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Procedural
• The Visual-ICE Cryoablation System should be placed in close proximity for accessible needle connection and use�
• Turn the Visual-ICE Cryoablation System ON before connecting the gas cylinders to ensure the proper diagnostic
tests are conducted�
• Confirm that the Manual Vent Valve is closed and Argon Shutoff Valve is in the ON position before connecting
the gas line to the system�
• If the system produces a continuous hissing sound, verify that the Manual Vent Valve is fully closed� If the
Manual Vent Valve is fully closed and the hissing sounds persists, shut OFF the system using the power control
knob located on the front of the system (Figure 1)� Close the gas supplies using the cylinder valves� Contact
Boston Scientific Technical Assistance Center�
• Failure to operate the Visual-ICE Cryoablation System within the working pressure limits indicated on the user
interface (Table 7) may affect the iceball formation�
• Boston Scientific recommends that only needles of the same type be placed together in a single channel� Do
not combine i-Thaw Function capable needles with non-i-Thaw Function capable needles in the same channel�
Additionally, using needles of differing types in a channel may affect the accuracy of the Gas Indicator�
• During use, avoid damage to the needle from other surgical instruments�
• Do not allow the MTS to touch the cryoablation needle during use; erratic temperature measurements may
be displayed�
• The cautery function should not be initiated if the Active Zone Indicator is visible outside the patient's skin�
• If a needle appears to be blocked, press the Thaw button to thaw the needle for at least one minute to clear
the blockage�
• When the argon cylinder pressure falls below the lower working pressure limit, the system displays an alert
message� To ensure optimal performance, replace an argon cylinder if the pressure falls below the lower
working pressure limit�
• Depressurize the system after the cryoablation procedure is completed (reference the System Shutdown
Section)�
• If the Visual-ICE Cryoablation System detects that helium gas is connected, the system defaults to helium thaw
mode and i-Thaw Function, FastThaw Function, and cautery function capabilities are disabled�
• Ice formation during the Flush and Thaw phases 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)�
• Any interruption of a programmed phase immediately terminates that phase and the programmed cycle�
• Activation of thermal cautery function immediately ceases all other cryoablation operations for the duration of
cautery function activity�
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Black (K) ∆E ≤5.0
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