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OPERATIONAL INSTRUCTIONS
WARNING: 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�
CAUTION: Carefully read all instructions prior to use� Failure to observe all warnings and precautions may result in
complications�
Additional Required Items
Accessory Products Used to Conduct Cryoablation Procedures
NOTE: See product specific Instructions for Use�
The following needles must be used with the Visual-ICE Cryoablation System:
• Boston Scientific Cryoablation Needles: The cryoablation needles are specifically designed for use with the
Boston Scientific Cryoablation Systems and are available in a range of configurations that produce various
iceball sizes and shapes, allowing the clinician to match the needles to the desired ablation zone� The
cryoablation needles are supplied sterile�
WARNING: Only use non-MRI needles with the system�
Optional Accessory Items:
• Cryoablation Needle Channel ID Stickers: Cryoablation Needle Channel ID Stickers are affixed to the needle
tubing to provide easier identification of the needles during a cryoablation procedure� Contact Boston Scientific
Technical Assistance Center to order Cryoablation Needle Channel ID Stickers�
• Boston Scientific MTS: The MTS contain four sensor locations along the distal shaft of the needle to monitor
temperature near the target site and adjacent critical structures�
• Boston Scientific Urethral Warming Set: The Urethral Warming Set is the conduit that circulates warm saline
through the urethra during a prostate cryoablation procedure�
The following items used with the Visual-ICE Cryoablation System are re-usable and should be cleaned and/or
sterilized in accordance with the Instructions for Use that accompanies each product�
• IV Pole and Bracket for use with a fluid warmer and pump system
The following items are needed to conduct cryoablation procedures and are not available from Boston Scientific�
• Argon gas cylinder(s)
• Helium gas cylinder(s) if using helium for thawing
NOTE: The argon gas must meet the purity requirements specified in the SYSTEM SPECIFICATIONS Section�
• A fluid warmer and pump system when using the Boston Scientific Urethral Warming Set
Boston Scientific recommends the use of a sterile drape (customer supplied) to cover the touch screen if the system
will be operated by members of the sterile team�
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Black (K) ∆E ≤5.0
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