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• Avoid contact with the distal portion of the cryoablation needle to maintain sterility during testing�
• Continuously monitor needle insertion, needle positioning, iceball formation and removal using image
guidance (such as direct visualization, ultrasound, or Computed Tomography (CT)) to ensure adequate tissue
coverage and to avoid damage to adjacent structures�
• Portable RF communications equipment (including peripherals such as antenna cables and external antennas)
should be used no closer than 30 cm (12 inches) to any part of the Visual-ICE Cryoablation System, including cables
specified for use with the system� Otherwise, degradation of the performance of this equipment could result�
• Confirm the high-pressure gas supply line(s) is securely connected before opening the gas cylinder(s)�
• Secure the safety cable at the end of the gas supply line to the System before connecting the argon gas
supply line to the argon gas inlet� The safety cable provides backup protection if the gas supply line becomes
inadvertently disconnected from the system� Do not use a gas supply line with a missing safety cable� Doing so
could compromise the safety of personnel in the room� Contact Boston Scientific Technical Assistance Center for
further instructions�
• Each needle must be locked into a needle channel before initiating a cryoablation procedure to avoid the risk of
forceful ejection of the needles while under gas pressure�
• If the needles are still connected, do not unlock the channels or disconnect the needles from the needle
connection panel until all operations in the channel have completed�
• Use Freeze and Thaw operations only when the needle is placed in the target tissue�
• Needle handles and the gas line may frost during freezing� Avoid prolonged contact with frosted portions of a
needle handle to avoid unintended thermal tissue damage to the patient or clinician�
• Needle tubing may become extremely cold when conducting freeze cycles during a cryoablation procedure� It
is important that a patient's skin is protected from direct contact with needle tubing to avoid the potential for
thermal injury to the patient� Ensure an appropriate insulating barrier is placed as needed (such as towels) or
other method is employed to prevent needle tubing from touching a patient's skin�
• The needle handle may become warm during active thawing� Pay attention to the needle handle position�
Prolonged contact with warm portions of the needle handle could cause unintended thermal tissue damage/
burn to the patient or clinician�
• Active thawing produces heat along the distal needle shaft� Use care to avoid thermal injury/burn to
nontargeted tissues�
• Ensure adequate thawing or cooling before attempting to remove needles from the patient�
• Discontinue all needle operation prior to needle removal to minimize risk of thermal injury and/or tissue injury�
• When conducting FastThaw Function or when conducting cautery function for Track Ablation, be alert for the
Active Zone Indicator as the needle is withdrawn to prevent unintended tissue damage from the hot needle�
• Do not touch the Visual-ICE Cryoablation System while touching the patient to avoid the risk of shocking the
patient if an inadvertent electrical fault exists�
• Do not touch the screen if the touch screen monitor goes blank for more than five (5) seconds during a
procedure� Immediately turn off power to the system and end the procedure to avoid inadvertent activation of
needles�
• Warn procedure personnel prior to venting the Visual-ICE Cryoablation System to avoid startling them�
• If it is difficult to loosen the pressure gauge connected to the cylinder, or the high-pressure gas supply line(s)
cannot be disconnected from the inlet connections, do not apply excessive force to release the gas supply line or
to loosen the pressure gauge� The gas line may still be under pressure�
• Do not pull on the power cord� Grasp the plug, not the power cord, to disconnect the device from the wall socket�
• Dispose of device and accessories in accordance with the Disposal Section�
13
Black (K) ∆E ≤5.0
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