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Power Control Knob
The Power Control Knob powers ON the Visual-ICE Cryoablation System in preparation for a procedure�
Needle Channels
The Needle Connection Panel contains ten numbered needle channels; each channel contains two ports to support
connection of up to two cryoablation needles� Each channel operates independently of all other channels in either
freezing or thawing mode� The electrical connection is used for needles with a memory chip, i-Thaw Function, FastThaw
Function or cautery function capabilities� The locking bar on each channel locks the needles into the ports to secure
them during the procedure�
Operating Principle
The Visual-ICE Cryoablation System is a mobile system intended for cryoablative tissue destruction using a minimally
invasive procedure� The system is computer-controlled with a touch screen user interface that allows the user to
control and monitor the procedure� Innovative gas dryers produce consistent iceballs and boost freezing performance
for all needles�
The therapy delivered by the system is based on the Joule-Thomson effect displayed by compressed gases� The Joule-
Thomson effect is a change in the temperature of a compressed gas as it flows through a narrow orifice and expands
to a lower pressure� Certain gases, such as argon, decrease in temperature due to the Joule-Thomson effect, while
other gases, such as helium, increase in temperature�
The Visual-ICE Cryoablation System uses high-pressure argon gas that circulates through closed-tip cryoablation
needles to induce tissue freezing� Active tissue thawing is achieved by circulating helium gas through the needles or,
alternatively, using a heating element inside the cryoablation needle which can be energized to cause thawing (i-Thaw
Function)� The Visual-ICE Cryoablation System also controls the heating element inside cryoablation CX needles to
provide active helium-free thawing (i-Thaw Function or FastThaw Function) and track ablation (cautery function)�
Tissue ablation is achieved by repeated freeze and thaw cycles with both freezing and thawing contributing to cell
death� Generally, multiple freeze-thaw cycles are used to achieve complete destruction of the target tissue�
When multiple cryoablation needles are placed into or near the target tissue and freezing is initiated, an iceball grows
around the distal end of the needle shafts� In time, the iceballs coalesce and completely engulf the target tissue�
An important benefit of cryoablation is that imaging procedures, such as ultrasound and CT, are able to display the
location and size of the iceball� This benefit of cryoablation is used for proper control of the therapy� During use,
the procedure must be monitored via image guidance to ensure adequate tissue coverage and to avoid damage to
adjacent structures�
In addition to image guidance, Boston Scientific provides temperature sensors to aid in monitoring tissue temperature
near the target site and adjacent critical structures� These temperature sensors can provide quantitative data to
supplement the qualitative information provided by the imaging modality� Needle tip temperature display for CX-type
needles provides a visual means to monitor needle performance�
Materials
See Boston Scientific cryoablation needle and accessory product IFUs for specific information on materials�
Non-pyrogenic
See Boston Scientific cryoablation needle and accessory product IFUs for specific information on pyrogenicity�
User Information
The Visual-ICE Cryoablation System is designed to be operated by medical professionals who have a thorough
understanding of the technical principles, clinical applications, and risks associated with cryoablation procedures�
Optional education is available from your Boston Scientific representative�
10
Black (K) ∆E ≤5.0
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