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<h2>Indications, Safety, and Warnings</h2> <h3>Indications</h3> <p>The CardioInsight™ cardiac mapping system is intended for acquisition, analysis, display and storage of cardiac electrophysiological data and maps for analysis by a physician.</p> <h3>Contraindications</h3> <p>There are no known contraindications.</p> <h3>Warnings and precautions</h3> <h4>Cardiac mapping system</h4> <h5>Warnings</h5> <ul> <li>Do not modify the attachment plug or use a power adapter. This could cause an electrical hazard. If you require a different electrical socket plug, contact your local Medtronic Representative. CardioInsight™ must always be connected to the power source properly.</li> <li>Ensure that all power sources are appropriately rated and are properly grounded or earthed. If the CardioInsight™ system is not properly grounded or earthed, it becomes a possible electric shock hazard. Protection against electrical shock has been provided through an isolation transformer and chassis grounding via a plug to an appropriate power source.</li> <li>Electroanatomical mapping with CardioInsight™ should ONLY be performed after the risks of the entire procedure, including radiation exposure and time required for signal collection, have been adequately considered for each patient.</li> </ul> <h5>Precautions</h5> <ul> <li>The installation and setup of CardioInsight™ and its software should ONLY be performed by trained Medtronic personnel.</li> <li>Portable or mobile RF communications equipment may affect CardioInsight™.</li> <li>Extension cords and electrical power bars should NEVER be used with CardioInsight™.</li> <li>CardioInsight™ should not be connected to any equipment that is not supported by or part of the system.</li> <li>The isolation transformer should NEVER be placed on the floor for use.</li> <li>Do not stack other equipment on the mapping amplifier or the system cart.</li> <li>Do not use the cart for any other purpose than storing and using CardioInsight™.</li> <li>The workstation that is supplied as part of CardioInsight™ is not intended for use without the isolation transformer.</li> <li>Devices that connect to CardioInsight™ via Universal Serial Bus (USB) such as an external hard drive should be used ONLY after approval by Medtronic as they may introduce computer viruses.</li> <li>Installation of software not authorized by Medtronic on the CardioInsight™ workstation can cause the system to display inaccurate results or otherwise malfunction, and will void the terms of the product warranty.</li> <li>Do not replace the amplifier fuses while the system is in use or connected to the patient.</li> <li>Assembly, repair, and modifications of the system over its service life will be evaluated based on the requirements of IEC 60601-1 prior to implementation.</li> <li>CardioInsight™ should ONLY be used by trained personnel or under the guidance of trained Medtronic personnel.</li> <li>CardioInsight™ should ONLY be used in an institution’s environment.</li> <li>Do not use CardioInsight™ in the presence of flammable anesthetic mixtures with air, oxygen, or nitrous oxide.</li> <li>The CardioInsight™ acquisition should be performed on the same day as the completion of the CT scan.</li> <li>The system cables, including the Sensor Array signal cables and patient ground reference cable are provided non-sterile. DO NOT sterilize the cables.</li> </ul> <h4>Sensor array</h4> <h5>Warnings</h5> <ul> <li>DO NOT use the Sensor Array if the patient has sensitivity, open sores, or a severe skin condition or disease of the thorax area.</li> <li>DO NOT perform magnetic resonance (MR) imaging with the Sensor Array on the patient. The Sensor Array may cause harm to the patient if used in MR imaging. Remove Sensor Array prior to performing MR imaging studies.</li> <li>Remove or peel back front Sensor Array panels prior to using an external defibrillator on the patient.</li> </ul> <h5>Precautions</h5> <ul> <li>The Sensor Array should only be connected to the CardioInsight™ Cardiac Mapping System.</li> <li>The Sensor Array is meant to be used only during computed tomography (CT) imaging procedures that use legally marketed CT scanners.</li> <li>The CardioInsight™ acquisition should be performed on the same day as the completion of the CT scan. The Sensor Array should not be removed or repositioned between the CT scan and the acquisition.</li> <li>The Sensor Array is not sterile and cannot be sterilized. Care should be taken to keep the Sensor Array outside of any sterile field.</li> <li>DO NOT expose the Sensor Array to organic solvents such as alcohol. If an organic solvent is used on patient, allow to dry for at least one minute prior to applying Sensor Array.</li> <li>DO NOT expose the Sensor Array and electrical connectors to fluids or solvents, except when following the cleaning instructions in the Operator’s Manual.</li> <li>Store Sensor Array flat (parallel to the floor) with the correct side facing up, as labeled, according to the environmental storage conditions.</li> <li>Store Sensor Array panels in their sealed protective pouches until use.</li> <li>The Sensor Array is intended for single use ONLY. Reusing the Sensor Array may result in poor system performance or transmission of infection.</li> <li>Panels from different Sensor Array sizes should NEVER be mixed and matched for use.</li> <li>DO NOT cut or fold the circuitry on the Sensor Array.</li> </ul> <h3>Potential Adverse Events</h3> <p>None known</p> <p><br /> <i>Refer to the device technical manual for detailed information regarding the procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1-800-328-2518 and/or consult the Medtronic website at www.medtronic.com.</i></p> <p><b>Caution:</b> Federal law (United States) restricts these devices to sale by or on the order of a physician.</p> <p>MAJ_84196</p>

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