IceCure™ Medical Ltd.
DMS-7063 rev. C
ProSense™
Confidential
User Manual
86
US User Manual
Warning
Do not start the
Freeze
step before the cryoprobe cool zone center is aligned
with the center of the target tissue.
Warning
Cryoprobe, introducer, temperature sensor and holder materials are not
compatible with magnetic resonance imaging
Before activating the
Freeze
step, insert the cryoprobe into the target tissue according to
the following steps:
1.
Plan the trajectory of the cryoprobe prior to placement. The center of the cool
zone shall be along the longest dimension of the target tissue as possible (if
required parallel to the chest wall in breast applications).
2.
In percutaneous procedures, insert introducer or cryoprobe under ultrasound
guidance or other appropriate imaging guidance:
•
Confirm longest dimension of the target tissue
•
Perform a 3 mm skin incision (for example using #11 blade)
•
Position the tip of the cryoprobe according to Cryoprobe placement
calculation shown on the screen
Caution
Artifacts from the devices may appear in the Ultrasound or CT image.
3.
When an introducer is used to guide the Cryoprobes to the tissue location, an
introducer with tight dimensions should be used. The cryoablation may be
affected by the use of an introducer that is too big and create an air barrier
between the freezing power of the cryoprobe and the tissue, inject 5cc of sterile
saline or water into the introducer lumen to improve heat exchange between the
cryoprobe and the tissue, if too big Introducer was chosen.
Warning
Ensure that cryoprobes are used with matching introducers. Use of longer
cryoprobes may result in undesired tissue perforation.
For optimal cryoprobe positioning please note the following:
Cryoprobe
Diameter/ Gauge
Shaft
Tip ±3mm
Tip Shape
Ice Ball Shape
Cool Zone Center
From needle tip
[mm]
Part Number
3.4 mm / 10G
127
mm
Trocar
Spheric
12 mm
FAP7100000
