ICEfx™ Cryoablation System
1-3
• Galil Medical Urethral Warming Set: The Urethral Warming Set is the conduit that circulates
warm saline through the urethra during a prostate cryoablation procedure.
The following items used with the ICEfx Cryoablation System are re-usable and should be cleaned
and/or sterilized in accordance with the Instructions for Use that accompanies each product.
• IV Pole and Bracket for use with a uid warmer and pump system
The following items are needed to conduct cryoablation procedures and are not available from Galil
Medical.
• Argon gas cylinder(s)
NOTE: The argon gas must meet the purity requirements specied in Section 9.5.
• A uid warmer and pump system when using the Galil Medical Urethral Warming Set
1.2.3 Storage
Store the ICEfx Cryoablation System in a cool, dry, secure location. Storage conditions should be
within -15°C to +50°C and 10% to 90% relative humidity.
1.3 Intended Use
The Galil Medical ICEfx Cryoablation System is intended for cryoablative destruction of tissue during
minimally invasive procedures; various Galil Medical accessory products are required to perform
these procedures. The ICEfx Cryoablation System is indicated for use as a cryosurgical tool in the
elds of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery (with
the exception of cardiac tissue), ENT, gynecology, oncology, proctology, and urology. This system is
designed to destroy tissue (including prostate and kidney tissue, liver metastases, tumors, and skin
lesions) by the application of extremely cold temperatures.
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