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PRECAUTIONS
General
• Carefully read all instructions prior to use� Failure to observe all warnings and precautions may result in complications�
• Do not use the Visual-ICE Cryoablation System if any moisture or condensation is present on the surfaces of the
system� Allow the system to dry completely for 12 hours prior to powering up 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�
• Take precautions to avoid potential electrostatic discharge� If an electrostatic discharge occurs after touching the
monitor, the screen may flicker and MTS temperature readings may be inaccurate for a few seconds� The system will
remain functional and the monitor will refresh momentarily�
• Use care to avoid electrostatic discharge (ESD) events when removing the cover from the Visual-ICE Cryoablation
System� Boston Scientific recommends that the operator touch one or more metal parts on the rear of the system
prior to touching anything on the Needle Connection Panel�
• No data regarding cryoablation in combination with other therapies is available from Boston Scientific�
• Use the Boston Scientific supplied USB flash drive only to export reports or update software� Other data or software
may corrupt the Visual-ICE Cryoablation System�
• Do not connect any other USB equipment to the Visual-ICE Cryoablation System USB port�
• Do not use a USB extension cable to connect the USB flash drive to the USB port� Connect USB flash drive directly
to the USB port provided on the Visual-ICE Cryoablation System� Use of a USB extension cable may result in
electromagnetic emissions exceeding regulatory limits�
• Select a unique Patient ID that does not reveal the patient's identity to other system users�
Handling
• Handle the Visual-ICE Cryoablation System with care� Rough handling may damage the system and cause it to
become inoperable� The system should never be tilted�
• Maneuver the Visual-ICE Cryoablation System by pulling on the system using the rear handle�
• Do not set food, drinks, or other objects on top of the system� Doing so may damage the system�
• Do not store liquids in the storage compartment� The storage compartment is not watertight�
• 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 lb)�
• Prior to lowering the monitor, ensure that no objects are located in the monitor storage basin� Use care when
lowering the monitor into the monitor storage basin; do not use excessive force to avoid damaging the monitor�
• Use care when lowering or swiveling the touch screen monitor to avoid the potential for pinching fingers�
• Lift the Visual-ICE Cryoablation System to clear any threshold that is higher than 1 cm� Two people, one on each
side, should use the handles to lift the system�
• Clean the Visual-ICE Cryoablation System by following the instructions in the Handling and Storage Section�
Do not use cleaning agents such as Betadine Antiseptic Solution or bleach solution, which may damage the
touch screen�
• Position the argon cylinder close enough to the system to ensure that the gas supply line is not stretched and
does not present a trip hazard�
• 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 Cryoablation System to minimize the potential for tripping�
Black (K) ∆E ≤5.0
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