IceCure™ Medical Ltd.
DMS-7064 rev. C
ProSense™
Confidential
User Manual
123
European User Manual
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.
ProSense™
cryoablation system - Step-by-Step procedure
Before starting the procedure, a functional test
must be
carried out!
System preparation and Functional 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 on the console touch screen).
5.
Enter the cryoprobe serial number.
Each procedure must be carried out with a new sterile
cryoprobe. Press the Next button on the screen.
6.
Remove the handle’s cap,
and attach the cryoprobe to the handle and press
Next
. The
Next
button will be shown only when the cryoprobe is connected properly.
7.
The following message will appear
"Inspect the cryoprobe and press the appropriate
button".
When the system is ready, place the cryoprobe inside a sterile Saline or water cup.
8.
Press TEST (by pressing on the console touch screen).
Make sure
that you don’t s
ee any
bubbles, that the shaft is not frozen, and that a small ice-ball is created at the tip of the
cryoprobe.
9.
If the test was successful, press SUCCESS. If not, start over with a new sterile cryoprobe if
required.
Procedure
10.
Select treatment modality: Preset Cycles/ Manual Mode. You can modify the steps as
needed
during procedure.
11.
Insert the cryoprobe into the tissue, and navigate with the help of Ultrasound or CT 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.
•
Monitor ice-ball under ultrasound at all times.
•
Inject saline buffer as needed to protect the skin.
•
You may manually stop the first
Freeze
step and start the
Thaw
process by pressing
Skip
. This is done by pressing on the console touch screen.
•
You may manually stop the second
Freeze
step and start the
Extraction
process by
pressing
Extraction
. This is done by pressing on the console touch screen.
14.
During the
Extraction
process, gently remove the cryoprobe. When the
Extraction
process is
finished you can press
Finish
if you have managed to remove the cryoprobe from the body. If
not, continue the
Extraction
process by pressing
Extraction
and try again to gently remove
the cryoprobe. In some cases, you can choose the relocate option for additional freezing
steps.
•
in some cases, the following message may appear -
“Please wait for passive
Thaw
”
In this case, wait for passive
Thaw
and gently extract the cryoprobe from the tissue
.
15.
Do not disengage the cryoprobe from the handle until the following message appears -
“Safe to disengage the
cryoprobe
from the handle”
16.
After disengaging the cryoprobe
, immediately replace the handle’s cap.
