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";s:4:"text";s:22476:"Die 3-dimensionale Erfassung der Anatomie einer Herzkammer erfolgt durch Abtasten der endokardialen Kontur mit dem Mappingkatheter (Erstellen einer 3-D-Geometrie). site, nor does it replace the CARTO® 3 System Instructions for Use (IFU). 3 Seiten. The workstation must not be used for any other. For, example, "Press " means "Press the Ctrl button on the keyboard. Installation and testing of the equipment should be performed. Always verify mapping catheter tip position in relation to the ultrasound, ♦ When working with maps that combine ultrasound data (contours), ♦ When comparing the anatomy, or the frame images, or the pictures, displayed in the Ultrasound Viewer with the display in the Map, Use your common clinical practice, such as fluoroscopy or inspection, of IC signals, to verify the location of the catheters throughout the, procedure. Normal operation of a pacemaker is not, Verify the ICD programming after completing the CARTO® 3, The CARTO® 3 System might interfere with fluoroscopy systems that, use magnetic field based proximity sensors or with digital fluoroscopic, systems. It complies with the Medical Device Directive 93/42/EEC and with the, EMC directive 89/336/EEC as amended by 92/31/EEC and 93/68/EEC. Current. Diese Katheter (NAVI-STAR, Biosense Webster) dienen dem Mapping, aber auch der Ablation. Any unauthorized attempt to repair equipment that is still under warranty, CAUTIONS, WARNINGS, AND OTHER TYPES OF NOTES, Throughout this Manual, you will see cautions, warnings, and other types of, Cautions warn of possible damage to patient data or to the CARTO® 3, Warnings are the most serious of advisories and warn of, possible injury to the patient or user, or of permanent. When using external defibrillators with an incompatible, synchronizing function, disable the CARTO® 3 System Location Pad. Notes give plain good advice, and/or additional information of, In addition, information for experienced users, or examples that clarify, These types of notes provide additional information that. In rare cases, however, touching the system while it, is turned on might result in an ESD and cause a visible transient, location error in the display. The clinical significance of utilizing the CFAE Module to help identify, areas with complex fractionated atrial electrograms for catheter ablation, of atrial arrhythmias, such as atrial fibrillation, has not been established, Please use your common clinical practice, such as fluoroscopy or, inspection of IC signals, to verify the location of the catheters, throughout the procedure. Connect the system to the required network(s) and to other systems. This manual does not replace the users’ training course given at a CARTO® 3, System training center or upon installation of the equipment at the customer's. To prevent electrocution, be sure that patient cables and electrodes. © 2020 Alle Rechte vorbehalten The following warnings pertain specifically to preventing fire, explosion, or. The following warnings specifically relate to situations in which the accuracy. of the CARTO® 3 System Location Technology might be compromised. UT is the AC mains voltage prior to application of the test level. patient cable yoke, and noise immunity is not compromised. and to help you locate specific information. Atrial Fibrillation Fact Sheet. Only licensed medical practitioners who have completed the. Devices incl ETHICON MENTOR Leiden Gel Breast Implant Sizer Product Insert Data Sheet, CARTO 3 System, and CoolFlow System… include contours, and subsequent misinterpretation of contour maps. -, Suchen Sie unter 132.682 medizinischen Ausstattungen, CARTO® THERMOCOOL® Bi-Directional Catheter, QWIKSTAR DS 7F 26-pole with 8 mm Tip/Thermocouple, QWIKSTAR 7F 26-pole with 4 mm Tip/Thermocouple, 7F Quadrapolar Catheter with 8 mm Tip/Thermocouple, 6F Quadrapolar Pediatric Catheter with Non-Braided Tip/Thermocouple, 6F Quadrapolar Pediatric Catheter with Non-Braided Tip/Thermistor, Wittkampf (Posterioseptal) Catheter/Thermocouple, Wittkampf (Posterioseptal) Catheter/Thermistor, 7F and 8F Quadrapolar Catheter with 4 and 5 mm Long Reach Braided Tip/Thermocouple, 7F and 8F Quadrapolar Catheter with 4 and 5 mm Long Reach Braided Tip/Thermistor, 7F and 8F Quadrapolar Catheter with 5 mm Braided Tip/Thermocouple, 7F and 8F Quadrapolar Catheter with 5 mm Braided Tip/Thermistor, 7F and 8F Quadrapolar Catheter with 4 mm Braided Tip/Thermocouple, 7F and 8F Quadrapolar Catheter with 4 mm Braided Tip/Thermistor, 6F and 7F Quadrapolar Catheter with Non-Braided Tip/Thermocouple, 6F and 7F Quadrapolar Catheter with Non-Braided Tip/Thermistor, CELSIUS THERMOCOOL Irrigated Tip Catheter, NAVISTAR THERMOCOOL Irrigated Tip Catheter, QWIKCABLE Autoclavable Cable for Diagnostic Catheters with Redel Connector (RT), WEBSTER 4F, 5F, and 6F Hexapolar Pediatric Catheter, WEBSTER Compli Soft Tip Quadrapolar Catheter, WEBSTER Deflectable Octapolar Pediatric Catheter with Redel Connector for His Application, WEBSTER 5F and 6F Quadrapolar Pediatric Catheter, WEBSTER 5F Deflectable Bipolar Pediatric Catheter, CELSIUS® DS Temperature Sensing Ablation Catheters 7F Quadrapolar with 8mm Tip/Thermocouple, CARTOSound Image Integration Module with SOUNDSTAR Catheter, CARTO RMT Electroanatomical Navigation System Brochure, QWIKSTAR DS Navigation and Ablation Catheters, QWIKSTAR Navigation and Ablation Catheters, NAVISTAR THERMOCOOL? incorrect target for ablation or perforation. The Location Pad's. For example, "Click File > New Map", means "Click New Map from the File menu. Changes that are made too quickly on the ultrasound system might, not be detected by the CARTO® 3 System, due to an inherent. CARTO® THERMOCOOL® Bi-Directional Catheter. The system has, Physicians and medical staff designated to be CARTO® 3 System users must. complete the training course prior to using the system. Unauthorized software should not be installed on the system. The low-level magnetic fields generated by the Location Pad, an integral part. same but the position of the patches relative to the heart has changed, the system will not give a warning and an incorrect map might be, If magnetic sensors are placed outside the mapping field, the CARTO® 3, System shows an onscreen warning message and requires either, repositioning of the sensors inside the mapping field or repositioning, Metal interference is caused when a ferromagnetic material is placed, within the magnetic working area. Such a cable is, identified by the presence of the defibrillation-proof, symbol on the molded plastic “leads-end” of the, The CARTO 3 System comes equipped with an, equipotential earth pin. Notes. trunk cable. 2 Seiten. • These guidelines might not apply in all situations. Biosense Webster Inc. to service the CARTO® 3 System. The Location Pad is heavy and can cause injury if dropped. requirements for the applicable IEC 60601 series safety standards. 3 Seiten. reflection from structures, objects, and people. The, "immediate vicinity" is within 5 cm of the catheter tip for, instruments the size of those used in the operation room (such as, scissors, scalpels, ECG nipples, other catheter electrodes, and, pacemakers). Throughout this Manual, typographical conventions are used for easy reading. CARTO 3 advanced 3D mapping system, integration, scalability and insights for electrophysiology diagnosis and treatment. This might, Auto-matching of acquisition parameters must be enabled when, working with the Cypress System (Tools options in the Ultrasound, Disabling this option could lead to incorrect presentation of maps that. It might be necessary to take mitigation, measures, such as re-orienting or relocating the CARTO® 3, Table 2: Guidance and Manufacturer’s Declaration — Electromagnetic, below. Annual service activity will include any actions that Biosense Webster Inc. considers necessary to ensure proper operation of the System. The system is ready for clinical use only after it has been fully tested and, The workstation (PC®) supplied with the CARTO® 3 System is a dedicated, computer for the system. allowable between the image intensifier and the patient table. CARTO® 3 System. The CONFIDENSE ™ Mapping Module offers CARTO ® 3 System users a complete and streamlined high-density mapping solution. The system assumes that, when the relative position between these patches is maintained, the, position of the patches relative to the heart is also maintained. defibrillation-proof connectors of approved medical equipment only. shown in Figure 1 appears on the power supply. However, when the relative position between the patches remains the. When the interference is major, a warning will be generated. Catheter. Pace routing can be performed only to a preselected pair of electrodes. Table 3: Guidance and Manufacturer’s Declaration — Electromagnetic, • At 80 MHz and 800 MHz, the higher frequency range. CATALOGUE 2018. interfere with the programming of implantable cardiac pacemakers. connected as per standard hospital procedure. 5 Seiten . Doing so may stop the procedure and damage the, Do not position the PIU in a way that a stream of air from the internal. ", A single keyboard command is written between angled brackets. The label. parts away from other conducting parts, including ground. information provided in the related text. ♦ Metal interference might also be caused by a ferromagnetic material, placed within the immediate vicinity of the catheters. Es handelt sich um unverbindliche Preisangaben, die sich je nach Land, Rohmaterialkursen und Währungsvariationen ändern können. may be referred to some of the information supplied herein. Call. To prevent observing ESD disturbances, use ESD. All menu options and fields that appear on the screen are in smaller, sized boldface Arial font. If it is necessary to program or interrogate a pacemaker or defibrillator, while using the system, turn off the Location Pad, using the icon on, the workstation monitor. findings. Parts and accessories used must meet the. ♦ To find out the magnetic working area for a specific installation, refer to the Image Intensifier Chart provided upon installation of, the CARTO® 3 System. 4 Seiten. The order of the following warning statements does not give any indication, Each catheter has indications, contraindications, and warnings or, precautions that are specific to that catheter. Mittels simultaner Registrierung von elektrischen Signalen entsteht anschließend ein elektroanatomisches Map. * Die Preise verstehen sich ohne Lieferkosten und Zollgebühren und enthalten keine der Zusatzkosten, die aus Installationsoptionen oder Inbetriebnahme resultieren. Some pictures of the workstation are provided courtesy of Dell Computer Corporation, ©Dell, Chapter 1: About This Manual ...................................................................... 1, Cautions, Warnings, and Other Types of Notes ......................................... 2, Document Conventions ............................................................................ 2, Chapter 2: Safety Information ....................................................................... 5, System Setup Standards ............................................................................. 6, Patient Indications .................................................................................... 6, Qualified Users and Training ..................................................................... 6, Warnings ................................................................................................... 7, General ............................................................................................. 7, Preventing Fire, Explosion, and Electrical Shock .............................. 8, Defibrillation ..................................................................................... 9, Location .......................................................................................... 10, CARTOSOUND™ Module .................................................................. 11, CARTO® 3 System Interference with Other Medical, Equipment ...................................................................................... 12, Annual Service Activity ........................................................................... 13, Electromagnetic Compatibility (EMC) .................................................... 13, Legend to Accompanying Labels ............................................................. 15, Chapter 3: System Hardware ....................................................................... 19, Hardware Classifications and Standards ................................................... 19, Patient Interface Unit (PIU) .................................................................... 20, PIU Power Supply ........................................................................... 24, PIU and Related Components ......................................................... 24, Workstation Components ........................................................................ 27, Location Pad (LP) ................................................................................... 27, Catheters and Patches .............................................................................. 28, Catheter Definition Tool ................................................................. 30, System Cabling ........................................................................................ 30, Grounding Requirements ................................................................ 31, General Cabling Guidelines ............................................................. 31, Chapter 4: Successful Boot Verification ...................................................... 35, Chapter 5: Interface with External Devices ................................................ 37, Interfacing with EP Recorders ................................................................ 37, EP Recording System Connectivity ................................................. 38, Interfacing with RF Generators ............................................................... 38, RF Generator Connectivity ............................................................. 38, Connect to Stockert RF Generator EP/IO Box .............................. 39, Stimulators .............................................................................................. 39, Pacing Stimulator Connectivity ........................................................ 39, Connect CARTO® 3 System to a Pacing Device ................................ 41, Hospital PACS Connectivity .................................................................... 42, NIOBE System Connectivity .................................................................. 42, Interfacing with Ultrasound Systems ....................................................... 42, Ultrasound Connectivity .................................................................. 42, CARTO® 3 System Presets for Use with Ultrasound, Systems ........................................................................................... 43, Chapter 6: Periodic Maintenance ................................................................ 47, Replacing Parts ........................................................................................ 47, Replace Fuses .................................................................................. 48, Cleaning .................................................................................................. 48, When the System Is Idle .......................................................................... 48, Chapter 7: Troubleshooting CARTO® 3 System ........................................... 49, Initial Approach to Troubleshooting ....................................................... 49, Handling Error Messages ........................................................................ 50, Error Message Descriptions ............................................................ 51, System-Related ................................................................................ 51, Application-Related ......................................................................... 52, ECG-Related ................................................................................... 53, PIU-Related .................................................................................... 53, Catheter-Related .............................................................................. 58, Location Pad-Related ...................................................................... 70, Patch-Related .................................................................................. 71, Location-Related ............................................................................. 78, RMT-Related ................................................................................... 79, Ultrasound-Related .......................................................................... 79, Chapter 8: Handling Noise .......................................................................... 83, System Cabling ........................................................................................ 83, Noise, EP Lab, and CARTO® 3 System ..................................................... 84, Importance of Ground Connections ....................................................... 84, Electrical Ground Connection ......................................................... 85, Virtual Ground Connection ............................................................ 86, EP Lab Setup Considerations .................................................................. 87, Importance of Correct Patient Cable Connections .................................. 87, Noise Sources in an EP Lab .................................................................... 88, Software Filters on the CARTO® 3 System ................................................ 89, Default Settings ............................................................................... 89, Chapter 9: System Specifications ................................................................. 91, CARTO® 3 Components Dimensions and Weight ..................................... 91, Power Consumption ................................................................................ 92, Environmental Conditions ...................................................................... 92, Index ............................................................................................................... 95, Figure 1: Power Supply Mains Inlet—Warning Label ........................................ 9, Figure 2: Patient Interface Unit (PIU) Sockets ................................................. 21, Figure 3: Patient Interface Unit (PIU) .............................................................. 24, Figure 4: Schematic Diagram of System Cables and Connection, Points: Cart Installation ................................................................................... 32, Figure 5: Schematic Diagram of System Cables and Connection, Points: Boom Installation ................................................................................ 33, Figure 6: PIU Rear Panel LED Indicators ....................................................... 35, Figure 7: Connecting the EP/IO Box to CARTO® 3 System ............................. 39, Figure 8: PIU Sockets for Stimulator Connectivity .......................................... 40, Figure 9: PIU Connections for a Stimulator: General Input (red), and Direct Inputs (blue) .................................................................................. 41, Figure 10: Error Message Example ................................................................. 51, Figure 11: Correct Electrical Ground Connection ........................................... 85, Figure 12: Incorrect Electrical Ground Connection ......................................... 86, Figure 13: Virtual Ground Connection ............................................................ 87, Figure 14: Patient Cable Connection ............................................................... 88, Table 1: Guidance and Manufacturer’s Declaration —, Electromagnetic Emissions ............................................................................. 13, Table 2: Guidance and Manufacturer’s Declaration —, Electromagnetic Immunity .............................................................................. 14, Table 3: Guidance and Manufacturer’s Declaration —, Electromagnetic Immunity .............................................................................. 15, Table 4: Legend to Symbols Appearing on the System Hardware, and Documentation ........................................................................................ 16, Table 5: Catheter Interface Cables ................................................................... 23, 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: System Cables .................................................................................. 34, Table 11: CARTO® 3 System Components Dimensions and, Weight (metric) ................................................................................................ 91, Table 12: CARTO® 3 System Components Dimensions and, Weight (English) .............................................................................................. 92, Table 13: CARTO® 3 System Power Specifications ............................................ 92, Table 14: Environmental Conditions ............................................................... 92, Cautions, Warnings, and Other Types of Notes ................................................. 2, Document Conventions .................................................................................... 2, This manual is for the use of clinical personnel trained and authorized by. 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