apply the electrode in the same location and verify that navigation is accurate, compared to fluoroscopy and
surface electrode has signals. It may be necessary to re-validate.
become disconnected or
loose, indicated by a warning
message.

ECG signals are not • Verify that the system reference patch is connected to the patient.
functioning properly. • Verify that the ECG cables are connected properly.
• If not using a RecordConnect, verify that the ECG cable was labeled by St. Jude Medical.
EnSite Precision™ Cardiac Mapping System Instructions for Use Troubleshooting
ARTEN600004505 Rev. B Troubleshooting Common Problems
253

EnGuide Stability Problems

An EnGuide locator position • Verify that the ablation catheter is connected to the GenConnect interconnect.
seems to be incorrect: • Verify that EnGuide is locating the intended electrode.
• The EnGuide locator • Verify that none of the ring electrodes on the roving catheter (or EnSite™ Array™ Catheter) are covered by an
intermittently displays insulator (such as a sheath) or obstructed by tissue. If the proximal electrodes of the ABL catheter are covered
jumps in location or with a sheath and ABL Distal Stabilize is enabled, turn off ABL Distal Stabilize to allow for location of the distal
changes in color. electrode.
• Displayed location of the • Verify that catheter jumpers are connected properly.
roving catheter on the
• Verify that the surface electrodes are properly adhered to the patient and connected to the system.
Cardiac Mapping System
differs from the displayed • Verify that the wires for the surface electrodes are positioned in a way that there is no tension on the wire.
catheter location on • Attempt to use the EnGuide system on a different catheter. Signal improvement may indicate a damaged EP
fluoroscopy or another catheter or connecting cable.
mapping system. • Select Amplifier > Reset Amplifier.
• The movement of the • For EnSite™ Array™ Catheter studies, verify that electrode rings E1 and E2 are in the same chamber.
EnGuide locator is
inconsistent with the
movement of the roving
catheter.
• The EnGuide locator
“jitters.”

An EnGuide locator • In an EnSite™ NavX™ Navigation and Visualization Technology study, if EnGuide locators appear kinked, there
appears kinked or displays may be a problem with the catheter. A new catheter or extension cable may display better results.
fewer electrodes than • If EnGuide is displaying fewer electrodes than expected (based on EnGuide settings) the electrodes may be
expected. spaced too close to one another for EnGuide to display different electrodes, or there may be a problem with the
roving catheter, such as a weak electrode or short.

Patient Irregular Respiration Patterns Follow these steps:

Patient – sleep apnea, coughs,
1. Wait for the respiration pattern to stabilize. The EnGuide may return to its original
snoring
expected location
2. Manually recollect respiration compensation data. See “Respiration Compensation”
on page 137.
3. Switch to manual to prevent additional collection (disable adaptive respiration
compensation). See page “Respiration Compensation” on page 137.
4. If multiple shadows have been placed use EnGuide Alignment tool to adjust the
visually realign the catheter to the model. See “EnGuide Alignment” on page 140.
5. Build a new model if steps above do not resolve the problem.

Patient Rate or Rhythm change • Heart rate or rhythm changes have the potential to change the physical anatomical
volume of the heart chamber. If the rate or rhythm changes occur after a model has been
created, new model may need to be created for the new rate or rhythm.

Patient Isoproterenol bolus • Wait for the respiration pattern to stabilize. The EnGuide may return to its original
expected location.

Patient Heart Motion • If the heart has physically moved from its original position, create a new model if
necessary.

Device Interaction Cardioversion Follow these steps:

1. Wait for the EnGuide to return to its original expected location
2. If multiple shadows have been placed use EnGuide Alignment tool to adjust the
visually realign the catheter to the model. See “EnGuide Alignment” on page 140.
3. Build a new model if steps above do not resolve the problem.

Device Interaction Introduction of a Guide Wire • Remove the guidewire if it is not in use.

Device Interaction Pacing – connection of a • If there is no active pacing on the electrode pair, remove the connection of the stimulation
stimulation channel to channels.
electrodes
 Troubleshooting EnSite Precision™ Cardiac Mapping System Instructions for Use
254 Troubleshooting Common Problems ARTEN600004505 Rev. B

Surface Electrode Surface Electrode Detachment Follow these steps:

Changes 1. Replace the detached surface electrode a new surface electrode
2. Build a new model.

Surface Electrode Surface Electrode movement Follow these steps:

Changes relative to the location of the
1. Switch to an intracardiac reference if available to prevent additional instability due to
heart
surface electrode movement.
2. If multiple shadows have been placed use EnGuide Alignment tool to adjust the
visually realign the catheter to the model. See “EnGuide Alignment” on page 140.
3. Build a new model if use of the alignment tool is not successful.

Surface Electrode Pushing on a patch - Inflation Try the following options:

Changes of a blood pressure cuff • Avoid pushing on the patch or remove the object pushing on the patch
• Switch to an intracardiac reference if available

Surface Electrode Adding or removing patient • Avoid moving bedding materials such as a pillow that have the potential to disturb the
Changes bedding materials surface electrode

System Related Positional Reference Moves Try the following options:

• Move catheter to original location as observed on Fluoroscopy images. If Positional
Reference Tool is enabled use the tool to realign the reference.
• Switch from the intracardiac Positional Reference to the System Reference. Then choose
a different electrode for positional reference.
• Build a new model if use of the Positional Reference Tool is not successful.
EnSite Precision™ Cardiac Mapping System Instructions for Use Troubleshooting
ARTEN600004505 Rev. B Troubleshooting Common Problems
255

Magnetic Tracking Problems

No communication with • Verify that power is supplied to the EnSite Precision™ Link, Sensor Enabled™
EnSite Precision Link • Verify that the fiber optic connection between the EnSite Precision™ Link and EnSite™ Amplifier is secure and
working
• Reconnect DWS and EnSite Precision™ Link by performing a right-click on the EnSite Precision™ connection
indicator
• End the study and start a new study

System not recognizing PRS • Verify connection of the EnSite Precision™ Field Frame cable to the EnSite Precision™ Link
• Ensure that the EnSite Precision™ Field Frame cable is not coiled
• Replace the PRS

PRS icons are gray • Ensure that the EnSite Precision™ Field Frame cable is not coiled
• Ensure that the two PRS sensors are separated and are not being separated by a pillow or other piece of
equipment

Valid PRS status is • Ensure that the EnSite Precision™ Field Frame cable is not coiled
intermittent • Replace the PRS

PRS-A is gray or amber • Confirm position of PRS is within the field frame
- Adjust the EnSite Precision™ Field Frame position
- Adjust patient if the EnSite Precision™ Field Frame position cannot be adjusted
- Position the PRS-A appropriately on patient
• Raise the Fluoroscopy detector
• Remove presence of metallic equipment in the presence of the magnetic field Example: patient warming
equipment, monitor boom
• Disconnect and reconnect the PRS to the EnSite Precision™ Link

PRS-P is gray or amber • Confirm that the position of the PRS is within the borders of the EnSite Precision™ Field Frame window
- Adjust the EnSite Precision™ Field Frame position
- Adjust patient if EnSite Precision™ Field Frame position cannot be adjusted
- Position the PRS-P appropriately on patient
• Raise the patient table
• Remove presence of metallic equipment in the presence of the magnetic field Example: patient warming
equipment, monitor boom
• Disconnect and reconnect the PRS to the EnSite Precision™ Link

Metal Distortion meter • The reference state should be set with the C-arm position in which model will most likely be created
triggered • Correct or remove any recently added equipment
- If the C-arm has recently moved, move it back to the baseline position
- If programming a device, remove the telemetry wand
• If the it cannot be resolved with equipment adjustments, define a new baseline by selecting Set Reference State.
This will require recollection of SE points
• If an adjustment to the rail limits on the meter is needed to correct the problem, new model data collected may
have a level of error compared to previously collected model data and the EnGuide Stability Monitor may result in
increased numbers of notifications.

System not collecting SE • Confirm catheter status indicators is green

points • Verify Metal Distortion is Enabled
• Confirm catheter selected as Active EnGuide
• Confirm catheter type is Sensor Enabled™
• Verify the electrodes on the catheter are out of the sheath
• For ablation catheter, ensure Stabilize ABL is off
• Irregular respiration pattern may cause points to not be collected due to respiratory gating. Monitor the Respiration
gating waveform.

Software Interface Problems

Unable to enter Review An action is incomplete. Verify that the model has been completed. Verify that recorded segments have been
Mode or end study. completed and annotated.
 Troubleshooting EnSite Precision™ Cardiac Mapping System Instructions for Use
256 Troubleshooting Common Problems ARTEN600004505 Rev. B

Unable to access controls to • Verify that Offline Review mode is selected; the external media is not intended to be used to export data or
export information to the animations during a study.
external media.

The study screen display If the system appears to be running but does not respond to keyboard or mouse input, press and hold the <Alt> key
freezes. on your keyboard, then press the <Tab> key. The system should then return to normal operation.
The study screen freezes after a manual reset of the EnSite™ Amplifier or an inadvertent reset following a
defibrillation. Possible messages include: Data rate is out of range or No data is being received from the
EnSite™ Amplifier. When one or both of these messages appear, click [OK]. If the screen remains frozen, perform
the following steps:
• Power cycle the EnSite™ Amplifier by turning the EnSite™ Amplifier power switch off and (after five seconds) then
on.
• Select Amplifier > Reconnect and wait up to 2 minutes for the EnSite™ Amplifier to complete its self-test
routines.
• Select <Alt> + <Tab> to see if the study screen starts responding.
• To force the system to shut down, select <Alt> + <F10> YES, REALLY EXIT VELOCITY.
• To end the current session, or to force the system to shutdown or restart, select <Ctrl> + <Alt> + <Del>, and
choose the desired option.
If the problem still persists, contact EnSite Precision™ Cardiac Mapping System Technical Support.

An on-screen warning A number of problems are reported by displaying a message in a window. One or more buttons are available, which
message has appeared. specify the action to take to remedy the identified problem.
A desktop manager window may also pop up on-screen when an application is not responding. It will have two
options - “Terminate” or “Keep Running.” Select the desired option.
Note: Further details on problems related to the current version of the software can be viewed by selecting Release
Notes under the Help menu.
Other information may be displayed along with these messages indicating what caused the problem. Note this
information for future reference should you wish to contact support personnel.
Caution: Always respond to warning messages as soon as possible. Failure to do so may cause an inability to
record data or to communicate properly with the EnSite™ Amplifier.
Different buttons may appear based upon the severity of the identified problem. Some examples of these button
options are:
• [Reconnect] reconnects to the EnSite™ Amplifier.
EnSite Precision™ Cardiac Mapping System Instructions for Use
ARTEN600004505 Rev. B 257

Care and Service APPENDIX B

Service and Technical Support

Due to the complexity of this system, service may be performed only by trained personnel. Contact your EnSite Precision™ Cardiac
Mapping System representative or distributor for service and technical support.

St. Jude Medical

One St. Jude Medical Drive
St. Paul, MN
55117-9913 USA
+1 855 478 5833
+1 651 756 5833
sjm.com

St. Jude Medical

Coordination Center BVBA
The Corporate Village
Da Vincilaan 11 Box F1
1935 Zaventem
Belgium
+32 2 774 68 11
sjm.com

Australian Sponsor:
St. Jude Medical Australia Pty Limited
17 Orion Rd.,
Lane Cove NSW 2066
AUSTRALIA
+61 (02) 9936 1200
 Care and Service EnSite Precision™ Cardiac Mapping System Instructions for Use
258 Setting Environmental Information ARTEN600004505 Rev. B

Setting Environmental Information

Setting the System Clock

1. Login as the Service user.
2. From the title screen, click [Services] and select Utilities.
3. Adjust the System Time section on the left side of the screen using the arrow buttons to set the current time.

NOTE: This is a 24 hour clock. The clock can only be set to a time that is at least 18 hours later than the time that the last study
ended.

NOTE: After the user sets the system clock, the system prompts the user to confirm system shutdown.

Setting the Powerline Frequency

The powerline frequency can be set to either 50 Hz or 60 Hz. For North
American locations, 60 Hz is generally appropriate. For European locations,
50 Hz is generally appropriate.
1. During a study, select Amplifier > Amplifier Settings > Power Line.
2. Use the Powerline Frequency checkboxes to select a powerline
frequency.

Figure 215. Setting the powerline frequency.

Setting the Owner Information
Information about the hospital can be entered into the software. The saved hospital name is displayed on the title screen and saved with
studies on the external media. From the title screen, select [Services] and then click the Hospital tab. Complete the available fields
and select [Apply]. See Figure 216 on page 258.

The owner information is used to administer support tools such

as EnSite Connect.

NOTE: If multiple EnSite Precision™ Cardiac Mapping

Systems are present at the same location, enter an
identifier such as “LAB A.”

Figure 216. The owner information helps EnSite Support organize

information.
EnSite Precision™ Cardiac Mapping System Instructions for Use Care and Service
ARTEN600004505 Rev. B Customer-Performed Maintenance
259

Customer-Performed Maintenance

EnSite™ Amplifier
Cleaning
WARNING: Cleaning is recommended after each use. All surfaces should be cleaned with a dry, lint free cloth, gently applied. Where
necessary, alcohol can be applied on such a cloth to remove grease and stains. The monitor screens can be cleaned with
an appropriate solution.

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

CAUTION: Do not clean system components with bleach.

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

CAUTION: Do not sterilize system components.

CAUTION: Do not immerse system components in liquid.

Periodic Inspection
The system components should be inspected by the customer on a monthly basis:
■ Ensure that the fans on system components are operating when power is on. Periodic fan filter cleaning or replacement is
recommended.
■ Check the components, cables, and connections for mechanical damage.
■ Check cables and connectors for damaged pins.
■ Verify that inscriptions and labels on the system components are properly and completely fixed.
■ Visually inspect that this Instructions for Use document is undamaged and complete.

Cleaning/Replacing the EnSite™ Amplifier Air Filter

Important: Clean the EnSite™ Amplifier air filter every 30 days.
1. Use a Phillips screwdriver to remove the fastener holding the filter handle
in place (Figure 217 on page 259).
2. Slide the handle and filter out of the EnSite™ Amplifier by pulling away
from the EnSite™ Amplifier. Do not remove the filter from the handle
unless you are replacing the filter.
3. Clean or replace the filter:
To clean the filter, pick off the lint layer and vacuum out the remaining
dust.
To replace the filter:
a. Remove the filter from the handle by unscrewing the two
mounting screws (Figure 218 on page 260).
b. Discard the filter.
Figure 217. Removing the filter handle.
 Care and Service EnSite Precision™ Cardiac Mapping System Instructions for Use
260 Customer-Performed Maintenance ARTEN600004505 Rev. B

c. Mount a new filter in the handle using the two screws. The
gestated side of the filter should be oriented as shown.
4. Slide the filter into the channels in the EnSite™ Amplifier until the handle
is flush with the side of the EnSite™ Amplifier.
5. Fasten the handle to EnSite™ Amplifier using the Phillips screw.

Replacing Fuses
The EnSite™ Amplifier power supply is protected by two replaceable fuses
located near the power cord connection.

Use only 5x20mm type, 5 amp, 250 VAC fuses (T5AL250V). Always replace
both fuses.

To remove the fuses, remove the power cord, flip up the fuse cover, and pull out Figure 218. Removing the filter.
the red fuse holder. The fuses are located on opposite sides of the fuse holder.
Replace both fuses, reinsert the red fuse holder, flip down the fuse cover, and
reattach the power cord.

EnSite™ DWS
Cleaning
The DWS should be inspected for excessive dust build-up every 3 months. Dry air should be used to remove any excessive dust.
Perform this away from other equipment.

EnSite Precision™ Link, Sensor Enabled™

Cleaning
WARNING: Cleaning is recommended after each use. All surfaces should be cleaned with a lint free cloth, using one of the following
cleaning solutions:
■ Isopropyl Alcohol
■ Cidex™
■ Cidex OPA™
■ Sani-Cloth™ AF Germicidal Disposable Wipes

Periodic Inspection
The EnSite Precision™ Link, Sensor Enabled™ components should be inspected by the customer on a monthly basis:
■ Ensure that the fans on system components are operating when power is on. Periodic fan filter cleaning or replacement is
recommended.
■ Check the components, cables, and connections for mechanical damage.
■ Check cables and connectors for damaged pins.

Cleaning/Replacing the EnSite Precision™ Link, Sensor Enabled™ Air Filter

The rear of the unit contains a filter cover held in place with magnets. The filter should be washed in warm water as needed. The filter
must be dry before replacing. The recommended inspection time is every 3 months.
EnSite Precision™ Cardiac Mapping System Instructions for Use Care and Service
ARTEN600004505 Rev. B Customer-Performed Maintenance
261

EnSite Precision™ Patient Reference Sensors (PRS)

Cleaning
The EnSite Precision™ Patient Reference Sensors are intended for multiple uses. After each use, the user shall clean and maintain the
Electrodes as follows:
■ Clean the PRS (not including its connector) by wiping it with a cloth saturated with 70% alcohol solution, Cidex™, Cidex OPA™,
or Sani-Cloth™ AF Germicidal Disposable Wipes.
■ Inspect the PRS and replace if damaged.
■ At the end of the day, disconnect the PRS and store in the reusable plastic trays.

Storage
PRS may be stored in the reusable plastic tray:
1. Insert the PRS and connector into one half of the tray.

2. Press and snap-on the top half of the tray (4 snaps secure the tray halves).

3. Wrap the cables around the groove. Pull the cable inside the groove.

4. Tuck the end of the cable inside the groove.

 Care and Service EnSite Precision™ Cardiac Mapping System Instructions for Use
262 Field Service Representative Performed Maintenance ARTEN600004505 Rev. B

Field Service Representative Performed Maintenance

The EnSite™ Amplifier should be tested annually. These tests require specialized equipment and training. Contact an EnSite
Precision™ Cardiac Mapping System-trained field service representative to schedule testing.

Replacement Parts
Table 30. EnSite Precision™ Replacement Parts

Part Name Part Number

Amplifier EE3000

Amplifier Accessory Kit 100012711

DWS Accessory kit 100026253

NavLink 100003063

ArrayLink 100014469

Display Workstation EE3000

Display Workstation (DWS 6) Model - Z620
Display Workstation (DWS 7) Model - Z640

GenConnect • IBI - 100011877

• Stockert - 100040090
• EPT - 100011879
• ATAKR - 100011880

RecordConnect • GE - 1000005745
• WorkMate - 100005746
• Siemens - 100005747
• Bard-Stamp - 100013362
• Bard Clear Sign - 100018069
• Universal 100010720

Monitor - DWS and remote, 24” or 21” 100022163 (24”) or 100017757 (21”)

ECG Cable 100013101

Fiber Optic Cable 42-04659-001

EnSite Precision™ Module, Sensor Enabled™, Patient Reference H702492

Sensors

EnSite Precision™ Link, Sensor Enabled™ H702470

EnSite Precision™ Field Frame H702469

EnSite Precision™ Field Frame Cable Kit H702471

EnSite Precision™ Field Frame Mounting Kit H702472

EnSite Precision™ Link, Sensor Enabled™, Bedrail Kit H702474

EnSite Precision™ Module, Sensor Enabled™, Power Kit - OUS H702505

EnSite Precision™ Cardiac Mapping System Instructions for Use Care and Service
ARTEN600004505 Rev. B Moving the System
263

Moving the System

Do not disconnect any cables other than those mentioned below. These are not user-serviceable connections.

If the system must be moved, adhere to the following guidelines:

1. Disconnect external equipment (EnSite Precision™ Link, Sensor Enabled™, EnSite Precision™ Field Frame. NavLink™
Module, ArrayLink™ Module, CathLink™ Module, SJM ECG Cable, RecordConnect, and GenConnect) from the EnSite™
Amplifier.
2. Disconnect any catheters, external stimulator, system reference, ECG electrodes, unipolar reference, recording system, and
ablation system connected to the EnSite Precision™ Patient Reference Sensors,NavLink™ Module, ArrayLink™ Module,
CathLink™ Module, SJM ECG Cable, RecordConnect, and GenConnect.
3. Disconnect power cords from external power sources. Any cords connected to an isolation transformer secured to a cart can
remain connected.
4. Disconnect the fiber-optic cable from the EnSite™ Amplifier.
5. For dual monitor systems, disconnect the second monitor cables from the DVI extender at the back of the DWS.
6. Secure all cables on the carts to which they are attached.
7. After moving the system, inspect all connections for damage, reconnect the system. Damaged cables or components must be
replaced.

NOTE: When reconnecting the fiber-optic cable to the EnSite™ Amplifier, be sure to align the tabbed edge of the cable
connector to the slotted edge of the jack.
8. Power ON the system. Monitor the startup procedure as described in “Starting the System” on page 107.

Installing EnSite™ Cardiac Mapping System Software Licenses

EnSite™ products are activated by installing appropriate licenses. A base license must be installed before installing any optional
module such as EnSite™ Fusion™ or EnSite™ Verismo™.

NOTE: Attempts to install EnSite™ optional modules on a system without a base license for the EnSite™ Cardiac Mapping
System will fail.

Preparing to Install
Required equipment:
■ A computer with Internet connection
■ Software Upgrade Kit
■ USB Flash Drive

or
■ CD Writer, needed in order to burn the license(s) to CD

These processes have been validated using Internet Explorer 6.0 through Internet Explorer 9.0.

NOTE: Retrieve licenses before the site visit, if Internet access could pose an issue. The EnSite™ computer hostname will be
required for the license.

Requirements
A Software Upgrade Kit, which includes:
 Care and Service EnSite Precision™ Cardiac Mapping System Instructions for Use
264 Installing EnSite™ Cardiac Mapping System Software Licenses ARTEN600004505 Rev. B

Table 31.

Name Description

Software Necessary to retrieve software licenses. The Certificate contains an Activation

Certificates ID, which is a code used to log onto the license server website and retrieve a
license

CD Media for copying and transferring licenses

Installation Installation Report is used to document the installation and maybe returned to
Report St Jude Medical

NOTE: The host name is always of the forms:

■ esiXXXX for Precision™ v.2.x or newer
■ mwsGXXXXXX for LRSs or
■ dwsGXXXXXX for Precision™ v.2.x or newer where XXXXXX is a number and G is a capital letter.

Retrieve License(s) and Create Media

The Web site requires that a base system license is created first before creating optional module licenses.

The following steps must be performed on a computer with an Internet connection and CD writer or USB flash drive to acquire the
licenses.
1. Go to the SJM licensing server website at: https://ensite-license.sjm.com/

NOTE: The Activation ID for the base license is the same as the hostname. Use the hostname from the DWS as the activation
ID and not what is on the box.
2. Enter the Activation ID in the Activation ID text box.
3. Click validate.

Figure 219. Activation ID text box.

4. Enter the Hostname of the computer
5. Click validate.

Figure 220. Hostname text box

6. Fill in license information: If you already have a base license, please go to step b otherwise please complete step a, to generate a
new base license.
For a base license, fill in license information as follows. It is recommended that a copy of the license is emailed to you for future
reference.
EnSite Precision™ Cardiac Mapping System Instructions for Use Care and Service
ARTEN600004505 Rev. B Installing EnSite™ Cardiac Mapping System Software Licenses
265

a. Select Yes, Download and Email License when finished

Figure 221.
■ Start Date: the intended date of install.
■ PIU/Amplifier Serial #: The serial number on the rear of the Patient Interface Unit (PIU). Enter ‘unknown’ or ‘none’ if the
PIU/Amplifier Serial # is unknown, or if it is for a LRS.
■ Installer Name: Full Name
■ Installer Email: SJM email address
■ Email License? choose how to deliver the license.
– Yes, Download and Email, to have the license downloaded immediately and emailed
– No, Just Download, to have the license downloaded immediately
b. Click Yes, Download and Email License when finished.
 Care and Service EnSite Precision™ Cardiac Mapping System Instructions for Use
266 Installing EnSite™ Cardiac Mapping System Software Licenses ARTEN600004505 Rev. B

NOTE: For an optional module license, fill in license information as follows. It is recommended that a copy of the license is
emailed to you for future reference.

Figure 222. Optional Module License

■ Start Date: the intended date of install.
■ Installer Name: full name.
■ Installer Email: SJM email address.
■ Email License? choose how to deliver the license.
Yes, Download and Email, to have the license downloaded immediately and emailed
– No, Just Download, to have the license downloaded immediately
■ Click Yes. The license file will begin downloading.
7. Save the license information to media. Do not change the, .lic, file extension. More than one file may be saved to the media.

Figure 223. Save License Information to Media

EnSite Precision™ Cardiac Mapping System Instructions for Use Care and Service
ARTEN600004505 Rev. B Installing EnSite™ Cardiac Mapping System Software Licenses
267

Verify the Contents of a License File

Once the license has been downloaded and saved onto the media, it is recommended to validate the contents of the license media.
1. Click on Validate/Check License CD link, as shown below

Figure 224. Validate/Check License CD Link.

This utility can be used to check the license file for following:
■ Hostname
■ Product
■ Start Date and Expiry (for demo licenses)
■ License filename format
■ Validity of the license data
2. Click Browse button, to locate the license file on the system.

Figure 225.
 Care and Service EnSite Precision™ Cardiac Mapping System Instructions for Use
268 Installing EnSite™ Cardiac Mapping System Software Licenses ARTEN600004505 Rev. B

3. Click Check File, button to verify the file.

A results screen will appear. Verify that the hostname and the product ID are correct.

Figure 226. Check File Results.

Install Licenses
For EnSite Software version 5.0 or Newer:
1. Take the license media created in Retrieve License(s) and Create Media on page 3 to the Display Workstation
2. Login as user service
3. Click Service > Install License From Media
4. Follow the prompts

Verify Installed Licenses

For Precision™ v.2.x or Newer:
1. Log in as user service.

2. Click About System > Software Inventory tab

EnSite Precision™ Cardiac Mapping System Instructions for Use Care and Service
ARTEN600004505 Rev. B Installing EnSite™ Cardiac Mapping System Software Licenses
269

3. Scroll through Software Inventory:

Figure 227. Software Inventory Screen.

The status of all currently licensed features for this system is displayed. The system example, above, has a permanent base EnSite
System license. This section will also display:
■ Status of any optional modules
■ Demo software
■ Demo days remaining

Re-Creating Licenses
If a license was created earlier and another copy of the existing needs to download use the same page to retrieve another copy.
1. Go to the SJM licensing server website at: https://ensite-license.sjm.com/lserv/
2. Enter the old Activation ID and hostname of the EnSite computer for the license created earlier

NOTE: This will not work if the Activation ID and hostname combination do not match any existing licenses.
■ The Web page will download the old license file and then it can be emailed.
 Care and Service EnSite Precision™ Cardiac Mapping System Instructions for Use
270 Installing EnSite™ Cardiac Mapping System Software Licenses ARTEN600004505 Rev. B

Manage Licenses
For Precision™ v.2.x or Newer:
1. Log in as service
2. Click Services > Manage Licenses, from the title screen. The Manage Licenses window displays the licenses on the system.

Figure 228. Manage Licenses Window.

3. Click INSTALL FROM MEDIA, to install licenses or upgrade software from media.
4. Click OK or CANCEL to close the window.
5. Click SHOW ERRORS to display errors encountered during the license install process.

Installation Report
Fill out the installation report supplied with the kit once the installation is complete.

Velocity license has not been installed

All EnSite systems require a base license to be installed to unlock the software.

Figure 229. License Not Installed Message.

EnSite Precision™ Cardiac Mapping System Instructions for Use Care and Service
ARTEN600004505 Rev. B Warranty Policy
271

1. Confirm that the system base license is installed as shown in the Verify Installed Licenses section.
2. Contact SJM Tech support, if the proper version of the base license is not installed
SJM Tech support numbers:
Toll Free: 800.374.8038
Phone Number: 651.523.6985

Installing a base license

Create and install a base system license for the EnSite™ Cardiac Mapping System before or at the same time as the optional module
licenses is installed.

For a new EnSite Velocity System or DWS replacement, use the system hostname as the Activation ID when logging into the SJM
licensing web site at: https://ensite-license.sjm.com/lserv/

Follow these Steps:

1. Connect with a web browser to : https://ensite-license.sjm.com/lserv/
2. Select Login with Activation ID
3. Enter the hostname of the DWS as the Activation ID (hostname example: dwsG123456)
4. Create the base system license
5. Save it to media or email to yourself
6. Install the base license first
7. Install option licenses, such as the Verismo or Fusion license.

Warranty Policy

For warranty information, contact your EnSite Precision™ Cardiac Mapping System representative or distributor for a description of
warranty coverage, service agreements, and replacement/upgrade component costs.

General Notices

EnSite™ products are returnable only with prior authorization from St. Jude Medical.

St. Jude Medical reserves the right to change or discontinue products without notice.
 Care and Service EnSite Precision™ Cardiac Mapping System Instructions for Use
272 General Notices ARTEN600004505 Rev. B
EnSite Precision™ Cardiac Mapping System Instructions for Use
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Technical Specifications APPENDIX C

Specifications
Table 32. EnSite™ Amplifier Specifications Table 33. Signal Processing Specifications
Input amplitude Absolute 10%; channel to channel 5%
Safety accuracy
Classification Class II EnGuide signal 8.138 kHz signal to up to four EP catheter
Amplifier 100014514 electrodes

Leakage Conforms with IEC 60601-1

Table 34. Display Workstation (DWS) Specifications
Defibrillator Conforms to IEC 60601-2-27
Protection Type CF, Type BF
Defibrillator-proof applied parts Workstation Multi core CPU PC, PCI Express graphics,
and DVD/CD writer
Isolation > 4000 volts; > 5000 volts surge
Display monitor Refer to the product literature provided with
Protection IPX0 the monitor for connector characteristics.
against the
ingress of water
Table 35. EnSite™ Precision™ Link, Sensor Enabled™
Specifications
Input from patient
Safety
ECG 12 lead
Classification Class II
Catheter 2 mm patient-safe jacks
Leakage Conforms to IEC 60601-1
EnSite™ Custom assembly
Array™
Defibrillator Conforms to IEC 60601-1
Protection Type CF, Type BF
EnSite Custom assembly
Precision™ Defibrillator-proof applied parts

Recording Custom assembly Isolation Conforms to IEC 60601-1

System
Protection IPX1
against the
Input from other equipment
ingress of water
Ablation Custom assemblies
generator
Table 36. Software Specifications

Table 33. Signal Processing Specifications Operating Linux

system
Sampling rate 2kHz nominal
Mapping St. Jude Medical proprietary software
Resolution 24 bits system

Gain accuracy ± 2%

Input signal DC ± 1500 mV

offset
 Technical Specifications EnSite Precision™ Cardiac Mapping System Instructions for Use
274 Specifications ARTEN600004505 Rev. B

Table 37. AC/MAINS Power Input Specifications Table 39. System Component Physical Characteristics

Input voltage 100, 110/120, 220/240 V 50/60 Hz Component Dimension in cm Weight in kg (lb)
(nominal)
Power inputs (nominal)
EnSite™ Amplifier 49 H, 46 W, 51 D 31 (68)
DWS 450 W maximum
components EnSite™ Amplifier 94 H, 62 W, 58 D 42 (92)
cart
EnSite™ 400 W maximum
Amplifier EnSite Precision™
Cardiac Mapping DWS6 & DWS7 DWS6: 15.5 (34.2)
Mode of Continuous System Workstation
operation 44.45 cm H
computer
17.15 cm W DWS7: 15 (33.1)
46.48 cm D
Table 38. Environmental Conditions
EnSite™ Amplifier +18 to +27 °C to 90% relative humidity, EnSite Precision™ 86 H, 63 W, 83 D 41 (90)
Operating non-condensing Cardiac Mapping
System Workstation
cart
EnSite™ Amplifier -25 to +55 °C to 90% relative humidity,
Transport/ non-condensing
storage EnSite Precision™ 9.9 H, 30.0 W, 21.8 L 5.6 lbs
Link, Sensor
Enabled™
EnSite Precision™
Surface Electrode Kit –
EnSite Precision™ 6.9 H, 55.5 W, 46.0 L 9.9 lbs
Storage Conditions -10°C to 40°C Field Frame

EnSite Precision™ • Temperature: +18°C to +27°C;

EnSite Precision™ 13.8 H, 61.0 W, 53.9 L 4.1 lbs
Link, Sensor Enabled • Relative Humidity: 30% to 75% (non- Field Frame Bracket
Hardware Operating condensing);
• Altitude: up to 3000 m.
Table 40. Standards of Compliance
EnSite Precision™ • Temperature: -10°C to +50°C;
Link, Sensor Enabled • Relative Humidity: 20% to 90% (non-
Hardware Storage condensing);
• Altitude: up to 5574 m.

Conforms to ANSI/AAMI STD ES60601-1, IEC STDS 60601-1-1,

60601-1-4 & 60601-1-6
Certified to CAN/CSA STD C22.2 NO. 60601-1

Conforms to UL STD 60601-1

Certified to CAN/CSA STD C22.2 NO. 601.1

All configurations shall comply with the system standard IEC

60601-1-1. Everybody who connects additional equipment to the
signal input part or signal output part configures a medical system
and is, therefore, responsible that the system complies with the
requirements of the system standard IEC 60601-1-1. If in doubt,
consult the technical services department or your local
representative.
EnSite Precision™ Cardiac Mapping System Instructions for Use Technical Specifications
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275

Electromagnetic Emissions – Declaration

Table 41. Electromagnetic Emissions Declaration

Declaration – Electromagnetic Emissions

The EnSite™ Amplifier / Workstation are intended for use in the electromagnetic environment specified below. The customer or the user of the
EnSite™ Amplifier / Workstation should assure that it is used in such an environment.

Emissions Test Compliance Electromagnetic Environment – Guidance

RF emissions Group 1 The EnSite™ Amplifier / Workstation uses RF energy only for its internal function.
CISPR 11 Therefore, its RF emissions are very low and are not likely to cause any
interference in nearby electronic equipment.

RF emissions Class A The EnSite™ Amplifier / Workstation is suitable for use in all establishments other
CISPR 11 than domestic and those directly connected to the public low-voltage power supply
network that supplies buildings used for domestic purposes.

Harmonic emissions Not applicable

IEC 61000-3-2

Voltage fluctuations/ Not applicable

flicker emissions
IEC 61000-3-3

CAUTION: Do not place the EnSite Precision™ Link, Sensor Enabled™ within 1 m of the EnSite Precision™ Field Frame.

CAUTION: Metallic equipment used in close proximity to the magnetic field during the procedure, such as a sterile drape holder,
may affect SE points and SE field scaling accuracy.

CAUTION: Do not place tool cables within 30 mm of the EnSite Precision™ Field Frame cable. If placed this close — particularly
if the cables are parallel to each other — the tool cable may become subject to electromagnetic interference.

CAUTION: Keep the EnSite Precision™ Field Frame approximately 75cm away from any exposed ground planes to prevent
interference that may affect SE points and SE field scaling accuracy.
 Technical Specifications EnSite Precision™ Cardiac Mapping System Instructions for Use
276 Electromagnetic Emissions – Declaration ARTEN600004505 Rev. B

Table 42. Electromagnetic Immunity Declaration I

Declaration – Electromagnetic Immunity

The EnSite™ Amplifier / Workstation are intended for use in the electromagnetic environment specified below. The customer or the user of the
EnSite™ Amplifier / Workstation should assure that it is used in such an environment.

Immunity Test IEC 60601 Compliance Level Electromagnetic Environment –

Test Level Guidance

Electrostatic ±6 kV contact ±6 kV contact Floors should be wood, concrete or ceramic tile. If

discharge (ESD) floors are covered with synthetic material the relative
humidity should be at least 30%.
IEC 61000-4-2 ±8 kV air ±8 kV air

Electrical fast ±2 kV for power supply lines ±2 kV Mains power quality should be that of a typical
transient/burst commercial or hospital environment.
IEC 61000-4-4 ±1 kV for input/output lines ±1 kV

Surge ±1 kV differential mode ±1 kV Mains power quality should be that of a typical

IEC 61000-4-5 ±2 kV common mode commercial or hospital environment.
±2 kV

Voltage dips, short <5% UT >95% dip in VNOM for 0.5 Mains power quality should be that of a typical
interruptions and voltage >95% dip in UT line cycle commercial or hospital environment. If the user of
variations on power supply the EnSite™ Amplifier / Workstation requires
for 0.5 cycle
input lines. continued operation during power mains
IEC 61000-4-11 interruptions, it is recommended that the EnSite™
40% UT 60% dip in VNOM for 5 line Amplifier / Workstation be powered from an
cycles uninterruptible power supply or a battery.
60% dip in UT
for 5 cycles

30% dip in VNOM

70% UT
30% dip in UT for 25 line cycles
for 25 cycles

<5% UT >95% of VNOM

for 5 sec
>95% dip in UT
for 5 sec

Power frequency 3 A/m 3 A/m Power frequency magnetic fields should be at levels
(50/60 Hz) characteristic of a typical location in a typical
commercial or hospital environment.
magnetic field
IEC 61000-4-8

Note UT is the a.c. mains voltage prior to application of the test level.
EnSite Precision™ Cardiac Mapping System Instructions for Use Technical Specifications
ARTEN600004505 Rev. B Electromagnetic Emissions – Declaration
277

Table 43. Electromagnetic Immunity Declaration II

Declaration – Electromagnetic Immunity

The EnSite™ Amplifier / Workstation are intended for use in the electromagnetic environment specified below. The customer or the user of the
EnSite™ Amplifier / Workstation should assure that it is used in such an environment.

Immunity Test IEC 60601 Compliance Electromagnetic Environment – Guidance

Test Level Level

Portable and mobile RF communications equipment should

be used no closer to any part of the EnSite™ Amplifier /
Workstation, including cables, than the recommended
separation distance calculated from the equation applicable
to the frequency of the transmitter.

Recommended separation distance

Conducted RF 3 Vrms 3 Vrms
IEC 61000-4-6 150kHz to 80 MHz V1 = 3 3.5
d = ------- P
V1

Radiated RF 3 V/m 3 V/m 3.5

d = ------- P 80 MHz to 800 MHz
IEC 61000-4-3 80 MHz to 2.5 GHz E1 = 3 E1

7
d = ------- P 800 MHz to 2.5 GHz
E1

where P is the maximum output power rating of the

transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in meters (m)

Field strengths from fixed RF transmitters, as determined by

an electromagnetic site survey,a should be less than the
compliance level in each frequency range.b

Interference may occur in the vicinity of equipment marked

with the following symbol:

Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.

Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures,
objects and people.

a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM
and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed
RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the EnSite™ Amplifier
/ Workstation is used exceeds the applicable RF compliance level above, the EnSite™ Amplifier / Workstation should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the EnSite™ Amplifier /
Workstation.

b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1]V/m.
 Technical Specifications EnSite Precision™ Cardiac Mapping System Instructions for Use
278 Electromagnetic Emissions – Declaration ARTEN600004505 Rev. B

Table 44. Separation Distances

Recommended separation distances between

portable and mobile RF communications equipment and the
EnSite™ Amplifier / Workstation

The EnSite™ Amplifier / Workstation are intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
The customer or the user of the EnSite™ Amplifier / Workstation can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment (transmitters) and the EnSite™ Amplifier / Workstation as recommended
below, according to the maximum output power of the communications equipment.

Rated maximum output power of Separation distance according to frequency of transmitter

transmitter m
W
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
3.5 3.5 7
d = ------- P d = ------- P d = ------- P
V1 E1 E1

0.01 .117 .117 .233

.10 .369 .369 .737

1 1.167 1.167 2.33

10 3.69 3.69 7.37

100 11.67 11.67 23.33

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using
the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according
to the transmitter manufacture.

Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures,
objects and people.
EnSite Precision™ Cardiac Mapping System Instructions for Use
ARTEN600004505 Rev. B 279

EnSite™ Fusion™ APPENDIX D

Registration Module

Indications for Use

The EnSite™ Fusion™ Registration Module is indicated for registering the EnSite™ NavX™ Navigation and Visualization
Technology system to anatomic models of any of the four individual cardiac chambers.

Warnings, Cautions, and Disclaimers

■ This IFU is a supplement to the EnSite™ Cardiac Mapping System Instructions for Use. Refer to the IFU for a full list of
Warnings, Cautions, and specifications.
■ The equipment is intended for use by qualified medical personnel and only after they have been trained in the proper use of this
equipment.
■ This system should be used by or under the supervision of physicians thoroughly trained in techniques of intracardiac
electrophysiology.
■ The IFU is recyclable. Dispose of all packaging materials as appropriate.

Introduction

The EnSite™ Fusion™ Registration Module is a software expansion module for the EnSite™ Cardiac Mapping System that provides
non-fluoroscopic navigation registered to a model of patient anatomy generated by CT or MR scanners. The EnSite™ Fusion™
Registration Module is intended for use with the EnSite Precision™ Surface Electrode Kit and cardiac models from CT or MR scans
segmented into a compatible file format.

Once the registration is applied, EnSite™ NavX™ Navigation and Visualization Technology mapping and labeling functions can be
applied to the Digital Image Fusion (DIF) surface, including Contact Mapping, Map Labels, Lesion Markers, and Anatomic Markers.

NOTE: For information on the indications for EnSite™ NavX™ Navigation and Visualization Technology and compatible file
formats, see the EnSite™ Cardiac Mapping System Instructions for Use.

NOTE: The features associated with the EnSite™ Fusion™ Registration Module are available for EnSite™ NavX™ Navigation
and Visualization Technology studies only. The EnSite™ Fusion™ Registration Module is not available for EnSite™
Array™ Catheter studies.
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280 Performing Registration ARTEN600004505 Rev. B

Performing Registration

The EnSite™ Fusion™ Registration Module provides non-fluoroscopic navigation, mapping, and labeling on a DIF model. The
dynamic registration process involves the following steps:
■ Importing a DIF model
■ Scaling the EnSite™ NavX™ Navigation and Visualization Technology navigation field
■ Placing fiducial point pairs

Importing a DIF Model

When used for registration, a DIF model is a surface rendering segmented from slice-based CT or MR data using the EnSite™
Verismo™ Segmentation Tool. A DIF model is imported in the Model task (Figure 228 on page 280). For information on importing
DIF models and compatible formats, see the EnSite™ Cardiac Mapping System Instructions for Use.

Figure 228. Importing a DIF model

NOTE: Registration should be performed for one cardiac chamber at a time. A high quality scan is necessary for the creation of
an accurate registration. The quality of the scan is fundamental to the user’s ability to create a highly detailed model
during the segmentation process. In turn, a detailed segmentation is essential to the user’s ability to identify precise
fiducial points during the registration process.
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281

Scaling the EnSite™ NavX™ Navigation and Visualization Technology Navigation Field
Field Scaling, available in EnSite™ Cardiac Mapping System software, compensates for local changes in impedance fields (Figure
229). For further information on Field Scaling, see the EnSite™ Cardiac Mapping System Instructions for Use.

NOTE: Field Scaling the EnSite™ NavX™ Navigation and Visualization Technology field is optional, but recommended.

Figure 229. An EnSite™ NavX™ Navigation and Visualization Technology model before (left) and after field scaling.
 EnSite™ Fusion™ Registration Module EnSite Precision™ Cardiac Mapping System Instructions for Use
282 Performing Registration ARTEN600004505 Rev. B

Placing Fiducial Point Pairs

Fiducial point pairs are markers that link matching locations between an EnSite™ Cardiac Mapping System model and a DIF model.
The points are connected by a spring-shaped icon (Figure 230).

Figure 230. Fiducial point pairs linked by a spring-shaped icon.

The EnSite™ Fusion™ Registration Module Control Panel

The EnSite™ Fusion™ Registration Module control panel (Figure 231 on page 282) is used to
place and edit fiducial point pairs. To display the EnSite™ Fusion™ Registration Module
control panel, click the EnSite™ Fusion™ Registration Module icon in the Model control
panel.

Table 45. The EnSite™ Fusion™ Registration Module Control Panel

A
Callout Item Description

A EnSite™ Fusion™ Display the EnSite™ Fusion™ Registration Module control panel.
B C
Registration Module

B Fiducials The name of the fiducial.

C Used A check mark in this column indicates that the fiducial is being used.
No check mark indicates that the fiducial is not being used.

D Add At Surface Select to place a fiducial point at the mouse location on the EnSite™
NavX™ Navigation and Visualization Technology model and DIF
model.

E Add At EnGuide Select to place a fiducial point at the Active EnGuide on the EnSite™
NavX™ Navigation and Visualization Technology model and mouse
location on the DIF model.

F Move Select to move one end of a fiducial point pair. D

F
G Select Select to select individual fiducial points.
G

H [Compute] Click to compute registration. The Apply button must also be selected H
to see the registration.
I

I Apply Select to show the registration. Deselect to remove the registration. J

K
J [Delete Fiducials] Click to delete the selected fiducial point.
L
M
K Use Fiducials Select to use the selected fiducial point. Deselect to not use the
selected fiducial point.
Figure 231. The EnSite™ Fusion™
L Show Fiducials Select to show all fiducial points; deselect to hide all fiducial points.
Registration Module control panel
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283

Table 45. The EnSite™ Fusion™ Registration Module Control Panel

Callout Item Description

M Show Points Select to show the EnSite™ NavX™ Navigation and Visualization
Technology model point cloud; deselect to hide.

Placing Fiducial Points

NOTE: The buttons referred to in the following instructions are located on the EnSite™ Fusion™ Registration Module control
panel (Figure 231 on page 282).
1. Display the models in Dual Views display (Figure 232).

Figure 232. A scaled EnSite™ NavX™ Navigation and Visualization Technology model adjacent to a DIF model of the same patient.
2. Click the EnSite™ Fusion™ Registration Module icon in the Model control panel to display the EnSite™ Fusion™ Registration
Module control panel (Figure 231 on page 282).
3. Place fiducial points to link common locations between the EnSite™ NavX™ Navigation and Visualization Technology and DIF
model.
■ To place a fiducial point at the mouse:
a. Select the Add at Surface button. While this button is selected, the left mouse button is used to place fiducial points on
both the EnSite™ NavX™ Navigation and Visualization Technology, and DIF surfaces. When the cursor is over the
EnSite™ NavX™ Navigation and Visualization Technology map display, it will be cross-hair shaped.
b. On the EnSite™ NavX™ Navigation and Visualization Technology model surface, left-click on a model location that is
also recognizable on the DIF surface. After placing a fiducial point on the EnSite™ NavX™ Navigation and
Visualization Technology side of the screen, the cursor will change to a cross-hair inside a square.

NOTE: When a fiducial point is placed on the EnSite™ NavX™ Navigation and Visualization Technology model surface, the
fiducial point will link to the nearest model point, not the model surface. This ensures that the location is tied to a previous
catheter position.
c. Left-click on the matching anatomic location on the DIF model. A spring-shaped icon will appear to connect the paired
fiducial points (Figure 233).
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284 Performing Registration ARTEN600004505 Rev. B

■ To place a fiducial point at the Active

EnGuide:
a. Manipulate the Active EnGuide
catheter so that the Active
Electrode is at an anatomic
location on the EnSite™ NavX™
Navigation and Visualization
Technology model that can also
be easily recognized on the DIF
side of the screen.
b. Select the Add at EnGuide Figure 233. Adding fiducial point pairs
button.
c. Left-click on the matching anatomic location on the DIF geometry. A spring-shaped icon displays to connect the paired
fiducial points.

NOTE: A point is created at the active

EnGuide position when the
mouse is clicked on the DIF
model.

Figure 234. Placing fiducial point pairs at the Active EnGuide

4. Click [Compute] to compute an initial registration. The model surfaces, point

cloud, and DIF model will be superimposed (Figure 235). If three or fewer
fiducial point pairs are in use, the registration will be a rigid overlapping
registration. Spring-shaped icons connecting fiducial points will not necessarily
collapse to a common location. However, if four or more fiducial point pairs are
in use the system will use a non-rigid dynamic registration to fuse the linked
fiducial locations together. In this scenario, registered points will appear as dots
instead of springs.

Figure 235. The overlapping point cloud, DIF

model, and EnSite™ NavX™ Navigation and
Visualization Technology model
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285

5. Evaluate the registration and continue placing fiducial points if necessary

(Figure 236). When defining fiducials in the overlapping view, the first
point will be placed on the EnSite™ NavX™ Navigation and
Visualization Technology model, and the second point will be placed on
the DIF model.

NOTE: After any change to fiducial point pairs, click [Compute] to apply
the change.

NOTE: Select the Apply button to see the results of any changes.

Figure 236. The DIF model and registered EnSite™

Editing Fiducial Points NavX™ Navigation and Visualization Technology
Several options are available for editing placed fiducial points. The controls for point cloud
editing fiducial points are located on the EnSite™ Fusion™ control panel
(Figure 231 on page 282).

To move one end of a fiducial point pair:

1. Select the Move button and click on one end of the fiducial. If the points are registered and overlapping, the end of the point that
is connected to the EnSite™ NavX™ Navigation and Visualization Technology model will be selected.
2. Drag the point to a new location.

Disabling/enabling individual points – To disable or enable an individual fiducial point pair:

1. Select the Select button, and click on either the fiducial in the map display or select it in the fiducial list. The selected fiducial
will turn red in the map display.
2. Select or deselect the Use Fiducial button to enable or disable the selected fiducial. In the fiducials list, all fiducials in use will
have a check mark in the Used column.
3. Click [Compute] to recompute the registration.
4. Confirm the catheter position relative to the anatomy using conventional means (e.g., fluoroscopy, intracardiac
echocardiography).

Deleting a point – To delete a fiducial point, select the point in the fiducial list, and then click [Delete Fiducials].

Removing a registration – Select the Apply button to remove a registration. When registration is removed, navigation and labeling
at EnGuide will apply to the EnSite™ NavX™ Navigation and Visualization Technology model.

Display Options

Several controls are available to manage the display of the DIF and EnSite™ NavX™ Navigation and Visualization Technology
models. These controls are located on “The EnSite™ Fusion™ Registration Module control panel,” Figure 231. on page 282, the “Map
Settings menu,” Figure 237. on page 286, and the “Map Display Sliders,” Figure 238. on page 287.

The EnSite™ Fusion™ Registration Module Control Panel Display Options

Show Fiducials – (The EnSite™ Fusion™ Registration Module control panel) Use this button to show/hide fiducials.
Show Points – (The EnSite™ Fusion™ Registration Module control panel) Use this button to show/hide the EnSite™ NavX™
Navigation and Visualization Technology model point cloud. The point cloud will include all surfaces included in the EnSite™
NavX™ Navigation and Visualization Technology model.
 EnSite™ Fusion™ Registration Module EnSite Precision™ Cardiac Mapping System Instructions for Use
286 Display Options ARTEN600004505 Rev. B

Map Settings Menu

Table 46. The Map Settings Menu

Selection Description

Label Text On Shows/hides the label text for all map labels, anatomic markers, tape
measures, lesions, virtuals, and EnGuide Shadows.

Label Show Allows or prevents label text for all map labels, anatomic markers, tape
Through measures, lesion markers, virtuals, and EnGuide Shadows from showing
through other objects.

Show EnSite™ Enables/disables the display of the contoured, three-dimensional surface

Model model(s) of a patient’s cardiac anatomy.

Show DIF Allows the DIF model (i.e., CT scan or MRI) to either be hidden or
Model displayed.

Project on DIF (After EnSite™ Fusion™ Registration has been performed) Project or
unproject 3D Labels and/or Lesions (referred to as 3DP), and map data
onto the DIF surface rather than onto the EnSite™ Cardiac Mapping
System model surface.
NOTE: Before registration, the Surface Distance is the distance from the
Active Electrode to the EnSite™ NavX™ Navigation and Visualization
Technology model surface. After registration, the Surface Distance is the
distance from the Active Electrode to the DIF model surface.

Show Mapping Causes surfaces to be colored using the current map color.

Hide Non-Map Hide surfaces that have no maps projected on them.

Surfaces
Figure 237. Map Settings menu

Map Display map colors with values greater than Color High as transparent
Transparency instead of purple, or (in EnSite™ Array™ Catheter only) charcoal gray in
On the gray scale scheme. Areas of the contact map that are not colored will
be hidden (EnSite™ Array™ Catheter or EnSite™ NavX™ Navigation and
Visualization Technology studies).

NOTE: Do not select the Map Transparency On box unless a map is

displayed.

Low Accuracy (EnSite™ Array™ Catheter studies only) Enables or disables a red
Grid On highlight on areas of the grid that are more than 4cm from the center of the
EnSite™ Array™ Catheter. Signal and Tape Measure accuracy may be
decreased in these areas.

Show Proximity (EnSite™ NavX™ Navigation and Visualization Technology studies only)
Indicator Enables the proximity indicator.

Fixed Proximity Allows the diameter of the proximity indicator to be set to a maximum of
Indicator 10mm, regardless of the current lesion size.

Show EnSite (EnSite™ Array™ Catheter studies only) Shows the EnSite™ Array™
Array Catheter.

Zoom Increases/decreases the size of the model in the display window. The
middle mouse/scroll wheel can also be used to zoom.

Color Contour Adjusts the gradation between colors on the map. At low Color Contour
values, colors appear as distinct bands. At high Color Contour values, there
is a smooth transition between colors.
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287

Table 47. Map Display Sliders

Callout Item Description

A Translucency Adjusts the density of the surface model between translucent and
Slider opaque. This control works independently for each view in dual map
displays. A
Refer to the EnSite™ Cardiac Mapping System Instructions for Use
for more information. B
B Edge When enabled, provides a rendering of the model where the body
Enhancement can be translucent but the edge remains distinctly defined. C
C Clipping Plane Clipping planes allow for a view of the interior and rear of the closed D
Slider model by cutting a plane away from the viewing space. The slider
provides a smooth, controlled way of adjusting the clipping plane.
Unlocking the Clipping Plane deletes it.

D Plane Lock Clipping planes can be locked in the model/map display window.
When locked, the orientation remains fixed
relative to the model. When unlocked, the orientation is parallel to Figure 238. Map Display Sliders
the screen. To change the orientation of a
locked clipping plane, unlock it, rotate, and lock it again.
 EnSite™ Fusion™ Registration Module EnSite Precision™ Cardiac Mapping System Instructions for Use
288 Display Options ARTEN600004505 Rev. B
EnSite Precision™ Cardiac Mapping System Instructions for Use
ARTEN600004505 Rev. B 289

EnSite™ Derexi™ Module APPENDIX E

Indications for Use

Refer to the EnSite™ Cardiac Mapping System Instructions for Use for Indications for Use.

Introduction

The EnSite™ Derexi™ Module consists of software features that uniquely integrate the EP-WorkMate™ Recording System with the
EnSite™ Cardiac Mapping System. This integration was introduced to consolidate patient and clinical information and to reduce the
duplication of work effort. The interface between the two systems allows for the sharing of information, which promotes ease of use
and a clearer representation of the case events.

NOTE: Refer to the EnSite™ Cardiac Mapping System IFU and the EP-WorkMate™ Recording System IFU for additional
information and regulatory considerations.

Minimum System Requirements

■ EnSite Precision™ Cardiac Mapping System 2.0
■ EP-WorkMate™ Recording System V. 4.3 or greater
 EnSite™ Derexi™ Module EnSite Precision™ Cardiac Mapping System Instructions for Use
290 EnSite™ Cardiac Mapping System / EP-WorkMate™ System Signal Connections ARTEN600004505 Rev. B

EnSite™ Cardiac Mapping System / EP-WorkMate™ System Signal

Connections

A RecordConnect is required to route the ECG and EP Catheter signals from the patient to both the EnSite™ Amplifier and the EP-
WorkMate™ Recording System Signal Conditioning Unit (SCU). The EP catheters are connected to the EP-WorkMate™ Recording
System’s Catheter Input Module (CIM), and the CIM is connected to the RecordConnect. The RecordConnect routes EP catheter
signals from the CIM to the EnSite™ Amplifier and to the EP-WorkMate™ Recording System SCU.

Figure 239. EnSite™ Cardiac Mapping System to the EP-WorkMate™ Recording System basic signal connections.
EnSite Precision™ Cardiac Mapping System Instructions for Use EnSite™ Derexi™ Module
ARTEN600004505 Rev. B Connecting to the EnSite™ Cardiac Mapping System
291

Connecting to the EnSite™ Cardiac Mapping System

A hardware connection must be made between the EP-WorkMate™ Recording System and the EnSite™ Cardiac Mapping System,
using an Ethernet cable and an Ethernet Isolator.

1. Connect the Ethernet cable to the EP- EP-Workmate ™ Recording System CPU
WorkMate™ Recording System CPU
(either an HP xw6400 or HP xw6600), HP xw6400 HP xw6400 or HP Z600
using the port shown at right:

Only Ethernet port Right-most Ethernet port

2. Optional, if using a switch. Connect

the other end of the EP-Workmate™
Recording System Ethernet cable to
switch port #1, and connect another
Ethernet cable to switch port #2:

Optional switch

3. Connect the 1’ Ethernet cable (B) into EnSite ™ Cardiac Mapping System Workstation
the 2nd Ethernet port from the right
(C) on the back of the EnSite™ Cardiac
Mapping System Workstation:
4. Connect the Ethernet cable from the
EP-Workmate™ Recording System A
CPU or switch (optional) to the
Ethernet Isolator (A).

C
 EnSite™ Derexi™ Module EnSite Precision™ Cardiac Mapping System Instructions for Use
292 Connecting to the EnSite™ Cardiac Mapping System ARTEN600004505 Rev. B

Connection States
On the EnSite™ Cardiac Mapping System, there are three possible connection states for the communication between the EnSite™
Cardiac Mapping System and EP-WorkMate™ Recording System (Disabled, Ready, and Connected). The following table shows and
describes the icons that display at the bottom of the EnSite™ Cardiac Mapping System screen during each of the following states.

NOTE: The EnSite™ Derexi™ Module license must be installed on the EnSite™ Cardiac Mapping System before the icons will
display.

Table 45.

State Description

Disabled Communication between the two systems is disabled. In this state,

communication between the two systems can only be enabled by the user.
Note: Each system is still fully functional as a stand-alone system.

Ready An unselected checkbox indicates that the EnSite ™ Cardiac Mapping

System is ready to accept a connection from the EP-WorkMate ™ Recording
System.
Note: Each system is still fully functional as a stand-alone system.

Connected The systems are connected and communication is active.

NOTE: This is an active icon that the user can use to disable or enable the connection at any time.
EnSite Precision™ Cardiac Mapping System Instructions for Use EnSite™ Derexi™ Module
ARTEN600004505 Rev. B Maps and Integration
293

Maps and Integration

Number of Maps / Map Points

When the EnSite™ Cardiac Mapping System and EP-WorkMate™ Recording System are connected, the number of remote EnSite™
Cardiac Mapping System maps is unlimited. The EP-WorkMate™ Recording System user is not allowed to change or delete an active
map while in Connected mode.

Signals are defined by the EnSite™ Cardiac Mapping System and are provided to the EP-WorkMate™ Recording System along with
the map point data.

Map Point Analysis

While connected, no signals are analyzed or measured by the EP-WorkMate™ Recording System; the Reference signal and Local
Activation Time (LAT) and peak-to-peak voltage values are calculated by the EnSite™ Cardiac Mapping System. Upon receipt of a
new map point, the new mapping point’s waveform is centered in the MAPPING WINDOW (in the EP-WorkMate™ Recording System)
and the data from the EnSite™ Cardiac Mapping System displays.

Mapping Constraints
■ Map names can only be Edited, Renamed, or Deleted via the EnSite™ Cardiac Mapping System Notebook in the RealReview task.
■ The EnSite™ Cardiac Mapping System will only accept a Point-Save request from the EP-WorkMate™ Recording System if both
systems are in Realtime mode.
■ When creating a new map, it is required that the EnSite™ Cardiac Mapping System take the first mapping point. Any Point-Save
requests from the EP-WorkMate™ Recording System, prior to the EnSite™ Cardiac Mapping System taking the first point, will
be rejected.
■ The EP-WorkMate™ Recording System is only allowed to change the annotation string of an EnSite™ Cardiac Mapping System
mapping point.
■ Only the EnSite™ Cardiac Mapping System can create a new map or change the active map.

Patient Connections

The connections between the patient and the two systems consist of a 12 lead ECG and intra-cardiac catheter connections. Connecting
the catheters and the 12 lead ECG cable is the same process for the standalone or integrated systems and has not been changed by the
data integration. For detailed patient connections, consult the Instructions for Use (IFU) for the EnSite™ Cardiac Mapping System and
the EP-WorkMate™ Recording System IFU.
 EnSite™ Derexi™ Module EnSite Precision™ Cardiac Mapping System Instructions for Use
294 Dual System Start-up Procedure using the EnSite Derexi Module
™ ™ ARTEN600004505 Rev. B

Dual System Start-up Procedure using the EnSite™ Derexi™ Module

The following procedure shows the steps required to setup a case study with the integration of the EP-WorkMate™ Recording System
and the EnSite™ Cardiac Mapping System, via the EnSite™ Derexi™ Module.
1. Ensure that both the EnSite™ Cardiac Mapping System and the EP-WorkMate™ Recording System are powered up.
2. Install license on the EnSite™ Cardiac Mapping System and configure the EP-WorkMate™ Recording System.
3. In the EnSite™ Cardiac Mapping System, fill in at least the patient weight from the Patient Information screen.
4. In the EnSite™ Cardiac Mapping System, select the EP-WorkMate™ Recording System from the RecordConnect drop-down
menu.
5. Begin a study from the EnSite™ Cardiac Mapping System:
a. Check that the EP-WorkMate™ Recording System heart icon (in the bottom right of the EnSite™ Cardiac Mapping System
Mapping window) is yellow.
b. As long as the EnSite checkbox in the EP-WorkMate™ Recording System is checked, the icon will turn green, meaning that
a connection between EnSite™ Cardiac Mapping System and the EP-WorkMate™ Recording System has been made (see
Figure 240 on page 296).
c. A pop-up message is generated: “Accept the Connection to EP-WorkMate™ for patient “First” “Middle Initial” “Last Name,”
“Patient ID”? [ACCEPT] [REJECT].”
6. In the EnSite™ Cardiac Mapping System, click the appropriate button to either [ACCEPT] or [REJECT] the connection:
a. Demographic data is sent from the EP-WorkMate™ Recording System to the EnSite™ Cardiac Mapping System.
b. A pop-up message is generated: “Updated Demographics Received from EP-WorkMate™: “First” “Middle Initial” “Last
Name,” “Patient ID” “Birthdate” “Gender” Physician” Diagnosis” “Procedure” [ACCEPT] [REJECT].
Note: If both the Patient Information and the Diagnostic Information received from the EP-WorkMate™ Recording System
is an exact match to the EnSite™ Cardiac Mapping System data, no pop-up message is generated.
7. In the EnSite™ Cardiac Mapping System, click the appropriate button to either [ACCEPT] or [REJECT] the demographic data.

NOTE: All data fields are updated in the EnSite™ Cardiac Mapping System database except the patient’s weight.
8. Create a model (if needed) in EnSite™ Cardiac Mapping System, either within the Model Workflow or from the One Map tool in
the Mapping Workflow.
9. Depending on which workflow was used in the EnSite™ Cardiac Mapping System, follow step (9.a.[Model task] or
9.b.[Mapping task]) to proceed with the case study:
a. If a model was created while in the Model task, the user must then select the Mapping task and access the Mapping Workflow
of the EnSite™ Cardiac Mapping System to take the first point. (The [Freeze]/[Save] feature is required to capture points.)
After a first point is taken by the EnSite™ Cardiac Mapping System, it will begin accepting mapping point requests from the
EP-WorkMate™ Recording System for the current active map.
b. If the points or the model were created using the One Map tool, the system is already in the Mapping task and is using the
Mapping Workflow. (The [Freeze]/[Save] feature is required to capture points.) After a first point is taken by the EnSite™
Cardiac Mapping System, it will begin accepting mapping point requests from the EP-WorkMate™ Recording System for
the current active map.
10. Proceed with the case in the EnSite™ Cardiac Mapping System.
11. Exit Study from the EnSite™ Cardiac Mapping System (if the demographic data and/or diagnostic data for the patient profile has
not been completed, a message will pop-up requesting that the patient demographic be updated. The user will not be allowed to
exit the study until all Patient Information and Diagnostic Information is complete).
EnSite Precision™ Cardiac Mapping System Instructions for Use EnSite™ Derexi™ Module
ARTEN600004505 Rev. B Interface Features & Descriptions
295

Interface Features & Descriptions

The following definitions describe features specific to the EnSite™ Derexi™ Module. Some of these features are only accessible from
the EnSite™ Cardiac Mapping System, some are only accessible from the EP-WorkMate™ Recording System, and some are accessible
on both systems. Except for the features exclusive to the EP-WorkMate™ Recording System, the feature descriptions given in this
document are specific to the EnSite™ Cardiac Mapping System only.

NOTE: For instructions on how these features are enabled from the EP-WorkMate™ Recording System, refer to the EP-
WorkMate™ Recording System IFU.

Active Map Change – This feature can only be executed from the EnSite™ Cardiac Mapping System. When a new map is created, the
active map name/ID is automatically sent to the EP-WorkMate™ Recording System. If the EP-WorkMate™ Recording System does
not already possess this map, one is created. The same process takes place when changing to a different map.

Add/Edit Annotation – This feature may be executed by either the EnSite™ Cardiac Mapping System or the EP-WorkMate™
Recording System. In the EnSite™ Cardiac Mapping System, mapping points are automatically labeled with the Tag and Type, but
additionally comments/annotations may be added by right-clicking on the trace point of interest and selecting Edit Annotation. This
new text will be added to the Points list. The annotation will also be sent to the EP-WorkMate™ Recording System, where it is saved
as a Procedure Log entry and in the Mapping Window as Notes.

Delete Map – This can only be done in the EnSite™ Cardiac Mapping System from the Notebook in the RealReview task. Click on
the map name to delete (this map cannot be open at this time) and click on the [Delete] button on the bottom right below the Notebook
entries. The map will also be deleted from the EP-WorkMate™ Recording System Mapping Window and the Procedure Log.

Delete Points – This feature may be executed by either the EnSite™ Cardiac Mapping System or the EP-WorkMate™ Recording
System. To delete a point in the EnSite™ Cardiac Mapping System, go to the Points tab in the Control Panel and select a point. Click
on the [Delete] button located at the bottom of the Control Panel. Points can also be deleted by right clicking in the black background
of the trace display and selecting Delete Point from the menu. The system that issues this request, sends the identifier of the selected
map point to delete to the other system.

NOTE: The same process can be used to Delete Hidden Points, and to Delete Unused Points, which are also in the menu.

Edit Mapping Points – In the EnSite™ Cardiac Mapping System only, the calipers and voltage levels can be edited in the waveform
display below the map by simply clicking and dragging the calipers and/or the voltage levels. As explained below, the annotation may
also be edited.

Reload Map – This request can only be issued from the EP-WorkMate™ Recording System. With the appropriate map identifier
present in the Map field of the Mapping Control Bar (EP-WorkMate™ Recording System), click on the [Reload Map] button. The
map is sent to the EnSite™ Cardiac Mapping System and the EnSite™ Cardiac Mapping System returns the map to the EP-WorkMate™
Recording System with all previous points plus any new points that have been added.

Rename Map – This change can only be made in the EnSite™ Cardiac Mapping System from the Notebook in the RealReview task.
Click on the map name to be changed and click on the [Edit] button. The Edit Event window is displayed. Here the map name can
be changed. The updated name is then sent to the EP-WorkMate™ Recording System.

Save Image – When requested by the EP-WorkMate™ Recording System, an image will be captured by the EnSite™ Cardiac Mapping
System. The image is then saved to the Notebook, on the EnSite™ Cardiac Mapping System, and then sends the single image (in jpeg
format) to the EP-WorkMate™ Recording System where it is stored in the Mapping window. Images requested by the EnSite™ Cardiac
Mapping System alone, are saved to the EnSite™ Cardiac Mapping System only. These images are not sent to the EP-WorkMate™
Recording System.
 EnSite™ Derexi™ Module EnSite Precision™ Cardiac Mapping System Instructions for Use
296 EP-WorkMate™ Recording System Mapping Controls ARTEN600004505 Rev. B

Save Mapping Points – The first point of a map must be defined by the EnSite™ Cardiac Mapping System. Points are captured by
clicking on the [Freeze] then [Save] buttons at the bottom of the EnSite™ Cardiac Mapping System Mapping window. Once the first
point is saved, the point is also sent to the EP-WorkMate™ Recording System where it is stored in the procedure Log file and
displayed. After the initial point is created in the EnSite™ Cardiac Mapping System, the EP-WorkMate™ Recording System can also
request that points be taken. (Refer to the EP-WorkMate™ Mapping System Interface for EnSite™ Derexi™ Module IFU for more
information).

NOTE: When creating a new map, the EnSite™ Cardiac Mapping System must take the first mapping point. Any Point-Save
requests made by the EP-WorkMate™ Recording System will be rejected prior to the first point taken by the EnSite™
Cardiac Mapping System.

Select Mapping Points – This feature may be executed by either the EnSite™ Cardiac Mapping System or the EP-WorkMate™
Recording System. In the EnSite™ Cardiac Mapping System, selecting a point can be accomplished by clicking on the trace of interest
under the Points tab. Clicking on the trace will highlight the trace and, if shown on the model, will cause the surface points/3D points
to flash on the anatomic model. The checkbox feature will toggle on/off the model points. The system that issues this request, sends
the identifier of the selected map point to the other system.

Sort Map – Mapping points can be sorted by either system. In the EnSite™ Cardiac Mapping System, select the Points tab in the
Control Panel and click on the down arrow of the drop-down Sort menu. Here the mapping points can be sorted according to Order
of Collection, Cycle length, or map type (e.g., LAT, Peak to Peak, Peak Negative, CFE Mean, CFE Std. Dev.).

Start Recording of Electrograms – In the EnSite™ Cardiac Mapping System, click the [Record] button below the Realtime data pane
on the left side of the screen to start recording segment data. The EnSite™ Cardiac Mapping System also sends a Start Recording
request to the EP-WorkMate™ Recording System, which also starts recording. If the EP-WorkMate™ Recording System is not already
recording, a new recording will begin.

Stop Recording – In the EnSite™ Cardiac Mapping System, click the [Stop] button below the Realtime data pane on the left side of
the screen to stop recording segment data. The EnSite™ Cardiac Mapping System also sends the Stop Recording request to the EP-
WorkMate™ Recording System.

Updating Demographics – To share patient demographics between the systems, the updates must be made on the EP-WorkMate™
Recording System. When patient demographics are changed on the EP-WorkMate™ Recording System, the updated information is
automatically sent to the EnSite™ Cardiac Mapping System. The EnSite™ Cardiac Mapping System user will be prompted to
[Accept] or [Reject] the updated patient demographics.

Patient demographics can also be updated on the EnSite™ Cardiac Mapping System, but these changes are not sent to the EP-
WorkMate™ Recording System. In the EnSite™ Cardiac Mapping System, click File and click Study/Patient Information. This
displays a patient demographics window, which can then be completed as needed. The case cannot be exited on the EnSite™ Cardiac
Mapping System until all required demographic information has been completed. Once all the fields are filled in, the [OK] button
becomes active. Clicking on the [OK] button will end the case.

EP-WorkMate™ Recording System Mapping Controls

The EP-WorkMate™ Recording System Mapping Control Bar has features that coincide with the EnSite™ Cardiac Mapping System
controls. These features are functional when the EnSite™ Derexi™ Module is connected and the EnSite box is checked (see Figure
240. below).

Figure 240. EP-WorkMate™ Recording System Mapping Control Bar.

NOTE: Refer to The EP-WorkMate™ Mapping System Interface for the EnSite™ Derexi™ Module for descriptions of these
controls and how they are used in conjunction with the controls in the EnSite™ Cardiac Mapping System.
EnSite Precision™ Cardiac Mapping System Instructions for Use
ARTEN600004505 Rev. B 297

EnSite™ Verismo™ APPENDIX F

Segmentation Tool Module

Indications for Use

The EnSite™ Verismo™ Segmentation Tool (H702504) is indicated for use in generating 3D models from CT, MR, or rotational
angiography DICOM image data. Generated models are intended to be displayed on the EnSite Precision™ Cardiac Mapping System.

Description

The EnSite™ Verismo™ Segmentation Tool is a software utility used to convert large volumes of sliced-based images into a
manageable 3D model of cardiac structures.

The EnSite™ Verismo™ Segmentation Tool accepts DICOM™ images from most CT and MRI scanners, including enhanced CT/MR
images. Once image data are imported into the EnSite™ Verismo™ Segmentation Tool, a 3D model can be extracted from the images
in a process called segmentation. Segmentation is the process of isolating an object of interest from a digital image using the greyscale
intensity of slice-based data. This model (see Figure 241) can be easily viewed and manipulated during an electrophysiology procedure
using the EnSite Precision™ Cardiac Mapping System software. See the EnSite Precision™ Cardiac Mapping System Instructions for
Use for information about viewing models.

Figure 241. Example of a segmented model.

 EnSite™ Verismo™ Segmentation Tool Module EnSite Precision™ Cardiac Mapping System Instructions for Use
298 Contraindications ARTEN600004505 Rev. B

Contraindications

There are no known contraindications to use.

Warnings and Precautions

There are no known warnings or precautions specific to this product. Refer to the EnSite Precision™ Cardiac Mapping System
Instructions for Use for warnings and precautions pertaining to the EnSite Precision™ Cardiac Mapping System.

Operator Requirements

The EnSite™ Verismo™ Segmentation Tool must be operated by, or under the supervision of, an electrophysiologist trained in the
operation of the EnSite™ Verismo™ Segmentation Tool and supported by other qualified personnel trained in the field of cardiac EP.

System Requirements and Considerations

EnSite Precision™ Cardiac Mapping System requirements – the EnSite™ Verismo™ Segmentation Tool v.2.0.1 can only be
installed on an EnSite Precision™ Cardiac Mapping System workstation with EnSite Precision™ v.2.0 Software or higher.

Verification – To ensure model accuracy, segmentation results should be compared to the original slice data by (or under the
supervision of) a physician.

DICOM conformance – the EnSite™ Verismo™ Segmentation Tool allows importation of slice-based images in DICOM 3.0 (2009)
data sets from CD/DVD or a PACS network.
■ The EnSite™ Verismo™ Segmentation Tool does not support direct connection to a PACS network. DICOM data sets located on
a PACS network are retrieved by the EnSite™ Courier™ Module and written to the EnSite Precision™ Cardiac Mapping System
Display Workstation (DWS) hard drive.
■ The EnSite™ Verismo™ Segmentation Tool does not support image export.
■ The EnSite™ Verismo™ Segmentation Tool does not accept non-orthogonal enhanced CT/MR images.
■ The EnSite™ Verismo™ Segmentation Tool does not accept non-orthogonal cine images with missing or inconsistent timing
information within each volume.

Refer to the EnSite™ Verismo™ Segmentation Tool v.2.0.1 DICOM Conformance Statement for details.

Overview of Segmentation

The following list provides an overview of the common segmentation tasks.

1. Power on the DWS and start the EnSite ™ Verismo ™ Segmentation Tool. “Indications for Use” on page 297
2. Select an image series to segment. “Selecting a Series for Segmentation” on page
301
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ARTEN600004505 Rev. B Optimal Characteristics for the EnSite™ Verismo™ Segmentation Tool
299

3. Subregion the series and begin segmentation. “Subregioning the Series” on page 302
“Loading the Series for Segmentation” on page
302
4. Grow a structure using either the Region Grow or Chamber tool. “Using the Region Grow Tool” on page 309
“Using the Chamber Tool” on page 311
5. Edit the model: “Using the Separator Tool” on page 313
• Separate chambers or remove extraneous information using the Separator or Trace tool. “Using the Trace Tool” on page 314
• Grow tubular structures with the Vessel tool. “Using the Vessel Tool” on page 312
• If necessary, use the Barrier tool to help the EnSite™ Verismo™ Segmentation Tool identify the “Using the Barrier Tool” on page 315
edge of a structure.
6. Perform any final cleanup: “Using the Structure List” on page 308
• Hide extraneous structures in the structure list. “Using the Reassign Tool” on page 316
• Use the Reassign tool to remove any small debris surrounding the model. “Key Points About Saving Models” on page 319
• If the surface of the model has distracting complexity, consider smoothing the surface.
7. Save and review the model: “Saving the Model to the Hard Drive” on page 319
• Save the model. “Exporting Models to CD or DVD” on page 319
• If the model will be used on a different workstation, export the DIF model to CD/DVD. “Reviewing the Final Model” on page 320
• Review the model before exiting.

Optimal Characteristics for the EnSite™ Verismo™ Segmentation Tool

Image Files

The following minimum requirements are provided to optimize the quality of the cardiac model generated through the EnSite™
Verismo™ Segmentation Tool segmentation process:

■ Missing Slices The EnSite™ Verismo™ Segmentation Tool cannot segment images
with missing slices
■ Slice Orientation Do not use oblique slice orientations
■ Slice Spacing Must be uniform, .5mm increments, such as .5mm, 1.0mm, and
1.5mm.
■ DICOM Header Use only standard letters and numbers in the DICOM header. Do not
use special characters, such as: ^ " & % $ # @ !
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300 Loading Files for Segmentation ARTEN600004505 Rev. B

Loading Files for Segmentation

Starting the EnSite™ Verismo™ Segmentation Tool

The manner in which DICOM files are loaded depends on whether the EnSite™ Courier™ Module is installed. If it is installed,
DICOM files may be loaded from a PACS network or from CD/DVD. If it is not installed, DICOM files may be loaded only from
CD/DVD.

Verismo Cleanup
Upon launching Verismo, the system allows you to perform a cleanup procedure before Verismo launches. Click the [Clean Verismo]
button. This procedure removes all temporary files. Perform a Cleanup procedure if Verismo fails to launch. See “Troubleshooting
Common Problems” on page 323 for more information.

NOTE: Performing a Cleanup will remove any data currently in the Verismo workspace, such as work in progress files. DIF files
will not be deleted.

Loading DICOM Files

1. Power on the EnSite Precision™ Cardiac Mapping System and login as described in the EnSite Precision™ Cardiac Mapping
System Instructions for Use manual.
2. From the title screen, click [Clinical], then [Verismo].
3. Select an Import From: source.
4. Click [Query] to display a list of files.
5. Select the desired file and click [Launch Verismo].

Using DICOM Files from Saved Data

To load DICOM files from data that you have previously saved:
1. Power on the EnSite Precision™ Cardiac Mapping System, as described in the previous section, “Loading DICOM Files”.
A pop-up message window will be displayed.
2. Select Use Saved Data and press Continue.

Figure 242. The selection window.

The previously saved patient will be displayed.

3. Click on the patient to display and select a desired image series for new segmentation, or select File > Resume Previous
Segmentation to resume the most recent segmentation series.
EnSite Precision™ Cardiac Mapping System Instructions for Use EnSite™ Verismo™ Segmentation Tool Module
ARTEN600004505 Rev. B Using the Wizard
301

Using the Wizard

The Wizard is intended to guide the clinician through the segmentation process (see
Figure 243). The Wizard will describe how to load files and provides an overview of
the segmentation tools.
■ Follow the suggested task at the top of the Wizard.
■ Below the task are several options. Selecting the option will provide additional
details and describe how to access the controls.
■ When a step is complete, click [Next].
Note: Clicking [Back] will access the previous step.
Note: The Wizard may be closed by clicking [Close] or [Finish]. To access the
Wizard again, select File > Resume Wizard.

Figure 243. The Wizard window.

Introduction to the Patient Screen

The patient screen is the interface for loading DICOM data

(see Figure 244). It includes the following features:
A
A. Menu bar – The menu bar provides access to commonly
used tools.

B. Wizard – The Wizard guides the clinician through the D

process of segmentation.

C. Progress bar – The progress bar indicates when the

workstation is processing data. If the progress bar is labeled
Cancel, clicking the progress bar will cancel the current task.
E F
D. Slice view – The slice view contains images from the B

selected data set. Data in the slice view can be manipulated.

See the appropriate section under “Using Basic Interface
Controls” on page 304. G

E, F, G. Patient, Study, and Series panels – These panels C

provide an interface for selecting a data series. See “Selecting

a Series for Segmentation” on page 301. Figure 244. The patient screen.

Selecting a Series for Segmentation

A DICOM data disk may contain multiple patients, multiple radiology studies for each patient, and multiple series per study. Use the
panels on the lower half of the screen to select a series for segmentation.
1. From the Patient panel, select a patient name.
2. From the Study panel, click on the study of interest.
 EnSite™ Verismo™ Segmentation Tool Module EnSite Precision™ Cardiac Mapping System Instructions for Use
302 Subregioning the Series ARTEN600004505 Rev. B

3. From the Series panel, click on the series of interest.

Note: Series that can be loaded for segmentation appear in black. If a series cannot be used for segmentation, the information for
that series appears in gray in the series panel, and an explanation of why the series may not be usable appears in the Usability
Indicator column. Refer to the appropriate section under “Troubleshooting Common Problems” on page 323.

Viewing Options
The following options are available for sorting patient data:
■ To add or remove columns of information from the patient, study, or series panels, click [List Options]. A window will appear with
display options. Select display options and click [Close].
■ Clicking on the heading at the top of a column will sort the data by that column.

Subregioning the Series

Subregioning is a process of identifying a region of interest within the scan for segmentation. Subregioning can improve the
performance of the segmentation tool by processing only the regions of interest. The goal of subregioning is to minimize the volume
to maximize processing speed.
1. A green bounding box appears in the image display.
Left-click on any handle of the bounding box and drag to
outline the region of interest (see Figure 245).
Note: During subregioning, the Zoom, Pan, and W/L
controls may help visualize the slice data. See “Using
Basic Interface Controls” on page 304.

2. Drag the Slice slider upward until the region of interest is

no longer visible; then drag the upper Range slider to the
same position (e.g., slice 180).
3. Drag the Slice slider downward until the region of
interest is no longer visible; then drag the lower Range
slider to the same position (e.g., slice 33).
Note: The number of recommended slices is greater than
10. Figure 245. Using the bounding box to subregion the slice data.

Loading the Series for Segmentation

After subregioning the series, the data may need to be preprocessed, filtered, and loaded into the segmentation interface.

Filtering removes grainy artifacts and non-uniformities that may affect thresholding operations. By default, filters are applied to CT,
but not to MR images. To adjust filter defaults, select Advanced > Settings and select the desired filter settings before loading the series
for segmentation.

Loading a subregioned series – To load the subregioned data series, click [Segment Series]. A progress bar is shown while the
subregioned volume is preprocessed, filtered, and then loaded.
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ARTEN600004505 Rev. B Using the Segmentation Interface
303

Note: If the size of the subregioned series is larger than 60Mb, a message will
appear providing the following options (see Figure 246):
■ Subregion – Return to the subregioning tools and identify a smaller region
of interest.
■ Resample – Resampling will reduce the size of the data by adjusting the
resolution of the images until the subregioned series is less than 60MB.
Resampling may decrease accuracy of measurement tools. See “Using the
Measurement Tools” on page 317.
■ Continue – Use the identified data set without further subregioning or
resampling. Processing speed may not be optimal.

Figure 246. Message indicating the volume size exceeds

60.0 Mb.

Note: If the image to be loaded for segmentation is not a CT or MR image, the

Preprocess window will appear (see Figure 247). Click [CT] to preprocess the
image as a CT image, [MR] to preprocess the image as an MR image, or [Skip]
to not preprocess the image. For XA (rotational angiography) series, process
the images as CT.

Figure 247. PreProcess window.

Using the Segmentation Interface

Introduction to the Segmentation Screen

The segmentation screen (see Figure 248) is used to
segment the scanned volume and render an output A
image for 3D visualization. It includes the following B
features: C E D

A. Menu bar – The menu bar provides access to

commonly used tools.

B. Control panel – The control panel contains

segmentation tools. The icons on the control panel
indicate which tool is currently active.
F G
C. Structure list – The structure list, featured in
several tools, selects which structures are affected by
segmentation.

D. 3D view – The 3D view shows the result of the

current segmentation.

E, F, G. Slice views – The slice views contain

images from the selected data series in transverse, Figure 248. The segmentation screen.
coronal, and sagittal planes.
 EnSite™ Verismo™ Segmentation Tool Module EnSite Precision™ Cardiac Mapping System Instructions for Use
304 Using Basic Interface Controls ARTEN600004505 Rev. B

Menu Bar Summary

Menu Option Function

File New Segmentation Start a new segmentation session.

Resume Wizard Continue the next step of the wizard.

Import DICOM Files Import currently saved DICOM files into the EnSite ™ Verismo ™ Segmentation Tool.

Resume Previous Segmentation Resume the most recent segmentation session.

Save As Save the displayed 3D model to the hard drive as a DIF file.

Save Work in Progress Save the segmentation results during a segmentation session, without creating a DIF
file.

Load Work in Progress Reload a segmentation session from a previous Save Work in Progress.

Save Template Save the current settings as a template.

Load Template Load a previously saved template.

Export to CD/DVD Save models to a CD/DVD.

Print Print the full segmentation screen, 3D heart model, or any of the slice views.
Exit Exit the EnSite ™ Verismo ™ Segmentation Tool and return to the EnSite Precision ™
Cardiac Mapping System title screen.

Edit Modify Structure Modify the current structure.

Load Default Threshold Restore the default threshold after manual adjustments have been made.

Clear Segmentation Result Clear all segmented results.

Display Info Select preferences for displaying patient, study, and series information on the Slice
views. Allows access to information from the DICOM header.
Options Set options for crosshairs display and the number of undo levels.

View Segmentation Model Show the 3D heart model.

View Segmentation Contours Compare tiled model, rendered model, and slice contours.

Advanced Smooth All Structures Refine all visible structures.

Settings Set preferences for filters and the Growth Limit for the Vessel tool.
Help About EnSite Verismo Display the software version.

Release Notes Display information about the software not contained in the IFU.

Using Basic Interface Controls

The EnSite™ Verismo™ Segmentation Tool interface provides controls for navigating in slice views, zooming, panning, and adjusting
the intensity of the image. These controls are located in the lower left and lower right corners of the slice and 3D panels.

Note: After segmentation, if the Slice control is active, moving the mouse over the Zoom, Pan, or W/L controls will deactivate the Slice
control. If the Zoom, Pan, or W/L controls is active, moving the mouse over the Slice control will deactivate the Zoom, Pan, or W/L
controls.
EnSite Precision™ Cardiac Mapping System Instructions for Use EnSite™ Verismo™ Segmentation Tool Module
ARTEN600004505 Rev. B Using Basic Interface Controls
305

Navigating in Slice Views

Each Slice view can be independently manipulated to find the slices and
plane most suitable for segmentation.

Use any of the following methods to select a slice in a single view:

■ Navigate slices from within a slice view.
– Middle-click in a slice view, then drag up or down to browse
through the set of scanned slices.
– With the cursor over a slice view, pressing the up or down arrow
keys will allow scanning through adjacent slices.
– Left-clicking Slice (in the lower left corner of a slice view) will
also allow navigation of slices by holding down the left mouse
button and moving the mouse. To exit this mode, left-click Slice
again.
– Right-clicking Slice will display a menu with options to go to the
first, middle, or last slice.
■ Use the crosshairs. The crosshairs facilitate navigation between slices
and show the relationship between the slice views and the 3D model
(see Figure 249). In the slice views, the cursors indicate the position
of the slice displayed in the other two views. Figure 249. Transverse image with crosshairs indicating
– To move crosshairs in a slice view, move the cursor near a coronal (yellow) and sagittal (red) slice orientations.
crosshair. The cursor will change to a crosshair cursor, indicating
whether one or both crosshairs are highlighted. Left-click and drag the mouse to move the crosshair.
– To move crosshairs in the 3D view, move the cursor near the intersection of the crosshair lines. The cursor will change to a
small cross. Left-click and drag to move the crosshairs.
Note: When dragging the crosshairs in 3D, the crosshairs can only be positioned to a surface location on the model.
– To disable the display of crosshairs in a single view, right-click in the view and deselect the crosshairs toggle. To disable the
display of all crosshairs, select Display > Options, and disable the Crosshairs toggle.

Using the Zoom Control

The zoom control appears in the lower right corner of the slice and 3D panels. By default, the zoom will be set to fit the image to the
panel in each view. Use the following controls to adjust the zoom level:
■ Left-click on Zoom to activate the zoom cursor. Then, left-click and drag the mouse up or down to zoom in or out. Left-click on
Zoom again to disable the zoom cursor.
■ Hold down the right mouse button on Zoom to display a menu, and select a zoom level:
– 0.25x – 4.00x – various magnifications.
– Fit Window – fits to panel.
– Fit Width – fits to panel width.
– Fit Height – fits to panel height.

Using the Pan Control

The pan control appears in the lower right corner of the slice and 3D panels. By default, the image will be centered. Use the following
controls to adjust the pan:
■ Left-click on Pan to activate the pan cursor. Then, left-click and drag the mouse in any direction to pan the image. Left-click on
Pan again to disable the pan cursor.
■ To center the image, hold down the right mouse button on Pan and select Reset.
 EnSite™ Verismo™ Segmentation Tool Module EnSite Precision™ Cardiac Mapping System Instructions for Use
306 Using Templates ARTEN600004505 Rev. B

Using the Intensity (W/L) Controls

The window Width/Level (W/L) control appears in the lower right corner of the slice panels. The W/L controls adjust the intensity of
the displayed slice data. This adjustment allows visualization of structures in the data. By default, the W/L will be set to a range
encompassing the minimum and maximum intensity values in the subregioned images. Adjusting W/L in any view will affect all three
slice panels.

Note: W/L adjustments do not affect the result of automated segmentation tools. To adjust intensities for automated segmentation, use
the thresholding and boundary emphasis controls under the related tools.

Use the following controls to adjust W/L:

■ To manually control W/L, left-click on W/L to display the W/L cursor. Then left-click and drag the mouse to adjust window (left
to right) and level (up and down). Left- click on W/L again to disable the intensity cursor.
■ To select a defined W/L, hold down the right mouse button on W/L and select a setting:
– Intensity values that were saved as a part of the DICOM data set appear as numeric values.
– Reset sets the W/L to a range encompassing the minimum and maximum intensity values in the subregioned images.

Rotating the 3D Model

The 3D model can be rotated to view the heart from various angles. The torso-shaped Orientation Reference in the upper right corner
shows the current rotation. Use the following controls to adjust the rotation angle:
■ To manually adjust the rotation, middle-click on the 3D model, and drag to rotate.
■ To select a pre-defined angle, left-click one of the rotation angles listed at the top of the panel.
– AP: Anterior to posterior, correlates to coronal slice view
– PA: Posterior to anterior
– LL: Left lateral, correlates to sagittal slice view
– RL: Right lateral
– CRA: Cranial
– CAU: Caudal, correlates to transverse slice view

Using Templates

Interface preferences may be saved in templates. The following attributes can be saved in templates:
■ Structure names and colors
■ Default structure
■ Information displayed in the upper left corner of slice and 3D views.
■ Show crosshairs on/off
■ Growth limit for vessel tool
■ Font size for labels and tape measure
■ Number of undo levels

To create a template – Modify the above attributes, and select File > Save Template.

To load a template – Select File > Load Template.

Note: Templates can only be saved or loaded from the segmentation screen, not the patient screen.
EnSite Precision™ Cardiac Mapping System Instructions for Use EnSite™ Verismo™ Segmentation Tool Module
ARTEN600004505 Rev. B Performing Segmentation
307

Performing Segmentation

Overview of Segmentation Tools

Segmentation is the process of isolating an object of interest using the gray-scale intensity of slice-based data. The EnSite™ Verismo™
Segmentation Tool uses two common segmentation techniques to create an accurate model for 3D visualization of cardiac structures.
■ Thresholding is a method of selecting any values within a range of intensities.
■ Boundary emphasis identifies sharp transitions in intensity.

Each segmentation tool is represented by an icon in the control panel. Clicking the icon will display the tool.

Region Grow – Segment a region that consists of many connected structures, such as the
blood pool.

Chamber – Segment a heart chamber.

Vessel – Segment a cardiac vessel.

Separator – Separate connected structures from one another.

Trace – Manually trace a region.

Barrier – Enhance boundaries between structures to improve the use of the Region Grow,
Chamber, Vessel, and Separator tools.

Reassign – Reassign a structure that was previously defined.

Label – Label the heart model.

Measure – Measure linear distances and volumes.

Additional Controls: Delete, Undo, Cancel

The following controls appear at the bottom of the control panel and apply to multiple tools:
■ [Delete] – For the current tool, start a delete mode that will allow items (seed point, barrier, trace, label, or measurement) to be
highlighted with the cursor and deleted with a left-mouse click.
■ [Delete All] – Delete all items placed on slice views or the 3D model, for example, all seed points, labels, measurements, or
barriers.
■ [Undo] – Undo the last segmentation process. The default number of Undo levels is 10. The number of levels is adjustable under
Display > Options.
■ [Redo] – Restore the last process reversed with Undo.
■ [Cancel] – Cancel all unapplied actions of the current segmentation tool and close the tool.
 EnSite™ Verismo™ Segmentation Tool Module EnSite Precision™ Cardiac Mapping System Instructions for Use
308 Using the Structure List ARTEN600004505 Rev. B

Using the Structure List

The Structure list manages the display of up to 16 structures (see Figure 250). It features
a drop-down menu of 16 structures and an ***Undefined*** option. One structure may
be selected from this list to be used by segmentation tools.

The ***Undefined*** option is used to remove information from the segmented model. Figure 250. The structure list.
All other structures add information to the segmented model. Undefined cannot be
locked, displayed, colored, or renamed.

Structure Attributes
Each structure has the following attributes (see Figure 250):
■ Lock – Locking a structure prevents modifications. To lock or unlock a structure, click on the lock icon. The icon for an unlocked
and modifiable structure appears in green (default), and the icon for a locked structure appears in red.
■ Display – Display controls whether the structure will be displayed in the 3D view. If the display is enabled (default), the display
icon appears as a small monitor, and the structure is shown in 3D view. If the display is disabled, the icon appears as a monitor
with a red slash, and the structure is hidden from 3D view. If a structure is not displayed, no part of that structure can be removed
or assigned to a different structure; however, a structure that is not displayed can still have additional information added to it by
other segmentation tools.
Note: Structures that are not displayed when a model is saved will not be available when the model is displayed on the EnSite
Precision™ Cardiac Mapping System software.
■ Color – The color controls the display color for the structure in the slice and 3D views.

Modifying Structures
Structure attributes may be modified.
1. Select a structure from the list to modify.
2. Select the [Modify] button adjacent to the structure list (see Figure 251), or
select Edit > Modify Structure. The Modify Structure window will appear.
3. Modify the structure attributes.
■ Name – Type a name using up to 16 characters, or select a name
from the list.
■ Color – Type a color name (“red”) or select [...] to display a color
selection tool.
Figure 251. The structure list and Modify Structure
■ Lock – Lock or unlock the structure. window.
■ Display – Display or hide the structure.
4. Select [OK].
EnSite Precision™ Cardiac Mapping System Instructions for Use EnSite™ Verismo™ Segmentation Tool Module
ARTEN600004505 Rev. B Using the Region Grow Tool
309

Using the Region Grow Tool

The Region Grow tool (see Figure 252) is used to quickly isolate a larger region of the
scanned volume such as the blood pool. Other segmentation tools can then be used to separate
individual structures from the blood pool. Region Grow requires the placement of one or more
seed points and manual adjustment of the threshold range.

1. Select the Region Grow icon.

2. Select a structure of interest from the list.
3. In the desired Slice view, left-click to place one or more seed points in the middle of the
structure.
Note: If seed points are placed incorrectly, use the [Delete] or [Delete All] buttons. See
“Additional Controls: Delete, Undo, Cancel” on page 307.

Figure 252. The Region Grow tool.

4. Adjust the Min. Threshold, Max. Threshold, and Boundary Emphasis sliders:
■ Lower the Min. Threshold until the structures of interest fill in with
translucent color. If boundaries between structures begin to fill with
color, the Min Threshold may be too low (see Figure 253).
■ The Max. Threshold generally does not need to be adjusted unless a hard
structure (bone, implanted metal) is present.
■ Drag the Boundary Emphasis slider to emphasize the boundaries between
structures. Raise the slider until a thin boundary appears around the
structures in the slice views (see Figure 254).
Note: If thresholding and boundary emphasis do not identify separations that can be
visually identified, consider using the Barrier tool before proceeding. See “Using
the Barrier Tool” on page 315.
5. Optional: To limit the area affected by Region Grow, select [Local Region] and Figure 253. While the threshold sliders are
adjust the bounding box in the slice views. adjusted, the affected portion of the model will
be indicated with a translucent overlay of the
structure color.
 EnSite™ Verismo™ Segmentation Tool Module EnSite Precision™ Cardiac Mapping System Instructions for Use
310 Using the Region Grow Tool ARTEN600004505 Rev. B

6. Click [Apply] to segment the defined structure. The segmented structure is shown
in the 3D view (Figure 255).
Note: If the effect of the segmentation is undesirable, use the [Undo] button to undo
the last change to the 3D model. See “Additional Controls: Delete, Undo, Cancel”
on page 307.

Figure 254. While the Boundary Emphasis

slider is adjusted, areas with a sharp change in
intensity are indicated in translucent white.

Figure 255. Initial 3D model from region grow.

EnSite Precision™ Cardiac Mapping System Instructions for Use EnSite™ Verismo™ Segmentation Tool Module
ARTEN600004505 Rev. B Using the Chamber Tool
311

Using the Chamber Tool

The Chamber tool (Figure 256) is used to quickly isolate a heart chamber from the scanned
volume. This tool requires the placement of a seed point in the middle of the chamber of
interest and manual adjustment of the threshold range. The Chamber tool emphasizes the
segmentation of a single chamber using an erosion algorithm. The erosion algorithm uses
thresholding and boundary emphasis values to automatically break thin connections to other
structures. The Chamber tool is often faster than Region Grow for segmenting a single
chamber, but generally has slightly less resolution.

1. Select the Chamber icon.

2. Select the chamber of interest from the list.
3. In the desired slice view, left-click to place a seed point in the middle of the chamber.
Note: If seed points are placed incorrectly, use the [Delete] or [Delete All] buttons. See
“Additional Controls: Delete, Undo, Cancel” on page 307.
4. Adjust the Min. Threshold, Max. Threshold, and Boundary Emphasis sliders:
■ Adjust the Min. Threshold until a dotted line appears around the structure of
interest. If the dotted line surrounds multiple structures, the Min. Threshold
may be too low.
■ The Max. Threshold generally does not need to be adjusted unless a hard
structure (bone, implanted metal) is present. Figure 256. The Chamber tool.

■ Drag the Boundary Emphasis slider to emphasize the boundaries

between structures. Raise the slider until a thin boundary appears
around the structures in the slice views.
Note: If thresholding and boundary emphasis do not identify separations that
can be visually identified, consider using the barrier tool before proceeding. See
“Using the Barrier Tool” on page 315.
5. Click [Apply] to segment the defined chamber (Figure 257). The segmented
structure is shown in the 3D view.
Note: The segmented structure will not precisely match the initial dotted line
because of the erosion algorithm described above.
Note: If the effect of the segmentation is undesirable, use the [Undo] button to
undo the last change to the 3D model. See “Additional Controls: Delete, Undo,
Cancel” on page 307.

Figure 257. A model produced by the Chamber tool.

 EnSite™ Verismo™ Segmentation Tool Module EnSite Precision™ Cardiac Mapping System Instructions for Use
312 Using the Vessel Tool ARTEN600004505 Rev. B

Using the Vessel Tool

The Vessel tool (see Figure 258) is used to quickly isolate a vessel from the scanned volume.
This tool grows a vessel on adjacent slices, using a seed point and a threshold range.
1. Select a structure from the list.
2. In the desired slice view, left-click to place a seed point in a vessel. The seed point
should generally be placed in a plane perpendicular to the vessel, such as the sagittal
view for pulmonary veins.
Note: The growth of structures using the Vessel tool is controlled by the Growth Limit.
The Growth Limit, available under Advanced > Settings, is user adjustable, but defaults to
1.5 times the size of the original slice.
Note: If seed points are placed incorrectly, use the [Delete] or [Delete All] buttons. See
“Additional Controls: Delete, Undo, Cancel” on page 307.
3. Adjust the Min. Threshold and Max. Threshold sliders:
■ Adjust the Min. Threshold until a dotted line appears around the structure of
interest. If the dotted line surrounds multiple structures, the Min. Threshold
may be too low.
■ The Max. Threshold generally does not need to be adjusted unless a hard
structure (bone, implanted metal) is present.
Figure 258. The Vessel tool.
Note: If thresholding does not identify separations that can be visually
identified, consider using the Barrier tool before proceeding. See “Using the
Barrier Tool” on page 315.
4. Select one of the following directions to grow the vessel:
■ (Superior/Anterior/Left) to grow the vessel in the specified direction.
■ Both directions to grow the vessel in both directions.
■ (Inferior/Posterior/Right) to grow the vessel in the specified direction.
5. Click [Apply] to segment the vessel (see Figure 259).
Note: If the effect of the segmentation is undesirable, use the [Undo] button to
undo the last change to the 3D model. See “Additional Controls: Delete, Undo,
Cancel” on page 307.

Figure 259. A completed vessel model of the

descending aorta.
EnSite Precision™ Cardiac Mapping System Instructions for Use EnSite™ Verismo™ Segmentation Tool Module
ARTEN600004505 Rev. B Using the Separator Tool
313

Using the Separator Tool

The Separator tool (see Figure 260) is used to separate structures for individual visualization,
for example, separating the left ventricle from the left atrium. This tool can also be used to
remove a portion of the 3D model if too much detail was segmented. Structures are separated
between two or more seed points placed on the surrounding structures.
1. Select the Separator icon.
2. Select a structure to separate (e.g. Left Atrium).
Note: Selecting “Undefined” from the structure list allows the separator tool to delete
portions of the segmented model.
3. In the desired Slice or 3D view, left-click to place one or more seed points on the
appropriate structure (e.g. left atrium).
Note: If seed points are placed incorrectly, use the [Delete] or [Delete All] buttons. See
“Additional Controls: Delete, Undo, Cancel” on page 307.
4. Repeat steps 2 and 3 as needed to continue identifying surrounding structures.
Note: To preserve the original structure, be sure to place at least one point in the original
Figure 260. The Separator tool.
structure. For example, if the “Left Atrium” structure also contains portions of the left
ventricle and aorta, place points not only in the left ventricle and aorta, but also in the left
atrium.
5. Drag the Boundary Emphasis slider to emphasize the boundaries between structures.
6. Click [Apply] to separate the defined structures (see Figure 261).

Figure 261. Before (left) and after (right) using separator.

Note: If separations do not occur at locations that can be visually identified, consider using the barrier tool before proceeding. See
“Using the Barrier Tool” on page 315.
Note: If the effect of the segmentation is undesirable, use the [Undo] button to undo the last change to the 3D model. See
“Additional Controls: Delete, Undo, Cancel” on page 307.
 EnSite™ Verismo™ Segmentation Tool Module EnSite Precision™ Cardiac Mapping System Instructions for Use
314 Using the Trace Tool ARTEN600004505 Rev. B

Using the Trace Tool

The Trace tool (see Figure 262) is used to manually outline a structure. It can be used to
create structures from slice views or reassign portions of the segmented model to a different
structure.

Using Trace in a Slice View

1. Select the Trace icon.
2. Select the structure to be traced, such as “Esophagus.”
3. In the desired slice view, left-click along an edge of the structure to be traced.
4. Left-click and drag around the edge of the contour to trace the structure (red line,
Figure 263). Release the mouse button to complete the trace, and connect the starting
point of the line to the ending point. The structure will be created on a single slice.
Note: To remove a trace from a single slice, use the [Delete] or [Delete All] buttons. See
“Additional Controls: Delete, Undo, Cancel” on page 307.
5. Advance to a parallel slice in the same view, and trace the structure again.
6. To grow the structure through adjacent slices, click [Propagate].
Note: If the effect of the segmentation is undesirable, use the [Undo] button to undo the
last change to the 3D model. See “Additional Controls: Delete, Undo, Cancel” on page
307.

Using Trace in the 3D View

Figure 262. The Trace tool.

1. Select the Trace icon.

2. Select a structure.
Note: Selecting “Undefined” from the structure list allows the Trace tool to
delete portions of the segmented model.
3. In the 3D view, left-click and drag the cursor around the structure to be
reassigned.
4. Release the mouse button to complete the trace.
Note: If the effect of the segmentation is undesirable, use the [Undo] button to
undo the last change to the 3D model. See “Additional Controls: Delete, Undo,
Cancel” on page 307.

Figure 263. Using the Trace Tool

EnSite Precision™ Cardiac Mapping System Instructions for Use EnSite™ Verismo™ Segmentation Tool Module
ARTEN600004505 Rev. B Using the Barrier Tool
315

Using the Barrier Tool

The Barrier tool (see Figure 264) is used to place divisions between structures that can be
visually identified, but may be difficult to automatically identify for a variety of reasons.
The Barrier tool improves the use of the Region Grow, Chamber, Vessel, and Separator
tools.

To create a barrier:
1. Select the Barrier icon.
2. In the desired Slice view, left-click and drag to draw a line (see Figure 265).

3. Advance to another slice in the same view and draw another line. Repeat this
process until the barrier has progressed from one side of the structures to the other.
■ When drawing barriers, always draw in the same general direction (left-
to-right, top-to-bottom, etc.)
■ Slices do not need to be consecutive.
■ The barrier tool will create an estimated line on all of the slices between
user-drawn lines. These estimated lines are displayed in purple; drawing
a new line on this slice will remove the estimated line.
■ Drawing a new line on a slice that already contains a line will replace
the previous line.
4. Click [Create Barrier] to grow the barrier through adjacent slices (see Figure 264).

Note: After creating a barrier, additional barriers may be drawn.

Note: To remove barriers, use the [Delete] or [Delete All] buttons. Refer to
“Additional Controls: Delete, Undo, Cancel” on page 307.
5. Continue segmentation using the appropriate tools.
Note: Barriers are not affected by Undo or Redo. Undo and Redo only affect changes
to the segmented model; barriers only appear in the 2D view. Figure 264. The Barrier Tool

Figure 265. A drawn barrier line Figure 266. A created barrier

 EnSite™ Verismo™ Segmentation Tool Module EnSite Precision™ Cardiac Mapping System Instructions for Use
316 Using the Reassign Tool ARTEN600004505 Rev. B

Using the Reassign Tool

The Reassign tool (see Figure 267) is used to reassign a structure that has already been defined. It is an efficient way to segment the
remaining structures from the slice or 3D views.

Reassigning a Structure
1. Select the Reassign icon.
2. Select the structure to be reassigned.
3. Select from the following assignment methods:
■ Entire Structure reassigns all components of one structure to a different
structure. For example, if a model of the left atrium was inadvertently
assigned to the Left Ventricle structure, use Entire Structure to reassign the
entire model to the Left Atrium structure.
■ Contiguous 3D reassigns all connected 3D regions to the defined structure.
For example, if a model in the Blood Pool structure contained the anatomy
of the descending aorta and the rest of the heart, and the aortic anatomy
was not connected to the posterior wall of the heart, this option would
allow the descending aorta to be reassigned to the Aorta structure.
■ Components less than 125 mm3 reassigns connected 3D regions less than 125
mm3. A new number can be typed if desired. For example, if the Left Figure 267. The Reassign tool.
Atrium structure includes many small disconnected and undesirable pieces,
this option can be used to reassign the small pieces to the Unassigned structure.
4. In the desired slice or 3D view, left-click to place a seed point on the structure to reassign.
Note: If seed points are placed incorrectly, use the [Delete] or [Delete All] buttons. See “Additional Controls: Delete, Undo,
Cancel” on page 307.
5. Click [Apply] to reassign the defined structure.
EnSite Precision™ Cardiac Mapping System Instructions for Use EnSite™ Verismo™ Segmentation Tool Module
ARTEN600004505 Rev. B Placing Labels
317

Placing Labels

The Label tool (see Figure 268) is used to label the 3D heart model. All labels are saved with the 3D model and will be included on
models imported into an EnSite Precision™ Cardiac Mapping System study.

Figure 268. The Label tool.

Figure 269. Using the Label tool.

1. Select the Label icon.

2. Type a label (up to 16 characters), select a predefined label from the list, or select Location from the list. When Location is
selected, a placed label will display Cartesian coordinates for the selected map location.
3. Select a font size for the label.
■ Small – 10 point
■ Medium – 12 point (default)
■ Large – 14 point
4. Left-click in a slice view or on the 3D model to place a label.
Note: If labels are placed incorrectly, use the [Delete] or [Delete All] buttons. See “Additional Controls: Delete, Undo, Cancel” on
page 307.

Using the Measurement Tools

The Measure tool (see Figure 270) is used to measure linear and screen distances between two user-selected points. Measurement
accuracy is based on the original scan data +/- one slice space.

Note: Resampling may decrease the accuracy of measurement tools. See “Loading the Series for Segmentation” on page 302.
 EnSite™ Verismo™ Segmentation Tool Module EnSite Precision™ Cardiac Mapping System Instructions for Use
318 Using the Measurement Tools ARTEN600004505 Rev. B

Figure 270. The Measurement Tool. Figure 271. Using the Measurement Tool

Measuring Distances
1. Select the Measure icon.
2. Select a font size for displaying the measured distance.
■ Small – 10 point
■ Medium – 12 point (default)
■ Large – 14 point
3. In any slice view or the 3D view, left-click and drag on the area to be measured.
■ Straight (slice or 3D views) is the shortest distance across the structure.
■ Screen (3D view only) is the projected screen distance, which changes as the 3D model is rotated. The screen measurement may
be useful for analyzing a distance at various angles.

Note: Measurements are shown on a model only when the Measure tool is selected. Measurements are not saved with the final DIF file.

Note: To delete tape measures, use the [Delete] or [Delete All] buttons. See “Additional Controls: Delete, Undo, Cancel” on page 307.
When using the delete tool with tape measures, click on the red ends of a tape measure.

Measuring Volumes
Click [Measure Volume] to display the calculated volumes for all structures.
EnSite Precision™ Cardiac Mapping System Instructions for Use EnSite™ Verismo™ Segmentation Tool Module
ARTEN600004505 Rev. B Saving and Exporting
319

Saving and Exporting

Key Points About Saving Models

The following points are important considerations in saving a model:
■ At the time that the model is saved, each visible structure is included in the final model. Disabling the view of a structure in the
Structure List will prevent that structure from being included. See “Using the Structure List” on page 308.
Note: When saving a model with more than one structure displayed in the structure list, the resolution of each individual structure
will be slightly reduced. The greater the number of displayed structures, the lower the resolution on each individual structure.
■ When segmentation is complete, the model must be saved to the hard drive, regardless of whether the model will be used on a
different workstation. The model may be exported after saving.
■ During the saving process, the final model is constructed by creating a thin shell around each visible structure in the 3D view. A
viewer will appear to display the surface of this shell. A contour viewer is also available to compare the shape of this shell directly
to the model in the 3D view and the original slice data.
■ To save partially completed segmentations or return to a previous segmentation, use the Save Work in Progress option.

Saving the Model to the Hard Drive

1. Select File > Save As.
2. Enter a file name.
3. In the Operator field, type the name of the clinician who performed the segmentation.
Note: The operator name may also be accessed from a list. Use the drop-down menu to access an operator from the list. To add
new operator names to the list, type the new operator name, and from the drop-down menu, select Add.
4. Optionally, notes about the segmentation session may be saved with the model in the Comments section. Comments will be
available during the EnSite Precision™ Cardiac Mapping System study.
5. Select [Save] to save the file on the EnSite Precision™ Cardiac Mapping System. When a model is saved, the system creates a
tiled surface of each displayed structure. The tiled model in DIF format is the version that will be accessed by the EnSite
Precision™ Cardiac Mapping System. When saving a model, the model viewer window will appear automatically. See “Using
the DIF Viewer” on page 320.
Note: During saving, a message may appear stating that the complexity of the model may slow the EnSite Precision™ Cardiac
Mapping System application. If this occurs, consider the following methods of reducing the complexity of the model:
■ Hide additional structures in the Structure List and save again.
■ Remove small debris from the model using either the Trace or Reassign tool, and save again.
■ Reduce the surface complexity by selecting Advanced > Smooth All Structures and save the model again.

Exporting Models to CD or DVD

To save the DIF file to a CD/DVD:
1. Select File > Export to CD/DVD. A list of saved models will appear.
2. Select saved files to back up on the CD/DVD.
3. Click OK to copy the files to the disk.
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Saving Work in Progress

Saving work in progress will help preserve the model in various stages of segmentation by returning to a previous point in the
segmentation process.

Note: Barriers, labels, and tape measures are not saved with work-in-progress files.
1. Select File > Save Work in Progress.
2. To recover this saved model at any time, select File > Load Work in Progress.

Reviewing the Final Model

Using the DIF Viewer

The DIF viewer (see Figure 272) displays the final 3D model surface as it will appear on the EnSite Precision™ Cardiac Mapping
System.

Figure 272. The DIF viewer.

The viewer may be accessed by two methods:

■ After saving a model by selecting File > Save As. The viewer will appear with the model loaded.
■ The viewer may also be accessed by selecting Display > View Segmentation Model. A list of available models will appear. Select
a model from the list.
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The following controls are available in the viewer:

■ Rotate – Hold down the middle mouse button and drag.
■ Zoom – Use the roller wheel on the mouse.
■ Wireframe – Options > Wireframe.
■ Bounding box display – Options > Bounding Box.
■ Default views – Views > AP/PA/LL/RL/CRA/CAU.
■ Close viewer – File > Exit.

Viewing Segmentation Contours

The segmentation contour viewer (see Figure 273) allows the clinician to compare a DIF surface model to the current rendered model
from the 3D view and the current slice data.

To access the segmentation contour viewer, select Display > View Segmentation Contour.
■ The rendered model from the 3D view appears as shaded solid areas.
■ The surface of the DIF model appears as thick opaque lines.
■ The slice images appear in a single view, which may be navigated using the same controls as the other slice views.

Figure 273. The segmentation contour viewer.

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Printing Images
1. Select File > Print.
2. Select from the following options:
■ Full Screen prints the entire Segmentation screen
■ 3D Rendering prints the 3D heart model
■ Transverse (CAU) prints the transverse Slice view
■ Coronal (AP) prints the coronal Slice view
■ Sagittal (LL) prints the sagittal Slice view

Troubleshooting

Contacting Technical Support

The following troubleshooting guide is intended to help users resolve common problems with the system. If problems cannot be
resolved by using the suggestions below, contact your EnSite Precision™ Cardiac Mapping System field representative or distributor.

WARNING: Service and Technical Support

651-756-6985
Toll Free: 800-374-8038, Option 1

www.sjm.com

Troubleshooting Tools
Technical Support may ask you to access one or more of the following software resources:

About EnSite Verismo – This information will provide technical support with general information about your software version. From
the EnSite™ Verismo™ Segmentation Tool menu bar, select Help > About EnSite Verismo.

Collect Log Files – This function collects all the log files from the system and exports them to a disk. Place a blank disk in the
DVD/CD writable drive. From the EnSite Precision™ Cardiac Mapping System title screen, click on the [About EnSite ...] button.
Click on the Utilities tab then click on the [Collect Log Files] button. Follow the on-screen prompts to complete the process. This
operation can take several minutes to complete.
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Troubleshooting Common Problems

When a problem occurs, perform the following steps:

Series will not load – Verify that the data was created in accordance with the “Optimal Characteristics for the EnSite™ Verismo™
Segmentation Tool Image Files” on page 299. If the series information displays but the series will not load, check the usability
indicator.
■ OK – No problems were detected.
■ Bad Dircos – Coordinate information is missing, or vectors are not at right angles.
■ Rot### – Volume is not orthogonal - direction cosines are reported.
■ NOT_3D – Only one section, or no slice locations, missing coordinate information, or all slices are at the same location.
■ Unsupported orientation – Volume is not a standard orthogonal.
■ GantryTilt – Gantry tilt field is nonzero.
■ IRREGULAR_SPACING – Spacing conflicts cannot be resolved.

EnSite Verismo is not responding – If the EnSite™ Verismo™ Segmentation Tool is not responding, press <Alt> + <F10>.

EnSite Verismo Cleanup – If the EnSite™ Verismo™ Segmentation Tool fails

to start, consider clearing out all temporary files. On the EnSite Precision™
Cardiac Mapping System title screen, click [About EnSite ] to display the
System Information window (see Figure 274). On the System Information
window, click the Utilities tab. Select the type of files to delete, and then click
[Delete].
■ Database – Delete the currently loaded DICOM files and all Work In
Progress files.
■ Templates – Delete the user-defined templates.
■ Work in Progress – Delete all Work in Progress files.
Note: The cleanup tool will not delete created DIF files. These models
may be deleted from within the Load DIF window in the EnSite
Precision™ Cardiac Mapping System software.

Figure 274. Use the Utilities tab to delete temporary files.

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EnSite Precision ™ Cardiac Mapping System Instructions for Use
ARTEN600004505 Rev. B 325

Courier™ PACS Module APPENDIX 0

Appendix

Introduction

The EnSite™ Courier™ PACS Module v.3.0 allows the EnSite™ Cardiac Mapping System user to communicate with the hospital
PACS server for the purposes of storing and retrieving patient data in DICOM format. Specifically, the EnSite™ Courier™ PACS
Module can be used to perform the following:
■ Retrieve CT/MR/XA (rotational angiography) images to segment with EnSite™ Verismo™ Segmentation Tool and store the
resulting segmented 3D model on a PACS (Picture Archiving and Communication System) server.
■ Retrieve pre-segmented 3D models from a PACS server, or receive pre-segmented 3D models from a third party advanced
visualization workstation. Pre-segmented 3D models can be loaded directly into a realtime or review EnSite™ Cardiac Mapping
System study.
■ Store and retrieve EnSite™ Cardiac Mapping System studies on a PACS server, and import the retrieved EnSite™ Cardiac
Mapping System studies for review.
■ Store EnSite™ Cardiac Mapping System study screenshots for viewing on a standard DICOM viewer.

NOTE: Refer to the EnSite™ Courier™ PACS Module DICOM Conformance Statement for information about compatible file
types and vendors.

NOTE: Refer to the EnSite™ Cardiac Mapping System Instructions for Use for additional information and regulatory
considerations.

Operator Requirements
The EnSite™ Courier™ PACS Module v.3.0 must be operated by, or under the supervision of, an electrophysiologist trained in the
operation of the EnSite™ Courier™ PACS Module v.3.0 and supported by other qualified personnel trained in the field of cardiac EP

Requirements

The EnSite™ Courier™ PACS Module v.3.0 requires the following:

■ EnSite™ Cardiac Mapping System v.2.0 or higher
■ EnSite™ Courier™ PACS Module License

Connections

The figure below shows the connectivity between the EnSite™ Cardiac Mapping System and a typical network connected to both a
PACS server and a third party advanced visualization workstation as used with the EnSite™ Courier™ PACS Module.
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Figure 275. EnSite™ Cardiac Mapping System connected to a PACS network when using the EnSite™ Courier™ PACS Module.

Configuring the EnSite™ Courier PACS Module

This section specifies the steps to configure the EnSite™ Cardiac Mapping System Display Workstation (DWS) for use with the
EnSite™ Courier™ PACS Module.
1. Configure DWS Network Settings
■ Connect the DWS to the network
■ Configure the IP Address
2. Configure the EnSite™ Courier™ PACS Module
■ Configure PACS server settings
■ Configure EnSite™ Courier™ PACS Module settings
3. Register the EnSite™ Courier™ PACS Module on the PACS server
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Configure DWS Network Settings

Connect the DWS to the Network

To connect the DWS to the network:
1. Plug one end of the network Ethernet cable into the DWS connection labeled
“A” (ETH0) on Figure 276.
2. Connect the opposite end of the cable into the Ethernet Isolator.
3. Connect another Ethernet cable into the opposite end of the Ethernet Isolator
and the remaining end to the facilities network.

Configure the IP Address

The EnSite™ Cardiac Mapping System uses DHCP as the default setting for
obtaining an IP address from the hospital network. If you have received a new
system and plan to use DHCP, you do not need the DHCP Configuration steps
below. Simply connect the Ethernet cable as described in “Connect the DWS to the
Network” above.

If the hospital does not allow use of a dynamic IP address, configure the EnSite™
Cardiac Mapping System with a static IP address. Refer to “Configure a Static IP
Address” on page 330.

Figure 276. Ethernet connection.

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Configure a Dynamic IP Address

For verifying DCHP settings, or to switch a system from a static IP configuration to DHCP, use this section.

To configure the EnSite™ Cardiac Mapping System DWS to use DHCP:

1. On the EnSite™ Cardiac Mapping System Title screen, select [Services]. The Services window will be displayed.

Figure 277. EnSite™ Cardiac Mapping System title screen.

2. On the Services window, select [Configure Network].

Figure 278. Services Screen.

3. The [Network Configuration] window will be displayed.

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Figure 279. Network Configuration window.

4. On the Network Configuration window:

a. Select the Devices tab.
b. Select eth0.
c. Select Edit. The Ethernet Device window will be displayed.

Figure 280. Ethernet Device window.

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5. On the Ethernet Device window:

a. Verify that Activate device when computer starts is not checked.
b. Select Automatically obtain IP address settings with dhcp (via the associated drop-down box).
c. Click [OK].
6. On the Network Configuration window Devices tab:
a. Verify that the Profile box is checked for all eth* interfaces.
b. Select File > Save. The following message will be displayed: “Changes are saved. You may want to restart the network and
network services or restart the computer.” Click [OK].
c. Select File > Quit.

Figure 281. Network Configuration, Devices tab.

Configure a Static IP Address

NOTE: If the EnSite™ Cardiac Mapping System DWS is physically moved, make sure that the IP address, subnet mask, and
default gateway address are valid for the new location.

To configure the EnSite™ Cardiac Mapping System DWS with a static IP address:
1. On the EnSite™ Cardiac Mapping System Title screen, select [Services].
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Figure 282. EnSite™ Cardiac Mapping System title screen.

2. In the Services window, select [Configure Network].

Figure 283. Services screen.

3. The [Network Configuration] window will be displayed.

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Figure 284. Network Configuration window.

4. On the Network Configuration window:

a. Select the Devices tab.
b. Select eth0.
c. Select Edit. The Ethernet Device window will be displayed.

Figure 285. Ethernet Device window.

5. On the Ethernet Device window:

a. Verify that the “Activate device when computer starts” option is selected.
b. Select Statically set IP addresses.
c. Specify the Address, subnet task, and default gateway address. This information should be obtained from the hospital IT
department.
d. Select Okay.
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Configure the EnSite™ Courier™ PACS Module

Configure PACS Server Settings

The PACS Server Settings window is used to set the connection parameters for the PACS servers. At least one PACS server must be
configured before the EnSite™ Courier™ PACS Module can be used.

To configure the PACS server settings:

1. From the EnSite™ Cardiac Mapping System title screen, click on the Archive or Import icon to launch the EnSite™ Courier™
PACS Module.

Figure 286. EnSite™ Cardiac Mapping System title screen.

2. From the EnSite™ Courier™ PACS Module main window, click on the Settings icon ( ) in the upper right corner of the
screen, then click PACS Servers tab.
3. The PACS Server Settings window is displayed (see Figure 287 on page 334). Click on the [Edit] button.
4. Click within a field to enter information. Each line represents one PACS server.
Refer to the details provided for each field in “Description of PACS Server Settings” on page 334.
5. After you have entered or confirmed information in all the fields, click the [Test Connection] button to test the connection to the
PACS server.
If the connection does not work, check that the information entered in each field is correct. If the IP Address, AE Title, or Port
Number are not correct, the EnSite™ Courier™ PACS Module will not be able to communicate with that PACS server.
6. Click on the [Save] button to save the settings.
OR
Click on the [Close] button to close the window.
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Description of PACS Server Settings

Figure 287. The PACS Server settings window.

A. Descriptive Name – The Descriptive Name cannot be blank. This will be the name used to identify the PACS server throughout the
EnSite™ Courier™ PACS Module workflows. To remove a PACS server from the list, delete the Descriptive Name and click [Save].

B. AE Title – The Application Entity (AE) Title of the PACS server. The AE Title is case sensitive.

C. IP Address – The IP address of the PACS server.

D. Port Number – The port number of the PACS server.

E. Query Level – The tier of information desired by the user (study/series/image)

F. Query/Retrieve – Select the checkbox if this server can be used for Query/Retrieve.

G. Storage – Select the checkbox if this server can be used for storage.
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H. Storage Commitment – Select from ASYNCHRONOUS, SYNCHRONOUS, or NOT SUPPORTED.

■ When ASYNCHRONOUS is selected, the EnSite™ Courier™ PACS Module will attempt a Storage Commitment request to
the PACS server and will continue to wait for a response. The EnSite™ Courier™ PACS Module will complete the storage
operation only when the Storage Commitment status notification is received from the PACS server.
■ When SYNCHRONOUS is selected, the EnSite™ Courier™ PACS Module will attempt a Storage Commitment request to
the PACS server and will wait for a specified timeout period for the response. The EnSite™ Courier™ PACS Module will
complete the storage operation either when the Storage Commitment status notification is received from the PACS server, or
when the timeout period expires.
■ When NOT SUPPORTED is selected, the EnSite™ Courier™ PACS Module will not attempt a Storage Commitment
request to the PACS server and the storage operation will complete as soon as transmission is complete.

I. [Test Connection] – Click this button to test the connection between the EnSite™ Courier™ PACS Module and the PACS server
after configuration is complete.

J. Close – Click the Close button to close the window.

K. [Edit] – All settings are read only when the window is displayed. Click this button to edit the settings.

L. [Save] – Click this button to save the changes. At the confirmation window, click [Yes] to confirm saving the settings.

Configure the EnSite™ Courier™ PACS Module Application Entity Settings

NOTE: If multiple EnSite™ Cardiac Mapping Systems are in use on the same network, make sure that each DWS has a unique
AE Title and is registered properly by the PACS Administrator.

To configure the EnSite™ Courier™ PACS Module Settings:

1. From the EnSite™ Courier™ PACS Module main window, click on the Settings icon in the upper right corner of the screen.
The Courier Settings window is displayed. Default settings are shown and should be changed
only when necessary--for example, when there are hospital-specific rules regarding AE Title and/or Port Number.
2. Click on the [Edit] button.
3. Click within a field to enter information.
4. After all information has been entered, click the [Save] then [Close] buttons to save the settings.

Description of EnSite™ Courier™ PACS Module Settings

Image Receiver Settings

These settings are used when receiving images.

A. AE Title – The AE title. The user can change the AE title, which can be up to 16 characters.

B. Port Number – The port number used by the to receive images. This field should not be changed by the user.

C. Timeout – The amount of time, in seconds, that the EnSite™ Courier™ PACS Module will allow for a single image to be transmitted
from the PACS server or advanced visualization workstation. This field should not be changed by the user.

Network Path
The Network Path tab allows the user to define the destination for archiving. Archived data can be stored on a USB drive, a DVD, or
a network drive.
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Figure 288. Network Path screen

NOTE: When configuring a network path, the type of file system needs to be specified. The supported file systems are NFS v3
or later and CIFS/SMB v.1.0. File servers using later versions of SMB are compatible when CIFS/SMB v.1.0 is also
enabled.

Storage Attributes
The Storage Attributes tab defines the size and amount of data that can be stored on a local network drive. This is a user-defined
parameter, and the default setting is the secondary selection.

Figure 289. Storage Attributes screen.

History Management
The History Management tab allows the user to manage locally the number of studies to retain on the EnSite™ Cardiac Mapping
System network. Once stored, the data can be retrieved from the Retrieval History function.

Figure 290. History Management screen.

Query Configuration
The Query Configuration tab allows the user to define the desired tier of data (study/series/image).
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Figure 291. Query Configuration screen.

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Register the EnSite™ Courier™ PACS Module on the PACS Server

To exchange information between the EnSite™ Courier™ PACS Module and the PACS server, you need to configure the PACS server
with the information contained in the Courier Settings window.
1. From the EnSite™ Courier™ PACS Module main window, click on the Courier Settings icon.
2. Talk with your PACS Administrator about entering these settings on the PACS server.
3. After these settings have been entered on the PACS server, test the connection from PACS server to the EnSite™ Courier™
PACS Module, if possible.
If the connection is successful, you are ready to begin using the EnSite™ Courier™ PACS Module.

Import Image Data into the EnSite™ Verismo™ Segmentation Tool for
Segmentation

After a patient has had a CT, MR, or XA scan, you can import the images into the EnSite™ Verismo™ Segmentation Tool for
segmentation and store the segmented 3D model to a PACS server, to the EnSite™ Cardiac Mapping System DWS hard drive, or to a
CD/DVD.

Launch the EnSite™ Courier™ PACS Module

To launch the EnSite™ Courier™ PACS Module:
1. From the EnSite™ Cardiac Mapping System title screen, click on the Verismo icon to launch the EnSite™ Courier™ PACS
Module.
The EnSite™ Courier™ PACS Module main window will be displayed.
2. Use the next section, “Perform a Query” on page 338, to locate the CT/MR/XA scan on the PACS server.
Alternately, use the section “Receive Study or CT/MR Scans” on page 340 to receive the images.

Perform a Query
To perform a query:
1. Confirm that the [Verismo] task is selected.
2. Specify the search criteria.

NOTE: The asterisk (*) may be used as a wildcard, if supported by your PACS server. If a Chinese or Japanese keyboard is used,
the asterisk must be entered in English input method.
■ At least one of the following must be entered: Patient ID, Patient Name, Accession Number, or Study Date (see yellow box
highlighting these items in Figure 292).
■ To specify Patient Name, type in the name with format “LastName^FirstName”. If expected record is not returned, use
wildcard search. For example:
a. LastName^FirstName*
b. LastName^*
c. Last Name*
d. *^FirstName
Similar wildcard searches can be used to specify the Referring Physician field.
■ To specify Study Date, select date, month and/or year in the format shown; the year also can be entered manually.
Alternatively, select Today or Yesterday from the drop-down list to auto-populate the date, month, and year fields.
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3. Select the Modality. The modality determines the types of images (CT/MR/XA) contained in the study. More than one Modality
type may be selected. If none are selected, all studies matching the search criteria will be displayed.
Note: Use CT, MR, and XA to query for images to segment in the EnSite™ Verismo™ Segmentation Tool.
4. Select the PACS server from the [Import from] drop-down menu.

Figure 292. Perform a query.

5. Click [Query] to launch Verismo.

Import a Study
Single or multiple series or one study may be selected.
■ To select a single item, such as a CT/MR/XA scan, click on the item.
■ To select multiple items, hold down the <Ctrl> key and click on each item.
■ To select multiple consecutive items, hold down the <Shift> key, click on an item and then click on another item. Alternatively,
click on an item and drag to select additional consecutive items.

NOTE: Some PACS servers only support single item retrieval.

NOTE: Only multiple studies for a single patient may be selected.

There are two ways to retrieve images:

■ To retrieve a complete study, select the study and then click [Launch Verismo] button.
■ To retrieve a single series, select the study, select the series, and then click [Launch Verismo] button.

Figure 293. Retrieving a study.

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When the [Import Study] button is clicked, the Retrieve in Progress bar will show the percentage of the images retrieved. After the
Retrieve is done, the EnSite™Verismo™Segmentation Tool is launched.

NOTE: When the Retrieve in Progress bar is displayed, the EnSite™ Courier™ PACS Module main window cannot be
repositioned.

NOTE: If you click on the [Cancel] button in the progress bar (see Figure 20 on page 24), image retrieval will be stopped;
otherwise, image retrieval will still continue until completed.

NOTE: If the Retrieve operation fails, a message will be displayed. Refer to “Retrieve Failed” on page 345 to determine the cause
of the failure.

Receive Study or CT/MR Scans

To receive Study or CT/MR scans:
1. From the EnSite™ Cardiac Mapping System title screen, click on the Verismo icon to launch the EnSite™ Courier™ PACS
Module.
The EnSite™ Courier™ PACS Module main window will be displayed.
2. To enable Receive mode, click the [Receive] button in the lower left corner of the Courier PACS window.
When the [Receive] button is clicked, it will change to [Stop Receive].
3. After all scans have been received, click on [Stop Receive]. All received studies will be listed for selection.

Archive Segmented 3D Model/Map to PACS Server

This allows the user to store segmented 3D models generated by the EnSite™ Verismo™ Segmentation Tool.
1. Return to the start-up screen and select [Archive]
2. If not already in the EnSite™ Courier™ PACS Module: From the EnSite™ Cardiac Mapping System title screen, click on the
Archive icon to launch the EnSite™ Courier™ PACS Module.
3. Select the archive server PACS name associated with the server on which you want to archive the data.
4. Select the [Archive DIF] Workflow Task, at top of the EnSite™ Courier™ PACS Module main window.
A window will display a list of the DIF files created by the EnSite™ Verismo™ Segmentation Tool.
5. Select the DIF file.
■ To select multiple items, hold down the <Ctrl> key and click on each item.
■ To select multiple consecutive items, hold down the <Shift> key, click on an item and then click on another item.
Alternatively, click on an item and drag to select additional consecutive items.
6. Select the destination PACS server from the drop-down menu at the lower right of the EnSite™ Courier™ PACS Module main
window.
7. Click the [Store] button.
The Store in Progress bar will show the percentage of the DIF models stored.

NOTE: You can overwrite a previously archived study by selecting the "Overwrite previous archive" option at the lower left
of the Archive Study screen.
If you click on the [Cancel] button in the Store in Progress bar, any files that have already been transmitted or have started
transmission will be stored; any files that have not started transmission will be canceled.
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8. An entry will be made in the Archive History when the transmission is completed. A second entry will be made in the Archive
History when Storage Commitment is completed, if this has been configured for the receiving PACS server.
A final storage status will be displayed for each study in the Archive History. For a description of the status, refer to the
Troubleshooting Chapter, “Storage Commitment Failed” on page 346.

Delete Study after Archiving

To delete a study after it is archived, select the "Delete the selected studies from the local drive after successful archiving" option
at the lower left of the Archive Study screen.

Import Pre-segmented 3D Models for Use in the EnSite™ Cardiac Mapping

System

When viewing a realtime or review study in the EnSite™ Cardiac Mapping System, you can use the EnSite™ Courier™ PACS Module
to import pre-segmented 3D DICOM Models from the PACS server, or from a third party advanced visualization workstation.

Retrieve Pre-segmented 3D Models from the PACS Server

1. From an EnSite™ Cardiac Mapping System study, select [Model Workflow], then select the DIF icon at the top of the Model
control panel. The DIF control panel will be displayed. From the DIF control panel, click [Load DIF...]. The Import Model Map
screen will be displayed.
OR
To launch the EnSite™ Courier™ PACS Module from the EnSite™ Cardiac Mapping System menubar, select File > Load DIF....
The Import Model Map screen will be displayed.
2. For Query and Retrieve instructions, refer to “Perform a Query” on page 338 and “Import a Study” on page 339, respectively.
3. After successful retrieval, all retrieved model maps are listed for preview.
4. Select a desired DIF Model and select Import from My PACS Server to load the file into the EnSite™ Cardiac Mapping System
study.

Receive Pre-Segmented 3D Models

The EnSite™ Courier™ PACS Module is able to accept pre-segmented 3D models from a third party advanced visualization
workstation. This capability, called Receive mode, must be enabled by the user. Any DICOM application entity that wants to send to
the EnSite™ Courier™ PACS Module must use the correct the EnSite™ Courier™ PACS Module AE Title, IP Address, and Port
Number. Refer to the Courier Settings window.

To receive pre-segmented 3D models from within an EnSite™ Cardiac Mapping System study:
1. From an EnSite™ Cardiac Mapping System study, click the DIF icon at the top of the Model control panel. The DIF control
panel will be displayed. From the DIF control panel, click [Load DIF...]. The DIF window will be displayed.
OR
To launch the EnSite™ Courier™ PACS Module from the EnSite™ Cardiac Mapping System menubar, select File > Load DIF....
The DIF window will be displayed.
2. To enable Receive mode, click the [Receive] button.
When the [Receive] button is selected, it will change to [Stop Receive]. Receive mode will stay active until [Stop Receive] is
selected. After Received Mode is stopped, all received studies will be displayed.
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Figure 294. Received studies.

Select a Study
1. Select the [Retrieve] button and preview the 3D model.
2. Select the DIF file, and click on the [Load DIF] button to load the DIF file into the EnSite™ Cardiac Mapping System study.

To receive pre-segmented 3D models from outside of an EnSite™ Cardiac Mapping System study:
1. From the EnSite™ Cardiac Mapping System title screen, click on the Import icon to launch the EnSite™ Courier™ PACS
Module.
The EnSite™ Courier™ PACS Module main window will be displayed.
2. From the EnSite™ Courier™ PACS Module main window, click the [Receive] button in the lower left corner of the window.
3. When complete, click on the [Stop Receive] button. The received 3D models will be available in the retrieval history to be loaded
into an EnSite™ Cardiac Mapping System study in the future.

NOTE: There is no limitation on the number of images received during a single connection.

Note: If the EnSite™ Courier™ PACS Module is receiving images when the [Stop Receive] button is clicked, the current transmission
will continue; however, subsequent transmissions will be disabled. Receive mode must be re-enabled for subsequent transmissions. If
the EnSite™ Courier™ PACS Module is not receiving images when the [Stop Receive] button is clicked, Receive mode will
immediately cease operation. Receive mode will remain active until stopped by the user.

Store EnSite™ Cardiac Mapping System Studies on PACS Server

1. If not already in the EnSite™ Courier™ PACS Module: From the EnSite™ Cardiac Mapping System title screen, click on the
Archive icon to launch the EnSite™ Courier™ PACS Module.
2. Click on the [Archive Study] Workflow Task.
A list of the EnSite™ Cardiac Mapping System studies on the DWS will be displayed.
3. Select one or more studies from the list to store.
■ If one study is selected, the notebook information and archive history of the study will be displayed on the righthand side of
the screen.
■ To select multiple studies, hold down the <Ctrl> key and click on each study.
■ To select multiple consecutive studies, hold down the <Shift> key, click on a study and then click on another item.
Alternatively, click on an item and drag to select additional consecutive items.
4. Select the PACS server to use for storing the studies.
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5. Click the [Archive] button.

The Store in Progress bar will show the percentage of the studies stored.
6. If you click on the [Cancel] button in the Store in Progress bar, any files that have already been transmitted or have started
transmission will be stored; any files that have not started transmission will be canceled.
A final storage status will be displayed for each study in the Archive History. For a description of the status, refer to the
Troubleshooting Chapter, “Storage Commitment Failed” on page 346.

NOTE: The result of viewing the EnSite™ Cardiac Mapping System study on a standard DICOM viewer depends on the PACS
server configuration, and may be displayed as a blank screen. This behavior is expected and does not indicate an error in
storage.

Import EnSite™ Cardiac Mapping System Studies from a PACS Server

1. From the EnSite™ Cardiac Mapping System title screen, click on the Import icon to launch the EnSite™ Courier™ PACS
Module.
2. From the EnSite™ Courier™ PACS Module Retrieve Workflow Task Window, make sure that EPS modality is selected (check
mark displayed) and use the PACS Server drop-down menu to select the PACS server to query.

NOTE: Some PACS servers may not support EPS modality type and may modify that field when an EnSite™ Cardiac Mapping
System study is stored. If a query with EPS modality type checked does not return the expected EnSite™ Cardiac
Mapping System study in the query result, clear all modality checkboxes and try the query again.
3. Enter the search criteria to locate the study.
Refer to “Perform a Query” on page 338.
4. Select the study and click on [Import Study].

NOTE: If the PACS server supports Series level retrieval, select the series with Series Description “Precision Study Data.”

Figure 295. Importing EnSite™ Cardiac Mapping System study from PACS server.

5. If only one study is retrieved, the study will be imported; If multiple studies or multiple version of the same study are retrieved,
a study selection window will be displayed. Select the desired study, and then click on the [Continue . . .] button to import the
study to the EnSite™ Cardiac Mapping System.
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NOTE: Only one study can be imported at a time.

6. If the selected study already exists on the DWS, a warning will be displayed: This study already exists on the system. Overwrite?
Select [Yes] to replace the existing study with the newly-imported study.
7. When the import is complete, the Courier™ PACS Module exits.
8. To view the imported study from the EnSite™ Cardiac Mapping System title screen, select Past Studies.
For more information on reviewing a study, refer to the EnSite Precision™ Cardiac Mapping System Instructions for Use.

Display EnSite™ Cardiac Mapping System Study Screenshots

EnSite™ Cardiac Mapping System study screenshots are saved as a separate series within the study and can be retrieved independently
from the EnSite™ Cardiac Mapping System study. These screenshots can be viewed using any standard DICOM viewer.

View Screenshots from Standard DICOM Viewer

EnSite™ Cardiac Mapping System study screenshots can be retrieved by any standard DICOM Query and Retrieve application
connected to the PACS server and then displayed by any standard DICOM viewer. To retrieve the screenshots, simply retrieve the
series within an EnSite™ Cardiac Mapping System study with the Series Description, “Precision Study Images.”

NOTE: If series level retrieval is not supported by the PACS server, retrieve the entire EnSite™ Cardiac Mapping System study,
and select the proper screenshot series for display.

Troubleshooting

Courier Log
The Courier Log is used to troubleshoot communication related issues. Click the Courier Log icon on the EnSite™ Courier™ PACS
Module main window to display the Courier Log window.

A. Log Level – The Log Level determines the type of information that is included in the Courier Log. The following levels are
available:
– INFO – (default) User Operation (Query, Retrieve, Criteria, Operation Status).
– WARNING – General warning messages in addition to INFO.
– DEBUG – General debug messages in addition to INFO, WARNING
– TRACE – Trace messages in addition to INFO, WARNING, DEBUG.

The default Log Level is INFO. The Log Level may be set higher. However, in most cases DEBUG is sufficient to debug any
communication related issues. The log level will stay in effect until the EnSite™ Courier™ PACS Module is closed, or until it is
changed.

NOTE: Log messages may be truncated. Click on [Log History] to load the untruncated log entries.

B. MB – This text box may be used to specify the megabytes of log messages from the end of the file to load.

C. [Log History] – When the Courier Log window is displayed, only the tail of the log file is displayed. The user can load extra log
history by clicking [Log History].

D. [Clear Screen] – Click this button to clear the entire log text window.

E. [Refresh] – Click this button to load the newly added log entry to the log file.
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F. Close – Click the [Close] button to close the Courier Log window.

Query Failed
Follow these steps to troubleshoot a failed query:
1. Check that the Ethernet cable is properly connected. If it is not properly connected, connect the cable as shown in Figure 276 on
page 327.
2. Open the PACS Server Settings window by clicking the Settings icon on the EnSite™ Courier™ PACS Module main window,
and then select the PACS Servers tab.
3. Check that the Query/Retrieve checkbox has a checkmark selected.
4. Click [Test Connection] to verify the connection. If the connection is successful, skip steps 5 and 6.
5. Check that the AE Title, IP Address, and Port Number are correctly typed. If they are not correct, correctly type the parameters
and click [Test Connection] to verify the connection.
6. If the PACS server was moved, check with the PACS Administrator to verify that the AE Title, IP Address, and Port Number are
still valid. If they are not valid, correct the parameters and go to step 5.
7. Do a simple test query. If the test query is not successful, go to step 9.
8. Do the original query. If the original query is successful, stop here.
9. Increase the Log Level to DEBUG and perform the original query.
10. Call Technical Support to report the problem. Be sure to have logs available.

Retrieve Failed
1. Open the Courier Settings window by clicking the Courier Settings icon on the EnSite™ Courier™ PACS Module main window.
2. Have the PACS Administrator verify that the EnSite™ Cardiac Mapping System DWS is properly registered and that the AE
Title, Port Number, and IP Address are correct. If more than one EnSite™ Cardiac Mapping System DWS is in use, each must be
properly registered and have a unique AE Title.
3. Verify that the Timeout setting is sufficient and increase it if needed.
4. Have the PACS Administrator perform an echo test from the server to the DWS. Make sure that this operation is successful
before proceeding.
5. Check the Courier Log for the presence of disk IO error messages. If the error is not present, skip step 6.
6. Click on the Courier Settings icon and then click on [History Management] tab then click on Edit button and then click on
Delete Retrieval History button. At the prompt, Delete Retrieval History? select Yes.
7. Re-try the retrieve. If the retrieve is successful, stop here.
8. Re-start EnSite™ Courier™ PACS Module and re-try the retrieve. If the retrieve is successful, stop here.
9. Re-boot the DWS and the PACS server, and re-try the retrieve. If the retrieve is successful, stop here.
10. Increase the Log Level to DEBUG and perform the original retrieve.
11. Call Technical Support to report the problem. Be sure to have logs available.

Image Incompatibility
Follow these steps to troubleshoot an image incompatibility:
1. Follow steps 1 through 6 for “Retrieve Failed” on page 345.
2. Try retrieving a simple image. If the retrieve is successful, stop here.
3. Increase the Log Level to DEBUG and perform the retrieve tried in Step 2.
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4. Call Technical Support to report the problem. Be sure to have logs available.

Receive Failed
Check that Receive mode is enabled. If it is enabled, then disable and re-enable Receive mode. If the receive still fails, follow the
troubleshooting steps for “Retrieve Failed” on page 345.

Storage Failed
1. Check that Storage mode is enabled on the PACS Server Settings.
2. If a pre-processing error occurs, the disk space may be full. Follow step 6 of “Retrieve Failed” section to clean the disk and try
storage again.
3. If a transmission error occurs, follow steps 1 to 2 and steps 4 to 6 of “Query Failed” section.
4. Repeat the original storage. If it is successful, stop here.
5. Increase the Log Level to DEBUG and perform the original storage.
6. Call Technical Support to report the problem. Be sure to have logs available.

Storage Commitment Failed

1. Open the PACS Server Settings window by clicking the Courier Settings icon and then PACS Server tab on the EnSite™
Courier™ PACS Module main window.
2. Confirm that the Storage Commitment setting (SYNCHRONOUS, ASYNCHRONOUS, NOT SUPPORTED) matches the setting
on the PACS server.
3. If SYNCHRONOUS has been selected for Storage Commitment, confirm that the Port Number setting is registered correctly on
the PACS server.
4. If ASYNCHRONOUS has been selected for Storage Commitment, the EnSite™ Courier™ PACS Module does not time out
waiting for the PACS server response. Click on [Cancel] button on the Store in Progress bar to stop the storage operation.
5. The message Storage Commitment not attempted occurs when the Storage Commitment option on the PACS Server Settings
window is set to Not Supported.
6. The message Storage Commitment request failed occurs when the Storage Commitment request is rejected by the PACS server
or there is no response from the PACS server before timeout occurs. Try increasing the timeout.
7. If a Committed Partial error is received, contact the PACS Administrator for assistance.
8. If Storage Commitment continues to fail, collect log and call Technical Support to report the problem.
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Glossary APPENDIX A

3D – Three-dimensional.

ABL – Ablation.

Abstract Syntax – the information agreed to be exchanged between applications, generally equivalent to a Service/Object Pair (SOP)
Class. Examples: Verification SOP Class, Modality Worklist Information Model Find SOP Class, Computed Radiography Image
Storage SOP Class.

Accession Number – Sequential numbers assigned by imaging vendors as unique identifiers of an examination.

AE – see Application Entity.

Application Entity (AE) – an end point of a DICOM information exchange, including the DICOM network or media interface
software; i.e., the software that sends or receives DICOM information objects or messages. A single device may have multiple
Application Entities.

AE Title – see Application Entity Title.

Active Electrode – The electrode on the active EnGuide that is used for creating surfaces, placing labels, placing lesions, and
collecting points for maps.

Active EnGuide – The the catheter that is used for creating surfaces, placing labels, placing lesions, and collecting points for maps.

Active EnGuide Silhouette – A silhouette outline of the Active EnGuide where it resides inside the chamber of interest. The outline
takes on the color of the assigned Active EnGuide color.

Anatomic marker – A tool that is used to connect points on the surface of the model with lines.

Animations – Recorded segments from a study.

Application Context – the specification of the type of communication used between Application Entities. Example: DICOM network
protocol.

Application Entity Title (AE Title) – the externally known name of an Application Entity, used to identify a DICOM application to
other DICOM applications on the network.

AP – Anterior Posterior.

ArrayLink™ Module – Used to connect the EnSite™ Array™ Catheter and Data Module to the EnSite™ Amplifier.

Asynchronous – Asynchronous Storage Commitment is returned to the requestor in a different DICOM association than the one by
which the request was sent (see Synchronous).

Auto Segment – The system automatically records segments to periodically store study information. These automatically recorded
segments are added to the Notebook where they are identified as type Auto Segment.
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AutoFocus – A tool that automates the dithering of the Color High and Color Low values to highlight early focal activation or small
diastolic or pre-systolic potentials.

Bio Impedance Scaling – A feature that corrects for the slow drift of the EnSite™ NavX™ Navigation and Visualization Technology
positions caused by a change in the saline concentration within body fluids over the course of a study.

Bookmark – A feature that allows the system to return to a specific time in review mode.

Boundary emphasis – Segmentation technique used to sharpen the edges of a structure so that the computer can identify what the
user sees as boundaries.

Calipers – A tool that is used to measure and adjust timing between signal features in the waveform display.

Cardiac Triggered Maps – Maps that use a surface electrocardiogram or an intra-cardiac electrogram as the reference to which
collected points are measured.

CAT5e – Category 5 cable.

Catheter Catalog – A collection of predefined catheters that can be used in a study.

CathLink™ Module – Used to connect diagnostic catheters to the EnSite™ Amplifier.

CFE – Complex Fractionated Electrogram.

CFE Mean maps – Maps that provide a fractionation index based on the cycle length between multiple, discrete, local activations in
an electrogram.

CFE Standard Deviation map – A map that provides a fractionation index based on the cycle length between multiple, discrete, local
activations in an electrogram.

CIFS – Common Internet File System

CIM – Catheter input module.

CL – Cycle Length. Cardiac Cycle Length.

Clipping Plane – Clipping planes allow for a view of the interior and rear of the closed map by cutting a plane away from the viewing
space.

Color High – A specific map value to be displayed as purple.

Color Low – A specific map value to be displayed as white.

Coronal plane – Image plane that divides the body vertically into a front and back. Also called the frontal plane.

CT – Computed Tomography.

CT scan – Imaging technique that provides a 3D computer model of a patient’s anatomy. CT (computed tomography) scanners use
detectors rather than film to collect and digitize x-ray images. CT images are used to examine cross-sections (slices) of the heart from
all angles.

D3D – DIF three-dimensional.

Data Module – The Data Module is included in the EnSite™ Array™ Catheter Kit and the EnSite™ Surface Electrode Kit. It contains
an EEPROM that must be validated prior to the start of a study.

DHCP – see Dynamic Host Configuration Protocol.

DICOM – see Digital Imaging and Communications in Medicine.

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DICOM Header – a text based portion of a DICOM file that describes the image dimensions and other information about the scan.

DIF – Digital Image Fusion.

Digital Imaging and Communications in Medicine (DICOM) – an industry standard that facilitates interoperability of medical
imaging equipment.

Digital Image Fusion – A three-dimensional model created from digital images collected from Spiral CT or MRI scans.

Distal Length – The length of the distal electrode, which is located at the tip of the catheter.

DVI – Digital Visual Interface.

DWS – Display Workstation.

Dynamic Host Configuration Protocol (DHCP) – used to automatically assign IP addresses, deliver TCP/IP configuration
parameters (such as the subnet mask and default router) and provide other configuration information such as the addresses of time
servers. DICOM requires fixed IP addresses and the configuration of AE Titles at each individual device.

ECG – Electrocardiogram.

ECG electrodes – Patch electrodes on the patient's skin, used to collect extra-thoracic cardiac signals.

Electrode – A conductor which collects voltage signals from a patient.

Electrogram – A waveform which represents a voltage signal generated from a patient.

EEPROM – Electrically Erasable Programmable Read-Only Memory. Also referred to as a Data Module.

Electrode Spacing – The distance from the edges of the electrodes on a catheter (not the distance from the centers of the electrodes).

EnGuide Alignment – A tool used to manually adjust the alignment of EnGuides relative to the model.

EnGuide navigation system – Is used to display catheters and electrodes.

EnGuide Shadows – A three-dimensional historic image of an EnGuide position.

EnGuide – The display of an EP catheter in the map display.

Enhanced CT and MR images – This refers to the multi-frame image objects defined by the DICOM standard for CT and MR. The
new multi-frame image objects collect frames into a single file with a standard structured header. This reduces the data size and file
transfer overhead.

Enhanced DICOM Object – the new enhanced objects for MR, CT, XA and RF (radiography/fluoroscopy) accommodate new
developments and acquisition techniques. As an example, for MR, the image data will be exchanged not only as individual images,
but as multiframe objects. Multiframe objects are a convenient way to package all the pixel data of a complete acquisition in one
message (or envelope). The differences between the individual frames of the multiframe object, such as the frame-rate, are described
in the multiframe header.

EnSite™ Array™ Catheter – The entire catheter from the proximal handle to the distal tip. The stainless steel braid, with the 64
electrodes, which is supported by the inflated balloon in the cardiac chamber.

EnSite™ Amplifier – The EnSite™ Amplifier accepts signals from the EnSite Precision™ Link, Sensor Enabled™, NavLink™,
ArrayLink™, CathLink™, SJM ECG Cable, RecordConnect, and GenConnect, converts these signals to digital format, and sends
them to the DWS for processing. The EnSite™ Amplifier is connected to the DWS through a fiber optic cable.

EnSite™ Connect – A feature that enables an EnSite Precision™ Cardiac Mapping System Technical Support representative to
connect to an EnSite DWS through a broadband Internet connection.
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EnSite™ Connect™ Remote Service Module – a tool to perform remote technical support of the DWS.

EnSite™ Courier™ Module – The EnSite™ Courier™ Module is a software expansion module to the EnSite Precision™ Cardiac
Mapping System Software. It enables the EnSite Precision™ Cardiac Mapping System user to communicate with the hospital PACS
server for the purposes of storing and retrieving patient data in DICOM format.

EnSite™ NavX™ Navigation and Visualization Technology – The EnSite™ NavX™ Navigation and Visualization Technology
feature supports the tracking of EP Catheter locations from sensed potential on each axis of an orthogonal electric field generated by
body surface patches.

EnSite™ Verismo™ Segmentation Tool – a software utility used to convert large volumes of slice-based images into a manageable
3D model of cardiac structures.

EP – Electrophysiology.

EP catheter electrodes – The tip or ring electrodes on the shaft of an EP catheter which must be in contact with the endocardial wall
to collect good signals.

EPS – a DICOM modality type for basic cardiac electrophysiology, the specification for digitalized electrical signals from the patient
cardiac conduction system collected in the heart. EPS is the modality type used to store EnSite Precision™ Cardiac Mapping System
studies.

Field Scaling – A feature that provides patient-specific scaling of EnSite™ NavX™ Navigation and Visualization Technology
dimensions to allow for distance measurements in EnSite™ NavX™ Navigation and Visualization Technology studies.

Fly-Eye – In an EnSite™ Array™ study, the display is divided into 64 labeled frames containing EnSite™ Array™ Catheter traces.

F.O. cable – Fiber optic cable. The fiber optic cable provides the data connection between the The EnSite™ Amplifier and the DWS.

Ganged Signals – A group of signals in which a specific function is performed on all of them at once (e.g., a high pass filter setting
is set for all of the ECG signals simultaneously).

GenConnect – GenConnect is used to connect the ablation catheter and dispersive surface electrodes to the The EnSite™ Amplifier.

Highpass Filter – A filter that reduces low-frequency signals (i.e., repolarization signals) and baseline drift.

HR – Heart Rate.

Information Object Definition (IOD) – the specified set of Attributes that comprise a type of data object; does not represent a specific
instance of the data object, but rather a class of similar data objects that have the same properties. The Attributes may be specified as
Mandatory (Type 1), Required but possibly unknown (Type 2), or Optional (Type 3), and there may be conditions associated with the
use of an Attribute (Types 1C and 2C). Examples: MR Image IOD, CT Image IOD, Print Job IOD.

Intra-Cardiac Electrogram – An electrogram produced using catheters placed within the heart.

IOD – see Information Object Definition.

IP Address – a numerical label that is assigned to devices participating in a computer network that uses the Internet Protocol for
communication between its nodes. An IP address serves two principal functions: host or network interface identification and location
addressing. An IP Address can either be fixed or dynamic (see DHCP).

Isochronal Map – A map that shows the progression of activation through the first surface.

Isopotential Map – A map of voltages on the endocardial surface where similar voltages are represented by similar colors.

Labels – Markers that are used to identify points on the model.

LAO – Left Anterior Oblique.

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LAT – Local Activation Time.

LED – Light Emitting Diode.

Lesion – Markers that are used to identify ablation points on the model.

Local Activation Time (LAT) Isochronal Map – A map that shows color-coded activation times for each collected location (or nearest
surface).

Local Activation Time – The difference in milliseconds between detected activation on the roving waveform and the reference
waveform.

Lowpass Filter – A filter that reduces high-frequency signals commonly caused by electronic interference.

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

Model – The geometric surface model which describes the size, shape, and orientation of a heart chamber in relation to the EnSite™
Array™ Catheter and including the location of the EnSite™ Array™ Catheter or EnSite Precision™ surface electrodes and any EP
catheter electrodes with location signals.

MRI – Magnetic Resonance Imaging.

MRI Scan – Imaging technique that uses magnetic signals rather than x-rays to provide a 3D model of the patient’s anatomy. MRI
(magnetic resonance imaging) is based on the absorption and emission of radiowave pulses of energy. MRI images are used to examine
cross-sections (slices) of the heart from all angles.

Navigation Accuracy – The error in navigating a catheter back to a defined location.

NavLink™ Module – Used to connect EnSite™ surface electrodes and the system reference surface electrode to the The EnSite™
Amplifier.

Negotiation – first phase of Association establishment that allows Application Entities to agree on the types of data to be exchanged
and how that data will be encoded.

NFS – Network File System

Noise Filter – A notch filter that reduces powerline noise.

Non-Cardiac Triggered Maps – Maps that are created by collecting points at one second intervals.

Non-Contact Map – A map that is created with the EnSite™ Array™ Catheter.

Notebook – A feature that allows recorded data and study information to be filed and annotated for future access.

Offline Review – An operating mode in which data from a previous study is viewed and edited. The EnSite™ Amplifier does not need
to be connected or powered on.

Omnidirectional Polarity – The voltage is an arithmetic combination of unipolar measurements between the source of interest, a
specific electrode, and 4 or more other sources from equally spaced directions surrounding this electrode.

OneMap Tool – A tool that is used to simultaneously create a model and a map.

OneModel Tool – Default type for model creation. The OneModel tool wraps the model surface tightly around collected points
without tying back to a center point and may provide enhanced anatomic detail of the cardiac model.
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Orientation Reference – A torso-shaped icon in the upper right of a map that indicates the current orientation of the map by rotating
as the map rotates.

Orthogonal – Intersecting or lying at right angles. The axes of scanned orthogonal images are perpendicular to each other and to the
coronal (frontal), transverse (horizontal), and sagittal (medial) planes of the body.

PACS – see Picture Archiving and Communication Systems.

PDU – see Protocol Data Unit.

Picture Archiving and Communication System (PACS) – an electronic and ideally filmless information system for acquiring,
sorting, transporting, storing, and electronically displaying medical images.

P-Neg – Peak Negative.

P-P – Peak-to-Peak.

Past Study – A study that was completed and recorded.

Peak-Negative (P-Neg) Voltage Map – A map that displays color-coded voltage values for each collected location (or nearest
surface).

Peak-to-Peak (P-P) Voltage Map – A map that displays color-coded voltage values for each collected location (or nearest surface).

Perspective View – A feature that allows the field of view, or perspective of the model, to be changed to increase the understanding
of the model, the position of the catheters and/or the identification of points of interest.

Pixel – Smallest distinguishable element of a digital image. See also voxel.

Polarity – A voltage is the difference between positive and negative poles. The polarity defines these poles.

Port Number – a numerical identifier for the data structures of the endpoints for host-to-host communications.

Positional Reference – An electrode that will remain stable during an EnSite™ NavX™ Navigation and Visualization Technology
study. The displayed position of all electrodes is relative to the location of the positional reference.

Presentation Context – the set of DICOM network services used over an Association, as negotiated between Application Entities;
includes Abstract Syntaxes and Transfer Syntaxes.

Presets – Store setting preferences for catheters, models, and maps.

Protocol Data Unit (PDU) – a packet (piece) of a DICOM message sent across the network. Devices must specify the maximum size
packet they can receive for DICOM messages.

Proximal Electrode – Any catheter electrode other than the distal electrode.

Proximity Indicator – Represents the position of the Active Electrode. The position of the indicator is size scaled based upon the
distance from the Active Electrode to the closest surface. The proximity indicator is drawn on the surface as a colored translucent spot,
matching the color of the Active Electrode.

Query / Retrieve – DICOM Query/Retrieve allows for querying a database from an archive, workstation, or other device for the
information it has available. It also allows for the retrieval (“pull”) of those objects, such as images.

R Value – The distance in millimeters from the center of the electrode array on the EnSite™ Array™ Catheter to the Active Electrode.

RAO – Right Anterior Oblique.

RealReview – A task in which recorded segments can be viewed.

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Realtime mode – An operating mode in which data is gathered, displayed, and recorded simultaneously while a patient is being
studied. Patient connections to the EnSite™ Amplifier are required, and the EnSite™ Amplifier must be powered on.

RecordConnect – RecordConnect is used to connect a recording system to the The EnSite™ Amplifier. A different RecordConnect
model is required for each make of recording system.

Reference Signal – The reference signal monitors a specific voltage point, based on the detection algorithm, of a specific waveform
to aid in the collection of activation data.

Render – To translate and regenerate an image. In the EnSite™ Verismo™ Segmentation Tool, heart structures are isolated from a
volume of scanned images and rendered for 3D visualization.

Resolution – Minimum distance at which two adjacent objects can be distinguished as separate.

Respiration Compensation – A feature that is used to compensate for catheter movement caused by a patient's breathing.

Respiration Meter – A meter that shows the current level of respiration, as computed by the relative impedance on the EnSite™
surface electrodes.

Respiration Rejection – A feature that is used to suspend model point collection and labeling functions when the patient's respiration
falls outside of a percentage of the Respiration Compensation range.

RF – Radio Frequency.

Rotational Angiography (RA) – A type of X-ray angiography where a series of images is acquired while the RA modality C-arm
performs a continuous rotation around the region of interest.

Roving Activation Interval – A timing parameter that is used in the detection of roving catheter activation.

Roving Signal – The roving signal is used for sampling local activation times (relative to the timing reference signal) and voltages
from various locations in the heart.

Sagittal plane – Image plane that divides the body into a right and left half. Also called medial plane.

Saturated Waveform – When a signal amplitude has reached its maximum value.

Saturation Recovery – A feature that allows for the quick recovery of signals to facilitate identification of post-therapy complexes.

SCP – see Service Class Provider.

SCU – see Service Class User.

Seed point – Reference point used by the EnSite™ Verismo™ Segmentation Tool to identify the heart structure of interest.

Segment – A recorded part of a study.

Segmentation – In digital image analysis, segmentation is the process of isolating the object of interest (foreground) from the rest of
the objects in the image (background).

Service Class Provider (SCP) – role of an Application Entity that provides a DICOM network service; typically, a server that
performs operations requested by another Application Entity (Service Class User). Examples: Picture Archiving and Communication
System (image storage SCP, and image query/retrieve SCP), Radiology Information System (modality worklist SCP).

Service Class User (SCU) – role of an Application Entity that uses a DICOM network service; typically, a client. Examples: imaging
modality (image storage SCU, and modality worklist SCU), imaging workstation (image query/retrieve SCU).
 Glossary EnSite Precision™ Cardiac Mapping System Instructions for Use
354 ARTEN600004505 Rev. B

Service/Object Pair (SOP) Class – the specification of the network or media transfer (service) of a particular type of data (object);
the fundamental unit of DICOM interoperability specification. Examples: Ultrasound Image Storage Service, Basic Grayscale Print
Management.

Service/Object Pair (SOP) Instance – an information object; a specific occurrence of information exchanged in a SOP Class.
Examples: a specific x-ray image.

Setup task – The task used to define the catheters used in a study.

SJM™ – St. Jude Medical.

SMB – Server Message Block

SM – Substrate Map.

SOP – see Service/Object Pair (SOP) Class and Service/Object Pair (SOP) Instance.

Spatial Filter – A filter that optimizes signals based on the placement of the EnSite™ Array™ Catheter.

Stabilize ABL – Stabilize ABL corrects the location of the distal electrode based on the properties of the catheter. ABL electrodes 2,
3, and 4 need to be displayed for Stabilize ABL to be enabled.

WARNING: Do not use Stabilize ABL in situations where electrodes 2, 3, or 4, on the ablation catheter, are covered by a sheath.

NOTE: If Stabilize ABL is enabled and the display of electrodes 2, 3, or 4 is turned off, Stabilize ABL is disabled and a message
displays to alert the user.

NOTE: If multiple ablation catheters are setup, Stabilize ABL is applied to each catheter independently and only when
appropriate.

NOTE: If Stabilize ABL is enabled for the catheter, NavX points cannot be collected.

Static Map – A map which is created by performing computations on a number of isopotential maps (e.g., an isochronal map).

Std Dev – Standard Deviation.

Storage Commitment – The DICOM storage commitment service is used by the modality or workstation to confirm that an image
has been permanently stored by a device, usually a server and/or archive station, and it is safe to delete the images locally.

Study – A medical session occurring in a single day, where EP procedures are performed on a patient.

Substrate map – A map that shows relative peak-negative unipolar voltage over a user-specified beat throughout the chamber.

Surface Proximity Distance – The distance from the Active Electrode to the model or DIF surface.

Sweep Speed – The number of mm/sec in the waveform display (time scale).

Synchronous – Synchronous Storage Commitment is returned using the same DICOM association (a DICOM communication
session) as the one by which the Storage Commitment request was sent (see Asynchronous).

System Reference Surface Electrode – A surface electrode that is required for proper system operation for both EnSite™ Array™
and EnSite™ NavX™ Navigation and Visualization Technology studies. The system reference surface electrode connects to the
NavLink™ Module.

Tape Measure – A tool that is used to measure the distance between points on the model of the endocardial surface.

Threshold – A voltage level at which an event is detected.

EnSite Precision™ Cardiac Mapping System Instructions for Use Glossary
ARTEN600004505 Rev. B 355

Thresholding – Segmentation technique that uses intensity values to distinguish between the foreground and background objects of
a digital image. The intensity threshold is chosen from a histogram of intensity values for the image.

Time Cursor – A vertical yellow line in the waveform display that indicates the time represented by the map display.

Traces – Waveforms.

Tracking Accuracy – The error between an induced catheter displacement and the corresponding measured displacement.

Tracking Virtual – A tool that is used to locate and interpret the Peak-Negative location in the chamber of interest.

Transfer Syntax – the encoding used for exchange of DICOM information objects and messages. Examples: JPEG compressed
(images), Little Endian explicit value representation.

Transverse Plane – Image plane that divides the body into upper and lower portions. The transverse plane is perpendicular to the
coronal and sagittal planes. Also called horizontal plane, axial plane, or transaxial plane.

Trigger Event – The detection event plus a user selectable time offset.

Triggering – To 'phase lock' both the waveform and the map displays, providing a view of the data which is synchronized with each
triggering event. Thus, when the triggering event is a heartbeat the waveforms and maps shall be repeatedly displayed, frozen at the
same point in time of each heart cycle.

Unipolar Reference – The signal return path for unipolar diagnostic catheter and EnSite™ Array™ Catheter signals.

UID – see Unique Identifier.

Unique Identifier (UID) – a globally unique “dotted decimal” string that identifies a specific object or a class of objects; an ISO-8824
Object Identifier. Examples: Study Instance UID, SOP Class UID, SOP Instance UID.

Velocity Filter – A feature that prevents model point collection during rapid catheter movements.

Velocity meter – A meter that shows the relative velocity of the Active Electrode (blue bar) and the velocity threshold (purple bar).

Verismo – A software utility used to convert large volumes of sliced-based images into a manageable 3D model of anatomic
structures.

Virtual Electrogram – An electrogram from a selected site on the endocardium computed from map potentials over the specified
timeframe

Virtuals – See virtual electrogram.

Virtual Electrode – A simulated electrode.

Virtual Waveform – A waveform based on simulated electrodes placed on the map display.

Voltage Caliper – A tool that displays the measured potential at the distal signal of the Active Electrode.

Volume – Set of cross sectional images obtained when scanned slices are stacked in computer memory. A volume or volumetric data
set is based on inter-pixel and inter-slice distances that represent a real-world volume.

Voxel – Short for volume and pixel. A voxel is a pixel with depth, thus it is the smallest distinguishable volume element of a digital
image. See also pixel.

Waveform – A representation on the screen of all the data from a signal within a defined timeframe where time moves from left to
right and the height of the waveform represents the amplitude of the signal.

Waveform Display – The area on the screen in which waveforms are displayed.
 Glossary EnSite Precision™ Cardiac Mapping System Instructions for Use
356 ARTEN600004505 Rev. B

Z Value – The distance in millimeters of the Active Electrode above or below the equator of the electrode array on the EnSite™
Array™ Catheter.

XA – X-ray angiography images.

EnSite Precision™ Cardiac Mapping System Instructions for Use
ARTEN600004505 Rev. B 357

Index APPENDIX B

Numerics compatible components 27

3D Annotation operating environment 27
power source 27
Mapping Control Panel 207
bookmarks
3D Labels
Mapping Control Panel 207 saving 48
boundary emphasis 307, 309, 311, 312, 313
3D Lesion Marker at EnGuide 220
3D Points
Mapping Control Panel 207 C
cables
A icons on connectors 62
inspection and damage 24
ABL Distal Stabilize 172
ablation catheter calipers
creating 165
connecting to GenConnect 78
Reference Activation Caliper 210
about EnSite menu 322
Add a Caliper 33 Roving Activation Caliper 211
using 165
Adding a Catheter to a Study 121
Voltage High Caliper 211
All Roving Waves 212
Amplifier Connections 51 Voltage Low Caliper 211
Cancel - segmentation tool 307
Amplitude 212, 214
Cardiac Triggered Mapping Settings 206
Anatomic Markers 179
anatomic markers cardiac triggered maps 202
Cardiac Triggered Reference
description 18, 179
Mapping Control Panel 206
placing 180
selecting and modifying 181 Catheter Catalog
adding a catheter 126
animations
deleting a catheter 126
creating and exporting 237
AP view 174 description 16, 125
sorting 126
Archiving Media 241
Catheter Input Settings 125
Archiving Studies 240
ArrayLink Catheter Preset
Deleting or Renaming a Catheter Preset. 127
connecting the EnSite Array Catheter 80
Loading 127
description 53
Arrow 33 catheter presets
deleting 127
Auto Color
description 126
Mapping Control Panel 208
auto segment 167 loading 127
renaming 127
AutoFocus
saving 127
feature description 17
methodology 194 catheters
adding to a study 121
settings 195
loading a preset 123
using to adjust color levels 194
Avenview Video Extender 59 manually defining 122
selecting from the catheter catalog 122
settings 125
B verifying catheter stability 185
Bad Dircos 323 CathLink
barrier 309, 311, 315 description 54
Barrier - segmentation tool 307 cautions 23
Best Duplicate 37 CD/DVD drive
best practices and recommendations using 235
 Index EnSite Precision™ Cardiac Mapping System Instructions for Use
358 ARTEN600004505 Rev. B

CFE mean maps 202 Data

chamber 311 export 238
Chamber - segmentation tool 307 Waveform 238
Cleanup Display 33 data
clear segmentation result 304 export 16
Clinical Menu 111 storage 16
Clipping Plane data module
description 16 validating 118
clipping plane Delayed Enhancement Magnetic Resonance Imaging (DEMRI) 16
description 170 Delete 214
clock Verismo 307
setting 258 Delete All
collect log files 322 Verismo 307
Collect Points 152 Delete Group 214
Collected point buffer 211 Delete Hidden Points 214
Collecting Respiration Data 137 Delete last 214
Collecting Surface Points 151 Delete Unused Points 214
Color 219 Delete Unused Points. 214
color 308 Deleting a Catheter from the Catheter Catalog 126
Color bar 210 DEMRI (Delayed Enhancement MRI) 16
color bar DEMRI (Delayed Enhancement MRI) Image Integration 161
adjusting manually 194 Diameter 219
adjusting using AutoFocus 194 DICOM conformance 298
interpreting 193 digital image
Color Contour 171 importing 159
comments 319 Digital Image Fusion (DIF) 159
Common Interface Elements 36 displaying DIF models 160
Compatible Components 28 feature description 16
Compatible Modules 28 Digital Image Infusion map (DIF Map) 16
components Directory Name 238
recommendations 27 disk handling 25
connection diagram 22 display 308
Connections Display Settings 33
ArrayLink™ Module 53 Display Workstation (DWS) 19
Auxiliary Unipolar Reference 81 Display WorkStation (DWS) Connections 22
Auxiliary unipolar reference 81 Dual View 39
Avenview Video Extender 59 Duplicate Points 213
CathLink™ Module 54
Diagnostic Catheters 79
ECG Surface Electrodes 75 E
EnSite™ Amplifier 62 ECG
EnSite™ Array™ Catheter 80 setting signal parameters 117
Field Frame 66 troubleshooting 252
GenConnect 56 ECG Cable
NavLink™ Module 53 cable connections 54
Opticis Video Extender 57 description, system components 19
Patient Reference Sensors (PRS) 64 ECG surface electrodes
Precision™ Field Frame 52 connecting 75
Precision™ Link, Sensor Enabled™ 52 Edit Points 152
RecordConnect 55 Electrode Polarity 213
Remote Monitor 57 Enable and Baseline the Catheter 128
RF Ablation Catheter and Generator 78 ending a study 233
SJM ECG Cable 54 EnGuide
Surface Electrodes 72 Alignment 140
System Reference Surface Electrode 63 Catheter Silhouette 172
contiguous 3D 316 color navigation indicators 145
contour viewer 319 display settings 172
Contraindications interpreting R value and Z value 144
Verismo 298 proximity indicator 144
Controls 31 Responsiveness 172
create barrier 315 surface proximity distance 144
Current Map Type EnGuide Displays 33
Mapping Control Panel 206 EnGuide Navigation Indicators 145
EnGuide Navigation System 143
EnGuide Responsiveness 144
D EnGuide Shadow 33
Dashed line 213 EnGuide Shadows
EnSite Precision™ Cardiac Mapping System Instructions for Use Index
ARTEN600004505 Rev. B 359

placing 183 G
selecting and modifying 184
GantryTilt 323
EnGuide Stability Monitor 16, 139
GenConnect
EnSite Amplifier connecting an ablation catheter 78
connecting cables to 62
description 56
connecting the fiber-optic cable 56
global virtuals
description 51 using to locate focal activation 192
powering on 107
Gray Scale 169
EnSite Array
growth limit 312
fly-eye display 130
EnSite Array Catheter
connecting to ArrayLink 80 H
EnSite Array Kit hard drive
description 20 out of space, troubleshooting 251
EnSite Precision™ Module, Sensor Enabled™ 19 Head
EnSite Surface Electrodes Interpreting Isopotential Color 193
connecting to NavLink 74 Hide point checkbox 213
positioning on patient 72 highpass filter
EnSite™ Amplifier 19 description 141
EnSite™ Array™ Catheter Setup 130 Home 211, 213
EnSite™ Cardiac Mapping System Hot key
Diagram 21 214
EnSite™ NavX™ Navigation and Visualization Technology Study without
RecordConnect 90
EnSite™ NavX™ Navigation and Visualization Technology, Sensor En- I
abled™ Field Scaling (NavX SE) 157 images
EnSite™ NavX™ Navigation and Visualization Technology, Sensor En- saving and accessing 236
abled™ Setup 132 Impedance and Magnetic Data 146
EnSite™ NavX™ Navigation and Visualization Technology, Sensor En- Imported DEMRI Image 161
abled™ Study with RecordConnect 93 Importing Studies 242
EnSite™ NavX™ SE Points 146 Indications for Use
Environmental conditions 274 EnSite Cardiac Mapping System 15
EP catheter setup 119 EnSite Derexi 289
export EnSite Fusion 279
data 16 EnSite Verismo 297
Verismo models to DVD/CD 319 information display settings 173
Export Interval Options 238 Interior Projection
Export to USB fails 235 Mapping Control Panel 207
Exporting 239 Interpolation
Exporting Data to External Devices 235 Mapping Control Panel 207
Interpreting Isopotential Color 193
IRREGULAR_SPACING 323
F Isochronal Mapping 199
fiber-optic cable Isochronal maps
connecting to the EnSite Amplifier 56 creating 200
Field Scaling 16, 156 description 189
field scaling LAT 202
applying 157, 158 methodology 199
filtering 302 Single-Beat 17
filters Isopotential maps
highpass 141 description 189
lowpass 141 interpreting 190
noise 141
spatial 141
First Deflection 16 L
Flash New Points lab
Mapping Control Panel 207 EnSite Precision™ Cardiac Mapping System setup 21
fly-eye display setup 21
description 130 Label 33
font size 317, 318 Label - segmentation tool 307
Fractionation Threshold Label Colors 179
Mapping Control Panel 206 labels
Freeze description 177
display button 211 placing 177
LAO view 174
Laplacian 191
Laplacian bipole
 Index EnSite Precision™ Cardiac Mapping System Instructions for Use
360 ARTEN600004505 Rev. B

polarity type 191 LAT maps 202

Last Deflection 17 managing 218
Last Duplicate 37 non-cardiac triggered maps 202
LAT maps 202 P-Neg voltage maps 202
Lesion 33 points display 213
Lesion at EnGuide 220 P-P voltage maps 202
Lesion control panel 223 propagation maps 205
Lesion List 220 reentrant maps 205
Lesion list 222 reference signal 203
Lesion Marker Tool 219 roving signal 203
Lesion Markers 220 types of maps 202
lesions waveform shadows 212
control panel 223 maps (noncontact)
description 220 Isochronal maps 189
list 222 Isopotential maps 189, 190
placing 221 Substrate maps 189, 196
selecting and modifying 222 types 189
Licenses max threshold 309, 311, 312
Installing 263 measure
load work in progress 304, 320 distance 318
local region grow 309 segmentation tool 307
lock, a structure, Verismo 308 measuring volumes 318
log files 322 Menu Bar
collecting and exporting 245 EnSite Cardiac Mapping System 31
Logging In 109 menu bar 304
lowpass filter Messages
description 141 System 46
Low-V ID Metal Distortion and Distortion Meter 139
Mapping Control Panel 206 Metal Distortion Meter 17
Low-VID 16 Meter Displays 33
min threshold 309, 311, 312
model
M creating multiple surfaces 152
Magnifying Glass 33 presets 148
Main Workspace Elements 30 using the surface list 155
maintenance viewer window, Verismo 319
customer-performed 259 Model Control Panel 150
Field Service Representative Performed 262 Model Presets 148
Managing Positional Reference Catheter Dislodgement 136 monitors
manual segmentation 314 connecting the remote monitor to the workstation 57
map clipping 170 description 19
map color mouse
interpreting 190 using 34
Map Display moving points on a model 153
Mapping Control Panel 206 MultiPoint Technology 16
map display menu 171
Map Name
Mapping Control Panel 206 N
Map point measurement 214 navigation
Map Settings Properties 171 warnings and cautions 24
Mapping Control Panel Settings 37 NavLink
Maps connecting a system reference surface electrode 63
Placing a Map Label 177 connecting a unipolar reference 81
Translucence 176 connecting EnSite surface electrodes 72
maps description 53
panning 35 NavLink™ Module 19
zooming 35 Network File System (NFS) versions prior to NFSv3 235
Maps -- Centering 176 new study
Maps -- Synchronize Dualviews 176 existing patient 114
maps (contact) new patient 113
cardiac triggered maps 202 operation overview 101
CFE mean maps 202 preparing for 87
CFE standard deviation maps 202 noise
collecting points 210, 216 reducing 252
control panel 206 noise filter
controlling the display 218 description 141
creating 216 noise floor
EnSite Precision™ Cardiac Mapping System Instructions for Use Index
ARTEN600004505 Rev. B 361

See upper limit Presets

Non-Cardiac Triggered CFE Maps 204 Export 239
Non-Cardiac Triggered Mapping Settings 209 Export configuration 239
NOT_3D 323 Load, Save 49
Notebook 47 presets
Number of points 214 model 148
print
Verismo menu bar 304
O Verismo options 322
OneMap progress bar 301, 303
control panel 215 Project Map to
description 215 Mapping Control Panel 206
OneModel Tool 154 propagate 314
operating environment propagation maps 205
recommendations 27 Properties 220
operator 319 proximity indicator 144
Opticis Video Extender 57 proximity to surface 173
orientation reference
displaying 174
owner information R
setting 258 R value 144
RAI Curtain 210
RAO view 174
P RealReview task
pan 305 annotations 226
Panning 214 bookmark 226
panning maps 35 images 226
password 109 lists and controls 226
Past Studies 115 screen 225
past study Realtime mode 29
reviewing 228 Reassign - segmentation tool 307
patient records Reassign Tool, Verismo 316
creating 113 reassigning points on a model 153
managing 230 RecordConnect
modifying 230 description 55
removing 231 recording
searching for 230 feature description 18
Patient Reference Sensor Patches 20 recording segments 167
Placement 64 Recording System 82
Patient Reference Sensors recording system
Patch Removal 64 using 82
Placement diagram 65 Redo
patient safety requirements 23 Verismo 307
pattern reentrant maps 205
types for virtual electrodes 191 Reference Activation Caliper 210
perspective view 176 Reference Offset Caliper 211
playing recorded segments 168 Reference Shadows 212
P-Neg voltage maps 202 reference signal
Point Display 148 detection algorithm 203
Point Pairs 148 setting 203
Points 211 Refractory 204
Points display 213 Refractory slider (CFE maps only) 209
Points list 211 region grow 309
Points/Labels Region Grow - segmentation tool 307
Mapping Control Panel 207 remote monitor
polarity connecting to the workstation 57
types for virtual waveforms 191 Remote Monitor Configuration Tool 61
Positional Reference Catheter Dislodgement 135 Replacement Parts 262
Positional Reference Tool 132 Respiration Compensation 137
power source respiration compensation
recommendations 27 collecting 137
specifications 274 definition 137
powerline frequency feature description 17
setting 258 respiration meter 139
P-P voltage maps 202 respiration rejection 138
Preparing for a Study 87 Respiration Gating 147
Preparing for an EnSite™ Array™ Catheter Study 101 respiration meter 17
 Index EnSite Precision™ Cardiac Mapping System Instructions for Use
362 ARTEN600004505 Rev. B

description 139 Mapping Control Panel 207

respiration rejection 17 Show Torso 176
description 138 shutting down
resuming a study 115 end of study procedure 233
review speed Signal Filters 141
adjusting 168 SJM Connect 246
reviewing past studies 228 Connect Window 246
RF filtering description 246
description 17 File Browser 248
Rot### 323 Proxy configuration 249
Rotate/Pan 33 Technical Support Chat Window 247
rotating 306 Updoading Studies 248
roving activation interval Uploading Logs 248
description 210 Using 246
Roving Activation Tic Mark 211 slice view 301, 303
Roving Shadows 212 Software Inventory Screen 269
roving signal Solid, bold with blue background 214
detection algorithm 203 Sort 213
setting 203 Sort Options
run external program 245 collected map points 18
Sorting the Catheter Catalog 126
Sparkle Map
S description 18
Saturation Recovery 140 SparkleMap
saturation recovery view activation sequence 205
description 18, 140 spatial filter
setting the controls 140 description 141
Save Split Screen 40
data after freeze 211 Stabilize ABL 18
save work in progress 304, 320 Starting a New Study
Saving Existing Patient 114
Catheter Preset 127 New Patient 113
saving Starting the System 107
key points 319 stop button
Scope 211, 213 using 167
Screen Layout storage
Controls 42 data 16
Presets 43 structure
Segment Length slider (CFE maps only) 209 list 308
segmentation interface 303 name 308
segments structure list
accessing 168 Segmentation Interface 303
automatically recorded 167 study
playing 168 ending 233
recording 167 study records
Selecting a Language deleting a study 231
Keyboard 108 managing 231
Screen 108 modifying 231
Selecting an Area for Capture 235 Substrate Map
Selecting and Modifying Labels 178 Creating 198
separator 313 Substrate Mapping 196
Separator - segmentation tool 307 Substrate maps
series 301 absolute 197
service creating 196
contacting technical support 257 description 189
Services Menu 112 global 197
Setting Up the Positional Reference Tool 134 Surface Electrode Placement 73
settings Surface Electrode Placement Order 74
EnGuide display 172 Surface Electrodes 20
information display 173 Surface Points
map properties 171, 286 Mapping Control Panel 207
setup surface proximity distance 144
lab 21 Sweep Speed 212
Sheath Filter Setup 128 synchronizing viewports 176
Show Mapping Metric system
Mapping Control Panel 208 components 19
Show Selected Points Only
EnSite Precision™ Cardiac Mapping System Instructions for Use Index
ARTEN600004505 Rev. B 363

description 15 username 109

features 16
moving 263
starting 107 V
system diagram 21 Validation 118
system reference surface electrode validation
description 20 description 118
Valleylab™ Single Use Patient Return Electrode 20
velocity filter 145
T Velocity Meter 145
Tape Measure 33 velocity meter 145
tape measures Verifying ECG Signal Quality 118
description 17, 186 Verismo file cleanup 323
measuring distance, Verismo 318 vessel 312
placing 187 Vessel - segmentation tool 307
selecting and modifying 188 video extender
technical specifications 273 description 19
Technical support viewports
Contacting 245 synchronizing 176
templates 306 views
The Surface List 155 creating and saving 175
Therapy Display 220 Views and Orientation Reference 174
Therapy task 219 virtual electrodes
thresholding 307 number of and pattern 191
time cursor Virtual Waveforms 191
adjusting 163 Placing 192
using in review 168 Using the Tracking Virtual 196
Time Interval 211 virtual waveforms
Time scale 210, 213 feature description 17
Timing Caliper 211 Virtuals 33
Timing caliper 214 Voltage High Caliper 211
Title Screen 109, 110 Voltage Low Caliper 211
To place a lesion marker volume, selecting 301
221
Torso Rotate 35
trace 314 W
Trace - segmentation tool 307 W/L 306
traces Warnings and Precautions
displaying and filtering 165 EnSite Cardiac Mapping System 23
Translucence 176 Verismo 298
troubleshooting 322 warranty 271
common problems 250 Waveform Display 34
contacting technical support 245 Waveform number 213
EnGuide Stability Problems 253 waveform traces
Magnetic Tracking Problems 255 description 18
on-screen messages 256 waveforms
patient signal problems 252 adjusting amplitude 164
print 251 basic controls 164
software interface problems 255 display features 163
system hardware problems 250 indicators 214
tools 245 mouse controls for 164
troubleshooting guide 245 moving 35
TurboMap 18 rearranging traces 164
removing from display 35, 164
selecting 35
U shadows 212
undefined 308 traces turn purple 163
Undo Width 204, 207
Verismo 307 Width slider (CFE maps only) 209
Unipole Waves 212 Window/Level 306
Unsupported orientation 323 Workspace
usability indicator 323 EnSite Cardiac Mapping System 30
USB device FAT32 file systems 235 workstation
Use Best Duplicate powering on 107
Mapping Control Panel 207 unexpected shutdown 251
Use Last Duplicate
Mapping Control Panel 207
 Index EnSite Precision™ Cardiac Mapping System Instructions for Use
364 ARTEN600004505 Rev. B

Z
Z value 144
zoom 305
zooming maps 35