Indications for use
The Focused Cryotherapy System is intended for cryoablative destruction of tissue during surgical procedures. The Focused Cryotherapy System is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery (with the exception of cardiac tissue), ENT, gynecology, oncology, proctology, and urology. See full indications.
Contraindications
There are no specific contraindications for the use of this device.
Warnings
The cryosurgical systems produce extreme cold which results in a necrotic effect on tissue. Visualization must be used at all times during a cryosurgical procedure. If at any point visualization stops or becomes impaired, discontinue treatment immediately. Verify the direction and orientation of the Directional Cryoprobe’s directional isotherm prior to beginning treatment. Position the Directional Cryoprobe’s ablation zone only in tissue intended for treatment. The Focused Cryotherapy System is not safe for use in the MR Environment.
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. Refer to the Instructions for Use and Operator’s Manual for complete indications, warnings, precautions, and potential complications. Full Important Safety Information.
