BTG ICEfx - Precautions

1-6 User Manual
1.7 Precautions
1.7.1 General
• Training on appropriate use of the ICEfx Cryoablation System is required prior to conducting a
cryoablation procedure.
• 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.
• The ICEfx Cryoablation Console and user interface are non-sterile. Contact with any part of the
Console 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
su󰀩cient gas is available to complete a treatment. At least one full spare cylinder should be
available for each treatment.
• Do not use the ICEfx 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.
• Direct the high-pressure argon gas supply line towards the oor and secure the line with the clip
located on the rear of the Console to minimize the potential for tripping.
• Conrm the high-pressure argon gas supply is securely connected before opening the gas
cylinder.
• Conrm that the Vent Valve is closed before connecting the gas line to the Console.
• Continuously monitor the cryoablation procedure using image guidance such as direct
visualization, ultrasound, or Computed Tomography (CT) to ensure adequate tissue coverage and
to avoid damage to adjacent structures.
• Galil Medical recommends using the Galil Medical Multi-Point Thermal Sensors (MTS) to monitor
the freeze / thaw temperatures for the intended treatment protocol and to monitor temperatures in
the adjacent organs and structures.
• Ensure that the MTSs are functioning properly before inserting into the patient by verifying that
they are reading a reasonable room temperature.
• Cryoablation freezes and destroys tissue. To limit this e󰀨ect to only the target ablation area, the
physician must determine the means to protect adjacent organs and structures.
• 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.
• 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.
• Portable and mobile radiofrequency (RF) communications equipment can a󰀨ect the ICEfx
Cryoablation System, causing it to operate improperly. Keep such equipment away from the
system (reference Section 9.8).
• Use only Galil Medical supplied components and accessories with the ICEfx Cryoablation
System.