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Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician�
REUSE WARNING
The single-use only devices used with the Visual-ICE Cryoablation System are sterile� Reuse, reprocessing or resterilization
may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient
injury, illness or death� Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or
cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one
patient to another� Contamination of the device may lead to injury, illness or death of the patient�
DEVICE DESCRIPTION
System Description
The Visual-ICE Cryoablation System is a mobile cryoablation system that contains ten needle connection channels
(each supporting two needle ports), four Multi-Point 1�5 Thermal Sensor Device (MTS) ports, one argon inlet connector,
one helium inlet connector, a recessed 19 inch touch screen monitor, a mouse track pad, a USB port, and an Ethernet
port (inactive)� The system hardware and operating software are housed within the system�
The system is mounted on four swivel caster wheels for system mobility� The system contains a three-way brake pedal
mechanism in front to immobilize the two front wheels of the system during a procedure and to provide directional
control during movement of the system� The rear wheels have individual brake pedals� Gas supply line clips at the
rear of the system (Figure 2) are used to direct the gas supply lines toward the floor, minimizing tripping hazards� A
compartment in the lower section provides storage for system accessories�
Contents
One (1) Visual-ICE Cryoablation System
One (1) Visual-ICE Cryoablation System User Manual: The User Manual may be physical copy or available online at www�
IFU-BSCI�com� The User Manual Describes the system and provides instructions for system operation and maintenance�
One (1) Visual-ICE Cryoablation System Quick Reference Guide: The Quick Reference Guide summarizes key steps
in system operation�
One (1) Wrench
One (1) Console Cover: The Console Cover is used to protect the Visual-ICE Cryoablation System during storage�
One (1) USB flash drive (4 GB) within an attached pouch: The USB flash drive is used to transfer procedure reports
to a customer's computer for saving or printing�
TWO (2) Single Cylinder Adapters: Single Cylinder Adapters are comprised of a high-pressure gas supply line
attached to a pressure gauge�
One (1) Argon Single Cylinder Adapter: The Argon Single Cylinder Adapter is a high-pressure argon gas
supply line with attached pressure gauge�
• To accommodate procedure room variations, the gas supply line is available in alternative lengths to
connect the argon cylinder to the Visual-ICE Cryoablation System� Reference Table 1�
One (1) Helium Single Cylinder Adapter: The Helium Single Cylinder Adapter is a high-pressure helium gas
supply line with attached pressure gauge�
• To accommodate procedure room variations, the gas supply line is available in alternative lengths to
connect the helium cylinder to the Visual-ICE Cryoablation System� Reference Table 1�
Optional
One (1) EZ-Connect2 Dual Cylinder Adapter: The EZ-Connect2 Dual Cylinder Adapter is an optional component used
to connect two gas cylinders in tandem to the Visual-ICE Cryoablation System� The dual cylinder adapter consists of
a four-way adapter assembly with argon pressure gauge and long gas supply line with system connection, short gas
supply line with cylinder connection� Reference the Dual Gas Cylinder Connection Section for instructions on using
the EZ-Connect2 Dual Cylinder Adapter�
Black (K) ∆E ≤5.0
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