IceCure Medical Ltd.
DSR3210000 rev. D
ProSense™
Confidential
User Manual
84
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5.3
Operational stages
5.3.1
Safe Operation in Percutaneous Procedures
When performing percutaneous cryotherapy procedures, meticulous observation of the
incision site and the skin overlying the treatment site is required. Skin protection
techniques must be implemented to avoid thermal injury to the skin.
To stabilize the hose, it can be put on a Holder accessory during the procedure
Skin protection techniques include, but are not limited to: dripping room-temperature
sterile saline on these areas; continuous monitoring of the growing ice ball by
ultrasound; utilizing an external thermocouple to measure skin temperature; injecting
sterile saline or local anesthetic between the skin and the ice ball formation; and placing
moist gauze between the skin and the cryoprobe.
5.3.2
Preliminaries
Before operating
ProSense™
cryoablation system, make sure you have completed all pre-
operational stages.
Warning
Insertion of the cryoprobe into the target tissue is performed under the
guidance of an appropriate imaging device and by an authorized practitioner
trained by IceCure Medical.
Warning
You must NOT allow the freeze process to start before the cryoprobe active
area is actually within the target tissue.
Before activating the freeze cycle, insert the cryoprobe into the target tissue according to
the following steps:
1.
Plan the trajectory of the probe prior to placement. The center of the cool zone
shall be along the longest dimension of the target tissue (if required parallel to
the chest wall in breast applications).
2.
In percutaneous procedures, insert probe under ultrasound guidance or other
appropriate imaging guidance:
•
Confirm longest dimension of the target tissue
•
Perform a 3 mm skin incision (for example using #11 blade)
•
Position the tip of the cryoprobe minimally 4 mm beyond the distal edge
of the long axis of the target tissue
