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6 Precautions
6.1 General
• The physician is solely responsible for all clinical use of the cryoablation needles
and thermal sensors and for any results obtained by use of the system. All clinical
decisions prior to and throughout the cryoablation procedure shall be made by the
physician based upon his/her professional opinion.
• Training on appropriate use of a Galil Medical Cryoablation System is required prior
to conducting cryoablation with a Galil Medical System.
• Continuously monitor the cryoablation procedure using direct visualization or image
guidance such as ultrasound or Computed Tomography (CT).
• Use TS/MTS to monitor attainment of the freeze / thaw temperatures for the
intended treatment protocol.
• Use TS/MTS to monitor temperature in target tissue near critical structures.
• Availability of back-up TS/MTS is recommended should a replacement or additional
TS/MTS be required during a procedure.
• Do not use TS/MTS near magnetic resonance imaging (MRI) equipment.
• Ensure appropriate stability of tubing to avoid inadvertent snagging of tubing and/or
TS/MTS shifting during a procedure.
• Use care in handling TS/MTS packages during transport and storage.
• Avoid extremes in temperature and humidity during transport and storage.
6.2 Handling and Sterilization
• Observe the expiration date of this product. Do not use past the listed expiration
date.
• Before opening a sensor pouch, check the sterilization indicator within the pouch.
• Each thermal sensor is provided for one-time use only. The sensor has not been
tested for multiple use. Do not resterilize a thermal sensor.
• Inspect the packaging for damage. Do not use a TS/MTS if packaging appears
opened or damaged, or the sensor is damaged; in the event of such occurrence,
contact a Galil Medical representative to arrange return of the complete package
with the product.
6
Instructions for Use
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