IceCure Medical Ltd.
DSR3000000 rev.L
Confidential
User Manual
95
IceSense3™
Warning messages
- Critical information will appear as a pop-up dialog with an “OK” button for acknowledging the
message.
Error messages
- Information that prevents the user from continuing the operation of the system will appear as a dialog
box that cannot be closed, stating the problem and possible solutions.
When such a message appears, the user should
carefully follow system instructions.
10
IceSense3™ cryoablation system - Step-by-Step procedure
Before starting the procedure a Pre-Test
must be
carried out!
System preparation and Pre-Test
1.
Press Prepare for treatment.
2.
Remove the Dewar’s cap and fill the Dewar with liquid nitrogen
in a safe manner.
3.
Place the Dewar inside the system and close the door.
4.
Press Next (by pressing the BLUE button on cryohandle OR by pressing on the console touch screen)
5.
Enter the probe serial number.
Each procedure must be carried out with a new sterile probe.
Press on the
'Next' button on the screen.
6.
Remove the handle’s cap, attach the probe to the handle and press Next. The ‘Next’ button will be shown only
when the probe is connected properly.
The following message will appear -
“Please wait until the system is ready for test”
7.
When the system is ready, place the probe inside a sterile Saline cup.
8.
Press Test (by pressing the BLUE button on cryohandle OR by pressing on the console touch screen).
Notice
that you don’t see any bubbles, that the shaft is not frozen, and that a small ice-ball is created at the tip of
the probe.
9.
If the test was successful press Success. If not start over with a new sterile probe if required.
Procedure
10.
Select treatment modality: Preset Cycles/ Manual Mode. You can modify the cycles as needed
during
procedure.
11.
Insert the probe to the tissue and navigate with the help of Ultrasound to stub through the lesion center.
12.
Activate treatment cycle: Press FREEZE on the console touch screen, OR Press the BLUE button on
cryohandle.
Monitor ice-ball under ultrasound at all times.
Inject saline buffer as needed to protect the skin.
You may manually stop the first freeze cycle and start the Thaw process by pressing Skip. This is done by
pressing the BLUE button on cryohandle OR by pressing on the console touch screen.
You may manually stop the second freeze cycle and start the Warm process by pressing Warm. This is
done by pressing the BLUE button on cryohandle OR by pressing on the console touch screen.
13.
During the warm process gently remove the probe. When the warm process is finished you can press finish if
you have manage to remove the probe from the body or continue the warm process by pressing Warm and
try again to gently remove the probe.
If you press Warm more than two times, the following message may appear -
“Unable to warm, Please wait for passive Thaw”
In this case wait for passive thaw and gently extract the probe from the tissue
.
14.
Do not disengage the probe from the handle until the following message appears -
“Safe to disengage the probe from the handle”
15.
After disengaging the probe, immediately replace the handle’s cap.