Indications, Safety & Warnings for Sensitherm Multi Esophageal Monitoring System | Abbott
CARDIOVASCULAR
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Sensitherm Multi Esophageal Monitoring System

Indications, Safety and Warnings

SensiTherm™ Multi Esophageal
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 Esophageal 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 Precision Cardiac Mapping System Indications

The EnSite Precision™ Cardiac Mapping System is a suggested diagnostic tool in patients for whom electrophysiology studies have been indicated. The EnSite Precision™ System interfaces to either the MediGuide™ Technology System or the EnSite Precision™ Module to combine and display magnetic processed patient positioning and navigation mapping information. When used with the EnSite™ Array™ Catheter, the EnSite Precision™ Cardiac Mapping System is intended to be used in the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone. OR, when used with an EnSite Precision™ Surface Electrode Kit, the EnSite Precision™ Cardiac Mapping System is intended to display the position of conventional electrophysiology (EP) catheters in the heart. Warnings: Refer to the ablation catheter labeling for a listing of adverse events related to the use of this device in conjunction with radio frequency ablation, as a part of the diagnosis and treatment of cardiac arrhythmias. For patient safety, any connections that directly connect the patient to the EnSite Precision Cardiac Mapping System must be routed through the appropriate module: EnSite Precision Link, Sensor Enabled™ NavLink, EnSite Precision Field Frame, ArrayLink, CathLink, SJM ECG Cable, RecordConnect, or GenConnect. When using the EnSite Precision Module 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 labeling for a listing of adverse events related to the use of this device in conjunction with radio frequency ablation, as a part of the diagnosis and treatment of cardiac arrhythmias. Precautions: Do not operate the EnSite Precision Field Frame within 10 meters (m) of another operating Field Frame. Do not place the EnSite Precision Field Frame cable inside the measurement volume or wrap it around the Field Frame, as it may create a magnetic interference. Do not coil the EnSite Precision Field Frame cable. The cable carries enough electric current that a magnetic field will be created when the cable is placed in a circular formation. This magnetic field may disturb the Field Frame’s magnetic field. Do not place the EnSite Precision Link, Sensor Enabled™ within 1 m of the EnSite Precision Field Frame - Do not place tool cables within 30 millimeters (mm) of the EnSite Precision 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. Metallic equipment used in close proximity to the magnetic field during the procedure, such as a sterile drape holder, may affect Sensor Enabled (SE) points and SE field scaling accuracy. Do not use the EnSite Precision Cardiac Mapping System in the presence of other magnetic fields. Do not drop the EnSite Precision Field Frame or subject it to impact. Physical damage to the Field Frame may alter the Field Frame’s factory calibration.

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DO YOU WISH TO CONTINUE AND EXIT CARDIOVASCULAR.ABBOTT?

CONTENTS OF THE SITE ARE NOT UNDER THE CONTROL OF ABBOTT.