SensiTherm™ Multi Temperature Monitoring System

Indications, Safety and Warnings

SensiTherm™ Multi Temperature Monitoring System

CAUTION: This product is intended for use by or under the direction of a physician. Prior to use, reference the Instructions for Use, inside the product carton (when available) or at manuals.sjm.com or eifu.abbottvascular.com for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events.

Indications for Use

The SensiTherm™ Multi Temperature Monitoring System is composed of SensiTherm Multi Monitor and SensiTherm™ Multi Probe and is intended for the continuous detection, measurement and visualization (in °C) of esophageal temperature. The intended environments of use are operating rooms and interventional electrophysiology rooms. The SensiTherm Multi Probe must be used in conjunction with the SensiTherm Multi Monitor. The role of esophageal temperature monitoring using this device in reducing the risk of cardiac ablation related esophageal injury has not been established. The performance of the SensiTherm Multi system in detecting esophageal temperature changes as a result of energy delivery during cardiac ablation procedures has not been evaluated.

Contraindications

The insertion of the SensiTherm Multi Probe in the esophagus is not recommended if the esophagus is deformed or irritated. There are no specific contraindications or side effects related to the use of SensiTherm Multi Monitor. However, the insertion of the probe by an unskilled operator can cause discomfort and slight abrasions to the patient. To avoid that risk, it is essential that SensiTherm Multi Monitor is used only by medical personnel.

Warnings and Precautions

Thermal stabilization: The technology used by SensiTherm Multi Monitor for the metering process requires that the handle of the probe and that of the patient cable are approximately at the same temperature. Hence, it is recommended to wait at least 15 minutes between the instant in which the components are brought in the working environment and the start of a measurement session, especially if the probe or the patient cable have long stationed in environments with temperature and/or humidity significantly different from those of use. It is recommended not to place the two handles in such a way that during the measurements only one of the two objects remains for a prolonged time in proximity to or in contact with a heat or cold source. Failure to observe these precautions can lead to an accuracy of the instrument lower than the one stated in the technical specifications. MR Unsafe: Due to the presence of metallic parts in the components of SensiTherm™ Multi Monitor, the device and its accessories must never be kept inside or in close proximity to a patient who is about to undergo magnetic resonance imaging. For the full list of warnings and precautions, please refer to the applicable Instructions for Use.

EnSite™ X EP System

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. The use of this device in conjunction with radio frequency ablation, as a part of the diagnosis and treatment of cardiac arrhythmias, may pose an increased risk of adverse events such as cardiac perforation, myocardial infarction, air embolism, and hematoma requiring surgical repair and/or blood transfusion. 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. 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.

Precautions: Ensure that surface electrodes, Patient Reference Sensors, and associated connectors do not contact one another, electrical ground, or metallic objects. EnSite™ X EP System components should be connected to power through an isolation transformer or the multiple socket outlet supplied with the system carts. Connecting equipment directly to a wall outlet may result in excessive leakage current. Do not operate the EnSite™ X EP System Field Frame within 10 m of another operating Field Frame. Do not place the EnSite™ X EP System Field Frame Cable inside the measurement volume or wrap it around the EnSite™ X EP System Field Frame, as it may create a magnetic interference. Metallic equipment used in close proximity to the magnetic field during the procedure, such as a sterile drape holder, may cause metal distortion. Do not place tool cables within 30 mm of the EnSite™ X EP System Field Frame Cable. If placed this close-particularly if the cables are parallel to each other the tool cable may become subject to electromagnetic interference. Do not use the EnSite™ X EP System in the presence of other magnetic fields. Do not drop the EnSite™ X EP System Field Frame or subject it to impact. Physical damage to the EnSite™ X EP System Field Frame may alter the EnSite™ X EP System Field Frame’s factory calibration.