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Phadia 100 - User Manual

Assay Run Quality Control

12-3501-20/12

Page 6.1

Chapter 6 - Assay Run Quality Control

This chapter describes the actions in the

Quality Control mode

Quality Control

Print Log

Print Quality Control Log

Print Curve Control-Log

Edit Log

Edit Quality Control-Log

Edit Curve Control-Log

Print Calibrators

Edit Calibrators

Set Active Calibrators

Accept Calibrators

Edit Calibrator Point

Export Quality Control-Logs

Export Curve Control Logs

Export Calibrators

Summary of Contents for Phadia 100

Page 1: ...Phadia 100 English 12 3501 20 12 User Manual...

Page 2: ...ia The new name has been applied to the instruments and related items e g Software and User Manu als The trademark ImmunoCAP has been removed from the System Reagents This is a trademark change only t...

Page 3: ...g 4 Assay Run Editing Functions 5 Assay Run Data Evaluation 6 Assay Run Quality Control 7 Monthly Calibration 8 Quality Assurance 9 Methods Test Panels Article Management 10 Printouts 11 Maintenance 1...

Page 4: ...Well Dispenser 6 USB ports Diskette Drive 6 TCP IP connector 6 Washing Solution Rinse Solution and Waste Bottles 7 ImmunoCAP Carousel 7 ImmunoCAP Waste Container 8 TechnicalSpecification 9 Instrument...

Page 5: ...rumentincludesfunctionsfor distributionofsamples ImmunoCAPandEliA wells and reagents processing of all assay steps for incubation and washing reading of measuring values calculations of analytical res...

Page 6: ...EliA Well Dispenser Printer Processing Lid Processing Chamber Pipette Arm Washing Solution Rinse Solution and Waste Bottles USB ports Diskette Drive Keyboard Sample Carousel Cover Sample Carousel Pip...

Page 7: ...used internally in the instrument Mains Power Inlet Washing Solution Rinse Solution and Waste Bottles Cooling fan Voltage selector and Primary fuses Power on off Secondary fuses VGA connector for serv...

Page 8: ...weight on these spots might damage the instrument Sample Carousel In the sample carousel you place the reagents and samples in given positions The positions are 1 48 Positions for calibrators curve co...

Page 9: ...erright of the instrument and two USB 2 0 type A ports on the instrument rear You can store data on a USB memory or an external USB hard drive and use it in a computer You can also import data from a...

Page 10: ...off immediately When you putthetubingbackonthebottle pressthenozzle on until you hear a clicking sound Fill the bottles with 1l of Washing Solution and 1l Rinse Solution for one assay run When runnin...

Page 11: ...deof ImmunoCAP Carousel in the Processing Chamber The instru ment will not indicate when the container is full NOTE ImmunoCAP Waste Container has to be emptied after every assay run WARNING Waste bott...

Page 12: ...5 Main frequency tolerances 1 Designed for continuous operation NOTE ImmunoCAP 100 must be connected to a grounded power outlet protective ground Power 550VA Primary Fuses 100 120V T 5 A L 230 240V T...

Page 13: ...rddrives One TCP IP connector is located at the upper right of the instrument rear The TCP IP connector can be used for connection to IDM Phadia Information Data Manager One serial port COM 2 is locat...

Page 14: ...Rx input 12 V Pin 7 RTS output 12 V Pin 8 CTS input 12 V Pin 6 DSR input 12 V Pin 4 DTR output 12 V Pin 5 GND signal ground Pin 1 DCD input 12 V Pin 9 RI input 12 V These serial ports must be connecte...

Page 15: ...agnetic UniCAP 100 EN 61000 6 3 2006 Generic emmission standard for residential commercial and light industrial environments EN 61000 6 2 2006 Generic immunity standard for industrial environments EN...

Page 16: ...rmit individual selection of the most suitable allergen panel When handling ImmunoCAP keep the carrier closed to avoid evaporation of buffer Do not leave the carrier open for more than 1 day at room t...

Page 17: ...tions Phadia100 waste bottle collects waste liquids containing human body fluids which might be infected When emptying and cleaning the waste bottle takeprecautionstoavoiddirectcontactwiththe liquids...

Page 18: ...ods can not be used togetherwithImmunoCAPmethods Precaution Phadia 100 is intended for in vitro diagnostic testing using reagents of Phadia only When operating Phadia 100 reagents manufactured from hu...

Page 19: ...until the instrument has reached room temperature If major temperature differences exist 10 C condensation will occur in the instrument 1 Remove the metallic clips at the top of the plywood box with a...

Page 20: ...e according to the following list AccessoryBox The following accessories are included Quantity Mains kit 100 120V 1 Mains kit 230 240V 1 Printer paper two rolls 1 ImmunoCAPHolderDisc 1 Elution Wells D...

Page 21: ...r doing this lift the in strument as instructed in the part Instrument Lifting Points Remove the wooden Screw the four feet onto the instrument Hexagonal screws outside the wooden bottom plate Wooden...

Page 22: ...n the fuse voltage selector cover using a screwdriver Insert the screwdriver at the top centre and apply pressure 11 Turnthepoweroninordertoopentheprocessingchamber Thechamber is opened by pressing th...

Page 23: ...out Elution Wells DiscandImmunoCAPHolder Disc from the accessory box andplacethemintheProcess ing Chamber Place the ImmunoCAP Holder Disc on top of the Elution Wells Disc in the Processing Chamber Al...

Page 24: ...arousel compartment 19 The instrument should now be ready to use 17 Awarninglabelinenglish is placed below the Pipette Arm If required place a warn ing label with appropriate lan guage on top of the e...

Page 25: ...he year you want and press enter 6 If the displayed month is correctpressenter Ifyouwish to change month type the month you want and press enter 7 If the displayed day is correctpressenter Ifyouwish t...

Page 26: ...l Service mode press 4 2 Press yes 3 Press yes 4 Pressnountilthelanguage you want appears then press yes 5 Press no until the format you want appears then press yes 6 Press no until the format you wan...

Page 27: ...Set sIgE Method The instrument can be set to use either ImmunoCAP Specific IgE 0 100 or ImmunoCAP Specific IgE as sIgE method At delivery ImmunoCAP Specific IgE 0 100 is set as default 1 In Install Se...

Page 28: ...can be set between 0 9 Press the key below PRINT if you want to make a printout to check the choosen contrast Press enter when the contrast is right Set and Change Passwords Youfindthe settingsandchan...

Page 29: ...change the settings Follow the steps below when you set the parameters for the bar code reader To connect a barcode reader of USB type please contact your local Phadia representative 1 In Install Serv...

Page 30: ...r IDM has to be set To enter this menu you need access to the laboratory password Follow the steps below when you set the IP address and Port 1 In Install Service mode press 7 2 Pressyes 3 Press no un...

Page 31: ...me has to be set To enter this menu you need access to the laboratory password Follow the steps below when you set the computer name 1 In Install Service mode press 8 2 Pressyes 3 Enterthecomputername...

Page 32: ...sage Information 5 InstrumentPanel 7 Panel 8 Menus 9 VerificationofInstrumentPerformance 16 ImmunoCAP Specific IgE 0 100 16 ImmunoCAP Specific IgE 18 ImmunoCAP Total IgE 19 ImmunoCAP ECP and ImmunoCAP...

Page 33: ...ith a question mark is answered with yes or no otherwise you can press the enter key to confirm and save the data To enter another menu item you can either press the no key or you can press a number k...

Page 34: ...ey To Enter Data When there is an underline you can type a value If you want to enter a new value delete the old value and then type the new The typed value is saved when you press enter When you ente...

Page 35: ...ue when there is a default value and is also used for shipping mode abort the selection by moving up one menu level To select an alternative press the key that repre sents the alternative you want to...

Page 36: ...us Information The status key displays infor mation about the process tak ing place The information can beaccessedatanytimebypress ing status Thestatusinformationmayalsobedisplayedautomaticallytoindic...

Page 37: ...be displayed automatically when an error occurs At the message information you can step back in the list of previous errors by pressing message With no you can step forward again To exit message info...

Page 38: ...oose letters specific to your language Press the enter key to confirm a function or entered text Use the mode key to step up one menu level Use the del key to delete the previous character on the disp...

Page 39: ...characters in each row The keyboard contains 51 keys The printer is a 40 80 character width printer Besides the alphanumeric keys you also have some functional keys The functional keys are described...

Page 40: ...tartProcess 1 4 Edit Request 1 4 1 Edit Sample ID 1 4 1 1 Change Sample ID 1 4 1 2 Change Test 1 4 1 3 Add Test 1 4 1 4 Delete Test 1 4 2 Delete Sample ID 1 4 3 Delete Calibrators 1 5 Load Old Run 1 6...

Page 41: ...le CC 3 2 6 Specific Run disable blank error 3 2 7 Specific Run disable fatal error 3 3 Export Data 3 4 Import Data 4 Quality Control 4 1 Print Log 4 1 1 Quality control log 4 1 2 Curvecontrol log 4 2...

Page 42: ...2 1 11 Default Cut off Concentration 5 2 2 Reagents 5 2 2 1 Volume 5 2 2 2 Incubation time 5 2 2 3 Identity 5 2 3 Reference 5 2 3 1 Curve control 5 2 3 1 1 Add Curve ctrl 5 2 3 1 2 Edit Curve ctrl 5...

Page 43: ...below reference 5 2 6 1 2 Text above reference 5 2 6 2 Reference curve 5 2 6 2 1 Concentration unit 5 2 6 2 2 Text below lowest 5 2 6 2 3 Add Class border 5 2 6 2 4 Edit Class border 5 2 6 2 5 Delete...

Page 44: ...oncentration 5 2 7 2 18 Emphasize on reports 5 2 7 2 19 Quant Below undiluted 5 2 7 2 20 Quant Above undiluted 5 2 7 2 21 Quant Below diluted 5 2 7 2 22 Quant Above diluted 5 2 7 2 23 Diluent in pos G...

Page 45: ...d Test Panel 6 2 2 Edit Test Panel 6 2 2 1 Add Test 6 2 2 2 Delete Test 6 2 3 Delete Test Panel 6 2 4 Print Test Panel 6 2 4 1 Summary of Test Panel 6 2 4 2 Specific Test Panel 6 2 4 3 All Test Panels...

Page 46: ...Communication Parameters 6 7 1 Baudrate 6 7 2 Databits 6 7 3 Stop bits 6 7 4 Parity 6 7 5 PortUsage 6 7 6 IDMTCP IPAddress 6 7 7 IDM TCP IP Port 6 7 8 Computer 6 9 Maintenance 6 9 1 DailyMaintenance 6...

Page 47: ...l for Specific IgG can be used and to verify Tryptase the protocol for ECP can be used The following general reagents are required Development Kit Washing Solution ImmunoCAP Specific IgE 0 100 Reagent...

Page 48: ...n Criteria for acceptance of Runs 2 and 3 Curve controls are within range the run is accepted by the instrument software The mean values for ImmunoCAP Specific IgE Control are within given ranges Immu...

Page 49: ...pecific IgE Control tested for three allergens in duplicate define controls according to Chapter 4 Assay Run Editing Functions ImmunoCAP Specific IgE Negative Control tested for the same three allerge...

Page 50: ...ate the CV as described in Calculation of CV values If all the criteria for total acceptance are fulfilled results can be used for clinical routine When method is accepted remember to set replicate to...

Page 51: ...Total IgE Criteria for Runs 1 through 3 are fulfilled Pooled coefficients of variation CV within assay runs are 6 for ImmunoCAP Total IgE Controls and patient samples Total CV for ImmunoCAP Total IgE...

Page 52: ...AP ECP Control in four replicates At least six individual patient samples in duplicate Criteria for acceptance of Runs 2 and 3 Curve control is within range the run is accepted by the instrument softw...

Page 53: ...Specific IgA Below you see an example for ImmunoCAP Specific IgG This is applicable also for ImmunoCAP Specific IgA The reagents differ depending on selected method Run 1 Full calibration curve 0 02 0...

Page 54: ...s and patient reports can be done Calculate the CV as described in Calculation of CV values If all the criteria for total acceptance are fulfilled results can be used for clinical routine When method...

Page 55: ...eptance of Runs 2 and 3 Curve controls are within range the run is accepted by the instrument software The mean values for the controls are within given ranges Criteria for total acceptance of ImmunoC...

Page 56: ...e software when a calibration curve is requested EliA ANA Control two levels in duplicate on EliA dsDNA Wells define controls according to Chapter 4 Assay Run Editing Functions At least six individual...

Page 57: ...der to maintain the instrument s performance please follow instructions in chapter 11 Maintenance Calculation of CV values For two and four ImmunoCAP ECP Control ImmunoCAP Tryptase Control replicates...

Page 58: ...Total CV within runs 100 Total CV 100 Calculation of CV with four replicates in each of three runs Total CV within runs 100 Total CV 100 VMean 0 5xVWithin MTot VWithin MTot VMean 0 75xVWithin MTot Rep...

Page 59: ...within runs 100 2 9 Total CV 100 5 1 VWithin MTot VMean 0 5xVWithin MTot VWithin MTot VMean 0 75xVWithin MTot Replicate Run 1 Run 2 Run 3 MTot VMean VWithin 1 2 87 3 43 2 98 2 3 01 3 27 3 20 Mean 2 9...

Page 60: ...eonyourdisplay Aslongasyou are in this mode you can use Phadia 100 without changing anything This is a copy of the entire software and nothing that you do in this software mode will affecttheactualins...

Page 61: ...ng to calculation and printing of results To run a routine assay you start by entering the request then move on to load and start the run The instrument will distribute ImmunoCAP EliA Wells samples an...

Page 62: ...ted and takes about 2 5 hours A laboratory report is automatically printed when the process is ended Maintenance has to be done according to the guideline in chapter 11 Maintenance Barcode reader A ba...

Page 63: ...instrument Workflow Enter Request Go to Prepare Run mode and select 1 1 Enter Request Type cal and choose method If not all methods are displayed you can find them if you press alt If a calibration c...

Page 64: ...nt and Sample Handling Be sure to load enough sample Check the volume of the Washing and Rinse Solution One liter is needed for each solution The prepared Washing Solution is stable for one week when...

Page 65: ...le tubes must be added to the sample volumes specified on the Consumption List Insufficent sample volume or empty sample tubes might lead to unreliable results NOTE Do not unscrew the cap from the bot...

Page 66: ...ing andmaintainingPhadia100 takeprecautionsto avoiddirectcontactwithpartsthathavebeenin contact with samples Wear protective gloves WARNING Phadia 100 processing chamber is exposed to human body fluid...

Page 67: ...OTE REQUESTS ENTERED The currently prepared run has been prepared on a remote PC and cannot be edited in the instrument RUN IS LOADED Loading of reagents ImmunoCAP EliA Wells or samples has already be...

Page 68: ...ethods that can be entered in one run is four 4 NOT ENOUGH ROOM FOR CALIBRATORS There is not enough ImmunoCAP EliA Well or sample positions left to add the calibrators to the run METHOD NOT COMPATIBLE...

Page 69: ...s If you enter more tests then there are available positions you will be asked if you want to skip the whole sample identity or just the tests left for that sample identity You can also leave the Ente...

Page 70: ...you want to change replicates or dilution factor please see chapter 4 Assay Run Editing Functions 5 To save the entered tests for the sample identity press enter again NOTE If you press the mode key b...

Page 71: ...d NO SAMPLE POS LEFT Skip Panel There is no position left for sample If you press yes the test panel will be removed PREDILUTED 1 10 Press yes if the sample is prediluted ten times this example INSTRU...

Page 72: ...if you want to skip the test You can enter this test in another assay If you press no you will return to the Skip Sample ID display 9 Do not forget to press enter before you leave this mode When you...

Page 73: ...ponent in the correct place The instrument will not warn you if the component is not the correct one NOTE Check for air bubbles or film on the surface of the reagents samples If thereareairbubblesorfi...

Page 74: ...not detect the surface properly 5 Check that the Washing Rinse and Waste bottles are loaded Press yes to confirm this step Make sure the volume is enough and that the tube connection is pressed down...

Page 75: ...pond with the lot number in the method It is possible to add the new lot number manually by pressing the shift and enter keys at the same time A display will pop up where you can enter the lot number...

Page 76: ...sult is going to be calculated You will be prompted to type the calibration code again However it is possible to continue this run and run calibrators with this code later by pressing the shift and en...

Page 77: ...bute the ImmunoCAP EliA Well to the correct position 14 Type the Lot Specific Code that is found on the label on the EliA Well foil bag and on the label on the EliA Well Carrier Press enter to confirm...

Page 78: ...Warnings that may prevent entering LOAD IS NOT COMPLETED Before the run can be started reagents samples and ImmunoCAP EliA Well must be loaded PRESSURE TOO LOW 1200 hPa The system pressure is too low...

Page 79: ...carrier is empty but more ImmunoCAP Elia Well of this type is required SAMPLE CAROUSEL COVER IS NOT PRESENT Put the Sample Carousel Cover in position PROCESSING LID IS NOT CLOSED Close the Processing...

Page 80: ...bration If status is OK the calibration curve is stored and available for use in routine runs If status is NOT OK the calibration curve is stored but not available for use in routine runs 20 Whentheru...

Page 81: ...Routine Assay Run Phadia 100 User Manual Page 2 50 12 3501 20 12...

Page 82: ...cribes reagent and sample handling the use of different tubes and dilutions Reagent Handling General 2 ReagentHandling ImmunoCAPSpecificIgA ImmunoCAPSpecificIgG ImmunoCAP Specific IgG4 EliA IgA EliA I...

Page 83: ...en to avoid evaporation andcontaminationtoguaranteereliableresults Try to minimize the time period between uncapping the reagents and starting the run Recap the reagents as soon the assay run is finis...

Page 84: ...tion Single dose vials are not to be pooled Air bubbles film It is important to pop air bubbles or film on the surfaceofreagentsandsamples useadisposable pipettetiptoavoidcontamination Ifyounotice fib...

Page 85: ...so very important that the instrument is well maintained according to the maintenance procedures in Chapter 11 in Phadia 100 User Manual Thingstobeawareofbeforeandafteranassay Perform a Daily Rinse be...

Page 86: ...times this also reduces the risk for bubbles in the vials Do not remove the caps of the sample tubes close to the instrument If needed use a disposable pipette tip to pop air bubbles or film on the s...

Page 87: ...en having problems with the IgG IgA and IgM assays For the next assay run use a new bottle of conjugate In the case when the message Reagent blank is too high occurs use a new Development Solution bot...

Page 88: ...o place a specific volume of the samples into the sample carousel The dead volume is not included in this volume since it differs somuchbetweendifferenttubes Ifthereisjustasmallvolumeofthesample take...

Page 89: ...l 100 Note Cap must be cut off 10 11 38 pl c 400 Ellerman 10 12 58 pl 100 Sourceunknown 9 11 70 pl 100 Venoject 11 12 75 gl 100 Sourceunknown 10 12 70 pl 100 Sourceunknown 11 12 74 gl 100 Sourceunknow...

Page 90: ...the inner diameter should be approximately 10 mm A round bottom is needed in order to have as little dead volume as possible The tubes must be of Ellerman type plastic laboratory tubes Ellerman tubes...

Page 91: ...Reagent and Sample Handling Phadia 100 User Manual Page 3 10 12 3501 20 12...

Page 92: ...10 Change Test 11 Add Test 15 Delete Test 18 Add QC 20 Edit QC 25 Set status 26 Identity 26 Test name 27 Replicate 27 Coefficient of variance limit response 28 Expected concentration 28 Expected stand...

Page 93: ...yes 2 In Enter Request mode press 4 3 In Edit Request mode press yes Warnings that may prevent entering REMOTE REQUESTS ENTERED The currently prepared run has been prepared on a remote PC and cannot b...

Page 94: ...e same time In this case all tests on this sample will be di luted 2 Press yes if you want to addapredilutedsample other wise press no If yes go to step 4 If predilution is selected the dilution facto...

Page 95: ...or between 1 and 1000 The instrument dilution can only be set to factor 1 2 5 10 20 50 or 100 When you are entering a request you can change the number of replicates and the dilution for one or severa...

Page 96: ...1 In Prepare Run mode press yes 2 In Enter Request press 4 3 InEditRequestpressyes 4 In Edit Sample ID press yes Warnings that may prevent entering REMOTE MODE SELECTED The instrument is set in PC re...

Page 97: ...occur SAMPLE ID ALREADY ENTERED The entered sample ID has already been used in this run YOU CANNOT CHANGE TO CALIBRATORS It is not possible to enter cal here if you want to add calibrators YOU CANNOT...

Page 98: ...lowingstepsdescribeshowyoucandeleteasampleandallincludedtests 1 In Prepare Run mode press yes 2 In Enter Request press 4 3 InEditRequestpressyes 4 In Edit Sample ID press 2 5 In Delete Sample ID press...

Page 99: ...run 1 InPrepareRunmodepress yes 2 In Enter Request press 4 3 InEditRequestpress yes 4 In Edit Sample ID press 3 Warnings that may prevent entering NO CALIBRATORS TO DELETE There are no calibrator add...

Page 100: ...identity and press enter 2 Press alt in the mode where you enter tests 3 Select the method you want by pressing the key below the method name If there are more than eight methods de fined in the softw...

Page 101: ...1 InPrepareRunmodepress yes 2 In Enter Request mode pressyes 3 Type qc at the Enter Sample ID and press enter 4 Select the method forthequalitycontrolyou want by pressing the key belowthemethod sname...

Page 102: ...ion factor for a specific sample 1 InPrepareRunmodepress yes 2 In Enter Request press 4 3 InEditRequestpressyes 4 In Edit Sample ID press yes Warnings that may prevent entering REMOTE MODE SELECTED Th...

Page 103: ...to a panel here Use Enter Request to add panels TOO MANY METHODS AT THE SAME TIME By changing this test the maximal number of four methods was exceeded METHOD NOT COMPATIBLE Changing to this method is...

Page 104: ...trument you can select factor 1 2 5 10 20 50 or 100 If the sample is prediluted you can select a factor between 1 and 1000 Messages that can occur NO ACTIVE CALIBRATORS ADD TO RUN There is no stored c...

Page 105: ...Manual Page 4 14 12 3501 20 12 METHOD NOT COMPATIBLE Adding this method is not possible there is already a method used that is not compatible with the method you selected INSTRUMENT DILUTION TOO HIGH...

Page 106: ...t The following steps describes how you can add tests to a specific sample 1 InPrepareRunmodepress yes 2 In Enter Request press 4 3 InEditRequestpressyes 4 In Edit Sample ID mode press yes Warnings th...

Page 107: ...th more than one test is selected you will return to the pre vious display point 8 where youcanaddthetestforthenew method If a method with only one test is selected the test is added to the run and yo...

Page 108: ...anel will be removed PREDILUTE Press yes if the sample is prediluted ten times this example INSTRUMENT DILUTION Press yes if the test is to be diluted ten times this example The dilution is carried ou...

Page 109: ...delete tests from a specific sample 1 In Prepare Run mode press yes 2 Press 4 3 Press yes 4 Press yes Warnings that may prevent entering REMOTE MODE SELECTED The instrument is set in PC remote mode N...

Page 110: ...unctions 12 3501 20 12 Page 4 19 3 4 5 6 4 9 To delete the selected test press enter If you do not want to delete the test press mode Ifalltestsaredeletedthesample ID will be deleted as well 1 4 1 4 D...

Page 111: ...de press yes 8 InAddQCmodepressyes 9 ChooseiftheQualityCon trol is to be set as ACTIVE MANUAL or INACTIVE by pressingnountilthedesiredsta tusisdisplayed Thenpressyes ACTIVE means that the Quality Cont...

Page 112: ...ST DOES NOT EXIST The test name does not exist for the method Please check the spelling SAME QC IDENTITY ALREADY EXISTS The identity is already used by another QC 12 Press 1 2 3 4 or 5 de pending on h...

Page 113: ...the maximum al lowed standard deviation for the Quality Control 1 is de fault 3 is recommended by Phadia AB Type 0 zero to deactivate the function Press enter to confirm this step NOTE If you are usi...

Page 114: ...ximum will be overridden 19 Typethelotnumber used mainly for Phadia controls Pressentertoconfirmthisstep 20 If the Quality Control is prediluted type a dilution fac tor between 1 100 1 is de fault Pre...

Page 115: ...to change the default order of the Quality Controls 24 Theinstrumentdisplaysa message that the quality con trol is added You will then return to th Add QC mode Run at least 20 assay runs to get the m...

Page 116: ...p mode press yes 3 Press 2 4 In Edit Method mode press yes 5 Select the method for which you want to define a QualityControlbypressingno until the desired method is dis played Then press yes 6 Press 9...

Page 117: ...e added if you decide so when an assay run is prepared 1 Press yes 2 Choose if the Quality ControlistobesetasACTIVE MANUAL or INACTIVE by pressing no until the desired status is displayed Then press y...

Page 118: ...enter to con firm this step Messages that can occur ENTERED TEST DOES NOT EXIST The test name does not exist for the method Please check the spelling SAME QC IDENTITY ALREADY EXISTS The identity is a...

Page 119: ...an change the maximum allowed CV 1 In Edit QC mode press 5 2 Press yes 3 Delete or type over the old maximum allowed CV Type the new maximum al lowed CV and press enter to confirm this step Expected c...

Page 120: ...a Quality Control it is recommended to run at least 20 assay runs to get the expected standard deviation in the Quality Control log You find the expected mean value at the end of the Quality Control...

Page 121: ...wed standard deviation It is also possible to deactivate this function 1 In Edit QC mode press 8 5 2 9 2 Edit QC sIgE sIgE Pos 1 Status 5 2 9 2 Edit QC sIgE sIgE Pos 7 Expected s 5 2 9 2 Edit QC sIgE...

Page 122: ...ete or type over the old lowest allowed concentra tion Type the new lowest al lowed concentration or type 0 zero to deactivate the func tion Press enter to confirm this step If you are using ImmunoCAP...

Page 123: ...g start date 1 In Edit QC mode press 11 2 Press yes 3 Delete or type over the oldlogstartdate Typethenew log start date and press enter to confirm this step Lot number The following step describes how...

Page 124: ...it QC mode press 14 2 Press yes 3 Delete or type over the old instrument dilution factor Type the new instrument dilu tion factor Choose between 1 2 5 10 20 50 or 100 Press enter to confirm this step...

Page 125: ...ss 16 2 Press yes 3 Delete or type over the oldordernumber Typeanum ber between 1 99 A low num ber means that the Quality Control will be processed be fore Quality Controls with higher numbers Type 0...

Page 126: ...pected concentration the expected s and the limit s or the range minimum and maximum besides the lot number You might also want to change the log start date These values can be changed in two ways eit...

Page 127: ...can skip loading the specificImmunoCAP EliAWell by pressing del 2 Press yes if you want to skip further loading of d1 Then you can continue loading as usual 3 At the end of the loading of ImmunoCAP El...

Page 128: ...ns The assay runs are identified by a sequence number and the time and date when the run was processed 1 In Prepare Run mode press yes 2 Press 5 3 Press yes Warnings that may prevent entering REMOTE M...

Page 129: ...Assay Run Editing Functions Phadia 100 User Manual Page 4 38 12 3501 20 12 Messagesthatcanoccur METHOD NOT COMPATIBLE Currently defined methods does not match the methods in the selected run...

Page 130: ...When you aborted the process you have to remove the reagents samples and ImmunoCAP EliA Well from the instrument 1 In Prepare Run mode press 2 2 Press yes 3 Press yes if you want to abort a run that i...

Page 131: ...press yes to delete all the request data for the prepared run Warnings that may prevent entering RUN IS NOT PREPARED There is no run currently prepared ImmunoCAP EliA Well IS LOADED ImmunoCAP EliA We...

Page 132: ...ition Press no and shift at the same time to move the carousel to previous posi tion You have to remove the ImmunoCAP EliA Well from the displayed position manually Press lid open to open the processi...

Page 133: ...Assay Run Editing Functions Phadia 100 User Manual Page 4 42 12 3501 20 12 NOTE ImmunoCAP and EliA Wells are not la belled Due to this fact you have to discard them...

Page 134: ...e any ImmunoCAP EliA Well when an assay run is being processed 3 Press enter to remove all the ImmunoCAP EliA Well The instrument will remove all ImmunoCAP EliA Well from the carousel to the waste con...

Page 135: ...e aborted the process you have to remove the reagents and ImmunoCAP EliA Well from the instrument 1 In Prepare Run mode press 2 2 Press yes 3 Press no if you do not want to abort a prepared run 4 Pres...

Page 136: ...Phadia 100 Data Evaluation 2 Print Patient Report 3 Print All Samples in a Run 3 Print Specific Sample 4 Print Laboratory Report 5 Print Specific Run 5 Re evaluate and Print specific Run with selecte...

Page 137: ...r these runs can be printed at any time Depending on your instrument it is possible to save assay runs to a USB memory an external USB hard drive or a diskette Saved assay runs can be imported later o...

Page 138: ...want to print by pressing yes untiltherunappears thenpress no The assay run is identified with a sequence number and the date and time when it was processed The patient report will be printed Message...

Page 139: ...ngs that may prevent entering NO RUNS EXIST There is no processed run to print patient reports for 4 Select the assay run by pressing no until the run ap pears then press yes 5 Select the sample you w...

Page 140: ...strument laboratory reports for processed runs and a laboratory report for processed runs with selected calibrators 1 In Prepare Run mode press 3 2 Press yes 3 In Print Patient Report press no 4 Press...

Page 141: ...printed Re evaluate and Print specific Run with selected Calibrators The following steps describes how you can re evaluate a run against other calibrators The calibrator code has to be the same as in...

Page 142: ...he method date time when processed and the calibration code They will be used to evaluate the selected assay run and the laboratory report is printed Messages that can occur NOT SAME CAL CODE AS RUN C...

Page 143: ...port mode 2 Press yes 3 Select the assay run in which you want to disable Curve Controls by pressing no until the assay run appears then press yes 4 Pressyesforeachmethod in which you want to disable...

Page 144: ...handling press 6inPrintLabo ratory Report mode 2 Press yes 3 Select the assay run for which you want to disable blank error handling by press ing no until the assay run ap pears then press yes Disable...

Page 145: ...disable fatal error Run 34 090503 08 57 NOTE Itisalwaysthedecisionoftheresponsible laboratory manager to accept an assay run Other assay performance parameters have to be taken into consideration 1 To...

Page 146: ...n choose between re quest consumption and distri bution lists The list is printed and you will returntothePrepareRunmode If there is an error message for the assay run the distribution list will autom...

Page 147: ...int Patient Report Thisprintoutlistsprocessedrunsstoredintheinstrument withdateandtimefor run methods calibration code and mode To print the summary of runs select the option 3 2 1 Summary of Runs on...

Page 148: ...ess yes 3 Press yes if you want to print the patient Report other wise press no 4 Press yes if you want to print the Laboratory Report otherwise press no 5 Press yes if you want to exportdata otherwis...

Page 149: ...MEDIA FULL ABORT The USB memory external USB hard drive or diskette is full Delete old files or change media Press no to overwrite data or press yes to abort DATA ON MEDIA OVERWRITE Data is already st...

Page 150: ...rd drive or a diskette and then be evaluated 1 InPrepareRunmodepress 3 2 Pressyes 3 Press yes if you want to printthePatientReport other wise press no 4 Press yes if you want to print the Laboratory r...

Page 151: ...e is labeled with another instrument Id Data can only be imported to the same instrument as it was exportedfrom MEDIA ERROR ABORT The USB memory external USB hard drive or diskette is not formatted or...

Page 152: ...ality Control mode Quality Control 2 PrintLog 3 Print Quality Control Log 3 Print Curve Control Log 4 EditLog 5 Edit Quality Control Log 5 Edit Curve Control Log 6 PrintCalibrators 8 EditCalibrators 9...

Page 153: ...ints will not be included in the calculation when the average and CV coefficient of variation is calculated for the log The last 100 determinations will be stored Response and acceptance of calibrator...

Page 154: ...You can choose between the quality log curve and the curve control log 4 Press no until the method you want appears then press yes Warnings that may prevent entering CANNOT SELECT THIS METHOD The sel...

Page 155: ...d 3 Press no until the quality control log you want appears then press yes The quality control log will be printed A new window may appear Selectalotnumberforthequal ity control press enter Print Curv...

Page 156: ...revent entering CANNOT SELECT THIS METHOD The selected method cannot be used for this operation Edit Quality Control Log You can set the status to active or inactive for a specific QC control point If...

Page 157: ...rs then press yes 4 Press no orshiftand no untilthequalitycontrol logyou want appears then press yes The control is identified by the date and time when processed and the concentration of the log poin...

Page 158: ...rve ctrl log CC 1 4 2 2 Curve Control Log sIgE CC 1 090405 14 29 0 71 4 2 2 Curve Control Log sIgE CC 1 090405 14 29 ACTIVE 3 Press no until the curve control log you want appears then press yes 4 Pre...

Page 159: ...s 1 In Prepare Run mode press 4 2 Press yes 3 In Print Log press 3 4 Press yes 5 Press no until the method you want appears then press yes Messages that can occur CANNOT SELECT THIS METHOD The selecte...

Page 160: ...In Print Log press 4 4 Press yes 5 Press no until the method you want appears then press yes Messages that can occur CANNOT SELECT THIS METHOD The selected method cannot be used for this operation Se...

Page 161: ...ibrators have been inactivated too long to be set to active compared to max reactivate time set in method CAL NOT ACCEPTED PROCEED ANYWAY The selected calibrators do not have the acceptance level OK I...

Page 162: ...alibrator Point This is a laboratory password protected function that means that you have to log in with the laboratory password You can change the response for a calibrator point 1 In the Edit Calibr...

Page 163: ...to recall the original response press enterand shift atthesametime If you want to exit without any changes done press mode The number of replicates are displayed Export Quality Control Logs 1 IntheEx...

Page 164: ...to abort DATA ON MEDIA OVERWRITE Data is already stored on the USB memory external USB hard drive or diskette Press yes to overwrite data or press no to change the USB memory external USB hard drive...

Page 165: ...nly be exported to media labeled with the same instrumentId MEDIA ERROR ABORT The USB memory external USB hard drive or diskette is not formatted or it is damaged Format the media or change it Press n...

Page 166: ...tQualitycon trol log press 3 2 Pressyes 3 Press no until the method you want appears then press yes Warningsthatmayprevententering CANNOT SELECT THIS METHOD The selected method cannot be used for this...

Page 167: ...abort MEDIA FULL ABORT The USB memory external USB hard drive or diskette is full Delete old files or change media Press no to overwrite data or press yes to abort DATA ON MEDIA OVERWRITE Data is alre...

Page 168: ...n 12 3501 20 12 Page 7 1 7 Chapter 7 Monthly Calibration This chapter describes the run and acceptance of the monthly calibration Concept 2 General Flow in Phadia 100 2 Acceptance of Calibration Curve...

Page 169: ...number calibration code of conjugate and for some methods also ImmunoCAP In subsequent assay runs the same combination of conjugate and ImmunoCAP must be used The obtained response curve is checked by...

Page 170: ...ctin and Tryptase use a 4 parameter logistic function These functions also called Rodbard normally use many iterations The parameters of the function are iteratively estimated until a good curvefit is...

Page 171: ...e will recommend the assay to be accepted If both curve controls are outside the inner limits in the same direction i e LOW LOW or HIGH HIGH the acceptance is depending on laboratory routines and judg...

Page 172: ...ts in the same direction LOW HIGH LOW HIGH Results calculated Curve flagged WARNING Results must be judged based on the QC results 4 Both curve controls are within the outer limits in the opposite dir...

Page 173: ...e outer limits in the same direction LOW HIGH LOW HIGH Results calculated Stored curve deactivated NOT OK WARNING Results must be judged based on the QC results 4 Both curve controls are within the ou...

Page 174: ...K OK HIGH LOW LOW HIGH OK OK Results calculated Curve flagged 3 Both replicates are within the outer limits in the same direction LOW HIGH LOW HIGH Results calculated Curve flagged WARNING Results mus...

Page 175: ...NOT OK 3 Both replicates are within the outer limits in the same direction LOW HIGH LOW HIGH Results calculated Stored curve deactivated NOT OK WARNING Results must be judged based on the QC results 4...

Page 176: ...ternal day to day QualityControl 4 Criteria for Control Samples 4 Quality Control of Specific IgE Assays 6 Quality control of other allergy autoimmunity and asthma methods 7 Control Charts 7 Inspectio...

Page 177: ...are striving to establish performance and comparability standards These ambitions require that diag nostic testing laboratories continuously assess their performance The laboratories performing in vit...

Page 178: ...rs The laboratory staff has to go through a training program before a new method can be used for routine testing The skill of an operator can be monitored by precision experiments using the same desig...

Page 179: ...e Sample Controls ImmunoCAP Specific IgE Control is a serum pool containing allergen specific IgE antibodies against different allergens Ready to use The wide range of allergen specific IgE antibodies...

Page 180: ...ith EliA IgG together with ANA tests EliA ANCA GBM Control positive negative are human serum pools to be used with EliA IgG together with ANCA GBM tests EliA APS Control positive negative is a human s...

Page 181: ...alues given in the Directions for Use for the Quality Control or for EliA on the package certificate Run a minimum of 20 assay runs to get the mean for the expected value and expected standard deviati...

Page 182: ...for each control sample of ImmunoCAP Gliadin IgA IgG Control LMH and ImmunoCAP Specific IgG Control LMH should fall within the range given in the package insert ForEliAANAControl EliAANCA GBMControl E...

Page 183: ...nvaluelineandwithincontrollimits 2SD Resultsoutsidethis range but inside 3 SD should act as a warning signal and a check of instruments and routines should be made Results outside 3 SD should result i...

Page 184: ...ion of Control Charts TheauthorsWestgardJO BarryPL HuntMRandGrothThaveinAmulti rule Shewhart chart for quality control in clinical chemistry Clin Chem 1981 27 493 501 defined four control rules that c...

Page 185: ...e systematic errors Rule 3 22s means a run is not accepted if two consecutive observations are outside the same limit either 2 SD or 2 SD This does not apply only to the same control sample A run is r...

Page 186: ...onitortheperformanceusinginternal and external quality control programs in order to maintain high quality results Quality Club is an international quality assessment program for laboratories using Pha...

Page 187: ...rmance and secure high standards of accuracy and reliability Specific IgE results for each of the three allergens requested per month are analysed by use of established statistical methods The results...

Page 188: ...ratory the report is based on at most 36 12x3 observations for Specific IgE and EliA Autoimmunity and 24 12x2 observations for Total IgE and ECP Any questions regarding the interpretation of the summa...

Page 189: ...quality control sample is used no expected values obtained in the laboratory are available In this case the ranges given in the package insert may be used Whenabout20or30observationshavebeencollected...

Page 190: ...mewhat different The allergen preparations used are of biological origin with no international reference preparations available They consist of a complex mixture of many different protein components A...

Page 191: ...f American Pathologists 1980 34 182 3 194 Costs of securing good quality Prevention costs expenses for developing using and improving a planned quality control program Examples are training calibratio...

Page 192: ...DeleteMethod 25 5 4 PrintMethod 26 5 4 1 Summary of Methods 26 5 4 2 SpecificMethod 26 5 4 3 All Methods 26 5 5 ExportMethod 27 5 5 1 SpecificMethod 27 5 5 2 All Methods 28 5 6 ImportMethod 29 6 2 Tes...

Page 193: ...e Menu Structure is the Method Setup You have to login with the laboratory password the password at delivery is unicap To get to Method Setup do the following 1 In Install Service mode pressyes 2 Pres...

Page 194: ...e in chapter 2 To navigate in Method Setup you can use the no and yes key or if you know the number of the function you just type it Confirm each step with enter To select an alternative just press no...

Page 195: ...new method will get all parameter settings from the template method Some of the parameters can be changed in 5 2 Edit Method If you do not select a existing method all parameters get default values N...

Page 196: ...VE CHANGES TO METHOD By pressing yes all changes are stored Select 5 2 Edit method then Select Method confirm with enter Warningsthatmayprevententering CANNOT EDIT OR DELETE METHODS NOW Itisnotpossibl...

Page 197: ...onfirm with enter 5 2 1 6 Method priority If there are more than one method in a run the Method prority decides in which order they will be allocated The lowest number will be allocated first Type a n...

Page 198: ...l up to 4 digits Confirm with yes 5 2 2 2 Incubation time PARAMETER NOT RELEVANT Not to be changed 5 2 2 3 Identity Type the identity Confirm with enter 5 2 3 Reference 5 2 3 1 Curve control You can...

Page 199: ...firm with enter Theinnerandouterlimitsforthecurvecontrolareexpressedasafactorthatwill be multiplied with the expected standard deviation 5 2 3 1 2 7 LimitsInner Innerlimitoftheconcentrationofthecurvec...

Page 200: ...it should not be used Warning will be given during Create Assay run and on the Laboratory Report Age until pre warning Type some days lower than the previous to get a warning in advance that it is tim...

Page 201: ...ator to the selected method Define identity concentration replicate normal response expected s limit s upper RU limit s lower RU limit s precision and limit s deviation 5 2 3 2 9 Edit Point Here you c...

Page 202: ...keytobeabletochangeparametersoftheX axisofthecalibration curve graph 5 2 4 1 1 Text Type the new text up to 15 characters and confirm with enter 5 2 4 1 2 Scale Select LOGARITHMIC or LINEAR scale 5 2...

Page 203: ...rm with enter You can select from Rodbard 5 parameter Richards Cut off Spline Spline non smooth Rodbard 4 parameter 5 2 5 2 Normal Weight A parameter that controls the curve fit Not to be changed 5 2...

Page 204: ...8 Lowest concentration Lowest concentration that will be reported 0 zero means at lowest calibrator 5 2 6 Report type In this function you can change the cut off and the reference curve 5 2 6 1 Cut o...

Page 205: ...samples with results above Warningsthatmayprevententering MAX NO OF CLASSES ALREADY USED Itisnotpossibletoaddanotherclassborder Alltheavailablepositionsarefilled NO CLASSES EXIST There are no classes...

Page 206: ...ss border 5 2 6 3 3 EditClassborder Select Class border type new text for values above 5 2 6 3 4 DeleteClassborder Select a cut off 2 ASM Class border Press yes to delete 5 2 6 4 ExtraReferenceclasses...

Page 207: ...st name is used for another test Please type another name Type the full name confirm with enter Type the number of replicates 1 digit confirm with enter Select report concentration yes or no No means...

Page 208: ...name confirm with enter 5 2 7 2 2 Fullname Type the full name confirm with enter 5 2 7 2 3 Replicate Type the number of replicates 1 digit confirm with enter 5 2 7 2 4 Reportconcentration Select repor...

Page 209: ...Select Lot Specific Code or not with the yes or no keys Confirm with yes 5 2 7 2 14 Dilutionfactor Type a number between 1 and 999 for PREDILUTED or 1 2 5 10 20 50 or 100 for INSTRUMENT DILUTION Conf...

Page 210: ...curve 5 2 7 2 21 QuantBelowdiluted Type in text to be written on lab report For diluted tests below the curve 5 2 7 2 22 QuantAbovediluted Type in text to be written on lab report For diluted tests ab...

Page 211: ...occur NO MATCHING TESTS FOUND There are no matching tests If you want to change one or more report paramaters for the matching tests press yes You have to go through all the parameters again change t...

Page 212: ...ty Control log Now you can use these obtained values for expected concentration and standard deviation It is recommended to use 3 as the standard deviation limit 5 2 9 1 Add QC Warnings that may preve...

Page 213: ...ty Control you want to edit Select the parameter you want to edit 5 2 9 2 1 Status Select ACTIVE MANUAL or INACTIVE Confirm with yes Active means that it will be added in all assay runs Inactive means...

Page 214: ...tivated 5 2 9 2 6 Expectedconc Type the expected concentration Confirm with enter Typing 0 Zero means that the function is deactivated 5 2 9 2 7 Expecteds Type the expected standard deviation Confirm...

Page 215: ...e the Dilution factor Confirm with enter 5 2 9 2 14 Instr dilutionfactor 1 2 5 10 20 50 or 100 Confirm with enter 5 2 9 2 15 TypeofQC Select either Concentration Quotient or qualitative Confirm with e...

Page 216: ...12 Page 9 25 9 Select Method confirm with yes The display will prompt you to PRESS ENTER TO DELETE METHOD Press enter and you will get the message METHOD DELETED If you try to delete a default method...

Page 217: ...apter 10 Printout for examples of the printing lists 5 4 1 Summary of Methods Selecting Summary of methods will give you a list of all methods that are defined in the actual Phadia 100 5 4 2 Specific...

Page 218: ...A ERROR ABORT The USB memory external USB hard drive or diskette is not formatted or it is damaged Format the media or change it Press no to continue or press yes to abort MEDIA FULL ABORT The USB mem...

Page 219: ...damaged Format the media or change it Press no to continue or press yes to abort MEDIA FULL ABORT The USB memory external USB hard drive or diskette is full Delete old files or change media Press no...

Page 220: ...or diskette NAME METHOD NOT SIMILAR UPDATE The selected method on the USB memory external USB hard drive or diskette has the same name as a method already used in the instrument but one or more param...

Page 221: ...st panels comes predefined 6 2 1 Add Test Panel 1 In Prepare Run mode se lect the number 6 key You will come to Install Service mode 2 In Install Service mode press 2 3 InTestPanelsmodeselect the yes...

Page 222: ...Add Test Panel and follow the instructions below 1 In the Test Panels mode press 2 2 Press yes 3 Press no until the test panelyouwanttoeditappears Press enter to select the test panel you want to edi...

Page 223: ...the test you want to delete appears Press yes to delete the test from the test panel 4 Press enter to confirm that you want to delete the test from the test panel Messagesthatcanoccur PANEL ALREADY E...

Page 224: ...ess 3 2 Pressyes 3 Pressnountilthetestpanel you want to delete appears Press enter to select the test panel you want to delete 4 Press enter if you want to delete the test panel The dis play shows whe...

Page 225: ...epare Run mode se lect 6 2 Pressyes 3 In Install Service mode select 6 4 In Article Management mode select yes 5 Press yes 6 Type the new article ID up to three characters and press enter 7 Press no u...

Page 226: ...to three numbers Press enter to con firm this step 4 Press no until the article type you want appears Then press yes 5 Type the new article methodovertheoldone upto four characters and confirm this st...

Page 227: ...the instructions below 1 In the Article Manage ment mode press 3 2 Pressyes 3 Type the ID of the article you want to delete and press enter 4 Pressentertoconfirmthis step The display shows that the ar...

Page 228: ...onnectanexternal USB hard drive and press en ter ImmunoCAP 100 Ver 3 0 14 10 17 1 Prepare Run ImmunoCAP 100 Ver 3 0 14 10 17 6 Install Service 6 Install Service 1 Login Logout 6 Install Service 11 Exp...

Page 229: ...memory externalUSB hard drive or diskette MEDIA NOT INSERTED ABORT Insert a USB memory or a diskette or connect an external USB hard drive Press no to continue or press yes to abort MEDIA WRITE PROTEC...

Page 230: ...ts as they are listed by the instrument Description of All Printouts 2 Request List 3 Consumption List 4 Distribution List 5 Laboratory Report 6 Patient Report 10 Calibrators 11 Quality Control Log 13...

Page 231: ...ith a copy of the printout The following reports and lists can be printed from the instrument Request List Consumption List Distribution List Laboratory Report Patient Report Calibrators Quality Contr...

Page 232: ...r Date and time of printout Number of replicates Software version number REQUEST LIST Run number 18 Run created 090508 16 15 Run origin Instrument S01 ImmunoCAP Specific IgE 0 100 1 fx1 f13 f17 f18 f2...

Page 233: ...E not including dead volume see User Manual S01 40 l S02 22 l tIgE QC1 40 l AWNA9 ImmunoCAP sIgE a IgE 12 tIgE a IgE 5 A3 REAGENT including dead volume sIgE Conjugate 900 l tIgE Conjugate 550 l A3 Dev...

Page 234: ...factor for instrument di luted sample Dilution factors for sample Run sequence number Date and time of the first entered request Instrument serial number Software version number Date and time of print...

Page 235: ...ber between 0 and 3 Cont LABORATORY REPORT Run number 18 Run created 090508 16 15 Process started 090509 08 23 Process ended 090509 11 19 Run origin Instrument ImmunoCAP Specific IgE 0 100 Calibration...

Page 236: ...oncentration kU l CALIBRATOR DATA NAME CONC RESP CV CALC CV CAL 0 00 0 001 20 0 00 20 0 00 mean 20 0 0 0 00 0 0 CAL 0 35 0 35 184 0 35 186 0 35 mean 185 0 8 0 35 0 8 CAL 0 70 0 70 355 0 71 343 0 69 me...

Page 237: ...printed here if the coefficient of variation is too high for the specific test Instrument serial number Date and time of printout If QC is NOT OK the limits de fined for it are written here Identity...

Page 238: ...0 09 03 27 BFVA0 09 04 ITEM Lot Expiry Development solution 939D1 10 10 Stop solution 11 05 Diluent EliA Diluent BFWA0 08 12 MEANS THAT REAGENT IS EXPIRED Position in ImmunoCAP Carousel Name of the re...

Page 239: ...ration 2 53 kUA l Class 2 fx1 f13 f17 f18 f20 f36 Class Positive ImmunoCAP Total IgE a IgE Total IgE Concentration 41 7 kU l ImmunoCAP Phadiatop phad Phadiatop Concentration 3 58 PAU l RESULTS FROM FO...

Page 240: ...t this list select 4 3 1 Specific Calibrators Cont Graphic image of the calibration curve If a point is rejected it will be printed as a cross This is only printed if calculation type is other than cu...

Page 241: ...17 5 2 6 CAL 100 100 19630 90 9 NAME RESP REMARK CAL 100 20818 Rejected Coefficient of variation of re sponses Calculated concentration of each replicate and the mean value Coefficient of variation of...

Page 242: ...nt was logged Lot number of each logged point as stated on QC vial The asterisc indicates that a point has been inactivated and is not plotted in the graph or included in the mean standard deviation o...

Page 243: ...TROL Elia IgG Identity ANA Pos sy LOG DATA RUN DATE TIME LOT NO CAL CODE LIMIT JUDGE 090508 9 15 BFU7B A0 1 00 OK 03460 090508 19 03 2 3 032 Method name Date and time of the run Calibration code of us...

Page 244: ...ean standard deviation or CV If a start date for the print is defined it is noted here Mean standard deviation and CV for all active points in the log Date and time when each point was logged Calibrat...

Page 245: ...Sequence number of the run Calibration code of used conju gate for each method Mode of the run Cal Calibrators included MC Monthly Calibration Concept A monthly calibration run with curve controls Me...

Page 246: ...y run is started A Blank Report is also printed when a Blank Check is run from 6 9 5 Run Blanks or when a Selftest in which the BlankCheckisincluded isperformedfrom6 9 6 Selftest Formoreinformation on...

Page 247: ...l number Software version number Date and time of printout Method version number Target value stated on FluoroC vial Date and time of the FluoroC run Measurement status OK The measurement was accompli...

Page 248: ...on ImmunoCAP EliA Well NO No calibration code on ImmunoCAP EliA Well Identity of the curve control Numberofreplicatesforthecurve control Expected standard deviation and inner and outer limits Type of...

Page 249: ...T 0 35 1 0 70 2 3 50 3 17 5 4 50 0 5 100 6 Cont Identity of the calibrator point Nominal concentration of calibra tor point Number of days before the in strument will request you to run a new calibrat...

Page 250: ...c Class f2 Milk 1 Conc Class f24 Shrimp 1 Conc Class f245 Egg 1 Conc Class f256 Walnut 1 Conc Class f26 Pork 1 Conc Class f3 Fish cod 1 Conc Class f342 Olive 1 Conc Class f4 Wheat 1 Conc Class f79 Glu...

Page 251: ...Printouts Phadia 100 User Manual Page 10 22 12 3501 20 12...

Page 252: ...nance 7 Monthly Maintenance Procedure 7 Lubrication of O rings 9 Cleaning of the Sample Carousel 10 Outside Cleaning 10 Restart the Instrument 10 Semiannual Maintenance 11 Replace Washing and Rinse Tu...

Page 253: ...as to be done with different time intervals Daily Weekly Monthly Semiannual Unscheduled Ifmaintenanceisnotperformedregularly theinstrumentwilldisplayamessage requestingtheappropriatemaintenance Youmay...

Page 254: ...purified water Unscrew the cap from the Washing Solution Bottle and connect it to the quick release Put the wash tubing in the beaker with purified water Check that the Waste Bottle is empty before y...

Page 255: ...ftheProcessingChamberincludescleaningoftheElutionWellsDisc ImmunoCAP Holder Disc and Processing Lid NOTE The ImmunoCAP Holder Disc is fragile and should be handled as glass Press lid open and open the...

Page 256: ...deoftheProcessingLidwithpurifiedwaterinordertosecure the ImmunoCAP ELiA Well transfer Install the Elution Wells Disc and ImmunoCAP Holder Disc Make sure not to exchange the Elution Wells Disc between...

Page 257: ...e Empty and rinse the bottles and the beaker three times with purified water NOTE Donotunscrewthecapfromthebottlesifthetubingsarestillconnected This can cause problems with insufficient distribution o...

Page 258: ...Pleasereadandfollowthewarningsandinstructionscarefully Monthly Maintenance is also used as a corrective action see Action List Monthly Maintenance Procedure A cleaning of Phadia 100 has to be done onc...

Page 259: ...onfirm this step by pressing the enter key 7 Presstheenterkeytostart the process The procedure takes approximately 30 min utes 8 When the process is fin ished rinse the Washing Solu tion and Rinse Sol...

Page 260: ...OTE See semiannual maintenance for information how to remove the drainage filter Reinstall the Drainage Filter the Elution Wells Disc and the ImmunoCAP Holder Disc in the Processing Chamber NOTE Befor...

Page 261: ...tenanceSolu tion NOTE Be careful not to damage the optical sensors located in the compartment Outside Cleaning Wipe off the instrument with a tissue moistened with prepared Maintenance Solution Do not...

Page 262: ...r key to confirm this step Replace Wash and Rinse Tubings IneachoftheWashingSolutionandRinseSolutionBottlestherearetubingswith bottle filters at the end that prevent particles from entering valves It...

Page 263: ...preventsparticlesfromenteringvalves It isadvisabletoreplaceiteverysixmonths Press lid open and open the Processing Lid Pull out the drainage filter from the Pro cessing Chamber using a pair of forceps...

Page 264: ...amonthadailymaintenancehas to be processed twice The first rinse has to run with purified water followed by a run without any liquid at all Wipe off any remaining liquid from the Processing Chamber Be...

Page 265: ...will automatically print a Blank Report where you can see the result of the selftest If you have received a section on the printout with remarks you have a Blank Error An action list will then be pri...

Page 266: ...ORT Run date time 090513 11 13 Source Other Reagent Blank 14 2 RU Rinse Blank 12 3 RU Dark Blank 7 9 RU 00847 090513 11 13 2 3 032 Blank Run The Blank Run checks the cuvette and reagents The Blank Run...

Page 267: ...remarks you have a Blank Error An action list will then be printed at the end of the report with instructions on how to eliminate the error For more information on how to eliminate the error see chap...

Page 268: ...hing Solution and Rinse Solution Bottles are filled and connected to the instrument The FluoroC run takes approximately seven minutes regardless of the warm up time 1 In the Prepare Run mode select th...

Page 269: ...oroC Run Report On the report you can see the result of the FluoroC run If you have received a NOT OK on the printout for FluoroC CV Rinse Blank voltage or Deviation from target you have a FluoroC err...

Page 270: ...the roll Insert the end of thepaperintothepaperinletof the paper holder Place the pa per roll in position 3 When the paper is visible in the paper collection area of the paper holder push it for ward...

Page 271: ...ower cord 2 Open the fuse voltage se lectorcoverusingascrewdriver Insert the screwdriver at the top center and apply pressure 3 Take out the fuse holders from the instrument and re move the old fuses...

Page 272: ...move the old fuse 4 Place a new fuse in the fuse holder and install it in the instrument 5 Connect the mains power cord Replace broken Bottle Holders on the Sample Carousel 1 Push the Bottle holder ba...

Page 273: ...ftheBottleholder markedby being encircled in Fig 2 Replace broken Tube Holders on the Sample Carousel 1 Unscrewthecenterscrew Fig 3 2 Lift the upper part of the Sample Carousel Fig 4 3 Remove the brok...

Page 274: ...g 7 6 PuttheTubeholderguide that you removed from inside the Sample Carousel bowl on top of the upper part of the Sample Carousel Fig 8 7 While holding the two parts together turn them up side again F...

Page 275: ...inse Make sure that there is enough Rinse and space in the Waste Bottle it normally should if it was enough at the start of the assay run 1 In Maintenance mode press the number 4 key 2 Press the yes k...

Page 276: ...Phadia 100 User Manual Maintenance 12 3501 20 12 Page 11 25 2 5 6 11 Log for Maintenance Please copy this form and make a note every time you perform maintenance Date Action Signature...

Page 277: ...Maintenance Phadia 100 User Manual Page 11 26 12 3501 20 12...

Page 278: ...t Up Errors 3 Start Up Warnings 3 OperatorInteractionMessages 4 PreparationErrors 6 ProcessingErrors 14 AssayResultErrors 37 Calibration Curve Errors 37 Curve Control Errors 41 Quality Control Errors...

Page 279: ...al malfunction Depending on the error type the operator will be provided with different kinds of information regarding the error and how to eliminate it In some cases the instrument will stop the proc...

Page 280: ...Start by switching Phadia 100 off wait 10 seconds and switch the instrument on again If the error returns make a note of the error code and contact your local Phadia representative Example of a start...

Page 281: ...ABORT If you receive this error remove the write protection or change USB memory external USB hard drive or diskette Press no if you want to continue or yes if you want to abort E010 MEDIA NOT INSERTE...

Page 282: ...ENTED YET These errors can occur with error codes between 001 002 and 101 611 For Phadia 100 Ver 3 0 use the menu 6 13 Shutdown and follow the instructions displayed to safely shut down the instrument...

Page 283: ...ating that that Sample Carousel Cover is not present in position Corrective actions Put the Sample Carousel Cover in position Will minimize evaporation from samples and reagents and also to protect th...

Page 284: ...HIGH What can cause the problem The Fluorometer Lamp Voltage is too high Corrective actions Follow instructions in Action List in order to identify or eliminate the errors Check fuse F905 and replace...

Page 285: ...ECK EliA WELL DISPENSE n What can cause the problem The ImmunoCAP Carousel cannot move Corrective actions Follow instructions in Action List in order to identify or eliminate the errors CheckforanyImm...

Page 286: ...nse Solution or Washing Solution have been loaded in both bottles The error can also occur when the Washing Solution has not been mixed thoroughly Corrective actions Follow instructions in Action List...

Page 287: ...not been performed within 24 hours after the last completedrun Itisimportanttoperformdailymaintenanceinordertokeepthe instrument in good condition Please perform daily maintenance every day see chapt...

Page 288: ...What can cause the problem ThiserrormightbecausedbycontaminationoftheDevelopmentSolutionorthe Elution Wells Disc might need cleaning 0354 090507 10 12 2 3 032 BLANK REPORT Run date time 090507 10 00...

Page 289: ...tions on the list first and thereby eliminate the error it could be that Monthly Maintenance can be skipped this time If the error remains contact your local Phadia representative THE DIFFERENCE BETWE...

Page 290: ...order to identify or eliminate the errors Perform Monthly Maintenance as corrective action before next run in order to clean the instrument Monthly Maintenance should be done even if the regular Mont...

Page 291: ...ptions Ensure sufficient volume in reagent vials See User Manual Index Dead volumes If a position is specified it refers to a position in the ImmunoCAP Carousel Check place the Sample Carousel Cover i...

Page 292: ...d position in the Sample Carousel and the component involved in the error Withthisinformationitmightbeeasiertoidentifyandeliminatethecause of the error Note that one sample might be found in several p...

Page 293: ...y Curve Controls or Calibrators their limits will take over and advise the operator Please note that warnings can cause Assay Result Errors If a Processing Error is labelled error the instrument will...

Page 294: ...FT MOVEMENT PipetteR positiontable XX 1x At Serum position XX 2x AtConjugateposition XX 3x AtDevelopmentposition XX 4x AtFluoroCposition XX 5x At Stop Solution position XX 6x At Diluent position XX 7x...

Page 295: ...gent volumes are enough for the rerun Look at consumption list and include dead volume for the sample tubes Rerun the results that have not been reported Load the assay run again by first using 1 5 Lo...

Page 296: ...a representative FATAL 04 00 CONTROLLER HALTED What can cause the problem This error is caused by an external disturbance or it has occurred an error in the electronics Corrective actions Follow instr...

Page 297: ...ct your local Phadia representative FATAL 13 XX Position nn PROCEDURE What can cause the problem This error occurs if the program cannot be executed It could happen if there is something wrong with th...

Page 298: ...Rerun the results that have not been reported Check that sample volume is enough including the sample tube dead volume otherwise new patient sample is needed Use 1 1 Enter requests and put in the req...

Page 299: ...n List in order to identify or eliminate the errors Check Remove if the movement of the ImmunoCAP Carousel has been ob structed ChecktheprocessingchamberforlooseImmunoCAP EliAWells look under the Elut...

Page 300: ...movement of the Wash Rake Corrective actions For Phadia 100 Ver 3 0 use the menu 6 13 Shutdown and follow the instruc tions displayed to safely shut down the instrument Switch Phadia 100 off wait 10 s...

Page 301: ...is enough including the sample tube dead volume otherwise new patient sample is needed Use 1 1 Enter requests and put in the requests that have not been reported If the error remains contact your loc...

Page 302: ...quests and put in the requests that have not been reported If the error remains contact your local Phadia representative FATAL 24 06 SAMPLE CAROUSEL MOTOR CAN T POS FLAG What can cause the problem The...

Page 303: ...sentative FATAL 24 08 CAP TRANSFER MOTOR CAN T POS FLAG The ImmunoCAP Transfer motor does not seem to work Contact your local Phadia representative 25 XX Position nn BENT PIPETTE The pipette has touch...

Page 304: ...IN FLUID Sub code see Pipette R position table What can cause the problem Theleveldetectordetectsfluidwhenitisnot supposed to A droplet of fluid may be stuck between the electrodes and the pipette as...

Page 305: ...t been reported If the error remains contact your local Phadia representative 30 XX Position nn CANNOT FIND SAMPLE What can cause the problem This error indicates that the sample tubes may be out of f...

Page 306: ...If the error remains contact your local Phadia representative 31 03 Corrective actions Contact your local Phadia representative 32 XX Position nn CANNOT FIND DEVSOL What can cause the problem This er...

Page 307: ...reported If the error remains contact your local Phadia representative 33 03 Corrective actions Contact your local Phadia representative ERROR 34 XX CANNOT FIND FLUOROC What can cause the problem Thi...

Page 308: ...s Rerun the results that have not been reported Check that sample volume is enough including the sample tube dead volume otherwise new patient sample is needed Use 1 1 Enter requests and put in the re...

Page 309: ...spirated correct volume There mighthavebeenanairbubbleintheconjugatevialwhichhasbeenpoppedwhen the Pipette tip went through it Corrective actions Follow instructions in Action List in order to identif...

Page 310: ...dia representative ERROR 44 00 FLUOROC VIAL EMPTY What can cause the problem The level detector has detected fluid before aspiration but not afterwards when it is leaving the FluoroC vial This warning...

Page 311: ...he problem The optical sensors have detected that the Sample Carousel has moved to the wrongposition Corrective actions Follow instructions in Action List in order to identify or eliminate the errors...

Page 312: ...could be contaminated Corrective actions Follow instructions in Action List in order to identify or eliminate the errors Make sure that the tubing from the Washing and Rinse Solution bottles are not...

Page 313: ...ed to safely shut down the instrument Switch Phadia 100 off Contact your local Phadia representative DATA This error is caused by a malfunction during transfer of data in the internal communication An...

Page 314: ...eps Do not empty the instrument before you perform the actions listed on the Action List since this might complicate identification of the cause of the error A more detailed information on each Assay...

Page 315: ...6 9 CAL 15 0 15 0 1126 15 5 CAL 100 100 9271 100 9042 97 5 mean 9156 1 8 98 8 1 9 CAL 200 200 15859 202 15867 202 mean 15863 0 0 202 0 1 100 1000 10000 100000 Rejected calibrator point Estimated calib...

Page 316: ...ormation see Explanation of Actions number 18 24 26 If the error remains contact your local Phadia representative LOWER PART OF CURVE IS TOO HIGH What can cause the problem In some cases pipetting Sto...

Page 317: ...ing Specific IgE Conjugate can give this error message Corrective actions FollowinstructionsinActionListinordertoidentifyoreliminatetheerrors For additional information see Explanation of Actions numb...

Page 318: ...ns number 7 22 24 38 If the error remains contact your local Phadia representative CALIBRATION CURVE OLDER THAN RECOMMENDED What can cause the problem The Calibration Curve is too old Corrective actio...

Page 319: ...ive this error message For Specific IgE method wrong Curve Controls can have been used Corrective actions FollowinstructionsinActionListinordertoidentifyoreliminatetheerrors For additional information...

Page 320: ...m most likely contamination of conjugate or CC vial with sample For EliA wrong Lot Specific Code Corrective actions FollowinstructionsinActionListinordertoidentifyoreliminatetheerrors For additional i...

Page 321: ...number 4 7 24 If the error remains contact your local Phadia representative CC 1 LOW and CC 2 HIGH What can cause the problem This error is very uncommon and is probably caused by more than one error...

Page 322: ...y caused by more than one error Corrective actions No corrective actions proposed except for EliA methods FollowinstructionsinActionListinordertoidentifyoreliminatetheerrors For additional information...

Page 323: ...on of Actions number 7 22 26 29 If the error remains contact your local Phadia representative CC 1 LOW and CC 2 HIGH What can cause the problem This error is very uncommon and is probably caused by mo...

Page 324: ...rmation see Explanation of Actions number 4 7 18 24 If the error remains contact your local Phadia representative CC 1 OK and CC 2 LOW What can cause the problem Pipetting problem For methods with two...

Page 325: ...ve actions proposed in Action List except for EliA methods FollowinstructionsinActionListinordertoidentifyoreliminatetheerrors For additional information see Explanation of Actions number 17 25 26 If...

Page 326: ...d to test the reagent blank which is subtracted from theresultsobtainedintheassayrun TheBlankCheckteststhequalityoftherinse and the function of the cuvette and fluorometer The Blank Errors are specifi...

Page 327: ...orrective actions Follow instructions in Action List in order to identify or eliminate the errors Perform Monthly Maintenance as corrective action before next run in order to clean the instrument Mont...

Page 328: ...Report it means that you have a LOW RU Error This kind of error never occurs for calibrators curve controls and Quality Controls When a LOW RU Error occurs it will affect the assay run in different w...

Page 329: ...a mechanical malfunction If you have received LOW RU for all positions load the assay run again by using 1 5 Load Old Run and rerun the samples If you have received LOW RU for some positions rerun th...

Page 330: ...hiserrormightbecausedbycontaminationoftheDevelopmentSolutionorthe Elution Wells Disc might need cleaning Missed pipetting of Conjugate or DevelopmentSolution Missed ImmunoCAP EliA Well dispensing The...

Page 331: ...e error remains contact your local Phadia representative FLUOROC RUN Run date time 090507 9 57 Measurement status OK Target value DW 12500 RU RESULTS Value Acceptance FluoroC voltage 1 3923 0 mV Fluor...

Page 332: ...ive Deviation from target 4 10 NOT OK IfyougetNOTOKafterDeviationfromTargetontheFluoroCRunReportand the deviation is between 4 and 10 or 4 and 10 rerun FluoroC using new room temperated vials of Fluor...

Page 333: ...ight position according to Distribution List Check that the Cal Code printed on Laboratory Report is the same as on the bottle in the Conjugate position in the sample carousel Always check that the as...

Page 334: ...tructed ChecktheprocessingchamberforlooseImmunoCAP EliAWells lookunderthe Elution Wells Disc check also under the Wash Rake Clean the processing chamber If problem persist call service 10 10 10 10 10...

Page 335: ...stopped 15 15 15 15 15 Check replace fuse F904 and F906 Please read Chapter 11 Replace fuses 16 16 16 16 16 Check replace fuse F905 Please read Chapter 11 Replace fuses 17 17 17 17 17 Check Lot Specif...

Page 336: ...me for the sample tubes Rerun the results that have not been reported Load the assay run again by first using 1 5 Load Old Run 24 24 24 24 24 Rerun the results that have not been reported Check that s...

Page 337: ...he Conjugate vial cap Small amounts of Conjugate coming in contact with the Development Solution affects the background signal of the Development Solution Residues of conju gate on the vial cap is eno...

Page 338: ...tion will foam 38 38 38 38 38 Check mix up between calibrators Checkreagentsusedbeforeunloadingfrominstrument PrintDistributionListif notalreadyprinted Checkthatrightreagentsareinassignedpositionaccor...

Page 339: ...ckthatthepowerisswitchedonand that the power LED is lit If the power LED is not lit check that the mains power cord is connected and that the cord is undamaged Connect or replace the cord if necessary...

Page 340: ...roll if necessary see chapter 11 Maintenance If there is paper in the printer switch Phadia 100 off wait 10 seconds and switch it on again If the error remains contact your local Phadia representative...

Page 341: ...Error Handling Phadia 100 User Manual Page 12 64 12 3501 20 12...

Page 342: ...ual Repacking 12 3501 20 12 Page 13 1 13 Chapter 13 Repacking This chapter describes the cleaning report and the repacking instructions Repacking 2 Cleaning Report 2 Phadia 100 Cleaning Report 2 Repac...

Page 343: ...ture on the Cleaning Report Please copy this form and use it Phadia 100 Cleaning Report Phadia 100 serial number Cleaned according to the Phadia 100 User Manual Phadia 100 Instrument has been cleaned...

Page 344: ...e Arm Place it on the Sample Carousel Cover and fasten it with tape 2 Make sure the Washing Solution Rinse Solution and Waste Bottles are empty Remove the Biohazard label from the Waste Container Fast...

Page 345: ...ndles and place it on the bottom plate of the plywood box NOTE This step requires two persons 9 Place the four spacing collarsintheirpositions Put theaccessoryboxinitsplace Lift the plywood box over t...

Page 346: ...ies 12 3501 20 12 Page 14 1 14 Chapter 14 Accessories This chapter notes the different accessories spare parts and supplement products to Phadia 100 Accessories for Maintenance 2 Spare Parts 2 Supplem...

Page 347: ...12 3500 95 ImmunoCAP Waste Container Rev 2 Instrument no 287 12 3505 19 Mains Kit 100 120V 12 3500 82 Mains Kit 230 240V 12 3500 83 Pipette Arm Cover 12 3500 81 Sample Carousel 12 3500 85 Sample Caro...

Page 348: ...Phadia 100 User Manual Index 12 3501 20 12 Page 15 1 15 Chapter 15 Index...

Page 349: ...Error 12 49 Disable 5 9 Blank Report 10 17 12 11 Blank Run 11 15 Bottle Cleaning 11 6 Rinse Solution 1 2 1 6 Washing Solution 1 2 1 6 Waste 1 2 1 6 C Calibration Code 2 31 2 45 Calibration Curve Erro...

Page 350: ...2 HIGH 12 46 CC 1 OK and CC 2 LOW 12 47 Change Dilution 4 3 Quality Control with New Lot 4 35 Replicate 4 4 Sample ID 4 5 Test 4 11 4 20 CHECK CAPS ON VIALS 12 9 EliA WELL DISPENSE 12 8 ImmunoCAP DISP...

Page 351: ...1 Electrical Malfunction 12 61 Electrical Safety Classification 1 11 ImmunoCAP 100E 1 11 UniCAP 100 1 11 Electro Magnetic Compatibility ImmunoCAP 100E 1 11 UniCAP 100 1 11 EliA Well Dispenser 1 2 1 5...

Page 352: ...23 Fuses Installation 1 18 Primary 1 3 1 8 Replacement 11 20 Secondary 1 3 1 8 H Heat Contribution 1 9 Humidity 1 9 I IDM 1 7 2 31 ImmunoCAP 1 12 2 30 Remove 4 41 Remove All 4 43 Skip Loading 4 36 Im...

Page 353: ...ly 11 3 Introduction 11 2 Log 11 25 Monthly 11 7 Semiannual 11 11 Unscheduled 11 13 Weekly 11 6 Manual Box 1 15 1 16 Mechanical Malfunction 12 61 MEDIA ERROR 12 4 FULL 12 4 NOT INSERTED 12 4 WRITE PRO...

Page 354: ...OUT OF RANGE 12 23 Pooling 3 3 Ports 1 3 1 9 POWER TEMPORARY LOST 12 19 Precautions 1 13 1 14 Predilution 3 9 Preparation Error 12 6 Prepared Run Abort 4 39 PRESSURE TOO LOW 12 7 12 33 Primary Fuses 1...

Page 355: ...eagent Handling EliA IgA 3 4 EliA IgG 3 4 General 3 2 ImmunoCAP Specific IgA 3 4 ImmunoCAP Specific IgG 3 4 ImmunoCAP Specific IgG4 3 4 Register Results from Quality Club 8 11 Remove EliA Well 4 43 Im...

Page 356: ...2 Technical 1 8 SPURIOUS HARDWARE INTERRUPT 12 18 SPURIOUS NMI INTERRUPT 12 19 Start Up Error 12 3 Start Up Warning 12 3 Stop Solution Handling 3 2 STOP SOLUTION VIAL EMPTY 12 32 Storage Conditions 1...

Page 357: ...INSE HAVE BEEN MIXED 12 9 Wash Tubings Replacement 11 11 WASH RINSE CHECK NOT OK 12 9 Washing Solution 1 10 Accuracy 1 10 Bottle 1 2 1 6 Washing Solution Bottle 1 2 1 6 Cleaning 11 6 Waste Bottle 1 2...

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