BTG ICEfx - Warnings

ICEfx™ Cryoablation System
1-5
1.6 Warnings
• Do not use this device for any purpose other than the stated intended use and indications for use.
• A thorough understanding of the technical principles, intended use, indications for use and
risk associated with cryoablation procedures is necessary before using this product. Use of
this device is restricted to use by or under the supervision of physicians trained in cryoablation
procedures with a Galil Medical cryoablation system.
• Do not use an ICEfx Cryoablation System near magnetic resonance imaging (MRI) equipment.
• Only use non-MRI needles with the ICEfx Cryoablation System.
• Do not start a cryoablation procedure before verifying that the ICEfx Cryoablation System and all
ancillary equipment are fully operational.
• Verify that the Ethernet cable is disconnected prior to starting a cryoablation procedure. Do not
connect the Ethernet cable during a cryoablation procedure.
• Do not use the ICEfx Cryoablation System if the system is visibly damaged, exposing any internal
components or sharp edges.
• Have su󰀩cient argon gas available to conduct the planned cryoablation procedure: the number
and type of needles, gas cylinder size, pressure and rate of gas ow a󰀨ect the required gas
volume.
• Secure the safety cable at the end of the gas supply line to the Console before connecting the
argon gas supply line to the argon gas inlet. The safety cable provides backup protection if the
gas supply line becomes inadvertently disconnected from the system.
• If the ICEfx Cryoablation Console is mounted on a cart, lock the wheels on the cart prior to using
the system to avoid inadvertent movement of the system during a procedure.
• Each needle must be locked into a needle channel before initiating a cryoablation procedure to
avoid the risk of forceful ejection of the needles while under gas pressure.
• Do not unlock a needle channel until all operations in the channel have completed.
• Before the patient is anesthetized, the Needle Integrity and Functionality Tests on the cryoablation
needles must be completed successfully to verify proper needle operation.
• Do not touch the ICEfx Cryoablation Console while touching the patient to avoid the risk of
shocking the patient if an inadvertent electrical fault exists.
• Do not pull on the power cord. Grasp the plug, not the power cord, to disconnect the device from
the wall socket.
• Do not modify the ICEfx Cryoablation System in any way. Only authorized Galil Medical personnel
or Galil Medical-trained authorized personnel are to service an ICEfx Cryoablation System.
• Do not touch the screen if the touch screen monitor goes blank for more than ve (5) seconds
during a procedure. Immediately turn o󰀨 power to the system and end the procedure to avoid
inadvertent activation of needles.
• 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 ICEfx Cryoablation System should not be operated in the presence of ammable fumes, e.g.,
ammable anesthetics or volatile substances.
• The ICEfx Cryoablation System should be inspected and serviced periodically according to the
system specications. Service must be performed by authorized service engineers. Reference
Section 7 for system care and maintenance information.