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User Manual - Galil Medical

1. 47 4 6 1 Advanced Freeze Controls oooccccccccccccnncccnnnccnnnnnnnnnnnncnononnnnnononannnnnnnnnnnrnnnononanenos 47 4 6 2 Advanced Thaw Controls oocccccccoonncnncccnonncnncnononncnnonononcnnnononannnnnononancnnncnnnancnns 48 4 6 3 Programming Cryoablation Cycles sess 50 4 6 4 Advanced Temperature Sensor Controls eese 52 5 ADMINISTRATIVE FUNCTIONS ee co 55 54 Gontigure SEUNS eege ag doce 55 5 1 1 Manual Software Update akata eei eut e Oo re eh ak aa aaa eeu dais 57 541 2 Configure rn Ed EE 58 6 SYSTEM CARE and MAINTENANCE sscceeecceecccnnssseeeeeeeeccnssseeeeeeneconnsseseeseeeses 59 Gis SVS LCM MNS ATO MEET S S mU 59 E cet aa DET 59 6 2 1 Cleaning the Visual ICE System nasa n aana eaaa anana ana eaaa nana anaa nnns 59 6 22 CIE AMING TS SV US ar Sacks Naas E Ga aa aaa bod a aa a ag e aaa a aa ka 59 6 3 Service and Preventive Maintenance ccccccccccnccconcncoconcnnononnnnnnnnnnnnononnnnononnnnnnonnnnnnnaneness 59 SE VS SII INS rM 60 7 TROUBLESHOOTING asia c C aa a ANENG aa Ta GAN aja a aa A EN ae aa KG a a aaa aaa da GN a 61 en Een ET e a banana kaa aan a m m mE 61 7 2 Electronics Electrical and User Error Related leeues 62 Tel Replacing FUSO Seron TI TI TUUM 64 e AAS WSS PIT Rr 65 LA Mechanica ISSUES er 68 7 5 Gas Cylinders and Gas Supply Lines nn00annnnnennnnneennnnonennnr
2. sa 8 49 am Wk Screen 42 Invalid Configuration Message 5 If updating the software to a newer version available on a USB flash drive insert the USB flash drive containing the software update into the USB port on the Visual ICE System Figure 3 Use the Browse button to select the update file and then press Update System does not turn ON i e the fan is not running or power is lost during procedure Page 62 of 86 7 2 Electronics Electrical and User Error Related Issues The power cable to the Visual ICE System is disconnected from the power outlet or from the rear panel of the system Connect the power cable to the Visual ICE System and to the power outlet The power control knob on the front panel of the system or power switch on the rear panel is OFF Figure 1 and Figure 2 Turn the power ON There is no power at the wall outlet Ensure the power outlet is switched ON Call the hospital Biomedical Engineer for assistance if needed A fuse may have blown Spare fuses are located in the power cord inlet on the system Figure 2Reference Section 7 2 1 for instructions on how to replace fuses in the system User Manual Symptom Potential Causes Solutions Channel or needle is not recognized by the system and not available for use Touch screen does not respond USB flash drive is not functioning Or The USB flash drive is not recognized by the system The Login Screen appeared after the system was
3. The Export Report button displays a window to choose the Export File Type Export Location File Name and File Path 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 3 3 Configure Settings The Configure Settings screen allows selection of settings used during a cryoablation procedure Settings that may be changed include MTS Needle Locations System Procedure and Registration Settings and Units reference Section 5 1 Control buttons have options for Calibrate Touch Screen Manage 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 3 17 pm PENE A Back Calibrate tanage User Manual Software dii Startup gt gt Configure er MTS Needle Locations System Settings Kianey Argon Cylinder Volume i ji 42 0000 Channel Status MTS Locations Helium Cylinder Temperature Sensors Volume 42 0000 mha Organ Map Y Liters ES Clear hospital name cinta J Link all channels A eeh and doctor name L Passive thaw timer Clear Hospital count up o Inactivity Timeout minutes A The time and date can only be 11 Feb 2013 changed by service personnel Time Tim
4. Freeze Close You selected to control all needles simultaneously Do you want to initiate x freeze for all active needles now YES NO You selected to control all needles simultaneously Do you want x freeze intensity applied to all needles now YES NO You selected to control all needles simultaneously Do you want to initiate thaw for all active needles now YES NO Thaw duration Thaw Close You selected to control all needles simultaneously Do you want to stop activity in all needles now YES NO Ten needles are active for i Thaw Please wait until thawing is complete before activating additional i Thaw needles This channel will use passive thaw 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 Visual ICE Cryoablation System User held Freeze button for Advanced Freeze Controls to preset intensity and time from drop down menus for the freeze phase Drop down intensity in 5 increments time in 1 minute increments User selected Freeze button in channel to control all active channels To proceed the user must confirm freezing of all active needles User selected a freeze intensity to control all active channels To proceed the user must confirm the selected intensity is to be applied to all active needles User selected Thaw button in channel to control all active channels
5. Screen 28 Report Exported message 4 4 System Shutdown WARNING Warn operating room personnel prior to venting the Visual ICE System to avoid startling them 1 If you did not choose to automatically vent the Visual ICE Cryoablation System turn the shutoff valve on the gas cylinders clockwise to close the gas cylinders Visual ICE Cryoablation System Page 45 of 86 2 Turn the Manual Vent Valve on the Visual ICE System to the OPEN position to release the high pressure gas from the system 3 Disconnect the high pressure gas supply lines from the Visual ICE System and from the gas cylinders Store the gas supply lines and gauge assemblies in the storage compartment provided on the system Figure 1 CAUTION Do not use excessive force to disconnect the gas supply lines from the system The conneciors will not disconnect if any gas pressure remains in the system Vent the system completely using the Manual Vent Valve and then try to disconnect the supply lines again 4 Turn the Manual Vent Valve to the CLOSED position after the gas has been vented 5 Press the 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 Wait until the screen goes black Turn the Power Control Knob to the OFF position Unplug the Visual ICE System and wrap the power cord around the cord wrap on the rear of t
6. Replace the retention clip plug in the power cord and tighten the thumb screw on the retention clip 8 Call Galil Medical Customer Service for new replacement fuses 7 3 Gas Issues Potential Causes Solutions The Visual ICE System does not allow The Argon Shutoff Valve may be in the GAS OFF testing of a needle in a locked channel position Verify that the Argon Shutoff Valve Figure 2 is in the GAS ON position to allow sufficient gas flow If necessary further open the gas cylinder valve by turning the valve counter clockwise to allow sufficient gas flow Verify that appropriate pressure is displayed on the Gas Indicator Visual ICE Cryoablation System Page 65 of 86 Symptom Potential Causes Solutions Needle is not freezing during the Needle 1 The argon gas cylinder valve may be closed Open Integrity and Functionality Test 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 Confirm that the argon gas cylinder is connected to the argon inlet The needle may be clogged Try to test it again If the needle still does not freeze e Press the Stop button to stop all activity on the channel Hold the needle connector firmly with one hand and unlock the channel to disconnect the needle Move the needle to a different channel and run the test again NOTE If only one needle is connected to
7. To proceed the user must confirm thawing of all active needles User held Thaw for Advanced Thaw Controls to preset thaw time from drop down menu Drop down time in 1 minute increments User selected Stop button in channel to control all active channels To proceed the user must confirm stop for all active needles User attempted to activate more than ten i Thaw needles The Visual ICE System supports simultaneous operation of no more than ten i Thaw needles After completing a thaw phase with ten needles additional needles may be activated for i Thaw User pressed Thaw button to open the Advanced Thaw Controls and the thermal cautery option The CAUTION is displayed upon user selecting advanced option for thermal cautery Page 75 of 86 Message Reason for Appearance CAUTION Needles used for thermal cautery will no longer User selected cautery an be able to conduct a freeze operation advanced thaw option Thermal cautery can be simultaneously active in a maximum User attempted to activate thermal of four needles Each active cautery needle must be in a cautery in a channel with two separate channel thermal cautery needles or User attempted to activate thermal cautery in another needle while four needles are in active cautery mode Are you sure you want to end the procedure User selected End Procedure and YES NO must confirm desire to end the procedure Do you want to automatically vent high pressure
8. available to conduct the planned cryoablation procedure the number and type of needles gas cylinder size pressure and rate of gas flow affect the required gas volume Securely attach gas supply lines to the gas cylinders and the Visual ICE System Use the safety cables provided The safety cables provide backup protection if the gas supply lines become inadvertently disconnected from the system Lock the wheels on the Visual 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 be completed successfully to verify proper needle operation Do not touch the chassis of the Visual ICE Cryoablation System while touching the patient to avoid the risk of shocking the patient if an inadvertent electrical fault exists Do not pull on the power cord Grasp the plug not the power cord to disconnect the device from the wall socket Do not modify the Visual ICE Cryoablation System in any way Only authorized Galil Medical personnel or Galil Medical trained authorized personnel are to service a Visual ICE system Do not touch the screen if the touch screen monitor goes blank for more than five 5 seconds
9. gt O Passive thaw timer Clear Hospital Inactivity Timeout count up minutes Date mw The time and date can only be 11 Feb 2013 changed by service personnel Time Time Zone Temperature Units m d fenem Wb eme e Use 24 hour clock o Fahrenheit Screen 39 Configure Settings Visual ICE Cryoablation System Page 55 of 86 Table 6 Configure Settings Controls Setting Description MTS Needle Locations Cylinder Volume Inactivity Timeout Language Maximize by Default Link all channels Passive thaw timer count up Custom Fields Upload Registration Clear Hospital Information Page 56 of 86 Customize the list of names to be provided for the MTS needles for each associated organ map Press Add Location to add a new name to the list Press Remove Location to delete a name from the list oelect the gas cylinder volume and units of measure according to the standard in the geographical region The gas cylinder volume and units can only be changed by administrative or service personnel Select the desired duration from 30 to 140 minutes that the system can be inactive before requiring you to re enter your password The default inactivity timeout is two hours select the language in which the software is displayed Select a section of the Procedure Screen to be maximized by default at login Check this box to automatically link all adjacen
10. treatment information Use the stylus or your finger to enter information on the virtual keyboard Available data entry fields are Patient ID Hospital Name Hospital Address Physician Name and Organ Type If you need to enter any other registration information two custom fields can be labeled in the Configure Settings screen reference Section 5 1 NOTE The Visual ICE System automatically loads the appropriate Organ Map based on the Organ Type selected on the Registration button CAUTION Select a unique Patient ID that does not reveal the patient s identity to other system users OPTIONAL Select the Notes button on the Procedure Screen to enter additional procedure notes You can enter notes in the Notes button at any time during the cryoablation procedure 2 Position the cryoablation needles and thermal sensors in the target tissue CAUTION During use avoid damage to the needle from other surgical instruments Page 42 of 86 User Manual OPTIONAL Reference Section 3 1 7 for instructions on placing needles and thermal sensors on the Organ Map CAUTION Use image guidance to verify that the cryoablation needles are placed at the desired location prior to activating a needle 3 Select the desired Freeze Intensity using the drop down menu NOTE Throughout the procedure monitor the amount of gas time remaining in the cylinders using the Gas Indicator on the Navigation Tool Bar Screen 26 If it is necessary to change the g
11. ICE Cryoablation System automatically checks for connectivity to the Galil Medical server Select the appropriate box for either uploading reports or downloading updates and press Start Screen 12 A confirmation message appears when the upload download process has been successfully completed Screen 13 Restart the Visual ICE System following successful completion of a software update download to begin using the new software version The current software version number is displayed in the upper right hand corner of the Startup Screen Screen 2 When Remote Upload Download is used to upload procedure reports to the Galil server the data are encrypted to protect the privacy of patient health information Visual ICE Cryoablation System Page 27 of 86 26 Sep 20 New software was released and is available Screen 12 Remote Upload Download Screen Screen 13 Successful Upload Download Page 28 of 86 User Manual 4 SYSTEM OPERATION Figure 6 depicts the order and steps of the Visual ICE Cryoablation System set up and treatment procedure Each step is described in detail in this chapter Confirm availability of gas needles and accessories Position Visual ICE System and lock brake Ensure Manual Vent Valve is closed and Argon Shutoff Valve is ON Power Visual ICE System ON Login Connect helium gas if applicable Connect argon gas Ensure safety cables are connected OPEN valve on helium then arg
12. NOT LIMITED TO ANY WARRANTIES OF MERCHANTIABILITY OF FITNESS FOR A PARTICULAR PURPOSE GALIL MEDICAL SHALL NOT BE LIABLE FOR ANY DIRECT INDIRECT INCIDENTAL OR CONSEQUENTIAL LOSS DAMAGE OR EXPENSE ARISING FROM OR RELATED TO THE USE OF THIS DEVICE For assistance contact www qgalilmedical com Galil Medical Inc 4364 Round Lake Road Arden Hills MN 55112 USA Telephone 1 877 639 2796 Fax 1 877 510 7757 USA Galil Medical Inc 4364 Round Lake Road Arden Hills MN 55112 USA Telephone 1 877 639 2796 Fax 1 877 510 7757 m wer 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 mail obelis net Eo Copyright 2012 Galil Medical MAN6060en 04 Oct 2012 Visual ICE Cryoablation System Page 85 of 86 This page intentionally left blank Page 86 of 86 User Manual For assistance contaci www qgalilmedical com Galil Medical Inc 4364 Round Lake Road Arden Hills MN 55112 USA Telephone 1 877 639 2796 Fax 1 877 510 7757 USA Galil Medical Inc 4364 Round Lake Road Arden Hills MN 55112 USA Telephone 1 877 639 2796 Fax 1 877 510 7757 REP Obelis s a Boulevard G n ral Wahis 53 1030 Brussels Belgium ep Telephone 32 2 732 59 54 Fax 32 2 732 60 03 E mail mail obelis net C Co Copyright 2012 Galil Medical MAN6060en 04 Oct 2012
13. SJ GALILMEDICAL Leading Through Innovation VISUAL ICGE CRYOABLATION SYSTEM Ry Only For assistance contaci 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 ec rer Obelis s a Boulevard G n ral Wahis 53 1030 Brussels Belgium a Telephone 32 2 732 59 54 Fax 32 2 732 60 03 E mail mail obelis net Table of Contents VISUALICE SAYOABLATION SYSTEM somo nas i Table of Contents ssaimisaica ce tnesewoscwncweenah i Ene kaa ajaa mms ii SE TADOS mem iii List OF Screens EE lii ul e v M V 1 SYSTEM OVERVIEW sisi xi SS uKaNFEVER HK EEFK EIE NINKI E VEVANE E USPE MEE MVFREMENM RII RSNEEMFIR Far EV PN TEE 1 A A m aa ake 1 12 Meenoed EE 1 ES HOW ID o PA 2 A I baana ce aaa ag a aa a ag a aaa bana a Ba aa a aa a aga ere 2 1 3 2 Accessory Products Used to Conduct Cryoablation Procedures 2 MOO SOLON AO sanegara ue o naen Kana a a aa D PP 2 1 4 INOICAUONS EEN 3 Eo SA 3 1 6 Warnings cccccccccsseecceceeeeeeeneeeeeesaeseeeeeeeeeeeseeeeesseeeeeessaaeeeeseeeeeseaeeeessaeeeessaeeeeessaeeessseeeeneas 4 Wad AA an kk kara dasa
14. Thaw needle thawing Use passive thaw or connect helium gas is not operational for thawing TEMPERATURE SENSOR ORGAN MAP sensor point 5 15 25 or 35 on MTS X met selected The MTS detected the selected alarm limit alarm temperature Sensor point 5 15 25 or 35 on MTS X met selected The MTS detected the selected alarm limit alarm rate of temperature change within 30 seconds An MTS is disconnected Reconnect the MTS to continue to An MTS became disconnected monitor temperature in that location during a procedure Defective MTS in channel X Replace with a new MTS The MTS display is out of the expected range when initially connected to the needle connection panel Are you sure you want to erase the entire drawing User selected the Clear Drawing button When selected all information placed on the organ map except needle placement will be erased All annotation and needles will be removed from the organ User changed the organ type from before proceeding Would you like to proceed with the organ the previously selected type type change PROCEDURE PROCEDURE You selected to control all needles simultaneously Do you User selected Test button in want to initiate test in all needles now channel to control all active YES NO channels To proceed the user must confirm test for all connected needles Page 74 of 86 User Manual Message Reason for Appearance Freeze intensity Freeze duration
15. USB flash drive with a new Galil Medical supplied USB flash drive Enter the appropriate password to return to the Procedure Screen The video cable may be disconnected WARNING Do not touch the screen if 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 Page 63 of 86 7 2 1 Replacing Fuses 1 Turn the Power Switch OFF on the rear of the Visual ICE System Loosen the thumb screw on the cord retention clip Remove the power cord from the retention clip Remove the two screws that secure the retention clip and remove the retention clip from the power inlet 3 Insert a small screwdriver into the slot on the bottom of the fuse holder to begin to snap the fuse holder out of the power inlet 4 While holding your hand under the fuse holder carefully slide the fuse holder out of the power inlet There are four fuses in the fuse holder Page 64 of 86 User Manual 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 Visual ICE System 7 Snap the fuse holder back into the power inlet
16. a typical location in a typical commercial or hospital environment NOTE Ur is the a c mains voltage prior to application of the test level Page 82 of 86 User Manual Table 10 Electromagnetic Immunity for Systems that are Not Life supporting Guidance and manufacturer s declaration electromagnetic immunity The Visual ICE Cryoablation System is intended for use in the electromagnetic environment specified below The customer or the user of the Visual ICE System should assure that it is used in such an environment l IEC 60601 Compliance l l Immunity Test Test Level Level Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of the Visual ICE System including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Conducted RF 3 Vrms Recommended separation distance IEC 61000 4 6 150 kHz to 80 MHz J ES JP 3 d vp 80 MHz to 800 MHz Radiated RF 3 V m 3 IEC 61000 4 3 80 MHz to 2 5 GHz d H VP 800 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 dis the recommended separation distance in metres m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Inter
17. detected between Tighten the connection using the wrench provided with the the gauge adapter and the cylinder Visual ICE System main valve Close the cylinder main valve and vent the gas from the Visual ICE System and the gas supply lines using the Manual Vent Valve Figure 2 Clean the sealing surface to remove any debris Tighten the gauge adapter using the wrench provided with the Visual ICE System 7 6 Needles Symptom Potential Causes Solutions A needle with a memory chip is not 1 Move the needle to a different port recognized by the system If the system still does not recognize the needle select the needle type from the drop down menu displayed by the system Page 68 of 86 User Manual Symptom Potential Causes Solutions During the freeze phase no iceball 1 Perform the following steps in the order in which they are forms on the needle s in the same described channel l l e Stop freezing thawing actions for all channels e Thaw the problematic needle s for 1 minute e Freeze the needle s to verify proper function If the problem persists discontinue use of the needle and disconnect it The needle may have a blockage At the discretion of the physician the needle may be disconnected from the system as follows End the procedure Perform automatic venting of the system Hold the needle connector firmly with one hand and unlock the channel to disconnect the needle Move the needle to a diffe
18. e Input Voltage 100 to 240 VAC single phase e Input Frequency 50 60 Hz e VA Rating 250 VA e IP Rating IP10 e Fuse Rating T 3 15A e Electrical Protection Class Type BF protection against shock e Signal Input Output Parts 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 needs to be installed and placed into service according to the EMC information provided below The Visual ICE Cryoablation System has been tested in the operating room environment for electromagnetic compatibility EMC and electromagnetic interference EMI compliance The Visual ICE Cryoablation System has been tested to be in compliance with IEC 60601 1 2 and EN 55011 Portable and mobile radiofrequency RF communications equipment can affect the Visual ICE Cryoablation System causing it to operate improperly Table 7 Cable Lengths Cable Length Power Cable 4 6 m 15 ft Ethernet Cable 3 m 10 ft Gas Tubing connected to needles 2 5 m 8 ft Page 80 of 86 User Manual WARNING Use of cables other than those specified with the exception of those sold by Galil Medical for use as replacement parts for internal components may result in increased emissions or decreased immunity of the Visual ICE Cryoablation System WARNING The V
19. inlets on the Visual ICE System Connect the helium high pressure gas supply line to the helium inlet of the Visual ICE System using the quick connect connector located at the rear of the system Figure 8 Visual ICE System Gas Connections EM Safety cable ER Quick connect connectors EM Humidity cover Secure the safety cable at the end of the gas supply line to the system WARNING Ensure that the safety cable is properly secured to the system in case the gas supply line becomes accidentally disconnected i Carefully turn the cylinder shutoff valve on the helium gas cylinder counter clockwise for one quarter turn Ensure that the pressure reading on the gauge responds immediately Turn the cylinder shutoff valve further counter clockwise approximately one full turn to open the gas cylinder so that sufficient gas flow is present Repeat the procedure outlined in Steps 2 through 7 to connect the argon gas 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 support a cryoablation procedure A four way adapter assembly with argon pressure gauge connects an 8 m gas supply line the primary gas cylinder and an auxiliary 3 m gas supply line If using the optional EZ Connect2 Adapter co
20. needle Avoid contact with the distal portion of the cryoablation needle Use care to avoid electrostatic discharge ESD events when removing the cover from the Visual ICE System Galil Medical recommends that the operator touch one or more metal parts on the rear of the system prior to touching anything on the Needle Connection Panel Do not store liquids in the storage compartment The storage compartment is not water tight 1 7 3 During Use Use image guidance to monitor needle insertion iceball formation needle positioning and removal Use Freeze and Thaw operations only when the needle is placed in the target tissue Failure to operate the Visual ICE System within the working pressure limits indicated on the user interface Table 5 may affect the cryoablation procedure Do not connect the Visual ICE System to the Internet during a procedure such connection may cause the software to become corrupt Active thawing produces heat along the distal needle shaft Use care to avoid thermal injury to non targeted tissues 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 system will remain functional and the monitor will refresh momentarily Do
21. not insert a USB flash drive into the Visual ICE System during a procedure The software will not recognize that a USB flash drive has been inserted during a procedure 1 7 4 After Use Depressurize the system after the cryoablation procedure is completed reference Section 4 4 Cut the needle and MTS tubing and dispose of used needle and MTS in a biohazard container in accordance with hospital and safety regulations Do not expose the touch screen to organic solvents such as alcohol which may damage the touch screen Clean the Visual ICE System per the instructions in Section 6 1 To avoid confusion at the beginning of a new procedure ensure that the o Manual Vent Valve is closed o Argon Shutoff Valve is in the GAS ON position Page 6 of 86 User Manual 1 8 Potential Adverse Effects Potential adverse events that may be associated with the use of cryotherapy may be organ specific or general and may include but are not limited to abscess adjacent organ injury allergic anaphylactoid reaction angina coronary ischemia arrhythmia atelectasis bladder neck contracture bladder spasms bleeding hemorrhage creation of false urethral passage creatinine elevation cystitis diarrhea death delayed non healing disseminated intravascular coagulation DIC deep vein thrombosis DVT ecchymosis edema swelling ejaculatory dysfunction erectile dysfunction organic impotence fever fistula glomerular filtration rate elevation hematoma
22. provided Visual ICE Cryoablation System Page 59 of 86 6 4 System Life The Visual ICE Cryoablation System is designed to have a service life of five 5 years At the completion of five years of use contact Galil Medical Customer Service to schedule system replacement refurbishing or disposal Page 60 of 86 User Manual 7 TROUBLESHOOTING Galil Medical suggests the following options for troubleshooting the Visual ICE System If the Suggested approaches do not resolve the issue contact Galil Medical Customer Service 7 1 Software Recovery In the event of software corruption or failure the software may be restored to the previous software revision Administrative and service users 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 and power up the system simultaneously The system displays the Software Recovery screen Rollback to the previous Load default configurations software version on the to the em E Screen 41 Software Recovery Screen 3 Press the Rollback button to restore the software to the previous software revision 4 OPTIONAL Press the Load button to update the software if the screen displayed a message indicating that the software configuration is invalid on the login screen Screen 42 Visual ICE Cryoablation System Page 61 of 86 i
23. received a temporary password User needs to use an emergency login User tried to access the Emergency Login and did not respond correctly to the challenge User must contact Customer Service in order to receive an emergency login response This action does not reset a password 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 SYSTEM NOT OPERATIONAL Software is unable to connect with hardware after attempt to reinitialize communication If the restart fails the system is not usable Page 70 of 86 User Manual Message Reason for Appearance System self checks failed Restart the system If problem persists contact Galil Medical Customer Service 1 877 639 2796 or appropriate market number galilcst galilmedical com The internal temperature of the Visual ICE System exceeds appropriate operating limits Discontinue the cryoablation procedure as soon as Safe to do so Contact Galil Medical Customer Service 1 877 639 2996 or appropriate market number galilcst galilmedical com No gas connected Gas was not appropriately vented from the Visual ICE System when the system was last used Vent the system using either the automatic vent option or the Manual Vent Valve Low level of helium argon gas Replace the gas cylinder with a new cylinder The gas pressure is not dropping Check that the gas cy
24. switch and the power control knob Figure 1 and Figure 2 are both easily accessible 2 Lockthe two front wheels using the Brake Pedal on the Visual ICE System If necessary lock the two 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 stable and uninterruptable power outlet NOTE If the power supply to the Visual ICE System is not stable or is noisy the MTS temperature readings may be inaccurate WARNING To avoid risk of electric shock this equipment must only be connected to a hospital grade electrical power outlet with a protective earth WARNING Do not touch the chassis of the Visual ICE Cryoablation System while touching the patient to avoid the potential risk of shocking the patient if an inadvertent electrical fault exists OPTIONAL When performing a prostate cryoablation procedure set up the Urethral Warming System by following the instructions provided in the Instructions for Use that accompany the Urethral Warming Set 4 Ensure that the power switch located on the rear of the system is in the ON position Figure 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 ne
25. tas eo Du A UIS dud eee de pu o IE eee 34 Figure 8 Visual ICE System Gas Connectiongs nasa aaa eaaa aane aana nane anaa anana nennen nnn nnns 35 Figure 9 EZ Connect2 Dual Cylinder Adapter aaa aaa eaaa anaa aana aane anana nean a nennen nennen nnns 36 Figure 10 Locking Needle into Channel 39 wie rcm oM MIS SONGO NOT TR T 42 List of Tables Table Startup Screen BIOS adios catorce o esie led litiasis 16 Table 2 Channel Control lr lides 19 Table 3 Organ Map COMMONS d esos 23 Table 4 Configure Settings lo tel EE 27 Table 5 Working Gas Hreseures 37 Table 6 Configure Settings Control 56 Table Cable E et EE 80 Table 8 Electromagnetic Emissions ccccconcnncccnnnnccconcnnononcnnnnnnnnnnnnnnnnnononennnnonnnnnonncnnononnnnnnennnnnnnaneness 81 Table 9 Electromagnetic Immunity cccccoccnnccconnnccconcnnoconnnnononnnnnononnnnononnnnnnnnnnnnonnnnnnnnnnnnnnennnnnonaneness 82 Table 10 Electromagnetic Immunity for Systems that are Not Life supporting 83 Table 11 Recommended separation distances between portable and mobile RF communications equipment and the Visual ICE Gwvsiem E E ee ER 84 List of Screens Screens LOGIN GET uiia un amata m NG tannic ELAN AA BE a aaa KE tec aM deste te teda D gagak KG itid tu et erre pae 15 Screen 2 otartib SCIeell sciunt ined iine ti aene ut arang lupa CAU ana a S e a ejaan
26. temperature display indicates that the needle is Cooling Screen 34 CAUTION Do not remove the needle from the patient until needle cooling is complete Removing the needle while it is still hot presents a risk of injury to adjacent tissue and or organs Cautery Control Internal Heater Port YA 5 v 00 00 Start Stop Cooling 2 A B Po econo y 00 0o star Stop Screen 34 Cautery Needle Cooling e f desired press the Cautery button to re initiate track ablation on additional sections of the needle track CAUTION Use image guidance to monitor needle location and position to avoid the risk of thermal injury to adjacent tissue organs e Observe the needle during removal for the 10 mm wide Active Zone Indicator on the needle The Active Zone Indicator on the needle is located 20 mm distal to the heating portion of the needle A biocompatible low friction coating covers the heating portion of the needle starting 4 mm from the needle tip and extending 45 mm along the needle shaft CAUTION The Cautery function should not be initiated if the Active Zone Indicator is visible outside the patient s skin 4 6 8 Programming Cryoablation Cycles Advanced Channel Controls for each channel provide options to change the needle type for the selected channel link two channels together and program up to three freeze thaw cycles 1 Press and hold the Channel button to enter Advanced Channel Controls for that channel S
27. the channel there may be some residual pressure behind the needle connector If the problem persists replace the needle with a new needle No helium gas is delivered to the needle The helium gas cylinder valve may be closed Open the gas cylinder valve by turning the valve counter clockwise to allow sufficient gas flow Verify that appropriate pressure is displayed on the Gas Indicator The needle may be clogged e Press the Stop button to stop all activity on the channel Hold the needle connector firmly with one hand and unlock the channel to disconnect the needle Move the needle to a different channel and run the test again NOTE If only one needle is connected to the system there may be some residual pressure behind the needle connector If the problem persists replace the needle with a new needle The Manual Vent Valve is leaking gas The Manual Vent Valve may be open Fully close the Manual Vent Valve Page 66 of 86 User Manual Symptom Potential Causes Solutions There is a hissing sound before the The system may be venting to reduce the pressure to needles are connected below 4200 psi to prevent damage to the system If the pressure drops to within working pressure range the system will operate normally The Automatic Vent Valve may be stuck open If the manual vent valve is fully closed and the hissing persists shut down the system and contact Galil Medical Customer Service The pressure d
28. the system inlet but the pressure inside the system is close to O The calculated flow rate for a given channel exceeds the optimum system requirement The cumulative flow rate for all channels exceeds the optimum system requirement Page 71 of 86 Reason for Appearance SOFTWARE You are not connected to the Internet Connect Ethernet User selected Remote upload cable or check the Ethernet port Contact your network download but the system is not administrator if unable to connect connected to the Internet You are connected to the Internet However there is no The Visual ICE System has found connection with the server at Galil Medical If problem the Internet but not Galil Medical persists contact Galil Medical Customer Service servers The user needs to call 1 877 639 2796 or appropriate market number Galil Medical because the problem galilcst galilmedical com is on the Galil Medical side Network connection was lost Check your cable connection Network connection lost during Establish new connection to complete your download upload and download of files reports and or software software update is complete Press the restart button New software or new files were updated Software name file name will be displayed on the start up menu after restarting the system The hardware is not compatible with the current software Try When the system is performing downloading software update from the Galil Med
29. the displayed organ and place move or remove needles within the organ map A blank drawing canvas is available for customized display Needles may be controlled from the organ map by using the Control Needle button Page 22 of 86 User Manual A9 E O bp Screen 8 Organ Map section Table 3 Organ Map Controls Select Organ button Select an organ map to be displayed on the drawing area Draw Line button Draw free form on the organ map or drawing area Line thickness and line color are selectable Draw Circle button Draw a circle of various sizes on the organ map or drawing area Line thickness and line color are selectable Move Circle button Move a circle to another area on the organ map This button appears only when a circle has been selected Erase button Erase lines previously added to the drawing space The size of the eraser is selectable Visual ICE Cryoablation System Page 23 of 86 Button Deseription 1 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 locations The status of the needle s placed on the organ map displays t
30. 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 cryoablation procedure Return defective needles to Galil Medical for inspection and replacement CAUTION Ice formation during the Flush phase indicates that argon gas is connected to the helium inlet Before proceeding change the cylinders and ensure that each gas supply line is connected to the correct cylinder reference Section 4 5 1 Freeze Ensure that ice begins to form around the tip of the needle WARNING A needle is defective if there is no ice formation during the Freeze phase Do not use a defective needle Obtain a new needle and repeat the testing procedure Thaw Ensure that the iceball detaches from the tip of the needle and that no bubbles escape from the needle tip CAUTION Ice formation during the Thaw phase indicates that the argon gas is connected to the helium inlet Before proceeding change the cylinders and ensure that each cylinder is connected to the correct inlet reference Section 4 5 1 Upon successful completion of the Needle Integrity and Functionality Test the Test button displays a green check and remaining control buttons on the channel become active The needle s are ready for use During the Needle Integrity and Functionality Test the Gas Indicators for both gases provide estimates of the time rema
31. Close and tighten the cylinder shutoff valves of both gas cylinders Slowly open the Manual Vent Valve to discharge gas from the system and the high pressure gas supply line Wait until all the pressure is released and both gauges on the gas supply lines indicate zero pressure 5 Use the appropriate wrench to remove the gauge assembly from the empty cylinder Page 46 of 86 User Manual Connect the gauge assembly to the full cylinder Close and tighten the Manual Vent Valve Carefully turn the cylinder shutoff valve on the helium gas cylinder 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 Carefully turn the cylinder shutoff valve on the argon gas cylinder 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 If no argon pressure is displayed on the Gas Indicator ensure the Argon Shutoff Valve is OPEN 10 Continue the cryoablation procedure at the next planned freeze or thaw phase 4 5 2 Dual Gas Cylinder Connection ds Safely position a full gas cylinder with the required gas type and purity near the empty cylinder Close and tighten the cylinder shutoff valve of the empty gas cylinder Con
32. Customer Service 1 877 639 2796 or appropriate market number galilcst galilmedical com if further assistance is required No name was entered The name entered doesn t match assigned names in the system No password was entered or the password entered doesn t match password associated with login name You have not entered the correct Password Reenter your Password Contact your System Administrator if assistance is required Contact Galil Medical Customer Service 1 877 639 2796 or appropriate market number galilcst galilmedical com if further assistance is required For a challenge response in order to reset your password contact Galil Medical Customer Service 1 877 639 2796 or appropriate market number galilcst galilmedical com User forgot their password Your password has been reset to XXX Change your password in the configuration screen when convenient For a challenge response in order to obtain an emergency login contact Galil Medical Customer Service 1 877 639 2796 or appropriate market number galilcst galilmedical com You have not entered the correct response You have not entered the correct response Internal communication failed Reconnection attempt failed Restarting Visual ICE System If problem persists contact Galil Medical Customer Service 1 877 639 2796 or appropriate market number galilcst galilmedical com User correctly answered the reset password challenge and
33. Unlock the locking bar s and remove all needles and MTS from the needle connection panel Cut needles and MTS from the tubing 12 Dispose of used needles and MTS in a biohazard container in accordance with hospital and safety regulations 13 When the procedure is complete press the End Procedure button on the Procedure Screen Three messages appear requesting action e Confirmation to end the procedure Press the Yes button to end the procedure e Request to save a report Press the Yes button to save a report e 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 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 do not unlock the channels or disconnect the needles from the needle connection panel while venting is in process 4 3 Reports At any time during a procedure press the Report button on the Procedure Screen to view a summary of the report information that has been saved up to that point At the end of a cryoablation procedure a report summarizing the complete procedure can be saved to the system and exported for use on a personal computer 1 To view a report that has been saved to the Visual ICE System press the View Reports button from the Startup Scree
34. User LM uetus 16 Screen 3 Procedure SGre m m 17 screen 4 Navigation Tool Bar i r ce ae edi uae A apa D ejaan a aan 18 Screen 5 Channel Controls and Channel Status section sese 20 lezione 21 Screen 7 Temperature Sensor sechon eene nennen nnne nna nnns sna nnn nnn 22 ocreen s Orga Map S GU ON sasaka aa ng ocu ctae va Rue bine cbe aha na luu Ng aaa aa du Ra gag iu An a aia dub lu oS AN 23 Screen 9 Proc dure Report Example oe kn aaa aaa 25 screen TO View Eelere aos 25 Screen 11 Comge SENG Sa aaa anga ui A cud ed aos 26 Screen 12 Remote Upload Download Gcreen 28 Screen 13 Successful Upload Download cccooonocccccooononcccconocancnnconoconoconononancenccnanarinsnnoinncnanios 28 Screen T4 Misablea CNN lia ivl de a Aa Ga da ak aaa a vedas eiat eo a esten ses ee eit Sue 31 Screen Os Went Gas MeSSaOUp u i ara eid oed dete ce eoa dete P A dete ee Nad ads 31 Visual ICE Cryoablation System Page iii of 86 Screen 16 Screen 17 Screen 18 Screen 19 Screen 20 Screen 21 Screen 22 Screen 23 Screen 24 Screen 25 Screen 26 Screen 27 Screen 28 Screen 29 Screen 30 Screen 31 Screen 32 Screen 33 Screen 34 Screen 35 Screen 36 Screen 37 Screen 38 Screen 39 Screen 40 Screen 41 Screen 42 Page iv of 86 LOON SOC Eken Rete ere nem a A eter ms area Aarne Sie ony TN 32 NG OEGI Mole n EE 32 Reset Password Challenge aaa aaaa aana nane a anana nana naa
35. View the Visual ICE Cryoablation System User Manual on the system Remote Upload Upload reports and download new software and configuration Download files from a Galil Medical server Field Service personnel login to modify configuration settings perform and record preventive maintenance activities Service NOTE This option is only available to authorized field service personnel Page 16 of 86 User Manual 3 1 Procedure Screen The Visual ICE System Procedure Screen provides a single screen view to control and monitor a cryoablation procedure The Procedure Screen is divided into sections for the Navigation Tool Bar Context Sensitive Help Channel Controls Channel Status Temperature Sensors and Organ Map The question mark icon in the title bar of each section on the Procedure Screen provides user selected self help for that section 9 33 am Ak WAN Settings amp Procedures onne Needles Connect only same type needles into a single channel of the Needle Connection Panel Connect only one ICeEDGE type needle per channel Remove connector cap s and insert needle s and MTS s selected port s ock each channel containing needle s by shifting the safety Tatch Scale Scroll Aet e add Screen 3 Procedure Screen xw Navigation Tool Bar ES Context Sensitive Help ECH Channel Control EN Channel Status 5 Temperature Sensors 6 Organ Map Visual ICE Cryoablation Sy
36. aa gaga bana Ka sia an ka baa Di aa sada agih pae AE aga gaga kaa a daa ea ag a a kae ini 4 PA RS 4 1 7 2 landing aik saanak a pena aa Kaga NAN AAS AA A aana pra Ka A nennen E IG AR nnns ba kaa a a nnn nsns nnns nans 5 LS MING SS ER 6 LA 2 gt oo tuii e i NE 6 1 8 Potential Adverse Effects erra reci eer scene a Ex n en ec a roc Ron a Ceo os C en e E 7 2 SYSTEM DESCRIETION as 9 2 1 Touch Screen Monttor ccc ccccccecceccecceceececceececeecueceeaecaecueaeeaececeeaesaecueceeaeceeeeaeeaecneseeaes 11 22 MOUSE raok e NETT 11 2 3 Storage CGompartment 11 24 Brake A 11 2 5 Argon Shutoff Valve ccccooonncnncccoconcconocononcnononononnnnnononancnnnonnnnncnnnonnnnnrnnnnnnnnnennnnonnnnrnnnnnnnns 12 2 6 el EEN 12 2 Manual Vent Valve iria id ada deca ica 12 2 8 Needle Connection Panel 0 c ccc cecccceeceececceececeeceeceeeeceecueceeaeceecueaeeaecuecesaececeeaesaesueaneaes 12 2 5 1 MIS Connection POLLS ie daana meo men ad aaa aa e aec ad ee rece aa ama pa aaa aa eaaa agi 13 2 02 ANNO EE 13 2 5 9 Power Control Knob ort E men ad aaa aaa adana aa pene aa amen eap aaa aa aane 13 2 544 Needle Channels tete oe eee Eo gege ecu adieu mee a aa amen eap aer aO aaa agi 13 2 9 Cryoablation Needles and Thermal Sensors occccccccoccccnnconcnncnnnconnnnnonnnonnnncnnnnonnnncnnnnnnnns 13 2 CER er OS SOMES INR OTI T TR kai gaga an a ag aa Ena ge aana a ag baki saga danta ag a a E aa cite 13 2 10 1 Included Accessories 13 2 10 2 Optional Ac
37. able 5 The Gas Indicator should indicate the pressure to be in the green range If 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 21 Connect the gas cylinders to the Visual ICE System 1 43 pm eee Settings amp Registration Procedures No Gas No Gas i E Connected n Connected Procedure Screen 21 No Gas Connected message Table 5 Working Gas Pressures Gas Nominal Working Pressure Working Pressure Limits 3500 psi 3200 3800 psi 241 bar 221 262 bar 24 1 MPa 22 1 26 2 MPa pa ES 2200 psi 1800 2500 psi 152 bar 124 172 bar 15 2 MPa 12 4 17 2 MPa NOTE When helium is not connected active thawing can be conducted with an Thaw capable cryoablation needle The system will flow argon gas at 500 psi 34 bar 3 4 MPa through the needle and will energize the internal heating element of the i Thaw capable needle when the Thaw button is pressed CAUTION e When the gas cylinder pressure falls below the lower working pressure limit the system displays an alert message in the Navigation Tool Bar To ensure optimal performance replace a gas cylinder if the pressure falls below the lower working pressure limit e Failure to operate the Visual ICE System within the working pressure limits may affect the cryoablation procedure e Ifthe system produces a continuous hissing sou
38. age guidance Galil Medical provides temperature sensors to aid in monitoring tissue temperature near the target site and adjacent critical structures These temperature sensors can provide quantitative data to supplement the qualitative information provided by the imaging modality Tissue ablation is achieved by repeated freeze and thaw cycles with both freezing and thawing contributing to cell death Generally multiple freeze thaw cycles are used to achieve complete destruction of the target tissue 1 2 Intended Use The Galil Medical Visual ICE Cryoablation System is intended for cryoablative destruction of tissue during minimally invasive procedures various Galil Medical accessory products are required to perform these procedures The Visual ICE System is indicated for use as a cryosurgical tool in the fields of general surgery dermatology neurology including cryoanalgesia thoracic surgery ENT gynecology oncology proctology and urology This Visual ICE Cryoablation System Page 1 of 86 system is designed to destroy tissue including prostate and kidney tissue liver metastases tumors skin lesions and warts by the application of extremely cold temperatures 1 3 How Supplied The Visual ICE System is supplied non sterile Galil Medical accessory products required to perform the cryoablation procedure are supplied separately 1 3 1 Contents Visual ICE Cryoablation System Visual ICE Cryoablation System User Manual Quick Re
39. al com Page 76 of 86 User Manual Message Reason for Appearance Service for the Visual ICE System is past due Unless The Visual ICE System was not serviced by DATE system will be inoperable until service is serviced on schedule During an conducted eight week grace period prior to the Contact Galil Medical Customer Service to schedule service system becoming inoperable the 1 877 639 2996 or appropriate market number User is reminded the service is galilcst galilmedical com past due The Visual ICE System is inoperable because service Is The grace period for servicing the required system expired Contact Galil Medical Customer Service to schedule service 1 877 639 2996 or appropriate market number galilcst galilmedical com The Visual ICE System is at the end of operational life The Visual ICE System reached Contact Galil Medical Customer Service the end of its 5 year operating life 1 877 639 2796 or appropriate market number to arrange return of this system to be refurbished replaced or disposed galilcst galilmedical com Visual ICE Cryoablation System Page 77 of 86 This page intentionally left blank Page 78 of 86 User Manual 8 SYSTEM SPECIFICATIONS The expected service life of the Visual ICE Cryoablation System is 5 years Contact Galil Medical for disposal instructions Upon request by a Galil Medical qualified service engineer a schematic of the system and or components will be provide
40. an individual MTS The color of the selected temperature sensor location corresponds to the color of the temperature line on the graph Press the Thermometer button to graph the coldest temperature on a selected MTS Press the Thermometer button again to return to the original display NOTE A maximum of four sensor locations can be displayed on the graph at any one time The four selected sensor locations can be from any of the connected MTS needles Visual ICE Cryoablation System Page 21 of 86 Button corresponding to 5 mm sensor location Triangle indicates coldest sensor Select the Scale button to adjust the graphical display of the temperature measurements such that the temperature throughout the entire procedure is visible Select the Scroll button to display a scroll bar to scroll through the graphical data during the procedure To enlarge the Temperature Sensors graphical display press the Maximize button Press the Minimize button to return the display to the original size Advanced Temperature Sensors Controls Pressing and holding an MTS Channel button provides an 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 6 4 3 1 7 Organ Map Use Organ Map to view or draw organs draw tumor shapes within
41. anana nennen nnns nnn nnns 33 PASS WOM WE E aaa a ajab aaa nal a ag aaa a aa aa na T 33 Emergency odiada a 33 No Gas Connected message saanane naen Geeta td 37 Procedure Sor tc E E TS 38 Thawing MOE message void 39 Needle Past Expiration Date id 40 Select Needle Type Men 40 Gas Time Remaining nnneneannneonennnnnsennnrenrnnrnrrsrnrnresrnrrrrrsrnrrrrsenrrressnnrrrrsrnrerrsennrrennnnenee 43 Export Report screen 45 Report Exported message 45 Advanced Freeze Control 48 Advanced Thaw Controls cccccccccccccssssssececceeeeeaeesceceeeeseeaeeeeeeeeeeessuaeaeeeeeeeessaaaeeeeeeees 48 Cautery Confirmation Message nennen nennen nnns nnn nnn nnn ns 49 Cautery Needle Warming asa eap dti tence ad eoa eid Sada 49 Cautery Ae Wee a destina negas aaa Ek t etii duties 50 Cautery Needle CODING iota dese eese tance da Dessous 50 Advanced Channel eet EE 51 linked CHANG S osc iu eat een DU ds 51 Advanced Cycle Controls ras aaa ae iuto P teta i rang hay ee aga bo ti dee cdita tect A 52 Advanced Temperature Sensor Controls ooccccccccocncnncnncnncnnncnnnnnconnnnnnnncnnnnononnnanononanenos 53 Sedis ESS ue 5 cates wc p 55 Software Update Confirmation cccccccccccccsesseceeceeseeceeeceeeeeceeeeeeaseeeseseaseeeesseaseeeesssaaees 58 Software Recovery Gcreen 61 Invalid Configuration Message viii ede nde 62 User Manual Symbols CE Mark of Conformit Cautio
42. are Other data or software may corrupt the Visual ICE System Do not use a USB extension cable to connect the USB flash drive to the USB port Connect the Galil Medical USB flash drive directly to the USB port provided on the Visual ICE System Use of a USB extension cable may result in electromagnetic emissions exceeding regulatory limits Do not perform a cryoablation procedure with the Ethernet cable plugged into the Visual ICE oystem to avoid the potential risk of corrupting the system software Only use the Ethernet cable when downloading software updates or when uploading reports to the Galil server 1 7 2 Handling Maneuver the Visual ICE System by pulling on the system using the rear handle Handle the Visual ICE Cryoablation System with care Rough handling may damage the system and cause it to become inoperable Visual ICE Cryoablation System Page 5 of 86 Do not bend or kink the gas supply lines Sharp bends or kinks may compromise the integrity of the gas supply lines Do not tilt the Visual ICE Cryoablation System Lift the Visual ICE 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 Do not roll the Visual ICE System over the gas supply lines 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
43. as cylinders during a procedure follow the instructions provided in Section 4 5 10 32 EES Settings amp Registration Procedures Est Remaining Est Remaining em 3 Time 00 30 52 a Time 00 53 21 Procedure Screen 26 Gas Time Remaining 4 Press the Freeze button on selected channels containing needles to begin the initial freeze phase of the procedure reference Section 4 6 1 for instructions on performing a timed freeze phase To adjust the freeze intensity press the Freeze Intensity button and select the desired intensity from the drop down menu The Freeze cycle will continue at the selected freeze level until this operation is changed or stopped CAUTION Continuously monitor iceball formation using image guidance such 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 5 Watch the timer to monitor the freeze phase elapsed time reference Section 3 1 5 for instructions on enlarging the timer display When the desired freeze duration has elapsed press the Stop button to enter an idle phase 6 If thermal sensors are used monitor the tissue temperature using the T
44. cessories ira siaran aana aaa aa AK bea aba aa Ka aan kaa a aaa Kaba aaa aa aa aaa a 14 3 NAVIGATING THE USER INTERFACE 0 cecceeceeceeceeceeceeceeceeccescuscesceseescescescneceeeeeeeeeees 15 3 1 Procedure Screen nn 17 3 1 1 Navigation Tool Baf cessed aac abres 18 3 1 2 Context Sensitive Help 18 Visual ICE Cryoablation System Page i of 86 3 1 3 User Selected Self Hein 18 3 14 Chamel Cono RN UT 19 So Chanel Stats ua oo 20 3 1 6 TLemperature SOASOrS iia iii 21 SEN VE Een EE 22 3u2 MEW REDON Sa aaa ak aaa na ees Bebe 24 39 Congue Ss CUS sak aaa a a aan LU EMT 26 o a a i E a a 27 3 5 Remote Upload Download aiteis a exei els A ak aas ee ee 27 4 SYSIEM 4OPEBATION EE 29 ME ocio ME di RETE aan E 30 SUME i e ullo RT L NG Kan 30 4 1 2 Connecting Gas Cylinders oocccccccconncnncccnnnncnnnnononncnnonononnnnnnnnnnnnnnnononancnnnononanenns 34 4 1 3 Pre Proced ure Testing WE 37 4 2 Performing a Cryoablation Procedure ooocccncccccocccnncccnoncnnnononancnnnnonnnncnnnnnnnanrnnnnnnnncnnnnos 42 o E Me EE 44 44 SY SIEM lia NE nen eee 45 4 5 Changing Gas Cylinders during a Procedure oooooocccccccccnncnoncccnnnccnonnnannccnnnncnnnnnannncnnncnnnns 46 4 5 1 Standard Gas Cylinder Setup asas ak aaa Laa a DA aa a NEG A nk aaa D Ka a aa a a Aan 46 4 5 2 Dual Gas Cylinder GONNGGU DIN ass a aaa Aa an NEG AA a aaa EA aa a Aa an An 47 46 Advanced GONI OS C
45. creen 35 Page 50 of 86 User Manual nnelStalus g ga Sca e Uu L r ELLE Screen 35 Advanced Channel Controls 2 Press the Link button to link two channels together for simultaneous operation When two channels are linked the Channel button shows both channels Screen 36 NOTE This function is not available on the channel labeled ALL You can only link channels that are on the same horizontal plane on the Needle Connection Panel e g 1 and 2 3 and 4 5 and 6 IceRod i Thaw IceRod i Thaw Screen 36 Linked Channels OPTIONAL Press the Unlink button to remove the link between two channels so that each operates independently 3 Press the Cycles button Screen 35 to enter Advanced Cycle Controls and program a freeze thaw cycle Visual ICE Cryoablation System Page 51 of 86 ba Advanced Cycle Controls NE Fy PE SAI EECH IS Som Re EEN Use Cycle Three Insert needles to Timed Free Confirm needle Freeze Intensity Choose freeze in Press Freeze bu Monitor iceball fc guidance JUse Passive Thaw n 1 Screen 37 Advanced Cycle Controls 4 Select the desired freeze intensity using the drop down menu adjust the freeze and thaw phase durations using the appropriate arrows or the scroll bars If passive thaw is desired check the Use Passive Thaw box 5 f more than one freeze thaw cycle is desired check the boxes to use Cycle Two and to u
46. cryoablation needles are available in a range of configurations that produce various iceball sizes and shapes allowing the clinician to match the needles to the desired ablation zone The Multi Point Thermal Sensors MTS contain four sensor locations along the distal shaft of the needle to monitor temperature near the target site and adjacent critical structures The cryoablation needles and MTS are supplied sterile in procedure kits or in needle kits 2 10 Accessories 2 10 1 Included Accessories Several accessories are shipped with the Visual ICE System e The Visual ICE User Manual describes the system and provides instructions for system operation and maintenance Visual ICE Cryoablation System Page 13 of 86 The Quick Reference Guide summarizes key steps in system operation The 8 m gas supply lines are used to connect argon and helium gas cylinders to the Visual ICE System The stylus may be used with the touch screen monitor for activating on screen buttons and entering information using the virtual keyboard The stylus is tethered to the system within the monitor storage compartment The Galil Medical USB flash drive is used to transfer procedure reports to a customer s computer for saving or printing The Ethernet cable is used to connect the Visual ICE System to a Galil Medical remote server for uploading reports and diagnostic data and for downloading software updates and User Manual updates The chassis cover is used to p
47. cts in the storage compartment The weight limit is 23 kg 50 lbs Do not store liquids in the compartment Liquids spilled in the storage compartment may drip into the system the compartment is not water tight 2 4 Brake Pedal The brake pedal operates on the front two wheels of the Visual ICE Cryoablation System Position the brake in the UP position 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 the front two wheels are free to roll and swivel If the flooring is uneven it may be necessary to lock the two rear wheels in addition to locking the front wheels Lock each rear wheel by using the individual locking pedal on each wheel Visual ICE Cryoablation System Page 11 of 86 2 5 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 6 Gas Inlets The gas supply lines connect the argon and helium gas supply from the respective gas cylinders to the argon and helium gas inlets The argon inlet is a plug connector the helium inlet is a socket connecior 2 Manual Vent Valve The Manual Vent Valve is used to vent the high pressure gas from the Visual ICE System if the automatic venting feature is not used 2 8 Needle Connect
48. d 8 1 Operating Conditions e Temperature 10 C to 40 C e Relative Humidity 30 to 75 8 2 Transportation and Storage Conditions e Temperature 15 C to 50 C e Relative Humidity 10 to 90 8 3 Mechanical Specifications e Weight 100 kg 220 Ibs e Height 107 cm 42 in monitor down 157 cm 62 in monitor up e Foot Print 56 x 66 cm 22 x 26 in e Storage Compartment Weight Capacity 22 kg 50 lbs e Monitor Storage Basin Weight Capacity 9 kg 20 lbs e Closed Monitor Weight Capacity 9 kg 20 Ibs 8 4 External Gas Supply e Argon Cylinder o Purity Level 99 998 or higher o Solid particle size 5 um e Helium Cylinder o Purity Level 99 995 or higher o Solid particle size lt 5 um 8 5 Gas Cylinder Specifications e Maximum Pressure 31 MPa 4500 psi 310 bar 41 4 MPa 6000 psi 414 bar USA Only e Recommended Volume of Gas Cylinders 42 50 L Visual ICE Cryoablation System Page 79 of 86 8 6 Accuracy of Displayed Values e Temperature Accuracy 3 C over range of 60 C to 40 C e Supplied Gas Pressure Accuracy 50 psi over range of 1000 psi to 6000 psi 3 4 bar over range of 69 bar to 414 bar 0 314 MPa over range of 6 9 MPa to 41 4 MPa e 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 6 9 MPa to 27 6 MPa e Time Intervals 5 seconds over any 10 minute interval 8 7 Electrical Specifications
49. d 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 8 53 am IKE A Settings amp Procedures Est Remaining Perform Needle Integrity and Functionality Test on each needle before use Press Test button on a needle channel to initiate needle testing Observe and check each needle during testing No bubbles at the needle tip during flush phase ce begins to form around the tip during freeze phase IZ MT amp Screen 14 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 pressurized gas in the system and the gas supply is not connected a message appears requesting you to vent the gas from the system Screen 15 Vent Gas Message Visual ICE Cryoablation System Page 31 of 86 The Login Screen appears after the boot up process is complete ges a ia kadi kad nn kulan kada a a katan kian lS ladi ata kaa kaa al ata aa dl a ladle tit Sta tadha la a and kaa akan el i lll laa aa lineal ladha a tani NN L gge aje Screen 16 Login Screen 9 Enter your assigned login name and password using the on screen virtual keyboard NOTE The login name and password are not case sensitive Numbers are displayed when the keyboard is in upper case To c
50. during a procedure Immediately turn off power to the system and end the procedure to avoid inadvertent activation of needles 1 7 Precautions 1 7 1 General Training on appropriate use of the Visual ICE Cryoablation System is required prior to conducting a cryoablation procedure The physician is solely responsible for all clinical use of the cryoablation system and for any results obtained by use of the system The physician makes all clinical decisions prior to and throughout the cryoablation procedure based upon his her professional opinion Page 4 of 86 User Manual The Visual ICE System and the user interface are non sterile Contact with any part of the system or the user interface by a member of the sterile team requires use of customer supplied sterile accessories such 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 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 Direct the high pressure gas supply lines toward the floor and secure the lines with the clips located on the rear of the Visual ICE System to minimize the potential for tripping Confirm that the Manual Vent Valve is closed befo
51. e Zone Use 24 hour clock Fahrenheit Screen 11 Configure Settings Page 26 of 86 User Manual Table 4 Configure Settings Options Calibrate Touch Calibrate the touchscreen Screen Change your password Administrative users may add users remove users or change the password of any user Manual Install a software update via a USB flash drive Software NOTE This function is available only to administrative Update and service users Configure the Ethernet connection for remote uploading of reports or downloading of software revisions or user manual updates NOTE This function is available only to administrative and service users Configure Ethernet 3 4 Service Screen The Service Screen is available only to Galil Medical trained authorized service personnel with a service login ID The Service Screen provides service users with the ability to run system diagnostics enable or disable system features adjust minimum and maximum gas pressures view event logs and perform manual system configuration 3 5 Remote Upload Download While the system is OFF connect the Ethernet cable 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 revisions or user manual revisions The Visual
52. e genitalia e General surgery Palliation of tumors of the rectum hemorrhoids anal fissures pilonidal cysts and recurrent cancerous lesions ablation of breast fibroadenomas e ENT Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth e Thoracic surgery Ablation of arrhythmic cardiac tissue cancerous lesions e Proctology Ablation of benign or malignant growths of the anus or rectum and hemorrhoids 1 5 Contraindications There are no known contraindications specific to the use of the Galil Medical Visual ICE Cryoablation System Visual ICE Cryoablation System Page 3 of 86 1 6 Warnings Do not use this device for any purpose other than the stated intended use and indications for use A thorough understanding of the technical principles intended use indications for use and risk associated with cryoablation procedures is necessary before using this product 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 Do not use a Visual ICE Cryoablation System near magnetic resonance imaging MRI equipment Do not start a cryoablation procedure before verifying that the Visual ICE System and all ancillary equipment are fully operational Do not use the Visual ICE Cryoablation System if the system is visibly damaged exposing any internal components or sharp edges Have sufficient gas argon helium
53. e will identify needles not Choose and connect a different needle type regulatory cleared or supported in country of operation Channel will be disabled until an appropriate needle is connected This needle lot number is identified as part of a recall and is Software check of the lot number of unavailable for use Return the needle to Galil Medical the needle identified a match with Connect a needle from a different lot number to continue the lot numbers in a regulatory recall procedure The needle Use by date is in the past Replace with a new Software check of the needle needle expiration date identified an expired date Visual ICE Cryoablation System Page 73 of 86 Message Reason for Appearance This needle has been previously used Replace with a new Software detects needle needle reconnected subsequent to an initial connection The software prevents needle reuse select needle type Needle memory chip not drop down menu of selections functioning or a needle without the memory chip is connected The currently selected needle on channel x does not have i Combinations of needles that are i Thaw capability Since helium is not connected passive thaw Thaw capable and that are not i is required on this channel Thaw capable are connected to the needle connection panel no helium gas is connected so passive thaw is required Channel Xa or Xb i Thaw needle is defective for electrical User informed if ant
54. eded 6 Confirm the Manual Vent Valve is fully closed Figure 2 If needed turn the knob clockwise until it is fully closed 7 Raise the monitor to the UP position and adjust it to a comfortable viewing and operating height and angle CAUTION Use care when swiveling the touch screen monitor to avoid the potential for pinching fingers 8 Turn the system ON using the power control knob located near the Needle Connection Panel Figure 4 During boot up the system performs several diagnostic tests to verify that the hardware and software are operating properly The system produces a series of clicking sounds as the system performs these self diagnostic This boot up process is completed in approximately 45 seconds NOTE If the system was improperly shutdown after the previous procedure the boot up process could take up to 2 minutes Page 30 of 86 User Manual NOTE It is important to power up the system prior to connecting the gas to the system If the system is not powered up prior to connecting the gas the diagnostic tests will not be performed by the software The diagnostic tests check e The correct version of firmware is running on the system e Critical system components including the solenoid valves internal power supplies cooling fans pressure 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 bordere
55. edle test freeze thaw or idle phase press the Timer button to enlarge the timer display Screen 6 You can enlarge timers for three selected channels simultaneously a channel number for each timer appears in the upper left corner of the timer window Press the timer to return it to its original size Page 20 of 86 User Manual Y Scale Scroll 0 5 10 15 Thawing Screen 6 Enlarged Timer To briefly display the time associated with a completed cycle press the section of the status bar for the selected operation Press the Scale button to adjust the graphical display of the channel status such that all operations are visible Press the Scroll button to adjust the graphical display to 5 minute increments the display scrolls throughout the procedure Press the Maximize button to enlarge the graphical display Press the Minimize button to reduce the display to the original size 3 1 6 Temperature Sensors The Temperature Sensors section Screen 7 displays the temperature measured for each sensor location on the connected MTS needles and a black triangle highlights 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
56. emperature Sensors section of the Procedure Screen reference section 3 1 6 7 To actively thaw the iceball press the Thaw button on the channels containing needles to start the thaw phase If the Visual ICE System detects that helium gas is connected the system defaults to helium thaw mode If needles of mixed type some helium thaw and some i Thaw are connected the system also defaults to helium thaw mode NOTE Thawing with i Thaw is limited to a maximum of 10 needles simultaneously Thawing with the FastThaw function reference Section 4 6 2 is limited to a maximum of 6 needles simultaneously OPTIONAL To initiate a thaw phase on all needles simultaneously press the Thaw button on the channel labeled ALL Pressing any function button on channel labeled ALL displays a message asking you to confirm simultaneous operation of all needles 8 Watch the timer to monitor the thaw phase elapsed time reference Section 4 6 2 for instructions on performing a timed thaw phase When the desired thaw duration has elapsed press the Stop button to enter an idle phase Visual ICE Cryoablation System Page 43 of 86 9 Repeat steps 3 through 8 until the desired number of freeze thaw cycles has been completed CAUTION Ensure adequate thawing before attempting to remove needles from the patient Discontinue all needle operation prior to needle removal to minimize risk of tissue injury 10 Remove all needles and MTS from the patient 11
57. enrnnnreonrnrnresrnreressnnrerennnne 68 TO NEC ks eee ee e a a a aa me gana a da a a a Sa ee ee a a dan NG 68 ET E REI Me bei erect aS ts 70 9 SYSTEM SPECIFICATIONS eieiei deeg ic 79 8 T Operating ONGKO Saka kas a sa a WG a AAN Ee bech 79 8 2 Transportation and Storage Conditions sn01nnneoeennnneneennnnosrnnnresrrnrnrrsrnreresrnnrrrennnne 79 9 9 Eeleren EE 79 384 Exema Gas SUDI nia aaa tcc m 79 8 5 Gas Cylinder Specifications ccccccccseecececceeeecececcceeeeeescceseeceeseceseneeeseceseeeensnoeseeeenses 79 8 6 Accuracy of Displayed Values a o eee 80 8 7 ege Ee Ee el 80 Page ii 0f 86 User Manual 8 7 1 Electromagnetic Compatibility and Immunity EMC and EMI 80 9 DISCLAIMER OF WARRANTY cccccccssssseeeescnsseeescceasseeseeoeasseeeseonasseeeseoanseeessooanneees 85 List of Figures Figure 1 Visual ICE Cryoablation System Front View 9 Figure 2 Visual ICE Cryoablation System Rear View ooccccccccccncnnncccooccnnnocononcnnnononnnnnnnononnnnnnnononanoss 10 Figure 3 Visual ICE Cryoablation System Monitor Storage Compartment nennsnaennenenneenenenennnene 11 Figure A Visual ICE Cryoablation System Needle Connection Hanel 12 Figure 5 Visual ICE Cryoablation System Needle Channel 13 Figure 6 Cryoablation Procedure FIOW snoannnnnsennnenosennnensrnrrresrnrrrnosrnrnrnsrnrrressnnrrensrnrnresnnrrrenennenee 29 Figure 7 Gas Cylinder Set up usce
58. er a needle s is inserted into the desired channel lock the channel by sliding the locking bar away from the center of the system Figure 10 Page 38 of 86 User Manual Figure 10 Locking Needle into Channel 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 defaults to helium thaw mode and i Thaw Fast haw and Cautery capabilities are disabled NOTE The Visual ICE System displays a message if one or more needles without i Thaw technology are connected and helium gas is not connected to the system Ensure the helium gas is connected to the system to use active thaw without I Thaw 27 Sep 2012 Settings amp Procedures Perform Needle Integrity and Functionality Test on each needle before use Press Test button on a needle channel to initiate needle testing Observe and check each needle during testing No bubbles at the needle tip during flush phase ce begins to form around the tip during freeze phase Visual ICE Cryoablation System Page 39 of 86 When the channel has been locked the software detects that a needle has been connected and the channel opens for tes
59. essed 19 inch touch screen monitor a mouse track pad two USB ports and an Ethernet port The system 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 at the rear of the system Figure 2 are used to direct the gas supply lines toward the floor minimizing tripping hazards A compartment in the lower section provides storage for system accessories Touch Screen Monitor Le Monitor Storage Compartment EX Mouse Track Pad Ca ete oman DREES o senor compe e via AH Figure 1 Visual ICE Cryoablation System Front View Visual ICE Cryoablation System Page 9 of 86 Figure 2 Visual ICE Cryoablation System Rear View P nsona aferar c reon recorrer a et comer seme mese 0 DEER verano DES Page 10 of 86 User Manual El Ethernet Port E USB 2 0 Full speed Port D USB 2 0 Low speed Port Figure 3 Visual ICE Cryoablation System Monitor Storage Compartment 2 1 Touch Screen Monitor 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 use
60. et conventions represent various user interface sections software buttons positions and steps e Software Screen section e Control button e ON position e 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 When the system is powered on the Login Screen appears after the boot up process is complete reference Section 4 1 1 o 3 wm Password MM rrr lalalala ll kaka and kahan lil eli Screen 1 Login Screen After logging into the system the Startup Screen displays several options Visual ICE Cryoablation System Page 15 of 86 10 29 am IER Startup Software Version 1 2 0 Logout User Manual Remote Upload View Reports Dalan Configure Settings Start Procedure Service re 27 GALILMEDICAL Screen 2 Startup Screen Table 1 Startup Screen Buttons Button Description Transition to the Procedure Screen to start a cryoablation Start Procedure procedure Log out of the system View the contents of a report and export reports to a Galil NOTE Administrative users may also delete reports Configure various system settings reference Section 5 1 Configure NOTE Some configuration parameters are limited to Settings administrative and or service users only
61. ference Guide USB flash drive 4 GB within an attached pouch High pressure argon gas supply line 8 m with attached pressure gauge o Optional 3 m argon gas supply line e High pressure helium gas supply line 8 m with attached pressure gauge o Optional 3 m helium gas supply line e Optional EZ Connect2 Dual Cylinder Adapter four way adapter assembly with argon pressure gauge 3 m gas supply line with cylinder connection 8 m gas supply line e Stylus e Chassis cover e Ethernet cable 3 m 1 3 2 Accessory Products Used to Conduct Cryoablation Procedures The following items used with the Visual ICE System are sterile single use only devices Do not re sterilize or reuse e Galil Medical Cryoablation Needles e Galil Medical Multi Point Thermal Sensors MTS e Galil Medical Urethral Warmer Set 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 e Galil Medical Prostate Procedure Template e Galil Medical Urethral Warming System The following items are needed to conduct cryoablation procedures and are not available from Galil Medical e Argon gas cylinder s e Helium gas cylinder s if using helium for thawing NOTE The argon and helium gases must meet the purity requirements specified in Section 8 4 Galil Medical recommends the use of a sterile drape customer supplied to cover the touch screen if the sy
62. ference may occur in the vicinity of equipment marked with the following symbol Dol NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy 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 Visual ICE System is used exceeds the applicable RF compliance level above the Visual ICE System should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the Visual ICE System Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m Visual ICE Cryoablation System Page 83 of 86 Table 11 Recommended separation distances between portable and mobile RF communications equipment and the Visual ICE System Recommended separation distances between portable and mobile RF communications equipment and the Visual ICE System The Visual ICE Cryoablation System is intended for use in an elect
63. fter successful login the Startup Screen appears Screen 2 4 1 2 Connecting Gas Cylinders WARNING Do not connect the Visual ICE 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 gas cylinders are chained to a wall or an approved cart to prevent inadvertent tipping of the cylinders CAUTION Galil Medical recommends having additional backup argon cylinders available for each treatment CAUTION Turn the Visual ICE Cryoablation System ON before connecting the gas cylinders to ensure the proper diagnostic tests are conducted NOTE If cryoablation needles with i Thaw technology are being used only argon gas is required to be connected If helium gas is connected the 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 Connect the helium high pressure gas supply line to the helium cylinder by securing the gauge assembly adapter onto the cylinder connection Figure 7 Figure 7 Gas Cylinder Set up IS Gauge assembly adapter EN Cylinder shutoff valve 3 Onthe rear of the Visual ICE System ensure that the Manual Vent Valve is in the CLOSED position Page 34 of 86 User Manual 4 o 6 Remove the humidity covers from the helium and argon
64. gas from the User is provided an option for System automatically venting the high YES NO pressure gas in the system Is the gas supply closed If user selects the option for YES NO automatic venting the user will need to confirm the gas supply is closed and to only activate venting after confirmation that the supply is closed Venting is in progress If needles are still connected do not User selected to automatically vent unlock channels or disconnect needles until venting is the high pressure gas at the end of complete the procedure Automatic venting successfully completed User chose to automatically vent the high pressure gas at the end of the procedure Do you want to shut down the system User selected Shutdown in the login screen The Visual ICE System is shutting down Please wait until oystem is in the process of closing shut down is complete before turning the power switch to the down off position A USB flash drive is still connected Remove the USB flash During shutdown the system drive before shutting down the system detects that a USB flash drive is still connected SERVICE Service the Visual ICE System soon Service must be User is reminded of the deadline to completed by DATE complete scheduled system Contact Galil Medical Customer Service to schedule service service Reminder will begin four 1 877 639 2996 or appropriate market number weeks prior to service due date galilcst galilmedic
65. hange 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 17 Incorrect Login Page 32 of 86 User Manual Additional Login Options If you forgot your password contact your System Administrator and request that the administrator log in go to the Manage Users screen and change your password Alternatively press the Forgot Password button at the top of the screen Screen 16 A displayed message provides a challenge to be relayed to Galil Medical Customer Service Screen 18 Reset Password Challenge Screen 18 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 19 and you will have an opportunity to change your password in the configuration screen Password Reset Screen 19 Password Reset In case of emergency press the Emergency Login button at the top of the screen Screen 16 A message is displayed with a challenge phrase Call Galil Medical Customer Service to receive the proper response phrase to enter then press the Login button Screen 20 NOTE This action does not reset your password Emergency Login Screen 20 Emergency Login Visual ICE Cryoablation System Page 33 of 86 A
66. he system 9 Cover the helium and argon inlets with the humidity plugs Cover the Visual ICE System with the chassis cover WARNING Do not pull on the power cord Grasp the plug not the power cord to disconnect the device from the wall socket 10 Clean the system after each use using the instructions provided in Section 6 2 Ensure the system is dry prior to storage 11 Lower the Touch Screen Monitor into the monitor storage compartment prior to system storage CAUTION Prior to lowering the monitor ensure that no objects such as the USB flash drive are located in the monitor storage compartment Use care when lowering the monitor into the storage compartment do not use excessive force to avoid damaging the monitor CAUTION Use care when lowering the touch screen monitor to avoid the potential for pinching fingers 4 5 Changing Gas Cylinders during a Procedure If it becomes necessary to replace a gas cylinder during a procedure stop all freezing and thawing operations 4 5 1 Standard Gas Cylinder Setup 1 Plan the appropriate time to make a cylinder 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 needles being used Also consider the number of planned freeze thaw cycles for the procedure oafely position a full gas cylinder with the required gas type and purity near the empty cylinder
67. he state of the needle Freeze Thaw Idle by color coding matching that identified in the Channel Status section Control Needle button Initiate freeze and thaw cycles of the selected needles Needle Lock button Lock a needle in place on the organ map so that it may not be inadvertently moved Clear All button Clear all drawings and needle placements from the drawing canvas Trash button Delete a needle on the organ map Previous Image button Change the view of the selected organ Next Image button Change the view of the selected organ 3 2 View Reports Procedure reports provide a summary of a cryoablation procedure The reports contain the information provided in the Registration screen details of the freeze thaw cycles number of MTS 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 Page 24 of 86 User Manual Temperature Sensors 0 sec 9 min 36 sec Organ Map Test 1 min 30 sec 175 Freeze 1 min 29 sec Stopped 8 sec Stopped 51 sec 150 Freeze 1 min 30 sec 100 Freeze 1 min 31 sec 25 Freeze 1 min 31 sec Thaw 1 min 6 sec Number of Freeze Thaw cycles 1 ivity Durations 1 min 31 sec 1 min 29 sec 1 min 30 sec 1 min 31 sec Warning Report might include patient protected health information handle EM SCH electro
68. hematuria hypertension hypotension hypothermia idiosyncratic reaction ileus impotence infection injection site reaction myocardial infarction nausea neuropathy obstruction organ failure pain pelvic pain pelvic vein thrombosis penile tingling numbness genitourinary perforation perirenal fluid collection pleural effusion pneumothorax pulmonary embolism pulmonary failure rectal pain renal artery renal vein injury renal capsule fracture renal failure renal hemorrhage renal infarct renal obstruction renal vein thrombosis rectourethral fistula scrotal edema sepsis skin burn frostbite stricture of the collection system or ureters stroke thrombosis thrombus embolism transient ischemic attack tumor seeding UPJ obstruction injury urethral sloughing urethral stricture urinary fistula urinary frequency urgency urinary incontinence urinary leak urinary renal leakage urinary retention oliguria urinary tract infection vagal reaction voiding complication including irritative voiding symptoms vomiting wound complication and wound infection Visual ICE Cryoablation System Page 7 of 86 This page intentionally left blank Page 8 of 86 User Manual 2 SYSTEM DESCRIPTION The Visual ICE Cryoablation System is a mobile cryoablation console that contains ten needle connection channels each supporting two needle ports four Multi Point Thermal Sensor sockets one argon inlet connector one helium inlet connector a rec
69. his page intentionally left blank Page 54 of 86 User Manual 5 ADMINISTRATIVE FUNCTIONS 5 1 Configure Settings The Configure Settings screen allows you to change system settings used during a cryoablation procedure A maximum of five 5 user accounts can be configured for each Visual ICE System Settings that may be changed include MTS Needle Locations System Procedure and Registration Settings and Units reference Table 6 Only Service personnel have the option to adjust the system time and date System Administrators 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 3 17 pm BE SIUE d Calibrate Manual Software hern Toa TA e anaye USO KE EN Sa Unngure CICIMICI Startup gt gt Co nfigu j MTS Needle Locations System Settings Argon Cylinder Volume Maximize by Default Custom Fields Kidney 42 0000 aka Channel Status MTS Locations Helium Cylinder Temperature Sensors Po Volume 42 0000 A Organ Map Upload Registration Liters Y None Clear hospital name C blc titers _ Link all channels m history and doctor name
70. ical servers self checks at start up an or from USB flash drive incompatibility is detected between the hardware and software Report upload is in progress User connected via Internet to Galil XX completed Medical and is uploading new files and or reports Percentage of upload completed is displayed based on remaining data and network speed Reports were successfully uploaded User successfully uploaded new and or revised reports to Galil Medical The Visual ICE System software is not compatible with The software will be checked regulatory approvals Please connect to the Galil Medical against approved software versions network to download the appropriate software for your market in the regulatory files for each If problem persists contact Galil Medical Customer Service respective market 1 877 639 2796 or appropriate market number galilcst galilmedical com New software was released and Is available for downloading User connected to the Galil Medical server New software Is available to download to the Visual ICE system An error occurred during the update process Retry update During User update of the system an error occurred that prevented completion of the update Page 72 of 86 User Manual Message Reason for Appearance Unable to export the report to the USB flash drive The USB User selected Save Reports to flash drive may be disconnected or full Flash Drive No flash drive is detected or there
71. ining before depletion of the cylinders assuming that all connected needles are operated simultaneously reference Section 3 1 1 7 When using Multi Point Thermal Sensors MTS prepare the desired number of sensors for testing The Visual ICE System supports use of four thermal sensors Connect each thermal sensor to an MTS connection port by pushing the connector into the port Ensure that the Visual ICE Cryoablation System Page 41 of 86 rectangular tongue on the MTS connector is aligned with the groove at the top of the connection port for proper MTS insertion Figure 11 Figure 11 MTS Connection 8 Confirm MTS functionality by verifying that the connected sensor produces a reasonable on screen temperature reading e g close to room temperature in the Temperature Sensor section of the software screen CAUTION Do not use an MTS that has failed the thermal sensor functionality testing erroneous temperature measurements may be displayed 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 OPTIONAL On the Procedure Screen select the Registration button to enter optional patient
72. ion Panel Page 12 of 86 User Manual Figure 5 Visual ICE Cryoablation System Needle Channel MTS Connection Port ES Software Reset L Power Control Knob ES Needle Channel Locking Bar Needle Port with Electrical Connection Channel Number 2 8 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 site 2 8 2 Software Reset The Software Reset button is used to boot the Visual ICE Cryoablation System into a recovery mode if the software becomes corrupted reference Section 7 1 2 8 3 Power Control Knob The Power Control Knob powers ON the Visual ICE Cryoablation System in preparation for a procedure 2 8 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 or with i Thaw technology The locking bar on each channel locks the needles into the ports to secure them during the procedure 2 9 Cryoablation Needles and Thermal Sensors The Visual ICE System is used only with Galil Medical cryoablation needles and thermal sensors The
73. ion message appears Screen 31 CAUTION Activation of thermal cautery immediately ceases all other cryoablation gt oper Hon us duration W er S activity i Screen 31 Cautery Confirmation message NOTE While the Visual ICE System is in cautery mode freezing and thawing are not allowed on any other channels e Press the desired needle port A or B on each channel containing a needle you wish to track ablate Only one needle per channel may activate the cautery function at a given time NOTE A maximum of four 4 needles may use the cautery function simultaneously The Visual ICE System uses a pre set duration of 30 seconds for each cautery phase This value is not adjustable but the duration can be stopped in advance of 30 seconds by pressing the Stop button e Press the Start button to start track ablation The internal temperature is displayed as the needle heats up and the timer indicates the status as Warming Cautery Control Internal Heater D O Jim Stopped L a Screen 32 Cautery Needle Warming Visual ICE Cryoablation System Page 49 of 86 After the internal heater temperature has ramped up to 220 C the 30 second timer begins and indicates the status as Cauterizing Screen 33 Cautery Control internal Heater Port D e LJ Cl le Screen 33 Cautery In Progress When the cautery function has terminated the timer indicates the status as Stopped and the
74. is insufficient space on the flash drive A software file is nonoperational If problem persists contact There is a problem with the Galil Medical Customer Service software s configuration files 1 877 639 2796 or appropriate market number galilcst galilmedical com Rollback to the previous software version on the system This User pressed the Software will rollback the software on this system Are you sure you Recovery button want to do this Load default configurations to the system Are you sure you User pressed the Software REPORTS REPORTS Do you want to save the report to the Visual ICE System YES NO User selected End Procedure and has an option to save the report before exiting from procedure Finalizing Procedure oystem activity is displayed during process of report saving Report saved successfully Report saved successfully to a USB flash drive Errors occurred while compiling the report The report may be User chose to access a report incomplete during a procedure or to save data to a report at the end of a procedure Errors occurred which may affect the completeness of the report NEEDLES The connected needle is not supported by the software A needle type not supported by the Choose and connect a different needle type software configuration is connected in the channel The connected needle is not supported by the software ooftwar
75. isplayed on the Gas Verify that the gas cylinder valve is sufficiently Indicator indicates the gas pressure is opened to allow gas flow If necessary open the too low Table 5 valve approximately another half turn Verify that the cylinder contains sufficient pressure using the gauge on the cylinder Replace the cylinder if needed During the Needle Integrity and The gases are connected incorrectly e g the helium Functionality Test the needle is freezing gas supply hose is connected to the argon cylinder and in the first 45 sec of the test instead of vice versa thawing and then starts thawing for 15 End th d sec instead of freezing nd the procedure Vent the high pressure gas from the system Disconnect the gas supply lines and re connect them to the correct cylinder Start a new procedure Run the needle test again lt is very difficult to loosen the pressure The gas lines were not vented and the gas lines are still gauge connected to the cylinder or you under pressure cannot disconnect the argon helium gas supply lines from the gas inlet connections 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 e Verify that the gas cylinders are CLOSED e lf the Visual ICE System is ON end the procedure and vent the system using the automatic vent function If the system is OFF vent it using the Manual Vent Valve loca
76. isual ICE Cryoablation System should not be used 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 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 Visual ICE System should assure that it is used in such an environment Emissionstest Compliance Electromagnetic environment guidance The Visual ICE System uses RF energy only for its internal function Therefore its RF RF emissions CISPR 11 Group 1 emissions are very low and are not likely to Cause any interference in nearby electronic equipment Harmonic emissions Voltage fluctuations flicker emissions IEC Complies 61000 3 3 Visual ICE Cryoablation System Page 81 of 86 Guidance and manufacturer s declaration electromagnetic immunity Table 9 Electromagnetic Immunity The Visual ICE Cryoablation System is intended for use in the electromagnetic environment specified below The customer or the user of the Visual ICE System should assure that it is used in such an environment IEC 60601 Electromagnetic environment Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips
77. left hand area of the touch screen The symbol then moves counter clockwise to the lower left lower right and upper right hand areas of the screen The final calibration location is in the center of the screen Manage Users Select your username and press the Change Password button to change your password Administrative users may add users remove users or change the password of any user Manual Software Update Press the Manual Software Update button to install a software update via a Galil Medical 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 connection for remote uploading of reports or downloading of software revisions or user manual updates This function is available only to administrative and service users 5 1 1 Manual Software Update Administrative and service users can manually update the Visual ICE System software via a Galil Medical USB flash drive 1 Press the Manual Software Update button on the Configure Settings screen Screen 39 2 Press the Browse button to select the update file and press Update A confirmation message appears when the software update is complete Screen 40 Visual ICE Cryoablation System Page 57 of 86 Screen 40 Sofiware Update Confirmation NOTE Allusers can update the sofiware using the Remote Upload Download button on the Startup Sc
78. left idle for more than 2 hours while on the Procedure Screen Touch Screen goes blank during a procedure Visual ICE Cryoablation System Check the corresponding Channel Locking Bar and ensure it is fully in the locked position At least one needle must be inserted into a channel for the channel to be available for use 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 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 The track pad may be used to control the system The touch screen may be out of calibration Navigate to the Configure Settings screen using the track pad and re calibrate the touch screen Turn OFF and restart the system using the power control knob on the front of the system Figure 1 The USB flash drive is not connected to the proper USB port Connect the USB flash drive to the port with the USB port icon Figure 3 The USB flash drive is not properly connected to USB port Remove the USB flash drive from the designated USB port on the system Wait a few seconds and reconnect the USB flash drive to the designated USB port If the problem persists try using a different Galil Medical supplied USB flash drive The USB flash drive is faulty Replace the
79. linder shut off valve is closed Before disconnecting the gas hose manually vent the Visual ICE System using the valve on the rear of the machine The Argon Shutoff Valve may be closed Check and open if necessary The gas flow rate in channel XX exceeds the system operation requirements and may impact performance Reduce the number of active needles The gas flow rate exceeds the system operation requirements and may impact performance Reduce the number of active needles Visual ICE Cryoablation System Software self checks located a failure that requires the system to be restarted The internal temperature of the system exceeds appropriate operating limits Less than 10 psi is detected in connected argon and or helium cylinders with message displayed in respective Gas Indicator The User should connect gas cylinder s to the Visual ICE oystem If gas cylinders are connected the gas cylinder pressure should be checked Upon startup there is gas pressure remaining in the system which will make it difficult to connect needles Remaining gas in the cylinder is calculated to last only ten more minutes User selected to automatically vent high pressure gas at the end of a procedure but the pressure is not dropping User selected to not use the feature to automatically vent high pressure gas from the System Argon pressure displayed on the Gas Indicator is close to 0 Gas high pressure is registered at
80. n Date of Manufacture mc UU Temperature Limitation Do Not Push USB Port HE Helium Gas Alternating Current Unsafe Voltage Electrical contacts greater than 40 V AC Power Switch Power ON Visual ICE Cryoablation System Catalog Number Serial Number Manufacturer ui 90 Humidity Limitation Consult Instructions for Use Ethernet Port AR Argon Gas Protective Earth ground Type BF Applied Part Power OFF Authorized Representative in the European Community Page v of 86 1 SYSTEM OVERVIEW WARNING A thorough understanding of the technical principles clinical applications and risk associated with cryoablation procedures is necessary before using this product 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 Visual ICE Cryoablation System and cryoablation procedures prior to operating the system Contact your local Galil Medical representative to schedule training CAUTION Carefully read all instructions prior to use Failure to observe all warnings and precautions may result in complications 1 1 Brief Description The Visual ICE Cryoablation System is a mobile console system intended for cryoablative tissue destruction using a minimally invasive procedure The system is computer controlled with a t
81. n Screen 2 A list of reports that have been saved to the system is displayed Select the desired report to view and press the View Reports button at the top of the screen 3 When viewing a report you may scroll through the report using the scroll bar on the right hand side of the screen or you may select a section to view by pressing the report section name on the left hand side of the screen 4 Press the Export Report button to save the report to the Galil Medical USB flash drive A window appears for you to select the file format and file name Enter the file name using the on screen virtual keyboard You may also choose to export the temperature sensor data in a file to be used for further analysis Page 44 of 86 User Manual 9 59 am WARSI WAN WA I eg mt VISUAL ICE CRYDABLATION SYSTEM 27 GALILMEDICAL 9 58 am 27 Sep 2012 Other Procedure Registration Procedure Temperature Sen Organ Map Procedure Needle Types a fe SH oz iceroarLus e Screen 27 Export Report screen CAUTION Use only a Galil Medical 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 5 Press the Export button to begin exporting the file Wait for confirmation before removing the USB flash drive from the system Report Saved
82. nd 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 1 Close the gas supplies using the cylinder shutoff valves Contact Galil Medical Customer Service 4 1 3 Pre Procedure Testing WARNING Prior to beginning a treatment and before the patient is anesthetized set up the Visual ICE System and perform functionality tests on each cryoablation needle and thermal sensor Visual ICE Cryoablation System Page 37 of 86 1 On the touch screen monitor press Start Procedure The Procedure Scr puede Secas 22 P 9 33 am PBK Settings amp Procedures Connect only same type needles into a single channel of the Needle Connection Panel Connect only one ICeEDGE type needle per channel Remove connector cap s and insert needle s and MTS s into selected port s Lock each channel containing needle s by shifting the safety latch Screen 22 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 4 CAUTION Do not kink pinch cut or pull excessively on the needle tubing Damage to needle handle or tubing may cause the needle to become unusable 4 Aft
83. ndicator toggles the display back to Pressure Gauge Registration Provides optional data entry fields to record Patient ID Hospital Name Hospital Address Physician Name and Organ Type Two custom fields are provided for additional information The names of the custom fields can be specified in the Configure Settings screen reference Section 5 1 Notes A location to input text Selecting this button displays the on screen keyboard for data entry Procedure notes entered in this location are included in the procedure report reference Section 3 2 Settings and Procedure Displays the Procedure Screen to begin a cryoablation procedure Report Displays a report of all procedure data that has been entered and captured for the current procedure The report can be saved to the Galil Medical USB flash drive Pressing the Report button during a procedure displays all procedure information saved up to that point in time End Procedure Button Ends the current procedure and returns to the Startup Screen Pressing this button generates a confirmation request a request to save the report and an option to automatically vent the system 3 1 2 Context Sensitive Help The Context Sensitive Help displays a summary of procedural steps to guide you through a cryoablation procedure Itis intended to provide only a general overview step by step instructions are provided in Section 4 3 1 3 User Selected Self Help The question mark icon in the upper
84. nect the 3 m auxiliary gas supply line to the four way adapter assembly using the quick connect connectors Connect the opposite end of the 3 m auxiliary gas supply line to the new cylinder Carefully turn the cylinder shutoff valve on the new gas cylinder 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 4 6 Advanced Controls 4 6 1 Advanced Freeze Controls The Visual ICE System provides the ability to program a freeze phase on any channel for a prescribed duration at a pre selected freeze intensity dk 2 Press and hold the Freeze button to access Advanced Freeze Controls Screen 29 select the desired freeze intensity and freeze duration using the drop down menus The freeze intensity is adjustable in 5 increments from 5 intensity to 100 intensity The freeze duration is adjustable from 1 to 15 minutes using either the drop down menu or scroll bar Visual ICE Cryoablation System Page 47 of 86 Advanced Freeze Controls mae AG Free ze r4 A gt y 1 Screen 29 Advanced Freeze Controls 4 6 2 Advanced Thaw Controls 1 Press and hold the Thaw button to access Advanced Thaw Controls Screen 30 The Advanced Thaw Controls menu provides the option to program the thaw duration for the current thaw phase from 1 to 10 minutes and the ability t
85. ng the Freeze button provides an option to set a selected Freeze phase time from 1 to 15 minutes Freeze Intensity drop down menu Provides an option to adjust the freeze intensity from 10096 to 596 or to select Stick intensity NOTE The Visual ICE System controls freeze intensity by adjusting the duration of argon flow over each 10 second block of time e g 3096 freeze intensity freezes for 3 seconds and idles for 7 seconds Visual ICE Cryoablation System Page 19 of 86 Thaw button Begins a Thaw phase Advanced Thaw Controls Pressing and holding the Thaw button provides an option to set a selected Thaw phase time from 1 to 10 minutes 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 select cryoablation needles Stop button Stops any activity 3 1 5 Channel Status Channel Status shows the status of each freeze thaw and idle phase with numeric and color coded displays on the progress indicator Variations in blue shading visually represent the selected freeze intensity B vun PLUS IceRod PLUS ER ee Im 025 ICeEDGE 2 4 Screen 5 Channel Controls and Channel Status section If a channel is diagnosed to be inoperative during system boot up the channel controls become inactive and a brief description of the problem is displayed on the right hand side of the Navigation Tool Bar During a ne
86. nic and printed copies appropriately Screen 9 Procedure Report Example The View Reports screen displays a list of all saved procedure reports in the Visual ICE System You may select a report to be viewed or exported or you may delete your own reports Users with an administrative login ID may delete any report Select the report and press View Reports 1 27 pm BEE ww Report Name de Hospital Name Doctor Name Procedure Type 1 26 pm 28 Sep 2012 No information entered No information entered L 1 26 pm 17 Sep 2012 No information entered No information entered 1 26 pm 14 Sep 2012 No information entered No information entered Other 1 26 pm 13 Sep 2012 No information entered No information entered Other 1 26 pm 03 Sep 2012 No information entered No information entered 1 26 pm 28 Sep 2012 VISUAL ICE S GALILMEDICAL CAYOABLATION SYSTEM 1 26 pm 28 Sep 2012 Report Sections Kidney Procedure Procedure gt Registration Temperature Sensors Patient ID No information entered Organ Map Hospital Name No information entered Notes E m E Hospital Address No information entered Doctor Name No information entered Procedure Screen 10 View Reports Screen Visual ICE Cryoablation System Page 25 of 86 To sort the list by Report Name Hospital Name Physician Name or Procedure Type press the appropriate header section of the report list
87. nnect the 8 m gas supply line with four way pressure gauge adapter assembly to the primary argon cylinder by securing the gauge assembly adapter onto the cylinder connection e Connect the end of the 8 m gas supply line to the argon inlet of the Visual ICE System using the quick connect connector Visual ICE Cryoablation System Page 35 of 86 e Connect the 3 m gas supply line to the four way adapter assembly using the quick connect connector located on the end of the 3 m gas supply line e Connect the opposite end of the 3 m gas supply line to the second argon cylinder by securing the end of the line to the cylinder connection e Open the primary cylinder valve first and use this cylinder until depleted Do not open the cylinder valve on the second cylinder until the initial cylinder has been depleted e Reference Section 4 5 2 for instructions on changing the gas cylinder during a procedure if the second cylinder is also depleted during the procedure Figure 9 EZ Connect2 Dual Cylinder Adapter EN 3 m Auxiliary Gas Supply Line Four way Adapter Assembly with Pressure Gauge EN 8 m Gas Supply Line CAUTION Before beginning the cryoablation procedure ensure availability of sufficient gas to conduct the planned cryoablation procedure reference Section 8 4 for gas purity requirements Page 36 of 86 User Manual 9 Ensure the Gas Indicator Screen 4 displays the minimum working pressure before initiating a procedure T
88. o use the FastThaw and or Cautery functions Advanced Thaw Controls em d Screen 30 Advanced Thaw Controls NOTE FastThaw and Cautery functions are only available when needles with that capability are being used Argon gas only must be connected to access these functions Connecting helium gas to the Visual ICE System disables these functions The FastThaw and Cautery functions are not available on the channel labeled ALL Page 48 of 86 User Manual 2 OPTIONAL The FastThaw function generates a temperature that is higher than that required for i Thaw resulting in a faster thaw time Select the thaw duration using the drop down menu or the scroll bar Press the FastThaw button to initiate the thaw cycle NOTE A maximum of 6 needles can thaw simultaneously using the FastThaw function 3 OPTIONAL Needle track ablation is achieved using the Cautery function in the Advanced Thaw Controls The needle track is ablated through the use of thermal energy Each cautery enabled needle is operated independently using the Advanced Thaw Controls for the channel and port in which the needle is connected The cautery enabled cryoablation needle must have been operated in freeze mode prior to activating the Cautery function Once a needle has been used for track ablation the needle may no longer be used for freezing e Press the Cautery button on the Advanced Thaw Controls menu to open the Cautery Control screen A confirmat
89. on Enter patient treatment information in Registration Button Prepare sterile needles for testing Connect needles to Visual ICE System and lock channels Perform Needle Integrity and Functionality Test Test Multi Point Thermal Sensors if applicable Insert needles into target tissue Deliver the cryoablation treatment and remove needles View and save reports if desired Depressurize the system and shutdown Figure 6 Cryoablation Procedure Flow Visual ICE Cryoablation System Page 29 of 86 4 1 Preparation for Use Prior to using the Visual ICE System inspect the chassis power cord brake safety cables gas supply lines gas connections and the monitor touch screen to ensure they are not damaged If any of the components are damaged contact Galil Medial Customer Service CAUTION If condensation is present on the system allow the system to dry completely for 12 hours prior to powering up the system Powering up the system with condensation could result in permanent damage to the electrical boards causing the system to be inoperable Before the patient is anesthetized set up the Visual ICE System connect the gas cylinders and conduct functionality tests on each cryoablation needle and thermal sensor reference Section 4 1 3 4 1 1 System Set up 1 Position the Visual ICE System alongside the patient table Ensure that the needle gas tubing has sufficient length to reach the patient Ensure that the power
90. ouch screen user interface that allows the user to control and monitor the procedure The therapy delivered by the system is based on the 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 Certain gases such as argon decrease in temperature 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 Galil Medical i Thaw technology in which a heating element inside the cryoablation needle can be energized to cause thawing When multiple cryoablation needles are placed into or near the target tissue and freezing is initiated an iceball grows around the distal end of the needle shafts In time the iceballs coalesce and completely engulf the target tissue An important benefit of cryoablation is that imaging procedures such as ultrasound and CT are able to display the location and size of the iceball This benefit of cryoablation is used for proper control of the therapy During use the procedure must be monitored via image guidance to ensure adequate tissue coverage and to avoid damage to adjacent structures In addition to im
91. r 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 the unit for storage NOTE The touch screen may need to be calibrated to obtain accurate responses from the touch screen commands reference Section 5 1 Three communication ports are located on the back panel of the monitor storage compartment Figure 3 The Ethernet port allows connection of the Visual ICE Cryoablation System to a Galil Medical remote server for uploading reports and diagnostic data and for downloading software updates and User Manual updates The USB 2 0 full speed port allows you to save reports to a Galil Medical USB flash drive for download to another computer or for printing The USB 2 0 low speed port is reserved for future system expansion 2 2 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 press the left button on the track pad 2 3 Storage Compartment The storage compartment may be used to store Visual ICE System accessories such as the pressure gauge assembly gas supply lines and tools Do not place very heavy obje
92. re connecting the gas lines to the system Continuously monitor the cryoablation procedure using image guidance such as direct visualization ultrasound or Computed Tomography CT to ensure adequate tissue coverage and to avoid damage to adjacent structures Galil Medical recommends using 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 effect to only the target ablation area the physician must determine the means to protect adjacent organs and structures Do not use cryoablation in combination with other therapies Results of combined therapies are unknown Do not set heavy objects on the monitor when in the down position or on the monitor storage basin when the monitor is in the up position The weight limit is 9 kg 20 lbs Portable and mobile radiofrequency RF communications equipment can affect the Visual ICE Cryoablation System causing it to operate improperly Keep such equipment away from the system reference Section 8 7 Use only Galil Medical supplied components and accessories with the Visual ICE System Use Galil Medical USB flash drive only to export reports or update softw
93. reen 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 and revisions to the user manual This function is only available to administrative and service users The Visual ICE 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 58 of 86 User Manual 6 SYSTEM CARE and MAINTENANCE 6 1 System Installation Installation instructions for the Visual ICE System are included in the shipping carton available online at www galilmedical com customerservice or by contacting your local Galil Medical representative 6 2 Cleaning 6 2 1 Cleaning the Visual ICE System Clean the Visual ICE Cryoablation System after each use by following the steps below 1 Clean the Touch Screen Monitor when the Visual ICE Cryoablation System is powered OFF e Wipe the screen gently with a damp gauze wipe e Use water or isopropyl alcohol only e Do not use any other cleaning agent such as Betadine or bleach solution 2 Clean the body of the Visual ICE Cryoablation System by wiping with a damp gauze wipe e Use soap and water or isopropyl alcohol only e Do not use any other cleaning agents such as Betadine or bleach solution e Do not allow water or other liq
94. rent channel and run the test again Connect a new cryoablation needle to any of the channels Perform the Needle Integrity and Functionality Test Continue the procedure with the newly tested needle Only some of the temperature Move the MTS needle to a different port sensor locations on the MTS needle are registered on the screen Replace the MTS needle MTS needle is connected but Move the MTS needle to a different port temperature is not registered on the screen During the Needle Integrity and WARNING Do not use the needle Functionality test Replace the MTS needle e Disconnect the needle from the Visual ICE System Bubbles are seen escaping from and segregate the needle the needle Or Contact Galil Medical Customer Service for further Ice does not form on the edge of instructions upon completion of the procedure the needle tip Use a different needle to continue the procedure Needle was bent or damaged WARNING Do not use the needle hil k lle attempting to Unpack or use Segregate the needle Use a different needle to continue the procedure Contact Galil Medical customer service for further instructions upon completion of the procedure Visual ICE Cryoablation System Page 69 of 86 7 7 Displayed Messages Reason for Appearance e LOGO LOGIN You have not entered the correct Login Name Reenter your Login Name Contact your System Administrator if assistance is required Contact Galil Medical
95. right hand corner of each section provides access to additional help information Press the question mark icon to access an explanation of the buttons and fields available in each section of the Procedure Screen Page 18 of 86 User Manual 3 1 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 5 The Channel labeled ALL operates all active channels simultaneously Table 2 Channel Controls Channel button Identifies the active channel s Advanced Channel Controls Pressing and holding the Channel button provides options to change the needle type selected for that channel link two adjacent channels together for simultaneous operation and program up to three freeze thaw cycles Channel labeled ALL Allows testing freezing and thawing on ALL active channels simultaneously Press the button for the desired function Test Freeze or Thaw on this channel to activate that function on all needles simultaneously Test button Begins the Needle Integrity and Functionality Testing that is required prior to using any cryoablation needle No other controls are enabled until needle testing is complete Freeze button Begins a Freeze phase at the selected freeze intensity Advanced Freeze Controls Pressing and holdi
96. romagnetic environment in which radiated RF disturbances are controlled The customer or the user of the Visual ICE System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Visual ICE System as recommended below according to the maximum output power of the communications equipment Separation distance according to frequency of transmitter m Rated maximum 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz output power of transmitter For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Page 84 of 86 User Manual 9 DISCLAIMER OF WARRANTY Although reasonable care has been used in the design and manufacture of this product Galil Medical has no control over conditions under which this product is used GALIL MEDICAL THEREFORE DISCLAIMS ALL WARRANTIES WHETHER EXPRESSED OR IMPLIED WRITTEN OR ORAL INCLUDING BUT
97. rotect the Visual ICE System from dust water and debris during storage and transportation 2 10 2 Optional Accessories Additional accessories are available from Galil Medical that may be used in the cryoablation procedure Refer to the Instructions for Use packaged with each accessory for more details The Prostate Procedure Template is used to guide needle placement during a prostate cryoablation procedure The Urethral Warming System is used to circulate warm saline solution through the Urethral Warmer Set during a prostate cryoablation procedure The single use disposable Urethral Warmer Set is the conduit that circulates warm saline through the urethra during a prostate cryoablation procedure Optional 3 m gas supply lines are available to connect the argon and helium cylinders to the Visual ICE System The 3 m gas supply lines replace the 8m gas supply lines if they are determined to be too long for typical system use The EZ Connect2 Dual Cylinder Adapter is an optional device used to connect two gas cylinders in tandem to the Visual ICE System The dual cylinder adapter consists of a four way adapter assembly with argon pressure gauge a 3 m auxiliary gas supply line with gas cylinder connection and an 8 m gas supply line with auxiliary gas supply connection Reference Section 4 1 2 for instructions on using the EZ Connect2 Adapter Page 14 of 86 User Manual 3 NAVIGATING THE USER INTERFACE Throughout the User Manual types
98. se Cycle Three as appropriate Program the additional cycle s by repeating step 4 for each additional cycle 6 Press the Go button to initiate the cryoablation procedure with the programmed cycles CAUTION Any interruption of a timed phase immediately terminates that phase and the programmed cycle 7 Repeat steps 1 to 6 to program additional channels 4 6 4 Advanced Temperature Sensor Controls 1 Press and hold the MTS button for a selected MTS to enter Advanced Temperature Sensor Settings The advanced controls window provides an option to set visual alarms to notify you when a chosen temperature measurement falls below a desired value or when the rate of temperature drop is greater than a desired value for a select sensor location on the MTS The option to name the MTS location is also provided Page 52 of 86 User Manual Screen 38 Advanced Temperature Sensor Controls Select the desired alarm type and desired sensor location using the drop down menus Press the lt button and adjust the temperature to define the desired alarm limit Press the Set button to set the alarm Ur om 2 IM OPTIONAL Select a name to be displayed above the MTS channel location using the Needle Name drop down menu The list of needle names provided is derived from the list available in the Configure Settings screen reference Section 5 1 and is associated with the selected organ map Visual ICE Cryoablation System Page 53 of 86 T
99. short interruptions and voltage variations on power supply input lines IEC 61000 4 1 1 Power frequency 50 60 Hz magnetic field IEC 61000 4 8 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 1 kV line s to line s 2 kV line s to earth lt 5 Ur gt 95 dip in Ur for 0 5 cycle 40 Ur 60 dip in Ur for 5 cycles 70 Ur 30 dip in Ur for 25 cycles lt 5 Ur gt 95 dip in Ur for 5 s 6 kV contact 8 kV air 2 kV for power supply lines 1 kV for input output lines 1 kV line s to line s 2 kV line s to earth gt 95 dip in Ur for 0 5 cycle 60 96 dip in Ur for 5 cycles 30 96 dip in Ur for 25 cycles gt 95 dip in Ur for5s Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment Mains power quality should be that of a typical commercial or hospital environment If the user of the Visual ICE System requires continued operation during power mains interruptions it is recommended that the Visual ICE System be powered from an uninterruptible power supply or a battery Power frequency magnetic fields should be at levels characteristic of
100. stem Page 17 of 86 3 1 1 Navigation Tool Bar 9 33 am Jak Kr Registration settings amp 3489 mm eg Procedures End SS 3200 psi 800 1800 psi 2500 Procedure Screen 4 Navigation Tool Bar The Navigation Tool Bar contains the Pressure Gauge Gas Indicator and procedure buttons that you can select to enter registration information configure procedure settings enter procedure notes view and export reports and end the procedure On occasion error messages may be displayed in lieu of the logo Pressure Gauge Gas Indicator Displays the working pressure of the argon and helium gases within the system NOTE The Visual ICE System contains internal regulators that regulate the gas pressure to appropriate working limits The pressure displayed on the Gas Indicator is the internal regulated pressure and not the cylinder gas pressure Pressing the Pressure Gauge toggles the pressure gauge to display the estimated amount of time remaining before the gas cylinders are 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 connected and as the freeze intensity is adjusted Pressing the Gas I
101. stem will be operated by members of the sterile team 1 3 3 Storage otore the Visual ICE System in a cool dry secure location Storage conditions should be within 15 C to 50 C and 10 to 90 relative humidity Page 2 of 86 User Manual 1 4 Indications The Visual ICE Cryoablation System is indicated for use as a cryosurgical tool in the fields of general surgery dermatology neurology including cryoanalgesia thoracic surgery ENT gynecology oncology proctology and urology This system is designed to destroy tissue including prostate and kidney tissue liver metastases tumors skin lesions and warts by the application of extremely cold temperatures The Visual ICE Cryoablation System has the following specific indications e Urology Ablation of prostate tissue in cases of prostate cancer and Benign Prostate Hyperplasia BPH e Oncology Ablation of cancerous or malignant tissue and benign tumors and palliative intervention e Dermatology Ablation or freezing 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 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 e Gynecology Ablation of malignant neoplasia or benign dysplasia of the femal
102. t channels for simultaneous operation e g 1 and 2 3 and 4 5 and 6 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 Enter custom names to label the two custom fields available for entering information in the Registration screen Use the drop down menu to enable or disable the option to upload registration data with the procedure reports By default registration data is not uploaded This function is only available to administrative or service personnel Clear the hospital name address and physician name from the system history file User Manual Setting Descipion The time zone can be changed by administrative or service Time Zone personnel The Visual ICE System automatically adjusts for Daylight Saving Time Pressure Units Select the units of pressure that the Gas Indicator displays Temperature Select the temperature units that the Temperature Sensors Units section displays and 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
103. ted on the rear of the system Upon completion close the Manual Vent Valve Gas begins leaking through a needle The channel may have a loose or broken socket port after gas flow was started using the Disconnect the needle and move the needle to a different Test Freeze or Thaw buttons channel Conduct the Needle Integrity and Functionality Test again on the needle Visual ICE Cryoablation System Page 67 of 86 7 4 Mechanical Issues Symptom Potential Causes Solutions Needle cannot be firmly connected Verify that the locking bar is in the UNLOCKED in the needle port position Needle connector may be defective Use a different needle Residual gas pressure may be in the needle port Use a different channel Locking bar on the Needle Verify that all needles in the channel are fully inserted Connection Panel cannot be in the needle connection ports positioned in the LOCKED position The Locking Bar may be defective Move the needle to a different channel Chassis does not move freely Release the brake to unlock the front wheels Check the individual rear wheel brakes and ensure the brakes are released 7 5 Gas Cylinders and Gas Supply Lines Safety cable is missing at either Do not use a gas supply line with a missing safety cable the cylinder side or the system Doing so could compromise the safety of personnel in the side of the gas supply line room Contact Galil Medical Customer Service A gas leak was
104. terile table prior to beginning the needle testing process Page 40 of 86 User Manual e Fill a large basin at least 30 cm in diameter halfway with sterile water or saline e Place the needles individually or in groups in the basin such that the full length of the needle shaft is submerged in the water or saline 6 Perform the Needle Integrity and Functionality Test on each needle by pressing the Test button on the channel containing the needle s The 90 second test automatically conducts a series of flush freeze and thaw phases The durations of these phases are 45 seconds flush with helium 15 seconds freeze with argon and 30 seconds thaw with helium NOTE When helium is not connected the 90 second test consists of 45 seconds low pressure argon flow 15 seconds freeze with high pressure argon and 30 seconds of low pressure argon flow NOTE If a previously tested needle is moved to a new channel at any time during a procedure the Needle Integrity and Functionality Test must be conducted again on that needle OPTIONAL Alternatively all needles may be tested simultaneously by pressing the Test button on the channel labeled ALL A message requests confirmation to test all needles If appropriate choose YES OPTIONAL f additional testing is required press the Test button again to repeat the test During testing carefully watch each needle for the following Flush Ensure no bubbles are formed along the needle shaft and
105. ting A dark grey channel button indicates a channel with needles connected If the needle contains a memory chip the Visual ICE 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 and gas flow to that channel is disabled iv Scale Scroll Screen 24 Needle Past Expiration Date If the needle does not contain a memory chip a menu appears Screen 25 Select the proper needle type from the drop down menu Test Needles Ma Perform Needle Integrity and Functionality Test on each needle before use Press Test button on a needle channel to initiate needle testing Observe and check each needle during testing No bubbles at the needle tip during flush phase ce begins to form around the tip during freeze phase Screen 25 Select Needle Type Menu 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 Press and hold the Channel button to open Advanced Channel Controls which allows you to change the needle type for a channel as needed 5 Prepare to conduct Needle Integrity and Functionality Testing CAUTION Take care to maintain sterility of each needle during testing Secure the needle tubing to the s
106. uid to drip or seep inside the cryoablation needle 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 stylus with a dry gauze wipe 6 3 Service and Preventive Maintenance Only trained and authorized service engineers are permitted to conduct service and system preventive maintenance on the system Preventive maintenance on the Visual ICE Cryoablation System will be performed annually CAUTION Do not attempt to service the Visual ICE Cryoablation System If service is required contact Galil Medical Customer Service The Visual ICE Cryoablation System will display a reminder on the screen approximately one month prior to when the preventive maintenance is due If the reminder message appears and the preventive maintenance has not yet been scheduled contact your Galil Medical authorized service representative to schedule the service NOTE When the reminder message begins to appear it is important to schedule preventive maintenance in order for the system to continue to operate Upon request by a Galil Medical qualified service engineer a schematic of the system and or components will be

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