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BTG ICEfx User Manual

BTG ICEfx
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ICEfx™ Cryoablation System
User Manual
Only

Table of Contents

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BTG ICEfx Specifications

General IconGeneral
BrandBTG
ModelICEfx
CategoryMedical Equipment
LanguageEnglish

Summary

System Overview

Brief Description

Provides an overview of the ICEfx Cryoablation System and its function.

How Supplied

Details the components included with the ICEfx Cryoablation System and accessories.

Intended Use

Defines the system's purpose and indications for cryoablative tissue destruction.

Indications

Lists the specific medical fields and conditions for which the system is indicated.

Contraindications

States any conditions or situations where the system should not be used.

Warnings

Highlights critical safety information and potential hazards associated with system use.

Precautions

Outlines important steps and considerations for safe operation and handling.

Potential Adverse Events

Lists potential side effects or complications that may occur during or after procedures.

System Description

Console

Describes the main unit of the ICEfx Cryoablation System, including its interface and ports.

ICEfx Cart

Details the optional cart used for supporting and moving the ICEfx Console.

System Setup

Preparation for Use

Steps to inspect and prepare the system components before operation.

Attaching the Console to the ICEfx Cart

Instructions for securing the Console onto the ICEfx Cart.

Setting up the Console

Procedure for powering on, configuring, and logging into the system.

Connecting the Argon Gas

Steps for safely connecting the argon gas supply to the system.

Getting Started With the User Interface

Document Conventions

Explains the typesetting conventions used throughout the user manual.

Logging In

Details the process for accessing the system software via username and password.

Navigating the User Interface

Guides users on how to interact with the system's graphical interface.

Starting the Procedure

Initiates the cryoablation procedure setup and wizard.

Entering Case Information

Optional step to input patient and procedure-specific details.

Using the Procedure Screen

Describes the main interface for controlling and monitoring cryoablation.

Reports

Information on viewing, saving, and exporting procedure reports.

Configuring Settings

Options for customizing system parameters and user preferences.

Administrative Options

Access to advanced features like software updates and user management.

Performing the Cryoablation Procedure

Pre-Procedure Needle/MTS Testing

Essential steps to test needles and sensors before patient treatment.

Performing a Cryoablation Procedure

Detailed steps for conducting the cryoablation treatment.

System Shutdown

Shutting Down the System

Procedures for safely powering off and venting the system.

Removing the Console from the Cart

Instructions for detaching the Console for storage or service.

System Care and Maintenance

Cleaning the ICEfx™ Cryoablation System

Guidelines for cleaning the system components after use.

Service and Preventive Maintenance

Information on scheduled maintenance and authorized service.

System Disposal

Procedures for decommissioning and disposing of the system.

Troubleshooting

Software Recovery

Steps to restore or update the system software in case of failure.

Electronics, Electrical and User Error Related Issues

Troubleshooting for hardware, electrical, and user-caused problems.

Gas Issues

Solutions for problems related to argon gas supply and pressure.

Mechanical Issues

Guidance for resolving issues with physical components of the system.

Gas Cylinder and Gas Supply Line

Troubleshooting for problems with gas cylinders and supply lines.

Needles

Specific troubleshooting steps for cryoablation needles.

Multi-Point Thermal Sensors

Solutions for issues related to MTS sensor readings and connectivity.

Displayed Messages

Explanation of system messages and recommended actions for errors.

System Specifications

Operating Conditions

Defines the environmental parameters for system operation.

Storage Conditions

Specifies the temperature and humidity ranges for system storage.

Transportation Conditions

Guidelines for safely transporting the ICEfx Cryoablation System.

Mechanical Specifications

Details the physical dimensions, weight, and footprint of the system.

Argon Gas Supply

Requirements for the argon gas used with the system.

Gas Cylinder Specifications

Information on pressure and volume for gas cylinders.

Accuracy of Displayed Values

Specifies the precision of system measurements for temperature and pressure.

Electrical Specifications

Provides details on power input, frequency, and ports.

Essential Performance

Defines the core functional capabilities of the ICEfx System.

References

Patents

Information on patents covering the ICEfx Cryoablation System.

Trademarks

Lists trademarks associated with the system and related products.

Contact

Provides contact information for Galil Medical Customer Service and support.

Disclaimer of Warranty