IceCure
™
Medical Ltd.
DSR3200000 rev. G
ProSense
™
Confidential
User Manual
127
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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 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 ON 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 see 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 cycles as needed
during procedure.
11.
Insert the cryoprobe into the tissue, and navigate with the help of Ultrasound or other imaging
modality 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 or other imaging modality 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 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 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 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 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 cryo
probe, immediately replace the handle’s cap.
