Field Service Manual Rev-01
Contents
1. 20 ELECTRICAL 21 SECTION III OPERATION AND CLINICAL SEQUENCE 4 4 4 22 SECTION IV TROUBLESHOOTING AND MAINTENANCE cccssscsssscsssssssscsccscccssssssssecees 22 1 PURPOSE ee 22 TV22 _ SCOPE cite bh re rote 22 IV 3 DEFINITIONS ACRONYMG ccccccccccssssescecccccccessssssecceccseususescccsceseseuueasesccesesssaseacececseseuanens 23 gt MAINTENANCE sites tele te 23 27 APPENDEXCA SYSTEM NO TICES 5 250 31 APPENDIX B ADDITIONAL WARNING MESSAGES 39 APPENDIX C GUIDELINE amp SPECIFICATIONS FOR REFILLING 40 Medtronic CryoCath LP Page 1 of 41 TRM 002 2 CRYOCONSOLE GEN IV Rev 00 Index of Figures Figure 1 The CryoConsole Gen Accessories 7 Figure 2 The CryoConsole Gen IV and 2 40444 400 8 Figure North American tank and European 8 Figur2. Action Description 10300 The language you selected The language was not Select a different Language selected is not is not currently available changed language currently available Shut down the system and There is a problem with the restart it If the problem Shutdown system and call 11200 system ee the persists call Medtronic service technician Error1 Error1 X Error2 Y i CryoCath LP customer X Error2 Y service Disconnect the electrical umbilical cable from the 2000 Thereise problem wih ne iake actonin catheter continue the procedure system Flow detection initialization procedure persists call Medtronic Disconnect the electrical umbilical cable from the F Flow Curve Programming You must take action catheter and then 12201 2 withthe order to continue the reconnect it If the problem Be a ae procedure persists call Medtronic prog 9 service There is a problem with the You cannot continue the Call Medtronic CryoCath 12202 system file procedure LP customer service Incompatible System File There is a problem with the You cannot continue the Call Medtronic CryoCath 12209 system file procedure LP customer service incompatible Failure File Disconnect the cat
3. Do NOT change the password Password Setting Old Password New Password Continn new password i Cancel Figure 11 Password Setup panel 4 5 Date amp Time Setup panel The Date amp Time Setup panel allows the user to change the date and time of the CryoConsole Figure 12 shows the Date amp Time Setup panel System Setting Time 20 20 20 Hour Minute Second 0 10 Date 19 19 1999 Day Month Year 43 77989 Cancel Figure 12 Date amp Time Setup panel IV 4 6 Touch Screen Setup panel The purpose of this panel is to calibrate the touch screen when the precision is out of range When the user pushes on the Touch Screen Setup button the system gives instructions on how to calibrate the touch screen Medtronic CryoCath LP Page 25 of 41 002 2 CRYOCONSOLE GEN IV Rev 00 4 7 Site Setup panel The purpose of this panel is to gt Choose the language of the CryoAblation Data Manager gt Enter the site name gt Update the physician outcome and diagnosis list of the CryoAblation Data Manager To set the language select a language from the Language drop down list To enter the site name write the site name in the New Site text box and press the Update Site button This name will appear on the home screen after power up To update one of the three lists press the desired button Physician Outcome Diagnos
4. shut down the 50009 There is a problem with the Injection has stopped system and restart it If 825 Failure has been system there is still a problem call initiated by the CPU Medtronic CryoCath LP customer service Disconnect the catheter There is a problem with the TEON electrical umbilical cable 50010 system and the and reconnect it If 826Temperature temperature could drop dure problem persists call Threshold programming below acceptable limits prose Medtronic CryoCath LP customer service Disconnect the coaxial umbilical cable from the Injection has stopped You console make Suie that 819 2 Ensure the inside of 50011 The path of the refrigerant must take action in order to the portit was attached to console coaxial port is is obstructed continue the procedure is clear of obstruction and reconnect the coaxial umbilical cable to the console If problem persists replace 50012 The path of the refrigerant Injection has stopped You the coaxial umbilical cable 819 3 Ensure integrity of 2 must take action in order to refrigerant path continue the procedure catheter umbilical 1 50013 The refrigerant level is too You cannot continue the Replace the refrigerant 829 Refrigerant level low to continue procedure tank failure Try again If the problem persists shut down the 50014 There is a problem with the poe take Pn system and res
5. and authenticate software upgrade MDT diskettes and then launch the upgrade This application facilitates software upgrades without the need for a field service representative intervention This software is installed on CryoConsole depending on the approved country of installation 11 5 3 CryoAblation Data Manager CDM From the main interface panel the software provides four major functional areas for the user to access the CryoTherapy Panel the Review Patient Records Panel the Service System Panel and the Shut Down System button Selecting the Begin CryoTherapy button brings up the Patient Data Panel where the patient information is entered and saved to the hard disk Through this panel the user initiates a CryoTherapy procedure When a CryoTherapy procedure is requested the software ensures that a valid catheter is connected to the CryoConsole When it is connected the CDM downloads a catheter identification code stored on a smart chip located inside the catheter handle The catheter code is used to identify a catheter specific file located on the hard disk of the CryoConsole This file allows the software to program the user interface on the procedure panel and set their default values and contains parameters required for the proper operation of the identified catheter During a procedure the software continuously displays relevant information on the screen The temperature profiles are saved to the hard disk for future recall Data
6. e Replace the coaxial umbilical then OK If the warning persists e Replace the catheter Electrical Connector Animation Verify the electrical connections Replace the ECG box Replace the Electrical Umbilical Replace the catheter Scavenging Connector Animation e Verify the scavenging connection at the CryoConsole and wall outlet e Verify the hospital s scavenging system is working in case of an active system Table 6 Warning messages corrective action Medtronic CryoCath LP Page 39 of 41 TRM 002 2 CRYOCONSOLE GEN IV Rev 00 Appendix Guideline amp Specifications for refilling gt The refrigerant to be refilled is UN 1070 99 5 liquid phase with a humidity level less than 50ppm It is important that the refiller supply the user with a Certificate of Analysis at each refilling which would provide proof that the refilled refrigerant met or exceeded the specifications indicated above It is also important that the Certificate of Analysis refers to the gas quality after it has been put into the refrigerant tank gt The refrigerant must be refilled in the supplied Medtronic CryoCath LP tank The approximate amount of refrigerant to refill is 1016 for North America 8 3lbs for Europe These tanks consist of three 3 parts cylinder dip tube and valve It is important that the gas supplier be aware of the stainless steel dip
7. gt Medtronic Medtronic CryoCath LP Technical Reference Manual For Hospital Biomedical Engineers TRM 002 MDT 2 CryoConsole Rev 00 Manufacturer Medtronic CryoCath LP 16771 Chemin Ste Marie Kirkland Quebec Canada H9H 5H3 Tel 514 694 1212 Fax 514 694 7075 TRM 002 2 CRYOCONSOLE GEN IV Rev 00 SECTION I GENERAL INFORMAT ION cccssssssssssccssscssccscccccsssscsscseccccccscsssssccecescecssssssccecees 5 Tile CPURPOSE xe face aries dees Bie avec 5 12 gt SCOPE iets ei eee 5 13 DEFINITIONS AND ACRONYMS ontenan danena aa a aa 5 14 WARNINGS PREGAUTIONS 6 1 9 GENERAT 7 16 TECHNICAL SPECIFICATIONS 0001000 0 aan 13 FUNCTIONAL SYSTEM DESCRIPTION cccscssssssssssssscsssscccssssssscsscccesssssssceces 17 1 PURPOSE 17 2 17 DEFINITIONS AND 68 2 21 2 060 000000000000 17 SYSTEM OVERVIEW olen es ne 17 5 SOFTWARE INTERFACE it 18 6 MECHANICAT S YSTEM 3
8. gt The selected CryoAblation catheter gt Supplies and Accessories including Sterile single use Coaxial Umbilical Sterile single use Electrical Umbilical Non sterile Auto Connection Box Non sterile ECG Cable Gas Scavenging Hose Refrigerant Tank cylinder Power Cord Foot switch Optional Oo Oo Figure 1 CryoConsole and Accessories Medtronic CryoCath LP Page 7 of 41 TRM 002 2 CRYOCONSOLE GEN 00 Figure 2 CryoConsole Gen and Accessories Note Figure 1 and Figure 2 show the North American set up Nitrous Oxide tank The European tank differs from the North American tank in size weight and capacity Figure 3 shows the visual difference between the two North American tank J 7 European tank Figure 3 North American tank and European tank The CryoConsole only operates in temperatures between 15 C and 30 C 60 F and 86 F an altitude ranging from sea level to 2400 meters 8000 feet and at a maximum humidity of 75 Medtronic CryoCath LP Page 8 of 41 TRM 002 2 CRYOCONSOLE GEN IV Rev 00 1 5 1 Description of the System MDT 2 CryoConsole The CryoConsole Gen III reference 103A2 and 103E2 is a type CF 115 230v 50 60Hz 10amp with respect to electric shock fire mechanical hazards in accordance with UL 2601 1 1997 and CAN CSA C22 2 No 601 1 control number 75HN and IEC 601 1 The CryoConsole Gen IV
9. service There is a problem with the You cannot view the 3 12305 message messages Click Ok to continue Failure file not found 12306 The system could not save The language was not Select a different Error Saving Language Medtronic CryoCath LP Page 31 of 41 002 2 CRYOCONSOLE GEN IV Rev 00 Notice Problem Consequence Action Description your language selection changed language or install or Code create a new configuration file Try again If the problem The system could save 12307 the a calibration 2 Calibration Saving Error parameters Try again If the problem The system could not open You cannot view the persists call Medtronic 12308 the patient file patient file CryoCath LP customer service Try again If the problem 42309 The system could not open You cannot view the persists call Medtronic Patient file Empty file the patient file patient file CryoCath LP customer check code is incorrect service Try again If the problem 12310 system You cannot view the persists call Medtronic the patient file patient file CryoCath LP customer service Try again If the problem 42314 The system could not open You cannot view the persists call Medtronic Invalid Patient File file the patient file patient file CryoCath LP c
10. shows the numbered series in relation with the source of the notice Series Source of the notice 10000 Language confirmation panel 11000 System Start up Failure 12000 13000 14000 System Warning 15000 File Reading Error 16000 Disk Space 17000 File Writing Error 18000 System Alert 19000 System Error 20000 Directory Error 21000 System Self Test Failure 22000 23000 24000 25000 Message Panel 50000 Hardware Failure 60000 Hardware Warning Table 3 Notice series IV 5 3 1 2 Hardware System Notice The hardware system notices are the most common errors that are seen in the field while troubleshooting a problem The watchdog board is the hardware responsible for triggering a hardware failure or a hardware warning The associated system notices are the 50000 and 60000 series notices Whenever the console fails the Power up test it will give you yellow system notice 11200 saying There is a problem with the system Error1 X X X Erro2 Y Y Y Be sure to note these two error numbers before calling Technical Support Table 5 in Appendix System Notices shows all of the system notices the problem the consequence and recommended action Table 6 in Appendix Additional Warning Messages shows warning messages not included in the system notices Medtronic CryoCath LP Page 30 of 41 TRM 002 2 CRYOCONSOLE GEN IV Rev 00 Appendix System Notices
11. space To continue insert another Disk is full w chg disk in 17306 on the diskette diskette arid press Archive amp ConvDb Otherwise press Cancel 18300 There is a problem with the You cannot continue the Shut down the system and You are not able to Medtronic CryoCath LP Page 33 of 41 002 2 CRYOCONSOLE GEN IV Rev 00 Notice Problem Consequence Action Description system procedure restart it If the problem continue the procedure persists call Medtronic Reboot System CryoCath LP customer service Try again If the problem There is problem copying You cannot copy the file to 2 Medionic disk 1 19300 4 denied check disk the file diskette CryoCath LP customer fail file and conv db service Try again If the problem 19301 There is a problem finding You cannot copy the file to persists call Medtronic File not found or directory the file diskette CryoCath LP customer in path not found service Try again If the problem There is a problem findin You cannot copy the file to ersists call Medtronic 10302 ie file LP customer General error occurred service Try again If the problem 19303 copying You cannot copy the file to persists call Medtronic Insufficient memory to the file diskette CryoCath LP customer compl
12. tube The gas supplier must connect to the 0 tank valve outlet connector CEODEUX 10500275 gt Provided that the gas refiller has the proper equipment and adaptors to attach to the Medtronic CryoCath LP 0 tank and that they provide an appropriate Certificate of Analysis on the refrigerant quality specifications then it is acceptable for Medtonic customers to obtain their tank refilled by a supplier of their choice gt All parties handling the refrigerant tanks must be aware that when the tanks have any refrigerant in them at all they are considered to be containing dangerous goods Class 2 2 Non Flammable Non toxic Gas and Class 5 1 Gases Oxidizer and should be handled accordingly Medtronic CryoCath LP Page 40 of 41
13. L 81 L 32 L 17cm L 6 5 W 15cm W 6 0 2 5 1 0 Cord Length Cord Length 6 7m 12 1035C 1035CW 10350 6 0 1 1035 20 10350 L 10350 7 5 L 10350 25 1035DW Yellow Scavenging hose L 1035 9 0m L 10356 30 1035E White Scavenging hose L 10352 10 5 L 1035 40 1035EW ID 0 75 cm ID 0 3 1035F OD 1 375 cm OD 0 55 1035FW 1038N Power cord North America L 2 5 L 8 2 1038E Power cord EU L 2 5m L 8 2 1038U Power cord UK L 2 5m L 8 2 1038 Power cord L 2 5m L 8 2 Refrigerant Tank Table 2 Accessories Specifications The refrigerant is liquid nitrous oxide N20 gt European refrigerant tank REF 103NE gt North American refrigerant tank REF 10332 Medtronic CryoCath LP Page 15 of 41 TRM 002 2 CRYOCONSOLE GEN IV Rev 00 The CryoConsole operates with a refrigerant tank that contains high pressure liquid nitrous oxide Store and handle the nitrous oxide refrigerant tanks according to the hospital gas storage management policy Exposure to nitrous oxide should be minimized to prevent short term behavioural and long term reproductive health effects Do not use Medtronic CryoCath LP refrigerant tanks on any other equipment Use only the refrigerant tank obtained by Medtronic CryoCath LP The Threshold Limit Value TLV for nitrous oxide is 25ppm as re
14. P Quality guidelines A Return Goods Authorization RGA number is necessary and is distributed by Medtronic CryoCath LP Customer Service Non sterile accessories should be cleaned with a dry cloth and stored with the CryoConsole after use Only accessories provided by Medtronic CryoCath LP can be used with the CryoConsole Do not expose catheter or accessories to fluids or solvents Medtronic CryoCath LP Page 12 of 41 TRM 002 2 CRYOCONSOLE GEN IV Rev 00 1 6 Technical Specifications MDT 2 CryoConsole REF 103A2 103E2 104A2 104E2 Regulatory Approvals MDT 2 CryoConsole Gen reference 103 2 and 103E2 is a type 115 230v 50 60Hz 10 with respect to electric shock fire mechanical hazards in accordance with UL 2601 1 1994 CAN CSA C22 2 No 601 1 IEC 601 01 and control number 75 HN The CryoConsole Gen IV reference 104A2 and 104E2 is a type CF defibrillation proof 110 120 230v 50 60Hz 10A with respect to electric shock fire mechanical hazards in accordance with UL 2601 1 1997 EN IEC 60601 1 CAN CSA C22 2 No 601 1 M90 CSA file 220418 MDD CLASS CE Mark Certificate of Conformity No 0088 LRQ 0959680 PMA approved device PO20045 MDL 32473 Canada REF MDT 2 CryoConsole After power up normal operating parameters are 110V 10 10 amps CE 230V 10 5 amps At power up the equipment could draw a transient current of 10 greater than the nominal valu
15. al Ventilation System Passive Scavenging If a non recirculating general ventilation system is present in the hospital the discharge end of the scavenging hose can be placed up an exhaust vent and the 0 will be vented out of the building Care should be taken to ensure that the tubing is placed far enough into the duct system to prevent the 0 from re entering the room Exhaust Directly to Outdoors Passive Scavenging Since the gas is under positive pressure the discharge end of the scavenging hose can be exhausted directly outdoors This can be accomplished by placing the end of the hose out a window or attached to a pipe placed through a wall or ceiling to the outdoors Care must be taken to ensure that the discharge location is NOT an area where people are normally present or in close proximity to an outside air intake or window where the could re enter the building The standard scavenging hose length provided by Medtronic CryoCath LP is 10 5m 40 long If a longer hose is required please contact Medtronic CryoCath LP Customer Service Medtronic CryoCath LP Page 16 of 41 TRM 002 2 CRYOCONSOLE GEN IV Rev 00 Section Functional System Description ll 1 Purpose The purpose of this section is to give a basic knowledge of the functional system of the MDT 2 CryoAblation System therefore ensuring that appropriate actions are taken 2 Scope This section briefly describes the functional system o
16. arated in two main sections These sections are the maintenance and the software interface Medtronic CryoCath LP Page 22 of 41 002 2 CRYOCONSOLE GEN 00 IV 3 Definitions and Acronyms The following definitions and acronyms are used in this section CDM CryoAblation Data Manager CPU Central Processing Unit DAQ Data acquisition board FPGA Field Programmable Gate Array HDD Hard Disk Drive NIBBLE Four binary digits or half of a byte A nibble can be conveniently represented by one hexadecimal digit IV 4 Maintenance In addition to act as an interface for the user the CryoAblation Data Manager software installed on the CryoConsole is an interface for the Field Service Representative during a maintenance job The representative can access the maintenance section by touching the Service System button located on the main panel shown in Figure 7 Some panels require the use of a keyboard attached to the maintenance panel above the cylinder The connector type of the keyboard must be a type AT CRYOCATH Begin CryoTherapy Review Patient Records Figure 7 Main panel 4 1 System Setup panel This screen is used to monitor the tank level read by the load cell as well as the tank pressure read by the pressure transducer The user can return to the Main Panel by pressing the Return to Main Panel button or access the System Maintenance panel by pressing the Advanced Troubleshooting b
17. axial umbilical cable procedure and reconnect them 60003 Low refrigerant level of Replace refrigerant tank Sa tans Ensure that the hospital You must take action in scavenging system is 60004 Problem with scavenging order to continue the turned on and that the Boe scavenging procedure scavenging hose is systemi securely attached Medtronic CryoCath LP Table 5 System Notices Page 38 of 41 002 2 CRYOCONSOLE GEN IV Rev 00 Appendix B Additional Warning Messages WARNING Messages Possible Corrective Action Check refrigerant tank level Verify the cylinder level and cylinder pressure in the system set up panel e Center the cylinder on the plate support Load Cell e Verify the hose connection has no bends or kinks e Verify the actual cylinder weight using a hospital s calibrated scale e Replace the cylinder after completion of the procedure Check mechanical connectors e Verify the coaxial connections e Replace the coaxial umbilical e Replace the catheter Note This animation can occur in the patient screen when the baseline flow is around the threshold value of 100 sccm This usually means there is a leak in the system or the flow meter needs to be calibrated Vacuum Connection Panel Upon pressing OK field and the warning persists e Verify coaxial connections then OK If the warning persists
18. commended by NIOSH National Institute for Occupational Safety and Health 0 Specifications Description Cryogenic liquid nitrous oxide Molecular Formula 0 UN 1070 99 5 liquid phase with humidity level less than 50ppm Gas Scavenging Requirements The CryoConsole produces Nitrous Oxide waste gas that should be removed from the system There are three options for scavenging Selecting the appropriate scavenging method is the hospital s responsibility Use only the scavenging hose obtained by Medtronic CryoCath LP Exhaust 0 to Vacuum Scavenging System Active Scavenging This is the Medtronic CryoCath LP recommended method for removing waste gas The scavenging hose should be attached to a hospital evacuation or vacuum system The hospital system should meet the following requirements Gas to scavenged Nitrous Oxide 0 Scavenging refrigerant 5000 sccm SCAVENGING vacuum le ttn gt 15 in Mercury Hg or gt 380mm Hg or lt 7 4 psia or lt 51 KPa Scavenging hose length provided approximately 6 1m 20 up to 18 3m 60 SCAVENGING DISS Some adaptors for common connection systems are available Exhaust into a Non recirculating Gener
19. connected properly The electrical umbilical cable is m perly The vacuum is disabled due to problem with the coaxial umbilical cable Problem with scavenging Low refrigerant level Figure 16 Message List Medtronic CryoCath LP Page 28 of 41 TRM 002 MDT 2 CRYOCONSOLE GEN 00 system notices includes different presentation of the information It presents notice with three distinctive fields Problem Consequence and Action Figure 17 and Figure 18 show the four notice types A blue notice is for information only and no action is required in order to get into the Therapy panel and start and injection A yellow notice requires an action in order to go into the Therapy panel An orange notice is a failure that will stop an injection or prevent the user from starting one This notice can be reset and no immediate action needs to be taken A red notice is a critical console failure that will cause the termination of the procedure The console needs to be shutdown and Medtronic CryoCath LP Technical Support must be informed The safety system has detected fluid In the console and the system is inoperable Figure 18 Caution and Notice System Notice Medtronic CryoCath LP Page 29 of 41 TRM 002 2 CRYOCONSOLE GEN IV Rev 00 The notices are part of anumbered series Table 3
20. e 4 The CryoConsole 111 04 4 4 0 10 Figure 5 CryoConsole Gen IV features 1 10 Figure 6 FOOL switch ud Ran ciate 11 Figure 7 23 Figure 8 System Setup panel 24 Figure 9 Password 24 Figure 10 System Maintenance nne 25 Figure 11 Password Setup 25 Figure 12 Date amp Time Setup panel 25 Figure 13 Site Setup 26 Figure 14 Backup Patient Files 26 15 Floppy 27 Figure 162 Message 115 28 Figure 17 Danger Warning System 29 Figure 18 Caution and Notice System 22224 4 40404000 29 Medtronic CryoCath LP Page 2 of 41 TRM 002 2 CRYOCONSOLE GEN IV Rev 00 Index of Tables Table 1 CryoConsole dee ae 13 Table 2 Accessories Specifications 15 Table S Series 30 Medtronic CryoCath LP Pa
21. e you sure you want to save these data 23404 Catheter File Database This catheter file already exists Do you want to overwrite it Warning Do you want to overwrite the existing file Overwriting catheter file 23405 Analog Data Overwrite the existing analog data file Overwrite analog data file 24300 There is not enough space on the diskette To continue insert another diskette and press Ok Otherwise press Cancel Change disk then press Ok Conv or archive ok to continue else cancel 25400 Error in File Selection Click Ok to retry otherwise click Cancel and copy c cryosys system Analo gData txt manually Error in File Selection Click OK to Retry or Cancel and copy c cryosys system AnalogD ata txt manually 25401 Copy Failed Click Ok to retry otherwise click Cancel and copy c cryosys system Analo Copy Failed Click OK to Retry or Cancel and copy c cryosys system AnalogD Medtronic CryoCath LP Page 35 of 41 TRM 002 2 CRYOCONSOLE GEN IV Rev 00 Notice Problem Consequence Action Description gData txt manually vy ata txt manually The electrical umbilical Injection has stopped You Disconnect both ends of 50000 cable is not connected must take action in order to the electrical umbilical els Catheter connecti
22. er Minute PSla Pound per Square Inch Absolute KPa Kilopascal Medtronic CryoCath LP Page 5 of 41 TRM 002 2 CRYOCONSOLE GEN IV Rev 00 1 4 Warnings Precautions DO NOT ATTEMPT to service the MDT 2 CryoConsole Only technicians fully trained by MDT can service the CryoConsole Training courses and custom made tools are available at MDT Only the catheters accessories gas cylinders and spare parts that have been obtained from Medtronic CryoCath LP are to be used with the CryoConsole Even though the CryoConsole has passed the requirements of IEC 601 1 UL report 75HN it is the user s responsibility after installation and maintenance to verify and ensure that the CryoConsole meets the applicable electrical safety requirements Electrical Safety Test Test performed by Medtronic Field Hospital BioMedical Engineer Engineer Print Name Signature Date Nitrous Oxide Usage gt MDT 2 CryoConsole operates on high pressure liquid 0 delivery Store and handle the 0 cylinder according to hospital gas management policy Make sure to know their location for future needs gt When using the CryoConsole during a procedure or during servicing Nitrous oxide must be safely vented through the connected scavenging according to policies amp procedures of each hospital in each country Refer to the MDT 2 CryoConsole O
23. es Operational Parameters 103E2 15 C to 30 C 60 F to 86 F 103A2 Maximum of 75 humidity 104 2 Altitude from sea level to 2400 meters 8000 feet 104A2 Dimensions Gen Ill Gen IV Metric Imperial Metric Imperial 127 50 157 62 82 32 58 5 23 W 54 21 W 54 6 W 21 5 Weight Gen Ill Gen IV Metric Imperial Metric Imperial 145 kg 320 Ibs 131 kg 289 Ibs Without tank Without N20 tank Without N20 tank Without 0 tank Table 1 CryoConsole Specifications Medtronic CryoCath LP Page 13 of 41 TRM 002 2 CRYOCONSOLE GEN IV Rev 00 Accessories The ECG cable and auto connection box provide an interface between the Medtronic CryoCath LP and a standard EP system via 2mm touch proof connectors The scavenging hose is used to evacuate from CryoConsole to the hospital gas scavenging outlet The optional foot switch is a remote control to initiate and stop injection of refrigerant Copies of all the Regulatory Approvals are available upon request Medtronic CryoCath LP Page 14 of 41 TRM 002 2 CRYOCONSOLE GEN IV Rev 00 103FS Genlll 104FS GenlV Footswitch optional REF Accessories Metric Imperial L 14cm L 5 5 W 7 cm W 2 5 2037A Auto connection box 5 1 8 0 5 1 1 Ibs approx 2035W ECG cable
24. ete operation service Try again If the problem 19304 There is a problem copying You cannot copy the file to persists call Medtronic Invalid path for either of the file diskette CryoCath LP customer the file names service Try again If the problem 19305 problem copying You cannot copy the file to persists call Medtronic 2 the file diskette CryoCath LP customer fail file service Try again If the problem There is a problem copying You cannot copy the file to persists call Medtronic 19306 the file diskette CryoCath LP customer pissu service Try again If the problem 20300 There is a problem copying You cannot copy the file to persists call Medtronic One of the path the file diskette CryoCath LP customer components not found service Try again If the problem There is a problem copying You cannot copy the file to persists call Medtronic 20301 the file diskette CryoCath LP customer General l O error evened service Try again If the problem 20302 There is a problem copying You cannot copy the file to persists call Medtronic Insufficient memory to the file diskette CryoCath LP customer complete operation service Try again If the problem There is a problem finding You cannot copy the file to persists call Medtronic 20303 the file diskette CryoCath LP customer service Try again If the problem There is a problem copying You cannot copy the file to per
25. ewing copied to a floppy disk or deleted from the hard disk The third functional area which can be selected from the main panel is the Service System Panel This is to aid certified service personnel in performing routine system maintenance and to help technical personnel in troubleshooting the system To prohibit unauthorized personnel from accessing restricted system information several troubleshooting panels are password protected Medtronic CryoCath LP Page 19 of 41 TRM 002 2 CRYOCONSOLE GEN IV Rev 00 The last functional area is the Shut Down System button Before turning off the power of the CryoConsole make sure to wait until the message It is now safe to turn off your computer is displayed on the screen 11 5 4 Catheter Files Each catheter used with the CryoConsole requires different settings of operations Therefore the data for each catheter is stored in a catheter file When a catheter is approved for use with the CryoConsole the associated catheter file is installed in the appropriate directory 11 5 5 Hardware File The CryoConsole uses a binary file called Hardware file which contain the necessary parameters for interpreting analog signals including the appropriate tank formula for the calculation of remaining The hardware file is dependant of the CDM software version and the CDM software is configured to load the appropriate file based on the console configuration North American European o
26. f the CryoConsole introducing the software interface the mechanical system and the electrical system 1 3 Definitions and Acronyms The following definitions and acronyms are used in this section MDT Medtronic CryoCath LP EP Electrophysiology LCD Liquid Crystal Display CDM CryoAblation Data Manager PID Proportional Integral Derivative CPU Central Processing Unit ISA BUS Industry Standard Architecture BUS AC Alternating current DC Direct current IDE Integrated Drive Electronics 1 4 System Overview The CryoConsole is a combination of mechanical assemblies controlled by electronic circuitry Control interfaces are available on the front and back panels of the unit allowing the system to be integrated in EP Lab set up The catheter electrical connection is fed to the system through an isolation interface located on the patient board This electrical interface provides a protection against electrical hazards and protects the CryoConsole unit from defibrillator discharges The user interfaces with the CryoConsole through a LCD touch screen two indicators and two controls located on the front panel of the CryoConsole The LCD touch screen shows a series of menus for operation of the CryoConsole and display of relevant information The user starts the application of a procedure by pushing the hardware injection ON button for 2 seconds and stops the procedure at any time by pressing the hardware injection OFF button Medt
27. ge 3 of 41 TRM 002 2 CRYOCONSOLE GEN IV Rev 00 THIS MANUAL DOES NOT REPLACE THE OPERATOR S MANUAL ITS APPENDICES AND THE INSTRUCTIONS FOR USE FOR EACH RESPECTIVE CATHETER THE TERM CATHETER IS USED THROUGHOUT THIS MANUAL TO DESCRIBE BOTH CARDIAC CRYOABLATION CATHETERS AS WELL AS SURGICAL CRYOABLATION DEVICES Medtronic CryoCath LP Page 4 of 41 TRM 002 2 CRYOCONSOLE GEN IV Rev 00 Section General Information 1 Purpose The purpose of this section is to give general information of the CryoConsole functionality characteristic and accessories available 2 Scope This manual applies to the Medtronic CryoCath LP MDT 2 CryoAblation System Gen North American Ref 103A2 European Ref 103E2 as well as Gen IV system North American Ref 104A2 European Ref 104E2 The CryoAblation Data Manager versions supported by this manual are 3 03 and 3 04 13 Definitions and Acronyms The following definitions and acronyms are used in this section MDT Medtronic CryoCath LP IEC International Electro technical Commission ISO International Organization for Standardization UL Underwriters Laboratories TLV Threshold Limit Value NIOSH National Institute for Occupational Safety and Health ECG Electrocardiogram CSA Canadian Standards Association MDD Medical Device Directive LRQ Lois Refondues du Qu bec 7F 9F 7 French 9 French CE Conformit Europ enne Sccm Standard Cubic Centimeters p
28. heter and reconnect it If the 12204 There 2 me vou 5 me problem persists call Invalid Catheter Data File Medtronic CryoCath LP customer service Disconnect the catheter You must take action electrical umbilical cable 12205 212 Withithe order to continue the and reconnect it If procedure problem persists replace the catheter The catheter may be 12206 outside the patient causing 2 Unacceptable catheter use the catheter tip temperature placement Catheter Compatibility to be too low Try selecting the language There is a problem with the The language setting has oo lf the problem Can t load language 12300 language library s changed back to English persists Medtroni library Library Name guag YENS 9 g ish CryoCath LP customer service 12301 problem with the The system functionality is Install or create anew System file error system file limited system file 12302 There are no messages Click Ok to continue The es CryoAblation console The CryoAblation console 12303 maintenance should be Click Ok to continue maintenance should be done by a qualified person done by a qualified person Try to change the The system could not save The password was not password agan If the Field Password Saving 12304 the password chanded problem persists call Error i ged Medtronic CryoCath LP customer
29. igerant Medtronic CryoCath LP Page 10 of 41 002 2 CRYOCONSOLE GEN IV Rev 00 When pushing the Injection On button for 2 second the button lights up green and the refrigerant injection begins Injection stops when the red Injection Off button is pressed when the timer runs out or when a system notice is triggered 1 5 2 Accessories The accessories include a sterile single use coaxial umbilical a sterile single use electrical umbilical an auto connection box and an ECG cable During a medical intervention the non sterile accessories must be handled in such a way not to introduce them into the sterile field The electrical umbilical provides the electrical connection between the CryoConsole and the catheter through the auto connection box The coaxial umbilical provides the refrigerant during injection and recovers the vapour from the catheter to the CryoConsole The auto connection box and the ECG cable provide an interface between the catheter and a standard EP system The auto connection box has a mechanical relay that automatically connects the thermocouples upon injection and disconnects them when injection stops and the temperature at the distal end of the catheter reaches 32 C or above The purpose of this feature is to reduce the noise superimposed on the intra cardiac signal recording 1 5 2 1 Optional Accessory The foot switch serves as a remote control to start and stop the injection The
30. injection will start if the foot switch is pressed for more than 2 5 seconds To stop the injection the switch must be pressed for 0 5 second The foot switch connector is located on the bottom back of the CryoConsole as shown in Figure 6 Using the foot switch does not change the functionality of the injection button The reference number for the Gen III footswitch is 103FS and the reference number for the Gen IV footswitch is 104FS Foot switch connector Figure 6 Foot switch connector 1 5 2 2 Connection Sequence Connect the scavenging hose the power cord and the optional foot switch if applicable To connect the accessories in preparation for a case first connect the non sterile accessories to the CryoConsole gt Auto connection box gt ECG Cable Medtronic CryoCath LP Page 11 of 41 TRM 002 2 CRYOCONSOLE GEN IV Rev 00 Then introduce the sterile items into the sterile field and connect them from the sterile field gt Sterile electrical umbilical gt Sterile coaxial cable gt CryoAblation catheter Under no circumstances should any sterile coaxial or electrical umbilical be re sterilized or re used All sterile products once used are to be discarded with accordance to hospital procedures Should the customer or Medtronic CryoCath LP Technologies request that any accessory be returned to Medtronic CryoCath LP for inspection it must be disinfected cleaned and packaged as per Medtronic CryoCath L
31. is enter the physician name outcome or diagnosis in the text box and press the Add button To delete an entry select the entry in the list and press Delete Refer to Figure 13 Site Setup Add ts Updati Language English Diagnosis Site General Hospital New Site Update Site Betum te Maintenance Panel Figure 13 Site Setup panel 4 8 Back Up Patient File The purpose of this panel is to make a back up of all the patient data currently stored on the hard drive When downloaded from this panel the files are saved in binary format These files should be downloaded and sent to MDT on a regular basis Backup Patient Files 5 55 File s selected 7 05 20030505 10 06 59 il nik 20030505 12 3 06 59 nik 20030605 1440511412003 06 59 nik 20030705 12505 14 2003 06 59 Close Figure 14 Backup Patient Files panel Medtronic CryoCath LP Page 26 of 41 002 2 CRYOCONSOLE GEN IV Rev 00 These files help us understand any problem encountered during an injection see behaviors that may have not appeared during an injection and helps us identify any possible behavioural patterns To download these files 1 Navigate to the System Maintenance panel 2 Select Backup Patient Files 3 Insert a floppy disk in the floppy drive 4 Press Backup The console will start downloading the patient files that have a check ma
32. le Asa result you would not be 23300 Are you sure you want to able continue this To exit press Yes Are you sure you want to exit patient s procedure would have to create a new patient file Otherwise press No exit from this panel 23301 The patient file will not fit on one diskette You will need multiple diskettes To continue press Ok Otherwise press Cancel Not enough disk space You will need multiple disks do you wish to continue Conv db copy to disk 23302 Are you sure you want to end the procedure If you end procedure the system returns to the main screen and closes the patient file To end the procedure press yes Otherwise press No End Procedure By ending the procedure you will return to the main screen and close the patient file Are you sure you want to end the procedure Response to user selecting abort in failure panel 23400 File Delete Are you sure you want to delete the file File Delete Are you sure you want to delete the file pt db 23401 System Shut Down Are you sure you want to quit System Shutdown Are you sure you want to quit 23402 Patient Database This patient file already exists Do you want to overwrite it Database Conversion Database already exists overwrite 23403 Temperature Calibration Are you sure you want to save the temperature calibration System Saving Ar
33. model 104A2 and 104E2 is a type CF 115 230v 50 60Hz 10amp with respect to electric shock fire mechanical hazards in accordance with CAN CSA C22 2 No 601 1 M90 file 220418 and IEC 601 1 1998 Medtronic CryoCath LP recommends that the biomedical engineer of the site perform regular electrical leakage current measurements in order to ensure that the system leakage current does not exceed the allowable current as required by the applicable standards IEC 601 1 The CryoConsole houses the electrical mechanical components and the software for controlling and recording the CryoTherapy procedure It stores and controls delivery of liquid N20 under high pressure through the coaxial umbilical to the catheter recovers the refrigerant vapour from the catheter under vacuum and disposes the refrigerant through the hospital scavenging system The CryoConsole has numerous safety systems to prevent any potential hazards Pressurized 0 is delivered from the CryoConsole through an ultra fine robust injection tube to the tip of the catheter The warmed vapor is returned to the CryoConsole through a Inside the tip the liquid 0 vaporizes as it encounters heat maintained from the surrounding tissue under vacuum Medtronic CryoCath LP Page 9 of 41 002 2 CRYOCONSOLE GEN IV Rev 00 Figure 4 The CryoConsole Gen III features The CryoConsole Pressurized 0 is delivered fr
34. ole Enter the console ID now Please do it now er You may not be able to Free some space on the The hard disk is almost 14301 Menara 1 complete another hard drive before the next full Free some space procedure procedure before the next procedure Try again If the problem 15300 There is problem finding You cannot copy the file to persists call Medtronic the diskette CryoCath LP customer file pt db conv ptdb service 3 Try again If the problem 15301 There is problem finding You cannot copy the file to persists call Medtronic File not found please the file diskette CryoCath LP customer remove disk copy cath db service Try again If the problem 15302 There is problem copying You cannot copy the file to persists call Medtronic 2 2 the diskette CryoCath LP customer ptdb service Try again If the problem Insufficient memory to 15303 There is a problem copying You cannot copy the file to persists call Medtronic complete operation copy the file diskette CryoCath LP customer fail file mkdir copy conv service ptdb Try again If the problem There is a problem finding You cannot copy the file to persists call Medtronic sige 19304 the file diskette CryoCath LP customer Invalid path copy fail file service Try again If the problem 15305 There is a problem copying You cannot copy the file to persists call Medtronic Access denied copy fail the file diske
35. om the has numerous CryoConsole through an ultra fine robust safety systems injection tube to the tip of the catheter to prevent potential gt 5 A warmed 5 returned to the CryoConsole through a Inside the tip the lumen vaporizes as it encounters heat maintained from the surrounding tissue under vacuum Figure 5 The CryoConsole Gen IV features The hardware controls the safety monitoring system while the software provides the interface to the patient information procedure temperature temperature set point time set point and procedure data information Numerous safety systems exist to control the safe delivery of liquid N2O to the catheter and the return of the vapour 1 Inside the catheter Vacuum System The shaft is always under vacuum unless blood is detected Leak Detection The leak detector detects blood ingress 2 the catheter handle Blood Detection An infrared sensor inside the handle detects blood 3 Inside the CryoConsole Flow Detection The system monitors the flow of the returned 0 vapour will shut off the injection if the flow is outside the parameterized range Fluid Detection An ultrasound detector will disable the system if fluid is detected inside the console vacuum line Vent The vent system sucks back the refr
36. on failure properly continue the procedure cable and reconnect them The vacuum is disabled Injection has stopped You Disconnect both ends of 50001 due to problem with the must take action order to coaxial umbilical cable ailure coaxial umbilical cable continue the procedure and reconnect them You must take action in Disconnect both ends of 50002 2 order to continue the the coaxial umbilical cable Baseline Flow procedure and reconnect them Injection has stopped You 7 819 1 gas pressure X 50003 must take action in order to tank is psi ensure refrigerant tank system continue the procedure is open Injection has stopped You 50005 Catheter leak is detected must take action order to Replace the catheter 821 8 continue the procedure Injection has stopped You 50006 Bigga the must take action in order to Replace the catheter continue the procedure The system is inoperable 50007 There is fluid in the You cannot continue the Please shut it down and 823 Fluid is detected console procedure call Medtronic CryoCath inside console vacuum line LP customer service Try again If the problem persists shut down the 50008 Injection has stopped 21 824 Software Failure Medtronic CryoCath LP customer service Try again If the problem persists
37. ontinue the procedure service There is too much Injection has stopped You Replace the coaxial 820 1 Change coaxial 20029 refrigerant flowing must taxe actionin orogr to umbilical cable umbilical continue the procedure Injection has stopped You Position the catheter tip so 7 50030 2 must take action in order to that it makes better contact tip continue the procedure with the tissue Try again If the problem Injection has stopped You There is a problem with the persists Medtronic 50031 injection process must take action in order to CryoCath LP customer 847 Vent valve S6 failure continue the procedure service You must take action in Disconnect both ends of 60000 ne order to continue the the coaxial umbilical cable 848 Baseline Flow is not connected properly procedure and reconnect them 60001 The electrical umbilical You must take action in Disconnect both ends of 849 Check electrical cable is not connected order to continue the the electrical umbilical connector Medtronic CryoCath LP Page 37 of 41 002 2 CRYOCONSOLE GEN IV Rev 00 Notice Problem Consequence Action Description procedure cable and reconnect them The vacuum is disabled You must take action in Disconnect both ends of 850 Check vacuum 60002 due to a problem with the order to continue the the coaxial umbilical cable connector co
38. pensate and adjust the proportional valve according to either the temperature or the flow depending on the catheter used The third transducer is used to measure the pressure out of the catheter thus verifying that 2 gas is flowing out of the catheter and that no blockage occurs inside the catheter 1 6 3 Regulators A pressure regulator is a device that adjusts pressure at a desired value Since a pressure of 760 psig is enough to ablate at 75 C we use two regulators first to bring down the pressure to 840 psig and second to bring it down to 810 psig 11 6 4 Solenoid Valves Solenoid valves are electro mechanical devices that use a solenoid to control valve activation In the CryoConsole there are five solenoid valves performing specific duties gt The first valve is the injection solenoid valve turning on and off the injection circuit gt The second valve is the switch 1 7 Electrical System 1 7 1 Electrical System Overview The LCD touch screen and the front panel implement the user interface with the CryoConsole The LCD touch screen is a graphical user interface which displays CryoConsole status data and accepts user data and control inputs via screen touches The front panel consists of controls and displays that show CryoConsole status The side IDE panel consists of a mouse keyboard and analog connectors The mouse and keyboard connectors are connected to the CPU board through extension cables Those connectors sho
39. perator s Manual for proper venting as described in Section CryoConsole Pre procedure set up gt Use only tanks supplied by Medtronic CryoCath LP gt Use only Medtronic CryoCath LP supplied scavenging hose gt Do NOT restrict or kink the scavenging hose gt Do NOT disconnect the catheter or the scavenging hose from the MDT 2 CryoConsole until ALL is safely vented from the system a few seconds after the end of the last injection gt Cylinders are NOT for use on any other equipment Medtronic CryoCath LP Page 6 of 41 002 2 CRYOCONSOLE GEN IV Rev 00 gt Threshold Limit Value TLV for is 25ppm as recommended by the National Institute for Occupational Safety and Health NIOSH gt Exposures to should be minimized to prevent short term behavioural and long term reproductive health effects gt Do not open the gas tank valve until it is properly connected and tightened to the CryoConsole gt Do not disconnect the high pressure lines from the cylinder until the pressure gauges read 0 psi Close the gas tank valve and allow the to safely vent from the system lines by turning the vent valve on the tank side couterclockwise before disconnecting the high pressure lines General Description The Medtronic CryoCath LP CryoAblation System consists of three principal components gt MDT 2 CryoConsole with CryoAblation Data Manager software
40. r other 1 6 Mechanical System 1 6 1 Mechanical System Overview The mechanical assembly delivers a controlled pressurized refrigerant to the catheter recovers the refrigerant vapour from the catheter and evacuates the residual refrigerant from the catheter at the end of the injection The mechanical system can be split into the following three sub systems gt Refrigerant delivery plumbing gt Refrigerant recovery system gt Refrigerant evacuation system The delivery system uses liquid as refrigerant which is sub cooled to an appropriate temperature prior to being injected inside the catheter through the injection umbilical tube The system recovers the vapour from the catheter and sends it to the hospital scavenging system through a scavenging hose Electromechanical valves pressure transducers and flow meter are used in order to control and monitor the status of different areas of the mechanical assembly 11 6 2 Pressure Transducers A pressure transducer is a device that converts input pressure into low level electrical electronic signals volts In the CryoConsole we use three pressure transducers The first transducer is used to measure the tank pressure The second transducer is used to measure the pressure delivered by the Medtronic CryoCath LP Page 20 of 41 TRM 002 2 CRYOCONSOLE GEN IV Rev 00 proportional valve That pressure is fed to the PID system that will be used as a feedback to com
41. recording starts at the Medtronic CryoCath LP Page 18 of 41 TRM 002 2 CRYOCONSOLE GEN IV Rev 00 beginning of an injection and stops when the temperature reaches 10 C after stopping the injection This feature allows the recording of the temperature thawing profile If a warning or failure occur the user is immediately notified If a system failure is detected during the procedure the software stops saving the temperature profiles and opens a separate file where it logs the current state of the system This system state file contains the most recent 99 system failures Depending on the type of catheter connected the CryoConsole controls the catheter in two different ways Temperature Control only during CryoMapping During a procedure pressurized refrigerant is delivered in order to reach and maintain a predetermined ablation temperature This continuous temperature control assures a compensation for heat load changes due to the blood movement during cardiac cycles or due to changes in the contact between the catheter tip and the tissue Temperature control is performed using two control loops a hardware pressure control loop and a software temperature control loop The CDM controls the tip temperature by reading the current tip temperature and determines the required delivery pressure set point using a special algorithm based on digital proportional integral derivative PID compensator The pressure set point is sent
42. rk to the floppy disk As the files get saved on the floppy the checkmark is removed The console may request you to change the disk if it gets full The downloading process is finished when all the checkmarks disappear and the green light on the floppy drive turns off Figure 15 Floppy Drive Green Light IV 5 Software Interface 5 1 General information The CryoConsole includes software called CryoAblation Data Manager CDM The main role of the CDM is to acquire and display system data from the hardware set procedure parameters save procedure data on the system hard disk and offer some automatic operational features At system start up the software initiates a system self test which ensures proper functionality of the watchdog system and other system and safety features Should the self test fail the CDM disables the system in order to prevent the user from proceeding and displays a coded error message on the screen 5 2 1 5 Medtronic CryoCath LP Page 27 of 41 002 2 CRYOCONSOLE GEN IV Rev 00 At start up CDM performs a series of tests to verify the CryoConsole hardware and proper operation If a test fails two error codes are generated and displayed on the CryoConsole screen The first series of power up tests is related to the software integrity including the testing of the system and configuration files These files contain important informa
43. ronic CryoCath LP Page 17 of 41 TRM 002 2 CRYOCONSOLE GEN IV Rev 00 When the optional foot switch is in use the user starts the application of a procedure by depressing the footswitch for 2 3 seconds and stops the procedure at any time by depressing the footswitch for 0 5 seconds The watchdog system is the focal point of any data sent and received either to or from the software user interface The watchdog system is the brain of the system control which continually monitors the mechanical assembly state user requests and process failure and or warning detection It also acts as an interface between the software user and the mechanical plumbing which ensures patient and user safety should the software fail 1 5 Software Interface 11 5 1 Software Interface Overview The CryoConsole includes the software called CryoAblation Data Manager CDM and the software called Boot Strap Module v3 02 and above The main role of the software is to acquire and display system data from the hardware set procedure parameters save procedure data on the system hard disk and offer some automatic operational features At system start up the software initiates a system self test which ensures proper functionality of the watchdog system and other system and safety features Should the self test fail the CDM disables the system in order to prevent the user from proceeding 1 5 2 Boot Strap Module The role of the Boot Strap Module is to detect
44. ror with the flow curve data curve data to diskette CryoCath LP customer following flow curve data service Filename You cannot continue The patient name field is i Enter the patient s name Please enter patient 12320 without pel a patent order to continue in order to continue 12321 There is no diskette in the Insert a diskette and press No disk in the floppy drive drive Ok Please insert a disk Try again and if problem File copying error 12322 Catheter file copying error Cannot copy catheter file persists call Medtronic General input output error 9 5 to floppy CryoCath LP customer with the following service Filename Disconnect the catheter and reconnect it If the Catheter file error 12323 problem persists call Following file is not a valid catheter 795 catheter Medtronic CryoCath LP catheter file filename customer service Try again If the problem 13300 You cannot calibrate the persists call Medtronic Could not load Calibration file touch screen CryoCath LP customer Library service Medtronic CryoCath LP Page 32 of 41 TRM 002 2 CRYOCONSOLE IV 00 Notice Problem Consequence Action Description You cannot continue Console ID is not set yet 14300 The console is empty without cons
45. sists call Medtronic 20304 the diskette CryoCath LP customer Gees service Try again If the problem There is a problem copyin You cannot copy the file to persists call Medtronic ae 0905 the file diskette CryoCath LP customer service Shut down the system and restart it If the problem You are not able to 21200 Toere IS Se cannol 22 the persists call Medtronic continue the procedure system procegure CryoCath LP customer Call a service technician service 22400 System Shut Down Please wait while your Please wait while your Medtronic CryoCath LP Page 34 of 41 TRM 002 2 CRYOCONSOLE IV 00 Notice Problem Consequence Action Description system shuts down system shuts down 22401 Target Temperature Not Minimum temperature is Minimum temperature is Attained warmer than d C warmer than X C 22402 System Shut Down Please close gas tank Please close gas tank Make sure the refrigerant Make sure the refrigerant 22403 System Startup tank has been opened tank is opened 2 turns counter clockwise Catheter integrity test a 2 Injection will be enabled in 22500 injection will be enabled X seconds shortly System self test Please System Startup Self test 22501 Refilling Reservoir 22502 injection will be enabled shortly If you exit the system will close this patient fi
46. t down the 50022 problem withthe order to continue the system and restart tt 838 Vacuum pump failure console procedure there is still a problem call Medtronic CryoCath LP customer service Disconnect the coaxial umbilical cable from the console and make sure that the port it was 5 F You must take action in There is problem with the attached to is clear of 50024 vent order to 2 the obstruction Make sure 840 Vent system failure procegure there is no obstruction in the catheter or coaxial umbilical cable and reconnect it Try again If the problem There is a problem with the Injection will nor start You persists call Medtronic 841 User Request backup pode injection process eee CryoCath LP customer interface failure continue the procedure service Injection has stopped Try again If the problem 50026 There is a problem with the You must take action in persists call Medtronic 842 Injection valve S1 injection process order to continue the CryoCath LP customer failure procedure service Try again If the problem Injection has stopped You 50027 must take action in order to 4 843 Vent valve 52 failure continue the procedure service Injection has stopped You Try again It the problem There is a problem with the persists Medtronic 844 Vacuum valve S3 20028 injection process MUST LAKE oon ose CryoCath LP customer failure c
47. tart it If 830 Sub cooler console einer there is still a problem call compressor failure procedure Medtronic CryoCath LP customer service The CryoMapping Injection has stopped You Position the catheter tip so 50016 temperature exceeded the must take action in order to that it makes better contact 852 tip PRESET range of continue the procedure with the tissue Medtronic CryoCath LP Page 36 of 41 TRM 002 2 CRYOCONSOLE GEN IV Rev 00 Notice Problem Consequence Action Description temperature Check whether the fans are working Shut down Injection has stopped You the system and wait 10 50017 The console is running hot cannot continue the minutes before restarting goa Ee procedure it If the problem persists Is nig call Medtronic CryoCath LP customer service Wait 10 minutes before Injection has stopped You continuing the procedure 3 50018 cannot continue the If the problem persists call 634 710 h enough procedure Medtronic CryoCath LP temperature 1s hig customer service Ensure that the hospital Injection stopped You scavenging system is 50021 Problem with scavenging must take action in order to turned on and that the 537 system continue the procedure scavenging hose is securely attached Try again If the problem 4 You must take action in persists shu
48. tion that could affect the functionality of the system The second series of tests is related to the interface between the software and the hardware These tests verify the proper operation of the data acquisition digital and analog input output lines The data acquisition test is crucial to the performance of other tests if this test fails the remaining tests are not performed The third series of tests is related to the functionality of the FPGA and the functionality of major safety features The FPGA component is part of the Watchdog board 5 3 CDM Codes and Messages The CDM software uses codes and messages to inform the user the status of the CryoConsole Always note the message number before calling Technical Support in order to resolve the issue faster 5 3 1 1 System notice hierarchy A message to the user is called a system notice That system notice can be of four different types depending on the message content Starting from the least important and going to the most important messages are the notice caution the warning and the danger They respectively are blue yellow orange and red Depending on the source of the notice the software will assign a different importance to this notice To prevent the user from missing a system notice the first screen appearing to the user is the Message List notice showing all of the system notices Figure 16 shows the Message List screen The coaxial umbilical cable
49. to the hardware pressure controller which assures a continuous control of a proportional valve based on a pressure transducer reading Flow Control for all catheters during CryoAblation During a CryoTherapy procedure pressurized refrigerant is delivered to reach and maintain a specific pre determined flow value This flow value ensures optimal tip temperatures required for ablation As in the temperature control case two control loops are used A hardware pressure control loop and the software flow control loop The CDM controls the refrigerant flow by reading the flow meter and determining the required delivery pressure set point to maintain that flow using a special algorithm based on digital proportional integral derivative PID compensator Should the CDM fail a redundant hardware system is implemented as part of the Watchdog system to monitor the pressure set point sent by the CDM Furthermore the Watchdog system monitors the state of the CPU and the software in order to detect a freeze or abnormal loops and takes action by placing the mechanical plumbing into a safe mode Another important feature of the Watchdog system is to block the analog set point controlled by the CDM whenever an injection OFF is requested or a failure is generated If the Review Patient Records option is selected a file manager panel is displayed This allows the user to select from a list of previously run procedures The selected file may then be opened for vi
50. tte CryoCath LP customer file ptdb service 16300 There is no diskette in the Insert a diskette and press No disk in the floppy drive drive Ok Please insert a disk 16301 There is not enough space Insert another diskette and Not enough disk space on the diskette press Ok Change disk Try again If the problem 17300 There copying You cannot copy the file to persists call Medtronic the diskette CryoCath LP customer Copy ptdb amp MkDir service Try again If the problem There is a problem copying You cannot copy the file to persists call Medtronic 17901 the file diskette CryoCath LP customer Sirot geued service Try again If the problem 17302 There is a problem copying You cannot copy the file to persists call Medtronic Insufficient memory to the file diskette CryoCath LP customer complete operation service Try again If the problem There is a problem copyin You cannot copy the file to persists call Medtronic 1309 ihe file diskette CryoCath LP customer Invalid path service Try again If the problem There is a problem copying You cannot copy the file to persists call Medtronic 1904 the file diskette CryoCath LP customer access denied service Try again If the problem 17305 There is a problem copying You cannot copy the file to persists call Medtronic Specified path is a the file diskette CryoCath LP customer directory not a file service There is not enough
51. uld only be used by Field Service representatives Also found on this panel is an hour meter that indicates the number of hours the CryoConsole has been powered on This information is useful for maintenance purposes The 1 44 Mb floppy disk drive is mounted in the procedure panel and is used to download patient data on disks and to upload upgrades to the CDM software and catheter identification files Medtronic CryoCath LP Page 21 of 41 TRM 002 2 CRYOCONSOLE GEN IV Rev 00 1 7 2 Power Distribution The power entry module with voltage selector thermistors slow blow fuses line filter and power switch are rated at 250V operating voltage The power supply isolation transformer and line filter are rated at 50 60 Hz The voltage selector on the primary side of the isolation transformer is used to enable the 120v 240v conversion 1 7 2 1 Thermistors The thermistors are only installed on the power inlet cables of CryoConsole powered by 220V The thermistors purpose is to protect against any existing inrush current when the system is first switched on Section Operation and Clinical Sequence Please refer to the Operator s Manual its appendices as well as the appropriate nstructions For Use for the respective catheter Section IV Troubleshooting and Maintenance IV 1 Purpose This section proposes troubleshooting steps to follow when the CryoConsole is not operating correctly IV 2 Scope This section is sep
52. ustomer check code is incorrect service You cannot view the Call Medtronic CryoCath 12312 15 patient file LP customer s rvice Patient Record Empty 12313 There isa problem with the The system cannot update Install or create a new Failure file error message file the file messages file setcdmver 12314 There is a problem opening The system cannot update Install or create a new Configuration file error the configuration file the file configuration file setcdmver There is a problem with the system cannot load fiat Invalid Catheter Data File 12315 catheter file the catheter parameters Derete Please delete it You cannot continue 12316 Tie catneter without entering a catheter Enter the catheter name Temperature calibration 12317 The temperature has not You cannot calibrate the ee 4 is can not be performed yet reached 20 30 degrees temperature yet Please check patient board emperature temperature Try again If the problem File copying error General 12318 There is error copying You cannot copy the persists call Medtronic input output error with the the patient file patient file to diskette CryoCath LP customer following patient service Filename If the problem persists File copying error General 12319 There is error copying You cannot copy the flow contact Medtronic input output er
53. utton Figure 8 shows the System Setup panel Medtronic CryoCath LP Page 23 of 41 002 2 CRYOCONSOLE GEN 00 Temperature 23 lt Zeroing Calibration Signal Bower tip Teas 10 0 1000958 Advanced Troubleshooting Betum to Main Panel Figure 8 System Setup panel 4 2 Password panel When pressing the Advanced Troubleshooting button the system notice 12303 The CryoAblation console maintenance should be done by a qualified person appears The CryoConsole requires a password to proceed The low level access password is user Only trained service engineers will have access to all required passwords The user enters the password and presses Ok Enter your Password Figure 9 Password panel 4 3 System Maintenance panel In this panel the user can choose between six different sections Password Setup Date amp Time Setup Touch Screen Setup Site Setup Back Up Patient Files Figure 10 shows the System Maintenance panel Medtronic CryoCath LP Page 24 of 41 002 2 CRYOCONSOLE GEN IV Rev 00 System Maintenance ap Backup Patient Files Remm to Main Panel Figure 10 System Maintenance panel 4 4 Password Setup panel The purpose of this panel is to change the default password used to access the System Maintenance panel Figure 11 shows the Password Setup panel
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