• Do not use the Visual-ICE Cryoablation System near magnetic resonance imaging (MRI) equipment�
• The Visual-ICE Cryoablation System should not be used adjacent to or stacked with other equipment�
• Lock the wheels on the Visual-ICE Cryoablation System prior to using the system to avoid inadvertent
movement of the system during a procedure�
• To avoid risk of electric shock, this equipment must only be connected to a hospital grade electrical power outlet
with a protective earth�
• Do not start a cryoablation procedure before verifying that the Visual-ICE Cryoablation System and all ancillary
equipment are fully operational�
• Use of cables other than those specified, with the exception of those sold by Boston Scientific for use as
replacement parts for internal components, may result in increased emissions or decreased immunity of the
Visual-ICE Cryoablation System�
• Only use non-MRI needles with the Visual-ICE Cryoablation System�
• Boston Scientific recommends using the Boston Scientific MTS to monitor the freeze / thaw temperatures for the
intended treatment protocol and to monitor temperatures in the adjacent organs and structures�
• Do not use the needle if it is bent or damaged while attempting to unpack or use it� Never use a defective
needle for a cryoablation procedure� A defective cryoablation needle that has a gas leak can cause a gas
embolism in the patient�
• Do not kink, pinch, cut or pull excessively on the needle tubing� Damage to needle handle or tubing may cause
the needle to become unusable�
• Have sufficient argon gas available to conduct the planned cryoablation procedure: the number and type of
needles, gas cylinder size, pressure and rate of gas flow affect the required gas volume (reference the SYSTEM
SPECIFICATIONS Section for gas purity requirements)� At least one full spare cylinder should be available for
each treatment�
• High-pressure gas is dangerous if handled improperly� Local laws and safety rules regarding pressurized gas
systems, reservoirs and components should always be observed�
• Ensure that the gas cylinders are chained to a wall or an approved cart to prevent inadvertent tipping of the
cylinders�
• Do not connect the Visual-ICE Cryoablation System to a gas supply exceeding 6000 psi (414 bar, 41�4 MPa) to
avoid damage to internal system components�
• The Visual-ICE Cryoablation System should not be operated in the presence of flammable fumes, e�g�,
flammable anesthetics or volatile substances�
• Do not bend or kink the gas supply line� Sharp bends or kinks may compromise the integrity of the gas supply line�
• Do not roll the Visual-ICE Cryoablation System over the gas supply line; such activity may damage the line�
Procedural
• Prior to starting a cryoablation procedure, set up the Visual-ICE Cryoablation System (reference the System Set-up
Section) and then perform Needle Integrity and Functionality Tests� Tests must be successfully completed in
order to begin the procedure�
• Do not use the needle if there is no ice formation during the Freeze phase� Obtain a new needle and repeat the
testing procedure�
• Do not use the needle if bubbles are seen escaping from the needle during Needle Integrity and Functionality Test�
• Ensure adequate measures are taken to protect organs and structures adjacent to the targeted tissue�
• Ensure that the MTSs are functioning properly before inserting into the patient by verifying that they are
reading a reasonable room temperature�
• The sterile field and sterility of cryoablation needles should be maintained at all times� Do not contaminate the
distal end of the sterile cryoablation needle�
Black (K) ∆E ≤5.0
12