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• A thorough understanding of the technical principles, clinical applications, and
risk associated with cryoablation is necessary before using this product. Use of
this device should be restricted to use by or under the supervision of physicians
trained in cryoablation procedures with a Galil Medical Cryoablation System.
• Do not use TS/MTS near magnetic resonance imaging (MRI) equipment.
• The Galil Medical Thermal Sensor (TS/MTS) is a disposable product and
is designed as a single-use product. This device has not been validated for
resterilization or reprocessing. Potential anticipated risks associated with
reprocessing of this product include, but are not limited to, inadequate sterilization
thereby creating an increased risk of patient infections and increased risk of
bloodborne pathogen disease transmission; degradation of performance due to
material fatigue and loss of thermal sensor function, thereby creating increased
patient risks, including but not limited to the risk of inadequate or excessive
patient treatment.
• Whenever operating a Galil Medical Cryoablation System, a TS or MTS should
be used to monitor tissue temperatures during Freezing and Thawing cycles,
comparing procedure temperatures to the intended treatment protocol.
• BEFORE THE PATIENT IS ANESTHETIZED, Needle Integrity and Functionality
Tests on each cryoablation needle and Thermal Sensor Integrity and Functionality
Tests on each thermal sensor must be completed successfully.
• A defective TS/MTS must never be used and should be returned to Galil Medical
for evaluation.
• In the rare event that a thermal sensor breaks while inserted in the tissue, act
immediately to remove sensor parts from the patient's body and report such
event to Galil Medical.
• Discontinue all needle operation prior to needle and thermal sensor removal to
minimize risk of tissue injury.
• Remove thermal sensors from the patient prior to disconnecting the thermal
sensors from the cryoablation system.
Single-Point 1.5 Thermal Sensor™ and Multi-Point 1.5 Thermal Sensor™
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