BTG ICEfx - How Supplied

1-2 User Manual
1.2 How Supplied
The ICEfx Cryoablation System is supplied non-sterile. Galil Medical accessory products required to
perform the cryoablation procedure are supplied separately.
1.2.1 Contents
• ICEfx Cryoablation Console
• Optional ICEfx Cryoablation Cart: The cart provides storage for up to four cryoablation needle
boxes and provides a hook to hold an accessory bag. When the cart is ordered with the Console,
the Console is attached to the cart prior to shipment.
• ICEfx Cryoablation System User Manual: The User Manual describes the system and provides
instructions for system operation and maintenance.
• ICEfx Cryoablation System Quick Reference Guide: The Quick Reference Guide provides a
visual overview of system setup and operation.
• USB ash drive (4 GB) within an attached pouch: The Galil Medical USB ash drive is used to
transfer procedure reports to a customer’s computer for saving or printing.
• High-pressure argon gas supply line with attached pressure gauge
o To accommodate procedure room variations, the gas supply line is available in alternative
lengths to connect the argon cylinder to the Console. Reference Table 9-1.
• Ethernet cable (3 m): The Ethernet cable is used to connect the Console to a Galil Medical
remote server for uploading reports and diagnostic data and for downloading software updates.
• Wrench: The Wrench is used when connecting or disconnecting the gas supply line.
• Accessory Bag: The Accessory Bag is used for storing the system accessories and can be
attached to the hook on the side of the ICEfx Cart.
• Optional EZ-Connect2 Dual Cylinder Adapter: is an optional device used to connect two argon
cylinders in tandem to the ICEfx System. The dual cylinder adapter consists of a four-way adapter
assembly with argon pressure gauge and auxiliary gas supply connection attached to a long gas
supply line and a short auxiliary gas supply line with gas cylinder connection. Reference Section
3.4 for instructions on using the EZ-Connect2 Adapter.
1.2.2 Accessory Products Used to Conduct Cryoablation Procedures
The following items used with the ICEfx Cryoablation System are sterile, single-use only devices. Do
not re-sterilize or reuse.
NOTE: Single-use accessories are described in separate Instructions for Use.
• Galil Medical Cryoablation Needles: The ICEfx Cryoablation System is used only with Galil
Medical cryoablation needles. The cryoablation needles are available in a range of congurations
that produce various iceball sizes and shapes, allowing the clinician to match the needles to the
desired ablation zone. The cryoablation needles are supplied sterile in procedure kits or in needle
kits.
WARNING. Only use non-MRI needles with the system.
• Cryoablation Needle Labels: Needle labels are a󰀩xed to the needle tubing to provide easier
identication of the needles during a cryoablation procedure. Contact Galil Medical Customer
Service to order labels.
• Galil Medical Multi-Point Thermal Sensor™ (MTS): The Multi-Point Thermal Sensors (MTS)
contain four sensor locations along the distal shaft of the needle to monitor temperature near the
target site and adjacent critical structures.