TechnicalPublicationsDirection 2335256-100Version IIILast update : June 2008TRACERlab MX FDGService manual GE Healthcare GE Medical Systems Benelux s.a. Rue Marie Curie, 78B4431 Loncin (Lige) , BELGIUM www.gehealthcare.com 07 06/23/20081 / 1 Erratum TRACERlab MX Service manual By this erratum be informed that the voltage specification changed and you have to consider: 240 V instead of 220 V 115 V instead of 110 V 4Version III - Last Update : June 2008 TRACERlab MX FDG - SERVICE MANUALDirection 2335256-100This page was left intentionally blank.Version III - Last Update : June 2008 TRACERlab MX FDG - SERVICE MANUALDirection 2335256-1005WARRANTY AND LIABILITYTheManufacturerorsupplierofthisequipmentwillnotacceptliabilityforinjurytopersonnelordamageto equipment that may result from misuse of this equipment, failure to observe the hazard notice contained in this manual, or failure to observe local regulations. In addition, he will not accept any liability for the consequences of the administration in humans of any compound produced by this equipment. The decision to authorize use of any lot of any of these compounds for humans is the sole responsibility of the user or of his designated pharmacist.Whilst every effort has been made to ensure the technical accuracy of this manual, the information contained hereinissubjecttochangewithoutnotice.Themanufacturerorsuppliermakesnowarrantyofanykindwith regard to this material.The manufacturer or supplier shall not be liable for errors contained herein, or for incidental or consequential damages arising from the equipment described in this manual.DISTRIBUTOR :GEMS Benelux s.a.78, rue Marie Curie, B-4431 Lige (Loncin)BELGIUMTel. : +32 (0)4 247 84 21 Fax : +32 (0)4 247 84 20www.gehealthcare.be6Version III - Last Update : June 2008 TRACERlab MX FDG - SERVICE MANUALDirection 2335256-100This page was left intentionally blank.Version III - Last Update : June 2008 TRACERlab MX FDG - SERVICE MANUALDirection 2335256-1007TABLE OF CONTENTSCHAPTER 1 : INTRODUCTION 17CHAPTER 2 :HEALTH AND SAFETY INFORMATION 192.1 Radiation safety 192.2 Caution relating to caustic substances 202.3 Caution relating to toxic substances 202.4 Caution relating to inflammable substances 202.5 Caution relating to liquid spillage 212.6 Electrical safety 212.7 Temperature hazard 212.8 Mechanical motion safety 212.9 Caution relating to heavy objects 212.10Accident involving personal injury 222.11 Accident involving fire 222.12Safety labels222.13Hazardous areas inside the TRACERlab MX FDG22CHAPTER 3 :SERVICE JOB SAFETY ANALYSIS 26CHAPTER 4 :CE MARKING 29CHAPTER 5 : DESCRIPTION OF THE EQUIPMENT311.General description312.Dimensions of the TRACERlab MX FDG323.Weight of the TRACERlab MX FDG 324.Connections324.1Connections at the rear324.2Connections on the front335.Front view of the TRACERlab MX FDG 336.Rear view, central part of the TRACERlab MX FDG 367.Left side (as seen from the front)387.1Nitrogen supply circuit397.2Compressed air supply circuit398.Right side view of the TRACERlab MX FDG 409.Top view of the TRACERlab MX FDG 42CHAPTER 6 : MAINTENANCE MODE431.Setting of the TRACERlab MX FDG to the maintenance mode 432.Activation of the rotating valve actuators453.Activation of internal valves454.Operation of the syringe drivers458Version III - Last Update : June 2008 TRACERlab MX FDG - SERVICE MANUALDirection 2335256-100This page was left intentionally blank.Version III - Last Update : June 2008 TRACERlab MX FDG - SERVICE MANUALDirection 2335256-10095.Operation of the heater476.Operation of the vacuum pump477.Operation of the clamps holding the cassette in place488.Resetting of the outputs48CHAPTER 7 : CALIBRATION OF THE ACTIVITY DETECTORS491.Routine calibration procedure492.Manual calibration procedure523.Setting the four activity detectors to zero544.Display the detectors slope and offset545.Adjustment of the detector positioning in the case of saturation55CHAPTER 8 : WEEKLY MAINTENANCE57CHAPTER 9 : YEARLY MAINTENANCE591.Replacement of the tube from the eluent pinch valve592.Replacement of the tube from the 18F inlet pinch valve593.Replacement of the waste cap and waste tube594.Checking the TRACERlab MX FDG604.1Checking the valve connected to the pump (valve 2-1)614.2Checking the electronic vacuum gauge614.3Checking the vacuum pump624.4Checking the high flow-rate, the HF valve (valve 1-19) and the nitrogen valve (valve 2-5)624.5Checking the low flow-rate, LF valve (valve 1-20)and the nitrogen valve (valve 2-5)634.6Checking the low pressure level and the LP valve (valve 1-23)634.7Checking the high pressure level and the HP valve (valve 1-18)634.8Checking the Vac valve (valve 1-17)644.9Checking the Vacuum to 18O water valve (valve 1-21)644.10Checking the kit exhaust valve (valve 1-24)644.11Checking the eluent valve (valve 1-15)644.12Checking the 18F inlet valve (valve 1-16)644.13Checking the heater temperature644.14Checking the syringe drivers654.15Checking the position of the 3 ml syringe driver654.16Checking the rotating actuators and the Compressed air valve (valve 2-3)654.17Checking the clamp kit mechanism and the Compressed air valve (valve 2-3)665.Calibration of the detectors66CHECKLIST PROPER FUNCTIONING OF THE TRACERlab MX FDG67CHAPTER 10 : EXTENSIVE MAINTENANCE AFTER 3 YEARS69CHAPTER 11 : CLEANING AND SANITIZING71CHAPTER 12 : TROUBLESHOOTING731.Error detected during the synthesizer test73 10Version III - Last Update : June 2008 TRACERlab MX FDG - SERVICE MANUALDirection 2335256-100This page was left intentionally blank.Version III - Last Update : June 2008 TRACERlab MX FDG - SERVICE MANUALDirection 2335256-100111.1Heater error731.2Syringue actuator error741.3Compressed air error741.4Nitrogen error742.Syringe driver error743.Error detected during the cassette test754.During synthesis an error message on the screen informs you that the pressure in the waste bottle did not rise as expected765.Abnormality during the preliminary steps before the transfer of the irradiated water765.1The syringes are not hooked onto the syringe drivers765.2The mannose triflate precursor was not diluted properly775.3The activity cannot be transferred from the target to the TRACERlab MX FDG 776.Low yield (8.5)8510.2The pH is too low (>4.5)8512Version III - Last Update : June 2008 TRACERlab MX FDG - SERVICE MANUALDirection 2335256-100This page was left intentionally blank.Version III - Last Update : June 2008 TRACERlab MX FDG - SERVICE MANUALDirection 2335256-1001310.3The FDG solution is not clear and colorless8610.4There are unknown radioactive impurities in the FDG solution8610.5The amount of residual free 18F ions is abnormally high 8610.6The amount of partially hydrolyzed labeled precursor is abnormally high8710.7The pH is too high, the amount of residual ethanol is too high and the osmolality is too high 87CHAPTER 13 : REPORT ANALYSIS891.Enriched 18O-water recovery892.Labeling of the precursor and prepurification893.Hydrolysis, purification and transfer to the final vial89CHAPTER 14 : REMOTE CONTROL BOX91CHAPTER 15 : GENERAL CHECK PROCEDURE IN THE CASE OF LOW YIELDS95APPENDIX97Removal of the coveMR-001-00198Replacement of the activity inlet pinch valve tubeMR-001-00299Replacement of the elution system pinch valve tubeMR-001-003100Replacement of the elution system tube inserts (on the conical block)MR-001-004100Replacement of the elution systemMR-001-005102Replacement of the electronic vacuum gaugeMR-001-006106Replacement of the vacuum pumpMR-001-008108Replacement of the 30 ml syringe actuator mechanismMR-001-009111Replacement of the 3 ml syringe actuator mechanismMR-001-010115Adjustment of the activity detector position in the case of saturationMR-001-011121Adjustment of the pressure levels : High Pressure (HP) & Low Pressure (LP)MR-001-012123Replacement of the nitrogen filter cartridge and/or compressed air filter cartridgeMR-001-013126Replacement of an internal valveMR-001-015131Replacement of the 18F inlet pinch valveMR-001-016133Replacement of the PLC power supplyMR-001-017136Replacement of the 24 Vdc power supplyMR-001-018139Replacement of the CPU batteryMR-001-020142Replacement of the mains fuseMR-001-021145Replacement of the heater fuseMR-001-022 146 Replacement of the PLC fuseMR-001-02314714Version III - Last Update : June 2008 TRACERlab MX FDG - SERVICE MANUALDirection 2335256-100This page was left intentionally blank.Version III - Last Update : June 2008 TRACERlab MX FDG - SERVICE MANUALDirection 2335256-10015CHAPTER 1 - INTRODUCTIONTheTRACERlabMX FDGisacompactautomatedsystemthatconvertsexternallyproduced 18F-fluorideinto 2-[18F]-fluoro-2-deoxyglucose (FDG) ready for quality control, usable in Positron Emission Tomography (PET). The TRACERlab MX FDG : Service Manual is one part of the global package entitled TRACERlab MX FDG : User Documentation. It contains the necessary information to assist the user during maintenance and servicing operations on the TRACERlab MX FDG : description of the maintenance mode, calibration procedure for the activity detectors, troubleshooting information, weekly and yearly checks and maintenance, repairing procedures, etc.BeforeanymaintenanceandservicingoperationiscarriedoutontheTRACERlabMX FDG,eachoperator must read the TRACERlab MX FDG : Service Manual and be fully aware of its contents.The TRACERlab MX FDG : User Documentation package consists of three additional manuals : TRACERlab MX FDG : Preinstallation and Installation ManualContains the information necessary to install the TRACERlab MX FDG and the site requirements. TRACERlab MX FDG : Operator ManualContainsthenecessaryinformationtoassisttheoperatorinroutineFDGproductionusingthe TRACERlab MX FDG, i.e. health and safety information, a short description of the equipment and the chemical process, a description of the control tools and displays available to the user, and all necessary operating instructions. TRACERlab MX FDG : Consumable Manual Contains all the information related to the consumables such as reagents needed for the production of FDG, single use cassette and additional items needed for the production of FDG. 16Version III - Last Update : June 2008 TRACERlab MX FDG - SERVICE MANUALDirection 2335256-100This page was left intentionally blank.Version III - Last Update : June 2008 TRACERlab MX FDG - SERVICE MANUALDirection 2335256-10017CHAPTER 2 : HEALTH AND SAFETY INFORMATIONImportant :All personnel associated with the operation of the TRACERlab MX FDG must be appropriately qualified, made familiar with its operation and informed of all applicable health and safety regulations.Allpersonnelmustreadthischapterandbefullyawareofitscontentsbeforeoperatingorservicingthe TRACERlab MX FDG.Itisthecustomersresponsibilitytoensurethatallpersonnelinvolvedintheoperationandserviceofthe TRACERlab MX FDG observe the health and safety regulations at all times.2.1. Radiation SafetyAllpersonnelassociatedwiththeoperationoftheTRACERlabMX FDGhavetobeinformedofallapplicable radioprotection laws and regulations and must be qualified in the handling of radioactive material.TheTRACERlabMX FDGisnotshielded.Itmustbeoperatedwithinahotcellwithsufficientshieldingtobe compliant with local radioprotection regulations. The waste bottle must be shielded, even when located within the hot cell. It is mandatory to close the door of the hot cell and keep the door closed during transfer of the radioactive 18F fluoride from the cyclotron to the TRACERlab MX FDG and during the entire FDG synthesis. After synthesis, thevialcontainingtheFDGsolutionhastobeplacedinashieldedcontainer.TheFDGvialmustbehandled using a manipulator (pliers) to avoid any radiation hazard during this operation. The FDG solution can also be transferreddirectlyintoashieldedviallocatedeitherintheproductionhotcell,orinaneighboringhotcell. After synthesis, the 18F transfer line, some parts of the TRACERlab MX FDG, the waste bottle and the disposable synthesis cassette will still be contaminated with radioactive material. Therefore the door of the hot cell must be kept closed until sufficient decay before removal of the cassette.After use, although it was rinsed, the disposable synthesis cassette contains residues of radioactive material. Do not remove the cassette before complete decay if it is not necessary. If possible, leave it in place for 24 hours. If the cassette has to be removed before complete decay of the radioactivity, ensure that this operation is done in a manner that avoids unnecessary radiation exposure to the operator (the removal operation must be done quickly, and the door of the hot cell must be closed immediately afterwards). The cassette contaminated with radioactive materialmustbediscardedincompliancewithlocalradioprotectionregulations.Itisrecommendedthatitis stored behind shielding for at least 48 hours after synthesis. Note that the cassette can also be contaminated with long half-life radioactive target impurities. Measure the remaining radioactivity on the cassette in order to ensure proper storage until sufficient decay.Itismandatorytouseprotectivegloveswhenhandlingthecontaminatedcassetteorwhenoperatingthe TRACERlab MX FDG after a hot synthesis.Accidentalliquidspillagesmaycontainradioactivematerial.Useprotectivegloveswhilewipingoffliquid spillages.18Version III - Last Update : June 2008 TRACERlab MX FDG - SERVICE MANUALDirection 2335256-100In the event of a radiation accident, all personnel must observe the applicable local laws and regulations.2.2 Caution relating to caustic substancesFollowingcausticsubstancesareinvolvedintheFDGproductionprocesswithTRACERlabMX FDG :sodium hydroxide solution and hydrochloric acid. Avoidskinandeyecontactwiththesesubstanceswhileconnectingthedisposablesynthesiscassetteandthe reagents onto the TRACERlab MX FDG, and while removing the cassette and the reagents from the TRACERlab MX FDG, since skin burns and damage would result. In the event of contact with the skin or eyes, wash the affected area immediately with copious amounts of water and seek prompt medical attention.Use protective gloves and safety glasses when handling the reagents and the cassette.After use, the disposable synthesis cassette may contain residues of caustic substances. Ensure that the cassette is discarded in a manner avoiding any risk of hazard due to these caustic substances.2.3 Caution relating to toxic substancesFollowing toxic substances are involved in the FDG production process with the TRACERlab MX FDG : acetonitrile, sodium hydroxide solution and hydrochloric acid. These toxic substances are hazardous if inhaled or swallowed. In the event of swallowing do not induce vomiting and seek prompt medical attention.Avoidskinandeyecontactwiththesesubstanceswhileconnectingthedisposablesynthesiscassetteandthe reagents onto the TRACERlab MX FDG, and while removing the cassette and the reagents from the TRACERlab MX FDG. Intheeventofskinandeyecontact,washtheaffectedarea withcopious amountsofwaterandseek prompt medical attention.Use protective gloves and safety glasses when handling the reagents and the cassette.After use, the disposable synthesis cassette may contain residues of toxic substances. Ensure that the cassette is discarded in a manner avoiding any risk of hazard due to these toxic substances.2.4 Caution relating to inflammable substancesFollowinginflammablesubstancesareinvolvedintheFDGproductionprocesswiththeTRACERlabMX FDG: acetonitrile and ethanol.These inflammable substances have to be handled in a manner avoiding any risk of ignition.Use protective gloves when handling the reagents and the cassette.Afteruse,thedisposablesynthesiscassettemaycontainresiduesofinflammablesubstances.Ensurethatthe cassette is discarded in a manner avoiding any risk of hazard due to these inflammable substances. Version III - Last Update : June 2008 TRACERlab MX FDG - SERVICE MANUALDirection 2335256-10019 2.5 Caution relating to liquid spillageSevere liquid spillage on the TRACERlab MX FDG may cause the main fuses to blow and may result in damage to the TRACERlab MX FDG. Cut off the power supply and wipe off any liquid spillage immediately. If the liquid is radioactive, wait until the radioactivity has decayed.Liquidspillagesmaycontainradioactive,causticortoxicsubstances.Useprotectivegloveswhilewipingoff liquid spillages.2.6 Electrical safetyBeforepoweringuptheTRACERlabMX FDG,whileinstallingtheequipment,makesurethatthevoltage corresponds to the requirements (label at the rear of the TRACERlab MX FDG)When carrying out maintenance on the TRACERlab MX FDG, make sure that the power supply is cut off prior to any operation.Cut off the power supply when removing the cover of the TRACERlab MX FDG.Note that the TRACERlab MX FDG is marked with the symbol and is compliant with the applicable European Directives and norms (cf. section related to CE marking)2.7 Temperature hazardA heating device is located on the front part, in the cavity destined for the reaction vessel.Do not touch the heating device when mounting the cassette onto the TRACERlab MX FDG, or when removing the cassette. In the case of malfunctioning, or when the heater is operated through the maintenance mode, high temperatures (up to 200 C) can be reached. To avoid skin burns, do not touch the heating element.2.8 Mechanical motion safetyThe following moving parts are part of the TRACERlab MX FDG : three syringe drivers, the pneumatic rotating actuators, the pneumatic clamps holding the cassette in place, and the elution mechanism moving down onto the reservoir of the cassette when the cassette is clamped.Do not touch these parts when they are in movement or when the cassette is clamped onto the TRACERlab MX FDG2.9 Caution relating to heavy objectsThe TRACERlab MX FDG weighs about 50 kg and can cause injury if not installed in a stable manner.20Version III - Last Update : June 2008 TRACERlab MX FDG - SERVICE MANUALDirection 2335256-100 2.10 Accident involving personal injuryIn the event of an accident involving personal injury, seek urgent medical attention.2.11 Accident involving fireIn the case of fire, follow the local emergency procedures. 2.12 Safety labelsThe following safety labels are used on the TRACERlab MX FDGDont touch the heating element while operating the TRACERlab MX FDG. The heater can reach high temperatures and cause skin burns.Location of the label :Front panel, near the heating element.Read the service manual before any servicing or sanitizing operation. Refer the servicing toqualified personnel. Location of the label :Right-hand lower corner on the front panel and left-hand lower corner on the rear panel. Switch off the mains power before removing the cover. Refer the servicing to qualified personnel. Location of the label : Right lower corner on the front panel and left lower corner on the rear panel. Ensure that the TRACERlab MX FDG is powered at the right voltage (240 Vac or 115Vac).Location of the label :Rear panel, near the power supply plug.2.13 Hazardous areas inside the TRACERlab MX FDGCut off the main power supply before removing the cover of the TRACERlab MX FDG or before any replacement of worn parts or repairing procedure.The following components, represented in the pictures below, are powered at 220V (or 115 V).- The main power supply plug and the wires connected to it240VAC115VAC240VAC115VAC240VAC115VAC240VAC115VACCAUTION !Version III - Last Update : June 2008 TRACERlab MX FDG - SERVICE MANUALDirection 2335256-10021- The 24Vdc power supply and the wires connected to it - The PLC power supply and the wires connected to it-Thetransformerandthewiresconnectedtoit(onlyforaTRACERlabMX FDGdesignedfor115Vacpower supply)- The main terminal connector block and the wires connected to it- The solid state relay and the wires connected to it- The heater and the wires connected to itDo not touch these components when the TRACERlab MX FDG is powered up. 22Version III - Last Update : June 2008 TRACERlab MX FDG - SERVICE MANUALDirection 2335256-100Solid state relay24 V DC power supplyPLC power supplyMain terminal block Toroidal Transformer(only for equipment powered at 120V)Power Supply plug Hazardous areas powered at 220Vac or 115VacVersion III - Last Update : June 2008 TRACERlab MX FDG - SERVICE MANUALDirection 2335256-10023HeaterHazardous areas powered at 220Vac or 115Vac (continuation)CHAPTER 3 : TRACERLAB MXSERVICE JOB SAFETY ANALYSIS (1)IMPORTANT SAFETY PROCEDURES TO BE OBSERVED PRIOR TO COMMENCING WORK :Measure radiation level in the room.Verify last production date and time. Use it to calculate estimated radiation level in the Process Module.Decide if radiation level low enough to start work, control removal of previous cassette and emptying of waste Jar.Verify if last production was completed.Verify cleanness and check for any chemical spillage.Verify system installation.RadiationNoneRadiationRadiationChemicalRadiationChemicalMechanicalIonization effect.Ionization effect and surface contamination.

Activity from previous production collected in the waste jar and O18 water recovery jar. Ionization effect and surface contamination.Exposure to Acetonitrile, Sodium Hydroxide, Hydrocloric acid and other chemicals.Ionization effect and surface contamination. Exposure to Acetonitrile, Sodium Hydroxide, Hydrocloric acid and other chemicals.The FDG-Tracer Lab weighs 48 Kg.DO NOT START ANY JOB IF THE DOSE RATE IS TOO HIGH, ALWAYS REQUEST APPROVAL FROM THE CUSTOMER RADIATION OFFICER.DO NOT START ANY JOB IF DOSE RATE TOO HIGH ACCORDING WITH THE JOB TIME NEEDED AND YOUR PERSONAL ACCUMULATED DOSE.IF THE CHEMICAL IS RADIOACTIVE, WAIT UNTIL THE RADIOACTIVITY HAS DECAYED TO A LEVEL COMPATIBLE WITH THE JOB TIME AND YOUR PERSONAL ACCUMULATED DOSE.BE SURE THAT ALL PRODUCTION WAS DELIVERED AND THAT RESIDUAL REAGENTS HAVE BEEN FLUSHED TO THE WASTE JAR. IF THE CHEMICAL IS RADIOACTIVE, WAIT UNTIL THE RADIOACTIVITY HAS DECAYED TO A LEVEL COMPATIBLE WITH THE JOB TIME AND YOUR PERSONAL ACCUMULATED DOSE.WEAR PPE TO AVOID SKIN AND EYE CONTACT WITH THESE SUBSTANCES. IN CASE OF CONTACT WASH ABUNDANTLY THE AFFECTED AREA WITH WATER AND REQUEST MEDICAL ATTENTION.VERIFY THAT THE SYSTEM IS INSTALLED IN A STABLE SUPPORT.SAFETY - REMEMBER : TIME; DISTANCE; SHIELDINGNEVER WORK ALONE IN THE RADIATION AREAJOB TITLE : Examine the casing of the Process ModuleTASKRiskLevelCAUSESHAZARDPPECONTROL MEASURESPPE Ensure the following PPE is available and worn at all times SAFETY SHOES FULL BODY LAB COAT SHOES COVER SAFETY GLASSES OR FACE SHIELD PROTECTIVE GLOVES PERSONAL FILM AND ELECTRONIC DOSIMETERWORKING ENVIRONMENT Ensure the following factors are present; ROOM VENTILATION ADEQUATE LIGHTINGLOTO Lock out and verify all ELECTRICAL SUPPLIES GASEOUS SUPPLIES COMPRESSED AIR SUPPLIESRISK LEVELOK to proceed with taskProceed with cautionDo not proceed until all safety precautions have been completed/... TRACERLAB MXSERVICE JOB SAFETY ANALYSIS (2)Look at containers and lines for any damage, leakage and level of flling.RadiationChemicalIonization effect and surface contamination.Exposure to Acetonitrile, Sodium Hydroxide, Hydrocloric acid and other chemicalsIF THE CHEMICAL IS RADIOACTIVE, WAIT UNTIL THE RADIOACTIVITY HAS DECAYED TO LEVEL THAT CAN BE SAFELY HANDLED.WEAR PPE TO AVOID SKIN AND EYE CONTACT WITH THESE SUBSTANCES. IN CASE OF CONTACT WASH ABUNDANTLY THE AFFECTED AREA WITH WATER AND REQUEST MEDICAL ATTENTION.SAFETY - REMEMBER : TIME; DISTANCE; SHIELDINGNEVER WORK ALONE IN THE RADIATION AREAJOB TITLE : Examine all waste liquid containersTASKRiskLevelCAUSESHAZARDPPECONTROL MEASURESRISK LEVELOK to proceed with taskProceed with cautionDo not proceed until all safety precautions have been completedJOB TITLE : Diagnostic procedure Disconnect system from electric power and close all gas suppliesVisual inspection Inspect cables and connectors Verify visually power supply and fusesElectricalNoneNoneElectricalContact with live or charged componentsContact with live or charged componentsAPPLY LOTO PROCEDURE.VERIFY THAT SYSTEM IS OFF AND LOTO APPLIED BEFORE REPLACING OR TOUCHING FUSES OR OTHER ELECTRONIC COMPONENTSJOB TITLE : Replace worn partsReplace tubes from the two pinch valvesReplacement of the Elution block.ChemicalRadiation/ regulationRadiation/ regulationExposure to Acetonitrile, Sodium Hydroxide, Hydrocloric acid and other chemicalsAccumulation of activity (solid deposit) inside the silicon tube of the INLET pinch valve.Accumulation of activity (solid deposit) inside the fuid pathwayWEAR PPE TO AVOID SKIN AND EYE CONTACT WITH THESE SUBSTANCES. IN CASE OF CONTACT WASH ABUNDANTLY THE AFFECTED AREA WITH WATER AND REQUEST MEDICAL ATTENTION.DO NOT DISPOSE OF THIS PIECE OF SILICON TUBE INTO THE TRASH. IT IS LIKELY TO CONTAIN TRACES OF LONGER HALF-LIFE ISOTOPES RELEASED BY THE TARGET SYSTEM. PLACE IT FOR STORAGE IN A LEAD CONTAINER FOR A FEW MONTHS. CUSTOMER SAFETY OFFICER WILL DECIDE WHEN IT CAN BE SAFELY DISPOSED OF. BE AWARE THAT TARGET TRANSFER LINE MAY STILL CONTAIN ACTIVITY AND MAY BE PRESSURIZED. WEAR PPE TO AVOID SKIN AND EYE CONTACT WITH THESE SUBSTANCES. IN CASE OF CONTACT WASH ABUNDA.DO NOT DISPOSE OF THIS PIECE INTO THE TRASH. IT IS LIKELY TO CONTAIN TRACES OF LONGER HALF-LIFE ISOTOPES RELEASED BY THE TARGET SYSTEM. VERIFY ACTIVITY LEVEL WITH APPROPRIATE SURFACE CONTAMINATION MONITOR. IF NEEDED, PLACE IT FOR STORAGE IN A LEAD CONTAINER./...26Version III - Last Update : June 2008 TRACERlab MX FDG - SERVICE MANUALDirection 2335256-100This page was left intentionally blank. TRACERLAB MXSERVICE JOB SAFETY ANALYSIS (3)Check the electronic vacuum gaugeCheck the pumpCheck all the internal valvesCheck the gas fow ratesCheck gas pressure levelsCheck the heaterCheck the syringe driversCheck the rotating actuatorsNoneNoneNoneNoneNoneNoneNoneNoneThermalMechanicalHeating device in reaction vessel cavityPinch risk from moving partsDO NOT TOUCH THE HEATING DEVICE WHEN MOUNTING THE KIT.AVOID TO TOUCH THEM WHILE THEY ARE MOVING OR WHEN THE KIT IS CLAMPED.SAFETY - REMEMBER : TIME; DISTANCE; SHIELDINGNEVER WORK ALONE IN THE RADIATION AREAJOB TITLE : Replace worn partsTASKRiskLevelCAUSESHAZARDPPECONTROL MEASURESRISK LEVELOK to proceed with taskProceed with cautionDo not proceed until all safety precautions have been completedReplace waste tubes and fttings exposed to radioactive liquid and gases.Replace valves subjected to chemical corrosion.ChemicalChemicalElectricalFluid remaining in the tubeExposure to Sodium Hydroxide, Hydrocloric acid or other chemicals.Contact with charged components.WEAR PPE TO AVOID SKIN AND EYE CONTACT WITH THESE SUBSTANCES. IN CASE OF CONTACT WASH ABUNDANTLY THE AFFECTED AREA WITH WATER AND REQUEST MEDICAL ATTENTIONWEAR PPE TO AVOID SKIN AND EYE CONTACT WITH THESE SUBSTANCES. IN CASE OF CONTACT WASH ABUNDANTLY THE AFFECTED AREA WITH WATER AND REQUEST MEDICAL ATTENTION.VERIFY THAT SYSTEM IS OFF AND LOTO APPLIED BEFORE REPLACING OR TOUCHING FUSES OR OTHER ELECTRONIC COMPONENTSUNLOCK ENERGY SOURCES AND SET SYSTEM TO OPERATIONAL CONDITIONSJOB TITLE : Check all module components. (It is assumed that the module contains no activity at that time).JOB TITLE : Install new FDG kitInsert new kit in placeEndVersion III - Last Update : June 2008 TRACERlab MX FDG - SERVICE MANUALDirection 2335256-10027CHAPTER 4 - CE MARKINGTheTRACERlabMX FDGismarkedwiththesymbolinconformancewiththefollowingdirectivesand harmonized standards : Electromagnetic Compatibility (EMC) Directive 89/336/EEC-CISPR 22 Information technology equipment - Radio disturbance characteristics - Limits and methods of measurement-Harmonized Standard EN61326 - 1 : 1997 Electrical equipment for measurement, control and laboratory use - EMC requirementsLow Voltage Directive 73/23/EEC-Harmonized Standard EN61010-1 : 2001Safety requirements for electrical equipment for measurement, control and laboratory useAlabelwiththerequiredpowersupplyvoltageisalsolocatednearthepowersupplyplugattherearofthe TRACERlab MX FDG.ThelabelwiththesymbolislocatedontherightsideoftheTRACERlabMX FDGtogetherwithalabel mentioning the model denomination, the serial number, the required power supply voltage and frequency.The following label is placed on the right side of an TRACERlab MX FDG to be powered at 220 Vac : The following label is placed on the right side of an TRACERlab MX FDG to be powered at 115 Vac :28Version III - Last Update : June 2008 TRACERlab MX FDG - SERVICE MANUALDirection 2335256-100This page was left intentionally blank.Version III - Last Update : June 2008 TRACERlab MX FDG - SERVICE MANUALDirection 2335256-10029CHAPTER 5 : DESCRIPTION OF THE EQUIPMENT1. General descriptionThemostcharacteristicfeatureoftheTRACERlabMX FDGistheuseofadisposablesynthesiscassette(also called kit) : the chemicals come in contact only with commercially available disposable components assembled as a hardware cassette based on the Luer connection system. Thehardwarecassetteisbuiltaroundthreemultiplestopcockmanifolds.Itincludesthelabelingreaction vial,theconnectionsforincomingandoutgoingfluids,spikesfortheconnectionwiththereagentcontainers, aswellasvariousSolidPhaseExtraction(SPE)cartridges,syringesandfilters.Thereagentsarepackedin standard containers with color coded crimp caps. The color coding permits easy identification of the reagents and corresponds with the colors of the spikes where they are plugged on.The front panel of the TRACERlab MX FDG closely matches the cassette and the reagent containers. It has an array of pneumatic actuators allowing the rotation of the valves of the manifolds, and three linear actuators to drive thesyringes.Thelabelingreactionvesselisplacedinaheaterequippedwithathermocouplefortemperature regulation.Avacuumpumpallowsthedrainingofthewastefluidsoutofthesystemintoashieldedexternal wastebottleconnectedtothepump.Thedifferentvacuumlevelsneededduringthesynthesis(fortheliquid transfers, solvent evaporation, etc.) are regulated through an electronic vacuum gauge. Solenoid valves located in the TRACERlab MX FDG ensure the connection between gas supply lines, vacuum lines and the cassette. Four radiation detectors are built into the system, allowing the measurement of the radioactivity entering the system, in the reaction vessel, on the hydrolysis cartridge and in the [18F]FDG final vial. A Programmable Logical Controller (PLC), located inside the TRACERlab MX FDG, operates all subsystems such as valves, actuators, heater, vacuum pump and sensors. The PLC is connected to a PC via a standard RS232 serial line cable. There is no electronic or switching box between the PLC and the PC. TheroleofthegraphicaluserinterfaceonthePCistoassisttheoperatorthroughouttheFDGproduction procedure, to allow visualization of the process, to view and record data and to prepare an after-synthesis report. Oncethesynthesishasbeenstarted,theTRACERlabMX FDGbecomesindependentfromthecomputerand will perform the synthesis autonomously. If the PC is disconnected or fails during the process, the process will continue normally until the end, as usual. The TRACERlab MX FDG can even be operated without a PC, using the remote control box. However, in this case there is no possibility of logging data or of viewing any measurements such as radioactivity, pressure or temperature.The TRACERlab MX FDG can be operated in the Synthesis Mode or in the Maintenance Mode.The Synthesis Mode is the mode used for routine FDG production. In this mode the operator is guided through thewholeFDGproduction.FormoredetailsaboutthismoderefertotheTRACERlabMX FDG:Operator Manual. The Maintenance Mode allows to operate any component of the TRACERlab MX FDG : rotating valve actuators, internal valves, syringe actuators, heater, vacuum pump and clamps holding the cassette in place. This operating mode is used to check the proper functioning of these components. 30Version III - Last Update : June 2008 TRACERlab MX FDG - SERVICE MANUALDirection 2335256-1002. Dimensions of the TRACERlab MX FDGThe dimensions of the TRACERlab MX FDG are as follows :length :564 mm (22.2") depth : 362 mm (14.3")height :420 mm (16.5")3. Weight of the TRACERlab MX FDGThe TRACERlab MX FDG weighs about 50 kg.4. ConnectionsThe permanent connections are located at the rear of the module. Refer to the TRACERlab MX FDG : Preinstallation and installation manual for more details.4.1 Connections at the rearThe following connections are located at the rear of the TRACERlab MX FDG (listed from right to left, as seen from the back) :- COMPR AIR connection : compressed air inlet (clean and dry air at 6-8 bars) with quick connect fitting for 4 mm O.D. tube;-N2connection:synthesisgasinlet(drynitrogenofhighpurityat2-10bars)withfemaleLuerlock connector;- INPUTSplug : logical input socket plug (not used for the FDG synthesis);- OUTPUTS plug : logical output socket plug (not used for the FDG synthesis);-REMOTECONTROLplug:logicalinput/outputsocketplugallowingconnectiontotheRemoteControl Box, or to get a 24 Vdc signal when the TRACERlab MX FDG is ready to receive the irradiated 18O-water and when the FDG is ready. Note that the connection of the Remote Control Box is optional and not required to operate the TRACERlab MX FDG;- REMOTE DETECTOR plug : socket plug allowing switching from the built-in activity detector located at the cavity destined to receive the final product vial, to an external detector in case the final vial is not located in the TRACERlab MX FDG but for example in a neighboring hot cell;- HEATER FUSE;-P.C.plug:serialconnectionplug,standardDB9plugforRS232serialcommunicationcablebetweenthe TRACERlab MX FDG and the operator PC;-Power supply plug : standard IEC plug (240 Vac or 115 Vac.) with grounding and fuses;-TOWASTEconnection:maleluerlockconnectortowhichtheinletoftheexternalwastebottleis connected;- FROM WASTE connection : female luer lock connector to which is the outlet of the external waste bottle is connected;- EXHAUST connection : gaseous outlet of the pump, male luer lock connector to which a gas collection bag may be connected (to let gaseous radioactivity decay) or a line leading to the chimney of the hot cell;Version III - Last Update : June 2008 TRACERlab MX FDG - SERVICE MANUALDirection 2335256-100314.2 Connections on the frontThe following connections located on the front panel of the TRACERlab MX FDG ensure the connections between the TRACERlab MX FDG and the cassette.- 18O-Water recovery fitting, located on the bottom left of the front panel, used to set the 18O-Water recovery vial to vacuum;-Apermanenttube,locatedbelowthe18Finletvalveontheleftsideofthefrontpanel,connectsthefront panel to the elution system and the reservoir of the cassette. The corresponding female luer lock connector on the front panel provides pressure and vacuum to the elution system and the reservoir receiving the irradiated 18O-water ;- The target line (i.e. the line used to transfer the irradiated 18Owater from the cyclotron to the TRACERlab MX FDG) is connected directly to the elution system and the reservoir via the tube passing through the 18F inlet valve on the left side of the front panel;- 2 female luer lock connectors are used to connect the cassette to the TRACERlab MX FDG ;- Pressure inlet connector on the left side of the front panel : supplies gas (nitrogen) to the left of the cassette ;- Exhaust connector on the right side of the front panel, sets the cassette to vacuum and drains the fluids to the waste;5. Front view of the TRACERlab MX FDGThe white lead piece on the front panel of the TRACERlab MX FDG is designed to closely match the disposable cassette.Thefrontpanelhas3syringedriversandanarrayof15rotatingactuatorsadaptedtothestopcock manifolds of the cassette.The elution system with the cap for the reservoir, located in the upper left corner of the front panel, can move up and down. In the upper position, the reservoir and the anion exchange cartridge of the synthesis cassette can be placed or removed. The cap connects to the reservoir when the elution system is in the down position. The elution system can be moved by pressing the Clamp button located on the front panel of TRACERlab MX FDG. This will also actuate the three clamps used to hold the cassette on the front panel (see below).Three clamps, flush with the horizontal table in their released position, pop out of the table surface when actuated and hold the cassette in place during the FDG production process. This is done by pressing the Clamp button located on the front panel of the TRACERlab MX FDG.There are two cavities in the horizontal table. The left cavity receives the reaction vessel and contains the heater, whereas the right cavity receives the final FDG vial. Both cavities are equipped with a radiation detector.3 light indicators located on the front panel of the module will inform the operator when the TRACERlab MX FDG is powered up , when it is ready to receive the irradiated 18O-water and when the final FDG is ready (synthesized).32Version III - Last Update : June 2008 TRACERlab MX FDG - SERVICE MANUALDirection 2335256-100123 4 5 4 6 7 4899223 5 6 7 4811232412121314 15 16 171820 21 Front view without the front cover and without the white lead piece matching the cassette.Version III - Last Update : June 2008 TRACERlab MX FDG - SERVICE MANUALDirection 2335256-10033NName and description1Radiation detector # 1: behind the anion exchange cartridge.2Rotating actuator # 1 (the actuators are numbered from the left to the right).318O-Water recovery fitting: sets the 18O-water recovery vial to vacuum.4Clamps: hold the cassette in place.5Heater equipped with a radiation detector (# 2): contains the reactor vessel. 6Radiation detector # 3: behind the tC-18 cartridge used for hydrolysis.7Cavity equipped with a radiation detector (# 4): housing for the vial that will receive the final FDG. 8Rotating actuator # 15 (the actuators are numbered from left to right).9Lead shielding: closely matches the cassette.10Cassette holder: maintains the cassette in place during synthesis.11Exhaust connector: female luer lock connector, connects the cassette to the TRACERlab MX FDG - sets the cassette to vacuum and drains the fluids to the waste.12Vacuum adjustment potentiometer.13Mechanical vacuum gauge.14Syringe driver # 3 (30 ml).153lightindicators:informtheoperatorwhentheTRACERlabMX FDGispoweredup,whenitisreadyto receive the irradiated 18O-water and when the final FDG is ready (synthesized).16Clamp button: actuates the clamps and moves the elution system down onto the reservoir of the cassette.17Syringe driver # 2 (3 ml).18Screws: to adjust the height of the water bag hook.19Hook: to attach the water bag.20Syringe driver # 1 (30 ml).21Elution system containing a pinch valve and a conical block, fitting onto the reservoir of the cassette2218F inlet valve: the target line (i.e. the line used to transfer the irradiated 18Owater from the cyclotron to the TRACERlab MX FDG) is connected directly to the elution system and the reservoir via the tube passing through it.23Permanenttubeprovidingpressureandvacuumtotheelutionsystemandthereservoirofthecassette. Connected between the front panel and the elution system. 24Pressure inlet connector: female luer lock connector connects the cassette to the TRACERlab MX FDG - supplies gas (nitrogen) to the left of the cassette.34Version III - Last Update : June 2008 TRACERlab MX FDG - SERVICE MANUALDirection 2335256-1006. Rear view, central part of the TRACERlab MX FDGThe electronic and electric parts are gathered in the central part of the TRACERlab MX FDG. Most of them are visible from the rear when the cover is removed :- PLC, with 32 + 16 logical outputs, 16 logical inputs and 3x4 analog inputs;- 24 Vdc, 150 W supply, used to energize all the PLC outputs and the syringe actuators;- Solid state relay that controls the heater resistance;- 3 subassemblies of rotating actuators, and related valve manifolds;- 3 linear drive boards, with electric motor (syringe drivers);- 1 pneumatic linear motion board for the reservoir cap;- 1 transformer for the TRACERlab MX FDG to be powered at 115Vac.16 171819 20 21 22 23 24 25 26 27131091 2 3 4 5 6 7 811141215Version III - Last Update : June 2008 TRACERlab MX FDG - SERVICE MANUALDirection 2335256-10035N Name and description1Power supply : 24 Vdc, 150 W supply, used to energize all the PLC outputs 2PLC power supply : 110 Vac or 220 Vac to 24 Vdc energizes the PLC3PLC key : left : RUN middle : REMOTE right : PROGRAM4PLC CPU (SLC 5/04 16 K RAM) : processor containing the PLC programs (ladders)5PLC32logicaloutputs(24Vdc0.5Aperpoint8Apermodule):32logicaloutputselectronically protected. 6PLC 16 logical outputs (24 Vdc 1A per point 8A per module) : 16 logical outputs electronically protected.7PLC 16 logical inputs (24 Vdc) : 16 logical inputs electronically protected.8PLC 4 analog inputs : 3 cards of 4 analog inputs.9Solid state relay : controls the heater resistance10Subassembly of rotating actuators and related valve manifolds # 11 to 15.11Subassembly of rotating actuators and related valve manifolds # 6 to 10.12Subassembly of rotating actuators and related valve manifolds # 1 to 5.13Vacuum pump : sets the waste bottle and the cassette to vacuum.14Transformer : converts 115 Vac to 220 Vac (only on TRACERlab MX FDG at 115Vac).15Nitrogen filter : filters the incoming nitrogen at 7 m.16EXHAUST connection : gaseous outlet of the pump, male luer lock connector to which a gas collection bag may be connected (to let radioactivity decay) or a line leading to the chimney of the hot cell.17FROM WASTE connection : female luer lock connector to which is connected the outlet of the external waste bottle (tube which sets the waste bottle to vacuum)18TOWASTEconnection:maleluerlockconnectortowhichisconnectedtheinletoftheexternalwaste bottle (tube connecting the outlet of the cassette to the waste bottle)19Power supply plug : standard IEC plug (240 Vac or 115 Vac.) with grounding and fuses.20P.C. plug : serial connection plug, standard DB9 plug for RS232 serial communication cable between the TRACERlab MX FDG and the user interface computer.21HEATER FUSE. Housing for the fuse dedicated to the heater.22REMOTE DETECTOR plug : plug allowing the switching from the built-in activity detector located at the cavity destined for the final product vial, to an external detector, in the case where the final vial is not located in the TRACERlab MX FDG but for example in a neighboring hot cell.23REMOTE CONTROL plug : logical input/output socket plug allowing connection of the Remote Control Box, or to get a 24 Vdc signal when the TRACERlab MX FDG is ready to receive the irradiated 18O-water, or when the FDG is ready. 24OUTPUTS plug : logical output socket plug (not used for the FDG synthesis).25INPUTS plug : logical input socket plug (not used for the FDG synthesis).26N2connection:synthesisgasinlet(drynitrogenofhighpurityat2-10bars)withfemaleLuerlock connector.27COMPR AIR connection : compressed air inlet (clean and dry air at 6-8 bars) with quick connect fitting for 4 mm O.D. tube.36Version III - Last Update : June 2008 TRACERlab MX FDG - SERVICE MANUALDirection 2335256-1007. Left side view (as seen from the front) The nitrogen supply circuit and the compressed air supply circuit are gathered together on this left panel. Nitrogen is used as a synthesis gas and compressed air is used to actuate the pneumatic parts of the TRACERlab MX FDG. 1 2 3 4567811109Version III - Last Update : June 2008 TRACERlab MX FDG - SERVICE MANUALDirection 2335256-10037NName and description1HP valve (valve 1-18) : the high pressure valve provides high pressure (0.7 bars) to the elution system and the reservoir of the cassette. 2HF valve (valve 1-19) : the high flow valve provides flow-rate (between 300 and 600 ml/min at a pressure of about 0.7 bars) to the pressure inlet connection on the front panel. The flow is fixed by a flow restrictor consisting of a very small inner diameter tube located downstream of the valve. 3LF valve (valve 1-20) : the low flow valve provides flow-rate (between 25 and 45 ml/min at a pressure of about 0.7 bars) to the pressure inlet connection on the front panel. The flow is fixed by a flow restrictor consisting of a very small inner diameter tube located downstream of the valve.4Electronic circuit board containing resistances for the activity detectors.5HP pressure regulator : the high pressure regulator sets the pressure to 0.7 bars for the HP valve (valve 1-18), the HF valve (valve 1-19) and LF valve (valve 1-20).6Compressed air pressure switch : checks if the incoming air pressure reaches a minimum of 3.5 bars.7LP pressure regulator : the low pressure regulator sets the pressure to 0.4 bars for the LP valve (valve 1-23).8Nitrogen pressure switch : checks if the incoming nitrogen pressure reaches a minimum of 1.5 bars.9Compressed air filter and pressure regulator : filters the incoming compressed air at 5m and sets the air pressure to 4.5 bars.10Vac valve (valve 1-17) : the vacuum valve connects the waste bottle to the elution system and the reservoir of the cassette.11LP valve (valve 1-23) : the low pressure valve provides low pressure to the elution system and the reservoir of the cassette.7.1 Nitrogen supply circuitApressureswitchverifiesthesupplyofnitrogentotheTRACERlabMX FDG.Thenitrogensuppliedtothe TRACERlab MX FDG is filtered by a filter located near the bottom of the panel, and the pressure level is regulated through 2 gas pressure regulators : the high pressure regulator (HP) and the low pressure regulator (LP).The flow-rate settings are determined by adjusting the pressure regulators, and by fixed flow restrictions downstream from the regulators.- The line opened by valve n1-20 (upper regulator, 0.7 bars) sets the low gas flow-rate used during the evaporation process;- The line opened by valve n1-19 (upper regulator, 0.7 bars) sets the high flow-rate used for pressurizing vials and syringes, for flushing transfer lines, ...etc.- Thelineopenedbyvalven1-23(lowerregulator,0.4bars)setsthepressureusedtopushthetargetwater through the recovery cartridge;- The line opened by valve n1-18 (upper regulator, 0.7 bars) is used to pressurize the eluent and to flush the anion exchange cartridge; - The line opened by valve n1-17 is used to set the reservoir above the anion exchange cartridge to vacuum. This aids the transfer from the target.7.2 Compressed air supply circuitA pressure switch verifies the continued supply of compressed air to the TRACERlab MX FDG. The compressed air supplied to the TRACERlab MX FDG is regulated and filtered by the pressure regulator located near the bottom of the panel. 38Version III - Last Update : June 2008 TRACERlab MX FDG - SERVICE MANUALDirection 2335256-1008. Right side view of the TRACERlab MX FDGAll devices related to waste collection are located on or near the right side panel- The pump that creates vacuum,- The valve that isolates the module from the external exhaust tube,- The electronic vacuum gauge, which controls the pump and the valve.12345Version III - Last Update : June 2008 TRACERlab MX FDG - SERVICE MANUALDirection 2335256-10039NName and description1Kit exhaust valve (valve 1-24) : connects the waste bottle to the Exhaust connector on the front panel. Used to creates a vacuum in the cassette (also called kit) and to drain the out-coming waste fluids to the waste bottle.2Valve 2-1 : valve which is closed automatically when the pump is not activated. Used to isolate the system and to prevent any possible inlet from the exhaust connector at the rear, through the pump into the cassette when the pump is not activated.3Vacuum to 18O water valve (valve 1-21) : connects the waste bottle to the 18O-Water recovery fitting on the front. Sets the 18O-Water recovery vial to vacuum.4Electronic vacuum gauge5Solid state relay : provides power (220 Vac) to the heater.40Version III - Last Update : June 2008 TRACERlab MX FDG - SERVICE MANUALDirection 2335256-1009. Top view of the TRACERlab MX FDGNName and description1Mechanical vacuum gauge.2Syringe driver # 3 (30 ml).3Syringe driver # 2 (3 ml).4Hook : to attach the water bag.5Syringe driver # 1 (30 ml).6Elutionsystempneumaticactuator:movestheelutionsystemfrontpiecedownontothereservoirofthe cassette.718F inlet valve : see section relating to the front view8Power supply : 24 Vdc, 150 W supply, used to energize all the PLC outputs 9PLC : Programmable Logical Controller1 2 395 6 78Version III - Last Update : June 2008 TRACERlab MX FDG - SERVICE MANUALDirection 2335256-10041CHAPTER 6 : MAINTENANCE MODEThe maintenance mode allows to act upon any component of the TRACERlab MX FDG : rotating valve actuators, internal valves, syringe actuators, heater, vacuum pump and clamps holding the cassette in place. This operating mode is used to check the proper functioning of these components.Thedisposablesynthesiscassetteisalsocalledkit.Thetermkitisgenerallyusedintheuserinterface software, rather than cassette.1. Setting of the TRACERlab MX FDG to the maintenance modeOntheWindowsdesktop,double-clickontheFDGsupervisionsoftwareshortcut.ThiswilllaunchtheFDG supervision program, and all necessary associated software components.AfewsecondslateryouwillreachtheAboutwindowshowingapictureoftheTRACERlabMX FDGand program version information. This window can be reopened anytime by pressing the About tab at the top of the window.42Version III - Last Update : June 2008 TRACERlab MX FDG - SERVICE MANUALDirection 2335256-100At this stage, the TRACERlab MX FDG is in stand-by mode, i.e. in safe mode, with all output de-energized. The general layout of the main window consists of a set of sub-windows accessible through tabs : About, Maintenance, Synthesis, Report, Trending and Calibration. According to the status of the TRACERlab MX FDG, some tabs are deactivated by the system, restricting access to the corresponding view.Inthe case where the TRACERlabMX FDGisnot powered up ornot connected to thePC,thefollowing error indicator will be displayed in the bottom right-hand corner of the About window.As long as the supervision program is running, the link to the TRACERlab MX FDG unit is continuously monitored. Should a fault condition occur, the About window will pop-up, indicating that the PLC is not powered up, or not connected to the PC.Click on the Set to maintenance mode button in the lower left-hand corner. This will open the Maintenance window.Version III - Last Update : June 2008 TRACERlab MX FDG - SERVICE MANUALDirection 2335256-100432. Activation of the rotating valve actuatorsThereare15pneumaticrotatingactuatorsallowingtherotationofthedisposablevalvesofthecassette.All these valves are aligned on the axis of the cassette when not activated. Each actuator can turn by 90, but only in one direction : either to the left, or to the right (except for the second actuator, see below). To activate a rotating actuator click on the corresponding rotating valve displayed on the screen. When activated, the corresponding valves become green.The only actuator which can turn in both directions is the second one from the left side, which is located below the anion exchange cartridge of the cassette. To activate this rotating actuator, click on the corresponding rotating valve as displayed on the screen. Then the valve position dialog box will be opened, allowing the actuator to be turned either to the right, or to the left.3. Activation of internal valvesThere are 11 internal valves which can be activated through the maintenance mode : 18F inlet pinch valve (normally open) : inlet of irradiated 18O water containing the 18F ions (connection to the conical reservoir of the cassette) Vac valve (normally closed) : valve allowing to set the conical reservoir of the cassette to vacuum (connection with the waste bottle) LP valve (normally closed) : valve allowing the pressurizing of the conical reservoir of the cassette at a low pressure level HP valve (normally closed) : valve allowing the pressurizing of the conical reservoir of the cassette at a high pressure level LF valve (normally closed) : valve supplying nitrogen to the cassette inlet at the low flow-rate level (and at a high pressure level) HF valve (normally closed) : valve supplying nitrogen to the cassette inlet at the high flow-rate level (and at a high pressure level) Nitrogen valve (normally open) : main nitrogen supply valve Compressed air valve (normally open) : main compressed air supply valve Eluent valve (normally closed) : valve connecting the eluent vial to the conical reservoir of the cassetteVacuum 18Owatervalve(normallyclosed):valveallowingtosettheenriched 18Owaterrecoveryvialto vacuum (connection with the waste bottle)44Version III - Last Update : June 2008 TRACERlab MX FDG - SERVICE MANUALDirection 2335256-100 Kit exhaust valve (normally closed) : valve allowing to drain the waste fluids to the external waste bottle and to set the kit, i.e. the cassette, to vacuum.Click on the corresponding symbol on the screen to open or close a valve. The valve is displayed in red when closed and in green when open, e.g. the picture below shows the display on the screen when the HF valve is opened and the LF valve remains closed.4. Operation of the syringe driversThere are 3 syringe drivers on the front panel of the TRACERlab MX FDG : Two syringe drivers for 30 ml syringes equipped with a hooking mechanism, allowing the syringe piston to be pushed and pulled. One syringe driver for a 3 ml syringe. This syringe driver allows the syringe piston to be pushed only.The position of the syringe drivers is given in mm above the empty position (piston down to the bottom). The range for the position of the syringe drivers is between 0 and 92 mm.These syringe drivers can be operated in 2 ways :1. Drag the syringe piston to the chosen position2. Enter the chosen position in the setpoint field of the corresponding position dialog box.Drag the syringe pistonEnter a position setpointVersion III - Last Update : June 2008 TRACERlab MX FDG - SERVICE MANUALDirection 2335256-100455. Operation of the heaterTooperatetheheater,enterthechosentemperature(between0and200C)intheSetpointfieldofthe Temperature dialog box. The current measured temperature is displayed in the field below the setpoint.The temperature measurements are monitored and displayed graphically versus time in the temperature trending window accessible through the Trending tab in the top part of the screen.6. Operation of the vacuum pumpThevacuumpumpallowstosetthewastebottletovacuum.Tooperatethevacuumpump,enterthechosen vacuum level (between -1 and 0 bars) in the Setpoint field of the Pressure dialog box. The current measured vacuum is displayed in the field below the setpoint.The vacuum measurements are monitored and displayed graphically versus time in the pressure trending window accessible through the Trending tab in the top part of the screen.Note :These pressure dialog boxes can be used to perform leak tests in the maintenance mode: for example, one can check if there is a leak on the waste bottle cap or on the enriched 18O-water recovery vial cap as follows: 1. Waste bottle leak test :Choose a vacuum setpoint of 0.6 bars in the Pressure dialog box. After a few seconds the setpoint is reached. If there is a leak on the waste bottle cap or the connections and tubes leading to the waste bottle there will be a drop in the measured vacuum and the pump will start again after a few seconds. A drop in vacuum of up to 0.00346Version III - Last Update : June 2008 TRACERlab MX FDG - SERVICE MANUALDirection 2335256-1000.003 bars per sec is not significant and the synthesis will not be affected. Note that the kit test (i.e. the cassette test) performed before an FDG synthesis will detect leak drops above 0.001 bars per sec2. Enriched water recovery vial leak test : Forthistest,theenriched 18O-waterrecoveryvialhastobeconnectedtoacassetteortheconnectorusedto connect this vial to the cassette has to be blocked. Connect the water recovery vial to the waste bottle by opening the Vacuum 18O water valve. Choose a vacuum setpoint of 0.6 bars in the Pressure dialog box. After a few seconds the setpoint is reached. If there is a leak on the enriched 18O-water recovery vial cap, on the waste bottle cap, or on the connections and tubes leading to the waste bottle or the 18O-water recovery vial, there will be a drop in the measured vacuum and the pump will start again after a few seconds. A drop in vacuum of up to 0.003 bars per sec is not significant and the synthesis will not be affected. Note that the kit test (i.e. the cassette test) performed before an FDG synthesis will detect leak drops above 0.001 bars per sec. 7. Operation of the clamps holding the cassette in placeThe pneumatic clamps holding the cassette in place can be activated and deactivated through the Clamp Kit button.8. Resetting of the outputsThe Reset outputs button in the lower right-hand corner, allows the operator to de-energize all the outputs and reset the setpoints to zero Version III - Last Update : June 2008 TRACERlab MX FDG - SERVICE MANUALDirection 2335256-10047CHAPTER 7 : CALIBRATION OF THE ACTIVITY DETECTORSThe four activity detectors can be calibrated using the Calibration window accessible in the maintenance mode through the corresponding tab at the top of the screen.Note that the accuracy of the activity measurements through these built-in detectors is about 10 %.The calibration is made by adjustment of the calibration parameter named Slope. The slope is the ratio between the digital electrical output level of the detector and the correct radioactivity level. (The digital detector signal is 16 bit, per mCi). For this reason, if you increase the Slope, the displayed value will decrease, e.g. if you multiply the slope by a factor of 2, the activity measurement given by the detector will be divided by 2.The calibration of the detectors is carried out through a comparison of the activity reading given by the built-indetectorandtheeffectiveactivityinfrontofthedetector.Adosecalibratorprovidingaccurateactivity measurements is needed for the calibration.There are two ways to calibrate the detectors : Routine calibration andManual calibration1. Routine calibration procedureIt is recommended that a routine calibration of the four activity detectors is carried out at least once a year, during the yearly maintenance of the TRACERlab MXFDG. For the calibration of the detectors, it is necessary to accurately measure the activities using a calibrated dose calibrator and to write down the measured values as well as the time of measurement. Make sure that the time on the clock used for these measurements corresponds to the time given on the PC with the FDGsupervision software.If some decimal values are not properly accepted while performing the calibration, this is related to the decimal separator fixed in the Windows regional settings. Choose a dot as a decimal separator in the Windows settings.To carry out the calibration proceed as follows :1. Perform a hot run with a starting activity level close to the average routine production level. It is not necessary to perform a special run uniquely for the calibration of the detectors. The calibration of the detectors can be donewitharoutineFDGproductionrun.Notethatthefourthdetector,measuringtheactivityintheFDG solution, can only be calibrated if the final product vial is located in the relevant cavity.2.Aftersynthesissavethereport.DonotstartanewFDGsynthesisbeforecompletionofthecalibration procedure.48Version III - Last Update : June 2008 TRACERlab MX FDG - SERVICE MANUALDirection 2335256-1003.IfthecalibrationofthedetectorismadeusingaroutineFDGproductionrun,itisnecessarytoaccurately measuretheactivityinthefinalproductvialusingadosecalibratorbeforereleaseoftheFDGsolutionfor medical use. Write down the effective activity in the final product vial and the time of measurement. 4.Aftersufficientdecay,afterreachingaradiationlevelbelowthelimitsgivenbyapplicableradiationsafety regulations, remove the cassette from the TRACERlab MXFDG and dismantle the cassette. Use protective gloves while handling the contaminated cassette.5.Measuretheresidualactivityonthefollowingitemsandwritedownthemeasuredactivityandtimeof measurement : FDG final product vial, external waste bottle, enriched water recovery vial, conical reservoir, QMA cartridge (blue ring), hydrolysis tC18 cartridge (red ring), purification tC18 cartridge (red ring), alumina Ncartridge(greenring),reactorvesselwithcapandtubes,tubeleadingtothefinalproductvialandfilter, Manifold 1 with fittings, Manifold 2 with fittings, Manifold 3 with fittings and the two 30 ml syringes.6. Set the TRACERLab MXFDG to the Maintenance mode7. Open the Calibration window through the tab at the top of the screen. Version III - Last Update : June 2008 TRACERlab MX FDG - SERVICE MANUALDirection 2335256-100498. Proceed with step 1 (box in the upper left-hand corner) : get the time at the start of synthesis and the activity measurements taken by the built-in detectors during the hot run by pressing the Get values from last synthesis button.Notethatthesevaluescanalsobetakenfromthesynthesisreportandbeintroducedmanually,for example when another FDG production has been carried out after the run carried out for calibration purpose. Press the Next button to proceed. 9. Proceed with step 2 (box on the right-hand side) : fill in the fields with the activity measurement on each item and the time of measurement. Press the Next button to proceed. Themostimportantactivitymeasurementsarethetenfirstitemslistedabove.Ifyouomittomeasurethe residual activity on some items, put a 0 activity level in the corresponding Radioactivity field and fill in the time of measurement field with a random time. Omitting some activity measurements might lead to a lower accuracy of calibration.50Version III - Last Update : June 2008 TRACERlab MX FDG - SERVICE MANUALDirection 2335256-10010. Proceed with step 3 (box in the lower left-hand corner) :the box now displays the current slopes for the four detectors and the new slopes calculated using the activity measurements. It is recommended that a record of both values is kept in your internal files relating to the TRACERlab MXFDG. 11. Transfer the new slope values to the TRACERlab MXFDG by pressing the Transfer values to synthesizer button.Assoonasthetransferisfinishedthecurrentslopewillbereplacedbythenewslopeinthe corresponding fields of the Step 3 box. Additional radiation safety recommendation :The FDG synthesis for calibration purpose should be performed as early as possible in the morning and the measurement of the activity as late as possible in the evening to allow the activity to decay. For example, if the run is performed at 6:00 in the morning with 1000 mCi, there would be about 11 mCi left at 18:00 in the evening. The activity will be distributed approximately as follows : about 60 % in the FDG vial, about 35 % in the waste bottle and about 5 % (usually less than 3 %) on the different cassette components. For each item, the activity measurement can be done in a few seconds. Normally the dose calibrators are shielded and thus there is exposure only while putting the item into the dose calibrator and while removing it.BeforestartingtheFDGsynthesis,ensurethatthewastebottleisproperlyshielded(withinthehot-cell)to avoid unnecessary exposure while removing the cassette from the synthesizer at the end of the day.Checkthatthewastebottlefitsintothedosecalibrator.Ifnot,thewastefluidshavetobetransferredinto another vial fitting into the dose calibrator.Afteropeningthehotcellattheendoftheday,thefirstthingtodoistoremovetheFDGvialfromits location in front of the detector (cavity on the front of the TRACERlab MX FDG) and to place it into a shielded container.After removal of the cassette and disconnection of the waste bottle, place the cassette and the waste bottle into a shielded container until measurement of the residual activity.2. Manual calibration procedure The slopes can also be adjusted manually. To estimate a new slope, the activity measurement displayed on the screen must be compared with the real activity on the corresponding element, measured with a dose calibrator. To Version III - Last Update : June 2008 TRACERlab MX FDG - SERVICE MANUALDirection 2335256-10051allow for comparison, both activity measurements have to be corrected for decay using the same reference time.The slope can be adjusted by multiplying the current slope by a corrective factor, which is the ratio between the activitymeasurementgivenbythedetectoroftheTRACERlabMXFDG(correctedfordecay)andtheactivity measurement on the relevant cassette component given by a dose calibrator (corrected for decay).Note that the activity detectors are very sensitive to the geometry of the radioactive source, Therefore they have to be calibrated with the same geometrical distribution of radioactivity as during a FDG synthesis.To allow for an accurate manual calibration, it is recommended that a hot synthesis is performed, to abort the synthesis as soon as the activity is on the relevant cassette component in front of the detector to be calibrated and to measure the activity on the relevant cassette component after sufficient decay : -For detector 1 : abort the synthesis after the trapping of the 18F onto the anion exchange (QMA) cartridge.-For detector 2 : abort the synthesis after evaporation of the solvents, just before the labeling step.-For detector 3 : abort the synthesis after the trapping of the labeled intermediate onto the tC18 cartridge, just before thehydrolysis step.- For detector 4 : abort the synthesis after the transfer of the FDG solution into the final product vial.Example :With a slope of 6.35, the detector behind the QMA cartridge gives an activity measurement of856 mCi, after the trapping of 18F onto the cartridge at 5:03.The decay-corrected activity (reference time = start of synthesis i.e. 5:00) is 872 mCi.Afterthetrappingofthe 18FontotheQMAcartridge,thesynthesisisabortedandtheactivityontheQMA cartridge is measured after sufficient decay. The activity measured on the QMA cartridge is 4.892 mCiat 19:14 i.e. 1063 mCi corrected for decay to the reference time.Thus the corrective factor is 0.82 (i.e.872/1063) and the adjusted slope is -5.21 (i.e. 6.35 * 0.82)Proceed as follows to transfer new estimated slopes into the TRACERlab MXFDG:1. Set the TRACERlab MXFDG to the Maintenance mode2. Open the Calibration window through the tab at the top of the screen.3. The current slopes for the four detectors are displayed in the Step 3 box (lower left-hand corner). Take these values to estimate new slopes as described above.52Version III - Last Update : June 2008 TRACERlab MX FDG - SERVICE MANUALDirection 2335256-100 4. Click on the Manu button to switch to the manual calibration mode and new fields will appear allowing the entering of the new slopes. Enter the new slopes. If some slopes are not modified, the current slope value must be copied in the field designated for the new slopes. It is recommended that a record of both values is kept in your internal files relating to the TRACERlab MXFDG. 5.Whenallthenewslopefieldshavebeenfilledin,theTransfervaluestosynthesizerbuttonbecomes accessible, and the values can be transferred to the TRACERlab MXFDG.3. Setting the four activity detectors to zeroThe activity detectors might give an activity measurement, even in the absence of any source of activity, due to a drift of the detectors electrical output depending on environmental parameters such as temperature. Therefore beforeeachsynthesisthebackgroundismeasuredandalltheactivitymeasurementsareautomaticallysetto zero and the drift is corrected at the beginning of the FDG production process, thus it is not necessary to set the activity readings to zero manually.Theactivitydetectorscanbeforcedtozero(takingintoaccountthebackgroundandcorrectingthedrift)by pressing the Zero activity calibration of all detectors button in the Calibration window.4. Display the detectors slope and offsetThe detector slope and offsets can be displayed by pressing the Display detector slopes and offsets button in the Calibration window.Version III - Last Update : June 2008 TRACERlab MX FDG - SERVICE MANUALDirection 2335256-10053The following Radioactivity detectors window is displayed :The offset values should normally range between 26000 and 31000. The offset may be out of range if :- Zero calibration of all detectors was performed while activity was still present- detector wiring fault- non a standard detector.5. Adjustment of the detector positioning in the case of saturationAt high activity levels, i.e. several curies of starting activity, the activity detectors might saturate.In this case the activity measurement displayed on the screen will not exceedacertain value, whatever the level of activity in front of the detector.In the case of saturation of the detectors, the distance between the detector and the radioactive source has to be increased. Refer to the procedure MR-001-011, of the appendix, to adjust the position of the activity detectors 54Version III - Last Update : June 2008 TRACERlab MX FDG - SERVICE MANUALDirection 2335256-100This page was left intentionally blank.Version III - Last Update : June 2008 TRACERlab MX FDG - SERVICE MANUALDirection 2335256-10055CHAPTER 8 : WEEKLY MAINTENANCEEvery week it is recommended to carry out a preventive maintenance on the TRACERlab MX FDG. This weekly maintenance consists of the replacement of the silicone tube from the eluent pinch valve. The dimensions of the tube from the eluent pinch valve are : inner diameter = 0.58 mm, outer diameter = 2.4 mm, length = 100 mm. Refer to the procedure MR-001-003 in the appendix of this manualImportant notes :To avoid the tube remaining pinched where it is in the pinch valve, it is strongly recommended to carry out one of the following procedures between 2 syntheses : 1. move the tube within the pinch valve by a few mm before each FDG production. 2. take the tube out of the pinch valve (but leave the tube connected onto the elution system) between two FDG productions. Ensure that the tube is placed back into the pinch valve before the next FDG synthesis. Itisalsorecommendedtoremovethetubefromthevalvewhentheequipmentisnotusedformorethanone week.Some Kryptofix or potassium carbonate from the eluent mixture may crystallize and accumulate in the silicone tube of the eluent pinch valve, which may lead to an obstruction of the tube. It is recommended that the tube is replaced as soon as white residues are noticed.The tube should be replaced as soon as it is seen that the eluent vial is not completely empty after a synthesis, i.e. as soon as you notice that the tube remains pinched where it had been in the valve.56Version III - Last Update : June 2008 TRACERlab MX FDG - SERVICE MANUALDirection 2335256-100This page was left intentionally blank.Version III - Last Update : June 2008 TRACERlab MX FDG - SERVICE MANUALDirection 2335256-10057CHAPTER 9 : YEARLY MAINTENANCEIt is recommended that maintenance and verification are carried out once a year on the TRACERlab MX FDG. This yearly maintenance consists of, the replacement of the silicone tubes from the pinch valves, the replacement of the tubes connecting the external waste bottle to the TRACERlab MX FDG, the checking of the TRACERlab MX FDG, the replacement of worn parts (if needed) and finally, the calibration of the four activity detectors. In the case where a component is worn or broken and has to be replaced, refer to the Maintenance and Repairing procedures given in the appendix.1. Replacement of the tube from the eluent pinch valveThe dimensions of the tube from the eluent pinch valve are : inner diameter = 0.58 mm, outer diameter = 2.4 mm, length = 100 mm. Refer to the procedure MR-001-003 in the appendix of this manualImportant note :To avoid the tube remaining pinched where it is in the pinch valve, the tube has to be moved within the pinch valve by a few mm before each FDG production. It is very important to perform this operation before each run and to replace the tube monthly. If these operations are not carried out, the eluent may not be transferred to the reservoir, leading to a failure of the FDG synthesis (refer also to the Troubleshooting section).Some Kryptofix or potassium carbonate from the eluent mixture may crystallize and accumulate in the silicone tube of the eluent pinch valve, which may lead to an obstruction of the tube. It is recommended that the tube is replaced as soon as white residues are noticed.The tube should be replaced as soon as it is seen that the eluent vial is not completely empty after a synthesis, i.e. as soon as you notice that the tube remains pinched where it had been in the valve.2. Replacement of the tube from the 18F inlet pinch valveThe dimensions of the tube from the activity inlet pinch valve are : inner diameter = 1 mm, outer diameter = 3 mm, length = 55 mm. Refer to the procedure MR-001-002 in the appendix of this manual.Important note :Radioactive target impurities with a long half-life may accumulate over time on the silicone tube of the 18F inlet pinchvalve.Itisrecommendedthatthetubeisreplacedassoonasthepermanentradiationlevelonthetube becomes too high. Use protective gloves while replacing the silicone tube. Store the used tube behind shielding until sufficient decay and discard it in compliance with local radioprotection regulations. To reduce the permanent radiation level on this tube it is recommended that the area on which target impurities can accumulate is reduced by using a tube as short as possible.3. Replacement of the waste cap and waste tubeReplacethewastecapandthesiliconetubeconnectingtheexternalwastebottletotheTRACERlabMX FDG 58Version III - Last Update : June 2008 TRACERlab MX FDG - SERVICE MANUALDirection 2335256-100(Ordering reference : 2333437). Take care not to confuse the waste connections at the rear of the TRACERlab MX FDG : the waste tubes have to be connected onto the From Waste and onto the To Waste connectors.Important notes :Thewastetubemaybecontaminatedwithradioactivecompounds.Useprotectivegloveswhilereplacingthe silicone tube. Store the used tube behind shielding until sufficient decay and discard it in compliance with local radioprotection regulations.Replace the tube as soon as leaks are detected systematically during the kit test. The waste cap may age, leading to leaks. If evidences of aging are noticed on the cap and tube, it is recommended to replace these items.4. Checking the TRACERlab MX FDGThetestsdescribedbelowcanbecarriedoutremotelyusingthemaintenancemode,withoutneedingtotakethe TRACERlab MX FDG out of its hot cell. Refer to the chapter concerning the maintenance mode for more details. A waste bottle has to be connected, and compressed air and nitrogen have to be supplied to the TRACERlab MX FDG for all these tests.The following accurate and calibrated tools are needed for checking the TRACERlab MX FDG : a flow-meter for the range between 0 and 50 ml/min, a flow-meter for the range between 0 and 1000 ml/min, a manometer for the range between 0 and 1 bar, a vacuometer for the range between 1 an 0 bar and a thermometer for a range between 0 and 100 C. Replace parts only if the acceptance criteria are out of the given range. Refer to the procedures in the appendix for the replacement of worn parts, or contact the supplier or manufacturer of the equipment. Thevalvenumberinginthediagrambelowcorrespondstothenumberingoftheelectricschemeinthe appendix.1-161-171-231-181-201-192-5 2-3 1-211-152-1Version III - Last Update : June 2008 TRACERlab MX FDG - SERVICE MANUALDirection 2335256-100594.1 Checking the valve connected to the pump (valve 2-1)Setthepumptoavacuumlevelof0.4bar.Anincreasingvacuumlevelmeasuredbytheelectronicvacuum gauge (value displayed on the screen) and a gas flow at the exhaust connection at the rear of the synthesizer indicates that the valve is working properly. If defective, contact the supplier or manufacturer of the equipment.After the test, release the vacuum in the waste bottle as follows : reset all the outputs, open the kit exhaust valve until the vacuum level as displayed on the screen is around 0 and close the kit exhaust valve.4.2 Checking the electronic vacuum gaugeConnect the external vacuometer onto the exhaust connection on the right side of the front panel. Using the maintenance mode, set the waste bottle to increasing vacuum levels (for example -0.3 , -0.5 and 0.7 bars), open the kit exhaust valve (valve 1-24) and compare the value displayed on the screen with the value given by the external vacuometer. The difference between both values should be lower than 0.05 bar. In the case of a drift of the electronic measurement, adjust the value using the built-in potentiometer as described below. In the case of a defective vacuum gauge or vacuum potentiometer, replace the worn part as described in the relevant procedure (MR-001-006 in the appendix)Adjustment of the vacuum measurement in the case of a drift :The vacuum measurement can be adjusted using the screw located in the hole below the mechanical vacuometer onthefrontpanel.Theadjustmentismadebycomparingthevacuumleveldisplayedonthescreenandthe vacuum measured using an external, accurate and calibrated vacuometer.1. Turn the screw of the potentiometer completely clockwise using a 2 mm flat-headed screwdriver. 2. Set the waste bottle to vacuum (setpoint of at least 0.6 bar). The pump will continue running until reaching thesetpointaccordingtothemeasurementdisplayedonthescreen.Theeffectivevacuumasgivenbythe reference vacuometer will be lower.3. Gentlyturnthescrewofthepotentiometeranticlockwiseuntilthevacuumleveldisplayedonthescreen matchesthevacuumlevelgivenbythereferencevacuometer.Thepumpwillstarteachtimeyouturnthe screw.4. If you turn the screw too fast you might reach a higher vacuum on the reference vacuometer. If this happens, turn the screw of the potentiometer a little bit clockwise, open the waste bottle cap and close it again. Adjust the vacuum again, as explained above. 60Version III - Last Update : June 2008 TRACERlab MX FDG - SERVICE MANUALDirection 2335256-1005. Thevacuumdisplayedonthescreenshouldmatchthevacuumgivenbythereferencevacuometer,witha tolerance of 0.05 barThe electronic vacuum gauge can also be checked using the built-in mechanical vacuometer on the front panel of the synthesizer. Note that the accuracy of this vacuometer is limited. If the check is made using the front panel vacuometer, do not open the kit exhaust valve. After the test, release the vacuum in the waste bottle as follows : reset all the outputs, disconnect the external vacuometer from the exhaust connector, open the kit exhaust valve until the vacuum level as displayed on the screen is around 0 and close the kit exhaust valve.4.3 Checking the vacuum pumpUsing the maintenance mode set the waste bottle to a vacuum level of 0.8 bar. Using a standard 250 ml waste bottle,thisvacuumlevelshouldbereachedwithin1minute.Setthesetpointto0andfollowthevalueofthe vacuumdisplayedonthescreen.Thevacuumdropshouldbelowerthan0.001barpersecond.Aweakpump has to be replaced preventively according to the procedure MR-001-008 in the appendix. Note that leaks in the internal tubing of the synthesizer may also lead to an extension of the time required to reach the vacuum and toavacuumdropafterreachingthesetpoint.Incaseofaleakintheinternaltubing,contactthesupplieror manufacturer of the equipment.After the test, release the vacuum in the waste bottle as follows : reset all the outputs, open the kit exhaust valve until the vacuum level as displayed on the screen is around 0 and close the kit exhaust valve.4.4 Checking the high flow-rate, the HF valve (valve 1-19) and the nitrogen valve (valve 2-5) Connect the 0-50 ml fow-meter onto the pressure inlet connection (where the cassette inlet tube on the left hand side is connected for the FDG synthesis). Verify that there is no gas fow when the HF valve (valve 1-19) is not activated (default status in the maintenance mode). A fow noticed while the valve is closed indicates that there is a leak either through the HF valve, either through the LF valve. Replace the valves one by one as described in the procedure MR-001-015 (see appendix) and check if there is no more leak. Connect the 0-1000 ml flow-meter onto the pressure inlet connection and open the HF valve (valve 1-19). The measured flow-rate should be in the range between 300 and 600 ml/min. If the flow-rate is out of this range contactthesupplierormanufactureroftheequipment.Ifthevalveisdefective,replaceitasdescribedinthe procedure MR-001-015 (see appendix).IfthereisnonitrogenflowatallwhileopeningtheHFvalveandtheLF(seebelow),thisindicatesthat themainnitrogensupplyvalve,i.e.thenitrogenvalve(valve2-5)maybedefective.Contactthesupplieror manufacturer of the equipment.Note : in the case another inert gas than nitrogen is used (e.g. helium) the fow rates may be out of range. Do not use other gases than nitrogenVersion III - Last Update : June 2008 TRACERlab MX FDG - SERVICE MANUALDirection 2335256-100614.5 Checking the low flow-rate, LF valve (valve 1-20), and the nitrogen valve (valve 2-5) Connect the 0-50 ml f low-meter onto the pressure inlet connection (where the cassette inlet tube on the left hand side is connected for the FDG synthesis). Verify that there is no gas fow when the LF valve (valve 1-20) is not activated (default status in the maintenance mode). A fow noticed while the valve is closed indicates that there is a leak either through the LF valve, either through the HF valve. Replace the valves one by one as described in the procedure MR-001-015 (see appendix) and check if there is no more leak.Leave the 0-50 ml flow-meter connected onto the pressure inlet connection and open the LF valve (valve 1-20). The measured flow-rate should be in the range between 25 and 45 ml/min. If the flow-rate is out of this range contact the supplier or manufacturer of the equipment. If the valve is defective, replace it as described in the procedure MR-001-015 (see appendix).IfthereisnonitrogenflowatallwhileopeningtheLFvalveandtheHF(seeabove),thisindicatesthat themainnitrogensupplyvalve,i.e.thenitrogenvalve(valve2-5)maybedefective.Contactthesupplieror manufacturer of the equipment.Note : in the case another inert gas than nitrogen is used (e.g. helium) the fow rates may be out of range. Do not use other gases than nitrogen.4.6 Checking the low pressure level and the LP valve (valve 1-23)Connect the 0-50 ml fow-meter onto the connection on the front panel where the white elution system is connected (do not confuse it with the activity inlet connection on the pinch valve). Verify that there is no gas fow when the LP valve (valve 1-23) is not activated (default status in the maintenance mode). A fow noticed while the valve is closed indicates that there is a leak either through the LP valve, either through the HP valve. Replace the valves one by one as described in the procedure MR-001-015 (see appendix) and check if there is no more leak.Connectthemanometerontotheconnectiononthefrontpanelwherethewhiteelutionsystemisconnected. OpentheLPvalve(valve1-23).Thepressurelevelshouldbeintherangebetween0.35and0.5bars.Ifthe pressure level is out of this range, adjust it as described in the procedure MR-001-012 (see appendix). If the valve is defective, replace it as described in the procedure MR-001-015 (see appendix).4.7 Checking the high pressure level and the HP valve (valve 1-18)Connect the 0-50 ml fow-meter onto the connection on the front panel where the white elution system is connected (do not confuse it with the activity inlet connection on the pinch valve). Verify that there is no gas fow when the HP valve (valve 1-23) is not activated (default status in the maintenance mode). A fow noticed while the valve is closed indicates that there is a leak either through the HP valve, either through the LP valve. Replace the valves one by one as described in the procedure MR-001-015 (see appendix) and check if there is no more leak.Connect the manometer onto the connection on the front panel where the white elution system is connected. Open the HP valve (valve 1-18). The pressure level should be in the range between 0.6 and 0.8 bars. If the pressure 62Version III - Last Update : June 2008 TRACERlab MX FDG - SERVICE MANUALDirection 2335256-100level is out of this range, adjust it as described in the procedure MR-001-012 (see appendix). Note that changing the pressure level will have an effect on the LF and HF flow-rates (see relevant sections above). If the valve is defective, replace it as described in the procedure MR-001-015 (see appendix).4.8 Checking the Vac valve (valve 1- 17)Set the waste bottle to vacuum (for example -0.8 bars). Open the Vac valve (valve 1-17), air will flow into the waste bottle and the pump will start to maintain vacuum. If the valve is defective, replace it as described in the procedure MR-001-015 (see appendix). 4.9 Checking the Vacuum to 18O water valve (valve 1-21)Set the waste bottle to vacuum (for example -0.8 bars). Open the Vacuum to 18O water valve (valve 1-21), air will flow into the waste bottle and the pump will start to maintain vacuum. If the valve is defective replace it as described in the procedure MR-001-015 (see appendix).4.10 Checking the kit exhaust valve (valve 1-24)Set the waste bottle to vacuum (for example -0.8 bars). Open the kit exhaust valve (valve 1-24), air will flow into the waste bottle and the pump will start to maintain vacuum. If the valve is defective, replace it as described in the procedure MR-001-015 (see appendix).4.11 Checking the eluent valve (valve 1-15)Connect a cassette onto the synthesizer but without reagent vials. A used cassette can be taken for this purpose. Clampthecassette,closethe18FinletvalveandopentheVacvalve.Setthewastebottletovacuum(for example -0.8 bars). Open the eluent valve (valve 1-15), air will flow into the waste bottle and the pump will starttomaintainvacuum.Ifthevalveisdefective,replacetheelutionsystemasdescribedintheprocedure MR-001-005 (see appendix).4.12 Checking the 18F inlet valve (valve 1-16)Visuallycheckingthevalve:activatethe18Finletvalve(valve1-16)andlooktoseeifthesiliconetubeis pinched properly. If the valve is defective, replace it as described in the procedure MR-001-016 (see appendix).4.13 Checking the heater temperatureTake a reaction vial from a used cassette, remove the cap, fill the vial with 3 ml of water and place it into the heater. Set the heater to a temperature of 30 C. After stabilisation of the temperature, set it to 80C. The temperature of 80C should be reached within 60 sec on the screen. Wait for at least 3 minutes before measuring the temperature ofthewaterusinganexternalthermometer.Adifferenceof5Cbetweenthemeasuredtemperatureandthe Version III - Last Update : June 2008 TRACERlab MX FDG - SERVICE MANUALDirection 2335256-10063temperaturedisplayedonthescreenisacceptable.Iftheheaterorthethermocoupleisdefective,contactthe supplier or manufacturer of the equipment.4.14 Checking the syringe driversVisually checking the syringe drivers : actuate the 3 syringe drivers and verify if they move properly (moving 10 mm within 8 sec for the 30 ml syringe drivers and moving 10 mm within 12 seconds for the 3 ml syringe driver) . There is no need for high accuracy regarding the position of the two 30 ml syringe drivers but the position of the 3 ml syringe driver should be checked as described below. For the 30 ml syringe drivers there should be no more than 2 ml of air left in the syringe when the syringe driver is in the 3 mm position. If one of the syringe drivers is defective, replace it as described in the procedure MR-001-009 or MR-001-010 (see appendix). 4.15 Checking the position of the 3 ml syringe driverConnect a cassette onto the synthesizer, but without reagents. A used cassette can be taken for this purpose. Fill a 3 ml syringe (as used for the reagents), with 1 ml of water and connect it onto the corresponding position of the cassette. Actuate the rotating actuator below the syringe and the third actuator of the right hand manifold. Set the syringe driver to the 7 mm position. The volume injected into the hydrolysis cartridge should be in the range between 700 and 800 l (between 200 and 300 l left in the syringe). In the case where the position of the 3 ml syringe driver has to be adjusted, refer to the procedure MR-001-010 in the appendix.4.16 Checking the rotating actuators and the Compressed air valve (valve 2-3)Visually checking the rotating actuators, rotation within 1 sec. Note that a slow rotation or no movement at all is generally due to an insufficient compressed air pressure level.actuator 1 : 90 rightactuator 2 : 90 left and rightactuator 3 : 90 rightactuator 4 : 90 rightactuator 5 : 90 rightactuator 6 : 90 leftactuator 7 : 90 leftactuator 8 : 90 rightactuator 9 : 90 rightactuator 10 : 90 rightactuator 11 : 90 rightactuator 12 : 90 leftactuator 13: 90 rightactuator 14 : 90 leftactuator 15 : 90 right64Version III - Last Update : June 2008 TRACERlab MX FDG - SERVICE MANUALDirection 2335256-100In the case of a defective rotating actuator, contact the supplier or manufacturer of the equipment.If the rotating actuators and the clamp mechanism cannot be activated (see below), this indicates that the main compressedairsupplyvalve,i.e.theCompressedair(valve2-3)maybedefective.Contactthesupplieror manufacturer of the equipment.4.17 Checking the clamp kit mechanism and the Compressed air valve (valve 2-3)Visually checking the clamp kit (clamp cassette) mechanism : activate the mechanism by pressing the clamp button on the front panel and check that the elution mechanism moves down, and that the clamps move out of the front. Note that a slow movement of this mechanism or no movement at all is generally due to an insufficient compressed air pressure level.If the clamp mechanism and the rotating actuators cannot be activated (see above), this