Visual-ICE™ Cryoablation System
4-13
11.
Perform the Needle Integrity and Functionality Test on each needle by pressing the
Test
button
on the channel containing the needle(s). The 90-second test automatically conducts a series of
flush, freeze, and thaw phases. The durations of these phases are: 45 seconds flush with helium,
15 seconds freeze with argon, and 30 seconds thaw with helium.
OPTIONAL:
Alternatively, all needles may be tested simultaneously by pressing the
Test
button
on the channel labeled
ALL
. A message requests confirmation to test all needles. If appropriate,
choose YES.
OPTIONAL:
If additional testing is required, press the
Test
button again to repeat the test.
NOTE:
When helium is not connected, the two-minute test consists of 50 seconds low-pressure
argon flow, 15 seconds freeze with high-pressure argon, and 55 seconds of low-pressure argon
flow.
NOTE:
If a previously tested needle is moved to a new channel at any time during a procedure,
the Needle Integrity and Functionality Test must be conducted again on that needle.
NOTE:
If a previously tested needle containing a memory chip is moved to a new channel during
a procedure, the Visual-ICE System will recognize the needle has successfully completed the
Needle Integrity and Functionality Test.
During testing, carefully watch each needle for the following:
Flush
: Ensure no bubbles are formed along the needle shaft and tip.
Ensure that no iceball is formed during the Flush phase.
WARNING. A defective cryoablation needle that has a gas
leak can cause a gas embolism in the patient. Never use
a defective needle for a cryoablation procedure. Return
defective needles to Galil Medical for evaluation.
CAUTION.
Ice formation during the Flush phase indicates
that argon gas is connected to the helium inlet. Before
proceeding change the cylinders and ensure that each gas
supply line is connected to the correct cylinder (reference
Freeze:
Ensure that ice begins to form around the tip of the needle.
WARNING. A needle is defective if there is no ice
formation during the Freeze phase. Do not use a
defective needle. Obtain a new needle and repeat the
testing procedure.
Thaw: CAUTION.
Ice formation during the Thaw phase indicates
that the argon gas is connected to the helium inlet. Before
proceeding change the cylinders and ensure that each
cylinder is connected to the correct inlet (reference Section
Upon successful completion of the Needle Integrity and Functionality Test, the
Test
button
displays a green check and remaining control buttons on the channel become active. The
needle(s) are ready for use.
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