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Visual-ICE™ Cryoablation System

9-1

9 REFERENCES

9.1 Patents

The Visual-ICE™ Cryoablation System is covered by one or more US and foreign patents listed at

http://www.GalilMedical.com/patents

9.2 Trademarks

GALIL, IceEDGE, IceFORCE, IcePearl, IceSeed, IceSphere, IceRod, I-Flow, i-Thaw, Multi-Point, and

Visual-ICE 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.

9.3 Contact

Galil Medical Inc., 4364 Round Lake Road, Arden Hills, MN 55112, USA

Galil Medical Customer Service:

+1 877 639 2796

+1 651 287 5000

(

[email protected])

Содержание Visual-ICE

Страница 1: ...User Manual ...

Страница 2: ...ills 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 Telephone 32 2 732 59 54 Fax 32 2 732 60 03 E mail mail obelis net ...

Страница 3: ...8 1 8 Potential Adverse Events 1 9 2 SYSTEM DESCRIPTION 2 1 2 1 Touch Screen Monitor 2 3 2 2 Communication Ports 2 4 2 3 Mouse Track Pad 2 4 2 4 Storage Compartment 2 4 2 5 Brake Pedal 2 5 2 6 Argon Shutoff Valve 2 5 2 7 Gas Inlets 2 5 2 8 Manual Vent Valve 2 5 2 9 Needle Connection Panel 2 6 2 9 1 MTS Connection Ports 2 6 2 9 2 Software Reset 2 7 2 9 3 Power Control Knob 2 7 2 9 4 Needle Channels...

Страница 4: ... Thaw and FastThaw Control for CX type Needles 4 20 4 6 2 Cautery Control for Track Ablation 4 22 4 6 2 1 Cautery Control for 1 5 CX Needles 4 22 4 6 2 2 Cautery Control for 2 1 CX Needles 4 24 4 7 Advanced Channel Controls 4 25 4 7 1 Select Needle Type Control 4 25 4 7 2 Link Channels Control 4 25 4 7 3 Cycle Programming Control 4 26 4 8 Advanced Temperature Sensor Controls 4 29 5 ADMINISTRATIVE ...

Страница 5: ...g Conditions 8 1 8 2 Storage Conditions 8 1 8 3 Transportation Conditions 8 1 8 4 Mechanical Specifications 8 1 8 5 External Gas Supply 8 1 8 6 Gas Cylinder Specifications 8 2 1 1 Accuracy of Displayed Values 8 2 8 7 Electrical Specifications 8 2 8 7 1 Electromagnetic Compatibility and Immunity EMC and EMI 8 2 9 REFERENCES 9 1 9 1 Patents 9 1 9 2 Trademarks 9 1 9 3 Contact 9 1 10 DISCLAIMER OF WAR...

Страница 6: ... Storage Compartment 2 4 Figure 2 4 Visual ICE Cryoablation System Needle Connection Panel 2 6 Figure 2 5 Visual ICE Cryoablation System Needle Channel 2 6 Figure 4 1 Visual ICE System Gas Connections 4 6 Figure 4 2 Gas Cylinder Set up 4 7 Figure 4 3 EZ Connect2 Dual Cylinder Adapter 4 8 Figure 4 4 Locking Needle into Channel 4 11 Figure 4 5 MTS Connection 4 14 ...

Страница 7: ...e 4 1 Cryoablation Procedure Flow 4 1 Table 4 2 Working Gas Pressures 4 9 Table 5 1 Configure Settings Controls 5 1 Table 8 1 Cable Lengths 8 3 Table 8 2 Electromagnetic Emissions 8 3 Table 8 3 Electromagnetic Immunity 8 4 Table 8 4 Electromagnetic Immunity for Systems that are Not Life supporting 8 5 Table 8 5 Recommended separation distances between portable and mobile RF communications equipmen...

Страница 8: ...ect Login 4 4 Screen 4 5 Reset Password Challenge 4 5 Screen 4 6 Password Reset 4 5 Screen 4 7 Emergency Login 4 5 Screen 4 8 No Gas Connected message 4 9 Screen 4 9 Optimizing Lines message 4 10 Screen 4 10 Procedure Screen 4 10 Screen 4 11 Thawing Mode message 4 11 Screen 4 12 Needle Past Expiration Date message 4 12 Screen 4 13 Select Needle Type Menu 4 12 Screen 4 14 Gas Time Remaining 4 15 Sc...

Страница 9: ...ystem vii Screen 4 29 Advanced Temperature Sensor Controls 4 29 Screen 5 1 Configure Settings 5 1 Screen 5 2 Software Update Confirmation 5 4 Screen 7 1 Software Recovery Screen 7 1 Screen 7 2 Invalid Configuration Message 7 2 ...

Страница 10: ...viii User Manual This page intentionally left blank ...

Страница 11: ...uctions for Use 3 USB Port 4 Ethernet Port 3 Do Not Push 5 Helium Gas 5 Argon Gas 4 Alternating Current 4 Protective Earth 4 Unsafe Voltage Electrical contacts greater than 40 V AC 4 Type BF Applied Part 4 Power Switch 4 Power Off 4 Power On 1 Authorized Representative in the European Community 6 Do Not Discard Return to Galil Medical at end of service life 7 ETL Product Listing Symbols ...

Страница 12: ...mplementors Forum Inc standard icon 4 IEC TR 60878 3 2015 Graphical symbols for electrical equipment in medical practice 5 Symbols created by Galil Medical based on the symbols for Helium and Argon in the Periodic Table of Elements 6 EN 50419 2006 Marking of electrical and electronic equipment in accordance with article 11 2 of Directive 2002 96 EC WEEE 7 ETL Product Listing mark indicates the pro...

Страница 13: ... due to the Joule Thomson effect while other gases such as helium increase in temperature The Visual ICE System uses high pressure argon gas that circulates through closed tip cryoablation needles to induce tissue freezing Active tissue thawing is achieved by circulating helium gas through the needles or alternatively by the use of a heating element inside the cryoablation needle which can be ener...

Страница 14: ...eration USB flash drive 4 GB within an attached pouch The Galil Medical USB flash 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 Refere...

Страница 15: ... Warming Set is the conduit that circulates warm saline through the urethra during a prostate cryoablation procedure CIVCO Percutaneous Instrument Template The following items used with the Visual ICE System are re usable and should be cleaned and or sterilized in accordance with the Instructions for Use that accompanies each product Galil Medical Prostate Procedure Template The Prostate Procedure...

Страница 16: ...n cancers and other cutaneous disorders Destruction of warts or lesions angiomas sebaceous hyperplasia basal cell tumors of the eyelid or canthus area ulcerated basal cell tumors dermatofibromas small hemangiomas mucocele cysts multiple warts plantar warts actinic and seborrheic keratosis cavernous hemangiomas peri anal condylomata and palliation of tumors of the skin Gynecology Ablation of malign...

Страница 17: ...ICE System prior to using the system to avoid inadvertent movement of the system during a procedure Each needle must be locked into a needle channel before initiating a cryoablation procedure to avoid the risk of forceful ejection of the needles from the system while under gas pressure Before the patient is anesthetized the Needle Integrity and Functionality Tests on the cryoablation needles must ...

Страница 18: ...ing the Galil Medical Multi Point Thermal Sensors MTS to monitor the freeze thaw temperatures for the intended treatment protocol and to monitor temperatures in the adjacent organs and structures Ensure that the MTSs are functioning properly before inserting into the patient by verifying that they are reading a reasonable room temperature Cryoablation freezes and destroys tissue To limit this effe...

Страница 19: ... such activity may damage the lines The Visual ICE Cryoablation System is non sterile When attaching cryoablation needles to the system do not contaminate the sterile field or the sterile cryoablation needle Avoid contact with the distal portion of the cryoablation needle Position the Visual ICE System in a manner to avoid draping needle tubing across the patient Needle tubing may become extremely...

Страница 20: ...rawn to prevent unintended tissue damage from the hot needle If a needle appears to be blocked press the Thaw button to thaw the needle for at least one minute to clear the blockage Take precautions to avoid potential electrostatic discharge If an electrostatic discharge occurs after touching the monitor the screen may flicker and MTS temperature readings may be inaccurate for a few seconds The sy...

Страница 21: ...infection injection site reaction myocardial infarction nausea neuropathy obstruction organ failure pain pelvic pain pelvic vein thrombosis penile tingling numbness perirenal fluid collection pleural effusion pneumothorax probe site paresthesia prolonged chest tube drainage prolonged intubation pulmonary embolism pulmonary insufficiency failure rectal pain rectourethral fistula renal artery renal ...

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Страница 23: ...tem 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 a...

Страница 24: ... 7 8 Figure 2 1 Visual ICE Cryoablation System Front View 1 Touch Screen Monitor 2 Monitor Storage Compartment 3 Mouse Track Pad 4 Needle Connection Panel 5 Power Control Knob 6 Storage Compartment 7 Brake Pedal 8 Wheels casters ...

Страница 25: ... The cryoablation procedure is controlled through the use of the touch screen monitor The monitor can be tilted and rotated to provide the optimal viewing and operating angle for the user The touch screen monitor includes a virtual on screen English QWERTY keyboard for entering procedure related data and may be operated with either a stylus or by finger touch The monitor folds flat into the top of...

Страница 26: ...ernet Port 2 USB 2 0 Full speed Port 3 USB 2 0 Low speed Port 2 3 Mouse Track Pad The mouse track pad is located within the recessed monitor storage cavity The mouse track pad provides an alternative to the touch screen as a means of interacting with the system Use the track pad to move and position the cursor on the monitor To press a button on the screen position the cursor over the button and p...

Страница 27: ...dition to locking the front wheels Lock each rear wheel by using the individual locking pedal on each wheel 2 6 Argon Shutoff Valve The Argon Shutoff Valve is used to turn the gas supply to the Visual ICE Cryoablation System ON or OFF It should be left in the GAS ON position and used to turn OFF argon gas only in an emergency 2 7 Gas Inlets The gas supply lines connect the argon and helium gas sup...

Страница 28: ... 2 Software Reset 3 Power Control Knob 4 Needle Channel 5 Locking Bar 6 Needle Port with Electrical Connection 7 Channel Number 2 9 1 MTS Connection Ports Four MTS Connection Ports are located above the Needle Connection Channels The MTS connection ports support connection of the Galil Medical Multi Point Thermal Sensors that are used to monitor temperature within and near the cryoablation target ...

Страница 29: ...in preparation for a procedure 2 9 4 Needle Channels The Needle Connection Panel contains ten numbered needle channels each channel contains two ports to support connection of up to two cryoablation needles Each channel operates independently of all other channels in either freezing or thawing mode The electrical connection is used for needles with a memory chip i Thaw FastThaw or Cautery capabili...

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Страница 31: ...reen section Control button ON position OPTIONAL optional or alternate step The Visual ICE Cryoablation System provides a graphical user interface that facilitates rapid communication between the user and the system through a touch screen interface 3 1 Login Screen When the system is powered on the Login Screen appears after the boot up process is complete reference Section 4 1 1 Screen 3 1 Login ...

Страница 32: ...inistrative users may also delete reports Configure Settings Configure various system settings reference Section 5 1 NOTE Some configuration parameters are limited to administrative and or service users only User Manual View information on how to access an electronic version of the User Manual Remote Upload Download Upload reports and download new software and configuration files from a Galil Medi...

Страница 33: ...divided into sections for the Navigation Tool Bar Context Sensitive Help Channel Controls Channel Status Temperature Sensors and Organ Map The title bar of each section on the Procedure Screen provides user selected self help for that section 1 5 2 3 4 6 Screen 3 3 Procedure Screen 1 Navigation Tool Bar 2 Context Sensitive Help 3 Channel Control 4 Channel Status 5 Temperature Sensors 6 Organ Map ...

Страница 34: ...re depleted The estimated times are displayed in hours minutes seconds During needle testing both pressure gauges display the estimated time remaining The initial estimates during needle testing are based on the assumption that all connected needles are operating simultaneously at 100 freeze intensity The Gas Indicator updates in real time as needles are disconnected or additional needles are conn...

Страница 35: ...he buttons and fields available in each section of the Procedure Screen 3 3 4 Channel Controls Channels 1 through 10 are labeled individually and contain independent controls for Test Freeze Freeze Intensity Thaw and Stop Each individual channel displays the needle type of the needles connected adjacent to the channel controls Screen 3 5 The Channel labeled ALL operates all active channels simulta...

Страница 36: ...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 Thaw button Begins a Thaw phase Advanced Thaw Controls Pressing and holding the Thaw button provides an option for enabling FastThaw and an option for enabling track ablation via the Cautery button The FastThaw and Cautery functions are available only on CX type cryoab...

Страница 37: ...el Status section Variations in orange shading visually distinguish active thaw helium or i Thaw FastThaw and Cautery phases Screen 3 6 Screen 3 6 Active Thaw Channel Status section For i Thaw and CX type needles the Channel Status also displays the internal gas temperature at the needle tip during freeze phase and the estimated temperature range for the needle shaft during active thaw phase The t...

Страница 38: ... the enlarged timer also displays the internal needle tip temperature during the freeze phase and the estimated temperature range of the needle shaft during the thaw phase NOTE During the needle warming phase for CX type needles the timer will display a rotating warming indicator Timers for three selected channels can be simultaneously enlarged Press the timer to return it to its original size Scr...

Страница 39: ...s the coldest temperature on each MTS Temperature vs Time can be plotted for any four selected sensor locations from the connected MTS needles Press the button corresponding to the selected sensor location on an MTS to select that sensor location to be graphed Press the respective MTS Channel button to graphically display all four sensor locations of an individual MTS The color of the selected tem...

Страница 40: ...n option to set visual alarms when a chosen temperature measurement falls below a desired value or when the rate of temperature drop is greater than a desired value This advanced control also provides an option to label the MTS location reference Section 4 8 3 3 8 Organ Map The Organ Map may be used to provide a pictorial representation of tumor location needle placement and cycle activity for a s...

Страница 41: ...e eraser is selectable Place Needle button Select and place needles and MTS on the organ map Needles are selectable and identified by channel and needle port e g 1a 1b 2a etc MTS are selectable by MTS port Drag the needle or MTS to the desired location on the Organ Map to place it Place each needle on the Organ Map as it is inserted into the target tissue to avoid potential mix up of needle locati...

Страница 42: ...needles graphical history of freeze thaw and cautery phases graphical history of MTS readings organ map used with needle placement identification and any notes entered by the physician Screen 3 12 Procedure Report Example To view a report that has been saved to the Visual ICE System press the View Reports button from the Startup Screen Screen 3 2 The View Reports Screen displays a list of all save...

Страница 43: ...ure Type press the appropriate header section of the report list The Export Report button displays a window to choose the Export File Type and File Name for exporting the report Reports can be exported in HTML PDF or CSV formats An additional option is available to export raw MTS data for further analysis Screen 3 14 Export Report Screen ...

Страница 44: ...nage Users Manual Software Update and Configure Ethernet reference Section 5 1 The Manual Software Update and the Configure Ethernet buttons are available only to system administrators and service personnel Only Service personnel have the option to adjust the system time and date Screen 3 15 Configure Settings Table 3 5 Configure Settings Options Button Function Calibrate Touchscreen Calibrate the...

Страница 45: ... between the Ethernet port in the monitor storage compartment and an Ethernet wall socket in the facility Power the system ON and login Select the Remote Upload Download screen to connect to a Galil Medical server for remote uploading of procedure reports or downloading of system software versions The Visual ICE Cryoablation System automatically checks for connectivity to the Galil Medical server ...

Страница 46: ...3 16 User Manual Screen 3 16 Remote Upload Download Screen Screen 3 17 Successful Upload Download ...

Страница 47: ...nd Functionality Test Test Multi Point Thermal Sensors if applicable 4 Conduct Cryoablation Procedure Insert needles into target tissue Deliver the cryoablation treatment and remove needles View and save reports if desired Depressurize the system and shutdown 4 1 Preparation for Use Prior to using the Visual ICE System inspect the chassis power cord brake safety cables gas supply lines gas connect...

Страница 48: ...ethral Warming Set Instructions for Use 4 Ensure that the power switch located on the rear of the system is in the ON position Figure 2 2 This power switch should remain ON at all times The Visual ICE System will not turn ON if this power switch is in the OFF position 5 Confirm that the Argon Shutoff Valve on the Visual ICE System is in the GAS ON position Turn it to the GAS ON position if needed ...

Страница 49: ...nd the needle type display window bordered in red notes the channel is defective A message indicating the failure is displayed in the upper right hand corner of the Navigation Tool Bar Screen 4 1 Disabled Channel A failure that prevents use of the system displays a message directing you to contact Galil Medical Customer Service reference Section 7 7 If the Visual ICE System software detects pressu...

Страница 50: ... login name and password are not case sensitive Numbers are displayed when the keyboard is in upper case To change text case use the shift button on the virtual keyboard NOTE If you leave the user interface idle for a pre set time with no activity the Visual ICE System software requires you to re enter your password to unlock the user interface reference Section 5 1 Screen 4 4 Incorrect Login ...

Страница 51: ...5 Screen 4 5 Reset Password Challenge Customer Service will provide a response to be entered on the screen using the virtual keyboard Your password will be reset Screen 4 6 and you will have an opportunity to change your password in the configuration screen Screen 4 6 Password Reset In case of emergency press the Emergency Login button at the top of the screen Screen 4 3 A message is displayed wit...

Страница 52: ... connected If helium gas is connected i Thaw technology is disabled and only thawing with helium gas is available 1 Position the gas cylinder s close enough to the Visual ICE System to ensure that the gas supply line is not stretched and does not present a trip hazard 2 On the rear of the Visual ICE System ensure that the Manual Vent Valve is in the CLOSED position 3 Remove the humidity covers fro...

Страница 53: ...gas flow is present 9 Repeat the procedure outlined in Steps 4 through 8 to connect the argon gas cylinder to the Visual ICE System using the argon gas supply line If no argon pressure is displayed on the system pressure gauge ensure the Argon Shutoff Valve is in the GAS ON position OPTIONAL The EZ Connect2 Dual Cylinder Adapter connects two cylinders of argon gas to the Visual ICE System to suppo...

Страница 54: ...edure if the second cylinder is also depleted during the procedure 2 3 1 Figure 4 3 EZ Connect2 Dual Cylinder Adapter 1 Auxiliary Gas Supply Line 2 Four way Adapter Assembly with Pressure Gauge 3 Gas Supply Line CAUTION Before beginning the cryoablation procedure ensure availability of sufficient gas to conduct the planned cryoablation procedure reference Section 8 5 for gas purity requirements 10...

Страница 55: ...ystem produces a continuous hissing sound verify that the Manual Vent Valve is fully closed If the Manual Vent Valve is fully closed and the hissing sounds persists shut OFF the system using the power control knob located on the front of the system Figure 2 1 Close the gas supplies using the cylinder valves Contact Galil Medical Customer Service 4 1 3 Gas Line Flushing After argon is connected and...

Страница 56: ...screen monitor press Start Procedure The Procedure Screen appears Screen 4 10 Screen 4 10 Procedure Screen 2 Using aseptic technique carefully remove the cryoablation needle from the package and place in a sterile work area 3 Remove the connector cap and then connect the needle to the Visual ICE System needle connection panel Figure 2 4 CAUTION Do not kink pinch cut or pull excessively on the need...

Страница 57: ...at will be tested CAUTION Galil Medical recommends that only needles of the same type be placed together in a single channel Do not combine i Thaw capable needles with non i Thaw capable needles in the same channel Additionally using needles of differing types in a channel may affect the accuracy of the Gas Indicator CAUTION If the Visual ICE System detects that helium gas is connected the system ...

Страница 58: ...proper needle type from the drop down menu Screen 4 13 Select Needle Type Menu 8 After selecting the first needle the selection for subsequent needles defaults to the initial selection Confirm needle type displayed in each channel matches the needle type connected 9 Press and hold the Channel button to open Advanced Channel Controls which allows you to change the needle type for a channel as neede...

Страница 59: ...has successfully completed the Needle Integrity and Functionality Test During testing carefully watch each needle for the following Flush Ensure no bubbles are formed along the needle shaft and tip Ensure that no iceball is formed during the Flush phase WARNING A defective cryoablation needle that has a gas leak can cause a gas embolism in the patient Never use a defective needle for a cryoablatio...

Страница 60: ...played CAUTION Do not allow the MTS to touch the cryoablation needle during use erratic temperature measurements may be displayed 4 2 Performing a Cryoablation Procedure WARNING Do not touch the screen if the touch screen monitor goes blank for more than five 5 seconds during a procedure Immediately turn off power to the system and end the procedure to avoid inadvertent activation of needles 1 OPT...

Страница 61: ...uch as direct visualization ultrasound or Computed Tomography CT to ensure adequate tissue coverage and to avoid damage to adjacent structures OPTIONAL To initiate a freeze phase on all needles simultaneously press the Freeze button on the channel labeled ALL Pressing any function button on the channel labeled ALL displays a message asking you to confirm simultaneous operation of all needles NOTE ...

Страница 62: ...ocedure Screen Three messages appear requesting action Confirmation to end the procedure Press the Yes button to end the procedure Request to save a report Press the Yes button to save a report Request to automatically vent the high pressure gas Press the Yes button to automatically vent the system The system prompts you to close the gas supplies before venting The automatic venting takes approxim...

Страница 63: ...supplied USB flash drive with the Visual ICE System Do not use that flash drive for purposes unrelated to Visual ICE System data and reports 4 Press the Export button to begin exporting the file Wait for confirmation before removing the USB flash drive from the system Screen 4 16 Report Exported message ...

Страница 64: ...he Logout button on the Startup Screen to log out of the system 6 Press the Shutdown button on the Login Screen to power down the system A message appears requesting confirmation to shut the system down 7 Wait until the screen goes black Turn the Power Control Knob to the OFF position 8 Unplug the Visual ICE System and wrap the power cord around the cord wrap on the rear of the system WARNING Do n...

Страница 65: ...ylinder counter clockwise for one quarter turn Ensure that the pressure reading on the gauge responds immediately Turn the cylinder valve further counter clockwise to open the gas cylinder so that sufficient gas flow is present 9 Carefully turn the cylinder valve on the argon gas cylinder counter clockwise for one quarter turn Ensure that the pressure reading on the gauge responds immediately Turn...

Страница 66: ...trols The Visual ICE System provides options to select helium free thawing i Thaw and FastThaw and to conduct track ablation Cautery NOTE i Thaw FastThaw and Cautery functions are only available when needles with that capability are connected NOTE Argon gas only must be connected to access these functions Connecting helium gas to the Visual ICE System disables these functions 4 6 1 i Thaw and Fast...

Страница 67: ... faster thaw time NOTE A maximum of 7 needles can thaw simultaneously using the i Thaw function a maximum of 4 needles can thaw simultaneously using the FastThaw function 3 During the needle warming phase for CX type needles the channel status will display a rotating warming indicator Screen 4 19 Screen 4 19 Advanced Thaw Needle Warming 4 When the threshold temperature for i Thaw or FastThaw is re...

Страница 68: ...d the risk of thermal injury to adjacent tissue organs CAUTION Track ablation produces heat along the distal needle shaft Use care to avoid thermal injury to adjacent tissue organs CAUTION The needle handle may become warm during track ablation Pay attention to the needle handle position Prolonged contact with warm portions of the needle handle could cause unintended thermal tissue damage to the p...

Страница 69: ...OTE A maximum of four 4 needles may use the cautery function simultaneously 4 Press the Start button to initiate track ablation Cautery During the needle warming phase the Cautery Control Screen will display a rotating warming indicator Screen 4 22 Screen 4 22 1 5 CX Needle Warming When the cautery threshold temperature is reached Cauterization automatically begins o The timer will display Cauteri...

Страница 70: ...e the cautery function simultaneously NOTE The duration for the cautery phase for 2 1 CX type needles may be selected from 30 seconds to 3 minutes adjustable in 30 second increments If a 2 1 CX type is connected a drop down menu will provide cautery duration choices 4 Select the cautery duration from the drop down menu 5 Press the Start button to initiate track ablation Cautery During the needle w...

Страница 71: ... to enter Advanced Channel Controls for that channel Screen 4 24 2 Select the proper needle type from the drop down menu 3 Press the OK button Screen 4 24 Advanced Channel Controls 4 7 2 Link Channels Control 1 Press and hold the Channel button to enter Advanced Channel Controls for that channel Advanced Channel Controls 2 Press the Link button to link two channels together for simultaneous operat...

Страница 72: ...cle Sequence menu using the left Arrow button next to the Freeze controls 5 Select the desired thaw by clicking on the available options in the Thaw controls Select the thaw duration using the appropriate arrows or the scroll bar 6 Add the programmed thaw cycle to the Cycle Sequence menu using the left Arrow button next to the Thaw controls 7 Program additional cycles by repeating steps 3 6 as app...

Страница 73: ...em 4 27 11 Repeat steps 1 to 10 to program additional channels NOTE Programmed sequences may be saved by selecting the Save Cycle button Name the sequence then press the Save button Screen 4 27 Screen 4 27 Cycle Sequence Controls ...

Страница 74: ...vanced Channel Controls for the selected channel press the Cycles button and press the Load Cycle button Using the drop down menu select the saved sequence press the Load button then press the Go button Screen 4 28 Screen 4 28 Saved Sequence Controls ...

Страница 75: ... selected MTS to enter Advanced Temperature Sensor Settings Screen 4 29 Advanced Temperature Sensor Controls 2 Select the desired alarm type and desired sensor location using the drop down menus 3 Press the Up or Down button and adjust the temperature to define the desired alarm limit 4 Press the Set button to set the alarm OPTIONAL Select a name to be displayed above the MTS channel location usin...

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Страница 77: ...s can change the Time Zone When settings have been changed press the Back button to return to the Startup screen A message is displayed summarizing the changes made to the settings and asking for confirmation to save the settings Press Yes to save the settings No to exit the screen without saving your changes or Cancel to return to the Configure Settings Screen and continue making changes Screen 5...

Страница 78: ...s cylinder is low Link all channels Check this box to automatically link all adjacent channels for simultaneous operation e g 1 and 2 3 and 4 5 and 6 Passive thaw timer count up Check this box to automatically display elapsed time during passive thaw The digital timer reads Stopped and the time elapsed in passive thaw is indicated Active Flush Unless disabled by removing the check from this box an...

Страница 79: ...d graphs Control buttons at the top of the screen provide options for Calibrate Touch Screen Manage Users Manual Software Update and Configure Ethernet Calibrate Touch Screen Press the center of the symbols to calibrate the touch screen Follow the on screen prompts as you move from one location to another The system begins the calibration process by displaying a symbol in the upper left hand area ...

Страница 80: ...tware Update Confirmation NOTE All users can update the software using the Remote Upload Download button on the Startup Screen reference Section 3 5 5 1 2 Configure Ethernet The Visual ICE System must be configured to access one of two Galil Medical servers for remote uploading of reports and downloading of software updates This function is only available to administrative and service users The Vi...

Страница 81: ...dle connection ports The needle connection ports must remain completely dry at all times 3 Ensure that cleaned surfaces are dry prior to closing or turning on the system CAUTION Do not set food drinks or other objects on top of the Visual ICE Cryoablation System Doing so may damage the system 6 2 2 Cleaning the Stylus Clean the stylus after each use by wiping down with isopropyl alcohol Dry the st...

Страница 82: ...is required place a request with a Galil Medical qualified service engineer 6 5 System Disposal In compliance with Waste Framework Directives when a Visual ICE System is decommissioned contact Galil Medical Customer Service to schedule system replacement refurbishing or disposal ...

Страница 83: ...sers may update the software with an appropriate USB flash drive 1 Shutdown the Visual ICE System 2 Hold down the Software Reset button by inserting a straightened paper clip into the Software Reset hole while simultaneously powering up the system The system displays the Software Recovery Screen Screen 7 1 Software Recovery Screen 3 Press the Rollback button to restore the software to the previous...

Страница 84: ...tartup Screen Screen 3 2 Press the Manual Software Update button on the Configure Settings Screen Screen 3 15 Insert the USB flash drive NOTE Wait 20 seconds for the system to recognize the flash drive Press the Browse button Select the file to conduct the upgrade Press the Update button NOTE o Wait until a displayed message confirms completion of the update o The upgrade may take half an hour to ...

Страница 85: ...annel for the channel to be available for use 3 If a needle with a memory chip is being used and steps 1 2 are unsuccessful select a new needle for use Contact Galil Medical Customer Service to arrange return of the non operational needle 4 The channel may be defective Do not use this channel Move the needle s to a different channel Conduct the Needle Integrity and Functionality Test again Touch s...

Страница 86: ... the touch screen monitor goes blank for greater than five 5 seconds during a procedure Immediately turn off power to the system and end the procedure to avoid inadvertent activation of needles Contact Galil Medical Customer Service 7 2 1 Replacing Fuses Instruction Photo 1 Turn the Power Switch OFF on the rear of the Visual ICE System Loosen the thumb screw on the cord retention clip 2 Remove the...

Страница 87: ...lder carefully slide the fuse holder out of the power inlet There are four fuses in the fuse holder 5 Catch the fuse holder and fuses as the fuse holder is removed from the power inlet The two fuses that remain in the fuse holder are the fuses that are part of the system circuit 6 Replace the fuses in the fuse holder with the two loose fuses NOTE Use only Galil Medical specified fuses in the Visua...

Страница 88: ... is fully open Needle is not freezing during the Needle Integrity and Functionality Test 1 The argon gas cylinder valve may be closed Open the gas cylinder valve by turning the gas cylinder valve counter clockwise to allow sufficient gas flow Verify that appropriate pressure is displayed on the Gas Indicator 2 Confirm that the argon gas cylinder is connected to the argon inlet 3 The needle may be ...

Страница 89: ...al Vent Valve may be open Fully close the Manual Vent Valve There is a hissing sound before the needles are connected 1 Check that the regulated pressures are within the working pressure limits green range on the Gas Indicator display The system may be venting to reduce the pressure to below 4200 psi to prevent damage to the system If the pressure drops to within working pressure range the system ...

Страница 90: ...er pressure WARNING Do not apply excessive force to release the gas supply lines or to loosen the pressure gauge The gas lines may still be under pressure Verify that the gas cylinders are CLOSED Verify the pressure gauge at the gas cylinder is 0 If in the Procedure Screen verify the gas pressure display shows no gas connected If the Visual ICE System is ON end the procedure and vent the system us...

Страница 91: ...ove freely 1 Release the brake to unlock the front wheels 2 Check the individual rear wheel brakes and ensure the brakes are released 7 5 Gas Cylinders and Gas Supply Lines Symptom Potential Causes Solutions Safety cable is missing at either the cylinder side or the system side of the gas supply line Do not use a gas supply line with a missing safety cable Doing so could compromise the safety of p...

Страница 92: ...ly some of the temperature sensor locations on the MTS needle are registered on the Temperature Sensors display 1 Move the MTS needle to a different port 2 Replace the MTS needle 3 Contact Galil Medical Customer Service MTS needle is connected but temperature is not registered on the Temperature Sensors display 1 Move the MTS needle to a different port 2 Replace the MTS needle 3 Contact Galil Medi...

Страница 93: ...act your System Administrator if assistance is required Contact Galil Medical Customer Service if further assistance is required o 1 877 639 2796 or o 1 651 287 5000 o support galilmedical com No name was entered OR The name entered didn t match assigned names in the system 10 02 Login You have not entered the correct Password Reenter your Password Contact your System Administrator if assistance i...

Страница 94: ...e to be relayed to Customer Service 10 04 Password Reset Your password has been reset to XXX Change your password in the configuration screen when convenient User correctly entered the reset password challenge and received a temporary password 10 05 Emergency Login To obtain an emergency login contact Galil Medical Customer Service o 1 877 639 2796 or o 1 651 287 5000 o support galilmedical com Re...

Страница 95: ...e o 1 877 639 2796 or o 1 651 287 5000 o support galilmedical com User tried to reset their password and did not respond correctly to the challenge User must contact Customer Service in order to reset their password PROCEDURE 20 01 Cannot Start Test The gas pressure is too low to begin a procedure Check that the gas cylinders have enough pressure to start the procedure User pressed the Test button...

Страница 96: ...rol all needles simultaneously Do you want to initiate x freeze for all active needles now YES NO User selected Freeze button in ALL channel to control all active channels To proceed the user must confirm freezing of all active needles 20 05 Freeze All Intensity You selected to control all needles simultaneously Do you want x freeze intensity applied to all needles now YES NO User selected a freez...

Страница 97: ...needles now YES NO User selected Stop button in ALL channel to control all active channels To proceed the user must confirm stop for all active needles 20 10 Cautery CAUTION Activation of thermal cautery immediately ceases all other cryoablation operations for the duration of cautery activity Do you want to proceed with cautery YES NO User pressed Thaw button to open the Advanced Thaw Controls and...

Страница 98: ... Automatic Vent The gas pressure is not dropping Check that the gas cylinder shut off valve is closed User selected to automatically vent high pressure gas at the end of a procedure but the pressure was not dropping User must ensure the shut off valve is closed 20 15 Automatic Vent Venting is in progress If needles are still connected do not unlock channels or disconnect needles until venting is c...

Страница 99: ...imit for FastThaw reached Wait until thawing is complete before activating additional FastThaw needles This channel will use passive thaw User attempted to activate more than four FastThaw needles The Visual ICE System supports simultaneous operation of no more than four FastThaw needles After completing the thaw phase with four needles additional needles may be activated for FastThaw 20 21 Maximu...

Страница 100: ... of advanced thaw Advanced thaw activity is unavailable User attempted to initiate Advanced Thaw in a channel The channel did not contain i Thaw or FastThaw capable needles 20 25 Advanced Thaw Unavailable Advanced thaw activity is unavailable on channel X while helium is connected Use helium thaw or disconnect helium User attempted to initiate Advanced Thaw while helium was connected If helium is ...

Страница 101: ...t the estimated remaining volume in the gas cylinder is low The alert can be configured by the user to be displayed at an interval of 0 to 15 minutes Reference Table X Low Cylinder Alert NEEDLES 40 01 Unsupported Needle The connected needle is not supported by the software Choose and connect a different needle type A needle type not supported by the software configuration was connected in the chan...

Страница 102: ...appropriate needle is connected 40 05 Used Needle This needle has been previously used Replace with a new needle The software prevents needle reuse and identified a needle previously used The channel will be disabled until a new needle is connected 40 06 Corrupt Memory Needle Memory chip is corrupt on Channel X Manually select the needle type User connected a needle containing a bad memory chip Us...

Страница 103: ...ive thaw is required TEMPERATURE SENSOR ORGAN MAP 50 01 MTS Alarm Sensor point 5 15 25 or 35 on MTS X met selected alarm limit The MTS detected the selected alarm temperature 50 02 MTS Alarm Sensor point 5 15 25 or 35 on MTS X met selected alarm limit The MTS detected the selected alarm rate of temperature change within 30 seconds 50 03 MTS Disconnected An MTS is disconnected Reconnect the MTS to ...

Страница 104: ...are not connected to the Internet Connect Ethernet cable or check the Ethernet port Contact your network administrator if you are unable to connect User selected Remote upload download but the system was not connected to the Internet A connection must be established to conduct the upload or download 60 02 Network Connection You are not connected to the Internet Connect Ethernet cable or check the ...

Страница 105: ...ser needs to call Galil Medical because the problem is on the Galil Medical side 60 04 Update Failed An error occurred during the update process Retry update During User update of the system an error occurred that prevented completion of the update Another update should be attempted 60 05 Incompatible Hardware The hardware is not compatible with the current software Try downloading a software upda...

Страница 106: ...ive market Incompatibility with regulatory approval was identified The appropriate software should be downloaded 60 07 Invalid Configuration A software file is nonoperational If problem persists contact Galil Medical Customer Service o 1 877 639 2796 or o 1 651 287 5000 o support galilmedical com There was a problem with the software s configuration files Contact Galil Medical 60 08 DHCP Request E...

Страница 107: ...tware to the previous software version 60 10 Software Recovery Are you sure you want to restore the default settings for all configurations YES NO User pressed the Software Recovery button then selected Load Activation will restore the system default settings for all configurations REPORTS 70 01 Save Report Do you want to save the report to the Visual ICE System YES NO User selected End Procedure ...

Страница 108: ... 70 04 Report Saved Report saved successfully Report successfully saved to a USB flash drive 70 05 Duplicate Filename The chosen filename already exists on the USB flash drive Choose a different filename User tried to export a report to a USB flash drive using a filename duplicate to a filename on the flash drive To export the report a different filename must be chosen 70 06 Report Error Unable to...

Страница 109: ...cation If the restart fails the system is not usable 80 02 Startup Failure System self checks failed Restart the system If problem persists contact Galil Medical Customer Service o 1 877 639 2796 or o 1 651 287 5000 o support galilmedical com Software self checks located a failure that required the system to be restarted 80 03 Pressure Alert Pressure exceeds safe operating limits Close the gas cyl...

Страница 110: ... 1 877 639 2796 or o 1 651 287 5000 o support galilmedical com System detected a low battery System operation may be impacted if operated with a low battery System Error messages are displayed in the right corner of the navigation tool bar The User is offered details of the error by Press here instruction 80 30 System Error Gas pressure display may be inaccurate Monitor procedure carefully using i...

Страница 111: ...pened further 80 32 System Error Channel X is defective Choose another channel At the conclusion of the procedure contact Galil Medical Customer Service Galil Medical Customer Service o 1 877 639 2796 or o 1 651 287 5000 o support galilmedical com A defective solenoid on Channel X was detected another channel should be selected 80 33 System Error Defective MTS in channel X Replace with a new MTS G...

Страница 112: ... number of active needles Galil Medical Customer Service o 1 877 639 2796 or o 1 651 287 5000 o support galilmedical com The calculated flow rate for a given channel exceeded the optimum system requirement The number of active needles should be reduced 80 36 System Error The gas flow rate exceeds the system operation requirements and may impact performance Reduce the number of active needles Galil...

Страница 113: ...al ICE System is past due Contact Galil Medical Customer Service to schedule service o 1 877 639 2796 or o 1 651 287 5000 o support galilmedical com The Visual ICE System was not serviced on schedule During subsequent start ups the User is reminded the service is past due 90 03 System End of Life The Visual ICE System is at the end of operational life Contact Galil Medical Customer Service to arra...

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Страница 115: ...rt If the original shipping containers are 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 8 4 Mechanical Specifications Weight 100 kg 220 lbs Height 107 cm 42 in monitor down 157 cm 62 in monitor up Foot Print 56 x 66 cm 22 x 26 in Storage Compartment Weight ...

Страница 116: ... 50 60 Hz VA Rating 250 VA IP Rating IP10 Fuse Rating T 3 15A Electrical Protection Class I Type BF protection against shock Signal Input Output Ports one 1 Ethernet port one 1 USB 2 0 full speed port one 1 USB 2 0 low speed port 8 7 1 Electromagnetic Compatibility and Immunity EMC and EMI The Visual ICE Cryoablation System needs special precautions regarding electromagnetic compatibility EMC and ...

Страница 117: ...ed adjacent to or stacked with other equipment If adjacent or stacked use is necessary the Visual ICE System should be observed to verify normal operation Table 8 2 Electromagnetic Emissions Guidance and manufacturer s declaration electromagnetic emissions The Visual ICE Cryoablation System is intended for use in the electromagnetic environment specified below The customer or the user of the Visua...

Страница 118: ...nt Surge IEC 61000 4 5 1 kV line s to line s 2 kV line s to earth 1 kV line s to line s 2 kV line s to earth Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip ...

Страница 119: ...nce in metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site surveya should be less than the compliance level in each frequency rangeb Interference may occur in the vicinity of equipment marked with the following symbol NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propa...

Страница 120: ...power of the communications equipment Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz 0 01 0 117 0 117 0 233 0 1 0 369 0 369 0 738 1 1 167 1 167 2 333 10 3 689 3 689 7 379 100 11 667 11 667 23 333 For transmitters rated at a maximum output power not listed above the recommended separation...

Страница 121: ... IcePearl IceSeed IceSphere IceRod I Flow i Thaw Multi Point and Visual ICE 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 9 3 Contact Galil Medical Inc 4364 Round Lake Road Arden Hills MN 55112 USA Galil Medical Customer Service 1 877 639 2796 1 651 287 500...

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Страница 123: ... OF THIS DEVICE GALIL IceEDGE IceFORCE IcePearl IceSeed IceSphere IceRod I Flow i Thaw Multi Point and Visual ICE 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 2012 2018 Galil Medical Inc All rights reserved MAN8060en 09 2018 09 For assistance contact www g...

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Страница 126: ...lls MN 55112 USA Telephone 1 877 639 2796 Fax 1 877 510 7757 Obelis s a Boulevard Général Wahis 53 1030 Brussels Belgium Telephone 32 2 732 59 54 Fax 32 2 732 60 03 E mail mail obelis net GALIL IceEDGE IceFORCE IcePearl IceSeed IceSphere IceRod I Flow i Thaw Multi Point and Visual ICE are trademarks of Galil Medical Ltd BTG and the BTG roundel are registered trademarks of BTG International Ltd Gal...

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