Changes that are made too quickly on the ultrasound system might, not be detected by the CARTO® 3 System, due to an inherent.
stryker 5400-134-279: each. Failure to do so might result in incorrect, Before a procedure, prepare the system according to the guidelines in, When a life-sustaining pacing catheter is required, use only directly, connected pacing inputs.
The CARTO® 3 System is based on the following three foundations: ECG: The ECG subsystem supports receiving Body Surface ECG.
in relation to the magnetic locations of the sensor-based catheters. of the CARTO® 3 System Location Technology might be compromised.
The following warnings pertain specifically to use of the CARTOSOUND™, The CARTOSOUND™ Module is not supported when using the RMT.
About Biosense Webster, Inc.Biosense Webster, Inc., a Johnson & Johnson company, pioneered EP diagnostic catheters more than 20 years ago and continues to lead the industry as an innovative provider of advanced cardiac diagnostic, therapeutic, and mapping tools. of the CARTO® 3 System, might cause interference in surrounding equipment.
Learn More About Janssen's Phase 3 COVID-19 Vaccine Candidate Study Here, Biosense Webster Announces Launch of the CARTO® 3 MEM Base Version, This site uses cookies as described in our. Use only Biosense Webster supplied ECG patient cables.
Failure to do so.
for Use (IFU) to obtain information relevant to that specific catheter. Annual service, activity will be scheduled for normal business hours (with the exception of, nationally recognized holidays) or, if performed concurrently with functional, The following tables present data regarding compliance of the CARTO® 3, Table 2: Guidance and Manufacturer’s Declaration — Electromagnetic, The CARTO 3 System is intended for use in the electromagnetic environment specified, The customer or the user of the CARTO 3 System should assure that it is used in.
Failure to do so may seriously damage the CARTO® 3 System hardware. Biosense Webster, Inc.Sandy Pound, 908-218-2720(o) 908-218-2720(m) 908-432-2829Spound@its.jnj.com, Pharmaceutical Companies of Johnson & Johnson, Advancing New Healthcare Solutions Through Collaboration, Reimagining the Way Healthcare Is Delivered, Learn About the Company's Rich Heritage at Our Digital Museum. Covered by one or more of the following US Patents: 5,391,199; 5,443,489; 5,480,422; 5,546,951; 5,568,809; 5,713,946; 5,718,241; 5,738,096; 5,752,513; 5,954,665; 6,066,094; 6,226,542; 6,272,371; 6,285,898; 6,400,981; 6,690,963; 6,716,166; 7,090,639; 7,517,318; Some pictures of the workstation are provided courtesy of Dell Computer Corporation, ©Dell, Chapter 1: About the CARTO® 3 EP Navigation System ............................. 1, System Foundations .................................................................................. 2, Concept of Operation ............................................................................... 2, ECG ................................................................................................. 3, Magnetic Location Technology ......................................................... 3, Advanced Catheter Location (ACL) Technology ............................... 3, Curve Visualization ........................................................................... 4, 3D Maps ........................................................................................... 5, Fast Anatomical Mapping ( FAM ) Method ....................................... 5, System Components ................................................................................. 6, Typical Setup ............................................................................................. 6, Initial Installation ...................................................................................... 7, Important Information for Experienced CARTO® XP, System Users ............................................................................................. 7, Viewing CARTO® XP Studies ............................................................. 8, Viewing System Information ..................................................................... 8, Chapter 2: Safety Information ....................................................................... 9, System Setup Standards ........................................................................... 10, Patient Indications ................................................................................... 10, Qualified Users and Training ................................................................... 10, Warnings ................................................................................................. 11, General ........................................................................................... 11, Preventing Fire, Explosion, and Electrical Shock ............................. 12, Defibrillation ................................................................................... 13, Location .......................................................................................... 14, CARTOSOUND™ Module .................................................................. 15, CARTO® 3 System Interference with Other Medical, Equipment ...................................................................................... 16, Servicing ................................................................................................. 17, Annual Service Activity ................................................................... 17, EMC Labeling ......................................................................................... 17, Legend to Accompanying Labels ............................................................. 20, Chapter 3: System Hardware ....................................................................... 23, Hardware Classifications and Standards ................................................... 23, PIU and Related Components ................................................................. 24, Workstation Components ........................................................................ 27, Pacing Stimulator Connectivity ................................................................ 27, RF Generator Connectivity ..................................................................... 29, Ultrasound Connectivity .......................................................................... 29, EP Recording System Connectivity ......................................................... 30, Hospital PACS Connectivity .................................................................... 30, NIOBE System Connectivity .................................................................. 31, Catheters and Patches .............................................................................. 31, Catheter Definition Tool ................................................................. 32, Patient Interface Unit (PIU) .................................................................... 33, PIU Power Supply ........................................................................... 37, Location Pad (LP) ................................................................................... 37, System Cabling ........................................................................................ 37, Grounding Requirements ................................................................ 38, General Cabling Guidelines ............................................................. 38, Component Measurements ...................................................................... 42, Environmental Conditions ...................................................................... 42, Periodic Maintenance .............................................................................. 43, Replacing Parts ................................................................................ 43, Cleaning .......................................................................................... 43, When the System Is Idle .................................................................. 44, Chapter 4: ECG Functionality ..................................................................... 45, ECG Viewers .......................................................................................... 45, Annotations ............................................................................................ 46, Stimulation Functionality and Indications ................................................ 46, ECG Signal Processing ............................................................................ 47, Unipolar Reference ................................................................................. 47, Recording System Output ....................................................................... 48, Saving Recorded ECG Data .................................................................... 48, Chapter 5: Location Functionality ............................................................... 49, Magnetic Location Technology ............................................................... 49, Advanced Catheter Location Technology ................................................ 49, Body Coordinates and Location Reference .............................................. 50, Modes of Location Processing ................................................................ 50, Chapter 6: Mapping ...................................................................................... 53, Electroanatomical Mapping ..................................................................... 53, Acquiring Location Data ......................................................................... 54, Using Acquire Button ...................................................................... 69, CARTO® 3 System Location Accuracy Zones ................................... 55, Using Fast Anatomical Mapping (FAM) Method ..................................... 57, Reconstruction Details Level ........................................................... 58, Displaying FAM Maps ..................................................................... 59, Acquiring Points while Using FAM ................................................. 60, FAM Toolbar .................................................................................. 62, Chapter 7: System Operating Concepts ...................................................... 65, Modes of Operation ................................................................................ 65, Handling Error Messages ........................................................................ 66, Setup Guides ........................................................................................... 66, Hardware Setup ............................................................................... 69, Location Setup ................................................................................ 67, Study Setup ..................................................................................... 67, Catheter Setup ................................................................................. 68, Map Setup ....................................................................................... 68, File Management ..................................................................................... 69, Exporting Data ............................................................................... 69, When to Back Up Data ................................................................... 70, Chapter 8: Data Connectivity for EP Recording Systems ........................ 71, Recording System Data Connectivity ....................................................... 71, Communication States ............................................................................. 72, Chapter 9: CARTOSOUND™ Image Integration Module ............................. 73, About the CARTOSOUND™ Module .......................................................... 73, Safety Considerations for CARTOSOUND™ Module .................................. 74, Connections between CARTO® 3 System and Ultrasound, System ..................................................................................................... 74, Compatibility with Selected Ultrasound Systems ............................. 75, CARTO® 3 Connection to Ultrasound Systems ................................. 75, Catheter Connections to the PIU .................................................... 76, Setting Up the Ultrasound System ................................................... 76, Concepts and Software Options .............................................................. 78, Ultrasound Viewer .......................................................................... 78, Contours in CARTO® 3 System Maps ............................................... 79, Chapter 10: CARTOMERGE® PLUS Image Integration, Module ........................................................................................................... 81, About the CARTOMERGE® PLUS Image Integration Module, With Image Processing Package .............................................................. 82, Importing CT and MRI Images ............................................................... 82, Overview of the Image Processing Package ............................................. 83, Segmenting CT or MRI Images with the Image Processing, Package ................................................................................................... 83, Segmentation of Image Studies ....................................................... 84, Overview of the Segmentation Process ........................................... 84, Verifying Segmentation Quality ....................................................... 85, Registering Surface Images to CARTO® 3 Maps ........................................ 85, Landmark Pairs ............................................................................... 86, Registration Process ........................................................................ 87, Verifying Registration ...................................................................... 91, Chapter 11: Complex Fractionated Atrial Electrogram, (CFAE) Software ........................................................................................... 95, Displaying a New CFAE Map ................................................................. 95, Selected Point Viewer .............................................................................. 96, Chapter 12: CARTO® RMT Software Module .............................................. 97, CARTO® 3 RMT Hardware ...................................................................... 98, Handling the RMT LP ..................................................................... 98, Safe Use of the CARTO® 3 System Cart ............................................ 98, Working in the CARTO® RMT Software Module ...................................... 99, Performing a CARTO® RMT Study .................................................. 99, RMT Connection Status ................................................................ 100, Exporting Patient Data to the NIOBE System .............................. 101, Automatic Export of Real-Time Mapping Catheter, Locations ...................................................................................... 101, Exporting Point Locations to the NIOBE System ......................... 101, Remote Acquisition of Points ........................................................ 101, RMT Toolbar ................................................................................ 101, Changing the Direction of the NIOBE Magnets ........................... 102, Synchronizing the Orientation ....................................................... 103, Contact/Angle Display .................................................................. 103, Displaying Constellations with Maps ............................................. 103, Chapter 13: Error Messages and Alerts ..................................................... 105, Error Message and Alert Codes ............................................................. 106, System-Related ...................................................................................... 106, Application-Related ............................................................................... 107, ECG-Related ......................................................................................... 109, PIU-Related ........................................................................................... 109, Catheter-Related .................................................................................... 114, Location Pad-Related ............................................................................. 124, Patch-Related ........................................................................................ 126, Location-Related ................................................................................... 132, RMT-Related ......................................................................................... 133, Ultrasound-Related ................................................................................ 133, Chapter 14: Troubleshooting ...................................................................... 141, ECG Noise ........................................................................................... 141, Communication Problems ..................................................................... 142, Index ............................................................................................................. 143, Figure 1: Power Supply Mains Inlet—Warning Label ....................................... 13, Figure 2: Patient Interface Unit (PIU) .............................................................. 24, Figure 3: PIU Sockets for Stimulator Connectivity .......................................... 28, Figure 4: Patient Interface Unit (PIU) Sockets ................................................. 34, Figure 5: Schematic Diagram of System Cables and Connection, Points: Cart Installation ................................................................................... 39, Figure 6: Schematic Diagram of System Cables and Connection, Points: Boom Installation ................................................................................ 40, Figure 7: Acquire Button and Drop-Down Menu ............................................ 54, Figure 8: Back Patch Accurate Mapping Zone ................................................. 55, Figure 9: Chest Patch Accurate Mapping Zone ................................................ 56, Figure 10: Mapping Catheter Accurate Mapping Zone .................................... 57, Figure 11: High Resolution Level (Left) and Low Resolution, Level (Right) .................................................................................................... 59, Figure 12: FAM Map with Projected Electroanatomical Points ........................ 61, Figure 13: FAM Reconstruction with Applied EA Points ................................ 62, Figure 14: The Point List with EA Points Applied to the FAM, Reconstruction ................................................................................................ 62, Figure 15: Displaying the Fan Outline ............................................................. 79, Figure 16: Landmarks ...................................................................................... 86, Figure 17: Matching Maps or Vessel Tags to Surface Images ........................... 89, Figure 18: Projection of Color and ABL Tags on the Surface, Image .............................................................................................................. 91, Figure 19: Registration Match View ................................................................. 93, Figure 20: Heavy Object Label on the RMT LP .............................................. 98, Table 1: EP Equipment to Complement Use of the CARTO® 3, System (Not Supplied with the System) ............................................................. 6, Table 2: Guidance and Manufacturer’s Declaration —, Electromagnetic Emissions ............................................................................. 17, Table 3: Guidance and Manufacturer’s Declaration —, Electromagnetic Immunity .............................................................................. 18, Table 4: Guidance and Manufacturer’s Declaration —, Electromagnetic Immunity .............................................................................. 19, Table 5: Legend to Symbols Appearing on the System Hardware, and Documentation ........................................................................................ 20, Table 6: Elements Connected to the Front of the PIU .................................... 25, Table 7: Elements Connected to the Back of the PIU ...................................... 25, Table 8: Mechanical Equipment for Positioning the PIU, (Optional) ....................................................................................................... 26, Table 9: Equipment for Applying RF Energy (Optional) ................................. 26, Table 10: Catheter Interface Cables ................................................................. 36, Table 11: System Cables .................................................................................. 41, Table 12: Key to the Diagrams ........................................................................ 55, Table 13: Default Volume-Reconstruction Display, Combinations During FAM Acquisition .......................................................... 60, System Foundations .......................................................................................... 2, Concept of Operation ....................................................................................... 2, ECG .......................................................................................................... 3, Magnetic Location Technology .................................................................. 3, Advanced Catheter Location (ACL) Technology ........................................ 3, Curve Visualization .................................................................................... 4, 3D Maps .................................................................................................... 5, Fast Anatomical Mapping ( FAM ) Method ................................................ 5, FAM with Multi-Electrode Sensor-Based Catheters ............................ 5, System Components ......................................................................................... 6, Typical Setup ..................................................................................................... 6, Initial Installation .............................................................................................. 7, Important Information for Experienced CARTO® XP System, Users ................................................................................................................. 7, Viewing CARTO® XP Studies ...................................................................... 8, Viewing System Information ............................................................................. 8, This document uses various types of notes. As in all mapping procedures, ensure that the location reference does, not move during the study. Please click below to continue to that site. Consult the, Do not perform pacemaker interrogation or programming, while the Location Pad is activated. Dr. Reddy is compensated for his services as a member of the company’s scientific advisory board and provides other consulting services. The third-party trademarks used herein are trademarks of their respective owners. If the reference moves, contour display, might appear in an incorrect position, leading to misinterpretation and. Equipment that does, not comply with IEC 60601-1 standard is not compatible with the, Contact the local Biosense Webster representative before connecting, the CARTO® 3 System to any device that is not recommended for use, Preventing Fire, Explosion, and Electrical Shock, The following warnings pertain specifically to preventing fire, explosion, or, For continued protection against the risk of fire, use only replacement, fuses that have the same type and rating as the original fuses. Do not cover the vent openings of the PIU or workstation while they, are functioning. Caution: US Federal law restricts this device to … are equipped with a Biosense Webster location sensor and ID. Always keep the conductive parts of lead electrodes and associated. Your use of the information on this site is subject to the terms of our Legal Notice. If you do not select a system, the CARTO® 3 System boots by default. The Location Pad is heavy and can cause injury if dropped. 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