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• Secure the needle tubing to the sterile table prior to beginning the needle testing process�
• Fill a large basin (at least 30 cm in diameter) halfway with sterile water or saline�
• Place the needles, individually or in groups, in the basin such that the full length of the needle shaft is
submerged in the sterile water or saline�
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 Cryoablation 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 Boston Scientific
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
the Standard Gas Cylinder Setup Section)�
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: Ensure that the iceball detaches from the tip of the needle and that no bubbles escape from the needle tip�
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 the
Standard Gas Cylinder Setup Section)�
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Black (K) ∆E ≤5.0
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