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DSR7000000-REV G -IFU FOR CRYOPROBE
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USA
IceSense3®, IceCure®, IceSense® and ProSense® are Trademarks of IceCure Medical.
Ltd. In the United States and other countries. IceCure Medical Ltd. and other parties may
also have trademark rights in other terms used herein.
Figure 3:
Cryoprobe selection
Figure 7: For illustration only Color Tag
labels for cryoprobe and the matching
introducer
The cryoprobe serial number (S/N) appears on the
screen/cryoprobe package/cryoprobe plastic grip.
Cryoprobe connection
Never reuse a single-use cryoprobe.
Connect the cryoprobe to the cryohandle, while maintaining
sterility of the cryoprobe:
1- Remove the plug that covers the cryoprobe connection point.
2- Insert the cryoprobe into the insertion point in the handle as
shown on the system screen and screw it until a “NEXT” button
appears on screen then confirm screwing by an additional slight
rotation to confirm that cryoprobe connection is secured.
3- Remove the cryoprobe tip protector.
When done, press “
NEXT
” on the
screen.
: Cryoprobe connection screen
5
ure
Fig
Cryoprobe operation
Perform a functional
pre-test
to ensure system efficacy and safety
as explained in the User Manual.
If a functional problem occurs or there is any unusual appearance
(such as frost on the plastic cover near the cryohandle, bubbles or
any unusual appearance), press "CANCEL" on the system screen
and follow system instructions until you are required to safely
remove the cryoprobe from the cryohandle. Before operating the
cryoablation system, make sure you have completed all pre-
operational stages.
You must NOT allow the freeze process to start before
the cryoprobe tip is actually within the target tissue.
Before activating the freeze cycle, insert the cryoprobe into the
target tissue under imaging guidance following the steps:
1.
Confirm longest dimension of the target tissue
2.
Plan the trajectory of the cryoprobe prior to placement.
When clinically safe, the center of the cool zone shall be along
the longest dimension of the target tissue.
3.
The black safety mark should be completely in the tissue.
4.
In percutaneous approach, perform a 3 mm skin incision (for
example using #11 blade) before the cryoprobe is inserted.
5.
Position the tip of the cryoprobe at the distal end of the long
axis of the target tissue, when clinically safe
6.
Center of the cool zone, should be in the center of the tissue
to be ablated (see figure 2 for the distance of the cool zone
from the tip of the cryoprobe that is visible under Ultrasound
or CT imaging)
7.
Maintain sterility and patient safety.
Be aware of the markings on the cryoprobe: the
wide black mark
closest to the tip is the safety mark. In percutaneous procedures
it
must be completely
inside the tissue
to avoid skin burns. The rest
of the marks indicate depth of cryoprobe insertion: each mark
equals one centimeter with distinctive markings at 5 and 10 cm
(50
& 100 mm).
Figure 6: illustration of FAP7200000 cryoprobe markings on the cryoprobe
Once you have verified the cryoprobe is located in its right place,
you may begin
freezing.
Portions of the cryoprobe other than the freeze zone,
including the plastic cover that is located near the
cryoprobe handle, may become cold and cause tissue
damage. If unwanted freezing occurs, immediately stop the
freezing process. In case of frost on shaft, start Extraction if
possible. If not, wait for passive Thaw. In both cases, use skin
protection techniques.
To prevent injury, cryoprobes must be closely observed during use
for signs of unwanted freezing.
During
Thaw
, the ice ball melts partially or totally depending on the
thaw time and the tissue properties.
Keep the cryoprobe location steady in the target tissue during all
of the thaw period. Control the process under Ultrasound or CT
imaging system.
The
Extraction
step occurs at the end of every treatment. Its
purpose is to allow the cryoprobe’s removal from the target tissue
in the fastest and safest way.
At the end of the extraction step, a message will be displayed on
system
screen. Wait for the message, then gently remove the
cryoprobe from the target tissue.
Do not force removal of the cryoprobe from the tissue as it might
increase the risk of hematoma.
If the cryoprobe cannot easily be extracted from the tissue, press
the “
Extraction
” icon on screen to initiate another
Extraction cycle.
In case the Extraction
process isn’t available, wait for passive Thaw.
Before removing the cryoprobe from the tissue, make
sure the freeze effect has been deactivated and the
cryoprobe can be easily withdrawn. Never use excessive force to
extract the cryoprobe.
Cryoprobe disassembling
After removing the cryoprobe from the target tissue, and only if
system screen displays a message that it is safe to disengage the
cryoprobe, detach the cryoprobe from the cryohandle as follows:
1.
Unscrew the used cryoprobe from the cryohandle and
dispose of it appropriately.
2.
Remove the single-use sterile cover from the cryohandle.
3.
Close the cryohandle with the covering plug.
Following each cryosurgical procedure, discard the single use
devices (single-use cryoprobe, single-use introducer, single-use
Figure 4: The cryoprobe
