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User Manual - Galil Medical

1. 5 1 PALIN 255i used iu acea bedient MD vie iade te bana EAS ua ida eben fe Edid 5 2 2 Turning On The Seednet System Unius uut aaa ate ile ese tio aeu E E 5 I 5 3 Seednet Needles Instalation eeseceetttetttetntte ettet 5 2 5 4 Connecting The Cable And Probe To The Machine 5 4 2 9 Functionality Test Of The Needles Or Probes eeeesseeeeeeeess 5 5 5 6 Temperature Sensors Installation essere 5 6 5 7 Operauns Procedi Srann a a ae 5 6 5 8 Shutdown Of The Seednet System Beato ee E A EIA RN 5 8 Chapter COMPUTER INTEREACE Sarei a 6 1 6 1 Une ee brace KDdd a auanpi socios anb 6 1 6 2 boot Up PrOPCCOUETO occid heresies ee hoe ati Sd dope Aretes dubeds 6 1 6 3 Prostate Proc CUT cs bete ieatac menu USEC a aCe ior aerate rE 6 5 6 4 Kidney PEOCe due so s ceDIepii Seu E D cone DE Cabe 6 14 6 5 Other PrOCGQUfe simis bets a tec udo a oiu co dirae etd 6 23 Galil Medical Proprietary Information 1V SeedNet User s Manual Table of Contents Continued Chapter7 SYSTEM MAINTENANCE eere 7 1 Grete ta i Ie Jn coiere dietro edo tinte oed 72 UCIT ZATION sci T 7 3 Replacing The Gas Cylinders 7 4 Supply And Refilling Of Gas Cylinders 7 5 SPP A ie n eT ERO oe STS ee eee teras 7 6 Periodic Service Preventive Maintenance Pm Chapter 8 URETHRAL WARMING SYSTE
2. If the machine does not detect a signal from a specific TS or TC during the operation due to failure disconnection or any other reason the machine will terminate the gas flow to the channel s related TS or TC and will mark the specific channel s CD button In addition a warning popup message will appear on the screen see figure 6 42 When using a probe the user should verify that it is well connected to the red cable before continuing Galil Medical Proprietary Information 6 29 SeedNet User s Manual Computer Interface The user is required to change the specific channel s CD mode to intensity 1n order to continue the procedure Warning No signal from control device Verify that the control device for channel 2 is properly connected Change the control mode to intensity before continue Figure 6 42 Change to intensity If the machine does not detect a signal from a specific TC while using H P Probes with intensity mode during the operation due to failure disconnection or any other reason a warning popup message will appear on the screen see figure 6 43 each time the OFF button is pressed The user should verify that the probe is well connected to the red cable before continuing It is up to the user to decide whether to continue the procedure with no TC temperature reading or to terminate the operation Warning No signal from thermocouple or thermosensor Verify that the therm
3. The software will not allow the marking of more than 5 needles per group A SeedNet needle may be removed by clicking on the needle location Insertion of Temperature Sensors Insertion of Temperature Sensors can be marked after selecting the TS on the Select menu The temperature of each TS is displayed in the circle of its location 6 3 8 Saving PATIENT log FILES Two log files are created for each cryosurgical procedure clinical and operational These files are named CL_XXX log and OP_XXX log respectively The XXX in each file name is a unique sequential serial number for the procedure The clinical CL log file stores the information from the Clinical Data Screen The operational OP log file saves the temperature and pressure data from the actual surgical procedure The following items are recorded the global time in seconds the temperature the operating modes F for freeze T for thaw and O for off for each needle the temperature of each external temperature sensor and the pressure of the freezing and thawing gases When exiting and turning off the system these log files are automatically saved to the hard disk The files are saved in a tab delimited format that facilitates convenient input into standard spreadsheet programs such as Excel and data analysis see review operation files guide attached to the user s manual Additionally the software gives the user the ability to save t
4. When the pressure drops below 2900psi 196bar 19 6MPa for Freezing and 1500psi 101 bar 10 1MPa for Thawing the pressure display blinks in red The three buttons on the right side of the screen enable the operator to move to the Show Template screen and to End Procedure In the lower part of the screen every probe group has its own row marked G1 through G5 and color coded according to the color of the group connector on the manifold front panel see figure 3 4 The display of these rows changes according to the control mode selected See below On the left side of every group s row a time field displays the time elapsed for the current operating mode Freeze or Thaw The time field gives the amount of time in minutes and seconds that the current operating mode has been operating Each change of the operating mode causes the timer to reset to zero The intensity of freezing for each group 1s displayed in colored bars along the row see paragraph 6 3 5 Each row includes the operation buttons Pressing the Freeze button will operate the system in the controlled mode defined The Thaw button is used to defreeze a group of needle tips in order to release the needles from the frozen tissue The Thaw operating mode has a default maximum operating time of 60 seconds after which the operating mode is switched to Off automatically For additional thaw time the Thaw button should be depressed again Pressing the Off button will st
5. Allow the machine to complete the test procedure before you remove the needles from the water bath Never operate needles or probes outside water or tissue When the test procedure is completed Freeze and Thaw buttons will appear as well as a green mark under the group number NOTE Functionality tests for groups 1 through 4 are available only once per surgical procedure If additional needles are required in one of these groups the functionality test of the additional needles can be performed on group 5 Group 5 can perform multiple functionality tests In order to activate the functionality test again the lock bar should be unlocked the needle connector inserted and the lock bar locked again At this time the functionality test may be performed NOTE For convenient insertion of 17 gauge needles it is recommended to hold the needles by their handles and manually support around the middle of the shaft A Warning Do not grasp the needle with auxiliary tools as doing so may cause damage to the shaft Bent needles should not be used If the shaft is damaged immediately remove the needle in complete from the patient 5 6 TEMPERATURE SENSORS INSTALLATION When Temperature Sensors are to be used for the current cryosurgical procedure they should be installed into their appropriate connectors on the front panel refer to Figure 3 4 The Temperature Sensor connector is built of two flat pins The connector has to be connected to th
6. Kidney Other H P 3450psi 234bar 23 4MPa 3450psi 234bar 23 4MPa A000psi 272bar 27 2MPa 2200psi 150bar 15 0MPa 2200psi 150bar 15 0MPa 4000psi 272bar 27 7MPa Table 3 1 Galil Medical Probes Working Pressure Regulated 50psi Prostate Kidney Other L P Kidney Other H P 3000psi 204bar 20 4MPa 3000psi 204bar 20 4MPa 3500psi 238bar 23 8MPa 1500psi 102bar 10 2MPa 1500psi 102bar 10 2MPa 2000psi 137bar 13 7MPa Table 3 2 Lowest Working Pressure Replace Cylinder 50psi Gas Supply Control Devices The control devices serve both internal and external gas supply options and consist of Pressure regulator gauges which indicate the remaining gas pressure in the source cylinders and the inlet working pressure to the machine Pressure discharge valves for discharging the pressure from the system The gas control and distribution assemblies which are not user serviceable are located inside the rack and should never be maintain by the customer MAXIMUM IMLET PRESSURE External Freezing Gas 4106 ps 10 ar IT MPa 1l External Thawing Gas Connector male a e Connector female anarak a Argon discharge Valve mscnanGe oscHamoe 2 La z Helium USB port Discharge Valve Se use zu Remote Control Unit Video Output connector 9 e connector LAN PRINTER R5232 LAN port 7 B am m RS 232 connector Flopp
7. SYSTEM 1 Verify that the system s electrical plug is not connected to the voltage outlet 2 Verify that the Freezing Gas Shutoff valve is turned to the ON position 3 Verify that the thawing gas and the freezing gas discharge valves are closed tightly 4 Take off the cover plugs from the machine Argon and Helium gas connectors Connect the external flexible hose for freezing gas between the external Argon gas cylinder and the external freezing gas connection on the SeedNet unit Connect the external flexible hose for thawing gas between the external Helium gas cylinder and the external thawing gas connection on the SeedNet unit Ensure that the safety cables at both ends of the flexible hoses are secured see figure 5 1 Open the cylinder valves Figure 5 1 Safety Cable Locking 5 Verify on the pressure regulators gauges that the available Freezing and Thawing gas pressure in the cylinders is at least 4300psi 297bar 29 7MPa Consult Galil Medical for the minimum required pressure as for your specific gas reservoir volume Galil Medical Proprietary Information 5 SeedNet User s Manual Operating Instructions A Warning Do not turn the handles of the gas cylinder valves to the fully opened position Ensure that all gas cylinder valves are opened before starting any cryosurgical procedure Check that the reading on the pressure gauges is more than the minimum recommended values 4300psi 297 bar 29 7MPa for fr
8. Stick in order to activate the probe in the Stick mode choose the specific probe TC P1 P2 etc as a control mode and adjust its target temperature to 20 C see figures 6 27 and 6 28 Thaw button is used to defreeze a group of needle tips in order to release the needles from the frozen tissue The Thaw operating mode has a default maximum operating time of 60 seconds after which the operating mode is switched to Off automatically For additional thaw time the Thaw button should be depressed again Off button stops the gas flow to the specific port The operator can stop the operation of all probes simultaneously by pressing the red STOP ALL button see figure 6 26 The upper left side of the screen serves for displaying the temperature history chart of external Temperature Sensors TS or the probe built in thermocouple TC To switch between the charts press the Gray button next to the chart Each TS or TC is marked in a different color and its current temperature is displayed digitally in degrees Centigrade to the right of its number The temperature history chart is for the last 60 minutes and is subdivided to 10 minutes Up to 5 TS can be connected at one time to the machine When a probe with a defective thermocouple TC is connected to the system a warning of the missing TC identification appears in the relevant probe s port In this case no temperature information is available for the probe see figure 6 27 It is po
9. The SeedNet machine is housed in a rack assembly mounted on four caster wheels for ease of transport The front wheels can be locked so that the unit will remain stable and not move during the procedure Power Control Panel Located on front of the rack The Power Control Panel includes the Key Switch the Power On indicator and the Emergency Stop button see figure 3 2 Key Switch Emergency Stop Button Power on Indicator Figure 3 2 The Power Control Panel The Key Switch turns the system on and off In order to start the SeedNet System the key must be turned clockwise to the Start position There is an automatic spring that returns the key to the ON position vertical To shutdown the system after properly exiting the system turn the key counterclockwise to the OFF position horizontal If electricity has been cut off blackout etc the system will restart only if the key switch is turned to the Galil Medical Proprietary Information 3 2 SeedNet User s Manual System Description start position again The system can be operated ONLY with the key provided by Galil Medical An extra key is included with the spare parts The Power on Indicator is a green light located on the operator control panel The indicator lights up when the SeedNet System is turned on and remains on until the power is turned off The Emergency Stop Button is a red mushroom like switch designed for emergency shutdown of the unit Pressing
10. been finished Pressing the END PROCEDURE button in the Operation Screen will open a popup window with 3 icons see figure 6 19 Pressing Clinical will enter the user into the Clinical Screen again see figure 6 13 In this screen it is possible to fill in the required clinical data After filling in the data there are two options either to exit the current procedure and to turn off the machine see paragraph 6 3 9 or to start a new Prostate procedure P METASTASIS Hide Glinical Data Prostate d929 0907 PCS PFHTOGGGUIG 4 EXIT Figure 6 12 Clinical Data Screen before entering operation screen Galil Medical Proprietary Information 6 6 SeedNet User s Manual Computer Interface E S 1 JALIL MEDICAL 2 SIOUDE BOERS Prostate Patient ID poB 4 mon YEAR Bone Scan Results Posmive Negare PSA if 0 0 eq T 4 10 T 10 20 FT x20 ng ml Combined Gleason Score EH IE Ex Did the patient underge prior treatment for prostate cancer r NO M Brachy TURP External Ream T Antiandrogen therapy Other Prostate Size 0 0 or H 4 0 0 w 4 0 0 L 4 0 9 cm StarttaNew A Procgdurg TNM IUmo nones METASTASIS Did the patient present any of the following symptoms 1 Impotence NO DES 2 Incontinence NO TotalGross T Moderate T Mild BAIT Figure 6 13 Clinical Data Screen accessed from the operation screen There are two ways to fill in the data by
11. gt GALILMEDICAL SACO sexe Soph User Manual GALILMEDICAL bet User Manual NOTICE OF CONFIDENTIALITY The information contained in this document is confidential to assigned recipient and is intended for use of the addressee only Unauthorized use disclosure or copying is strictly prohibited and may be unlawful If you have received this document in error please notify Galil Medical Inc immediately January 2005 C C 0473 Rev B DOCO000110 SeedNet Users Please read this document carefully before using the SeedNet System For assistance contact USA Galil Medical Inc 401 Plymouth Road Suite 130 Plymouth Meeting PA 19462 Telephone 1 877 639 2796 Fax 1 877 510 7757 Europe Galil Medical UK Ltd The Office Building Suite 21 Gatwick Road Manor Royal Crawley West Sussex RH10 9RZ United Kingdom Telephone 44 0 1 293 459848 Fax 44 0 1 293 459840 Israel Galil Medical Israel Ltd PO Box 224 Yokneam 20692 Israel Telephone 972 4 9591080 Fax 972 4 9591077 www galilmedical com Manufactured by Galil Medical Ltd Yokneam Gate 1 Tavor Bldg Yokneam 200692 Israel Tel 972 4 9591080 Fax 972 4 9591077 SeedNet User s Manual Table of Contents Table of Contents Chugpter o SAF EEI icteric oy nae vee tele inp nner rea veterinary ee tee ie Prin yes dea obesidad ume 1 1 1 1 UR UU 1 1 1 2 Definitions of Warnings and Cautions eese 1 2 1 3 PrOD r D
12. is displayed on the computer monitor The computer workstation 1s fully integrated into the SeedNet System The monitor is placed on the rack top rotating boom together with the Keyboard and the Track pad see figure 3 1 while the microprocessor and A D board are located inside the rack housing A 37 floppy disk drive installed at the rear of the machine can be used to back up important information that 1s stored as log files created for each procedure see figure 3 3 Further information about operating the computer and available user screens is given in chapter 6 Gas Supply System The SeedNet System is operated by using high pressured Argon and Helium gases supplied from an external gas source External gas supply system An external source larger gas cylinders see paragraph 10 2 of Argon and Helium gases is to be connected to the system Two special flexible hoses and two pressure regulators both provided by Galil Medical connect between the gas cylinders and two quick connectors located on the back panel of the system see figure 3 3 The Argon and Helium gas cylinders should be filled up to 6000 psi 408 bar 40 8MPa See gas specifications in chapter 11 Galil Medical Proprietary Information 3 3 SeedNet User s Manual System Description The pressure regulators reduce the inlet pressure from the cylinders to the machine working pressure according the following tables Prostate Kidney Other L P
13. 19462 Telephone 1 877 639 2796 Fax 1 877 510 7757 Galil Medical UK Ltd The Office Building Suite 21 Gatwick Road Manor Royal Crawley West Sussex RH10 9RZ United Kingdom Telephone 44 0 1 293 459848 Fax 44 0 1 293 459840 Galil Medical Israel Ltd PO Box 224 Yokneam 20692 Israel Telephone 972 4 9591080 Fax 972 4 9591077 Manufactured by Galil Medical Ltd Yokneam Gate 1 Tavor Bldg Yokneam 20692 Israel Tel 972 4 9591080 Fax 972 4 9591077 mme A T A mnnnncen U4 5 1 11 SeedNet User s Manual Indications for Use Chapter 2 Indications for Use 2 1 INDICATIONS FOR USE The SeedNet System is intended for cryogenic destruction of tissue during surgical procedures It 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 The system is designed to destroy tissue by the application of extreme cold temperatures including prostate and kidney tissue liver metastases tumors skin lesions and warts The SeedNet System has the following specific indications Urology ablation of prostate tissue in cases of prostate cancer and Benign Prostate Hyperplasia BPH Oncology ablation of cancerous or malignant tissue and benign tumors and palliative intervention Dermatology ablation or freezing of skin cancers and other cutaneous d
14. 8 Urethral Warming System 8 1 GENERAL The Urethral Warming System provides steady circulation of warm saline solution through a warming catheter to transfer heat to the urethral tissue and maintain it at constant near body temperatures while the surrounding prostate tissue is being frozen during a cryosurgical procedure A plastic fluid cassette is inserted between the microprocessor controlled heat plates located within the warmer device Pre adjusted target temperature set to 43 C 1s displayed on the LCD screen requiring the user only to turn the device ON The Warmer Tubing connects all the components of the Urethral Warming System and allows the Peristaltic Roller Pump to circulate the warm saline solution through the system in a closed loop A Warning ONLY authorized Galil Medical personnel should perform the initial setup of the Urethral Warming System Warming Catheter IV Bag Flow Indicator Peristaltic Roller Fluid Warmer Device Pump Isolation Transformer Figure 8 1 Urethral Warming System Galil Medical Proprietary Information 8 1 SeedNet User s Manual Urethral Warming System 8 2 URETHRAL WARMING SYSTEM DESCRIPTION The Urethral Warming System see figure 8 1 is an accessory to the SeedNet cryosurgical system and consists of the following parts Fluid Warmer Device Peristaltic Roller Pump Warmer Tube No 3 Warming catheter and warmer tubes No 1 and 2 as one assembly Warmer Ca
15. Barcode scanner in order to scan Galil Medical products labels and simplify the process of entering the barcode numbers to the system see Chap 9 Galil Medical Proprietary Information 3 6 SeedNet User s Manual Installation and Setup Chapter 4 Installation and Setup 4 1 SPACE AND POSITIONING REQUIREMENTS The user should allocate space with adequate ventilation and free airflow The working area for the unit should be prepared according to the dimensions given in the system specifications In order to guarantee proper ventilation always keep the sides of the unit at least 0 5 meters 20 inches from walls or other obstructions to airflow Caution After positioning the unit lock the front wheel brakes 4 2 ELECTRICAL REQUIREMENTS The SeedNet System is factory pre wired for the local line voltage as ordered by the customer Accordingly the unit will require a line supply of 100 120 VAC 15 A 60 Hz single phase or 230 VAC 10 A 50 Hz single phase The unit is grounded through the power cable plugged into the wall power outlet Good grounding is essential for safe operation An extra external grounding port is located at the rear of the machine under the cable s reel The main fuses for the unit are T 6 3 A 250 V Slow Blow both for 100 120 VAC and for 230 VAC line supplies The fuses location is in the power supply unit located inside the rack under the computer Fuses should only be replaced by trained Gali
16. GALILMEDICAL SeedNet Disposable Accessories CAUTION 1 For use only with the SeedNet system 2 Sterility is assured only when the package is not damaged or opened 3 Do not use if the package is damaged or opened 4 Rx only Refer to SeedNet system User Manual for detailed instructions STERILE Galil Medical Inc 401 Plymouth Road Suite 130 Plymouth Meeting PA 19462 Telephone 1 877 639 2796 Fax 1 877 510 7757 Europe Galil Medical UK Ltd The Office Building Suite 21 Gatwick Road Manor Royal Crawley West Sussex RH10 9RZ United Kingdom Telephone 44 0 1 293 459848 Fax 44 0 1 293 459840 Israel Galil Medical Israel Ltd PO Box 224 Yokneam 20692 Israel Telephone 972 4 9591080 Fax 972 4 9591077 www galilmedical com Manufactured by Galil Medical Ltd Yokneam Gate Tavor Bldg Yokneam 206972 Israel Tel 972 4 9591080 Fax 972 4 9591077 Galil Medical Proprietary Information 1 10 Label 21 Disposable Probe Label for reference only Disposable Probe S9 GALILMEDICAL Galil Medical Proprietary Information CAUTION For use only with the CryoHit SeedNet system Sterility is assured only when the package is not damaged or opened Do not use if the package is damaged or open Rx only G Refer to CryoHit SeedNet system User Manual for detailed instructions Europe Israel Galil Medical Inc 401 Plymouth Road Suite 130 Plymouth Meeting PA
17. Kd R 44 51 26 Blister SIN END PROCEDURE Figure 6 16 Template Layout Display 6 3 3 FUNCTIONALITY TEST When a group of needles is connected to one of the manifold s columns and the locking bar is moved to the GREEN position the TEST button of this group is enabled see figure 6 17 The functionality test is performed by inserting all SeedNet needles tips of the same group at least 3 cm into sterile saline and pressing the TEST button The functionality test procedure will be performed by the system for 50 seconds see paragraph 5 5 and a counting clock will appear on the left side of the row see figure 6 17 Galil Medical Proprietary Information 6 9 SeedNet User s Manual Computer Interface At the end of the functionality test Freeze and Thaw buttons will appear together with a default setting of the Intensity Control mode of 100 Freezing intensity see figure 6 18 NOTE Functionality tests for groups 1 through 4 are available only once per surgical procedure If additional needles are required in one of these groups the functionality test of the additional needles can be performed on group 5 Group 5 can perform multiple functionality tests In order to activate the functionality test again the lock bar should be unlocked the needle connector inserted and the lock bar locked again At this time the functionality test should be performed Freezing 3322 psi 2264 psi GALIL MEDICAL Prostate
18. NEEDLES 6 4 2 2 Operation Screen when using PROBES High Press H P The basic structure of the screen 1s similar to the one used for needles The current Freezing and Thawing pressures are displayed in the upper row of the screen When the pressure drops below 2900psi 196bar 19 6MPa for Freezing and 1500psi 1O1bar 10 1MPa for Thawing the pressure display blinks in red In the lower part of the screen every probe port able to host only a single probe has its own row marked P1 through P5 and color coded according to the color of the port connector on the manifold front panel see figure 3 4 The display of these rows changes according to the control mode selected see below Note In order to activate the ports it 1s required to type or scan one blister number per port Galil Medical Proprietary Information 6 17 SeedNet User s Manual Computer Interface On the left side of every group s row a time field displays the time elapsed for the current operating mode Freeze or Thaw The time field gives the amount of time in minutes and seconds that the current operating mode has been operating Each change of the operating mode causes the timer to reset to zero The intensity of freezing for each group 1s displayed in colored bars along the row see paragraph 6 4 5 Each port includes the following operation modes Test Button see paragraph 6 4 3 Freeze button operates the system in the controlled mode defined
19. Range Minimum of Galil Needles Maximum Operating Temperatures 10 C to 30 C 50 F to 86 F Environmental Storage Temperatures 35 C to 85 C 31 F to 185 F Conditions Up to 80 operating Relative Humidity Up to 90 storage 11 2 GAS SPECIFICATIONS 1 Gas Purity a Gas purity specifications for Argon and Helium are as follows Argon gas purity level shall be 99 998 or higher Helium gas purity level shall be 99 995 or higher b The following table represents the maximum content of impurities allowed Water FLO mm Carbon Dioxide CO 10ppmv Excluding CH3 As Methane As Methane Solid particles Less than Sum Alternatively a Sum nominal filter may be installed at the gas supply outlet Galil Medical Proprietary Information 11 1 SeedNet User s Manual System Specifications 2 Exterior Gas Cylinder The SeedNet machine gas supply is from exterior gas cylinders a Exterior gas cylinder specifications Maximum pressure for refilling is either 310 bar 4500psi or 413 bar 6000psi Recommended Cylinder volume 42 50 Liters of water b Adapter for the gas cylinder valve supplied by the gas company Two 2 adapters one for Argon line and one for Helium line with 4 NPT male outlet c External pressure regulators are mounted onto the cylinders one for Argon line and one for Helium line in order to reduce the supplied pressure from the cylinders pressure to the machine wor
20. SER dus enter E ene CMM DoD Ui teeta E 1 2 1 4 Explosion and Eire Haz dt soraira n telnet deinen anton 1 3 125 Gras C y imdetateby aise acest ep M pata Mob MIN edi e Mb e ed ME 1 3 1 6 Burm Frase secant eeu ies ees eae eo MCCC NE AIR een 1 4 1 7 COUN GIS m 1 4 1 8 Compliance With International Standards ccccccccssssssseeeceeceeeeeeeeeeeeees 1 4 1 9 Equipment ClassiliCatiOn us oda eo essen e UE wudoensataacelemonisanavaueelwundennaeeees 1 4 1 10 Accompanying Labels uoce trien raria Peu s se derer esa tag eediness 1 5 Chapter2 INDICATIONS EOR USE eicciexantate hte eulos tei voe meals Ren u eh aai es uoo ds 2 2 1 IndiCcattoDs For Se iue seite eens oetectecceeaee anced edes aug ecto Mcd 2 2 WHOIS A Oualted USeE adus tas ae A UR oh Obra hn 2 2 2 93 CHIC AMIDE Te SIC PCT TE S 2 2 Chapters SYSLDENLDESCRIPLEIGON 5 e diitusdktle an Ou tot astu entia eati ouest 3 3 1 Concept OFOP TINON seiten c eter arene tuu bod om parcum tuo teneas Gb Ded aene 3 Chapter 4 INSTALLATION AND SETUP aiite bate oit et hut eeu PulT este butt ob uliss 4 4 Space And Positioning Requirements eese 4 4 2 I lectricab Regue meni Sisua Paene aset rudes dmu dores Lose eo set n vale 4 4 3 Shipment C OPmpobelits susc tdm Duci tud de si Ort a S uertice 4 4 4 InstalTatlOf es soos tton rete pg E UNO due e upsctM Ud E M REIN 4 Chapter 5 OPERATING INSTRUCTIONS ce enne eene eene eene eene eene eee nn 5
21. after which the operating mode automatically switches to OFF Sixty seconds should be a sufficient time to release the needle or probe from the tissue without warming up the bulk of the frozen tissue If more time is needed to help remove the needle or probe the Thaw operating mode should be selected again The OFF operating mode can then be chosen when sufficient thawing has been performed or the computer will automatically switch to OFF again after 60 seconds A Warning The release of the needle from the target tissue should ALWAYS be based on clinical judgment 5 8 SHUTDOWN OF THE SEEDNET SYSTEM 1 Make sure ALL needle or probe columns are in the OFF operating mode 2 Make sure all needles probes and Temperature Sensors are removed from the treated tissue 3 Close the external gas cylinder valves Caution Do not close the valves too tightly this may lead to premature valve failure Verify that the Freezing gas shutoff valve see figure 5 2 is in the ON position before performing step 4 4 Release the remaining gas in the system by opening the freezing and thawing gas discharge valves After all gas has been released tightly close both discharge valves Verify that no pressure is displayed on the screen or on the gauges for both gases Disconnect the gas supply tubing from the machine and plug the special cover plugs into the machine Helium and Argon connectors 5 Click on the END PROCEDURE button us
22. diagram of the SeedNet DVSIGTII pei E een nau teense 11 2 Galil Medical Proprietary Information vil SeedNet User s Manual List of Warnings and Cautions List of Warnings and Cautions Chapter 1 Safety Caution The SeedNet is a sophisticated cryo ablation system for intra body operations Any procedures performed using this system must be done by validly licensed and board certified surgeons who are trained and experienced in the use of this system Do not use this system if you have not been adequately trained in its use Also do not use this system until you have read the User s Manual in its entirety and fully understand its contents While every effort has been made to make this User s Manual comprehensible certain sections may be unclear or difficult to understand depending on the user s background and experience Do not use this system if there is any instruction direction precaution or note which you do not understand or which is unclear Contact an authorized Galil Medical representative for further information and clarification before proceeding to use the system The supplier and manufacturer of this system do not claim that it will be useful for assisting in the treatment of any particular condition or set of circumstances The surgeon using the system is fully responsible for assessing each situation based on his own experience and on the patient s condition While experience has shown that the system is use
23. dialog box will appear A When pressing the Exit button in any screen or when starting New Procedure in Clinical screen B When pressing End Procedure in the Operation screen Galil Medical Proprietary Information 6 30 SeedNet User s Manual Computer Interface Note If more than one procedure was performed in a row it is possible to save all procedures to a floppy diskette at the same time upon the final exit from the system see figure 6 41 To Backup Log File OF Procedura 78 Please Insert a diskette in Drive ai Figure 6 44 After pressing Exit or Start New Procedure Cu ila Exi To Backup Log Files Store Current Procedure Log File amp Exit E E AOE To Procedure 77 Return to Current Procedure wl Please Insert a diskelte in Drive a End Current Procedure Or Starta New Procedure Glinical Via Clinical Screen Figure 6 45 End Procedure Figure 6 46 Final Exit Galil Medical Proprietary Information 6 31 SeedNet User s Manual System Maintenance Chapter 7 System Maintenance This chapter describes routine maintenance procedures of the Galil Medical SeedNet System to be performed by the user A troubleshooting guide containing the most common system problems and their solutions is listed in Chapter 9 The procedures in this chapter and those listed in the troubleshooting chapter should be the only maintenance activities performed by the user All other service procedures are to be per
24. front panel see figure 3 4 1s divided into five columns numbered and marked with a colored border Each column is activated as a single group All SeedNet needles or probes connected to a particular group column operate together under the same mode 1 e Freeze Thaw or Off Figure 3 4 The Manifold Front Panel model dependent The top port of each group is equipped with special one way relief plug which is designed to prevent moisture from entering the gas lines during machine storage A locking bar is used to lock the needle connectors to the ports in every column The bar is marked red in the Unlocked position and green in the Locked position After connecting the needles to the manifold panel move all the locking bars to the Locked position green Galil Medical Proprietary Information 3 5 SeedNet User s Manual System Description When using the manifold up to 5 Temperature Sensors TS may be connected to their ports machine model dependent to be used as the control device for the SeedNet groups Accessories See Chapter 9 for more details SeedNet Needles and Probes The SeedNet needles and probes convert high pressure freezing gas to very cold low pressure liquid by using the Linde Hampson Joule Thomson phenomenon High pressure thawing gas is converted to hotter low pressure gas within the SeedNet needle as well The SeedNet needle is needle type with diameter of 1 5 mm 17 Gauge Flexi
25. messages indicate procedures or practices which if not observed could result in personal injury Do not proceed beyond a WARNING message until the conditions are fully understood and met Cautions Caution messages indicate procedures which if not observed could result in loss of data or damage to equipment Do not proceed beyond a CAUTION message until the indicated conditions are fully understood and met List of warnings and cautions is detailed on pages ix xiv 1 3 PROPER USE A Warning Do not use the workstation or the gas cylinders for any purpose other than running the SeedNet System The workstation supplied with the SeedNet System is intended to serve as a dedicated workstation for the SeedNet System and should not be used for any other purpose The gas cylinders used with the SeedNet System are intended to serve as dedicated gas cylinders for the SeedNet System and should not be used for any other purpose A Warning Always turn off the SeedNet System and remove the key when not in use Never allow untrained personnel to operate the SeedNet System A Warning Before starting any cryosurgical procedure sufficient freezing and thawing gas in the external cylinders must be available to the system See page 3 5 Gas Supply System for further details Galil Medical Proprietary Information 1 2 SeedNet User s Manual Safety 1 4 EXPLOSION AND FIRE HAZARD The SeedNet System includes electr
26. see figure 6 30 Pressing Clinical will enter the user into the Clinical Screen again In this screen it is possible to fill in the required clinical data After filling in the data there are two options either to exit the current procedure and to turn off the machine see paragraph 6 4 7 or to start a new procedure me CALIL MEDICAL Kidney Figure 6 25 Kidney Clinical Screen Before entering Operation Screen There are two ways to fill in the data by using the Track pad or the keyboard The following table explains the two options Moving from field to field Move the curser by sliding the Use the TAB key finger on the Track pad surface and clicking with the left button Typing Alphanumeric Use the Keyboard Use the Keyboard data Galil Medical Proprietary Information 6 15 SeedNet User s Manual Computer Interface Changing data in List box Click the small arrows on the left Up Down keyboard side of the box with the Track arrows pad left button Changing Check box Click inside the box with the Click the ENTER Track pad left button key 6 4 2 OPERATION SCREEN The Operation Screen is used to control the cryosurgical procedure and to display the procedure data Two kinds of Operation Screens for the use of either probes or needles can be used in the Kidney procedure see figures 6 26 and Figure 6 27 Upon entering the Operation Screen from the Main Menu screen a popup window will appear
27. the urethra prior to cryosurgery and is removed after the procedure This disposable unit is provided sterile for single use only and comes with a protective sheath It is made of a double balloon initially of 16 French in size When flow of warm water saline fills the catheter 1t reaches about 22 French in diameter The catheter is part of the closed circuit warming system The catheter includes inlet and outlet ports for continuous flow of warm water saline throughout the procedure The inlet port 1s connected through tubing to the out line of the pump and the exit port is connected to the cassette warmer and from there back to the IV bag thus forming a closed loop The warming catheter is part of the SeedNet Disposable kit which is supplied by Galil Medical Warmer Tubing Disposable tubing fluid is in use This disposable set includes three tubing units ratchet clamps and luer connectors refer to Figure 8 2 It also includes a plastic warmer cassette to be inserted into the warmer device in order to warm the saline solution The Warmer Tubing is part of the SeedNet Disposable kit which is supplied by Galil Medical Galil Medical Proprietary Information 8 2 SeedNet User s Manual Urethral Warming System IV bag Blue guide rail Ratchet Female luer connector Male luer connector Tube 3 3 92 cm Tube 2 9 5 290 cm Tube 1
28. this button immediately shuts off electrical power to the entire SeedNet System The emergency stop takes precedence over the key switch To release the emergency stop switch turn the red knob clockwise in the direction of the arrows To restart the SeedNet System the key switch must be turned to the start position Note that the emergency stop button does NOT turn off the gas supply to the system Only in an extreme event clogged valve or when the emergency stop button does not stop the flow of the gas the freezing gas shutoff valve located above the built in manifold should be used to shut off the Argon flow to the probes see figure 3 4 Caution Depress the emergency stop button only in cases of emergency It is recommended to exit the SeedNet System and software by the procedure given in section 5 7 Excessive use of the emergency stop button may cause damage to the computer workstation The Keyboard and the Track pad are used for the operation and controlling of the system by inputting data selecting needles selecting modes of operation etc Computer Assembly The computer interface 1s a mean of controlling the SeedNet needles and monitoring the performance of the system The computer allows for individual control of the gas supply to each SeedNet needles eroup in order to achieve the required user specified temperatures The temperature of each temperature sensor as well as the operating mode of each SeedNet needles group
29. use in presence of a flammable anesthetic mixture with air or nitrous oxide e Mode of operation Continuous Galil Medical Proprietary Information 1 4 SeedNet User s Manual Safety 1 10 ACCOMPANYING LABELS Figure 1 1 on Page 1 6 shows the labels affixed to the SeedNet System Figure 1 2 on page 1 7 illustrates their locations on the unit Label 19 1s located on the back cover of the needles blister shown on page 1 8 Label 20 1s located on the back cover of the probe blister shown on page 1 9 Labels description Label 1 Specifies the maximum inlet pressure from an external gas supply source Label 2 Argon IN port Label3 Helium IN port Label 4 Argon pressure discharge valve Label5 Helium pressure discharge valve Label6 CSA Label Label 7 Main Freezing shutoff valve label located above the SeedNet manifold Label 8 Identification label It states the manufacturer s name and address date of manufacturing model serial number and the electrical specifications of the unit Label9 Warnings regarding gas cylinders handling Label 10 US federal law restricts this device to sale by or on order of a physician label Label 11 Fuse type and rating of the unit label located on the power supply Label 12 Hospital Grade label Label 13 Video Output label Label 14 Printer label Label 15 Remote Control label Label 16 USB port label Label 17 LAN port label L
30. using the Track pad or the keyboard The following table explains the two options Moving from field to Move the curser by sliding the finger Use the TAB key field on the Track pad surface and click with the left button Typing Alphanumeric Use the Keyboard Use the Keyboard data Changing data in List Click the small arrows on the left Up Down keyboard box side of the box with the Track pad arrows left button Changing Check box Click inside the box with the Track Click the ENTER pad left button key 6 3 2 OPERATION SCREEN The Operation Screen is the screen that is used to control the cryosurgical procedure and to display the procedure data Upon entering the Operation screen from the Main Menu screen a popup window will appear see figure 6 14 as a reminder to use a new SeedNet disposable kit There are two options for the Operation Screen e The Operation Screen is shown in Figure 6 15 e The Template Layout Display Screen is shown in Figure 6 16 Select the displays by pressing the Show Template Show Procedure Data button Galil Medical Proprietary Information 6 7 SeedNet User s Manual Computer Interface With each new procedure use a new SeedNet disposable kit containing sterile SeedNet disposable products Figure 6 14 New Disposable Kit Message Mutual fields The following fields appear in both options The current Freezing and Thawing pressures are displayed in the upper row of the screen
31. 12 5 381 cm Urethral catheter Figure 8 2 Tubing Connection Diagram Galil Medical Proprietary Information 8 3 SeedNet User s Manual Urethral Warming System 8 3 WARMING SYSTEM TUBING ASSEMBLY INSTRUCTIONS The operation of the warming device is very simple The following instructions are for reference only Always refer to the data sheet supplied together with the SeedNet disposable kit Caution The location of all components including the pump warmer device and isolation transformer should not be changed from the initial setting They should never be removed from the IV pole Hang the IV bag onto the ram hook of the IV pole 2 Inject half ampoule of indigo carmine or if not available methylene blue into the saline solution of the IV bag 3 Disconnect tubing including the drip chamber from the warmer cassette and discard 4 Insert warmer cassette into the fluid warmer device Model Depended FW 600 603 FW 400 403 5 Attach the male luer connector of Tube 2 catheter to cassette to the female luer connector of the warmer cassette 6 Attach the female luer connector of Tube 3 cassette to bag to the male luer connector of the warmer cassette r m ES gt E 7 Feed tube 1 relevant section the one between the green labels through the pump head Note that the tubing from the IV bag should enter the pump head from the right side fluid flow direction is f
32. 16 02 12 Blister S N Figure 6 17 Operation Screen during Functionality Test 6 3 4 CHOOSING CONTROL MODE There are two Prostate operation control modes that can be set by the operator e Intensity Control mode see paragraph 6 3 5 e Temperature Control mode see paragraph 6 4 6 In order to change to the Temperature Control mode press the arrow on the button see figure 6 18 and select the External Temperature Sensor chosen as the control device for the group see paragraph 6 3 5 6 3 5 INTENSITY CONTROL MODE The basic concept behind the Intensity Control mode is to enable the operator to control the intensity of the cryosurgical freezing by setting the percentage of the freezing in a cycle of 10 seconds The sign in the group row see figure 6 18 indicates that the system is in the Intensity Control mode The percentage of the freezing intensity is displayed to the left of the Freeze button It can be changed in 20 steps by using the arrows or typing Pressing the Freeze button will operate the system with the defined intensity The colored bar chart is built of 1 minute bars corresponding to the time scale in the graph area above it according the following colors e Green for TEST mode Galil Medical Proprietary Information 6 10 SeedNet User s Manual Computer Interface e Blue for Freeze The intensity of the freezing 1s represented by the darkness of the blue color From dark blue for 100 t
33. E DISCONNECTING ANY GAS CYLINDER i A NEVER LEAVE ANY GAS CYLINDER CONNECTOR UNSECURED Machine Model FPRCH2013A through B and FPRCH2016A through B Galil Medical Proprietary Information 1 7 SeedNet User s Manual C2 OOOOQ CAUTION CAUTION US FEDERAL LAWRESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDEROFA FHYSICIAN GROUNDING RELIABILITY CAN ONLY BE ACHIEVED WHEN THE EQUIPMENT IS CONNECTED TO AN EQUIVALENT RECEPTACLE MARKE D HOSPITAL ONLY OR HOSPITAL GRADE ARGON IN ARGON DISCHARGE VIDEO VALVE OUTPUT PR Q INTER P O Box 224 Yokneam 20692 ISRAEL SeedNet e A oe Mfg Date Li MAXIMUM INLET PRESSURE 4500 psi 310 bar 31 MPa Use only Galil Medical certified gas supplier HELIUM IN HELIUM DISCHARGE VALVE O REMOT CONTROL e NO 1172463 Model Part No SeiaNo AC Rating V 4 E 50 60 Hz gero NS CC T READ MANUAL BEFORE ANY OPERATION WITH GAS CYLINDERS DISCONNECT THE SYSTEM FROM ELECTRICAL SUPPLY BEFORE ANY GAS CYLINDER HANDLING ALWAYS RELIEVE SYSTEM PRESSURE BEFORE WA RNING DISCONNECTIG ANY GAS CYLINDER NEVER LEAVE ANY GAS CYLINDER CONNECTOR UNSECURED Machine Model FPRCH2024A through I Galil Medical Proprietary Information Safety 1 8 SeedNet User s Manual Safety CAUTION US FEDERA
34. In case of a malfunction if the Freeze operation continues after switching from the Freeze operating mode to the OFF operating mode turn the freezing gas shutoff valve on the front panel to the OFF position This will stop all freezing gas flow and after natural thawing the probe may be removed from the patient A Warning Turn the freezing gas shutoff valve to the OFF position 1f the freezing operation continues after switching to the OFF operating mode Allow for natural thawing of the needle before removing it from the patient Thawing Procedure The purpose of the Thaw operating mode is to release the needles from the target tissue after the cryosurgical procedure is complete During the procedure the needle is situated in Galil Medical Proprietary Information 5 7 SeedNet User s Manual Operating Instructions frozen tissue and is locked in place In order to remove it the needle surface must be heated above the melting point of the frozen tissue The surrounding tissue melts partially and allows for free movement of the needle which can then be pulled out of the tissue To perform the thawing procedure the surgeon should verify that all tissue which needed to be frozen has been frozen When ready to proceed the surgeon should choose the Thaw operating mode by clicking on the Thaw icon of the appropriately numbered group on the computer monitor using the Track pad The Thaw mode will be active for 60 seconds
35. L LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A FHYSICIAN GROUNDING RELIABILITY CAN ONLY BE ACHIEVED WHEN THE EQUIPMENT IS CONNECTED TO AN EQUIVALENT RECEPTACLE MARKED HOSPITAL ONLY OR HOSPITAL GRADE MAXIMUM INLET PRESSURE 4500 psi 310 bar 31 MPa Use only Galil Medical certified gas supplier ARGON IN HELIUM GO HELIUM ARGON DISCHARGE DISCHARGE VALVE VALVE VIDEO REMOTE Omi OUTPUT USB CONTRO d E LAN PRINTER O A irt WARNING ff READ MANUAL BEFORE ANY OPERATION WITH GAS CYLINDERS DISCONNECT THE SYSTEM FROM ELECTRICAL SUPPLY i BEFORE ANY GAS CYLINDER HANDLING W ALWAYS RELIEVE SYSTEM PRESSURE BEFORE DISCONNECTIG ANY GAS CYLINDER AN NEVER LEAVE ANY GAS CYLINDER CONNECTOR UNSECURED S J lt p Manufactured by Galil Medical Ltd B3 PA S GALILMEDICAL Yokneam Gate 1 Tavor Bldg E3 S N Yokneam 20692 Israel 8 SeedNet Mfg Date i Model n Part No Serial No N 7 AC Rating V ES S0 60Hz Ce 0473 a BN NS LY a Machine Model FPRCH2024J and up FPRCH2046A and Higher Galil Medical Proprietary Information 1 9 SeedNet User s Manual Safety Label 20 Disposable Needle Label for reference onl 99
36. LES OR PROBES A Warning Perform the functionality test on each group of needles or any probe before use A defective needle must never be used Upon locking each column the TEST button in the Operation Screen will become active 1 Insert at least 3 cm of the metal shaft of all needles or probes connected to the same group into a sterile saline or water bath see figure 5 10 Do not allow any liquid to touch the needle s black handle 7 Figure 5 7 Functionality Test Single Needle 2 Press the TEST button of the appropriately numbered group on the computer monitor using the Track pad The system will run automatically and will perform a Thaw Freeze Thaw cycle 3 While in the Thaw mode make sure that there 1s no escape of bubbles from any needle or probe tip and that there is no ice ball formation A Warning A defective needle or probe with a gas leak can cause gas embolism in the patient and must never be used Ice formation at this stage means that Argon gas is connected to the Helium lines 4 Verify that ice begins to form around the tips of the needles or probes in the Freeze mode A needle or probe is defective 1f there is no ice formation during this period Galil Medical Proprietary Information 5 5 SeedNet User s Manual Operating Instructions A Warning A defective needle or probe that does not respond to the operating mode commands or that has been damaged in any way must not be used
37. LIZATION The SeedNet template should be thoroughly washed and cleaned right after the procedure and then sterilized The probe cable should not be sterilized It should be kept inside a sterilized plastic sleeve while in use and wiped with a clean cloth at the end of use Galil Medical sterilizes all its products using Ethylene Oxide gas and supplies them to the customer sterile and ready for use Galil Medical Proprietary Information 7 1 SeedNet User s Manual System Maintenance Galil Medical disposable products are intended for single use only and should not be resterilized under any condition excluding the SeedNet template 7 3 REPLACING THE GAS CYLINDERS A Warning Do not mix full and empty cylinders Always install a fully charged Argon gas cylinder and or a fully charged Helium gas cylinder E Ensure that ALL external gas cylinder valves are closed NO Release the remaining gas in the system by opening the freezing and thawing gas discharge valves When all gas 1s released tightly close both discharge valves UJ Using a large adjustable wrench or other appropriate tool disconnect the freezing and thawing pressure regulators at the connections with the gas cylinders Make sure that the regulators remain connected to the flexible hose 1 e place fully charged Argon and Helium gas cylinders in their appropriate locations and secure them to the wall with a chain Connect the pressure regulators to the cy
38. M 8 1 Sie io a E E et eee eee ete ania A Ped cr teh cee 8 2 Urethral Warming System Description 8 3 Warming System Tubing Assembly Instructions Chapter9 ACCESSORIES eiie ette tH M 9 1 Galil Medical Needles And Probes 92 Temperature SeDsOPS niente creators 9 3 External Flexible Gas Hoses eren 9 4 Seednet Template EC 9 5 Flexible Cables For Disposable Probe 9 6 Beat Code Redde custo e Mates equa ise hes Dep Cui aas etra 9 7 Guidance On The Use Of The Probes Chapter 10 TROUBLESHOOTING 2 eite eee tano perio Pass VOLT GOnBOral use gal a gio cit 10 2 TroubleshoOLue OHIO oot ter Eo Et set bte t elt tenes Chapter 11 SYSTEM SPECIFICATIONS err DLL Tecimal Datocnsoseeteedtuaiedesn a daa ad es 11 2 JO3sdSpDOCIHGCALODS drosente dto uad ehstsbext ao daaa 11 3 Schematic Diagram Of The System Galil Medical Proprietary Information Table of Contents SeedNet User s Manual Figure 1 1 Figure 1 2 Figure 3 1 Figure 3 2 Figure 3 3 Figure 3 4 Figure 5 1 Figure 5 2 Figure 5 3 Figure 5 4 Figure 5 5 Figure 5 6 Figure 5 7 Figure 6 1 Figure 6 2 Figure 6 3 Figure 6 4 Figure 6 5 Figure 6 6 Figure 6 7 Figure 6 8 Figure 6 9 Figure 6 10 Figure 6 11 Figure 6 12 Figure 6 13 Figure 6 14 Figure 6 15 Figu
39. R HOSPITAL GRADE INPUT VOLTAGE A MDE 19 ADE JE __ POWER SUPPLY ELC000003 LABEL 12 LABEL 13 ABEL 14 LABEL 15 ede NL S ruse u T 63A SB T6 3A SB 230 v INPUT VOLTAGE Ke POWER SUPPLY ELC000003 USB LAN RS232 LABEL 2 LABEL 16 LABEL 17 LABEL 18 LABEL 19 Figure 1 1 Machine Labels for reference only Galil Medical Proprietary Information SeedNet User s Manual Safety Figure 1 2 Location of Labels on Back panel CAUTION US FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A FHYSICIAN Tt CAUTION GROUNDING RELIABILITY CAN ONLY BE ACHIEVED WHEN THE EQUIPMENT IS CONNECTED TO AN EQUIVALENT RECEPTACLE MARKED HOSPITAL ONLY OR HOSPITAL GRADE MAXIMUM INLET PRESSURE 4500 psi 310 bar 31 MPa Use only Galil Medical certified gas supplier ARGON IN HELIUM ARGON HELIUM DISCHARGE DISCHARGE VALVE VALVE N N P O BOX 224 Yokneam 20692 ISRAEL je SeedNet sa Mfg Date Model Part No Serial No AC Rating V A Zh 50 60 Hz WARNING EB READ MANUAL BEFORE ANY OPERATION WITH GAS CYLINDERS A DISCONNECT THE SYSTEM FROM ELECTRICAL SUPPLY BEFORE ANY GAS CYLINDER HANDLING N ALWAYS RELIEVE SYSTEM PRESSURE BEFOR
40. Temperature Control mode to the Intensity control mode can also be done during the freezing If the machine does not detect a signal from a specific TS or TC during the operation due to failure disconnection or any other reason the machine will terminate the gas flow to the related channel s TS or TC and will mark the specific channel s CD button In addition a warning popup message will appear on the screen see figure 6 30 When using a probe the user should verify that it is well connected to the red cable before continuing The user is required to change the specific channel s CD mode to intensity 96 in order to continue the procedure Warning No signal from control device Verify that the control device for channel 2 is properly connected Change the control mode to intensity before continue Figure 6 30 Change to intensity If while using H P Probes with the intensity mode the machine does not detect a signal from a specific TC during the operation due to failure disconnection or any other reason a warning popup message will appear on the screen see figure 6 31 each time the OFF button is pressed The user should verify that the probe is well connected to the red cable before continuing It is up to the user to decide whether to continue the procedure with no TC temperature reading or to terminate the operation Galil Medical Proprietary Information 6 20 SeedNet User s Manual Compute
41. a particular group column operate together under the same mode i e Freeze Thaw or OFF TC female socket Model dependent Freezing Gas Shutoff valve Relief plugs to Temperature Sensor ports prevent moisture Model dependent Column group Locking bars protector Locking bar handle Figure 5 2 Manifold Front Panel Galil Medical Proprietary Information 5 2 SeedNet User s Manual Operating Instructions A locking bar is used to lock the needle connectors to the ports in every column The bar is marked red in the Unlocked position and green in the Locked position After connecting the needles to the manifold panel move all the locking bars to the Locked position green see Figure 5 2 A Warning Perform the functionality test on each group of needles before use A defective needle must never be used Refer to Figure 5 4 when performing the following steps Remove all five relief plugs from the columns top ports see figure 3 4 prior to performing the next steps 1 Take out a group of five SeedNet needles from their sterile packaging see figure 9 1 2 Remove the needle connector cover plugs by simply squeezing the back end of the cover and pulling it away from the needle connector Figure 5 3 Needle Connector cover plug 3 Verify that the appropriate column locking bar is in the Unlocked position red Connect the desired number of SeedNet needle connectors to the appro
42. abel 18 RS232 port label Label 19 CE Mark with number for conformance with the Medical Device Directive Label 20 Disposable Needle label Label 21 Disposable Probe label Galil Medical Proprietary Information 1 5 SeedNet User s Manual Safety MAXIMUM INLET PRESSURE ARGON HELIUM 4500 psi 310 bar 31 MPa p ARGON IN HELIUM IN DISCHARGE DISCHARGE VALVE VALVE Use only Galil Medical certified gas supplier LABEL 1 LABEL 2 LABEL 3 LABEL 4 LABEL 5 f OFF TAMS nE QIN m ES READ MANUAL BEFORE ANY OPERATION WITH GAS CYLINDERS CAUTION SeedNet DISCONNECT THE SYSTEM FROM ELECTRICAL SUPPLY US FEDERAL LAW RESTRICTS THIS DEVICE ON Mfg Date oo o e BERORR ANI GAS CYLINDER FANDEN TO SALE BY OR ON THE ORDER OF A FHYSICIAN ica l i 1 GISUKREEHE AN SxS Gvenoce O MAIN FREEZING GAS Model A IN NEVER LEAVE ANY GAS CYLINDER CONNECTOR UNSECURED SHUTOFF VALVE Port No Serial No LAN LABEL 6 LABEL AC Rating LABEL 9 LABEL 10 CE on 0 60 Hz 0473 LABEL 8 d VIDEO PRINTER REMOTE e d d CAUTION OUTPUT CONTROL TOSASB TESA SB GROUNDING RELIABILITY CAN ONLY BE ACHIEVED WHEN THE EQUIPMENT IS CONNECTED 1 00 1 20v TO AN EQUIVALENT RECEPTACLE MARKED HOSPITAL ONLY O
43. aid to avoiding damage to the valve e If substantial mechanical damage is suspected the gas cylinder in question should be sent for inspection to an authorized dealer e Do not use the gas cylinder if the inspection date has expired Return them to an authorized distributor for inspection Galil Medical Proprietary Information 1 3 SeedNet User s Manual Safety 16 BURN HAZARD The distal portion of the needle can reach very low 165 C and very high 65 C temperatures A Warning Use the Freeze and Thaw operating modes ONLY when the needle is placed in the target tissue Never touch the tip of the needle while the needle is being activated 1 7 GROUNDING The unit is grounded through the grounding conductor in the power cord A protective ground by way of the grounding conductor in the power cord is essential for safe operation Always plug the unit into a properly grounded Hospital Grade outlet An extra external grounding port is located on the rear of the machine under the cable s reel 1 5 COMPLIANCE WITH INTERNATIONAL STANDARDS The SeedNet System is designed and built according to the guidelines given in the international standards of ASTM Designation F882 96A standard performance and safety specification for cryosurgical medical instruments 1 9 EQUIPMENT CLASSIFICATION e Electric shock protection Class I Type BF e Protection against ingress of liquids Ordinary equipment e Not suitable for
44. always at the physician s discretion Galil Medical Proprietary Information 9 4 SeedNet User s Manual Probe Tip Minimum Cycle Ice ball Device Setting to Geometry Temp time diam Obtain Maximum Ice ball Diameter 2mm Sharp 120 C 10min 27x55mm Freeze setting with no lower temperature limit default 16mm Mushroom 50 C 5min surface shape 27x27mm Freeze setting with no lower temperature limit default 33x33mm Freeze setting with no lower temperature limit default 22x30mm Freeze setting Co with no lower temperature limit default 40 C Smin 24mm Mushroom surface shape E 1 5mm Sharp 110 C 30x50 Freeze setting IceRod with no lower temperature limit default 1 5mm_ Sharp 110 C 26x53mm Freeze setting 3 with no lower temperature limit default IceBulb Small tumors 10 15 mm mean diameter Medium tumors 15 40 mm mean diameter Large tumors 40 mm and up 10min 10min 10min a Accessories Recommended Applications a b Small isolated tumors US amp X ray Technology guidance Medium size tumors Large tumors with several probes working together Freezing bone large cavities Open approach Medium size tumors Large tumors with several probes working together Freezing bone large cavities Open approach Small tumors and tumors reached percutaneously US amp X ray Technology gui
45. ation control modes that can be set by the operator e Intensity Control mode see paragraph 6 5 5 e TS Temperature Control mode see paragraph 6 5 6 e TC Temperature Control mode see paragraph 6 5 6 Only when using probes In order to change to the Temperature Control mode press the arrow on the button see figure 6 38 and select the External TS or probe TC chosen as the control device for the column 6 5 5 INTENSITY CONTROL MODE The basic concept behind the Intensity Control mode is to enable the operator to control the intensity of the cryosurgical freezing by setting the percentage of the freezing in a cycle of 10 seconds The sign in the row see figure 6 37 indicates that the system is in the Intensity Control mode The percentage of the freezing intensity is displayed to the left of the Freeze button It can be changed in 20 steps by using the arrows or by typing Pressing the Freeze button will operate the system with the defined intensity Galil Medical Proprietary Information 6 28 SeedNet User s Manual Computer Interface The colored bar chart is built of 1 minute bars corresponding to the time scale in the graph area above it according the following colors e Green for TEST mode e Blue for Freeze The intensity of the freezing 1s represented by the darkness of the blue color from dark blue for 100 to very light blue for 20 e Red for Thaw e Gray for Off A new colored bar is added to the row
46. be retyped Gold Blister Numbers In case of an emergency only it is possible to enter the specific application s Operation Screen using the following Gold Blister Numbers Needles L P 913035900119 913035900255 Probes H P 960035500251 960035500387 960035500424 960035500560 960035500696 For additional Gold Blister Numbers please call Galil Medical customer service Pressing the Show Clinical Screen Button will enter the user into the Clinical Screen where the patient s ID and date of birth can be filled It is possible to enter this screen with out typing in or scanning the blister S N Pressing on the EXIT button causes the system to shut down Galil Medical Proprietary Information 6 23 SeedNet User s Manual Computer Interface Thawing 2633 Figure 6 36 Other Procedure Main Screen 6 5 1 CLINICAL DATA SCREEN The Other Clinical screen is used to type in the surgeon s name as well as the patient s ID and date of birth see figure 6 34 The data is saved automatically in a log file see paragraph 6 5 7 It is up to the user to decide if it is necessary to fill in the data in this screen in order to save it to the log files This is not a mandatory screen If the user desires it 1s also possible to enter into the clinical data screen after the surgery is finished Pressing the END PROCEDURE button in the Operation Screen will open a popup window with 3 icons see figure 6 40 Pres
47. ble tubing for disposable probe application depended The flexible tubing is used to connect the specific disposable probe to be used in the operation The tubing is for multiple uses This option is valid for machines model FPRCH2024A and higher as well as FPRCH2046A and higher Temperature Sensors The Temperature Sensors TS may be used by the surgeon to obtain additional information of the temperature field at chosen tissue locations both within and surrounding the frozen tissue The external temperature sensors can be installed at strategic locations in the tissue of interest They are usually used to confirm that the boundaries of the tumor have been frozen and that healthy tissue outside the tumor has not been damaged See Chapter 9 for additional information about the Galil Medical SeedNet needles and the temperature sensors Urethral Warming System The surgeon may use the Urethral Warming System together with the Warmer Tubing in order to transfer heat to the urethral tissue during urological cryosurgery procedures The system provides steady flow of warm water or saline from an I V bag to the catheter and thus transfers heat to the urethral tissue enabling to maintain it at constant near body temperatures while the surrounding prostate tissue 1s being cooled down to the cryosurgical temperatures See Chapter 8 for additional information about the Urethral Warming System Barcode Reader The machine is equipped with a CCD
48. care Do not bend the needle or probe Make sure that needle or probe connectors do not come in contact with any liquid Keep connectors covered Galil Medical Proprietary Information xil SeedNet User s Manual List of Warnings and Cautions A Warning Temperature sensors must be used as the control device while using SeedNet Chapter 10 Troubleshooting A Warning Do not attempt to perform any troubleshooting or corrective action beyond those specified in the following guide Any malfunction not listed in the guide or persisting after the recommended action has been taken must be referred to Galil Medical Galil Medical Proprietary Information xili SeedNet User s Manual Safety Chapter 1 Safety This manual is designed to serve as an accompanying document to the SeedNet System It is not intended to take the place of the user s training course which must be completed before using the SeedNet System 1 1 GENERAL The SeedNet System must be unpacked installed and tested by qualified Galil Medical personnel See Chapter 4 Installation and Setup for further information Do not use the SeedNet System on patients until you have completed the SeedNet training course See Chapter 5 Operating Instructions for further information Caution The SeedNet is a sophisticated cryo ablation system for intra body operations Any procedures performed using this system must be done by validly license
49. ceeeeeseaeeenees 6 2 Thawing gas pressure warning ccccccccccssseesseceececcceaseeseeeeeeeeeceaeeseeeceeeeeseaeaenees 6 2 Thawing gas pressure above 4500psi esee eene 6 3 ILLEGAL Darcode Mess ae cuussiieidbsis tiam dedit aci cud penia et pde Ms pez MM Ue tases 6 3 Maichine Pow SINIT E TE UE 6 4 Machine Main Screen with Pressure Messages ssseeeeeseeeeeeeeenn 6 4 Prostate Procedure Main SCIOC T srren aoe Sp RE ERES Ee eese eta pho I EEEE ARS 6 5 Prostate Procedure Main Screen with Blisters S NS eeeeeeeeessss 6 6 Clinical Data Screen before entering operation screen eeeeeesssss 6 6 Clinical Data Screen accessed from the operation screen ssss 6 7 New Disposable Kit MeSSdgE undi Dos toco tide Meet rs M GO tob loei 6 8 OP rO SEE Dostelosu etu a cannon teat MM D dE 6 9 Template Layout DISDIAy deine a Genes ea doo uode eiae i eese Go Cou hau dira doe ted 6 9 Operation Screen during Functionality Test 2 0 0 0 cceecscsecceeeeeeeesseseeeeeeeeeeeeas 6 10 Choosine C M Tor a Croup Ol needles sirius EEEE 6 11 C hinge tO DEC HSIES orto edelerdio ei naan wis ua hansen hea ae ei tanta 6 12 After pressing Exit or Start New Procedure ccceccccccccecccceeesseseeeeeeeeeeeaeeeeees 6 13 End Procedi esecutivo ned a 6 13 Ua Fd B reer eter er ee er ae E or a ee eee 6 13 Cannot Mix Probes Needles Message cccccccccccccns
50. certified SeedNet training course e You have read and understood all relevant material accompanying the SeedNet System A Warning If you do not meet the criteria for a qualified user do not use the SeedNet System 2 3 CLINICAL DECISIONS The practitioner is solely responsible for all clinical use of the SeedNet System and for any results obtained with the System The practitioner based upon his her professional opinion and experience shall make all clinical decisions prior to and throughout the cryosurgical procedure Use of the SeedNet System in special populations has not been established for the SeedNet System All indications and contraindications for the use of the machine as well as side effects are detailed in the specific application related protocols training provided to the qualified users Galil Medical Proprietary Information 2 2 SeedNet User s Manual System Description Chapter 3 System Description 3 1 CONCEPT OF OPERATION General The SeedNet System includes two sub systems see figure 3 1 e The SeedNet machine and the built in SeedNet manifold The SeedNet System induces freezing and thawing at the tip of the needle These freezing and thawing processes are based on the Joule Thomson effect The unique technology of the SeedNet System provides extremely rapid freeze and thaw operations The system s software controls the flow of gases from the gas sources through the manifol
51. d to the needle and probe tips The system can immediately switch from the freezing process to the thawing process after which the needle can be released Since the refrigerant is a high pressure gas at room temperature the needle lines remain flexible and at room temperature throughout the entire procedure The needles used with the SeedNet system are 1 5 mm 17 gauge needle type The control of the software modes Freeze Thaw and Off is by using the computer Track pad Front Panel SeedNet Manifold Figure 3 1 The SeedNet System General view Galil Medical Proprietary Information 3 SeedNet User s Manual System Description 3 2 SYSTEM OPERATION MODES The SeedNet System can be controlled to operate in the following modes The choice of mode can be selected with the Track pad FREEZE Freezing gas is routed to the needle via the valve assembly as necessary to achieve and maintain freezing temperature THAW Thawing gas is routed to the SeedNet needle via the valve assembly as necessary to achieve and maintain thawing OFF Freezing and thawing gas valves are closed No gas flow to the needle 3 3 SEEDNET STRUCTURE General The SeedNet system assembly has the following components e The SeedNet Machine e Accessories The SeedNet Machine The SeedNet machine includes the structure enclosure Power panel Control Panel the computer assembly and the gas supply panel Structural Enclosure
52. d after 10 minutes Clicking on the Shut down button will shut down the system Turn the key to the OFF position Wait 10 minutes and then turn the key to the START position If the message appears again do not use the system Shut down the system and call Galil Medical service Error 2 Error in syslem hardware Exit Software Shut down system Wait 10 minutes Restart the SeedNet System If error persists do not usc system and call Galil Medical service Cancel Shut Down Figure 6 2 Error Message 2 Galil Medical Proprietary Information 6 1 SeedNet User s Manual Computer Interface Freezing Gas Pressure Warning If upon booting the SeedNet system identifies that the freezing gas pressure is below 3100psi 213bar 21 3MPa the following message will appear on the screen Warning Freezing gas pressure below 3100 psi Figure 6 3 Freezing gas pressure warning If upon booting the SeedNet system identifies that the freezing gas pressure is above 4500psi 31 0bar 31MPa the following message will appear on the screen Warning Freeze gas pressure above 4500 psi Figure 6 4 Freezing gas pressure above 4500psi The user must acknowledge the notification by clicking on the OK button in order to continue to the next screen If the gas pressure in the cylinder is not sufficient the SeedNet system must be shut down and the Argon gas cylinders should be replaced with a fully charged cylinder I
53. d and board certified surgeons who are trained and experienced in the use of this system Do not use this system if you have not been adequately trained in its use Also do not use this system until you have read the User s Manual in its entirety and fully understand its contents While every effort has been made to make this User s Manual comprehensible certain sections may be unclear or difficult to understand depending on the user s background and experience Do not use this system if there is any instruction direction precaution or note which you do not understand or which is unclear Contact an authorized Galil Medical representative for further information and clarification before proceeding to use the system The supplier and manufacturer of this system do not claim that it will be useful for assisting in the treatment of any particular condition or set of circumstances The surgeon using the system is fully responsible for assessing each situation based on his own experience and on the patient s condition While experience has shown that the system is useful for certain applications in cryotherapy no representation or warranty has been or will be made that the system is useful for any specific person or condition US federal law restricts this device to sale by or on order of a physician Galil Medical Proprietary Information 1 1 SeedNet User s Manual Safety 12 DEFINITIONS OF WARNINGS AND CAUTIONS Warnings Warning
54. dance Medium size tumors Large tumors with several probes working together US amp X ray Technology guidance Medium size tumors Large tumors with several probes working together US amp X ray Technology guidance b The final decision regarding the use of the cryo probes is always at the physician s discretion Pressure 4000 psi Ambient temperature 20 C in water Temperature measured inside the probe internal thermocouple Pressure 3500 psi Ambient temperature 20 C in Gel Galil Medical Proprietary Information 9 5 SeedNet User s Manual Accessories The surgeon determines the number and size of probes to be used based solely on the ice ball diameter that he or she deems necessary The goal is to create an ice ball that covers the target tissue Galil recommends that the probe be placed in the center of the target tissue when only one probe is used When more than one probe is used the probes should be spaced to cover the entire target tissue with the resulting ice ball Generally 5 to 10 min of freezing are required to obtain the maximum ice ball diameter for each probe Two or three freeze cycles may be needed to freeze all of the target tissue Ultrasound or MRI should be used to visualize the target tissue and the ice ball when they cannot be viewed directly During the procedure the coverage of the target tissue with the ice ball 1s the only indicator that cryoablation has been achiev
55. e The freezing intensity can be preset or changed during the operation by using the Up Down arrows The color of the bar will change during the next minute period EE STOP ALL l 50 00 1 00 00 T Figure 6 29 Choosing Control Mode Galil Medical Proprietary Information 6 19 SeedNet User s Manual Computer Interface 6 4 6 TEMPERATURE CONTROL MODE The basic concept behind the Temperature Control mode is to use the external Temperature Sensors or the built in ones when using a probe as a control mode for the cryosurgical freezing The surgeon can define specific TS or TC to be used as the Control Mode CM for one or more group of needles probes The Temperature Sensors should be inserted into the tissue in locations where the surgeon is interested in controlling its temperature for example to verify low temperature or to verify high temperature In order to use the TS or TC as a control mode the arrow next to the sign has to be pressed and then the T mark or the P mark to be used as a CM should be chosen see figure 6 28 The target temperature for the group or port should be set in the window to the left of the Freeze button using the arrows or by typing After pressing the Freeze button the specific group will freeze continuously as long as the temperature measured by the CD is higher than the target temperature The target temperature can be changed during the freezing Shifting from the
56. e Messages A Warning Never use the Ctrl Alt Del command while using the SeedNet system Galil Medical Proprietary Information 6 4 SeedNet User s Manual Computer Interface 6 3 PROSTATE PROCEDURE Upon pressing the Prostate Procedure icon the Prostate Procedure Main screen appears see figure 6 10 This screen contains a display of the Argon and Helium gas pressures blister numbers typing windows and the Operation and Clinical screens icons If the gas pressure of any of the gases 1s too low below 3100psi for Argon and 2000psi for Helium a blinking red error message will appear on the right side of the screen The Prostate Operation button is disabled and it will be impossible to enter the Operation screen while this message is on In order to be able to enter the Operation screen it 1s also required to type in or scan using the Barcode reader see chapter 9 at least three SeedNet needle blister S Ns spaces 1 2 and 3 After typing in or scanning three blister S Ns and supplying sufficient gas pressure the Operation Screen Button becomes active see figure 6 11 Pressing this button will enter the user into the Operation screen see figure 6 15 Note If the machine is turned off due to an external power supply problem the 3 blister numbers that have been typed into the software will remain valid for up to 60 minutes If the machine is powered back on within this period of time the SeedNet system will automaticall
57. e appropriate column locking bar is in the Unlock position red Insert the cable machine side connector to the top hole of the column the cable fits only into this hole 3 Insert the cable s electrical plug TC signal to the same specific column s female TC socket on the front panel see figure 5 2 and 5 4 4 Lock the bar 5 Insert the probe cable into the sterile protective sleeve not supplied by Galil Medical The sleeve should be at least 180 cm long 6 Stretch the sterile sleeve over the cable Ensure that the end of the probe connector dose not extend beyond the sleeve Machine side Connector TC signal plug Disposable Probe Connector Figure 5 5 Probe Cable Connecting the disposable probe to the cable 1 Open the sterile probe blister and take out the probe Touch only the probe s black handle Unscrew the cover from the probe connector see figure 5 9 2 Gently screw the probe onto the cable handle until it is gently tightened Use the plastic strap of the protective sleeve to attach the sleeve to the probe handle Galil Medical Proprietary Information 5 4 SeedNet User s Manual Operating Instructions 3 Verify that the machine detects each probe that has been connected its column turns active 4 Perform a functionality test for each probe before inserting it into the tissue see paragraph 5 5 Plastic cover Figure 5 6 Disposable Probe 5 5 FUNCTIONALITY TEST OF THE NEED
58. e end of use Machine side l Connector TC signal plug Disposable Probe Connector Figure 9 6 Probe Cable Galil Medical Proprietary Information 9 3 SeedNet User s Manual Accessories 9 6 BARCODE READER Machines model FPRCH2024A and above as well as FPRCH2046A and above are equipped with a CCD Barcode scanner in order to scan Galil Medical product labels and simplify the process of entering the barcode numbers into the system The Barcode scanner is located behind the machine monitor The scanning of the labels can be performed in the screens were the Barcode number window exists In order to scan the barcode number from the product label place the label under the scanning area very close to the Barcode scanner The Barcode scanner buzzer will beep as soon as the barcode number is scanned and the scanned number will appear in the barcode window on the screen together with a lighting green dot Machine monitor Barcode Reader Scanning Area Figure 9 7 Barcode Reader 9 7 GUIDANCE ON THE USE OF THE PROBES Galil Medical provides probes for different applications The following table identifies the available tip geometries for each diameter probe its minimum attainable temperature the time to obtain its minimum attainable temperature its maximum ice ball diameter the device setting to obtain its maximum diameter and its recommended applications The final decision regarding the use of the cryo probes is
59. e front panel port with the pins positioned vertically and the smaller flat pin upward The Temperature Sensors may be used as a control device 5 7 OPERATING PROCEDURES Temperature Sensor The Temperature Sensors should be inserted into the desired locations in the tissue prior to beginning the procedure Insert the sensors at locations where they will give useful information about the progress of the freezing procedure For example the Temperature Sensors can be placed near the boundary of a tumor to ensure that the entire tumor has been frozen Alternatively the Temperature Sensors may be placed near an organ that should not be frozen during the procedure to ensure that the ice front has not advanced to this location Galil Medical Proprietary Information 5 6 SeedNet User s Manual Operating Instructions Control of the Needles or Probes The control of the system operation is done by default by the SeedNet software It is based on predetermined freezing intensity See chapter 6 for details The percentage of freezing intensity can be determined on the Operation Screen External Temperature Sensor TS is selected as the control device for each group in the Operation Screen See chapter 6 The control device is used to control the freezing operation according to the temperature of an external Temperature Sensor For example if TSI is selected as the control device freezing will continue until the current temperature of TS1 fal
60. e needle must never be used A Warning A defective needle or probe with a gas leak can cause gas embolism in the patient and must never be used Ice formation at this stage means that Argon gas is connected to the Helium lines A Warning A defective needle or probe which does not respond to operating mode commands or that has been damaged in any way must not be used A Warning Do not grasp the needle with auxiliary tools as doing so may cause damage to the shaft Bent needles should not be used If the shaft is damaged immediately remove the needle in complete from the patient Galil Medical Proprietary Information X SeedNet User s Manual List of Warnings and Cautions A Warning Use the Freeze and Thaw operating modes ONLY when the needle is placed in the target tissue A Warning Turn the freezing gas shutoff valve to the OFF position 1f the freezing operation continues after switching to the OFF operating mode Allow for natural thawing of the needle or probe before removing it from the patient A Warning The release of the needle or probe from the target tissue should ALWAYS be based on clinical judgment A Warning Before starting any cryosurgical procedure sufficient freezing and thawing gas in the external cylinders must be available to the system See page 3 5 Gas Supply System for further details Chapter 6 System Maintenance A Warning Never use the Ctrl Alt Del command w
61. e of any of the gases 1s too low below 3100psi for Argon and 2000psi for Helium a blinking red error message will appear on the right side of the screen The Other Operation button is disabled and it is be impossible to enter the Operation screen while this message is on It is also required to type in or scan using the Barcode reader see chapter 9 a needle or probe blister number in order to be able to enter the relevant application s Operation screen It is not possible to mix needle and probe blister numbers Following an attempt to do so a warning message will appear on the screen see figure 6 32 Error You can not mix different kinds of Probes Needles Figure 6 35 Cannot Mix Probes Needles Message After typing in or scanning blister S Ns and supplying sufficient gas pressure for a specific application the Operation Screen icon becomes active Pressing this button will enter the user into the specific application s Operation screen see figure 6 36 and Figure 6 37 Note If the machine is turned off due to an external power supply problem the blister numbers that have been typed into the software will remain valid for up to 60 minutes If the machine is powered back on within this period of time the SeedNet system will automatically enter the Operation screen and will be ready to continue the operation Important Data that was typed in the clinical screen prior to the power supply problem will be lost and should
62. e of any of the gases 1s too low below 3100psi for Argon and 2000psi for Helium a blinking red error message will appear on the right side of the screen The Other Operation icon is disabled and it will be impossible to enter the Operation screen while this message is on It is also required to type in or scan using the Barcode reader see chapter 9 a needle or probe blister number in order to be able to enter the relevant application Operation screen It is not possible to mix needle and probe blister numbers Following an attempt to do so a warning message will appear on the screen see figure 6 22 Error You can not mix different kinds of Probes Needles Figure 6 23 Cannot Mix Probes Needles Message After typing in or scanning blister S Ns and supplying sufficient gas pressure for the specific application the Operation Screen icon becomes active Pressing this button will enter the user into the specific application s Operation screen see figure 6 26 and Figure 6 27 Note If the machine is turned off due to an external power supply problem the blister numbers that have been typed into the software will remain valid for up to 60 minutes If the machine is powered back on within this period of time the SeedNet system will automatically enter the Operation screen and will be ready to continue the operation Important Data that was typed in the clinical screen prior to the power supply problem will be lost and should be rety
63. e window Galil Medical Proprietary Information 6 27 SeedNet User s Manual Computer Interface Freezing 4002 psi 3974 psi Figure 6 40 Other Procedure Operation Screen for PROBES 6 5 3 FUNCTIONALITY TEST When a group of needles or a single probe is connected to one of the manifold s columns and the locking bar is moved to the GREEN position the TEST button of this group port is enabled see figure 6 37 The functionality test is performed by inserting all needles or probe tips in the same group at least 3 cm into sterile saline and pressing the TEST button The functionality test procedure will be performed by the system for 50 seconds see paragraph 5 5 and a counting clock will appear on the left side of the row At the end of the functionality test the Freeze and Thaw buttons will appear together with a default setting of the Intensity Control mode of 100 Freezing intensity see figure 6 37 NOTE Functionality tests for columns 1 through 4 are available only once per surgical procedure If additional needles are required in one of these groups the functionality test of the additional needles can be performed on group 5 Group 5 can perform multiple functionality tests In order to activate the functionality test again the lock bar should be unlocked the needle connector inserted and the lock bar locked again At this time the functionality test should be performed 6 5 4 CHOOSING CONTROL MODE There are three oper
64. ed Galil Medical Proprietary Information 9 6 SeedNet User s Manual Troubleshooting Chapter 10 Troubleshooting 10 1 GENERAL A Warning Do not attempt to perform any troubleshooting or corrective action beyond those specified in the following guide Any malfunction not listed in the guide or persisting after the recommended action has been taken must be reported to Galil Medical 10 2 TROUBLESHOOTING GUIDE Key is missing Lost key Spare key is located behind the machine front panel No response on the If power on indicator not computer screen after key lit mest Main plug not connected Plug cord to wall outlet and turn to a wall outlet key to restart Emergency Stop is Release Emergency Stop and turn pressed key to restart If power on indicator lit Turn monitor on Monitor power off Software does not load Monitor power off Software or hardware Call Galil Medical service problems Cannot move the Front wheels are locked Unlock the wheels transport the SeedNet rack machine and lock the front wheels again No pressure reading on the No gas pressure Open cylinder valves of the regulators gauges external cylinders one half turn Low pressure reading on Gas cylinders are not full Replace gas cylinders with fully the regulator gauges charged ones No freezing gas pressure Main Shut off valve is Open Shut off valve reading on screen although closed pressure reading on the outlet regu
65. ed during the freezing Shifting from the Temperature Control mode to the Intensity Control mode can be done during the freezing If the machine does not detect a signal from a specific TS during the operation due to failure disconnection or any other reason the machine will terminate the gas flow to the groups to which the TS is related and will mark the specific groups CD button Galil Medical Proprietary Information 6 11 SeedNet User s Manual Computer Interface In addition a warning popup message will appear on the screen see figure 6 19 The user is required to change the specific groups CD mode to intensity in order to continue the procedure Warning No signal from control device Verify that the control device for channel 2 is properly connected Change the control mode to intensity before continue Figure 6 19 Change to Intensity 6 3 7 TEMPLATE LAYOUT DISPLAY OPERATION The Template Layout Display will assist the surgeon in visualizing the SeedNet needles in the standard template Pressing the Show Template button see figure 6 17 will display the screen Insertion of SeedNet Needles When the template screen is displayed the operator can select the desired needle group by pressing the arrows and marking the group By clicking the Hole in the desired coordinate the operator can mark where the group s needles are inserted The hole is filled by the color of the group
66. eedNet User s Manual Computer Interface Chapter 6 Computer Interface 6 1 USING THE TRACKPAD The Track pad is used to move the cursor on your computer screen and to perform activities To use the Track pad simply slide your fingertip across the Track pad surface in the direction you want the cursor to move To select or modify an item using the Track pad move the cursor on your computer screen to the appropriate field and click the left button of the Track pad 6 2 BOOT UP PROCEDURE Upon starting up the SeedNet System the computer boots up and automatically enters the machine Main screen see picture 6 8 During the boot up the computer performs internal self testing to assure its integrity and the correct start up of the system When the computer identifies an error in the system hardware notification will be given by means of a pop up window containing error messages or warnings The user should follow the message instructions Error 1 The SeedNet System has to be restarted Clicking on the Shut Down button will restart the system If the message appears again do not use the system Shut down the system and call Galil Medical service Error 1 Error in syslem hardware Please restart the SeedNet System lf error persists do not use system and call Galil Medical service Restart ScedNet system Shut Down Figure 6 1 Error Message 1 Error 2 The SeedNet System has to be shut down and restarte
67. eezing and thawing gas 6 Adjust the regulators outlet pressure according the following table Galil Medical Probes Working Pressure Regulated Kidney Other Kidney Other Prostate L P H P 3450psi 234bar 23 4MPa 3450psi 234bar 23 4MPa 4000psi 272bar 27 2MPa 2200psi 150bar 15 0MPa 2200psi 150bar 15 0MPa 4000psi 272bar 27 7MPa 7 Connect the electrical plug into an appropriate electrical outlet The machine voltage 1s shown on a label on the bottom of the back door 8 Verify that the emergency shut off button is not depressed 9 Turn the key switch clockwise to the start position and release it The key will return automatically to the vertical position 10 Verify that the computer workstation automatically boots up and enters the machine main screen The pressure supplied to the machine at this stage Argon and Helium should be within the 3100 4500psi range Fine tune the regulators adjustment or replace the gas cylinders if needed 11 At this point it is required to choose a specific application by clicking its icon see chapter 6 for details 5 3 SEEDNET NEEDLES INSTALATION The SeedNet Manifold is a built in unit located on the left side of the machine see figure 3 The manifold front panel see figure 5 2 1s divided into five columns groups numbered and marked with a colored border Each column is activated as an independent group AII SeedNet needles connected to
68. every minute The intensity of freezing can be preset or changed during the operation using the Up Down arrows The color of the bar will change during the next minute period mi STOP ALL 50 00 1 00 00 T Figure 6 41 Choosing Control Mode 6 5 6 TEMPERATURE CONTROL MODE The basic concept behind the Temperature Control mode is to use the external Temperature Sensors or the built in ones when using a probe as a control mode for the cryosurgical freezing The surgeon can define specific TS or TC to be used as the Control Mode CM for one or more group of needles probes The Temperature Sensors should be inserted into the tissue in locations where the surgeon is interested 1n controlling its temperature for example to verify low temperature or to verify high temperature In order to use the TS or TC as a control mode the arrow next to the sign has to be pressed and then the T mark or the P mark to be used as a CM should be chosen see figure 6 38 The target temperature for the group or port should be set in the window to the left of the Freeze button using the arrows or typing After pressing the Freeze button the specific group will freeze continuously as long as the temperature measured by the CD is higher than the target temperature The target temperature can be changed during the freezing Shifting from the Temperature Control mode to the Intensity Control mode can also be done during freezing
69. formed by Galil Medical authorized personnel only A Warning Maintenance by the user should be performed only when the unit is shut down and disconnected from electrical power and gas sources Performing maintenance procedures with the system ON and or under gas pressure may be hazardous to the user and or destructive to the system 7 1 GENERAL CLEANING A Warning Do not allow any liquid to enter the Galil Medical SeedNet system connectors or the accessory connectors 1 Following a cryosurgical procedure cover each connector with its specific cover 2 It is recommended to wipe the reusable accessories and remove visible soil with a damp cloth and warm soapy water 3 Dry the items by wiping them with a clean cloth or by forced air and wrap them in another clean cloth until disinfection 4 Disinfect the accessories by thoroughly cleaning them with a cloth dampened with a disinfectant such as Alconox and remove soil and detergent residues with a cloth dampened with water Visually inspect the components and either repeat the disinfection process or proceed to sterilize the accessories 5 Thoroughly clean the SeedNet machine and the manifold with a damp cloth and warm soapy water Clean the monitor s screen with a soft cloth and a mild window cleaning solution Take special care to ensure that the liquid does not spill onto the machine and the manifold Dry the items by wiping them with a clean cloth 7 2 STERI
70. ful for certain applications in cryotherapy no representation or warranty has been or will be made that the system is useful for any specific person or condition US federal law restricts this device to sale by or on order of a physician A Warning Do not use the workstation or the gas cylinders for any purpose other than running the SeedNet System A Warning Always turn off the SeedNet System and remove the key when not in use Never allow untrained personnel to operate the SeedNet System A Warning Before starting any cryosurgical procedure sufficient freezing and thawing gas in the external cylinders must be available to the system See page 3 5 Gas Supply System for further details Galil Medical Proprietary Information vili SeedNet User s Manual List of Warnings and Cautions A Warning High pressure gas is dangerous if handled improperly Energy stored under pneumatic pressure may cause serious injury or death Local laws and safety rules regarding pressurized gas systems reservoirs and components should always be observed Maintenance of high pressure gas systems should be performed by authorized personnel only A Warning Use the Freeze and Thaw operating modes ONLY when the needle is placed in the target tissue Never touch the tip of the needle or probe while the needle is being activated Chapter 2 Indications for Use A Warning If you do not meet the criteria for a qualified use
71. g for each group is displayed in colored bars along the row see paragraph 6 5 5 Each group includes the following operation modes Test Button See paragraph 6 5 3 Freeze button will operate the system in the controlled mode defined Thaw button is used to defreeze a group of needle tips in order to release the needles from the frozen tissue The Thaw operating mode has a default maximum operating time of 60 seconds after which the operating mode is switched to Off automatically For additional thaw time the Thaw button should be depressed again Off button will stop the gas flow to a specific group The operator can stop the operation of all needles simultaneously by pressing the red STOP ALL button see figure 6 36 The upper left side of the screen serves for displaying the temperature history chart of the external Temperature Sensors TS which can be connected to the system Each TS is marked in a different color and its current temperature is digitally displayed in degrees Centigrade to the right of its number The temperature history chart is for the last 60 minutes and is subdivided to 10 minutes It is possible if needed to type or scan an additional blister S N into the appropriate window r Freezin psi Thawin Ips grreezing 5201220 2281 ipsi SS aN M PAUL N AEDICAL Other I Figure 6 39 Other Procedure Operation Screen for NEEDLES Galil Medical Proprietary Information 6 26 SeedNet User s Man
72. he log files to a floppy diskette on several occasions in all cases a guiding dialog box will appear a When pressing the Exit button in any screen or when starting New Procedure in the Clinical screen see figure 6 13 b When pressing End Procedure in the Operation screen see figure 6 16 Galil Medical Proprietary Information 6 12 SeedNet User s Manual Computer Interface Note If more than one procedure was performed in a row it is possible to save all procedures to a floppy diskette at the same time upon the final exit from the system see figure 6 21 To Backup Log File Of Procedure 76 Please Insert a diskette in Drive a Store Current Procedure Log File amp Exit ELA To Backup Log Files From Procedura 75 To Procedure 77 Return to Current Procedure Please Insert a diskette Cancal j in Drive ach End Current Procedure Or Start a New Procedure Clinical Via Clinical Screen 7 Figure 6 21 End Procedure Figure 6 22 Final Exit Galil Medical Proprietary Information 6 13 SeedNet User s Manual Computer Interface 6 4 KIDNEY PROCEDURE Upon pressing the Kidney Procedure icon the Kidney Procedure Main screen appears see figure 6 23 This screen contains a display of the Argon and Helium Gas pressures the blister numbers typing windows and the Operation and Clinical screens icons The user can use either needles or probes when operating in the Kidney Procedure If the gas pressur
73. hile using the SeedNet system Chapter 7 System Maintenance A Warning Maintenance by the user should be performed only when the unit is shut down and disconnected from electrical power and gas sources Performing maintenance procedures with the system ON and or under gas pressure may be hazardous to the user and or destructive to the system Galil Medical Proprietary Information Xl SeedNet User s Manual List of Warnings and Cautions A Warning Do not allow any liquid to enter the Galil Medical SeedNet system connectors or the accessory connectors A Warning Do not mix full and empty cylinders Always install a fully charged Argon gas cylinder and or a fully charged Helium gas cylinder A Warning The SeedNet System is not user serviceable A Warning Periodic service of the gas cylinders must be performed ONLY by a Galil Medical certified gas supplier Chapter 8 Urethral Warming System A Warning ONLY authorized Galil Medical personnel should perform the initial setup of the Urethral Warming System Caution The location of all components including the pump warmer device and isolation transformer should not be changed from the initial setting They should never be removed from the IV pole A Warning Insertion of the warming catheter to the urethra must be performed while the pump and warmer device are turned off Chapter 9 Accessories Caution Handle needle or probe with
74. ing the Track pad If it is desired to store the log file on a floppy diskette insert the diskette into drive a when prompted see chapter 6 The SeedNet System application will terminate and the computer will shutdown 6 Turn off the SeedNet System by turning the key in the counter clockwise direction to the OFF position horizontal It is recommended to exit the SeedNet software and system in the described manner Excessive use of the Emergency Stop button may cause damage to the computer workstation 7 Disconnect the Temperature Sensors 8 Unlock each column and remove all the SeedNet needles 9 Insert all five relief plugs into the columns top ports see figure 3 4 Galil Medical Proprietary Information 5 8 SeedNet User s Manual Operating Instructions 10 Place all needles aside for disposal A Warning Before starting any cryosurgical procedure sufficient freezing and thawing gas in the external cylinders must be available to the system See page 3 5 Gas Supply System for further details 11 Replaced the used gas cylinders with fully charged cylinders see paragraph 7 3 12 Mark all freezing gas cylinders under 3500psi 241bar 24 1MPa and all thawing eas cylinders under 2500psi 172bar 17 2MPa as USED Install caps on the used cylinders and send them for refilling 13 Clean the SeedNet System and accessories as described in paragraph 7 1 Galil Medical Proprietary Information 5 9 S
75. isorders Destruction of warts or lesions angiomas sebaceous hyperplasia basal cell tumors of the eyelid or canthus area ulcerated basal cell tumors dermatofibromas small hemanglomas mucocele cysts multiple warts plantar warts actinic and seborrheic keratoses cavernous hemanglomas perianal condylomata and palliation of tumors of the skin Gynecology ablation of malignant neoplasia or benign dysplasia of the female genitalia General surgery palliation of tumors of the rectum hemorrhoids anal fissures pilonidal cysts and recurrent cancerous lesions ENT Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth Thoracic surgery ablation of arrhythmic cardiac tissue and cancerous lesions Proctology ablation of benign or malignant growths of the anus or rectum and hemorrhoids The SeedNet System may be used with a magnetic resonance imaging MRI device or an ultrasound device to provide real time visualization of the cryosurgical procedure This machine model is not intended for use with MRI device Proper use under MRI guidance requires applicable system and accessories Galil Medical Proprietary Information 2 1 SeedNet User s Manual Indications for Use 2 3 WHO IS A QUALIFIED USER You are a qualified SeedNet user only if you meet all of the following criteria e You are a board certified medical practitioner licensed in your country state as applicable e You have taken a
76. ity test should be performed 6 4 4 CHOOSING CONTROL MODE There are three operation control modes that can be set by the operator e Intensity Control mode see paragraph 6 4 5 e TS Temperature Control mode see paragraph 6 4 6 e TC Temperature Control mode see paragraph 6 4 6 Only when using probes In order to change to the Temperature Control mode press the arrow on the button see figure 6 28 and select the External TS or probe TC chosen as the control device for the column 6 4 5 INTENSITY CONTROL MODE The basic concept behind the Intensity Control mode is to enable the operator to control the intensity of the cryosurgical freezing by setting the percentage of the freezing in a cycle of 10 seconds The sign in the row see figure 6 13 indicates that the system is in the Intensity Control mode The percentage of the freezing intensity is displayed to the left of the Freeze button It can be changed in 20 steps by using the arrows or typing Pressing the Freeze button will operate the system with the defined intensity The colored bar chart is built of 1 minute bars corresponding to the time scale in the graph area above it according the following colors e Green for TEST mode e Blue for Freeze The intensity of the freezing 1s represented by the darkness of the blue color from dark blue for 100 to very light blue for 20 e Red for Thaw e Gray for Off A new colored bar is added to the row every minut
77. king pressure 11 3 SCHEMATIC DIAGRAM OF THE SYSTEM The following is a schematic diagram of the operation of the SeedNet System External Freezing External Thawing Gas Connection Gas Connection Computer Workstation Control Signals Trackpad Temperature measurement Freezing Gas c Shut off Valve Manifold Valve Manifold d x Manifold W Safety Relief Valve M a Manifold Safety Relief Valve Doo Valve Bis Manifold Figure 11 1 Schematic diagram of the SeedNet System MANIFOLD Galil Medical Proprietary Information 11 2
78. l Medical technicians or under direction of Galil Medical personnel 4 3 SHIPMENT COMPONENTS The SeedNet System wooden crate contains e SeedNet main system assembly including the system monitor barcode reader keyboard and mouse e External gas supply tubing and regulators e User s manual e Accessories according to order 4 4 INSTALLATION A Warning The SeedNet System must be unpacked installed and tested by Galil Medical authorized personnel only Galil Medical Proprietary Information 4 SeedNet User s Manual Installation and Setup Any damage to the container or to the unit that was found before opening the container or during unpacking installing or testing the unit should be reported immediately to your SeedNet distributor Galil Medical Proprietary Information 4 2 SeedNet User s Manual Operating Instructions Chapter 5 Operating Instructions 5 1 TRAINING Practitioners designated to be SeedNet users must attend a SeedNet training course prior to using the system The course is given by Galil Medical certified personnel A Warning e Only practitioners who have taken the SeedNet training course are authorized to use the SeedNet System Do not use the SeedNet System until you have read the User s Manual in its entirety and fully understand its contents Verify that the system is fully operational before starting a clinical procedure 5 2 TURNING ON THE SEEDNET
79. lator gauge Hear gas leak from the Open discharge valve Tighten discharge valve at Suspected leak in the Do not use the system and call system gas lines Galil Medical service The buttons on the screen Column bar not Locked Lock column bar are not active Galil Medical Proprietary Information 0 SeedNet User s Manual Troubleshooting Unreasonable temperature Temperature Sensor is Use different temperature sensor reading defective Defective TS port Use different port and call Galil Medical service During functionality test The needle is defective Do not use the needle Bubbles are seen escaping from the needle s tip OR Ice does not form on tip edge While in Freeze or Thaw Error in software or Press Emergency Stop button mode Off does not work hardware close all cylinder valves and call Galil Medical service Gas flow while machine Valve failure Insure that all cylinder valves are power is off closed and call Galil Medical service While in Freeze or Thaw Control Device not correct Choose correct Control Device modes no response Open the external cylinder valves Thaw mode does not work Press Thaw button again 60 second timer has expired Freeze does not work Turn the Freezing gas shutoff Freezing shutoff valve is valve to ON turned to OFF Clogged needle Replace the needle see note Barcode Reader does not Verify that the pr
80. lied Helium gas pressure is above 4500psi 310bar 31MPa the pressure regulator must be readjusted ILLEGAL Barcode Message In case of an attempt to type or scan into the software a barcode number of a specific procedure during a different procedure the machine will pop up an ILLEGAL Barcode Message detailing the error see figure 6 7 for an example ILLEGAL BARCODE You can not use Prostate procedure barcodes for Kidney procedure Figure 6 7 ILLEGAL barcode Message When the machine boot up is completed the Main screen appears This screen contains the access icons to the different operating applications see figure 6 8 If the gas pressure of any of the gases 1s below 3100psi for Argon and 2000psi for Helium or above 4500psi for both gases a blinking red error messages will appear on the right side of the screen together with blinking pressure values In this case the operating application icons will be disabled see figure 6 9 The SeedNet Operation button is disabled and it will be impossible to enter the Operation screen while this message i1s on It is required to adjust the pressure to its correct value in order to enable the operating applications icons Galil Medical Proprietary Information 6 3 SeedNet User s Manual Computer Interface Other Procedure Kidney Procedure Prostate Procedure EXIT Figure 6 8 Machine Main Screen Freezing Thawing Figure 6 9 Machine Main Screen with Pressur
81. linders accordingly Tighten the connections with a large adjustable wrench or another appropriate tool Verify that the flexible hoses securing cables are secured at both ends 4 Verify that the thawing gas and the freezing gas discharge valves are closed tightly before opening the cylinder valves 7 4 SUPPLY AND REFILLING OF GAS CYLINDERS Certified suppliers should perform supply and refilling of all gas cylinders only according to the gas quality specifications designated by Galil Medical see paragraph 10 2 Fully charged cylinders should be appropriately marked FULL so that it is clear that these cylinders are ready for use Following or during a cryosurgical procedure replace the Argon and Helium gas cylinders when the gas pressure drops to the levels detailed in the following table Prostate Kidney Other L P Kidney Other H P Argon 3000psi 204bar 20 4MPa 3000psi 204bar 20 4MPa 3500psi 238bar 23 8MPa 1500psi 102bar 10 2MPa 1500psi 102bar 10 2MPa 2000psi 137bar 13 7MPa Lowest Working Pressure Replace Cylinder 50psi The low pressure gas cylinders should be clearly marked USED and put aside for future refilling Once refilled the cylinders should be re marked as FULL It is highly recommended that the customer uses this labeling method Galil Medical Proprietary Information 7 2 SeedNet User s Manual System Maintenance 7 5 SPARE PARTS Spare parts a
82. long the row see paragraph 6 4 5 Galil Medical Proprietary Information 6 16 SeedNet User s Manual Computer Interface Each group includes the following operation modes Test Button see paragraph 6 4 3 Freeze button operates the system in the controlled mode defined Thaw button is used to defreeze a group of needle tips in order to release the needles from the frozen tissue The Thaw operating mode has a default maximum operating time of 60 seconds after which the operating mode is switched to Off automatically For additional thaw time the Thaw button should be depressed again Off button stops the gas flow to a specific group The operator can stop the operation of all needles simultaneously by pressing the red STOP ALL button see figure 6 26 The upper left side of the screen serves for displaying the temperature history chart of the external Temperature Sensors TS which can be connected to the system Each TS is marked in a different color and its current temperature is digitally displayed in degrees Centigrade to the right of its number The temperature history chart is for the last 60 minutes and is subdivided to 10 minutes It is possible if needed to type or scan an additional blister S N into the appropriate window Kidney Freezing 3217 psi 2241 psi CN GALIL MEDICAL Blister S N STOP ALL 10 00 20 00 30 00 40 00 50 00 1 00 00 Time Figure 6 27 Kidney Procedure Operation Screen for
83. ls below the specified target freeze temperature Target freezing temperatures can be specified in the Operation Screen during the procedure Refer to Figure 6 27 for a view of the computer screen showing target values for different groups The default target temperature 30 C appears and can be changed by using the arrows targets jump by 5 C or by typing in the desired value Refer to paragraph 6 5 for details about the Operation Screen To change between the operating modes for each group the buttons on the computer monitor should be used Each manifold column can be operated independently i e various manifold columns can be in different operating modes of freezing and thawing at the same time A Warning Use the Freeze and Thaw operating modes ONLY when the needle or probe is placed in the target tissue Freezing Procedure The Freeze operating mode is used to perform the cryosurgical procedure of freezing the desired tissue To perform the freezing procedure the surgeon should verify that the needle or probe has been inserted into the correct position in the tissue TS can be selected in the Operation Screen as a control device When the surgeon is ready to proceed the Freeze operating mode should be chosen by clicking on the Freeze icon of the appropriately numbered group using the Track pad The target temperature value of the control device can be changed either with the arrow buttons or by typing in the desired value
84. ly specially designed probes upon request Figure 9 2 Galil Medical Standard Probes 16mm 24mm Surface Hemi Sphere Table 9 1 Specifications of the standard disposable probes For full accessories list contact your sales representative Galil Medical Proprietary Information 9 SeedNet User s Manual Accessories 9 2 TEMPERATURE SENSORS In order to ascertain additional information of the temperature field at chosen tissue locations temperature sensors should be used Note The TS handle is marked with Yellow Green color for clear identification while in the template The temperature sensor is shown in Figure 9 3 Figure 9 3 External Temperature Sensor A Warning Temperature sensors must be used as the control device while using SeedNet 9 5 EXTERNAL FLEXIBLE GAS HOSES The External Flexible Gas Hoses enable the connection of the SeedNet System to external gas cylinders Different hoses are needed for Argon and Helium gases each with a different end connector The hoses are special high pressure hoses with a maximum working pressure of 4500 psi 310 bar For gas cylinders with pressure above 4500 psi 310 bar pressure regulators must be installed Figure 9 4 External Gas Supply Hose with regulator Galil Medical Proprietary Information 9 2 SeedNet User s Manual Accessories 9 4 SEEDNET TEMPLATE The SeedNet Template 1s used for guiding the SeedNet needles into the prostate during a pr
85. o very light blue for 20 e Red for Thaw e Gray for OFF A new colored bar is added to the row every minute The intensity of freezing can be preset or changed during operation using the Up Down arrows The color of the bar will change during the next minute period Freezing 3332 psi 2282 psi AS GALIL MEDICAL Prostate Show Template 5000 1 00 00 Time Figure 6 18 Choosing CM for a group of needles 6 3 6 TEMPERATURE CONTROL MODE The basic concept behind the Temperature Control mode is to use the external Temperature Sensors as a control device for the cryosurgical freezing The surgeon can define specific external Temperature Sensors TS to be used as the Control Device CD for one or more group of needles The Temperature Sensors should be inserted into the tissue in locations where the surgeon is interested in controlling the temperature for example to verify low temperature or to verify high temperature In order to use the TS as a control device the arrow next to the sign has to be pressed and then the TS to be used as a CD should be chosen see figure 6 18 The target temperature for the group should be set in the window to left of the Freeze button using the arrows or by typing After pressing the Freeze button the specific group will freeze continuously as long as the temperature measured by the CD is higher then the target temperature The target temperature can be chang
86. ocouple or thermosensor in channel is properly connected before continue Figure 6 43 No temperature signal 6 5 7 Saving PATIENT log FILES Two log files are created for each cryosurgical procedure clinical and operational These files are named CL XXX log and OP XXX log respectively The XXX in each file name is a unique sequential serial number for the procedure The clinical CL log file stores the information from the Clinical Data Screen The operational OP log file saves temperature and pressure data from the actual surgical procedure The following items are recorded the global time in seconds the temperature operating modes F for freeze T for thaw and O for off for each needle the temperature of each external temperature sensor and the pressure of the freezing and thawing gases In addition to the log files a folder containing pictures PNG type of the clinical and Operation screens 1s created When exiting and turning off the system these log files and the pictures folder are automatically saved to the hard disk The files are saved in a tab delimited format that facilitates convenient input into standard spreadsheet programs such as Excel to data analysis see review operation files guide attached to the user s manual Additionally the software gives the user the ability to save the log files and the pictures folder to a floppy diskette on several occasions in all cases a guiding
87. oet dedu iatis 6 24 Other Clinical Screen Before entering operation screen sssee 6 24 New Disposable Product Message eeeeeeessssseeseeeennnneeeeeeennnnnnnn 6 25 Other Procedure Operation Screen for NEEDLES ssssss 6 26 Other Procedure Operation Screen for PROBES suueeusssss 6 28 Choosme C ontolVIOOG sitae be nasties reais athe tota abu uod on idu aus ruin ta RUE 6 29 Chan Se 10 Intens iy ENT T DO DT TM 6 30 INO temperature S19 Dal cies gosse voron dat renes oaa petet ata up lp ato toi EE IET uro Tira ugue 6 30 After pressing Exit or Start New Procedure ccccccecccccceneeessseeecceceseaeeesees 6 31 End Procedure oai e tti de dte E du aucibus amer tu codes 6 31 End b ae weasel wes cse um quU Dd otis bes tue E adda eset 6 31 Urethral Warritne Sy stetisse i eae abt cad Maa cede bb bid oq M tits 8 1 Tubing Connection 1a OTA nessie eie tet Ru nach rehus tos toe du Peter ep deus 8 3 Five SeedNet needles Pack 9 1 Galil Medical Standard Pro Wes odeur puppes dte otv e e mup P bed dis 9 Exteral T mperatute Sens OF ara e om duod neto ek tonio dus 9 2 External Gas Supply Hose with regulator eeeeeeseeeeeeeee 9 2 SeedNet Templa pt RR Pp M ER NU EN 9 3 Probe aD G iota Bun teltetun E 9 3 Barcode Re ACC Feir eis ava Etu vd ioo ca qup tst tete t quentes dosi E totum uut eiu do indod 9 4 Schematic
88. ompt is in Place the prompt in the window scan the label the blister number and scan again window Defective barcode reader Type the blister number using the keyboard and call Galil Medical service Note It is not possible to open the locking bar of the clogged needle without releasing the gas pressure which is clogged in the line For clogged pressure release Argon or Helium perform the following steps 1 Close the external Helium cylinder valve 2 Gently open the Helium discharge valve and release the gas pressure 3 Press all THAW buttons on the screen in order to release the clogged pressure in the needle 4 Press all OFF buttons on the screen 5 Replace the specific clogged needle with a new sterile one which was pre tested for proper functionality see paragraph 5 5 6 Close the Helium discharge valve tightly 7 Open the Helium cylinder valve and continue working with the machine Galil Medical Proprietary Information 10 2 SeedNet User s Manual System Specifications Chapter 11 System Specifications 11 1 TECHNICAL DATA 140 cm 55 in 40 cm 15 7 in 60 cm 23 6 in Weight 77 kg 170 Ib 120 VAC 15 A 60 Hz single phase or Electrical Supply 230 VAC 10 A 50 Hz single phase Configured for destination country One 1 Argon and one 1 Helium gas Gas Supply External Source cylinders pressurized up to 4500psi 310 bar 31 Mpa 6000psi 414 bar 41 4Mpa Temperature
89. onic devices that may emit sparks and therefore should not be operated in the presence of flammable fumes e g flammable anesthetics or volatile substances An easily accessible fire extinguisher in the vicinity of the unit is recommended Verify that the SeedNet System has been ordered according to the appropriate line voltage of your country 100 120 VAC or 230 VAC Only replacement fuses that are rated at T 6 3A 250V Slow Blow for 230V line voltage or for 100 120V line voltage should be used Fuses should only be replaced by trained Galil Medical technicians or under direction of Galil Medical personnel The SeedNet System is designed to function at an operating pressure of up to 4500psi 310bar 31MPa Pressure regulators set to the machine working pressure see chapter 3 for details must be used The freezing and thawing gas should only be ordered from a Galil Medical certified gas supplier 1 5 GAS CYLINDER SAFETY A Warning High pressure gas is dangerous if handled improperly Energy stored under pneumatic pressure may cause serious injury or death Local laws and safety rules regarding pressurized gas systems reservoirs and components should always be observed Maintenance of high pressure gas systems should be performed by authorized personnel only e Gas cylinders should be kept away from heat sources e Gas cylinders should be handled with care to avoid any mechanical damage e Particular attention should be p
90. op the gas flow to a specific group The operator can stop the operation of all needles by pressing the red STOP ALL button see figure 6 15 The upper left side of the screen serves for displaying the temperature history chart of the external Temperature Sensors TS which are connected to the system Each TS is marked in a different color and its current temperature 1s digitally displayed in degrees Centigrade to the right of its number The temperature history chart is for the last 60 minutes and is subdivided to 10 minutes It is possible if desired to add an additional blister S N in the appropriate window above the Show Template button Galil Medical Proprietary Information 6 8 SeedNet User s Manual Computer Interface e a u z Freeze 10 gm Thaw ES ac TBO Free Freeze J Thaw ES o Figure 6 15 Operation Screen Template Layout Display The Template Layout Display is used to assist the surgeon in locating the probes while using a standard template When pressing on the Show Procedure Data button the Template display overlaps with the Procedure Data display Operation Screen It is possible if needed to insert an additional blister S N in the appropriate window above the Show Template button For using the Template display see paragraph 6 3 7 rroczing 3338 fps MENTI 2280 psi 2280 is KNN See A N bu Me GALIL MEDICAL Pi rostat te 1 A
91. ostate cancer treatment see figure 9 4 This template is identical to the templates used during brachytherapy procedures The SeedNet template is mounted onto the stepper of the brachytherapy system and is positioned near the perineum of the patient prior to performing the SeedNet procedure Two additional mounting pins are supplied in order to enable the mounting of the template to different models of brachytherapy steppers The 17 gauge holes of the SeedNet template are spaced 5 mm apart both vertically and horizontally The vertical holes are marked from 1 to 7 and the horizontal holes are marked from A to G This grid of holes corresponds to the grid seen on the screen of transrectal ultrasound systems and helps the physician to visualize where the needles will enter the prostate during insertion An added purpose of the template 1s to keep the probes securely in place after being positioned For cleaning and sterilization refer to paragraph 7 2 in chapter 7 ee Ca Eur Figure 9 5 SeedNet Template 9 5 FLEXIBLE CABLES FOR DISPOSABLE PROBE The flexible cables are used to connect Galil probes over 1 5 mm in diameter to the machine The cable contains signal wiring and gas supply tubing Connection of the cable to the machine and the probe to the cable is detailed in chapter 5 The probe cable should not be sterilized It should be kept inside a sterilized plastic sleeve while in use and wiped with a clean cloth at th
92. ped Gold Blister Numbers In case of an emergency only it is possible to enter the specific application s Operation Screen using the following Gold Blister Numbers Needles L P 912035400182 912035400219 Probes H P 972035300143 972035300279 972035300316 972035300452 972035300588 For additional Gold Blister Numbers please call Galil Medical customer service Pressing the Show Clinical Screen Button will enter the user into the Clinical Screen where the patient s ID and date of birth can be filled in It is possible to enter this screen without typing in or scanning the blister S N Pressing on the EXIT button causes the system to shut down Galil Medical Proprietary Information 6 14 SeedNet User s Manual Computer Interface Freezing BIETET esi 2233 psi Figure 6 24 Kidney Procedure Main Screen 6 4 1 CLINICAL DATA SCREEN The Kidney Clinical screen is used to type in the surgeon s name as well as the patient s ID and date of birth see figure 6 24 The data is saved automatically in a log file see paragraph 6 4 7 It is up to the user to decide whether it is necessary to fill in the data in this screen in order to save it to the log files This 1s not a mandatory screen If the user desires it 1s also possible to enter into the clinical data screen after the surgery 1s finished Pressing the END PROCEDURE button in the Operation Screen will open a popup window with 3 icons
93. priate column group NOTE You must start from the top port Insert each needle connector in its place by pushing while slightly rotating it Figure 5 4 Connecting needle to the manifold 4 Push the locking bar down to the Locked position green 5 Perform a functionality test for each entire needles group see paragraph 5 5 Galil Medical Proprietary Information 5 3 SeedNet User s Manual Operating Instructions Verification of SeedNet Needles Installation Needle identification is activated when locking each column group A group will not be activated if it is not in the Locked position Care should be taken not to activate a group for which no needles are connected Each machine port is color coded and numbered in order to keep track of each group when using several groups The active groups are distinctly displayed on the screen by a bright color while non active groups are indicated by light gray dimmed 5 4 CONNECTING THE CABLE AND PROBE TO THE MACHINE Specific applications require the use of probes whose diameter exceeds mm Such probes are connected to the machine via a flexible cable see figure 5 5 To connect the cable and probe to the machine follow these steps Connecting the cable to the machine Remove all five relief plugs from the columns top ports see figure 3 4 prior to performing the next steps 1 Remove the cover from the cable connectors 2 Verify that th
94. probe TC P1 P2 etc as a control mode and to adjust its temperature target to 20 C see figures 6 37 and 6 38 Thaw button is used to defreeze a group of needle tips in order to release the needles from the frozen tissue The Thaw operating mode has a default maximum operating time of 60 seconds after which the operating mode is switched to Off automatically For additional thaw time the Thaw button should be depressed again Off button will stop the gas flow to a specific port The operator can stop the operation of all probes simultaneously by pressing the red STOP ALL button see figure 6 36 The upper left side of the screen serves for displaying the temperature history chart of external Temperature Sensors TS or the probe built in thermocouple TC To switch between the charts press the Gray button next to the chart Each TS or TC is marked in a different color and its current temperature is displayed digitally in degrees Centigrade to the right of its number The temperature history chart 1s for the last 60 minutes and 1s subdivided to 10 minutes Up to 5 TS can be connected at one time to the machine When a probe with a defective thermocouple TC is connected to the system a warning of the missing TC identification appears in the relevant probe s port In this case no temperature information is available for the probe see figure 6 37 It is possible if needed to type or scan an additional blister S N to the appropriat
95. r do not use the SeedNet System Chapter 3 System Description Caution Depress the emergency stop button only in cases of emergency It is recommended to exit the SeedNet System and software by the procedure given in section 5 7 Excessive use of the emergency stop button may cause damage to the computer workstation Chapter 4 Installation and Setup Caution After positioning the unit lock the front wheel brakes A Warning The SeedNet System must be unpacked installed and tested by Galil Medical authorized personnel only Galil Medical Proprietary Information 1X SeedNet User s Manual List of Warnings and Cautions Chapter 5 Operating Instructions A Warning e Only practitioners who have taken the SeedNet training course are authorized to use the SeedNet System Do not use the SeedNet System until you have read the User s Manual in its entirety and fully understand its contents Verify that the system is fully operational before starting a clinical procedure A Warning Do not turn the handles of the gas cylinder valves to the fully opened position Ensure that all gas cylinder valves are opened before starting any cryosurgical procedure Check that the reading on the pressure gauges is more than the minimum recommended values 4300psi 297bar 29 7MPa for freezing and thawing gas A Warning Perform the functionality test on each group of needles or any probe before use A defectiv
96. r Interface Warning No signal from thermocouple or thermosensor Verify that the thermocouple or thermosensor in channel 2 is properly connected before continue Figure 6 31 No temperature signal 6 4 7 saving PATIENT log FILES Two log files are created for each cryosurgical procedure clinical and operational These files are named CL_XXX log and OP_XXX log respectively The XXX in each file name is a unique sequential serial number for the procedure The clinical CL log file stores the information from the Clinical Data Screen The operational OP log file saves temperature and pressure data from the actual surgical procedure The following items are recorded the global time in seconds the temperature the operating modes F for freeze T for thaw and O for off for each needle the temperature of each external temperature sensor and the pressure of the freezing and thawing gases In addition to the log files a folder containing pictures PNG type of the clinical and Operation screens 1s created When exiting and turning off the system these log files and the picture folder are automatically saved to the hard disk The files are saved in a tab delimited format that facilitates convenient input into standard spreadsheet programs such as Excel and data analysis see review operation files guide attached to the user s manual Additionally the software gives the user the ability to sa
97. re 6 16 Figure 6 17 Figure 6 18 Figure 6 19 Figure 6 20 Figure 6 21 Figure 6 22 Figure 6 23 Figure 6 24 Figure 6 25 Figure 6 26 Figure 6 27 Figure 6 28 Figure 6 29 Figure 6 30 Figure 6 31 Figure 6 32 Figure 6 33 Figure 6 34 Table of Figures Table of Figures Machine Labels for reference only 4 5 eede eicere eet rn eae tonne ep eo na knit 1 6 location of Jbabels onm Back panel suot rte aeter editt sies 1 7 The SeedNet System General yie Woren eot tate giga erint i gepostet ee pr doood 3 The PowerControl Panel ee itu A 3 2 The SeedNet Machine Back panel model dependent 3 4 The Manifold Front Panel model dependent sseseeeeeesssssss 3 5 Satety Cable DE068 KTUP acid o Mato euo Qaia ON 5 Manifold Front Patel cese tico a Fea ed sp Eco qao pee es ossa uuo gass 5 2 Needle Connector COVER DIUE oi ooo cod ic IRE Od OM RPM PUE RE I UM DNUS 5 3 Connecting needle to the manifold sarien 5 3 PROG Ca ON cer CC Dr ER 5 4 Disposable PIOUS cues Dodo bec OI resedit tehdeccimdbu truco undam Loma pru 5 5 Functionality Test Single Needle iei ieco sosta votar ep ie ere etna eid 5 5 Error Messa e qe D 3st ed ket a ei A SU de oie a nau 6 1 Error WICSS AOC Ge Z opes a tac sd stead nto tud a essit RE tr dd iouis 6 1 FEreezitte eds DIeSSUte WaPDTID cucciolo a oar ola bios 6 2 Freezing gas pressure above A500psi ccccccccccceesssseeeecceeeeeeaaeeeseee
98. re placed behind the Machine front panel see figure 3 1 and include a replacement key spare fuses and spare gas discharge valve seats The fuses and the gas discharge valve seats should be used by a Galil Medical authorized service representative or with guidance of a Galil Medical representative 7 6 PERIODIC SERVICE PREVENTIVE MAINTENANCE PM A Warning The SeedNet System is not user serviceable Periodic service requires opening the protective housing of the system and therefore should be performed ONLY by Galil Medical authorized service representatives r If there is any malfunction of the SeedNet System please contact Galil Medical customer support representative A Warning Periodic service of the gas cylinders must be performed ONLY by a Galil Medical certified gas supplier The schedule for periodic service is given in Table 7 1 below Main dryer unit and five line dryers Once a year Galil Medical service replacement Gas system inspection including Once a year Galil Medical service sufficient gas consumption verification Machine General inspection Galil Medical service Socket Assemblies set Once a year or every Galil Medical service 40 procedures Gas cylinders Once in five 5 years Certified gas supplier Table 7 1 Recommended routine inspection and Preventive Maintenance schedule Galil Medical Proprietary Information 7 3 SeedNet User s Manual Urethral Warming System Chapter
99. rom right to left Be careful not to damage the tubing with the pump head stretchers while turning the pump head lever in clockwise direction to the lock position Adjust the pump flow rate speed selector to 8 Do not exceed this speed Green UON gt Pump head lever Labels C O Speed selector Flow direction O seo am i 8 After ensuring that the ratchet clamp of Tube 1 is closed insert the spike of Tube 1 into an insertion port at the bottom of the IV bag 9 After ensuring that the pinch clamp of Tube 3 is closed insert the spike of Tube 3 into the other insertion port at the bottom of the IV bag Galil Medical Proprietary Information 8 4 SeedNet User s Manual Urethral Warming System 10 Verify that all ratchet clamps are open throughout the entire system before performing the next step 11 Connect the power cords of the fluid warmer device and the isolation transformer only the pump is plugged to the transformer to the wall outlet 110V 220V 12 Turn ON the pump and make sure that the tubing lines are filled with the blue saline solution OR FW 400 403 FW 600 603 Note All warmer models automatically turn on to a preset temperature of 43 C Do not change the FW 600 603 pre set temperature 14 Verify that the flow indicator is spinning 15 Based on clinical decision insert the warming catheter into the urethra Warning Insertion of the warming catheter to
100. see figure 6 25 as a reminder to use a new Sterile disposable product With each new procedure use new sterile disposable products Figure 6 26 New Disposable Product Message 6 4 2 1 Operation Screen when using NEEDLES Low Press L P The current Freezing and Thawing pressures are displayed in the upper row of the screen When the pressure drops below 2900psi 196bar 19 6MPa for Freezing and 1500psi 1O1bar 10 1MPa for Thawing the pressure display blinks in red In the lower part of the screen every needle group has its own row marked G1 through G5 and color coded according to the color of the group connector on the manifold front panel see figure 3 4 The display of these rows changes according to the control mode selected see below Note Scanning typing the blister number into the system will allow the user to choose any combination of two groups Gl to G4 to work with Group G5 is enabled for needle testing only If two or more blister numbers are scanned typed into the system all groups can be used as working groups including group 5 On the left side of every group s row a time field displays the time elapsed for the current operating mode Freeze or Thaw The time field gives the amount of time in minutes and seconds that the current operating mode has been operating Each change of the operating mode causes the timer to reset to zero The freezing intensity for each group is displayed in colored bars a
101. seeseeeeceeeeeeeeeesseeeeeeeeeeaas 6 14 Kadney Procedure Main Scree Menoni GET aue aO E 6 15 Kidney Clinical Screen Before entering Operation Screen 6 15 New Disposable Product MeSSAbDe s iita cedo peoe deor oto o vao t etel oe hee Po neste 6 16 Kidney Procedure Operation Screen for NEEDLES esssssssss 6 17 Kidney Procedure Operation Screen for PROBES suuusss 6 18 Choosmps ControD NO sodas empta a turae see va udi ege staat 6 19 Change TO THEO DS TD oos dicitar edis uctes dott dires idu uter distat rend dote cte tuned 6 20 INO Ee EPC GUO STO Diddl oer etre wich nied t cannons ce pd P onu end 6 21 After pressing Exit or Start New Procedure nessessssessseeressssssssererssssssseeeeees 6 21 End Procedir sucesos don oisi tuiexin edente toten prio uat tme dated bate 6 22 PoE C MR EE TE TL Em 6 22 Galil Medical Proprietary Information vi SeedNet User s Manual Figure 6 35 Figure 6 36 Figure 6 37 Figure 6 38 Figure 6 39 Figure 6 40 Figure 6 41 Figure 6 42 Figure 6 43 Figure 6 44 Figure 6 45 Figure 6 46 Figure 8 1 Figure 8 2 Figure 9 1 Figure 9 2 Figure 9 3 Figure 9 4 Figure 9 5 Figure 9 6 Figure 9 7 Figure 11 1 Table of Figures Table of Figures Continued Cannot Mix Probes Needles Message cccccccccccsseesseeceeeeeesaeeeseeeeeeeeeeeaas 6 23 Other Procedure Main Screech ooo eoo stone cte trop estado on
102. sing Clinical will enter the user to the Clinical Screen again In this screen it is possible to fill in the required clinical data After filling in the data there are two options either to exit the current procedure and to turn the machine off see paragraph 6 5 7 or to start a new procedure Figure 6 37 Other Clinical Screen Before entering operation screen There are two ways to fill the data using the Track pad or the keyboard The following table explains the two options Galil Medical Proprietary Information 6 24 SeedNet User s Manual Computer Interface Moving from field to field Move the curser by sliding the Use the TAB key finger on the Track pad surface and click with the left button Typing Alphanumeric Use the Keyboard Use the Keyboard data Changing data in List box Click the small arrows on the left Up Down keyboard side of the box with the Track arrows pad left button Changing Check box Click inside the box with the Click the ENTER Track pad left button key 6 5 2 OPERATION SCREEN The Operation Screen is the screen that is used to control the cryosurgical procedure and to display the procedure data Two kinds of Operation screens can be used for the Other procedure either for the use of probes or the use of needles see figures 6 36 and Figure 6 37 Upon entering the Operation screen from the Main Menu screen a popup window will appear see figure 6 35 as a reminder to use a new sterile di
103. sposable product With each new procedure use new sterile disposable products Figure 6 38 New Disposable Product Message 6 5 2 1 Operation Screen when using NEEDLES Low Press L P The current Freezing and Thawing pressures are displayed in the upper row of the screen When the pressure drops below 2900psi 196bar 19 6Mpa for Freezing and 1500psi 10lbar 10 1Mpa for Thawing the pressure display blinks in red In the lower part of the screen every needle group has its own row marked G1 through G5 and color coded according to the color of the group connector on the manifold front panel see figure 3 4 The display of these rows changes according to the control mode selected see below Note Scanning typing the blister number into the system will allow the user to choose any combination of two groups Gl to G4 to work with Group G5 is enabled for needle testing only If two or more blister numbers were scanned typed into the system all groups can be used as working groups including group 5 Galil Medical Proprietary Information 6 25 SeedNet User s Manual Computer Interface On the left side of every group s row a time field displays the time elapsed for the current operating mode Freeze or Thaw The time field gives the amount of time in minutes and seconds that the current operating mode has been operating Each change of the operating mode causes the timer to reset to zero The intensity of freezin
104. ssette IV Stand There is also a need of an IV bag 1 litter in volume with 2 ports not supplied Brief description of the Urethral Warming System components is provided Fluid Warmer Device A standard medical blood fluid warmer is in use The warmer uses a patented technology that incorporates a heat exchanger controlled by microprocessor to avoid overheating The controlling device includes an LCD screen that presents the current temperature The temperature is factory pre adjusted to 43 C The user only needs to power the warmer device to ON in order to operate it The device power cord should be plugged directly to the wall outlet 110v 220v Peristaltic Roller Pump The system uses a standard peristaltic pump with a soft start motor capable of wide flow rates of up to 570ml min The required flow rate is speed 8 550ml min Do not exceed this speed The pump is used with the Easy Load pump head for a simple and reliable peristaltic pump system With the use of the peristaltic pump system the warming fluid comes in contact only with the internal tubing in a closed circuit and therefore significantly reduces safety cautions The pump power cord is connected to an external isolation transformer The isolation transformer power cord is connected to the wall outlet 1 10v 220v Warming Catheter The urethral warming catheter allows the heat from the circulating fluid to transfer to the urethral tissue It is inserted into
105. ssible if needed to type or scan an additional blister S N to the appropriate window Freezing 4065 is EYO 3992 ps 7 Figure 6 28 Kidney Procedure Operation Screen for PROBES 6 4 3 FUNCTIONALITY TEST When a group of needles or a single probe is connected to one of the manifold s columns and the locking bar is moved to the GREEN position the TEST button of this group port is enabled see figure 6 26 The functionality test is performed by inserting all needles or probe tips of the same group at least 3 cm into sterile saline and pressing the TEST button Galil Medical Proprietary Information 6 18 SeedNet User s Manual Computer Interface The functionality test procedure will be performed by the system for 50 seconds see paragraph 5 5 and a counting clock will appear on the left side of the row At the end of the functionality test Freeze and Thaw buttons will appear together with a default setting of Intensity Control mode of 100 Freezing intensity see figure 6 26 NOTE Functionality tests for columns through 4 are available only once per surgical procedure If additional needles are required in one of these groups the functionality test of the additional needles can be performed in group 5 Group 5 can perform multiple functionality tests In order to activate the functionality test again the lock bar should be unlocked the needle connector inserted and the lock bar locked again At this time the functional
106. t is not advised to begin any cryosurgical procedure with low freezing gas pressure However after the acknowledgment of the low freezing pressure warning it is up to the user to take corrective action If the supplied Argon gas pressure is above 4500psi 310bar 31 MPa the pressure regulator must be readjusted Thawing Gas Pressure Warning If upon booting the SeedNet system identifies that the thawing gas pressure is below 2000psi 138bar 13 8MPa the following message will appear on the screen Warning Thawing gas pressure below 2000 psi Figure 6 5 Thawing gas pressure warning If upon booting the SeedNet system identifies that the thawing gas pressure is above 4500psi 310bar 31MPa the following message will appear on the screen Galil Medical Proprietary Information 6 2 SeedNet User s Manual Computer Interface Warning Thawing gas pressure above 4500 psi Figure 6 6 Thawing gas pressure above 4500psi The user must acknowledge the notification by clicking on the OK button in order to continue to the next screen If the gas pressure in the cylinder is not sufficient the SeedNet system must be shut down and the Helium gas cylinders should be replaced with a fully charged cylinder It is not advised to begin any cryosurgical procedure with low thawing gas pressure However after the acknowledgment of the low thawing pressure warning it is up to the user to take corrective action If the supp
107. the urethra must be performed while the pump and the warmer device are turned off 16 Allow the system to work for 15 minutes before marking the level of the saline solution in the IV bag for reference A decrease in the level of fluid below this line indicates a leak within the system Determine the source of the leak and take corrective action 17 Verify that the displayed temperature of the fluid warmer device does not exceed 43 C during operation Galil Medical Proprietary Information 8 5 SeedNet User s Manual Accessories Chapter 9 Accessories 9 1 GALIL MEDICAL NEEDLES AND PROBES The Galil Medical needles and probes convert high pressure freezing gas to very cold low pressure liquid by using the Linde Hampson Joule Thomson phenomenon High pressure thawing gas is converted to a hotter low pressure gas within the probes as well Galil Medical needles and probes are shipped pre sterilized and ready for use The needles and probes are available in a variety of packages For full details contact your sales representative The needles and probes are intended for single use only Caution Handle needle or probe with care Do not bend the needle or probe Make sure that needle or probe connectors do not come in contact with any liquid Keep connectors covered Figure 9 1 Five SeedNet needles Pack Galil Medical Standard Probes are shown in Figure 9 2 and listed in Table 9 1 Note Galil Medical can supp
108. ual Computer Interface 6 5 2 2 Operation Screen when using PROBES High Press H P The basic structure of the screen 1s similar to the one used for needles The current Freezing and Thawing pressures are displayed in the upper row of the screen When the pressure drops below 2900psi 196bar 19 6Mpa for Freezing and 1500psi 10lbar 10 1Mpa for Thawing the pressure display blinks in red In the lower part of the screen every probe port able to host only a single probe has its own row marked P1 through P5 and color coded according to the color of the port connector on the manifold front panel see figure 3 4 The display of these rows changes according to the control mode selected see below Note In order to activate the ports type or scan one blister number per port On the left side of every group s row a time field displays the time elapsed for the current operating mode Freeze or Thaw The time field gives the amount of time in minutes and seconds that the current operating mode has been operating Each change of the operating mode causes the timer to reset to zero The intensity of freezing for each group 1s displayed in colored bars along the row see paragraph 6 5 5 Each port includes the following operation modes Test Button See paragraph 6 5 3 Freeze button will operate the system in the controlled mode defined Stick in order to activate the probe in Stick mode it is required to choose the specific
109. ve the log files and the picture folder to a floppy diskette on several occasions in all cases a guiding dialog box will appear A When pressing the Exit button in any screen or when starting New Procedure in Clinical screen B When pressing End Procedure in the Operation screen Note If more than one procedure was performed in a row it is possible to save all procedures to a floppy diskette at the same time upon the final exit from the system see figure 6 31 To Backup Log File Of Procedura 78 Please Insert a diskette in Drive a3 Figure 6 32 After pressing Exit or Start New Procedure Galil Medical Proprietary Information 6 21 SeedNet User s Manual Computer Interface Store Current Procedure Log File amp Exit ELE TO pachip Log Fiia To Procedure 77 Return to Current Procedure S mm Please Insert a diskelte Lance in Drive a End Current Procedure Or Starta New ms Procedure Ghinical Via Clinical Screen Figure 6 33 End Procedure PARTIR OA pa Galil Medical Proprietary Information 6 22 SeedNet User s Manual Computer Interface 65 OTHER PROCEDURE Upon pressing the Other Procedure icon the Other Procedure Main screen appears see figure 6 33 This screen contains a display of the Argon and Helium Gas pressures the blister number typing windows and the Operation and Clinical screens icons The user can use either needles or probes when operating in Other Procedure If the gas pressur
110. y disk drive Printer connector EX apan B ARUAL BEFUNE ANY OPTRA WITH CAR CTLINDENE Ius mew E RHEEM FROM mut Jb rrcas air aas CrunCER a d ALWAD LOWE RT Pe Hif CH l cubes TE do LAUS CL BICHUH LE ven m LEAVE ANT Y Eid Crees COMME cron ussrcunpn Figure 3 3 The SeedNet Machine Back panel model dependent Galil Medical Proprietary Information 3 4 SeedNet User s Manual System Description Machine Back Panel The machine back panel may include the following depending on machine model refer to chapter 1 figure 1 2 Gas supply connectors See control devices above Floppy disk drive Allows the user to save the procedures data on a diskette Video output connector Option for MRI machines Remote control connector Option for MRI machines Printer output connector Future software version will allow the user to print required data USB Port Serial Communication RS232 Port Serial Communication LAN Port Ethernet Networking port requires 100kb sec line The SeedNet Manifold The SeedNet Manifold is a built in unit located on the left side of the machine see figure 3 1 The manifold increases the number of SeedNet needles that can be used and allows for the creation of needle groups Each SeedNet needles eroup is independently controlled The manifold top connection of each column also supports the ability to connect the flexible tubing for the disposable probe The manifold
111. y enter the Prostate Operation screen and will be ready to continue the operation Important Data that was typed in the clinical screen prior to the power supply problem will be lost and should be retyped Gold Blister Numbers In case of an emergency only it is possible to enter Operation Screen using the following Gold Blister Numbers 910005600146 910005600282 910005600319 For additional Gold Blister Numbers please call Galil Medical customer service Pressing the Show Clinical Screen Button will enter the user into the Clinical Screen see figure 6 12 It is possible to enter this screen without typing in or scanning a blister S N Pressing on the EXIT button causes the system to shut down Freezing 3311 ps Figure 6 10 Prostate Procedure Main Screen Galil Medical Proprietary Information 6 5 SeedNet User s Manual Computer Interface p E Freezing 3314 Thawing 2263 Figure 6 11 Prostate Procedure Main Screen with Blisters S Ns 6 3 1 CLINICAL DATA SCREEN The Clinical Data screen is used to type in the surgeon name the patient s ID and clinical data see figure 6 12 The data is saved automatically in a log file see paragraph 6 3 9 It is up to the user to decide if it is needed to fill data in this screen in order to save it to the procedure log files This is not a mandatory screen If the user desires it is also possible to enter into the clinical data screen after the surgery has

User Manual - Galil Medical

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