CARTO 3 System Instructions for Use sw ver 6.0.80 June 2021

© 2008 - 2019 by Biosense Webster, Inc. All rights reserved.

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

NOTE Any serious incident that has occurred due to, or during, the use of the product described herein should be reported to Biosense Webster. In Europe a report should also be made to the competent authority of the Member State in which the user and/or patient is established.

Third-party trademarks used herein are trademarks of their respective owners. For Biosense Webster patent information, see: http://www.biosensewebster.com/virtualpatentmarking

Some pictures of the workstation are provided courtesy of Dell Computer Corporation, ©Dell Computer Corporation 2007. Open Source Computer Vision Library The following statement is required for our use of the Open Source Computer Vision Library in the CARTO® 3 System. Copyright © 2000-2008, Intel Corporation, all rights reserved. Copyright © 2008-2010, Willow Garage Inc., all rights reserved. Third party copyrights are property of their respective owners. Redistribution and use in source and binary forms, with or without modification, are permitted provided that the following conditions are met: • Redistribution of source code must retain the above copyright notice, this list of conditions and the following disclaimer. • Redistribution in binary form must reproduce the above copyright notice, this list of conditions and the following disclaimer in the documentation and/or other materials provided with the distribution. • The names of the copyright holders may not be used to endorse or promote products derived from this software without specific prior written permission. P.N.: UG-5400-006H (06A) 3 June 2021

TABLE OF CONTENTS

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TABLE OF CONTENTS About the CARTO® 3 System ... 1 System Foundations ... 2 System Components ... 2 Initial Installation ... 3 Typical Setup ... 3 Important Information for Experienced CARTO® XP System Users ... 4 Viewing CARTO® XP Studies ... 4 Modules and Optional Features ... 4 ACCURESP™ Module ... 4 CARTOMERGE® Image Integration Module ... 4 CARTOSEG™ Segmentation Modules ... 5 CARTOREPLAY™ Module... 5 CARTOSOUND® Image Integration Module ... 5 CARTOUNIVU™ Module... 5 CARTO® 3 System-Complex Fractionated Atrial Electrogram (CFAE) Module ... 5 CONFIDENSE™ Module ... 6 FAM Dx ... 6 HD Coloring ... 6 PASO™ Module ... 6 CARTO® 3 System with RMT Module ... 7 CARTO® 3 System with CARTO SMARTTOUCH™ Module ... 7 CARTO VISITAG™ Module... 7 VISITAG SURPOINT™ Module ... 7 CARTO VIZIGO™ Software ... 7 Viewing System Information ... 7 Cautions, Warnings, and Other Types of Notes ... 8 Safety Information ... 9 System Setup Standards ... 10 Patient Indications ... 10 Qualified Users and Training ... 10 Warnings ... 11 General ... 11 Physical Setup ... 12 Preventing Fire, Explosion, and Electrical Shock ... 12 Defibrillation ... 13 Location Accuracy ... 13 CARTO® 3 System Interference with Other Medical Equipment ... 14 Safety for Modules and Optional Features ... 15 CARTOMERGE® Module ... 15 CARTOSEG™ Segmentation Modules ... 15 CARTOSOUND® Module ... 16 CARTOUNIVU™ Module... 16 CFAE Module ... 17 PASO™ Module ... 17 RMT Module ... 17 CARTO SMARTTOUCH™ Module ... 17 CARTO VISITAG™ Module... 18 CARTO VIZIGO™ Software ... 18 UG-5400-006H (06A)

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TABLE OF CONTENTS Servicing ... 18 Electromagnetic Compatibility (EMC) ... 18 Legend to Accompanying Labels ... 24 External Product Labels ... 26 Standards Compliance and Classifications ... 28 System Hardware ... 29 System Specifications ... 30 Component Dimensions ... 30 Power Consumption ... 30 Applied Current ... 31 System Input Impedance ... 31 Environmental Conditions ... 31 CARTO® 3 System Components ... 32 Patient Interface Unit (PIU) ... 32 Location Pad (LP) ... 39 Back and Chest Patches ... 40 Workstation and Accessories ... 40 Catheters... 41 Biosense Webster Diagnostic Catheters with Auto ID ... 41 Standard Diagnostic Catheters ... 42 Connectivity ... 42 Pacing Stimulator Connectivity ... 42 RF Generator Connectivity ... 45 Ultrasound System Connectivity ... 45 EP Recording System Connectivity ... 45 Hospital PACS Connectivity ... 46 NIOBE System Connectivity ... 46 Fluoroscopy System Connectivity ... 46 System Cabling ... 46 General Cabling Guidelines ... 47 System Cables and Connection Points ... 48 Periodic Maintenance ... 52 Annual Service Activity ... 52 Replacing Parts ... 54 Cleaning the System Components ... 54 Cleaning Patient Cables ... 55 When the System Is Idle ... 55 CARTO® 3 System Operating Concepts ... 56 ECG Functionality ... 57 Annotations ... 57 ECG Viewers ... 58 ECG Analog Output to the Recording System ... 58 Saving Recorded ECG Data ... 59 ECG Signal Processing ... 59 ICEG Unipolar Reference ... 59 Stimulation Functionality ... 60 Delivery of RF Energy ... 62 Pacing and RF Energy Delivery ... 62 Location Functionality ... 63 Magnetic Location Technology ... 63 Advanced Catheter Location (ACL) Technology ... 63 CARTO® 3 SYSTEM INSTRUCTIONS FOR USE

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Back Patches and Movement Identification... 64 CARTO® 3 System Location Accuracy Zones ... 65 Mapping Functionality ... 69 Catheter Visualization Modes ... 69 Catheter Visualization ... 69 Acquisition Panel ... 71 Electroanatomical Mapping ... 73 Fast Anatomical Mapping (FAM) Method ... 74 Combined EA and FAM Maps ... 76 Merging Maps ... 77 Performing a CARTO® 3 Study ... 78 Modes of Operation ... 78 Switching on the CARTO® 3 System ... 79 Opening Screen ... 79 System Status ... 80 Setup Guides ... 81 Hardware Setup ... 82 Location Setup ... 82 Study Setup ... 83 Catheter Setup ... 83 Map Setup ... 84 Initializing Catheter Visualization ... 85 Exiting the CARTO® 3 System ... 86 File Management ... 87 Backing Up, Restoring, and Deleting Studies ... 87 When to Back Up Studies ... 88 Exporting Data ... 89 Security ... 90 HIPAA ... 90 Antivirus ... 91 Virus Scan upon Exiting... 91 Unremovable Viruses ... 91 Viruses on USB Storage Devices ... 91 Firewall ... 91 ACCURESP™ Module ... 92 Supported Catheters ... 92 Respiration Gating Options in the CARTO® 3 System Interface ... 93 Preparing for a Study with Respiration Gating... 94 Respiration Gating Training ... 94 Respiration Gating Threshold ... 95 Respiration Graph ... 95 Mapping with Respiration Gating ... 96 FAM Reconstructions and Respiration Gating ... 96 EA Points and Respiration Gating ... 96 Respiration Gating and the CARTOSOUND® Module ... 97 CARTOMERGE® Image Integration Module ... 98 Overview ... 99 Importing CT and MRI Images ... 99 CARTOMERGE® Module Enhancements ... 100 Registering Surface Images to CARTO® 3 Maps ... 100 UG-5400-006H (06A)

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TABLE OF CONTENTS Landmark Pairs ... 100 Registration Process ... 101 Verifying Registration ... 103 Image Processing Package ... 105 Segmenting CT or MRI Images with the Image Processing Package ... 105 CARTOSEG™ Segmentation Modules ... 107 Importing Images to the CARTOSEG™ Segmentation Modules ... 108 CARTOSEG™ CT Segmentation Module ... 109 Loading Scans for Segmentation ... 109 Previewing Loaded Scans ... 110 Applying Segmentation ... 110 Segmented Object List ... 111 Editing Segmented Objects ... 111 Approve and Save Segmentation Results ... 112 CARTOSEG™ MR Segmentation Module ... 112 Loading MRI Series for Segmentation ... 113 Previewing the Loaded Data ... 114 Slice Alignment-Breathing Motion Correction ... 114 Registration ... 116 Segmentation ... 116 Segmented Object List ... 119 Editing Segmented Objects ... 120 Approve and Save MRI Segmentation Results ... 120 Segmenting 3D MR Series ... 120 Advanced MR Segmentation for Expert Users ... 121 Loading MR series for Segmentation (Advanced) ... 121 Previewing the Loaded Data (Advanced) ... 122 Slice Alignment-Breathing Motion Correction (Advanced) ... 122 Registration (Advanced) ... 122 Segmentation (Advanced Mode) ... 122 Approve and Save MRI Segmentation Result ... 124 CARTOREPLAY™ Module... 125 Overview ... 125 Timeline Mode ... 126 Activating Timeline Mode... 126 Timeline Mode Interface ... 127 Selecting the Reviewed Time ... 129 Displaying Timeline Catheters ... 129 Event Panel ... 129 Using Calipers ... 130 Retroactive Point Acquisition ... 131 Dual Monitor ... 131 Dual Monitor Layouts ... 132 Changing the Display Mode and Primary Monitor ... 133 CARTOSOUND® Image Integration Module ... 134 Working with the CARTOSOUND® Module ... 135 Safety Considerations for the CARTOSOUND® Module ... 135 Connections between CARTO® 3 System and Ultrasound System ... 136 Compatible Ultrasound Systems ... 136 CARTO® 3 System Connection to Ultrasound Systems ... 137 CARTO® 3 SYSTEM INSTRUCTIONS FOR USE

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Connecting the SOUNDSTAR® Catheter to the PIU ... 137 Ultrasound System Setup ... 137 Concepts and Software Options ... 140 Ultrasound Viewer ... 140 Contours in CARTO® 3 System Maps ... 141 Tagging Contours ... 141 CARTOUNIVU™ Module ... 142 Overview ... 143 Supported Fluoroscopy Systems ... 143 Installation ... 143 Magnetic Tolerance ... 143 Registration ... 144 Perform Registration ... 144 Receiving Fluoroscopic Captures ... 145 Viewing Captures in Review Mode ... 145 Rescaling Fluoroscopic Captures ... 145 Unsupported Modes ... 146 CARTOUNIVU™ Toolbar ... 148 Full-Motion Catheter Visualization ... 148 Synchronization Features ... 149 Heartbeat Synchronization for Cine Clips ... 149 Reference Annotation and Respiration Gating Indication ... 150 Automatic Frame Selection... 150 Complex Fractionated Atrial Electrogram (CFAE) Module ... 151 Displaying a New CFAE Map ... 152 Selected Point Viewer ... 152 CONFIDENSE™ Module ... 153 Overview ... 154 Continuous Mapping ... 154 Continuous Mapping Filters ... 154 Activating Continuous Mapping ... 156 Continuous Mapping Status ... 157 Manual Point Acquisition during Continuous Mapping ... 157 Continuous Mapping with Pattern Matching ... 158 Tissue Proximity Technology ... 165 Supported Catheters ... 166 Determining Proximity Status ... 166 Tissue Proximity Indication ... 166 Tissue Proximity Filter for MEM Point Acquisition ... 168 Wavefront Mapping Annotation ... 170 Wavefront Annotation Settings ... 170 Working with Wavefront Annotation ... 170 Split-Potential and Multi-Potential Points ... 171 Map Consistency Display... 174 Map Consistency Settings ... 175 Ripple Maps ... 176 Ripple Map Preferences ... 178 Viewing a Ripple Map ... 179 Marking Points ... 179 EP Recording System Interface ... 180 UG-5400-006H (06A)

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TABLE OF CONTENTS Communication States ... 180 Considerations When Using an EP Recording System with the CARTO® 3 System ... 181 End Stimulation Data ... 182 HD Coloring ... 183 Overview ... 183 HD Coloring Activation ... 183 HD Coloring User Interface ... 184 Maps with HD Coloring ... 184 Points and Projections in HD Coloring ... 184 Early Meets Late Option Enhancement ... 186 Propagation Maps in HD Coloring ... 187 Visualization of Points and Projections in HD Coloring Maps ... 188 Adjusting the Color Threshold ... 189 Multi-Electrode Mapping (MEM) ... 190 MEM Overview ... 190 Mapping Electrodes ... 190 Delivery of RF Energy During Multi-Electrode Mapping ... 191 MEM Point Group Acquisition ... 191 Accepting or Rejecting Points ... 192 Pace Mapping Software (PASO™) Module ... 193 PASO™ Module Overview... 193 Installation and Hardware Configuration ... 194 PASO™ Module Concepts ... 194 Induced Signals ... 194 Morphology of Interest ... 194 Reference IS ... 195 PM Signals ... 196 Comparing IS and PM Signals ... 196 PASO™ Module Preferences ... 197 PASO™ Module User Interface ... 197 General Workflow ... 198 CARTO® 3 System with RMT Module ... 199 RMT Hardware Configuration ... 200 Handling the RMT LP ... 200 Safe Use of the CARTO® 3 System Cart ... 200 Working in the RMT Module ... 201 Performing an RMT Study ... 201 RMT Connection Status... 202 Exporting Patient Data to the NIOBE System ... 202 Automatic Export of Catheter Locations ... 202 Exporting Point Locations to the NIOBE System ... 202 Back Patch Movement during an RMT Study... 203 Remote Acquisition of Points ... 203 RMT Toolbar ... 203 Changing the Direction of the NIOBE Magnets ... 204 Creating Design Lines ... 205 Synchronizing the Orientation ... 205 Contact/Angle Display ... 205 Displaying Lined Points Group with Maps ... 205 CARTO® 3 System with CARTO SMARTTOUCH™ Module ... 206 CARTO® 3 SYSTEM INSTRUCTIONS FOR USE

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Overview ... 206 Compatible Catheters ... 206 CARTO SMARTTOUCH™ Module Overview ... 207 CARTO SMARTTOUCH™ Module Hardware... 208 Installation ... 208 Working with the CARTO SMARTTOUCH™ Module ... 208 Force Preferences ... 208 Display Options in the CARTO SMARTTOUCH™ Module ... 209 Force Catheter Visualization ... 209 EA Maps with Force Data ... 209 Excluding High Force in FAM Reconstructions ... 210 Performing a Study with Force Data ... 210 CARTO VISITAG™ Module ... 211 CARTO VISITAG™ Module Overview ... 211 VISITAG™ Locations and Grid Cells ... 212 CARTO VISITAG™ Module Installation ... 212 CARTO VISITAG™ Module Preferences ... 213 Creating Presets for VISITAG™ Preferences ... 214 Using Global or Multiple Presets ... 215 Minimum Time Filter for Grid Cells ... 215 CARTO VISITAG™ Module Display ... 216 VISITAG™ Toolbar ... 216 Stability and Filter Indications ... 216 RF Sessions List ... 217 Displaying Cumulative Data... 218 CARTO VISITAG™ Module Distance Measurement Tool ... 219 CARTO VIZIGO™ Software ... 220 CARTO VIZIGO™ Software Overview ... 220 Building the Matrix ... 221 Paired Visualization ... 222 Interpolation Limit ... 222 CARTO VIZIGO™ Software Setup ... 223 Sheath Visualization Options ... 224 Define Sheath Visualization ... 224 Change Sheath Visualization During a Study ... 226 Other Visual Indications ... 226 Typical Workflow ... 227 Pairing or Unpairing the Sheath ... 227 Troubleshooting CARTO VIZIGO™ Sheath Visualization... 229 Error Messages and Alerts... 230 System Messages ... 231 Viewing Error Message Translations ... 231 Catheter-Related Messages ... 231 Message Text ... 231 Troubleshooting ... 269 ECG Noise ... 270 Communication Problems ... 270 Repeater Monitor Display ... 270 Index ... 271

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LIST OF TABLES

LIST OF TABLES Table 1: EP Equipment to Complement Use of the CARTO® 3 System (Not Supplied with the System) ... 3 Table 2: Summary of Test Results ... 18 Table 3: Guidance and Manufacturer’s Declaration - Electromagnetic Emissions ... 19 Table 4: Guidance and Manufacturer’s Declaration - Electromagnetic Immunity (Specifications for all Medical Electrical Equipment and Systems) ... 20 Table 5: Guidance and Manufacturer’s Declaration - Electromagnetic Immunity (Specifications for Medical Electrical Equipment and Systems That Are Not Life Supporting) ... 21 Table 6: Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the CARTO® 3 System (Specifications for Medical Electrical Equipment and Systems that are Not Life-Supporting) ... 23 Table 7: Legend to Symbols Appearing on the System Hardware and Documentation ... 24 Table 8: Description of External Product Labels ... 26 Table 9: CARTO® 3 System Compliance ... 28 Table 10: Quality System Standards ... 28 Table 11: System Component Dimensions ... 30 Table 12: CARTO® 3 System Power Specifications ... 30 Table 13: Current Applied through Electrodes Connected to the CARTO ® 3 System... 31 Table 14: Inputs to the CARTO® 3 System ... 31 Table 15: Environmental Conditions for CARTO® 3 System Storage and Operation... 31 Table 16: Components Connected to the Front of the PIU ... 33 Table 17: Components Connected to the Back of the PIU ... 34 Table 18: Mechanical Equipment for Positioning the PIU (Optional) ... 36 Table 19: PIU Connections ... 37 Table 20: Special Catheter Interface Cables (Equipped with Electronics) ... 38 Table 21: EP Lab and System Parts ... 49 Table 22: System Parts and Cables ... 50 Table 23: Functional Tests ... 53 Table 24: Back and Chest Patch Visualization ... 66 Table 25: Key to the Diagrams ... 67 Table 26: Opening Screen Buttons ... 79 Table 27: System Status Icons ... 80 Table 28: Dual Monitor Configuration Options ... 131 Table 29: Extended Mode Display Locations... 132 Table 30: Predefined Layouts for Dual Monitor Configuration ... 132 Table 31: Unsupported Fluoroscopy System Modes with CARTOUNIVU™ Module ... 146 Table 32: Map Related Filters for Continuous Mapping ... 155 Table 33: System Filters ... 155 Table 34: Acquisition Panel with Continuous Mapping ... 156 CARTO® 3 SYSTEM INSTRUCTIONS FOR USE

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LIST OF TABLES

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Table 35: Indication of Close Proximity ... 167 Table 36: Consistency Filter Settings ... 175 Table 37: Relation between Electrogram and Ripple Bar ... 176 Table 38: Icons for Communication States ... 181 Table 39: Points, Projections, and Tags ... 184 Table 40: Predefined Mapping Electrodes ... 191 Table 41: RMT Toolbar Options ... 203 Table 42: Overview of the Display Options ... 209 Table 43: Description of VISITAG™ Preset Options ... 215 Table 44: Catheter Stability Status Before and After Application of RF Energy ... 216 Table 45: Catheter Stability Status during Application of RF Energy ... 217 Table 46: Cumulative Data Description ... 218 Table 47: Sheath Visualization Options ... 224 Table 48: Visualization Options ... 226 Table 49: Visual Indications on Sheath ... 226 Table 50: Options for Pairing or Unpairing ... 228 Table 51: System-Related Messages ... 232 Table 52: Ultrasound-Related Messages ... 264

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LIST OF FIGURES

LIST OF FIGURES Figure 1: Sample System Label ... 26 Figure 2: Patient Interface Unit (PIU), Front Panel ... 33 Figure 3: Patient Interface Unit (PIU), Rear Panel ... 34 Figure 4: Patient Interface Unit (PIU) Sockets ... 37 Figure 5: PIU Sockets for Stimulator Connectivity ... 42 Figure 6: Generic (Locally Routed) Stimulation Socket Pair ... 43 Figure 7: Emergency Stimulation Socket Pairs... 43 Figure 8: Schematic Diagram of System Cables and Connection Points: Cart Installation ... 48 Figure 9: Schematic Diagram of System Cables and Connection Points: Boom Installation ... 49 Figure 10: Stimulation Routing Indication ... 60 Figure 11: Stimulation Routing Indication on Main Toolbar ... 60 Figure 12: RF Energy Indication ... 62 Figure 13: Back Patches and Location Pad as Displayed in Location Setup Screen... 64 Figure 14: Indication of Maps with Different Location Reference ... 65 Figure 15: Location Setup Screen ... 66 Figure 16: Back Patch Accurate Mapping Zone ... 67 Figure 17: Chest Patch Accurate Mapping Zone ... 68 Figure 18: Mapping Catheter Accurate Mapping Zone ... 68 Figure 19: Catheter Visualization when Electrodes Covered by Sheath ... 69 Figure 20: Readings Dashboard: Sample Mapping Configuration ... 72 Figure 21: Readings Dashboard: Sample Ablation Configuration ... 72 Figure 22: System Status Panel with Catheter Connection Indication ... 80 Figure 23: Layout of CT Segmentation Window in Data Loading Stage ... 109 Figure 24: Data Loading Layout ... 113 Figure 25: Series Replacement Warning Message ... 114 Figure 26: Slice Contours in S. Axis Align Layout ... 115 Figure 27: Initial LV Segmentation Contours Presented on Anatomy Series ... 117 Figure 28: LV Segmentation and Zones (Scar and Border Zone) Presented on Tissue Characterization Series ... 118 Figure 29: The Segmented LV and LA Chambers, in 2D and 3D Views ... 123 Figure 30: MRI Segmentation Results in the CARTOMERGE® Study ... 124 Figure 31: Monitor Pane Toolbar ... 126 Figure 32: Monitor Pane Toolbar when Timeline Mode Is Active ... 126 Figure 33: Timeline Toolbar ... 127 Figure 34: Timeline Toolbar with PASO™ Module ... 127 Figure 35: Timeline Mode Display ... 127 Figure 36: Review Line ... 128 CARTO® 3 SYSTEM INSTRUCTIONS FOR USE

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LIST OF FIGURES

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Figure 37: Event Panel... 128 Figure 38: Timeline and Real-time Catheter Visualizations ... 128 Figure 39: Event Panel with Selected Point and Various Events ... 130 Figure 40: Timeline Toolbar ... 131 Figure 41: Dual Monitor Extended Display Mode ... 132 Figure 42: Geometry Information Window Displaying Troubleshooting Information ... 147 Figure 43: Extended Cine Player ... 148 Figure 44: Chamber of Interest Selection ... 149 Figure 45: Status Slider on Extended Cine Player ... 150 Figure 46: Acquisition Filters Tab ... 154 Figure 47: Continuous Mapping Filter Status Window ... 157 Figure 48: Pattern Bank Window ... 159 Figure 49: Pattern Bank Window with Edited Pattern ... 160 Figure 50: Acquisition Filters: Pattern Matching ... 161 Figure 51: Pattern Matching Viewer with PTRN 2 locked ... 161 Figure 52: Pattern Matching Viewer in Play Mode (Left) and Stop Mode (Right) ... 162 Figure 53: Filter Status Window ... 163 Figure 54: Pattern Matching for Point: Acquired when Continuous Mapping Was Active (Left) and Not Active (Right) ... 164 Figure 55: Pattern Matching Column in the Point List ... 164 Figure 56: Point Group Acquired with Proximity Indication Filter... 169 Figure 57: Wavefront Preferences ... 170 Figure 58: Bipolar Signal and Corresponding Unipolar Signals ... 170 Figure 59: Beat Buffer Showing Recommended Beat (–6) for Wavefront Annotation... 171 Figure 60: Wavefront Preferences with Complex Point Tagging Installed ... 171 Figure 61: Complex Point Annotation ... 172 Figure 62: Tag Setup Dialog Box with Tags for Split-Potential and Multi-Potential Points ... 172 Figure 63: Visualization Setup Dialog Box ... 173 Figure 64: Retroactive Tagging Check Box ... 173 Figure 65: Marker on Outlier ... 174 Figure 66: Map Consistency Settings in the Point Filtering Dialog Box ... 175 Figure 67: Additional Map Consistency Settings ... 175 Figure 68: Ripple Map Preferences ... 178 Figure 69: Example of a Ripple Map ... 179 Figure 70: Ripple Markers in Map and Ripple Viewer ... 179 Figure 71: HD Coloring Map ... 184 Figure 72: Map with Early Meets Late Coloring ... 186 Figure 73: Propagation Map... 188 Figure 74: Visualization Setup Dialog Boxes for FAM and Point-by-Point Maps ... 188 Figure 75: Fill & Color Threshold Dialog Box ... 189 UG-5400-006H (06A)

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LIST OF FIGURES Figure 76: Morphology of Interest ... 195 Figure 77: Heavy Object Label on the RMT LP ... 200 Figure 78: VISITAG™ Presets ... 214 Figure 79: Grid Cells with Minimum Time Filter ... 215 Figure 80: Distance between Two VISITAG™ Locations ... 219 Figure 81: Distance Real-Time Catheter Position and Last VISITAG™ Location ... 219 Figure 82: CARTO VIZIGO™ Sheath Visualization with Matrix ... 221 Figure 83: Paired Visualization when Catheter Extends Beyond Interpolation Limit ... 222 Figure 84: PIU Connections ... 223 Figure 85: Sheath Visualization Options in Catheter Setup Screen ... 224 Figure 86: System Status Icon ... 230 Figure 87: Error Message Summary ... 230

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SYSTEM FOUNDATIONS

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Chapter 1

ABOUT THE CARTO® 3 SYSTEM In This Chapter: System Foundations ... 2 System Components ... 2 Initial Installation ... 3 Typical Setup ... 3 Important Information for Experienced CARTO® XP System Users ... 4 Viewing CARTO® XP Studies ... 4 Modules and Optional Features ... 4 ACCURESP™ Module ... 4 CARTOMERGE® Image Integration Module ... 4 CARTOSEG™ Segmentation Modules ... 5 CARTOREPLAY™ Module... 5 CARTOSOUND® Image Integration Module ... 5 CARTOUNIVU™ Module... 5 CARTO® 3 System-Complex Fractionated Atrial Electrogram (CFAE) Module ... 5 CONFIDENSE™ Module ... 6 FAM Dx ... 6 HD Coloring ... 6 PASO™ Module ... 6 CARTO® 3 System with RMT Module ... 7 CARTO® 3 System with CARTO SMARTTOUCH™ Module ... 7 CARTO VISITAG™ Module... 7 VISITAG SURPOINT™ Module ... 7 CARTO VIZIGO™ Software ... 7 Viewing System Information ... 7 Cautions, Warnings, and Other Types of Notes ... 8

NOTE In case of any differences between copies of the Instructions for Use, the electronic copy shall be considered the most recent. Contact Biosense Webster to order a printed copy of the Instructions for Use in any of the languages provided.

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SYSTEM FOUNDATIONS

SYSTEM FOUNDATIONS The CARTO® 3 System is based on the following three foundations: ECG

The ECG subsystem supports receiving Body Surface ECG signals and up to 78 Intracardiac (IC) Electrogram channels. It samples, filters, presents, and records ECG signals. In addition, it passes the ECG signals through to the recording system.

Location

The CARTO® 3 System includes two location technologies:

Mapping

•

CARTO® Magnetic Location Technology, supplying locations based on electromagnetic fields generated by the location pad and measured by Biosense Webster catheters that have embedded magnetic sensors.

•

Advanced Catheter Location (ACL), supplying location data from each electrode connected to the system. The location is calculated based on the signals received from six patches attached to the patient. The variation in tissue conductivity is calibrated using magnetic location technology that is not influenced by human conductivity.

The mapping technology is used to build maps of the heart chambers, for display in the Main Map Viewer. These maps are built by combining the accurate location data and ECG data. The system enables the following mapping methods: •

Electroanatomical (EA) mapping

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Fast anatomical mapping, using FAM (Fast Anatomical Mapping) technology

•

Ultrasound catheter mapping

Maps can also be combined. For example, EA points can be added to a reconstruction created from ultrasound contours. EA points can also be projected onto a FAM reconstruction. Their anatomical data can be added to the reconstruction. See also: •

ECG Functionality

•

Location Functionality

•

Mapping Functionality

SYSTEM COMPONENTS The main components of the CARTO® 3 System are: •

The Patient Interface Unit (PIU) and related equipment, including the Location Pad (LP) The PIU is stationed near the patient. The LP is positioned under the patient table.

•

The workstation and related equipment The workstation is typically stationed in the observation room.

Electrophysiological catheters are connected to the CARTO® 3 System PIU by means of appropriate cables. Biosense Webster Catheters with embedded ID are recognized automatically by the System. Other catheters can be defined by the user. For a list of EP equipment that complements use of the system, see "EP Equipment to Complement Use of the CARTO® 3 System (Not Supplied with the System)".

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INITIAL INSTALLATION

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Table 1: EP Equipment to Complement Use of the CARTO ® 3 System (Not Supplied with the System)

Complementary Equipment

Function

EP Recording System

Enables recording of the electrophysiological activity

Pacing Stimulator

Device used for the generation of pacing signals and sequences

RF Generator

Device used for generating RF energy for ablation

Irrigation Pump

For use with a compatible RF generator for catheter irrigation during ablation.

Ultrasound System (for use with the CARTOSOUND® Module)

Device used for intracardiac ultrasound. This device is connected to the system.

Stereotaxis NIOBE® Magnetic Navigation System (for use with the RMT Module)

Remote catheter navigation system

Fluoroscopy System (for use with the CARTOUNIVU™ Module)

Enables display of fluoroscopic captures in the CARTO® 3 System

Consult your Biosense Webster representative regarding the availability of compatible devices in your country. See also: •

System Hardware

INITIAL INSTALLATION Only personnel who are qualified by Biosense Webster may install the CARTO® 3 System. No one but personnel qualified by Biosense Webster should open the sealed boxes or packages containing the system components.

TYPICAL SETUP The PIU can be placed in one of the following locations: •

Fixed to a holder on the patient table

•

Fixed on a shelf near the patient table

•

Mounted on a IEC 60601-certified cart, which can be moved in the operating room as required

The Location Pad is attached to the underside of the patient table in its own holder. The Patch Unit is placed on or near the patient table. The workstation is located in the operating room or in an adjacent observation room. A repeater monitor can be set up in the operating room, next to the patient table, so that the attending physician can view all that is displayed on the CARTO® 3 System monitor. Cables should be placed inside cable ducts, where possible. See also: •

System Hardware

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IMPORTANT INFORMATION FOR EXPERIENCED CARTO® XP SYSTEM USERS

IMPORTANT INFORMATION FOR EXPERIENCED CARTO® XP SYSTEM USERS In addition to its own features, the CARTO® 3 System provides the same basic functionality of previous CARTO® Systems. CAUTION Experienced CARTO® XP System users may work independently with the CARTO® 3 System only after completing an introductory training course given by authorized Biosense Webster personnel.

Viewing CARTO® XP Studies You cannot view CARTO® XP Studies in the CARTO® 3 System. If you need to review CARTO® XP Studies, contact the Biosense Webster Service and Support Department.

MODULES AND OPTIONAL FEATURES This release of the CARTO® 3 System provides several modules and optional features for differing clinical needs. •

Some of these modules and features might not be available in your country. Consult your Biosense Webster representative regarding the availability of a particular module or feature in your country.

•

Biosense Webster service personnel are responsible for installing and activating modules and optional features.

•

Instructions and feature descriptions in this document assume that the module is available in your country and has been activated.

A brief overview of each module is given below. For full details on working with a specific module, refer to the documentation provided with that module.

ACCURESP™ Module The ACCURESP™ Module for Respiration Gating enables the CARTO ® 3 System to learn the patient's respiratory motion and train for it. This training allows the user to set a threshold for selective acquisition of location data. When EA points and FAM data are acquired within this threshold (from the end expiration period), heart movement due to respiration is minimal.

CARTOMERGE® Image Integration Module With the CARTOMERGE® Image Integration Module (CARTOMERGE® Module), you can import segmented CT or MRI image studies into the CARTO® 3 System. Three-dimensional (3D) surface images of the cardiac chamber or structure are automatically created when the image study is imported. After you register the surface images to a CARTO® 3 Map, you can use the surface images to guide mapping in a particular area of interest. If the images are not segmented, use the Image Processing Package to import, render, segment, and edit the raw data of CT or MRI studies. CARTO® 3 SYSTEM INSTRUCTIONS FOR USE

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MODULES AND OPTIONAL FEATURES

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CARTOSEG™ Segmentation Modules •

The CARTOSEG™ CT Segmentation Module is an advanced segmentation tool that generates segmentations of various anatomical structures from CT scans of the heart.

•

The CARTOSEG™ MR Segmentation Module is an advanced segmentation tool that generates segmentations of various anatomical structures from MRI scans of the heart. The MRI processing capability of the module enables definition and segmentation of specific tissues based on their intensities.

CARTOREPLAY™ Module The CARTOREPLAY™ Module records all ECG data and electrode location data (magnetic or ACL) for all connected catheters throughout the procedure. The recorded data can be accessed at any time during the study to view earlier ECG signals and catheter positions, and to retroactively acquire additional points for EA mapping.

CARTOSOUND® Image Integration Module The CARTOSOUND® Image Integration Module (CARTOSOUND® Module) combines real-time ultrasound image data with CARTO® 3 Maps. Ultrasound images are acquired with a compatible SOUNDSTAR® Catheter. The catheter includes an ultrasound transducer and a Biosense Webster location sensor. The ultrasound transducer emits and receives multiple rays of ultrasound. The realtime ultrasound images are displayed in the CARTO® 3 System, as well as on a compatible ultrasound system. Once the streaming ultrasound is stopped, a 3-second video clip is acquired. You can then draw a contour of the desired anatomy on a frame of ultrasound and add this information to a reconstruction. The 3-second ultrasound clip is saved with the contour, and the specific frame containing the contour is marked for easy identification. Contour data contributes anatomical information to the map. Contours are listed in the Point List CARTOSOUND® Maps can be combined with FAM maps, using the Anatomical Merge feature.

CARTOUNIVU™ Module With the CARTOUNIVU™ Module, fluoroscopic captures (images and cine clips) can be imported to and displayed in the CARTO® 3 System.

CARTO® 3 System-Complex Fractionated Atrial Electrogram (CFAE) Module The CARTO® 3 System-Complex Fractionated Atrial Electrogram (CFAE) Module (CFAE Module) enables detection of CFAEs on an IC-ECG, based on user-defined parameters. While the number of CFAE complexes that occur cannot be precisely determined, by defining a CFAE complex (via user-defined parameters), the system identifies the number of intervals between adjacent CFAEs, and the cycle length of these intervals. In this way, the number of CFAE complexes within certain amplitude and duration values can be estimated.

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MODULES AND OPTIONAL FEATURES

CONFIDENSE™ Module The CONFIDENSE™ Module is a collection of features that aid in the acquisition and understanding of CARTO® 3 Maps. •

The Continuous Mapping Feature enables continuous acquisition of EA points which meet a set of pre-defined filters.

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With Tissue Proximity Technology, the CARTO® 3 System uses impedance measurements to determine an electrode's proximity to cardiac tissue. If the distance is less than the radius of the electrode, the electrode is considered to be touching. The proximity status can be used for the following features: •

Tissue Proximity Indication in the map viewers, Point List, and Selected Point Viewer

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MEM point acquisition based on Tissue Proximity Filter

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The Wavefront Mapping Annotation uses an algorithm to search for the greatest negative deflection (-dV/dt) in each distal unipolar signal and mark it for the local activation time calculation.

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The Map Consistency Display is a point filter that identifies points whose Local Activation Time (LAT) values are not consistent with the LAT values of neighboring points. When this filter is applied, the CARTO® 3 System highlights these outliers.

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A Ripple Map is a dynamic display of bipolar electrogram data in an electroanatomical map. At each point, the corresponding bipolar electrogram is dynamically displayed as a bar perpendicular to the map surface.

FAM Dx When the FAM Dx Feature license is activated, any map-enabling catheter (including LASSO® NAV Catheters and PENTARAY® NAV Catheters) can be used to build the matrix and a FAM map. A therapeutic catheter is not needed.

HD Coloring HD Coloring is a visualization mode that provides an enhanced representation of a map's electroanatomical data, a new color interpolation algorithm, an updated propagation view, and an enhancement to the Early Meets Late option. The propagation view allows the user to view a cinelike version of the electrical propagation of the heart. The map maintains its LAT values and the propagation is highlighted on top of it.

PASO™ Module The Pace Mapping Software (PASO™) Module (PASO™ Module) can be used for correlating 12lead ECG captured during the patient's induced or spontaneous arrhythmia to other induced signals (IS) or to the signal captured while pace mapping. While induced arrhythmia signals are not associated with any point or map, the pace-mapped signal (PM) is always associated with an electroanatomical point. The System calculates a correlation index that helps to compare between pace mapped points and between different induced signals. You can use the automatically-assigned best match or choose your own.

CARTO® 3 SYSTEM INSTRUCTIONS FOR USE

UG-5400-006H (06A)