BTG ICEfx - Handling

ICEfx™ Cryoablation System
1-7
• Use Galil Medical USB ash drive only to export reports or update software. Other data or
software may corrupt the ICEfx Cryoablation System.
• Do not connect any other USB equipment to the ICEfx Cryoablation System USB port.
• Do not use a USB extension cable to connect the USB ash drive to the USB port. Connect the
Galil Medical USB ash drive directly to the USB port provided on the ICEfx Cryoablation System.
Use of a USB extension cable may result in electromagnetic emissions exceeding regulatory
limits.
• Do not perform a cryoablation procedure with the Ethernet cable plugged into the ICEfx
Cryoablation System to avoid the potential risk of corrupting the system software. Only use the
Ethernet cable when downloading software updates or when uploading reports to the Galil server.
• Any person who connects external equipment to the Ethernet or USB ports has formed a Medical
Electrical System and is therefore responsible for the system to comply with the requirements. If
in doubt, contact a qualied medical technician or your local representative or Galil Medical.
1.7.2 Handling
• Lift the ICEfx System to clear any threshold that is higher than 2 cm. Two people, one on each
side, should use the handles to lift the system.
• Lift the ICEfx System using the handles to clear any obstacle, either ascending or descending.
• Maneuver the ICEfx Cryoablation System using the handles.
• Handle the ICEfx Cryoablation System with care. Rough handling may damage the system and
cause it to become inoperable.
• When removing the ICEfx Console from the ICEfx Cart, lift the Console using the handles on the
underside of the base. Refer to Section 6.2 for instructions on how to remove the Console from
the ICEfx Cart.
• Do not bend or kink the gas supply line. Sharp bends or kinks may compromise the integrity of
the gas supply line.
• Do not tilt the ICEfx Cryoablation Console.
• Do not roll the ICEfx Cryoablation System over the gas supply line; such activity may damage the
line.
• The ICEfx Cryoablation System is non-sterile. When attaching cryoablation needles to the needle
connection ports, do not contaminate the sterile eld or the sterile cryoablation needle. Avoid
contact with the distal portion of the cryoablation needle.
• Position the ICEfx Cryoablation System in a manner to avoid draping needle tubing across the
patient. Needle tubing may become extremely cold when conducting freeze cycles during a
cryoablation procedure. It is important that a patient’s skin is protected from direct contact with
needle tubing to avoid the potential for thermal injury to the patient. Ensure an appropriate
insulating barrier is placed as needed (such as towels) or other method is employed to prevent
needle tubing from touching a patient’s skin.