IceCure™ Medical Ltd.
DMS-7064 rev. C
ProSense™
Confidential
User Manual
56
European User Manual
OPERATING THE SYSTEM
This chapter explains how to use the 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.
The device materials are not compatible with magnetic resonance imaging; thus, it is not
MR safe and should not be used in MRI procedures.
TRAINING: Practitioners electing to be cryoablation system users must attend a training
course prior to using the system. The course is taught by
IceCure™
Medical certified
personnel.
Procedure Overview
•
Patient and system preparation
•
Cryoprobe selection
•
System set-up and functional test
•
Cryoprobe placement
•
Cryoablation cycle
•
End of procedure
Pre-operational stages
Preparing the system for procedure
1.
If a cryoprobe is still connected to the cryohandle, remove and safely discard used
cryoprobe 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.
