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Visual-ICE

™

MRI Cryoablation System

12-1

12 REFERENCES

12.1 Patents

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

http://www.GalilMedical.com/patents

12.2 Trademarks

GALIL, IceRod, IceSeed, i-Flow, 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.

12.3 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 MRI

Страница 1: ...M R I C R Y O A B L A T I O N S Y S T E M RX Only User Manual...

Страница 2: ...lls 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 G n ral Wa...

Страница 3: ...otential Adverse Events 1 9 2 SYSTEM DESCRIPTION 2 1 2 1 Console 2 2 2 1 1 Touch Screen Monitor 2 4 2 1 2 Communication Ports 2 5 2 1 3 Mouse Track Pad 2 5 2 1 4 Storage Compartment 2 5 2 1 5 Software...

Страница 4: ...om 4 10 4 7 Opening Gas Cylinder Valves 4 11 5 PERFORMING THE CRYOABLATION PROCEDURE 5 1 5 1 Pre Procedure Testing 5 2 5 2 Performing a Cryoablation Procedure 5 5 5 3 Reports 5 7 5 4 Changing Gas Cyli...

Страница 5: ...Reports 10 24 10 9 6 System 10 25 10 9 7 Service 10 28 11 SYSTEM SPECIFICATIONS 11 1 11 1 Operating Conditions 11 1 11 2 Storage Conditions 11 1 11 3 Transportation Conditions 11 1 11 4 Mechanical Sp...

Страница 6: ...l ICE MRI Console Gas Connections 4 6 Figure 4 2 Gas Cylinder Set up 4 7 Figure 4 3 Connection of Junction Box Harness Gas Line 4 8 Figure 4 4 Connection of Junction Box Harness Fiber Optic Line 4 8 F...

Страница 7: ...orking Gas Pressures 4 12 Table 5 1 Cryoablation Procedure Flow 5 1 Table 8 1 Configure Settings Controls 8 2 Table 11 1 Cable Lengths 11 3 Table 11 2 Electromagnetic Emissions 11 4 Table 11 3 Electro...

Страница 8: ...sage 4 3 Screen 4 3 Login Screen 4 4 Screen 4 4 Incorrect 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 mes...

Страница 9: ...ation 3 Do Not Push 1 Consult Instructions for Use 4 USB Port 4 Ethernet Port 5 Helium Gas 5 Argon Gas 4 Alternating Current 4 Protective Earth 3 Unsafe Voltage Electrical contacts greater than 40 V A...

Страница 10: ...bols 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 Li...

Страница 11: ...Joule Thomson effect displayed by compressed gases The Joule Thomson effect is a change in the temperature of a compressed gas as it flows through a narrow orifice and expands to a lower pressure Cert...

Страница 12: ...1 Junction Box Harnesses for Console and Mobile Connection Panel The Junction Box Harnesses one for the Console one for the Mobile Connection Panel are used to connect to the junction boxes installed...

Страница 13: ...es and are not available from Galil Medical Argon gas cylinder s Helium gas cylinder s NOTE The argon and helium gases must meet the purity requirements specified in Section 11 5 1 2 3 Storage Store t...

Страница 14: ...reezing of skin 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 dermato...

Страница 15: ...e Do not use the Visual ICE MRI Cryoablation System if the system is visibly damaged exposing any internal components or sharp edges Have sufficient gas argon helium available to conduct the planned c...

Страница 16: ...as a sterile drape Galil Medical recommends having backup argon cylinders available for each treatment to ensure sufficient gas is available to complete a treatment Do not use the Visual ICE MRI Cryoa...

Страница 17: ...kink the gas supply lines Sharp bends or kinks may compromise the integrity of the gas supply lines Do not tilt the Visual ICE MRI Cryoablation Console or Mobile Connection Panel Lift the Visual ICE...

Страница 18: ...phase the gas in the Junction Box Harnesses is vented through the Console The venting sound might be startling to people in the vicinity A typical duration for helium gas venting after thawing is abou...

Страница 19: ...hemorrhage creatinine elevation creation of false urethral passage cystitis death deep vein thrombosis DVT delayed non healing diarrhea disseminated intravascular coagulation DIC ecchymosis edema swel...

Страница 20: ...1 10 User Manual This page intentionally left blank...

Страница 21: ...e control room The Mobile Connection Panel is located in the magnet room close to the MRI magnet The Mobile Connection Panel contains a Needle Interface with eight independent needle connection channe...

Страница 22: ...wheels for system mobility The Console contains a three way brake pedal mechanism in front to immobilize the two front wheels of the Console and to provide directional control during movement The rea...

Страница 23: ...een Monitor 2 Monitor Storage Compartment 3 Mouse Track Pad 4 Software Reset 5 Auxiliary Display Port 6 Junction Box Harness Electrical Socket 7 Junction Box Harness Fiber Optic Socket 8 Junction Box...

Страница 24: ...lve 10 Rear Wheel Brake Pedal 2 1 1 Touch Screen Monitor The cryoablation procedure is controlled by using the touch screen monitor The monitor can be tilted and rotated to provide the optimal viewing...

Страница 25: ...ch 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 press the l...

Страница 26: ...tion to prevent the front two wheels from swiveling during transportation Position the brake in the DOWN position to lock the front two wheels into place When the brake pedal is in the middle position...

Страница 27: ...orm of the Mobile Connection Panel provides fiber optic electrical and gas connection sockets for connection to a Junction Box Harness The Mobile Connection Panel is mounted on a wheeled platform for...

Страница 28: ...ressure Indicator LED to alert the user to the presence or absence of high pressure gas a STOP ALL button to stop all operations and a Test Channel 8 button for testing a needle added to channel 8 1 2...

Страница 29: ...r in the magnet room can add a needle to a needle connection port in channel 8 and initiate testing of the needle directly from the Mobile Connection Panel If an additional needle is required during t...

Страница 30: ...n Panel gas connection socket all eight gas line connections are made simultaneously 1 2 3 4 Figure 2 8 Mobile Connection Panel Junction Box Harness Sockets 1 Electrical Socket 2 Gas Connection Socket...

Страница 31: ...reen section Control button ON position OPTIONAL optional or alternate step The Visual ICE MRI Cryoablation System provides a graphical user interface that facilitates rapid communication between the...

Страница 32: ...export reports to a Galil Medical USB flash drive NOTE Administrative users may also delete reports Configure Settings Configure various system settings reference Section 8 1 NOTE Some configuration...

Страница 33: ...sonnel 3 3 Procedure Screen The Visual ICE MRI System Procedure Screen provides a single screen view to control and monitor a cryoablation procedure The Procedure Screen is divided into sections for t...

Страница 34: ...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...

Страница 35: ...annels simultaneously Table 3 3 Channel Controls Button Description Channel button Identifies the active channel s Advanced Channel Controls Pressing and holding the Channel button provides options to...

Страница 36: ...engths of the Junction Box Harnesses reductions in ice ball size are small for gas duty cycles between 100 and 50 If a scan with a high SAR level is performed while the needle is not freezing hazards...

Страница 37: ...y Screen 3 6 The enlarged Timer displays the channel number in the upper left corner of the timer window elapsed time and when freezing the selected freeze intensity Timers for three selected channels...

Страница 38: ...ed by the physician Screen 3 7 Procedure Report Example To view a report that has been saved to the Visual ICE MRI System press the View Reports button from the Startup Screen Screen 3 2 The View Repo...

Страница 39: ...3 5 Configure Settings The Configure Settings Screen allows selection of settings used during a cryoablation procedure Modifiable settings include System Procedure and Registration Settings and Units...

Страница 40: ...rvice users Configure Ethernet Configure the Ethernet connection for remote uploading of reports or downloading of software versions NOTE This function is available only to administrative and service...

Страница 41: ...to the Galil Medical server Select the appropriate box for either uploading reports or downloading updates and press Start Screen 3 11 A confirmation message appears when the upload download process h...

Страница 42: ...3 12 User Manual Screen 3 12 Successful Upload Download...

Страница 43: ...ety cables are connected 3 Connect Junction Box Harnesses Connect Junction Box Harness in the control room Connect Junction Box Harness in the magnet room Ensure the safety cables are connected NOTE D...

Страница 44: ...o rear wheels using the individual brakes on each wheel 3 Plug the power cord into a hospital grade power outlet electrical mains outlet with a ground connection Galil Medical recommends using a stabl...

Страница 45: ...transducers and temperature measuring circuits If the system detects a failure of an individual channel the channel is disabled and the needle type display window bordered in red notes the channel is...

Страница 46: ...ase 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 wit...

Страница 47: ...mer Service will provide a response to enter on the screen using the virtual keyboard Once a correct response is received your password is reset Screen 4 6 and you are given the opportunity to change...

Страница 48: ...hed and does not present a trip hazard 2 On the rear of the Console ensure that the Manual Vent Valve is in the CLOSED position 3 Remove the humidity covers from the helium and argon inlets on the Con...

Страница 49: ...the safety cable at the end of the gas line to the safety cable ring on the junction box b Remove the protective covers from the Junction Box Harness connectors and junction box sockets c Connect the...

Страница 50: ...A clicking sound indicates a successful connection NOTE To verify the fiber optic connector is secure pull on the check connection area identified by Figure 4 4 callout 3 If the fiber optic line is se...

Страница 51: ...ed position callout 4 A clicking sound indicates a successful connection d Connect the fiber optic connector on the Junction Box Harness to the fiber optic socket on the Console Figure 4 4 To make the...

Страница 52: ...mark callout 1 on the electrical socket with the red alignment dot callout 2 on the electrical connector and push in the connector A clicking sound indicates a successful connection NOTE To verify th...

Страница 53: ...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 Console to support a cryoablat...

Страница 54: ...the system detects that the pressure reading for either gas cylinder is less than 50 psi a message displays on the Navigation Tool Bar Screen 4 8 Connect the gas cylinders to the Visual ICE MRI Cryoab...

Страница 55: ...If the system 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...

Страница 56: ...4 14 User Manual This page intentionally left blank...

Страница 57: ...e needle is not freezing hazards associated with heating can be mitigated by selecting Stick mode from the Freeze Intensity drop down menu Initiate freeze activity by pressing the Freeze button Using...

Страница 58: ...creen 2 Using aseptic technique carefully remove the MRI cryoablation needle from the package and place in a sterile work area 3 Remove the connector cap and then connect the needle to the Needle Inte...

Страница 59: ...7 A menu appears with a selection of needle types Screen 5 2 Select the proper needle type from the drop down menu Screen 5 2 Select Needle Type Menu 8 After selecting the first needle the selection f...

Страница 60: ...procedure the Needle Integrity and Functionality Test must be conducted again on that needle During testing carefully watch each needle for the following Flush Ensure no bubbles are formed along the...

Страница 61: ...t is important that a patient s skin is protected from direct contact with needle tubing to avoid the potential for thermal injury to the patient Ensure an appropriate insulating barrier is placed as...

Страница 62: ...When the desired freeze duration has elapsed press the Stop button to enter an idle phase CAUTION At the end of the freeze phase the gas in the Junction Box Harnesses is vented through the Console The...

Страница 63: ...re venting The automatic venting takes approximately 1 1 2 minutes Before initiating automatic venting warn others in the vicinity to expect a venting noise CAUTION If the needles are still connected...

Страница 64: ...ylinder change by estimating the gas required to complete the procedure The Gas Indicator on the Navigation Tool Bar indicates how much time is remaining in each gas cylinder based on the selected gas...

Страница 65: ...ryoablation procedure at the next planned freeze or thaw phase 5 4 2 Dual Gas Cylinder Connection 1 Safely position a full argon gas cylinder with the required purity near the empty cylinder 2 Close a...

Страница 66: ...5 10 User Manual This page intentionally left blank...

Страница 67: ...Controls for that channel 2 Select the proper needle type from the drop down menu Screen 6 1 3 Press the OK button Screen 6 1 Select Needle Type 6 1 2 Link Channels Control 1 Press and hold the Channe...

Страница 68: ...sing the drop down menu and the freeze duration in minutes using the arrows or the scroll bar 4 Add the programmed freeze cycle to the Cycle Sequence menu using the left Arrow button next to the Freez...

Страница 69: ...oablation procedure with the programmed cycles CAUTION Any interruption of a programmed phase immediately terminates that phase and the programmed cycle 11 Repeat Steps 1 through 10 to program additio...

Страница 70: ...nce enter Advanced Channel Controls for the selected channel 2 Press the Cycles button 3 Press the Load Cycle button 4 Using the drop down menu select the saved sequence 5 Press the Load button Refere...

Страница 71: ...linders Store the gas supply lines and gauge assemblies in the storage compartment provided on the system Figure 2 2 CAUTION Do not use excessive force to disconnect the gas supply lines from the syst...

Страница 72: ...ole by pulling on the grooved grip identified by the callout in Figure 7 1 1 Figure 7 1 Disconnection of Junction Box Harness Electrical Line b Disconnect the fiber optic line from the fiber optic soc...

Страница 73: ...ed by the callout in Figure 7 2 c Disconnect the gas line from the gas connection socket on the junction box by turning the gas connection hub clockwise to the unlocked position Figure 7 3 d Disconnec...

Страница 74: ...as line e Place protective covers on the Junction Box Harness sockets on the junction box to provide protection from dust and debris 13 Clean the Console Mobile Connection Panel and Junction Box Harne...

Страница 75: ...stration Settings and Units reference Table 8 1 Only Service personnel have the option to adjust the system time and date System Administrators can change the Time Zone After changing settings press t...

Страница 76: ...ally 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...

Страница 77: ...ical USB flash drive This function is available only to administrative and service users Configure Ethernet Pressing this button allows administrative and service users to configure the Ethernet conne...

Страница 78: ...ding of reports and downloading of software updates This function is only available to administrative and service users The Visual ICE MRI System may be configured to use a static IP address or work w...

Страница 79: ...Do not set food drinks or other objects on top of the Visual ICE MRI Cryoablation System Doing so may damage the system 9 2 Service and Preventive Maintenance Only trained and authorized service engi...

Страница 80: ...9 2 User Manual This page intentionally left blank...

Страница 81: ...sers may update the software with an appropriate Galil Medical USB flash drive 1 Shutdown the Visual ICE MRI System 2 Hold down the Software Reset button by inserting a straightened paper clip into th...

Страница 82: ...tartup Screen Screen 3 2 Press the Manual Software Update button on the Configure Settings Screen Screen 3 10 Insert the USB flash drive NOTE Wait 20 seconds for the system to recognize the flash driv...

Страница 83: ...the system and not available for use 1 Verify that the Junction Box Harnesses are connected Reference Section 4 5 and Section 4 6 for information on connecting the Junction Box Harnesses 2 Check the c...

Страница 84: ...ds during a procedure Immediately turn off power to the system and end the procedure to avoid inadvertent activation of needles 2 Contact Galil Medical Customer Service 10 2 1 Replacing Fuses Instruct...

Страница 85: ...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 Visual ICE MRI Console...

Страница 86: ...ppropriate pressure is displayed on the Gas Indicator 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...

Страница 87: ...a new needle The Manual Vent Valve is leaking gas The Manual Vent Valve may be open Fully close the Manual Vent Valve There is a hissing sound before the needles are connected 1 The system may be vent...

Страница 88: ...e 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 1 Verify that the gas cylinders are CLOSED 2 Verify the...

Страница 89: ...reely 1 Release the brake to unlock the front wheels 2 Check the individual rear wheel brakes and ensure the brakes are released 10 5 Gas Cylinders and Gas Supply Lines Symptom Potential Causes Soluti...

Страница 90: ...and vent the system using the automatic vent function Upon completion close the Manual Vent Valve Contact Galil Medical Customer Service It is difficult to disconnect the Junction Box Harness connecto...

Страница 91: ...oblem persists connect a new needle into a different channel and test the needle Continue the procedure with the newly tested needle During the Needle Integrity and Functionality test Bubbles are seen...

Страница 92: ...87 5000 o support galilmedical com Reason for Appearance No name was entered OR The name entered did not match assigned names in the system Solutions 1 Reenter the Login Name 2 Contact the System Admi...

Страница 93: ...XX Change your password in the configuration screen when convenient Reason for Appearance User correctly entered the reset password challenge and received a temporary password Solutions Change the pas...

Страница 94: ...e Challenge displayed on the screen 2 Enter the Response provided by Customer Service 3 Press the Login button NOTE This action does not reset a password 10 07 Incorrect Response You have not entered...

Страница 95: ...ylinder 4 Replace the gas cylinder if needed 20 02 Argon Shut Off Valve The argon shut off valve may be closed Check and open if necessary Reason for Appearance At system start up the system detected...

Страница 96: ...awing on all active needles 20 07 Stop All Channels You selected to control all needles simultaneously Do you want to stop activity in all needles now YES NO Reason for Appearance User selected Stop b...

Страница 97: ...e gas cylinder shut off valve is closed Reason for Appearance User selected to automatically vent high pressure gas at the end of a procedure but the pressure was not dropping Solutions Verify that th...

Страница 98: ...wn the system YES NO Reason for Appearance User selected Shutdown in the Login Screen to power down the system Solutions Confirm shutdown of the system Reference Section 7 1 for the shutdown procedure...

Страница 99: ...tions Verify the Junction Box Harness between the Junction Box and Mobile Connection Panel is connected Reference Section 4 6 for information on connecting the Junction Box Harness in the magnet room...

Страница 100: ...manual venting 30 02 Gas Vent Manually vent the Visual ICE MRI System using the valve on the rear of the machine Reason for Appearance User pressed Close button after receiving a message that gas had...

Страница 101: ...he user selected to Configure Ethernet but the system was not connected to the Internet Solutions 1 Verify that the Ethernet cable is connected to the Ethernet port 2 Contact the network administrator...

Страница 102: ...0 o support galilmedical com Reason for Appearance The software was checked against approved software versions in the regulatory files for each respective market An incompatibility with regulatory app...

Страница 103: ...ce o 1 877 639 2796 or o 1 651 287 5000 o support galilmedical com Reason for Appearance The hardware is not compatible with the current software Solutions Contact Galil Medical Customer Service to sc...

Страница 104: ...piling the report The report may be incomplete Reason for Appearance User chose to access a report during a procedure or to save data to a report at the end of a procedure Errors occurred which may af...

Страница 105: ...ppearance Solutions 80 01 Communication Failure Internal communication failed Reconnection attempt failed Restarting Visual ICE MRI System If problem persists contact Galil Medical Customer Service o...

Страница 106: ...so 2 Contact Galil Medical Customer Service 80 05 Service Due Low battery detected Contact Galil Medical Customer Service o 1 877 639 2796 or o 1 651 287 5000 o support galilmedical com Reason for App...

Страница 107: ...r Appearance A defective solenoid on Channel X was detected another channel should be selected Solutions 1 Select a different channel 2 After completing the procedure contact Galil Medical Customer Se...

Страница 108: ...on for Appearance User was reminded of the deadline to complete scheduled system service Reminder begins four weeks prior to the service due date Solutions Contact Galil Medical Customer Service to sc...

Страница 109: ...urring during transport If the original shipping containers are not available the customer takes responsibility to ensure proper transport conditions are satisfied or contacts Galil Medical Customer S...

Страница 110: ...69 bar to 414 bar 0 314 MPa over range of 6 9 MPa to 41 4 MPa Built in Regulator Gas Pressure 50 psi over range of 1000 psi to 4000 psi 3 4 bar over range of 69 bar to 276 bar 0 314 MPa over range of...

Страница 111: ...as Supply Lines connected to argon and helium gas cylinders Available lengths 5 m 16 ft 8 m 26 ft Junction Box Harnesses Available lengths 5 m 16 ft 10 m 33 ft 15 m 49 ft NOTE The Gas Supply Lines and...

Страница 112: ...stem uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class A Har...

Страница 113: ...nvironment Surge IEC 61000 4 5 0 5 kV 1 kV line s to line s 0 5 kV 1 kV 2 kV line s to earth 0 5 kV 1 kV line s to line s 0 5 kV 1 kV 2 kV line s to earth Mains power quality should be that of a typic...

Страница 114: ...0 MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in metres m Field stren...

Страница 115: ...to the maximum output 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...

Страница 116: ...when gas flow is turned on by the user The ability to uninterruptedly prevent gas flow to user selected needles when gas flow is turned off by the user The ability to display the duration of operation...

Страница 117: ...rademarks GALIL IceRod IceSeed i Flow 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...

Страница 118: ...12 2 User Manual This page intentionally left blank...

Страница 119: ...NG FROM OR RELATED TO THE USE OF THIS DEVICE GALIL IceRod IceSeed i Flow and Visual ICE are trademarks of Galil Medical Ltd BTG and the BTG roundel are registered trademarks of BTG International Ltd G...

Страница 120: ...13 2 User Manual This page intentionally left blank...

Страница 121: ......

Страница 122: ...64 Round Lake Road Arden Hills MN 55112 USA Telephone 1 877 639 2796 Fax 1 877 510 7757 Obelis s a Boulevard G n ral Wahis 53 1030 Brussels Belgium Telephone 32 2 732 59 54 Fax 32 2 732 60 03 E mail m...

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