CARTO 3 Instructions for Use Sw Ver 7.2.40 March 2022

© 2008 - 2022 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 See the documentation CD accompanying the CARTO® 3 System for information on third party software notices applicable to this product.

P.N.: UG-5400-0072H (02A) 24 March 2022

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Table of Contents About the CARTO® 3 System ... 1 Indications for Use ... 1 Clinical Benefits ... 1 Potential Adverse Events ... 2 System Foundations ... 2 System Components ... 3 Initial Installation ... 4 Typical Setup ... 4 Modules and Optional Features ... 4 ACCURESP™ Module ... 5 Advanced Reference Annotation (ARA) ... 5 CARTOMERGE® Image Integration Module ... 5 CARTOSEG™ Segmentation Modules ... 5 CARTOREPLAY™ Module... 5 CARTOSOUND® Image Integration Module ... 5 CARTOUNIVU™ Module... 6 CARTO® 3 System-Complex Fractionated Atrial Electrogram (CFAE) Module ... 6 CONFIDENSE™ Module ... 6 FAM Dx ... 6 PASO™ Module ... 6 CARTO PRIME™ 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 About This Document ... 8 Cautions, Warnings, and Other Types of Notes ... 8 Safety Information ... 9 System Setup Standards ... 10 Qualified Users and Training ... 10 Warnings ... 10 General ... 10 Physical Setup ... 11 Preventing Fire, Explosion, and Electrical Shock ... 12 Defibrillation ... 12 Location Accuracy ... 13 CARTO® 3 System Interference with Other Medical Equipment ... 14 Safety for Modules and Optional Features ... 15 ARA... 15 CARTOMERGE® Module ... 15 CARTOSEG™ Segmentation Modules ... 15 CARTOSOUND® Module ... 16 CARTOUNIVU™ Module... 16 CFAE Module ... 17 CARTO PRIME™ Module ... 17 PASO™ Module ... 17 CARTO SMARTTOUCH™ Module ... 17 CARTO VISITAG™ Module... 17 CARTO VIZIGO™ Software ... 18 Servicing ... 18 Electromagnetic Compatibility (EMC) ... 18 UG-5400-0072H (02A)

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Legend to Accompanying Labels ... 23 External Product Labels ... 25 Standards Compliance and Classifications ... 27 System Hardware ... 29 System Specifications ... 30 Component Dimensions ... 30 Power Consumption ... 30 Applied Current ... 30 System Input Impedance ... 31 Environmental Conditions ... 31 CARTO® 3 System Components ... 32 Patient Interface Unit (PIU) ... 32 Location Pad (LP) ... 38 Back and Chest Patches ... 39 Workstation and Accessories ... 39 Catheters... 40 Biosense Webster Diagnostic Catheters with Auto ID ... 40 Standard Diagnostic Catheters ... 40 Connectivity ... 41 Pacing Stimulator Connectivity ... 41 RF Generator Connectivity ... 43 Ultrasound System Connectivity ... 44 EP Recording System Connectivity ... 44 Hospital PACS Connectivity ... 44 Fluoroscopy System Connectivity ... 44 System Cabling ... 45 General Cabling Guidelines ... 45 System Cables and Connection Points ... 46 Periodic Maintenance ... 51 Annual Service Activity ... 51 Replacing Parts ... 52 Cleaning the System Components ... 53 Cleaning Patient Cables ... 53 When the System Is Idle ... 54 CARTO® 3 System Operating Concepts ... 55 ECG Functionality ... 56 Annotations ... 56 ECG Viewers ... 57 ECG Analog Output to the Recording System ... 57 Saving Recorded ECG Data ... 58 ECG Signal Processing ... 58 ICEG Unipolar Reference ... 59 Stimulation Functionality ... 59 Delivery of RF Energy ... 62 Pacing and RF Energy Delivery ... 63 Location Functionality ... 63 Magnetic Location Technology ... 63 Advanced Catheter Location (ACL) Technology ... 63 Back Patches and Movement Identification... 64 CARTO® 3 System Location Accuracy Zones ... 66 CARTO® 3 System Instructions for Use

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Mapping Functionality ... 68 Catheter Visualization Modes ... 68 Catheter Visualization ... 69 Acquisition Panel ... 71 Fast Anatomical Mapping (FAM) Method ... 72 Electroanatomical Mapping ... 74 Combined EA and FAM Maps ... 79 Merging Maps ... 82 Performing a CARTO® 3 Study ... 83 Modes of Operation ... 83 Switching on the CARTO® 3 System ... 84 Opening Screen ... 84 System Status ... 85 Setup Guides ... 86 Hardware Setup ... 87 Location Setup ... 87 Study Setup ... 88 Catheter Setup ... 88 Map Setup ... 89 Initializing Catheter Visualization ... 90 Exiting a Study ... 91 Review Mode ... 91 Loading Maps from a Previous Study ... 92 Exiting the CARTO® 3 System ... 92 Workstation Optimization ... 93 File Management ... 95 Backing Up, Restoring, and Deleting Studies ... 95 When to Back Up Studies ... 96 Exporting Data ... 97 Security ... 98 Secure Login ... 99 Antivirus ... 99 Virus Scan upon Exiting... 99 Unremovable Viruses ... 99 Viruses on USB Storage Devices ... 100 Firewall ... 100 ACCURESP™ Module ... 101 Supported Catheters ... 101 Respiration Gating Options in the CARTO® 3 System Interface ... 102 Preparing for a Study with Respiration Gating... 103 Respiration Gating Training ... 103 Respiration Gating Threshold ... 103 Respiration Graph ... 104 Mapping with Respiration Gating ... 104 FAM Reconstructions and Respiration Gating ... 104 EA Points and Respiration Gating ... 105 Respiration Gating and the CARTOSOUND® Module ... 106 Advanced Reference Annotation (ARA) ... 107 ARA Overview ... 107 Performing a Study with ARA ... 108 UG-5400-0072H (02A)

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Activating ARA ... 108 ARA Algorithm Training Period ... 109 User Interface ... 110 Functionality When No Reference Annotations are Detected ... 113 Copying or Moving Points between Maps ... 114 ARA Behavior when Pacing is Active ... 114 CARTOMERGE® Image Integration Module ... 115 CARTOMERGE® Module Overview... 115 Importing CT and MRI Images ... 116 CARTOMERGE® Module Enhancements ... 116 Registering Surface Images to CARTO® 3 Maps ... 117 Landmark Pairs ... 117 Registration Process ... 118 Verifying Registration ... 119 Image Processing Package ... 120 Segmenting CT or MRI Images with the Image Processing Package ... 121 CARTOSEG™ Segmentation Modules ... 123 Importing Images to the CARTOSEG™ Segmentation Modules ... 124 CARTOSEG™ CT Segmentation Module ... 124 Loading Scans for Segmentation ... 125 Previewing Loaded Scans ... 125 Applying Segmentation ... 126 Segmented Object List ... 127 Editing Segmented Objects ... 127 Approve and Save Segmentation Results ... 127 CARTOSEG™ MR Segmentation Module ... 127 Loading MRI Series for Segmentation ... 128 Previewing the Loaded Data ... 130 Slice Alignment-Breathing Motion Correction ... 130 Registration ... 131 Segmentation ... 131 Segmented Object List ... 134 Editing Segmented Objects ... 134 Approve and Save MRI Segmentation Results ... 135 Segmenting 3D MR Series ... 135 Advanced MR Segmentation for Expert Users ... 136 Loading MR series for Segmentation (Advanced) ... 136 Previewing the Loaded Data (Advanced) ... 136 Slice Alignment-Breathing Motion Correction (Advanced) ... 137 Registration (Advanced) ... 137 Segmentation (Advanced Mode) ... 137 Approve and Save MRI Segmentation Result ... 138 CARTOREPLAY™ Module... 140 CARTOREPLAY™ Module Overview ... 140 Timeline Mode ... 140 Activating Timeline Mode... 141 Exporting CARTOREPLAY™ Module Data... 141 Timeline Mode Interface ... 142 Selecting the Reviewed Time ... 143 Displaying Timeline Catheters ... 144 Event Panel ... 144 CARTO® 3 System Instructions for Use

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Using Calipers ... 145 Retroactive Point Acquisition ... 145 Dual Monitor ... 146 Dual Monitor Layouts ... 147 Changing the Display Mode and Primary Monitor ... 147 CARTOSOUND® Image Integration Module ... 149 CARTOSOUND® Module Overview ... 149 Working with the CARTOSOUND® Module ... 150 Compatible Ultrasound Systems ... 150 About the SOUNDSTAR® 3D Catheter ... 151 Connections between CARTO® 3 System and Ultrasound System ... 151 CARTO® 3 System Connection to Ultrasound Systems ... 151 Connecting the SOUNDSTAR® Catheter to the PIU ... 152 Ultrasound System Setup ... 152 Concepts and Software Options ... 153 Contours in CARTO® 3 System Maps ... 154 Ultrasound Window ... 155 Tagging Contours ... 155 CARTOUNIVU™ Module ... 156 CARTOUNIVU™ Module Overview ... 156 Supported Fluoroscopy Systems ... 157 Installation ... 157 CARTOUNIVU™ Module Study ... 157 Registration ... 157 Receiving Fluoroscopic Captures ... 158 CARTOUNIVU™ Toolbar ... 161 Full-Motion Catheter Visualization ... 161 Synchronization Features ... 161 Heartbeat Synchronization for Cine Clips ... 162 Reference Annotation and Respiration Gating Indication ... 163 Automatic Frame Selection... 163 Complex Fractionated Atrial Electrogram (CFAE) Module ... 164 Displaying a New CFAE Map ... 164 Selected Point Viewer ... 165 CONFIDENSE™ Module ... 166 CONFIDENSE™ Module Overview ... 167 Continuous Mapping ... 167 Continuous Mapping Filters ... 167 Activating Continuous Mapping ... 169 Continuous Mapping Status ... 170 Continuous Mapping with Pattern Matching ... 173 Manual Point Acquisition during Continuous Mapping ... 185 Tissue Proximity Technology ... 185 Supported Catheters ... 185 Determining Proximity Status ... 186 Tissue Proximity Indication ... 186 Tissue Proximity Filter for MEM Point Acquisition ... 188 Wavefront Mapping Annotation ... 189 UG-5400-0072H (02A)

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Wavefront Annotation Settings ... 189 Working with Wavefront Annotation ... 189 Map Consistency Display... 190 Map Consistency Settings ... 192 Reviewing LAT Outliers ... 193 Ripple Maps ... 193 Ripple Map Preferences ... 195 Viewing a Ripple Map ... 196 Marking Points ... 196 EP Recording System Interface ... 197 Communication States ... 197 Considerations When Using an EP Recording System with the CARTO ® 3 System ... 198 End Stimulation Data ... 198 Pace Mapping Software (PASO™) Module ... 200 PASO™ Module Overview... 200 Installation and Hardware Configuration ... 201 PASO™ Module Concepts ... 201 Induced Signals ... 201 Morphology of Interest ... 201 Reference IS ... 202 PM Signals ... 203 Comparing IS and PM Signals ... 203 PASO™ Module Preferences ... 204 PASO™ Module User Interface ... 204 General Workflow ... 205 CARTO® 3 System with CARTO SMARTTOUCH™ Module ... 206 CARTO SMARTTOUCH™ Module Overview ... 206 Compatible Catheters ... 207 CARTO SMARTTOUCH™ Module Hardware... 207 Installation ... 208 Working with the CARTO SMARTTOUCH™ Module ... 208 Force Preferences ... 208 Display Options in the CARTO SMARTTOUCH™ Module ... 208 Force Catheter Visualization ... 209 EA Maps with Force Data ... 209 Excluding High Force in FAM Reconstructions ... 209 Performing a Study with Force Data ... 210 CARTO VISITAG™ Module ... 211 CARTO VISITAG™ Module Overview ... 211 VISITAG™ Sites and Grid Cells ... 212 CARTO VISITAG™ Module Installation ... 212 CARTO VISITAG™ Module Preferences ... 212 Creating Presets for VISITAG™ Preferences ... 213 Using Global or Multiple Presets ... 214 Minimum Time Filter for Grid Cells ... 214 CARTO VISITAG™ Module Display ... 215 VISITAG™ Toolbar ... 215 Stability and Filter Indications ... 215 CARTO® 3 System Instructions for Use

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VISITAG™ Indication in the Graphs Viewer ... 216 RF Sessions List ... 217 Displaying Cumulative Data... 217 VISITAG™ Sites and Projections ... 217 Distance Measurement Tool ... 218 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 CARTO PRIME™ Module ... 230 CARTO PRIME™ Module Overview ... 231 CARTO PRIME™ Module Installation ... 231 CARTOFINDER™ Module... 231 Supported Catheters ... 232 Working with the CARTOFINDER™ Module... 232 CARTOFINDER™ File Management ... 249 COHERENT Mapping ... 249 About the Coherent Mapping Algorithm ... 250 Viewing a COHERENT Map ... 251 Viewing Multiple COHERENT Maps ... 257 Recalculating the COHERENT Map ... 257 Parallel Mapping ... 258 Performing Parallel Mapping ... 258 Using Map Replay to Recalculate a Map ... 262 Continuous Mapping with CARTOREPLAY™ Module ... 263 LAT Hybrid Maps ... 264 Setting Up a LAT Hybrid Map ... 265 Display of LAT Hybrid Points ... 267 Interactions with Other Maps ... 268 Map Merge ... 268 Loading Maps from a Previous Study ... 269 Registering Maps from a Previous Study ... 272 Error Messages and Alerts... 275 System Messages ... 276 Viewing Error Message Translations ... 276 Catheter-Related Messages ... 276 Message Text ... 276 Troubleshooting ... 309 Troubleshooting Tools ... 309 UG-5400-0072H (02A)

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Viewing Troubleshooting Information ... 309 Metal Interference ... 311 Electrode View ... 312 Patches View ... 312 ECG Noise ... 313 Communication Problems ... 313 Repeater Monitor Display ... 314 Index ... 315

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LIST OF TABLES

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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) ... 22 Table 7: Legend to Symbols Appearing on the System Hardware and Documentation ... 23 Table 8: Description of External Product Labels ... 25 Table 9: CARTO® 3 System Compliance ... 27 Table 10: Quality System Standards ... 27 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... 30 Table 14: Inputs to the CARTO® 3 System ... 31 Table 15: Environmental Conditions for CARTO® 3 System Storage and Operation... 31 Table 16: Protection Against the Ingress of Water ... 31 Table 17: Components Connected to the Front of the PIU ... 33 Table 18: Components Connected to the Back of the PIU ... 34 Table 19: Mechanical Equipment for Positioning the PIU (Optional) ... 35 Table 20: PIU Connections ... 37 Table 21: Special Catheter Interface Cables (Equipped with Electronics) ... 38 Table 22: EP Lab and System Parts ... 48 Table 23: System Parts and Cables ... 49 Table 24: Functional Tests ... 52 Table 25: Back and Chest Patch Visualization ... 66 Table 26: Key to the Diagrams ... 67 Table 27: Acquisition Panel by Map Type... 71 Table 28: Acquisition Panel Buttons ... 71 Table 29: Predefined Mapping Electrodes ... 75 Table 30: Points, Projections, and Tags ... 80 Table 31: FAM Reconstruction with Applied EA Points ... 81 Table 32: Opening Screen Buttons ... 84 Table 33: System Status Icons ... 85 Table 34: Dual Monitor Configuration Options ... 146 Table 35: Extended Mode Display Locations... 147 UG-5400-0072H (02A)

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LIST OF TABLES

Table 36: Predefined Layouts for Dual Monitor Configuration ... 147 Table 37: Unsupported Fluoroscopy System Modes with CARTOUNIVU™ Module ... 160 Table 38: Map Related Filters for Continuous Mapping ... 168 Table 39: System Filters ... 169 Table 40: Acquisition Panel with Continuous Mapping ... 169 Table 41: Default Filter Settings ... 184 Table 42: Indication of Close Proximity ... 186 Table 43: Map Consistency Settings ... 192 Table 44: Relation between Electrogram and Ripple Bar ... 194 Table 45: Icons for Communication States ... 198 Table 46: Overview of the Display Options ... 208 Table 47: Description of VISITAG™ Preset Options ... 214 Table 48: Catheter Stability Status Before and After Application of RF Energy ... 215 Table 49: Catheter Stability Status during Application of RF Energy ... 216 Table 50: Cumulative Data Description ... 217 Table 51: Sheath Visualization Options ... 225 Table 52: Visualization Options ... 226 Table 53: Visual Indications on Sheath ... 226 Table 54: Options for Pairing or Unpairing ... 228 Table 55: CARTOFINDER™ Site Display ... 235 Table 56: CARTOFINDER™ Options in the Visualization Setup Dialog Box ... 237 Table 57: Point List Columns in CARTOFINDER™ Module Maps ... 238 Table 58: Color Scale Bar with CARTOFINDER™ Module Maps ... 242 Table 59: Coherent Visualization Setup Options ... 255 Table 60: Registration Toolbar "Prev" ... 273 Table 61: System-Related Messages ... 277 Table 62: Ultrasound-Related Messages ... 304 Table 63: Metal Interference Indication ... 311

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LIST OF FIGURES

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List of Figures Figure 1: Sample System Label ... 25 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 ... 36 Figure 5: PIU Sockets for Stimulator Connectivity ... 41 Figure 6: Generic (Locally Routed) Stimulation Socket Pair ... 41 Figure 7: Emergency Stimulation Socket Pairs... 42 Figure 8: Schematic Diagram of System Cables and Connection Points: Cart Installation ... 47 Figure 9: Schematic Diagram of System Cables and Connection Points: Boom Installation ... 48 Figure 10: Selecting Custom Mapping Channels ... 58 Figure 11: Stimulation Routing Indication ... 60 Figure 12: Stimulation Routing Indication on Main Toolbar ... 60 Figure 13: RF Energy Indication ... 62 Figure 14: Back Patches and Location Pad as Displayed in Location Setup Screen... 64 Figure 15: Indication of Maps with Different Location Reference ... 65 Figure 16: Location Setup Screen ... 66 Figure 17: Back Patch Accurate Mapping Zone ... 67 Figure 18: Chest Patch Accurate Mapping Zone ... 67 Figure 19: Mapping Catheter Accurate Mapping Zone ... 68 Figure 20: Catheter Visualization when Electrodes Covered by Sheath ... 69 Figure 21: Readings Dashboard: Sample Mapping Configuration ... 72 Figure 22: Readings Dashboard: Sample Ablation Configuration ... 72 Figure 23: Fill & Color Threshold Dialog Box ... 77 Figure 24: Map with Early Meets Late Coloring ... 78 Figure 25: Sample LAT Histogram ... 79 Figure 26: Visualization Setup Dialog Boxes for FAM (Right) and Point-by-Point Maps ... 82 Figure 27: System Status Panel with Catheter Connection Indication ... 85 Figure 28: Setup Buttons During Setup Phase ... 86 Figure 29: Main Screen in Review Mode ... 92 Figure 30: Viewing Maps from Previous Study ... 92 Figure 31: Hard Disk Optimization Dialog Box... 93 Figure 32: Hard Disk Optimization Confirmation ... 94 Figure 33: Single-channel ARA Reference Annotations- Selected Point Viewer ... 111 Figure 34: Multi-channel ARA in the Atrium- Selected Point Viewer ... 112 Figure 35: Multi-channel ARA in the Ventricle- Selected Point Viewer ... 112 Figure 36: Ultrasound Window: Body Surface ECG Reference Channel ... 112 Figure 37: Ultrasound Window: Atrial Mapping... 113 Figure 38: Pattern Matching Viewer with ARA ... 113 UG-5400-0072H (02A)

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LIST OF FIGURES

Figure 39: No Reference Annotation Indication ... 113 Figure 40: Layout of CT Segmentation Window in Data Loading Stage ... 125 Figure 41: Data Loading Layout ... 129 Figure 42: Series Replacement Warning Message ... 129 Figure 43: Slice Contours in S. Axis Align Layout ... 130 Figure 44: Initial LV Segmentation Contours Presented on Anatomy Series ... 132 Figure 45: LV Segmentation and Zones (Scar and Border Zone) Presented on Tissue Characterization Series ... 133 Figure 46: The Segmented LV and LA Chambers, in 2D and 3D Views ... 138 Figure 47: MRI Segmentation Results in the CARTOMERGE® Study ... 139 Figure 48: Monitor Pane Toolbar ... 141 Figure 49: Monitor Pane Toolbar when Timeline Mode Is Active ... 141 Figure 50: Timeline Toolbar ... 142 Figure 51: Timeline Mode Display ... 142 Figure 52: Review Line ... 142 Figure 53: Event Panel ... 143 Figure 54: Timeline and Real-time Catheter Visualizations ... 143 Figure 55: Event Panel with Selected Point and Various Events ... 145 Figure 56: Timeline Toolbar ... 145 Figure 57: Dual Monitor Extended Display Mode ... 146 Figure 58: Geometry Information Window Displaying Troubleshooting Information ... 160 Figure 59: Extended Cine Player ... 161 Figure 60: Chamber of Interest Selection ... 162 Figure 61: Status Slider on Extended Cine Player ... 163 Figure 62: Acquisition Filters Tab ... 168 Figure 63: Filters Status Toolbar ... 171 Figure 64: Filters Status Toolbar: No Point Acquired ... 171 Figure 65: Filters Status Toolbar: Collapsed ... 171 Figure 66: Filters Status Toolbar in Edit Mode... 172 Figure 67: Filters Status Toolbar with LASSO® Catheter ... 172 Figure 68: Filters Status Toolbar per Spline (Left) and per Electrode Pair ... 173 Figure 69: Filters Status Toolbar: Pattern Matching Correlation ... 173 Figure 70: Acquisition Filters: Pattern Matching ... 176 Figure 71: Pattern Matching Viewer in Play Mode (Left) and Stop Mode (Right) ... 177 Figure 72: Pattern Matching Viewer with Locked Pattern ... 177 Figure 73: IC Pattern in Pattern Matching Viewer, Play Mode ... 178 Figure 74: IC Pattern Display in Pattern Matching Viewer ... 179 Figure 75: Red (correlation below selected value) and Green value (correlation above selected value) ... 179 Figure 76: Selecting Channel Display in the Pattern Matching Viewer ... 180

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Figure 77: Pattern Matching for Point: Acquired when Continuous Mapping Was Active (Left) and Not Active (Right) ... 180 Figure 78: Pattern Matching Column in the Point List ... 181 Figure 79: Point Group Acquired with Tissue Proximity Filter ... 188 Figure 80: Wavefront Preferences ... 189 Figure 81: Bipolar Signal and Corresponding Unipolar Signals ... 190 Figure 82: Beat Buffer Showing Recommended Beat (–6) for Wavefront Annotation... 190 Figure 83: LAT Outlier Point in a Map ... 191 Figure 84: LAT Outlier in the Selected Point Viewer ... 191 Figure 85: Map Consistency Settings in the Point Filtering Dialog Box ... 192 Figure 86: Selecting LAT Outliers in the Point List ... 193 Figure 87: Ripple Map Preferences ... 195 Figure 88: Example of a Ripple Map ... 196 Figure 89: Ripple Markers in Map and Ripple Viewer ... 196 Figure 90: Morphology of Interest ... 202 Figure 91: VISITAG Presets... 213 Figure 92: Grid Cells with Minimum Time Filter ... 215 Figure 93: Distance between Two VISITAG™ Site ... 219 Figure 94: Distance Real-Time Catheter Position and Last VISITAG™ Site ... 219 Figure 95: CARTO VIZIGO™ Sheath Visualization with Matrix ... 222 Figure 96: Paired Visualization when Catheter Extends Beyond Interpolation Limit ... 223 Figure 97: PIU Connections ... 224 Figure 98: Sheath Icon in Catheter Setup Screen ... 224 Figure 99: Sheath Visualization Options in Catheter Setup Screen ... 225 Figure 100: Visualization Setup Dialog Box with CARTOFINDER™ Options ... 237 Figure 101: Point List for CARTOFINDER™ Module Maps ... 237 Figure 102: CARTOFINDER™ Site Channels in the Selected Point Viewer ... 239 Figure 103: Channel Details in the Selected Point Viewer ... 239 Figure 104: Example of Channel Selection for the CARTOFINDER™ Site ... 240 Figure 105: Hide Filtered CARTOFINDER™ Channels Option ... 240 Figure 106: Indication of Focal or Rotational Activity in the Selected Point Viewer ... 241 Figure 107: CARTOFINDER™ Color Scale Bar ... 243 Figure 108: CARTOFINDER™ Map ... 243 Figure 109: CARTOFINDER™ CL Settings ... 245 Figure 110: CARTOFINDER™ CL Color Scale Bar ... 245 Figure 111: CARTOFINDER™ Cycle Length Map ... 245 Figure 112: CARTOFINDER™ Dynamic Map ... 246 Figure 113: CARTOFINDER™ Dynamic Coloring Around a Single Electrode ... 247 Figure 114: CARTOFINDER™ Map Play Button ... 247 Figure 115: CARTOFINDER™ Map Player- Expanded View ... 247

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LIST OF FIGURES

Figure 116: Coherent Map (Left) and LAT Map (Right) ... 250 Figure 117: LAT Coloring (Left) and Coherent Coloring (Right) ... 251 Figure 118: COHERENT Cyclic Color Scale ... 252 Figure 119: Adjusted Cyclic Color Scale ... 252 Figure 120: COHERENT Maps with Different Color Scale ... 253 Figure 121: Color Scale Options ... 253 Figure 122: COHERENT Map with Manual Color Scale ... 253 Figure 123: COHERENT Map with Custom Color Scale ... 254 Figure 124: Coherent Visualization Setup Dialog Box ... 254 Figure 125: COHERENT Map with Updated Cycle Length ... 257 Figure 126: Recalculation Indication: Single Map ... 257 Figure 127: Recalculation Indication: Multiple Maps ... 257 Figure 128: Filters Status Toolbar with Parallel Mapping Group ... 261 Figure 129: LAT Hybrid Filters in Filters Status Toolbar ... 266 Figure 130: Filters Status Toolbar in a LAT Hybrid Map ... 267 Figure 131: LAT Hybrid Points in the Point List ... 268 Figure 132: Viewing Merged Maps ... 269 Figure 133: Maps from Previous Studies in the Additional Map Viewer ... 271 Figure 134: Registration Toolbar "Prev" ... 273 Figure 135: System Status Icon ... 275 Figure 136: Error Message Summary ... 275 Figure 137: Metal Values (Metal Values) Window ... 312 Figure 138: Patches View in the Main Map Viewer ... 313

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ABOUT THE CARTO® 3 SYSTEM

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Chapter 1

About the CARTO® 3 System In This Chapter: Indications for Use ... 1 Clinical Benefits ... 1 Potential Adverse Events ... 2 System Foundations ... 2 System Components ... 3 Initial Installation ... 4 Typical Setup ... 4 Modules and Optional Features ... 4 ACCURESP™ Module ... 5 Advanced Reference Annotation (ARA) ... 5 CARTOMERGE® Image Integration Module ... 5 CARTOSEG™ Segmentation Modules ... 5 CARTOREPLAY™ Module... 5 CARTOSOUND® Image Integration Module ... 5 CARTOUNIVU™ Module... 6 CARTO® 3 System-Complex Fractionated Atrial Electrogram (CFAE) Module ... 6 CONFIDENSE™ Module ... 6 FAM Dx ... 6 PASO™ Module ... 6 CARTO PRIME™ 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 About This Document ... 8 Cautions, Warnings, and Other Types of Notes ... 8

Indications for Use The intended use of the CARTO® 3 System is catheter-based cardiac electrophysiological (EP) procedures. The CARTO® 3 System provides information about the electrical activity of the heart and about catheter location during the procedure. The system can be used on patients who are eligible for a conventional electrophysiological procedure. The system has no specific contraindications.

Clinical Benefits Multiple studies from the published literature show that ablation procedures guided by CARTO® Systems resulted in similar acute and long-term efficacy and complication rates as procedures guided UG-5400-0072H (02A)

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ABOUT THE CARTO® 3 SYSTEM

by conventional fluoroscopic procedures, but with significantly lower fluoroscopy time and dose, compared to conventional fluoroscopy.

Potential Adverse Events A number of serious adverse reactions have been documented for catheter ablation procedures including pulmonary embolism, myocardial infarction, stroke, cardiac tamponade, and death. The following complications were also noted to have occurred during the study or have been reported in the literature: •

Catheterization/catheter procedure related: Vascular bleeding/local hematomas, thrombosis, AV fistula, pseudoaneurysm, thromboembolism and vasovagal reactions, cardiac perforation, tamponade, thrombi, air embolism, arrhythmias and valvular damage, pneumothorax and hemothorax.

•

Radiofrequency related: Chest pain/discomfort, ventricular tachyarrhythmia, transient ischemic attack (TIA), cerebrovascular accident (CVA), complete heart block, coronary artery spasm, coronary artery thrombosis, coronary artery dissection, cardiac thromboembolism, pericarditis, cardiac perforation/tamponade, valvular damage and increased phosphokinase level.

For additional information, see Safety Information.

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

The ECG subsystem supports receiving Body Surface ECG signals and 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

•

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

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3

projected onto a FAM reconstruction. Their anatomical data can be added to the reconstruction. Each study can have 35 maps, with a total of 100,000 points per study. A map can have up to 25,000 points. If the CARTO PRIME™ Module is installed,1 this increases to 300,000 points per study, with 50,000 points per map. 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 Table 1: "EP Equipment to Complement Use of the CARTO® 3 System (Not Supplied with the System)". 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 radiofrequency (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

Fluoroscopy System (for use with the CARTOUNIVU™ Module)

Enables display of fluoroscopic captures in the CARTO® 3 System

1 Where available

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NOTE Devices not specified as compatible with the CARTO® 3 System must not be connected to the 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 an 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. The Workstation is placed on a table or a dedicated cart. (Avoid placement on the floor.) 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

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.

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

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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. CARTO® 3 System Instructions for Use

UG-5400-0072H (02A)