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BTG Visual-ICE - Intended Use; How Supplied

BTG Visual-ICE
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1-2 User Manual
1.2 Intended Use
The Galil Medical Visual-ICE Cryoablation System is intended for cryoablative destruction of tissue
during minimally invasive procedures; various Galil Medical accessory products are required to
perform these procedures. The Visual-ICE System is indicated for use as a cryosurgical tool in the
elds of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery (with
the exception of cardiac tissue), ENT, gynecology, oncology, proctology, and urology. This system is
designed to destroy tissue (including prostate and kidney tissue, liver metastases, tumors, and skin
lesions) by the application of extremely cold temperatures.
1.3 How Supplied
The Visual-ICE System is supplied non-sterile. Galil Medical accessory products required to perform
the cryoablation procedure are supplied separately.
1.3.1 Contents
Visual-ICE Cryoablation System
Visual-ICE Cryoablation System User Manual: The User Manual describes the system and
provides instructions for system operation and maintenance.
Visual-ICE Cryoablation System Quick Reference Guide: The Quick Reference Guide
summarizes key steps in system 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 Visual-ICE Console. Reference Table 8-1.
High-pressure helium 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 helium cylinder to the Visual-ICE Console. Reference Table 8-1.
Optional EZ-Connect2 Dual Cylinder Adapter: is an optional device used to connect two
gas cylinders in tandem to the Visual-ICE MRI 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 4.5.3 for instructions on
using the EZ-Connect2 Adapter.
Console cover: Protects the Console from dust, water, and debris during storage and
transportation
Ethernet cable (3 m): The Ethernet cable is used to connect the Visual-ICE MRI Console to
a Galil Medical remote server for uploading reports and diagnostic data and for downloading
software updates.

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