EnSite X
EP System

Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events, and directions for use.

United States: Required Safety Information

Indications: The EnSite™ X EP System is a suggested diagnostic tool in patients for whom electrophysiology studies have been indicated. The EnSite™ X EP System provides information about the electrical activity of the heart and displays catheter location during conventional electrophysiological (EP) procedures.

Warnings: 

• For patient safety, any connections that directly connect the patient to the EnSite™ X EP System must be routed through the appropriate modules: EnSite™ X EP System SurfaceLink Module, EnSite™ X EP System 20 pin Catheter Input Module, EnSite™ X EP System 80-pin Catheter Input Module and Direct Connect Ports on the EnSite™ X EP System Amplifier.
• When using the EnSite™ X EP System, full protection against the effects of cardiac defibrillator discharge and other leakage currents is dependent upon the use of appropriate cables.
• Refer to the ablation catheter IFU for a listing of adverse events related to the use of this device in conjunction with ablation, as a part of the diagnosis and treatment of cardiac arrhythmias.
• Non-SE catheters cannot collect location data and should not be used for navigation in VoXel Mode because they do not have a magnetic sensor. However, they can be visualized and display intracardiac signals.
• Only connect items that have been specified as part of the EnSite X EP System or compatible with the EnSite X EP System to the multiple socket-outlets.
• The EnSite™ X EP System model display should be used in conjunction with conventional EP techniques to confirm catheter location.
• The AutoMark feature does not indicate lesion effectiveness. AutoMarks are placed based on user-defined parameters for catheter stability and RF metrics only. PFA AutoMarks are placed based on electrode location and user-defined PFA metrics only.
• Sudden impedance changes of the body or catheter electrodes caused by the connection of other devices (e.g., stimulator, defibrillator, and other devices) may create a location shift.
• The 2D and 3D LivePoint Displays should not be used as the primary / sole display of tissue proximity during an Electrophysiology study. Refer to the Current PFA Generator IFU for warnings related to the Volt ™ LivePoint Display.  

Precautions: 

• For patient safety, any connections that directly connect the patient to the EnSite™ X EP System must be routed through the appropriate modules: EnSite™ X EP System SurfaceLink Module, EnSite™ X EP System 20 pin Catheter Input Module, EnSite™ X EP System 80-pin Catheter Input Module and Direct Connect Ports on the EnSite™ X EP System Amplifier.
• When using the EnSite™ X EP System, full protection against the effects of cardiac defibrillator discharge and other leakage currents is dependent upon the use of appropriate cables.
• Refer to the ablation catheter IFU for a listing of adverse events related to the use of this device in conjunction with ablation, as a part of the diagnosis and treatment of cardiac arrhythmias.
• Non-SE catheters cannot collect location data and should not be used for navigation in VoXel Mode because they do not have a magnetic sensor. However, they can be visualized and display intracardiac signals.
• Only connect items that have been specified as part of the EnSite X EP System or compatible with the EnSite X EP System to the multiple socket-outlets.
• The EnSite™ X EP System model display should be used in conjunction with conventional EP techniques to confirm catheter location.
• The AutoMark feature does not indicate lesion effectiveness. AutoMarks are placed based on user-defined parameters for catheter stability and RF metrics only. PFA AutoMarks are placed based on electrode location and user-defined PFA metrics only.
• Sudden impedance changes of the body or catheter electrodes caused by the connection of other devices (e.g., stimulator, defibrillator, and other devices) may create a location shift.
• The 2D and 3D LivePoint Displays should not be used as the primary / sole display of tissue proximity during an Electrophysiology study. Refer to the Current PFA Generator IFU for warnings related to the Volt ™ LivePoint Display.