IceCure Medical Ltd.
DSR3000000 rev.L
Confidential
User Manual
45
IceSense3™
5
OPERATING THE SYSTEM
This chapter explains how to use the IceSense3™ cryoablation system and includes pre-operational,
operational and post-operational steps.
Note: This User Manual describes how to operate the device with a percutaneous cryoprobe that
requires imaging device for its clinical application.
The device can be used with a blunt cryoprobe for topical indications that are performed without
ultrasound imaging. For topical applications the practitioner should follow standard clinical
procedures that are not within the scope of this user manual.
The device can also be used for open surgical applications performed without the use of imaging
device. For these applications the practitioner should follow standard clinical procedures that are not
within the scope of this user manual.
TRAINING: Practitioners electing to be IceSense3™ cryoablation system users must attend a training
course prior to using the system. The course is taught by IceCure Medical certified personnel.
5.1
Procedure Overview
•
Patient and system preparation
•
Probe selection
•
System set-up and pretest
•
Probe placement
•
Cryoablation cycle
•
End of procedure
5.2
Pre-operational stages
5.2.1
Preparing the system for procedure
1.
If a probe is still connected to the cryohandle, remove and discard used probe from the
handle.
2.
Remove previously used single-use sterile sleeve from the cryohandle.
3.
Close the cryohandle with the covering plug.
4.
Arrange a sterile work environment in accordance with accepted standards.
5.2.2
Preparing the patient for procedure
1.
Position patient comfortably so that the target area is easily accessible and trajectory of the
probe is safe. For example: in the treatment of FA it is desirable that the probe will be placed
parallel to the chest wall.