IceCure Medical Ltd.
DSR3210000 rev. D
ProSense™
Confidential
User Manual
124
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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
ProSense™
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 wi
th liquid nitrogen
in a safe manner.
3.
Place the Dewar inside the system and close the door.
4.
Press NEXT (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,
and attach the probe to the handle and press NEXT. The NEXT button
will be shown only when the probe is connected properly.
7.
The following message will appear
"Inspect the probe and press the appropriate button".
When
the system is ready, place the probe inside a sterile Saline or water cup.
8.
Press TEST (by pressing on the console touch screen).
Make sure
that you don’t see an
y 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 into the tissue, and navigate with the help of Ultrasound to pierce through the
lesion center.
12.
Once positioning of the Cryoprobe is completed, the hose can be safely assembled on the Holder
arm (optional).
13.
Activate treatment cycle: Press FREEZE on the console touch screen, OR Press the BLUE button on
straight 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 EXTRACTION process by
pressing EXTRACTION. This is done by pressing the BLUE button ON cryohandle OR by
pressing ON the console touch screen.
14.
During the EXTRACTION process, gently remove the probe. When the EXTRACTION process is
finished you can press FINISH if you have managed to remove the probe from the body. If
not, continue the EXTRACTION process by pressing EXTRACTION and try again to gently
remove the probe. In some cases you can choose the relocate option for additional freezing
cycles.
•
in some cases, the following message may appear -
“Please wait for passive
THAW
”
In this case, wait for passive THAW and gently extract the probe from the tissue
.
15.
Do not disengage the probe from the handle until the following message appears -
“Safe to disengage the probe from the handle”
16.
After disengaging the probe, immediately replace the handle’s cap.
