Galil Visual-ICE MRI, User Manual

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1-6 User Manual
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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 .
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High-pressure gas is dangerous if handled improperly. Local laws and safety rules regarding
pressurized gas systems, reservoirs and components should always be observed.
• The Visual-ICE MRI Cryoablation System should not be operated in the presence of flammable
fumes, e.g., flammable anesthetics or volatile substances.
• The Visual-ICE MRI Cryoablation System should be inspected and serviced periodically
according to the system specifications. Service must be performed by authorized service
engineers. Reference Section 9 for system care and maintenance information.
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An electrocautery device should never touch a needle or be in close proximity to them when the
needle is connected to the MCP.
1.7 Precautions
1.7.1 General
• Training on appropriate use of the Visual-ICE MRI Cryoablation System is required prior to
conducting a cryoablation procedure.
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The physician is solely responsible for all clinical use of the cryoablation system and for any
results obtained by use of the system. The physician makes all clinical decisions prior to and
throughout the cryoablation procedure based upon his/her professional opinion.
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The Visual-ICE MRI Cryoablation System is non-sterile. Contact with any part of the system by
a member of the sterile team requires use of customer supplied sterile accessories, such as a
sterile drape.
• Galil Medical recommends having backup argon cylinders available for each treatment to ensure
sufficient gas is available to complete a treatment.
• Do not use the Visual-ICE MRI Cryoablation System if any moisture or condensation is present
on the surfaces of the system. Powering up the system containing moisture or condensation
could result in permanent damage to the electrical boards, causing the system to be inoperable.
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Direct the high-pressure gas supply lines toward the floor and secure the lines with the clips
located on the rear of the Visual-ICE MRI Cryoablation Console to minimize the potential for
tripping.
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Direct the Junction Box Harnesses towards the floor to minimize the potential for tripping.
• Confirm that the Manual Vent Valve is closed before connecting the gas lines to the Console.
• Continuously monitor the cryoablation procedure using image guidance to ensure adequate
tissue coverage and to avoid damage to adjacent structures.
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Cryoablation freezes and destroys tissue. To limit this effect to only the target ablation area, the
physician must determine the means to protect adjacent organs and structures.
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No data regarding cryoablation in combination with other therapies is available from Galil Medical.
• Do not set heavy objects on the monitor when in the down position or on the monitor storage
basin when the monitor is in the up position. The weight limit is 9 kg (20 lbs).
• Portable and mobile radiofrequency (RF) communications equipment can affect the Visual-ICE
MRI Cryoablation System, causing it to operate improperly. Keep such equipment away from the
system (reference Section 11.8).
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Use only Galil Medical supplied components and accessories with the Visual-ICE MRI
Cryoablation System.