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BTG ICEfx User Manual

Cryoablation system
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ICEfx™ Cryoablation System
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  • Page 1 ICEfx™ Cryoablation System User Manual Only...
  • Page 2 For assistance, contact: www.galilmedical.com USA: Galil Medical Inc., 4364 Round Lake Road, Arden Hills, MN 55112, USA. Telephone: +1 877 639 2796, Fax +1 877 510 7757 Galil Medical Inc., 4364 Round Lake Road, Arden Hills, MN 55112, USA. Telephone: +1 877 639 2796, Fax +1 877 510 7757 Obelis s.a., Boulevard Général Wahis 53, 1030 Brussels, Belgium.

  • Page 3: Table Of Contents

    2.1.9 Argon Gas Inlet 2.2 ICEfx Cart 2.2.1 Wheel Lock Levers 3 SYSTEM SETUP 3.1 Preparation for Use 3.2 Attaching the Console to the ICEfx Cart 3.3 Setting up the Console 3.3.1 Login 3.4 Connecting the Argon Gas ICEfx™ Cryoablation System...
  • Page 4 4 GETTING STARTED WITH THE USER INTERFACE 4.1 Document Conventions 4.2 Logging In 4.3 Navigating the User Interface 4.3.1 Setup and Gas Venting Wizards 4.3.2 Title Bar 4.3.3 Options Menu 4.4 Starting the Procedure 4.5 Entering Case Information 4.6 Using the Procedure Screen 4.6.1 Viewing the Timer 4.6.2 MTS Temperature Sensors 4.6.3 Initiating Testing 4-10...
  • Page 5 7 SYSTEM CARE and MAINTENANCE 7.1 Cleaning the ICEfx™ Cryoablation System 7.2 Service and Preventive Maintenance 7.3 System Disposal 8 TROUBLESHOOTING 8.1 Software Recovery 8.2 Electronics, Electrical and User Error Related Issues 8.2.1 Replacing Fuses 8.3 Gas Issues 8.4 Mechanical Issues 8.5 Gas Cylinder and Gas Supply Line...
  • Page 6 List of Figures Figure 2-1. Console Front View Figure 2-2. Console Rear View Figure 2-3. ICEfx Cart Figure 2-4. ICEfx Cart - Wheel Lock Levers Figure 3-1. Position ICEfx Console on Cart Figure 3-2. Tighten Retaining Screw on Cart Figure 3-3. Argon Shutoff Valve - ON Position Figure 3-4. Vent Valve - Fully Closed Figure 3-5. Attach Safety Cable to Console Figure 3-6.
  • Page 7 Table 9-1. Cable Lengths Table 9-2. Electromagnetic Emissions Table 9-3. Electromagnetic Immunity Table 9-4. Electromagnetic Immunity for Systems that are Not Life-supporting Table 9-5. Recommended separation distances between portable and mobile RF communications equipment and the ICEfx System ICEfx™ Cryoablation System...
  • Page 8 List of Screens Screen 3-1.Gas Indicator Screen 4-1. Title Bar Screen 4-2. Options Menu Screen 4-3. Start Case Screen Screen 4-4. Edit Case Information Screen Screen 4-5. Initial Procedure Screen Screen 4-6. Timer During FastThaw Screen 4-7. Procedure Screen - MTS Temperature Sensors Screen 4-8.

  • Page 9: Symbols

    Do Not Discard Return to Galil Medical at end the European Community of service life Only Caution: Federal (USA) law restricts this device to sale by Nonsterile or on the order of a physician. ETL Product Listing ICEfx™ Cryoablation System...
  • Page 10 Do Not Push Footnotes 1. EN ISO 15223-1:2016 Medical devices –Symbols to be used with medical device labels, labelling and information to be supplied – Part 1: General requirements 2. ASTM F 2503 – 13 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment 3.

  • Page 11: System Overview

    Use of this device is restricted to use by or under the supervision of physicians trained in cryoablation procedures with a Galil Medical Cryoablation System. CAUTION. All new users must be trained on the use of the ICEfx™ Cryoablation System and cryoablation procedures prior to operating the system. Contact your local Galil Medical representative to schedule training.

  • Page 12: How Supplied

    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.

  • Page 13: Storage

    The Galil Medical ICEfx 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 ICEfx Cryoablation System is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery (with the exception of cardiac tissue), ENT, gynecology, oncology, proctology, and urology.

  • Page 14: Indications

    Indications The ICEfx Cryoablation System is indicated for use as a cryosurgical tool in the fields 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.

  • Page 15: Warnings

    The safety cable provides backup protection if the gas supply line becomes inadvertently disconnected from the system. If the ICEfx Cryoablation Console is mounted on a cart, lock the wheels on the cart prior to using •...

  • Page 16: Precautions

    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.

  • Page 17: Handling

    Galil Medical. 1.7.2 Handling Lift the ICEfx System to clear any threshold that is higher than 2 cm. Two people, one on each • side, should use the handles to lift the system.

  • Page 18: During Use

    For non-CX needles: • If a needle without CX functionality is connected to the ICEfx System, active thawing is not possible. Needle release from an iceball will only be achievable with passive thaw. Use image guidance to ensure adequate thawing.

  • Page 19: After Use

    • Clean the ICEfx Cryoablation System by following the instructions in Section 7.1. Do not use cleaning agents such as Betadine or bleach solution, which may damage the touch screen. To avoid confusion at the beginning of a new procedure, ensure that the •...
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  • Page 21: System Description

    2 SYSTEM DESCRIPTION The ICEfx™ Cryoablation System consists of a portable Console and an optional ICEfx Cart. The Console may be used with or without the optional ICEfx Cart. Console The ICEfx Console is a portable helium-free desktop cryoablation unit. The front of the Console contains four needle connection channels (each supporting two needle ports), two Multi-Point Thermal Sensor sockets, and a recessed 10.1-inch touch screen monitor.

  • Page 22: Touch Screen Monitor

    The rear of the Console (Figure 2-2) contains the power switch, one USB port, one Ethernet port, a software reset button, an argon gas inlet, a Vent Valve, and an Argon Shutoff Valve. Figure 2-2. Console Rear View Power Switch Vent Valve USB Port Argon Shutoff Valve...

  • Page 23: Mts Connection Ports

    Two handles, one on each side are available for lifting the Console. The handles are recessed cutouts in the underside of the base. CAUTION. If the Console is attached to the ICEfx Cart, use the cart handles to lift the system. 2.1.4 Power Switch The Power Switch powers ON the Console in preparation for a cryoablation procedure.

  • Page 24: Argon Gas Inlet

    The argon inlet is a quick-connect connector. ICEfx Cart The optional ICEfx Cart provides a secure platform for the Console. The ICEfx Cart has four locking wheels to ensure the cart does not move during a cryoablation procedure. An opening inside the cart provides storage for up to four cryoablation needle boxes.

  • Page 25: Wheel Lock Levers

    2.2.1 Wheel Lock Levers Use the Wheel Lock Levers to lock the ICEfx cart in place during a procedure (Figure 2-4). The wheel lock levers can be locked from either side. Pressing the wheel lock lever DOWN locks the wheel and prevents movement during the procedure. Lifting the wheel lock lever UP unlocks the wheel.
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  • Page 27: System Setup

    Preparation for Use Prior to using the ICEfx Console, inspect the Console, power cord, brakes, safety cable, gas supply line, and the monitor touch screen to ensure they are not damaged. If any of the components are damaged, contact Galil Medical Customer Service.

  • Page 28: Attaching The Console To The Icefx Cart

    Attaching the Console to the ICEfx Cart NOTE: If the cart is ordered with the Console, the Console is attached to the ICEfx Cart prior to shipment. 1. Position the Console on the ICEfx Cart. The depression on the bottom of the Console rests on the dome on top of the ICEfx Cart.

  • Page 29: Setting Up The Console

    3. Plug the power cord into a hospital grade power outlet (electrical mains outlet) with a ground connection. Galil Medical recommends using a stable and uninterruptable power outlet. NOTE: If the power supply to the ICEfx Console is not stable or is noisy, the MTS temperature readings may be inaccurate.

  • Page 30: Figure 3-4. Vent Valve - Fully Closed

    Medical Customer Service. Reference Section 8.8 for information on displayed messages. If the ICEfx System software detects pressurized gas in the system and the gas supply line is not connected, a message will display requesting that you manually vent the gas from the system.

  • Page 31: Login

    If you leave the user interface idle for a pre‑set time with no activity and the idle timer is turned ON, the ICEfx System software requires you to re‑enter your password to unlock the user interface. The inactivity timeout value and idle timer are configurable from the Settings Screen (Reference Section 4.8).

  • Page 32: Connecting The Argon Gas

    Connecting the Argon Gas WARNING. Do not connect the ICEfx Cryoablation System to a gas supply exceeding 6000 psi (414 bar, 41.4 MPa) to avoid damage to internal system components. WARNING. Ensure that the argon gas cylinder is chained to a wall or an approved cart to prevent inadvertent tipping of the cylinder.

  • Page 33: Figure 3-6. Connect Argon Gas Supply Line

    5. Connect the argon high‑pressure gas supply line to the argon cylinder by securing the gauge assembly adapter onto the cylinder connection (Figure 3‑7). NOTE: The gas cylinder connection has left‑handed threads. Figure 3-7. Gas Cylinder Set-up ICEfx™ Cryoablation System...

  • Page 34: Figure 3-8. Open Argon Gas Cylinder

    6. Carefully turn the cylinder valve on the argon gas cylinder counterclockwise for one quarter turn. Ensure that the pressure reading on the gauge responds immediately. Turn the cylinder valve further counterclockwise (approximately one full turn) to open the gas cylinder so that sufficient gas flow is present.

  • Page 35: Figure 3-9. Ez-Connect2 Dual Cylinder Adapter

    • When the argon cylinder pressure falls below the lower working pressure limit, the system displays an alert message. To ensure optimal performance, replace an argon cylinder if the pressure falls below the lower working pressure limit. ICEfx™ Cryoablation System...
  • Page 36 • Failure to operate the ICEfx Console within the working pressure limits may affect the cryoablation procedure. If the Console produces a continuous hissing sound, verify that the Vent Valve is fully closed. • If the Vent Valve is fully closed and the hissing sounds persists, shut OFF the system using the power control switch located on the rear of the Console (Figure 2‑2).

  • Page 37: Getting Started With The User Interface

    4 GETTING STARTED WITH THE USER INTERFACE The ICEfx™ Cryoablation System provides a graphical user interface that facilitates rapid communication between the user and the system through a touch screen interface. This chapter provides information to help familiarize the user with the software user interface.

  • Page 38: Title Bar

    Pressure Gauge / Gas Displays the supplied pressure of the argon gas cylinder. Indicator NOTE: The ICEfx System contains an internal regulator that regulates the argon pressure to appropriate working limits. The Gas Indicator updates in real-time as needles are disconnected or additional needles are connected and as the freeze intensity is adjusted.

  • Page 39: Options Menu

    During a cryoablation procedure, select Report to display details for the current case. NOTE: Administrative users may also delete reports. User Manual View information on how to access an electronic version of the User Manual. Log Out Log out of the system. ICEfx™ Cryoablation System...

  • Page 40: Starting The Procedure

    Option Description Shut Down Shut down the system. Starting the Procedure After logging into the system, the Start Case Screen appears. Press START CASE to start a cryoablation procedure. Pressing START CASE displays a Start Case wizard to demonstrate system setup.

  • Page 41: Entering Case Information

    Enter notes about the procedure. This is a unique field designated on the Settings Screen. Define up to two Custom Fields on the Settings Screen. Custom Field NOTE: The Custom Fields are displayed if defined on the Settings Screen. ICEfx™ Cryoablation System...

  • Page 42: Using The Procedure Screen

    Control Description Hospital Name Type the name of the hospital in this field. Hospital Address Type the address of the hospital in this field. DONE Press DONE to save the registration information. Press CANCEL CASE to discard the entered registration information and CANCEL CASE return to the Start Case Screen.

  • Page 43: Viewing The Timer

    Screen 4-6 provides an example of a timer displayed during FastThaw. Table 4-6 provides additional information on the timer. Screen 4-6. Timer During FastThaw ICEfx™ Cryoablation System...

  • Page 44: Table 4-6. Timer Information

    Table 4-6. Timer Information Control Description The upper left portion of the timer displays information relevant to the current function: • Freezing — Displays the freeze intensity. Mode Thawing — Displays the thaw mode (i-Thaw or FastThaw). • • Cautery — Displays the cautery duration. For CX needles, the upper right portion of the timer displays temperature data for the current function: Testing —...

  • Page 45: Mts Temperature Sensors

    Settings Screen by setting the Number MTS value. The temperature of the sensor. The coldest temperature for each sensor is highlighted in blue Sensor Temperature if the MTS Display Coldest setting is turned On in the Settings Screen. ICEfx™ Cryoablation System...

  • Page 46: Initiating Testing

    4.6.3 Initiating Testing CAUTION. If a needle needs to be added during a procedure, connect the needle to an open channel. If there is no open channel available, reference Section 5.2.1 for the instructions for adding a CX needle to a channel with an open port. Press the Start button to initiate Needle Integrity and Functionality Testing.

  • Page 47: Initiating A Freeze Cycle

    Screen 4-9. Procedure Screen during Freezing Table 4-9. Freeze Controls Control Description Freeze button – Press to select the freeze function and to select the freeze intensity. ICEfx™ Cryoablation System 4-11...
  • Page 48 Select a freeze intensity from the menu or select “Stick” intensity. Freeze Intensity NOTE: The ICEfx System controls freeze intensity by adjusting the duration of argon flow over each 10 second block of time (e.g., 30% freeze intensity freezes for 3 seconds and idles for 7 seconds).

  • Page 49: Initiating A Thaw Cycle (Cx Needles Only)

    CAUTION. Thaw thoroughly and stop all needle operation prior to removing needles to minimize the risk of tissue injury. NOTE: If needle sticking is experienced, use a slight, gentle twist of the needle followed by slow withdrawal. ICEfx™ Cryoablation System 4-13...

  • Page 50: Thaw Controls

    4.6.5.1 Thaw Controls Screen 4-10. Procedure Screen during Thawing (FastThaw) Table 4-10. Thaw Controls Control Description Thaw button — Press the Thaw button to change from FastThaw to i-Thaw. The background color of the button is orange if FastThaw is selected and is yellow if i-Thaw is selected.

  • Page 51: Using Cautery (Cx Needles Only)

    During needle removal, watch for the 10 mm wide Active Zone Indicator on the needle to • guide needle withdrawal. The Active Zone Indicator is a marked band along the needle shaft, located 20 mm distal to the heating portion of the needle. ICEfx™ Cryoablation System 4-15...

  • Page 52: Cautery Controls

    4.6.6.1 Cautery Controls Screen 4-11. Cautery Screen Table 4-11. Cautery Controls Control Description Procedure button – Press to exit Cautery mode and return to the Procedure Screen. Cautery button – Press the Cautery button to select the cautery duration. Cautery Displays the Cautery status.

  • Page 53: Advanced Channel Controls

    1. To run a saved cycle sequence, press the individual channel button or the ALL channel button, and then press PROGRAM CYCLES. 2. The Program Cycles dialog displays. Select the desired cycle sequence from the list and press LOAD. Screen 4-13. Select Programmed Cycle 3. Press START to initiate the cycle. ICEfx™ Cryoablation System 4-17...

  • Page 54: Screen 4-14. Program Cycles Dialog

    To program freeze-thaw cycles: 1. To program freeze-thaw cycles for a specific channel, press the individual channel button or the ALL channel button, and then press PROGRAM CYCLES. 2. Press NEW on the Program Cycles dialog. Screen 4-14. Program Cycles Dialog The Programming Cycles Screen displays for the selected channel.

  • Page 55: Reports

    Reports from the expanded menu to view the saved procedure reports (when Press there is no active case). The All Reports Screen displays a list of all saved reports in the ICEfx System. Select the report you want to view and press VIEW REPORT. Screen 4-17. All Reports Screen When a report is selected from the All Reports Screen, the report that displays provides options to delete or export the report.

  • Page 56: Sorting A Report

    4.7.1.1 Sorting a Report To sort the list by Report Name, Hospital Name, Doctor Name, or Organ Type, press the appropriate header section of the report list. 4.7.1.2 Exporting a Report From the All Reports Screen, press VIEW REPORT to display the report you would like to export. From the View Report Screen, click EXPORT to export the report details and select the export file type and name.

  • Page 57: Configuring Settings

    The time zone can be changed by administrative or service personnel. Time Zone The ICEfx System automatically adjusts for Daylight Saving Time. Select the argon cylinder volume units according to the standard in Volume Units the geographical region.
  • Page 58 Setting Description Select the temperature units displayed for MTS sensors and CX Temperature Units needles. Select the clock type (12 or 24 hour). The clock type can be changed Clock Type by administrative or service personnel. Select the desired duration from 30 to 180 minutes that the system Inactivity Timeout can be inactive before requiring you to re-enter your password.

  • Page 59: Control Buttons

    1. Press the ADMIN button on the Settings Screen. 2. Press Software Update. 3. Select the Network option. 4. Connect the Ethernet cable to the Ethernet port. 5. Press Start. ICEfx™ Cryoablation System 4-23...

  • Page 60: Manual Software Update

    This function is only available to administrative and service users. The ICEfx System may be configured to use a static IP address or work with a DHCP server to obtain the address dynamically. Consult the network administrator about proper network access prior to configuring the system.

  • Page 61: Performing The Cryoablation Procedure

    Cycles to program freeze-thaw cycles. Remove needles and MTS • End Procedure (Press the END CASE button on • Procedure Screen) Procedure • View and save report if desired Export report to a Galil Medical supplied USB flash drive ICEfx™ Cryoablation System...

  • Page 62: Pre-Procedure Needle/Mts Testing

    Pre-Procedure Needle/MTS Testing WARNING. Prior to beginning a treatment and before the patient is anesthetized, setup the ICEfx™ System (reference Section 3) and then perform Needle Integrity and Functionality Tests on each cryoablation needle and MTS. 1. On the touch screen monitor, press START CASE. The Setup wizard displays to demonstrate the set up steps.

  • Page 63: Figure 5-1. Locking Needle Into Channel

    A dark gray channel button indicates a channel with needles connected. For CX needles, the ICEfx™ System automatically detects the type of needle being used, the lot number, and the expiration date of the product. If the system detects that the expiration date has passed, a message appears indicating that the needle is expired and gas flow to that channel is disabled.
  • Page 64 OPTIONAL: If additional testing is required, press the Test button again to repeat the test. NOTE: For CX needles, if a previously tested needle is moved to a new channel during a procedure, the ICEfx Cryoablation System will recognize the needle has successfully completed the Needle Integrity and Functionality Test.

  • Page 65: Performing A Cryoablation Procedure

    (such as towels) or other method is employed to prevent needle tubing from touching a patient’s skin. CAUTION. If a needle without CX functionality is connected to the ICEfx System, active thawing is not possible. Needle release from an iceball will only be achievable with passive thaw. Use image guidance to ensure adequate thawing.
  • Page 66 NOTE: Selecting ALL will initiate a Freeze phase at the intensity selected for each channel. To conduct freezing in all active channels at the same intensity, press the Freeze button for the ALL channel and select the freeze intensity to apply to all active channels. After selecting the freeze intensity, press the Start button for the ALL channel to initiate freezing on all active channels simultaneously.

  • Page 67: Adding A Cx Needle During A Cryoablation Procedure

    Also, consider the number of planned freeze-thaw cycles for the procedure. 2. Safely position a full argon cylinder, with the required gas type and purity, near the empty cylinder. ICEfx™ Cryoablation System...

  • Page 68: Dual Argon Cylinder Connection

    3. Close and tighten the argon cylinder valve. 4. Slowly open the Vent Valve to discharge gas from the system and the high-pressure gas supply line. Wait until all the pressure is released and the pressure gauge on the gas supply line indicates zero pressure.

  • Page 69: System Shutdown

    6 SYSTEM SHUTDOWN Shutting Down the System WARNING. Warn operating room personnel prior to venting the ICEfx™ System to avoid startling them. 1. If the Console was not vented at the end of the procedure, perform these steps to vent the system.

  • Page 70: Removing The Console From The Cart

    5. Press the Shutdown button on the Login Screen to power down the system. A message appears requesting confirmation to shut the system down. 6. Wait until the screen goes black. Turn the Power Switch on the rear of the Console to the OFF position.

  • Page 71: System Care And Maintenance

    Preventive maintenance on the ICEfx Cryoablation System is performed every two years. CAUTION. Do not attempt to service the ICEfx Cryoablation System. If service is required, contact Galil Medical Customer Service. The ICEfx Cryoablation System will display a reminder on the screen approximately one month prior to when the preventive maintenance is due.
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  • Page 73: Troubleshooting

    8 TROUBLESHOOTING Galil Medical suggests the following options for troubleshooting the ICEfx™ Cryoablation System. If the suggested approaches do not resolve the issue, contact Galil Medical Customer Service. Software Recovery In the event of software corruption or failure, the software may be restored to the previous software version.

  • Page 74: Electronics, Electrical And User Error Related Issues

    Turn the power ON. during procedure 2. The power cable to the ICEfx Console is disconnected from the power outlet or from the rear panel of the Console. Connect the power cable to the Console, checking that the power cable is fully seated.

  • Page 75: Replacing Fuses

    Photo 1. Contact Galil Medical Customer Service to obtain the replacement fuses required for this procedure. 2. Turn the Power Switch OFF on the rear of the ICEfx Console. 3. Pull on the red cable retention mechanism to disconnect the power cable from the power inlet.
  • Page 76 8. Replace the fuses in the fuse holder with the two replacement fuses supplied from Galil Medical Customer Service. NOTE: Use only Galil Medical specified fuses in the ICEfx Console. User Manual...

  • Page 77: Gas Issues

    Gas Issues Symptom Potential Causes / Solutions The ICEfx System does not allow testing 1. Verify that the system is at operating pressure. of a needle in a locked channel Reference Table 3-2 for information on working gas pressures.
  • Page 78 Symptom Potential Causes / Solutions Needle is not freezing during the Needle 1. The argon cylinder valve may be closed. Open the Integrity and Functionality Test gas cylinder valve by turning the gas cylinder valve counterclockwise to allow sufficient gas flow. Verify that appropriate pressure is displayed on the Gas Indicator.

  • Page 79: Mechanical Issues

    If there is pressure in the system, end the procedure and open the Vent Valve on the rear of the system to completely vent the system. Upon completion, close the Vent Valve. Cart does not move freely Release the wheel brake levers. ICEfx™ Cryoablation System...

  • Page 80: Gas Cylinder And Gas Supply Line

    • the gauge adapter and the ICEfx System. cylinder valve Close the cylinder valve and vent the gas from the ICEfx • System and the gas supply line using the Vent Valve (Figure 2-3). Verify the system is depressurized. Loosen and remove the gauge assembly adapter.

  • Page 81: Needles

    1. Move the needle to a different port. system. 2. If the system still does not recognize the needle, press the Channel button to display the needle type drop-down list. Select the needle type from the list. ICEfx™ Cryoablation System...

  • Page 82: Multi-Point Thermal Sensors

    3. Contact Galil Medical Customer Service. Displayed Messages The ICEfx System displays a message on the user interface when a user requests assistance or when user, needle or system errors are detected. NOTE: Record and report the message number (e.g., 10-01, 80-02) if assistance is required from Galil Medical Customer Service.
  • Page 83 User correctly entered the reset password Enter your new password below • challenge and should now set the new password. Solutions: 1. Enter the new password in the New Password field. 2. Enter the same password in the Confirm Password field. ICEfx™ Cryoablation System 8-11...
  • Page 84 Message Reason for Appearance / Solutions Reason for Appearance: 10-05 Emergency Login User requested an emergency login and To obtain an emergency login, contact Galil • received a challenge to be relayed to Medical Customer Service Customer Service. +1 877 639 2796 or Solutions: +1 651 287 5000 1.

  • Page 85: Procedure Messages

    The argon shut off valve may Check and open if necessary • be closed. Solutions: Verify that the argon shutoff valve is in the ON position. ICEfx™ Cryoablation System 8-13...
  • Page 86 Message Reason for Appearance / Solutions Reason for Appearance: 20-03 Test All User selected Test button in ALL channel • You selected to control all needles simultaneously to control all active channels. Do you want to initiate test in all needles now? •...

  • Page 87: Gas Messages

    Where X represents the Low Cylinder • Replace the gas cylinder as soon as feasible with Alert set on the Settings Screen (reference a new cylinder Section 4.8). Solutions: Replace the gas cylinder as soon as possible. ICEfx™ Cryoablation System 8-15...

  • Page 88: Needle Messages (Cx Needles)

    8.8.4 Needle Messages (CX Needles) Message Reason for Appearance / Solutions Reason for Appearance: 40-01 Unsupported Needle A needle type not supported by the The connected needle is not supported by the • software configuration was connected in software the channel. The channel will be disabled until an appropriate needle is connected.
  • Page 89 Reason for Appearance: 40-08 i-Thaw Error An i-Thaw needle was identified as not Channel [Xa or Xb] i-Thaw needle is defective for • i-Thaw operational. electrical thawing Solutions: • Use passive thaw Use passive thawing. • ICEfx™ Cryoablation System 8-17...

  • Page 90: Software Messages

    8.8.5 Software Messages Message Reason for Appearance / Solutions 60-01 Network Connection Reason for Appearance: User selected “Remote upload / download” You are not connected to the Internet • but the system was not connected to the Internet. A connection must be established Connect Ethernet cable or check the Ethernet port •...
  • Page 91 Service if further assistance is required. 60-06 Incompatible Software Reason for Appearance: The software was checked against The ICEfx System software is not compatible with • approved software versions in the regulatory approvals regulatory files for each respective market. An incompatibility with regulatory approval •...
  • Page 92 Message Reason for Appearance / Solutions Reason for Appearance: 60-09 Software Recovery User pressed the Software Recovery This will rollback the software on this system • button then selected Rollback. Activation will rollback the software to the previous Are you sure you want to do this? •...

  • Page 93: Reports Messages

    The chosen filename already exists on the USB flash drive using a filename duplicate to a flash drive filename on the flash drive. Choose a different filename • Solutions: To export the report, choose a different filename. ICEfx™ Cryoablation System 8-21...

  • Page 94: System Messages

    Restarting ICEfx System • Solutions: • If problem persists, contact Galil Medical Customer Service 1. Restart the ICEfx Console. +1 877 639 2796 or 2. Contact Galil Medical Customer Service if the problem persists. +1 651 287 5000 support@galilmedical.com Reason for Appearance:...
  • Page 95 2. Vent the system using the Vent Valve. 80-04 Temperature Warning Reason for Appearance: The internal temperature of the system • The internal temperature of the ICEfx System exceeded appropriate operating limits. exceeds appropriate operating limits Solutions: • Discontinue the cryoablation procedure as soon as safe to do so 1.
  • Page 96 Message Reason for Appearance / Solutions Reason for Appearance: 80-31 System Error Gas flow from the argon cylinder was Gas cylinder shut off valve is not open enough • insufficient. To improve gas flow, the to provide adequate flow. If necessary, open the cylinder valve should be opened further.

  • Page 97: Service Messages

    Reason for Appearance: 90-02 Service Due The ICEfx System was not serviced on Service for the ICEfx System is past due • schedule. During subsequent start-ups, the user is reminded the service is past due. • Contact Galil Medical Customer Service to...
  • Page 98 Reason for Appearance / Solutions Reason for Appearance: 90-03 System End of Life The ICEfx System reached the end of its The ICEfx System is at the end of operational life • operating life. Contact Galil Medical Customer Service to •...

  • Page 99: System Specifications

    Relative Humidity: 10% to 90% Transportation Conditions When shipping the ICEfx™ Cryoablation System, use the original shipping container to prevent damage from occurring during transport. If the original shipping container is not available, the customer takes responsibility to ensure proper transport conditions are satisfied or contacts Galil Medical Customer Service to obtain the appropriate shipping container.

  • Page 100: Accuracy Of Displayed Values

    (EMC) and needs to be installed and placed into service according to the EMC information provided below. The ICEfx Cryoablation System has been tested in the operating room environment for electromagnetic compatibility (EMC) and electromagnetic interference (EMI) compliance. The ICEfx Cryoablation System has been tested to be in compliance with IEC 60601-1-2 and EN 55011.

  • Page 101: Table 9-2. Electromagnetic Emissions

    Galil Medical for use as replacement parts for internal components, may result in increased emissions or decreased immunity of the ICEfx Cryoablation System. WARNING. The ICEfx Cryoablation System should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the ICEfx System should be observed to verify normal operation.

  • Page 102: Table 9-3. Electromagnetic Immunity

    The ICEfx Cryoablation System is intended for use in a professional healthcare facility electromagnetic environment with the immunity compliance levels specified below. The customer or the user of the ICEfx System should assure that it is used in such an environment.

  • Page 103: Table 9-4. Electromagnetic Immunity For Systems That Are Not Life-Supporting

    To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the ICEfx System is used exceeds the applicable RF compliance level above, the ICEfx System should be observed to verify normal operation.

  • Page 104: Table 9-5. Recommended Separation Distances Between Portable And Mobile Rf Communications

    The ICEfx Cryoablation System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the ICEfx System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the ICEfx System as recommended below, according to the maximum output power of the communications equipment.

  • Page 105: Essential Performance

    Essential Performance The ICEfx Compact Cryoablation System essential performance is defined as: • The ability to turn on and turn off the flow or argon to the connected cryoablation needles via command inputs from the user interface The ability to maintain uninterrupted gas flow to user-selected needles when gas flow is turned on •...
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  • Page 107: References

    10 REFERENCES 10.1 Patents http:// The ICEfx™ Cryoablation System is covered by one or more US and foreign patents listed at www.GalilMedical.com/patents 10.2 Trademarks GALIL, FastThaw, ICEfx, IceFORCE, IcePearl, IceRod, i-Thaw, and Multi-Point Thermal Sensor are trademarks of Galil Medical Ltd. BTG and the BTG roundel are registered trademarks of BTG International Ltd.
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  • Page 109: Disclaimer Of Warranty

    Multi-Point Thermal Sensor are trademarks of Galil Medical Ltd. BTG and the BTG roundel are registered trademarks of BTG International Ltd. Galil Medical Inc and Galil Medical Ltd are BTG International group companies. © 2018 Galil Medical Inc. | All rights reserved.
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  • Page 112 Multi-Point Thermal Sensor are trademarks of Galil Medical Ltd. BTG and the BTG roundel are registered trademarks of BTG International Ltd. Galil Medical Inc and Galil Medical Ltd are BTG International group companies. © 2018 Galil Medical Inc. | All rights reserved.

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