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Siemens ADVIA 2400 Operator'S Manual Download Page 99

Quality Control 

99 

 

4 Quality Control 

Quality control overview 

When to run control samples 

Refer to the ADVIA Chemistry system methods documentation for the quality control 
recommendations. 

Setting up quality control 

•

 

Use the QC Sample Definition window to define each of the 26 controls that can 
reside on the calibrator/control tray (CTT). 

•

 

Use the Control Data Setup window to enter the control average and standard 
deviation (SD) data for each control. 

Running the control samples 

•

 

Use the Start Conditions window to request control samples. You can run control 
samples alone, after calibration, or before patient samples. You can request to run 
only specific control samples or selected methods. 

•

 

The Ordinary control samp. meas. list on the Test Select window determines which 
tests are available to run. The Sample Select window determines which controls are 
available. 

•

 

Use the QC Sample Definition window to automatically run controls after a specified 
number of assays. 

•

 

The Auto control samp. meas. list on the Test Select window determines which tests 
are available to run. The Sample Select window determines which controls are 
available. 

Summary of Contents for ADVIA 2400

Page 1: ...ADVIA 2400 Chemistry System Operator s Guide 073D0403 01 Rev A 2009 06 ...

Page 2: ...g and hazard statements The ADVIA Chemistry system is manufactured in Japan for Siemens THE UNIVERSAL RACK HANDLING SYSTEM IS MANUFACTURED IN GERMANY FOR SIEMENS ORIGIN JAPAN Copyright and trademarks ADVIA Centaur and ADVIA are trademarks of Siemens Healthcare Diagnostics Acrobat is a trademark of Adobe Systems Incorporated San Jose CA Clorox is a trademark of The Clorox Company Oakland CA Windows...

Page 3: ...s 19 Sampling mechanisms 19 Sampling operation 19 Sample probe 20 Sample pump 20 Clot detection 21 Reaction tray 21 Reaction tray mixers 22 Reaction tray wash mechanisms 22 Reaction tray washer operation 24 Reaction tank 25 Sample tray 25 Sample tray 25 Sample tray operation 26 Container types 26 SMP Pause 26 Spectrophotometer 27 Reagents 27 Reagent mechanisms 27 Reagent trays 28 Reagent probes 29...

Page 4: ...the Menu Panel 38 Description of software windows 40 Request windows 40 Order Entry window 40 Sample Log window 40 Test Result Monitor window 41 Sample test status color codes 41 Review Edit window 43 Reaction Monitor window 43 RealTime Monitor window 43 Print Report window 44 Test Select window 44 Cup Tube Assign window 44 Test Utilization Statistics window 44 Correlation window 45 Calibration wi...

Page 5: ...Data Setup window 53 Sample Select window 54 QC Sample Definition window 54 Setup windows 54 System Specification Settings window 54 Analytical Parameters Chemistry window 55 System Test List window 56 Analytical Parameters Serum window 56 Process Sequence window 57 Ratio Parameters window 57 Contamination Settings window 57 Ctrl Cal Sample Setup window 57 User Code Settings window 58 New Test Def...

Page 6: ...ting a load list 75 Loading patient samples 76 Loading patient samples on the STT 76 Loading patient samples on the optional universal rack handler 77 Urgent samples and manual reruns are run from the onboard sampler STT 79 Starting the run 79 Running calibrators and reagent baselines RBL 80 Running control samples 80 Running an interrupt STAT sample 81 Monitoring an analysis while it is running 8...

Page 7: ... 91 Loading the reagent trays 91 Updating the Cumulative QC 91 Running automatic calibration 92 Using multiple reagent containers for the same test 92 3 Calibration 93 Calibration overview 93 When to calibrate 93 Setting up the calibration 93 Entering absolute or single point STD calibration methods 93 Entering multi standard calibration methods 94 How to calibrate a multi standard method 95 Runni...

Page 8: ...pes 119 Weekly maintenance 119 Performing the weekly wash 119 Checking and replenishing the lamp coolant 121 Checking lamp energy 122 Reading lamp energy data 123 Measuring cuvette blanks 124 Cell blank measurement results 124 Cleaning the analyzer and rack handler exterior panels 125 Monthly maintenance 126 Cleaning the turntable interiors STT CTT and RTT 126 Cleaning the inside of the STT CTT ho...

Page 9: ...itioning the ISE Na and K electrodes 157 Replacing ISE electrodes 158 Removing electrodes 159 Installing electrodes 159 Priming the ISEs 159 Calibrating the ISEs 160 Storing the reference electrode 160 Cleaning the dilution bowl and waste drain nozzle 161 Cleaning the dilution bowl 161 Cleaning the waste drain nozzle 162 Maintaining the ISE unit after the dilution bowl and waste drain nozzle are c...

Page 10: ... and hazard statements 178 Biohazard warning 178 Electrical warning 178 Laser warning 178 Household bleach warning 179 Regulatory compliance 179 Laser information 179 Appendix B Warranty and Support Information 183 Limited Instrument Warranty and Service Delivery Policy 183 Warranty period 183 Additional service period 183 Service calls 184 Service during normal hours 184 Extent of a service call ...

Page 11: ...nations of symbols associated with the ADVIA 2400 system 194 Warning and caution symbols 194 System operation symbols 195 System rating label symbols 196 Hardware component symbols 197 Ancillary reagent symbols 197 Connector symbols 198 System packaging label symbols 198 ...

Page 12: ...12 ADVIA 2400 Operator s Guide ...

Page 13: ...le tray or rack handler are aspirated and diluted by the dilution probe then dispensed into cuvettes in the dilution tray 3 The dilution mixer stirs the diluted sample 4 The sample probe dispenses the required amount of diluted sample into the RRV cuvettes the reagent is already in the cuvettes The system can use the remaining diluted sample in the DTT cuvettes for additional tests on a workorder ...

Page 14: ...sis is complete the lamp energy is checked at each wavelength Hardware Overview 1 ISE location 2 Pure water bottle 3 Horizontal pumps 4 Vertical pumps 5 ISE buffer bottle 6 Reaction bath oil bottle 7 Isotonic saline diluent bottle 8 Cuvette detergent bottle 9 Cell conditioner bottle 10 Reaction bath oil heater 11 Refrigerator filter 12 Reaction bath oil pump 13 Reaction bath oil filter 14 Power pa...

Page 15: ...button is pressed to stop the instrument in an emergency WARNING If you stopped the system using the Emergency Stop button you must perform a Weekly wash WASH2 prior to processing samples 6 OPERATE STANDBY switch turns the analyzer power ON OPERATE or OFF STANDBY 7 POWER lamp lights when the analyzer power is ON Figure 1 3 Power panel Analyzer back view 1 Main Power Switch powers the entire instru...

Page 16: ...top view 1 Sample tray 2 Sample dilution probe DPP 3 Dilution mixer DMIX 4 Dilution tray DTT 5 Dilution washer DWUD 6 Sample probe SPP 7 Reaction tray washer WUD 8 Reaction mixer 2 MIXR2 9 Reaction mixer 1 MIXR1 10 Reaction tray RRV 11 Reagent tray 2 RTT2 12 Reagent tray 1 RTT1 13 Reagent probe 1 RPP1 14 Reagent probe 2 RPP2 Figure 1 5 Analyzer top view ...

Page 17: ...wash pump 2 RWP2 Figure 1 6 Vertical pumps Horizontal Pumps 1 Dilution cuvette wash pump 1 DWP1 2 Dilution cuvette wash pump 1 DWP2 3 Dilution cuvette wash pump 1 DWP3 4 Dilution cuvette wash pump 1 DWP4 5 Switching valve WCV2 6 Switching valve WCV1 7 Reaction cuvette wash pump 1 WP1 8 Reaction cuvette wash pump 2 WP2 9 Reaction cuvette wash pump 3 WP3 10 Reaction cuvette detergent pump 1 DTP1 11 ...

Page 18: ...tion front view PC front view 1 Access door 2 CD RW drive 3 PC power switch Used to turn ON or OFF the power for the personal computer Normally it is left ON 4 PC hard disk drive access lamp Lights when reading or writing to the PC hard disk 5 PC power lamp Lights when the power for the personal computer is ON 6 USB ports Figure 1 9 PC front view ...

Page 19: ...nditions The sampling pump SP handles the aspiration and dispensing functions Sampling operation At initialization the SPP moves in the up position to the RRV cuvette then stops above the wash port The pumps stop when the SPP is positioned over the RRV cuvettes Each sampling cycle consists of these steps 1 The SPP moves to the aspiration position of the DTT and aspirates the sample 2 The SPP moves...

Page 20: ...ution DPP and the reagent probes RPP1 and RPP2 the SPP does not have liquid level sensing This is because the DTT cuvettes are always the same size Sample pump 1 Sampling pump SP 2 Sampling wash pump SCP Figure 1 12 Sample pumps The sampling pump SP withdraws sample from DTT and also dispenses sample into the RRV cuvettes The SPP executes both actions During both actions the sampling pump valves S...

Page 21: ...CTT Clot detection is active for samples run from the STT CTT rack handler or other LAS device Clot detection is inactive when the DPP aspirates from the DTT The clot detector is active each time the DPP probe enters a sample even when multiple aspirations are required If a sample is to be aspirated three times the DPP will make all three aspirations even if a clot is detected This may cause parti...

Page 22: ...Mixer 2 MIXR2 4 Mixer 2 wash port Figure 1 14 Reaction tray mixers The reaction tray RRV mixers MIXR1 and MIXR2 stir the contents sample and reagent of RRV cuvettes brought to their respective mixer positions Mixing is performed using a spinning reciprocating and vibrating paddle Strong and weak stirring options are available Both mixers are located behind the reaction tray MIXR1 mixes sample with...

Page 23: ...le The WUD has seven nozzles each performing a stage of the wash Each nozzle works on a different cuvette so the WUD washes seven cuvettes simultaneously the cuvettes are being washed in different stages at the same time After a cuvette is washed by one nozzle it moves to the next until washing is complete While the RRV rotates the WUD is in the up position The wash liquids pass through a preheate...

Page 24: ...al conditions 2 Second nozzle C1 Aspirates wash water D Dispenses detergent H2 Absorbs overflow liquid abnormal conditions 3 Third nozzle E Aspirates detergent B2 Dispenses wash water H3 Absorbs overflow liquid abnormal conditions 4 Fourth nozzle C2 Aspirates wash water F Dispenses cell conditioner H4 Absorbs overflow liquid abnormal conditions NOTE The fourth 4 and fifth 5 nozzles are separated b...

Page 25: ...tates to move the samples to the aspiration position The sample tray has two sections STT outer section Used for general samples and reference samples for multipoint calibrations It has two rows each with 42 positions total 84 You can place serum or urine samples into each position A barcode reader identifies samples in the STT It can interpret barcode formats Code 39 Interleaved 2 of 5 Codabar an...

Page 26: ...n the sample tray in the Test Result Monitor window If an assay is not running you can operate the unit manually from the Manual Operation window Container types You place sample containers defined in the Order Entry window in the STT and CTT You can use 5 mL 7 mL or 10 mL collection tubes or 2 mL sample cups You have to put the small sample cups into plastic holders before you place them in the t...

Page 27: ... energy and the optical density of the cuvettes This process is repeated for as many times and wavelengths as required by the assay conditions A cooling tank maintains the lamp temperature The system monitors the output energy of the halogen lamp during the cell blank check and after each assay The operator is alerted if the lamp performance is abnormal Use the Lamp Energy Monitor window to ensure...

Page 28: ...nd RPP2 aspirate the required reagent and dispense it into the reaction tray RRV cuvettes for analysis 1 Reagent tray 1 RTT1 2 Reagent tray 2 RTT2 Figure 1 20 Reagent trays Each tray has 50 positions RTT1 contains the first reagent R1 RTT2 contains the second reagent R2 You can use any reagent container for more than one test item a test item may require more than one reagent container Each reagen...

Page 29: ...ons During both actions the reagent pump valves RPEV1 1 RPEV2 1 RPEV1 2 and RPEV2 2 are closed After the reagent is aspirated the probes move to the wash ports where their outsides are washed RPEV2 1 and RPEV2 2 wash cup valves for RPP1 and RPP2 respectively are open during this process This allows water to flow over the outside of the probes After the reagent is dispensed the probes move back to ...

Page 30: ...n to temporarily stop testing on the analyzer or from a lab automation system so that reagents can be added or removed at the reagent trays NOTES Do not press the RGT Pause button while a barcode scan is executing The text on the RGT Pause button is gray when inactive and black when active After the button is selected the RGT Pause process can take some time The system will safely complete any tes...

Page 31: ... mixer moves up and over to the wash port where it is washed with deionized water During this period the dilution mixer wash valve DMEV is open and briefly the mixer rod is on The mixer is raised and moved to the mixer position where it is lowered into the DTT cuvette The rod is turned on to mix the sample The mixer is raised from the cuvette and moved back to the wash port The next cycle begins I...

Page 32: ... performing a stage of the wash Each nozzle works on a different cuvette so the DWUD washes ten cuvettes simultaneously The cuvettes are being washed in different stages at the same time After a cuvette is washed by one nozzle it moves to the next until washing is complete While the DTT rotates the DWUD is in the up position ...

Page 33: ...sh water 4 Fourth nozzle A2 Dispenses sample and wash water B2 Absorbs overflow liquid abnormal conditions 5 Fifth nozzle C3 Aspirates wash water 6 Sixth nozzle A3 Dispenses sample and wash water B3 Absorbs overflow liquid abnormal conditions 7 Seventh nozzle C4 Aspirates wash water 8 Eighth nozzle A4 Dispenses sample and wash water A5 Absorbs overflow liquid abnormal conditions 9 Ninth nozzle C5 ...

Page 34: ...then the sample voltage is measured The difference between these voltages the reference voltage and the temperatures of the liquids determine the concentration of Na Cl and K in the sample 1 Reference Electrode 2 Na Electrode 3 K Electrode 4 Cl Electrode 5 Mixer 6 Dilution Probe DPP 7 Sample 8 BPEV 9 ISE Degassing Unit 10 Buffer Solution 11 Buffer Pump BP 12 Temperature Stabilizer 13 DPEV 14 DP 15...

Page 35: ...es from the sample tray from an aspiration position specifically designed for the universal rack handler or another laboratory automation system LAS Use the universal rack handler for routine patient sample analysis only Process calibrators controls special diluents and reruns with the onboard sample tray STT 1 Laser Station 1 LS1 2 Conveyor 1 3 Conveyor 2 4 Main PCB Chassis 5 Cross Drive 6 Convey...

Page 36: ... Use the top display option Systems s to allow other windows to display on top of the Menu Panel and Operation Panel Startup window The Startup window is the first window you see when you turn on the PC and the last window when you stop the system Perform any of the following tasks at this window new start restart back up and restore system files set or clear the system data prior to startup shut ...

Page 37: ...n Panel buttons Status and message boxes The boxes on the right of the Operation Panel provide information on current system conditions 1 Operating modes 2 Load status indicator 3 Alarm message box 4 Time remaining indicator Figure 1 29 Status Message boxes Other tasks accessed from System s on the Operation Panel Use the System s list to perform these tasks To open the menu select System s at the...

Page 38: ... a different access level change the system password display version information and read or write a memo print the screen log on as a different user exit the system Logging on at a different access level Use this procedure to log on as a supervisor or tech_manager when you start the system you are automatically logged in as a user If you are already logged in as supervisor or tech_manager you can...

Page 39: ...the system version number and other information 2 To close the window select Return Printing the screen 1 At the System menu select Screen Print The entire screen as it displays on your monitor prints 2 Print the screen to the clipboard Logging on as a different user Use this procedure to log on a different user All results obtained for this operator annotates to the corresponding user code from t...

Page 40: ... at your host computer create workorders at the analyzer create an individual workorder create multiple workorders batch change an individual workorder change multiple workorders batch create a load list create a profile instruct the system to use system assigned position numbers configure the Order Entry window Sample Log window Perform any of the following tasks at this window view the sample lo...

Page 41: ... sample was ordered but not completed Discrepancies in color are due to the windows displaying different information For example a complete sample appears as dark blue on the Test Result Monitor window indicating that sampling is complete while in the Review Edit window the same sample appears as pale blue indicating that some tests are missing No sample white The position number does not contain ...

Page 42: ...tion in the Rack or LAS Sample Information window Sample barcode number Sample Status see the status codes listed on the Test Result Monitor window The time remaining to complete the processing of the sample NOTE If processing has completed or if there are no samples available for processing when you select the Rack or LAS Sample Info button the system displays a message that no sample information...

Page 43: ...e this window to observe changes in reaction data The changes are depicted as a function of time or of the 98 detection points in an analysis In the window you choose a test and a sample for which you want to display a reaction over time Once you make your choice a graph is created You can choose several plots for the graph Perform any of the following tasks at this window Check test reaction data...

Page 44: ...ests in this window for patient and control sample analysis and calibrations Use this window for the following tasks Disable down a test For example a test may be downloaded from a host system to analyzers in your lab but that test is not run on the ADVIA Chemistry System To down a test select one of the Test Select radio buttons and deselect it from the corresponding test table NOTE You can remov...

Page 45: ...to display the following Calibration menu View Calibration Curve window Use the View Calibration Curve window to review the detailed calibration curve data for a method to restore a calibration to monitor calibration trends to obtain a summary of all calibration information and to view RBL and calibration check information NOTE While running calibrations or processing samples the View Calibration ...

Page 46: ...a user specified time interval When a time interval expires the system recalibrates at the start of the next run NOTE You can run tests with 2 different lots of the same reagent but you cannot calibrate the 2 lots on the system at the same time You have to calibrate them one at a time After the system calibrates the lots separately you can place both reagents back on the system and run tests Perfo...

Page 47: ...e tasks monitor the maintenance status of the system delete maintenance records Lamp Energy Monitor window Perform any of the following tasks at this window check the spectrophotometer lamp energy perform offset analog to digital AD measurement ISE Operation window Use this window to perform various ISE tasks There is a display area at the top of the window where you can view the running status Pe...

Page 48: ...king unit position values BIOHAZARD Wear personal protective equipment Use universal precautions Manual operation of units may be necessary when performing maintenance and troubleshooting tasks The window contains a graphical image of the analyzer which depicts the operation you are performing IMPORTANT The operating mode must be READY or WAIT for you to run manual operations Also if you cannot pe...

Page 49: ...s The window continuously refreshes with new information and it updates after each barcode scan The Reagent Inventory window automatically opens at start up and remains opened When using other windows or when you select the X in the upper right corner the window minimizes to the taskbar at the bottom The reagents listed in the window are in alphabetical order Perform any of the following tasks at ...

Page 50: ... display in the Alarm message box on the Operation Panel but is recorded in the error message log Active is checked if the test is active Test Name displays the name and number of the test R1 Pos No displays the position of R1 on the reagent tray R2 Pos No displays the position of R2 on the reagent tray Reagent Information window Use this window to review and edit reagent information such as on sy...

Page 51: ...de maintenance database can store a maximum of 200 reagent codes assays and up to 2000 individual reagent barcodes If the database exceeds the limit of 2000 barcodes the oldest stored barcode is replaced with the most current barcode The reagents are listed in the same order as they display in the System Test List window The Reagent Barcode and Date Opened on System information for one or more rea...

Page 52: ...the wrong test name NOTE The maximum number of results displayed in the Daily Precision Control window is 200 When this number is reached the system deletes the results starting from the first entry and adds new results after the latest entry The system does not display a message that the maximum number of results was reached Perform any of the following tasks at this window view the Levey Jenning...

Page 53: ... additional control data can be saved for the day QC Cumulative window Use this window to manage the day to day cumulative QC information Perform any of the following tasks at this window specify the time interval you want to review view the Levey Jennings charts x r charts view the detailed control data information and omit invalid control results view the QC summary list use cumulative statistic...

Page 54: ...rmation required to run samples of up to 26 control products requesting an automatic run of control s after a user specified number of samples are processed Perform any of the following tasks at this window enter the sample information for a control configure the automatic control feature print the control sample information Setup windows NOTE You must log on as a supervisor tech_manager or servic...

Page 55: ...o 9 container types CAUTION Normal operation and the volume of sample aspirated depend on the specifications you enter here Incorrect settings may damage the probes and nozzles Type Container name Container diameters Container heights LLS sensitivity Liq volume judge Reagent bottles The settings below specify the reagent bottles used by the system These settings are used in the Reagent Inventory R...

Page 56: ...of results at the Review and Edit the Daily QC windows and the Print Report form you must not modify the order of the test items on the System Test List window after initial setup If you reposition any test items on the System Test List window results for samples already run could be associated with the wrong test name Perform any of the following tasks at this window add tests to list remove test...

Page 57: ...s window to set the conditions for preventing contamination of reagent probes and reaction tray cuvettes Each condition specifies an action to be taken if a specific interferer contaminates a specific receptor You can set up to 100 conditions each for reagent probes and RRV cuvettes Perform any of the following tasks at this window set conditions for avoiding reagent probe contamination set condit...

Page 58: ...rement of Na Cl and K electrolytes Perform any of the following tasks at this window enter settings for individual electrolytes Na Cl and K enter settings for all electrolytes check CTT settings Print Form Settings window Use this window to design or edit a print form for sample results When you print reports from the Print Report or the Review Edit window you will select a print form created here...

Page 59: ...ve the print form view the print preview print the print form Online Settings window Use this window to setup the communications between the system and a host computer NOTE Refer to the publication titled LIS Interface Guide for detailed information about this communications protocol Perform any of the following tasks at this window set the communication parameters that control the exchange of mes...

Page 60: ...lumn in the Review Edit window To define reflex testing for a given method you must list the reagent in the System Test List window Other Tasks Use the System S menu in the top left corner to perform the following tasks change the Top display option log on at a different access level Use this procedure to log on as a tech_manager or a supervisor when you start the system you are automatically logg...

Page 61: ... A EXE extension indicates the file is a program File date time The date the program file was created or last modified Size The size in bytes of the program file Controller This option displays information on the data tables in the system Column Description File name The name and path of the table A TBL extension indicates the file is a table Version The version of the program that is being used i...

Page 62: ... access the table of contents index search glossary and print functions The following are descriptions of the different areas of the online help 1 Select Contents tab and a table of contents displays 2 Select a given subject and a cascading list of relevant subtopics open Then select a subtopic to display it in the content frame 3 Select Index and a searchable keyword index displays 4 Enter the fi...

Page 63: ... case to view the entire popup select and drag the lower right corner of the viewer window to enlarge it and view the complete popup Topics have hyperlinks displayed in teal or shaded hotspots embedded in text or illustrations that link to displays of related or more detailed information Select teal text to activate hyperlinks The hyperlink is bold when the mouse pointer is over it Hyperlinks usin...

Page 64: ...64 ADVIA 2400 Operator s Guide ...

Page 65: ...rvice personnel You are automatically logged on at the user level during startup No operator is required If you log on at the supervisor or tech_manager levels when done you should log on to the user level no password required Starting the system 1 After the power is applied and the Windows operating system is loaded the ADVIA Chemistry system Startup window displays 2 Turn on the optional univers...

Page 66: ...ON Make sure that all probes and mixers are free to move without obstruction and that all analyzer covers are in place to avoid possible injury and damage to the analyzer 5 When the Start and the Ready indicators are off and the Initialize button on the Operation Panel activates turns black select Initialize 6 At the Windows desktop double select the rack handler icon 7 Log on as supervisor or tec...

Page 67: ...oc set list select the startup setting Set1 Set2 or Set3 you want to run 7 Select Start 8 To confirm select Yes The current operating mode displays in the System mode box and the time remaining to complete the startup displays in the Time until end box If a cell blank is run the system prompts you to save the results When done the system enters the Ready mode 9 To halt the startup do the following...

Page 68: ...ate Flow rate of the heating bath fluid in mL minute A flow rate 2000 mL minute or 6000 mL minute is considered abnormal 3000 5000 mL min 3000 or 5000 mL min Fill the incubation bath oil bottle with more oil Adjust the flow regulator valve Make sure the bath oil is circulating properly in the constant temperature bath RRV Oil Level Status of the quantity of heating bath fluid Insufficient liquid i...

Page 69: ...centrated waste tank A sensor monitors whether the tank is filled with waste OK NG Empty the concentrated waste tank If there is still a problem check the tubes for obstructions Waste tank Status of the volume of the optional waste tank A sensor monitors whether the tank is filled with waste OK NG Verify that the waste tubes are free of obstructions If the problem persists contact your local suppo...

Page 70: ...ace nonbarcoded reagent containers as follows 1 Place the reagent container s in the same position 2 For multiple reagent methods place R1 on reagent tray 1 and place R2 on reagent tray You can load more than one container for each reagent You must specify the reagent at the System Test List window 3 After replacing the reagent s you must establish the correct on system stability a Minimize the Re...

Page 71: ...tion 49 10 cuvette wash tube CTT position 50 DI water tube RTT1 position 49 10 cuvette wash 70 mL container RTT1 position 50 DI water 70 mL container RTT2 position 49 10 cuvette wash 70 mL container RTT2 position 50 DI water 70 mL container Weekly wash set up Same as WASH 2 except replace the 10 cuvette wash with 5 reagent probe wash in both the CTT and RTT positions Times required to perform prim...

Page 72: ...utomatic transfer area on the Online Settings window 2 Download workorders to the chemistry system a At the Menu Panel select Request then select Order Entry b Select Host request c In the Entry format area select the means for identifying the first workorder in step 2e d In the Last no entry format area select the means for identifying the last workorder in step 2f e In the Start no box identify ...

Page 73: ... To confirm select Yes 12 Select Enter The Number of workorder box increments Automatic incrementing is assigned using the Entry Setup window If autoincrement is on a new workorder displays with the next sample number and position number incremented 13 You can create another workorder or select Exit to leave If necessary select New to clear the window for entry of the next workorder Creating multi...

Page 74: ... select Order Entry 2 Select Batch Func 3 Perform any of the following tasks at the window a To erase workorders select Delete workorder b To change the test selectivity select Test correct 4 In the Entry format area select the means of identifying the first workorder in step 6 5 In the Last no entry format area select the means of determining the last workorder in step 7 6 In the Start no box ide...

Page 75: ...A load list contains only workorders that have position numbers To include workorders currently without position numbers use Creating List 1 At the Menu Panel select Request then select Order Entry 2 Select Create List 3 Select All or if you want to specify a range of position numbers select Posi no 4 If you selected Posi no define the tray and cup position a In the Last no entry format area selec...

Page 76: ...t SAMPLE LOAD OK displays 4 Load samples while the sample tray is in the sampler or remove the tray To remove the sample tray release the safety latches at position numbers 49 and 70 then grasp the sample tray by its handles and lift it out of the sampler well 5 Loading the samples a When using barcode labels Clean and properly position barcode labels on the sample tube Make labels face outward an...

Page 77: ...nly field personnel trained by Siemens should access laser assemblies IMPORTANT Define container types for use on either the universal rack handler LAS or the onboard sample tray STT When you use the same sample rack on the rack handler and on an ADVIA Centaur system select allowable tube sizes from the table below You must use the same tube size for every tube in a rack Tube Type Size Manufacture...

Page 78: ...Loading sample onto rack 3 Load the racks with the sample tubes and slide the loaded racks onto the rack carrier CAUTION You must have a unique barcode label on each rack to avoid universal rack handler user errors If you use the same sample rack on the rack handler and on an ADVIA Centaur system with the same ID labels but different series numbers 2 3 4 the rack handler reads the barcodes as dupl...

Page 79: ...ational states 3 Load samples on the STT 4 At the Operation Panel select Start 5 Complete the Start Conditions window and start the run Make sure to select the Analyze box for the onboard sampler After aspirating the STT samples the system resumes sampling from the rack handler if racks are available or it will enter the Watch mode while waiting for the next rack Starting the run WARNING If the sy...

Page 80: ... sample select From STT 1 Make sure the samples are loaded 2 In the Ordinary sample area next to Routine smp select Analyze This activates other fields 3 To specify how the samples are identified in the Ordinary sample area next to Analyze mode select Barcode or Cup posi If you select Barcode the system scans the entire STT tray for barcodes You can choose to scan for a single tray position or for...

Page 81: ...NG 1 Download or create the sample workorder and select Interr interrupt option on the workorder NOTE You can also select the priority using the Cup Tube Assign window if the sample is already on the sample tray and already has a workorder 2 At the Operation Panel select Pause to halt sampling 3 Load the new sample on the sample tray STT 4 At the Operation Panel select Start to resume sampling Run...

Page 82: ...or codes see page 41 Sample information and system status The button bar at the top of the window displays the Sample Search and Rack or LAS Sample Info buttons Select Sample Search to display a dialog box where you can search for sample information by sample number by STT position tray number and sample position or by rack LAS position rack number and sample position The search returns a Sample I...

Page 83: ...ew Monitoring samples loaded on the optional universal rack handler 1 At the universal rack handler Operation Panel window select View on the menu bar then select Rack Handler Operation Monitor or press F8 Perform any of the following tasks at the Rack Handler Operation Monitor window a follow the progress of each rack through the rack handler b locate racks that contain sample tubes with non read...

Page 84: ...elect Routine Only to view patient sample entries The following information is provided for each sample log entry Asp Date and Time External Type STT SampleID Rerun CTT Description Results 3 To view entries for recently aspirated samples select Update Searching the sample log 1 Select the search condition s you want and enter the applicable information Sample ID Enter the sample identification Sea...

Page 85: ...ically c If you want to delete the entire sample log select All 3 Select OK 4 To confirm select Yes Printing a list of the sample log entries 1 At the File menu select Print Setup 2 Verify that all printing options are correct then select OK 3 Select Print Log Summary 4 Verify that the aspiration dates and times represent the range of sample log entries you want printed a Change an aspiration date...

Page 86: ...eria used to accept or reject the ISE calibration Reviewing the sample results Sample results can be reviewed on and report from the RealTime Monitor and Review Edit windows Reporting results The system prints calibration control and patient sample results Only patient and control sample results are transmitted to a host computer Results are reported automatically as the sample analysis is complet...

Page 87: ...t button 3 At the Print Report window select a Sample Type T and File Data F a If you select Archive in the File Data F field the Filing File Name I field is activated b Select the Open button c Select a file name at the Open window 4 In the Specification range R field select the arrow in the field and select Input Range or All from the list 5 In the Number entry format N field select the arrow in...

Page 88: ...m error Shut down the system and reboot it message is generated to the system log Ignore this message 1 At the System S drop down list of the Menu Panel select Exit 2 When the confirmation message box displays select Yes 3 When the second confirmation message box displays select Yes After a brief delay the Startup window displays 4 Select Shutdown After a brief delay the message box opens to allow...

Page 89: ...2 is off To place system in the SLEEP state use the following System p s Power OFF check box is selected check mark present System Select System end PRIME Select None WASH1 Do check box is cleared no check mark WASH2 Do check box is selected check mark present WASH3 Do check box is cleared no check mark Automatic startup with analyzer power kept ON To keep analyzer power on until the automatic sta...

Page 90: ...ct the prime you want to run or select NONE A Prime is required only if a system reagent is replenished or a related component is replaced 4 Select the check box next to each wash you want to perform Select WASH2 for the shutdown wash b Select Save c To confirm select Yes 5 In the Select wash routine area select Shutdown 6 In the Proc set list select the shutdown setting Set1 Set2 or Set3 you want...

Page 91: ...alerted to this problem by the QC results Corrective action is to reload the reagents on the correct trays Updating the Cumulative QC Update the QC Cumulative window before more than 200 daily control samples are run The QC Daily Precision Control window can manage a maximum of 200 results for each control product level If an additional control sample is run the current 200th result Px200 is overw...

Page 92: ...control samples are run using the following priority order 1 Manual calibrations requested at the Start Conditions window 2 Manual controls requested at the Start Conditions window 3 Automatic calibrations requested on the Auto Calibration Setting dialog box 4 Automatic controls requested on the Auto Control Setting dialog box Using multiple reagent containers for the same test You can use multipl...

Page 93: ...IgM method sheets for instructions about setting standard values and calibrator handling and preparation NOTE If you are running IgA_2 IgG_2 or IgM_2 this does not apply For multi point calibration methods simplified calibration is available after a valid multi point calibration is performed Use the ISE Parameter Settings window to set up calibration for the electrolyte methods ISE Calibration sam...

Page 94: ...etting button in the MSTD column of the Procec test no list 2 To view the Multi Standard Setup window select Setting 3 In the TT no area select 98 or 99 4 In the Posi Box of the Blank row enter the cup position for the blank solution 5 For each standard do the following a Using the information in the calibrator package insert enter the Lot No Lot Name and Exp Date b In the Posi box enter the cup p...

Page 95: ...nd define Meas time and Container Type 10 Select Save 11 At the Test Select window select the test 12 At the Sample Select window select the calibrators Running calibration Use the Start Conditions window to request a calibration run If needed you can run the calibration samples followed by controls and patient samples as appropriate You can limit calibration to selected calibration samples or to ...

Page 96: ... Tests Displays all calibration history data for all ISE methods Other Activates the test list box to allow specific test selection highlight each test to display 4 Specify a date range to display data for calibrations performed on specific days for the tests selected a Type the Start Date yyyymmdd of the range if other than the default which is the current date b Type the End Date yyyymmdd of the...

Page 97: ...Quality Control 97 b Select Create CSV c Browse and select a folder in which to save the CSV file d Select Save 8 Close the window ...

Page 98: ...98 ADVIA 2400 Operator s Guide ...

Page 99: ...ntrol samples Use the Start Conditions window to request control samples You can run control samples alone after calibration or before patient samples You can request to run only specific control samples or selected methods The Ordinary control samp meas list on the Test Select window determines which tests are available to run The Sample Select window determines which controls are available Use t...

Page 100: ...ollowing windows for reviewing QC Use the Real Time QC window to review control performance during the day Use the Daily Precision Control window to review the control results at the end of the day and then to update the cumulative statistics Use the QC Cumulative window to evaluate long term trends in control performance If control results fail to meet the laboratory s established criteria for ac...

Page 101: ...nance schedule for recommended frequencies for ISE procedures marked with an WARNING Only Siemens trained users are to perform maintenance procedures CAUTION To avoid reporting faulty data deterioration of reproducibility or damage to the ISE module and its parts follow the precautions listed below Immediately clean up any spills or leaks Repair the source of leaks Do not leave the chloride electr...

Page 102: ...lamp energy check Perform cuvette blank cell blank measurement Clean the exterior module panels Monthly Clean the turntable interiors Clean or replace reagent containers 47 50 Drain the vacuum tank water Clean the dilution bottle Clean the cuvette wash bottle Clean the chiller filter Every 2 Months Clean the dilution tray cuvettes Clean the cuvette conditioner bottle Every 3 Months Replace the lam...

Page 103: ... of probes Replace any clogged probes See Replacing the Probes in the online Operator s Guide Clean all probes daily proceed to step 2 TIP Perform the Shutdown Wash and Weekly Wash as scheduled to prevent the probes from clogging 2 Clean each probe using one of the 3 methods described below Cleaning the probes using automatic advance probe motion 1 At the Menu Panel select Maint then select Manual...

Page 104: ...n any imperfections which could cause contamination Replace probes as necessary Refer to the online Operator s Guide for this procedure 6 Close the Manual Operation window then select Yes when prompted 7 At the Operation Panel select Initialize to return all probes to the home position over the wash cups 8 After cleaning ensure that no threads or fibers are left on the probes 9 Verify the analyzer...

Page 105: ... Accessible Location Dilution probe DPP Over the sample tray STT OR over the ISE Sample probe SPP Over the dilution tray DTT Reagent probe 1 RPP1 Over reagent tray 1 RTT1 Reagent probe 2 RPP2 Over reagent tray 2 RTT2 3 Place a lint free towel under the probe ...

Page 106: ...method IMPORTANT You can use this procedure only after you remove the wash covers 1 Select Maint 2 Select User Maintenance 3 At the User Maintenance window in the Position Probe for Routine Cleaning area select Start then select Yes when prompted 4 Wipe the probe with prep pads or lint free towels and 5 bleach solution 5 Check the alignment of the probe to the cuvette 6 If the probe is not centere...

Page 107: ...wash cups to avoid contamination of the mixers which results in carryover a Set the analyzer to Standby CAUTION Do not use excessive force while cleaning to avoid bending the mixing rods b Holding the mixing rods in one hand wipe each rod with lint free towels moistened with deionized water 3 Inspect the mixing wash cups for cleanliness then clean if dirty a Pour deionized water into the mixer was...

Page 108: ...ting and cleaning the reaction WUD and dilution DWUD cuvette washers Materials required Lint free towel Alcohol prep pads or lint free towels and 5 bleach solution 4 mm hex wrench Time 10 minutes Analyzer mode READY BIOHAZARD Wear personal protective equipment Use universal precautions 1 Inspect the exterior of the reaction cuvette washer WUD and dilution cuvette washer DWUD tubing for cleanliness...

Page 109: ...cuvette wash station WUD Figure 5 5 DWUD and WUD wash stations 4 Look for signs of wear or damage to the drying nozzle 2 If wear or damage is present call your local technical support provider or distributor 5 With prep pads or lint free towels soaked in 5 bleach solution wipe each wash head nozzle and inspect the pipet and tubing for clogs If clogs are present manually dislodge them by feeding th...

Page 110: ...ad nozzles are correctly centered in the cuvettes a At the Menu Panel select Maint then select Manual Operation For additional information concerning the Manual Operation window refer to the Manual Operation window in the online Operator s Guide b At he Manual Operation window double select 14 DWUD or 23 WUD c Select Move to slightly lower the washer nozzles then verify that they are correctly pos...

Page 111: ...event water and reagent from entering the dilution and reaction cuvettes 1 Inspect the cuvette covers for spills and splattering If there is any splattering is on the cuvette covers 1 proceed to step 2 Figure 5 7 Cuvette covers 2 Using lint free towels moistened with deionized water wipe down the covers WARNING Do not touch probes or mixing rods to avoid contamination 3 If splattering is extensive...

Page 112: ... the following steps 2 At the Menu Panel select Maint then select User Maintenance 3 At the User Maintenance window area labeled Probe posi adjust select Position adjust start All probes move to the cuvette positions allowing access to the wash ports The operating mode display on the Operation panel indicates that the instrument is in the WAIT state For additional information see the User Maintena...

Page 113: ... precautions 1 DCP 2 DIP 3 DOP 4 SCP 5 SP 6 RP 1 7 RWP 1 8 RP 2 9 RWP 2 Figure 5 9 Vertical pumps Checking the SP and DIP vertical pumps for leaks Liquid leaking from the seal on the sampling pump SP or the dilution aspiration pump DIP flows to the drive lever unit If the drive lever unit is wet the pump seal must be replaced 1 Closely inspect the plastic cylinder 1 for moisture Figure 5 10 Sp and...

Page 114: ...cylinders L ring holders tubes and fittings of the vertical pumps Figure 5 11 Typical vertical pump 2 If the pump is leaking you must replace the pump seal To replace the pump seal call your local technical support provider or distributor Checking the horizontal pumps for leaks Horizontal pumps consist of the dilution cuvette wash pumps DWP1 DWP2 DWP3 and DWP4 the reaction cuvette wash pumps WP1 W...

Page 115: ...a leak the seal s must be replaced To replace the seals call your local technical support provider or distributor Performing the startup wash WASH3 Materials required Deionized water Time 26 minutes Analyzer mode READY BIOHAZARD Wear personal protective equipment Use universal precautions The daily startup wash rinses the probe lines reaction cuvettes and dilution cuvettes NOTE Laboratories runnin...

Page 116: ...te Wash Solution Daily 5 Reagent Probe Wash 3 Weekly 2 RTT1 50 Deionized water 3 RTT2 47 Reagent Probe Wash 1 3 RTT2 48 Reagent Probe Wash 2 3 RTT2 49 10 Cuvette Wash Solution Daily 5 Reagent Probe Wash 3 Weekly 3 RTT2 50 Deionized water Figure 5 14 Location of wash solutions on the CTT and RTT trays 1 At the Operation Panel select Wash 2 Ensure the 10 mL tube at CTT 1 position 51 contains DI wate...

Page 117: ...wn wash uses a detergent to clean the probe lines reaction and dilution cuvettes and ISE components NOTE Laboratories running only urine samples or those running the system more than 8 hours per day are advised to perform the Weekly wash procedure in place of this Shutdown wash procedure For location of washes on the CTT and RTT trays refer to Figure 5 14 1 At the Operation Panel select Wash 2 Ens...

Page 118: ...RD Wear personal protective equipment Use universal precautions CAUTION Use only Siemens recommended ancillary reagents to avoid erroneous test results WARNINGS Read and follow the cautions on the box and label before handling any reagents Some method and system reagents are classified as hazardous material Avoid contact of method or system reagents with skin and eyes These materials can cause inf...

Page 119: ...on window in the Period wash area select OFF then select Set 3 In the Wash Electrode area do the following a Place a cup of the ISE Detergent in the identified position on the screen b In the Container field select the type of container for the was solution The recommended type of container is 6 2mlCUP Adp 4 In the Wash Electrode area select Execute then select Yes when prompted 5 At the ISE Opera...

Page 120: ...obe Wash 3 the cup at CTT position 15 contains ISE Detergent and a 10 mL tube of pure water is at CTT position 16 3 Ensure the bottle at RTT1 and RTT2 position 49 contains a 5 solution of Reagent Probe Wash 3 4 Ensure the bottle at RTT1 and RTT2 position 50 contains DI water NOTE At your laboratory s discretion you may use other positions for the washes on each of the trays but you must change the...

Page 121: ...system generates a lamp coolant warning and turns off the lamp 1 Lift off the lamp access cover 1 to gain access to the lamp coolant reservoir 2 Check the fluid level in the reservoir If the level is between the 5 and 9 cm marks the label is green on the reservoir proceed to step 4 If the reservoir fluid level is less than 5 cm the label is red on the reservoir add coolant as follows a Turn the re...

Page 122: ...ot touch or turn the reaction tray at any time during the lamp energy check procedure The reaction tray should turn freely If the reaction tray is shifted repeat the procedure since a shift could result in an erroneous lamp energy reading 1 At the Menu Panel select Maint then select Lamp Energy Monitor The Lamp Energy Monitor window displays 2 Ensure the bottle at position 50 in Reagent Tray 1 RTT...

Page 123: ... difference in the bottom field to the left of the graph then press Enter The lamp energy displays as a scatter plot If the points are mostly within 40 of the center the lamp is normal Otherwise replace the lamp 11 Only if you replaced the lamp or a cuvette segment select Regist Data then select OK in the Registration window If not proceed to step 12 NOTE The system uses the data from the lamp ene...

Page 124: ...ly procedure 1 At the Menu Panel select Maint then select User Maintenance 2 In the Cell blank meas check area select Start CB The measured cuvette blank values for all RRV cuvettes and a list of abnormal cells are available in the real time monitor in approximately 15 minutes 3 Select Yes to save the data 4 Evaluate the results 17 cuvette cells are in each cuvette set Replace cuvette sets when 4 ...

Page 125: ...d Reference value The reference value the average value of the measurements of all cuvettes remains the same until the next measurement Cleaning the analyzer and rack handler exterior panels Materials required Lint free towel 10 solution of bleach 5 sodium hypochlorite and water Time 10 minutes Analyzer mode READY BIOHAZARD Wear personal protective equipment Use universal precautions 1 Put the ana...

Page 126: ...CTT housing 1 Remove the Calibrator Control Tray loader CTT a Lift the standard cover from the loaders b Pull up on the two Nylatch fasteners 3 securing the CTT Tray loader in place c Lift out tray loader by the center handle 4 2 Remove the Sample Tray loader STT a Lift the Sample Tray evaporation cover b Pull up the two fasteners 5 securing the STT Tray loader in place c Lift out the STT tray by ...

Page 127: ...3 Replace the reagent tray loader a Ensure that it is securely in position b Tighten the white center knob c Replace the covers aligning the hole in the cover with the locating pin 4 Repeat steps 1 3 for RTT2 Cleaning or replacing the wash solution reagent containers 47 50 Materials required 5 reagent wedges empty 70 mL optional Probe Wash 1 Probe Wash 2 10 Cuvette Wash solution 5 Probe Wash solut...

Page 128: ... Conditioner 1 40 with water 600 µL 15 µL 11 ml NOTE The total volume of cuvette wash and cuvette conditioner used by the system can vary slightly from the volumes provided in the tables above This is normal behavior Cleaning and replenishing the dilution bottle Materials required Deionized Water Physiological saline 0 9 NaCl Time 10 minutes Analyzer mode READY BIOHAZARD Wear personal protective e...

Page 129: ...he dilution bottle 7 Prime the fluid lines NOTE If you are cleaning the detergent or cell conditioner bottles at this time you can prime all the fluid lines at once a At the Operation Panel select Prime b At the PRIME Settings dialog box select Prime 2 then type 10 or more in each of he number of times fields c Select Execute Cleaning and replenishing the cuvette wash bottle Materials required Dei...

Page 130: ...uvette wash bottle level sensor connector then push the connector in and turn it clockwise 9 Insert the filter and hose then fasten the cap NOTE Make sure that the filter holder is located at the bottom of the bottle 10 Prime the fluid lines NOTE If you are cleaning other bottles wait to perform this step for all fluid lines a At the Operation Panel select the Prime button b At the PRIME Settings ...

Page 131: ...equired 2 liter beaker Probe Wash 3 solution REF 03164495 PN B01 4183 01 Deionized water Time 15 minutes replacement 10 hours immersion Analyzer mode Off BIOHAZARD Wear personal protective equipment Use universal precautions Figure 5 19 Components of dilution tray cuvette 1 Prepare 1 5 liters of 5 Probe Wash 3 solution diluted with deionized water 2 Remove the 6 cuvette segments on the dilution tr...

Page 132: ...hutdown wash routine then verify the operation Cleaning and replenishing the cuvette conditioner bottle Materials required Deionized water Cuvette conditioner Time 10 minutes Analyzer mode READY BIOHAZARD Wear personal protective equipment Use universal precautions NOTE The cuvette conditioner bottle may be cleaned when it is refilled but must be cleaned at least once every 2 months 1 ISE buffer b...

Page 133: ... sensor connector then push the connector in and turn clockwise 10 Insert the filter and hose then fasten the cap NOTE Make sure that the filter holder is located at the bottom of the bottle 11 Prime the fluid lines NOTE If you are cleaning other bottles wait to perform this step for all fluid lines a At the Operation Panel select Prime b At the Prime Settings dialog box select Prime 2 and type 10...

Page 134: ...0 1 Lead Wire Connector 2 Lead Wire Connector 3 Lamp Screws 4 Lamp Plate 5 Alignment Hole and Pin Figure 5 20 Components of the lamp 1 Set the analyzer to Standby 2 Lift and remove the access panel in front of the Rotating Reaction Tray to expose the lamp housing WARNING The lamp housing is hot To avoid burns allow it to cool down approximately 10 minutes before touching any components 3 Loosen th...

Page 135: ...1 Then check the lamp energy 12 Register the data and verify that attenuations register at 100 voltages are between 5 9 and scatter is no greater than 40 13 Perform the cell blank measurement test NOTE Siemens recommends the assays on the system be calibrated after the lamp is replaced 14 Run QC controls to verify that all assays are within the laboratory s established control ranges Washing the I...

Page 136: ...s and safety glasses It is harmful if swallowed and may cause eye or skin irritation In case of skin or eye contact flush with large amounts of water 5 Remove the cap 1 from the dummy electrode and pour approximately 5 mL of ISE detergent solution into the dummy electrode CAUTION Be sure to tighten the cap on the dummy electrode If the cap is loose or defective the ISE detergent solution may leak ...

Page 137: ...al protective equipment Use universal precautions Use this procedure to clean the filters in the following bottles RRV reaction bath oil Diluent Cuvette detergent wash solution Conditioner 1 Set the analyzer to Standby 2 Open the filter cap at the front of each bottle and pull up the filter hose 3 Unfasten the connector at the end of the hose NOTE If any of the filters are ripped or damaged replac...

Page 138: ...01 One 18R filter REF 01448895 PN 073 0034 01 Hex wrench Time 15 minutes Analyzer mode READY BIOHAZARD Wear personal protective equipment Use universal precautions Clogged filters create an insufficient flow rate and produce air bubbles NOTE A set of filters is included in the supplies kit To avoid system down time replace the filter with the one in the kit resume operation and then clean and stor...

Page 139: ...pochlorite When handling bleach which can be used as a cleaning and antiviral agent wear protective clothing gloves and safety glasses It is harmful if swallowed and may cause eye or skin irritation 4 To clean the 18R filter a Place the filter in a beaker filled with a freshly made 10 solution of household bleach and water b After 30 minutes remove the filter and rinse it with deionized water and ...

Page 140: ...h solution clean the outside surfaces of the filter holder and hose 9 Insert the silicon filter hose into the water bottle 10 Insert the ten Teflon filter hoses in the tank 3 or 4 at a time 11 Prime the lines a At the Operation Panel select the Prime button b In the PRIME Set dialog box select PRIME 2 and type 10 or more for the number of times in all fields c Select Execute Replacing the reaction...

Page 141: ...ght CAUTION Be careful not to drop the cuvette set screws into other components of the instrument Do not remove the cuvette if it is in front of the detector 3 a Hold the cuvette set by the tab 2 and lift it from the tray b To remove the cuvette sets located by the detector unit or under the cuvette wash station WUD rotate the reaction tray by hand until the cuvettes are in an accessible location ...

Page 142: ...it from the tray c To remove the cuvettes under the dilution washer DWUD or cuvette splash cover rotate the dilution tray by hand until the cuvettes are clear 6 Install the new cuvette sets on the DTT and fasten the set screws by hand 7 Return the system to Operating mode 8 Perform the daily Shutdown wash WASH2 routine and verify the operation 9 Perform the lamp energy check procedure 10 Perform t...

Page 143: ...up window right select the disc b Select Format disc c Select Full format d Select OK e When prompted select Yes 4 At the Startup window select Back up 5 At the ADVIA Backup window select Make a Backup Copy 6 Select the Target Files to be backed up from the following options System Files Approximately 30 MB of disk space is required Data Files Disk space required is dependent on the amount of data...

Page 144: ...r that contains the backup files to restore and select Execute 4 At the Restore confirmation window select OK If the disk contains all the backed up files required for the restore procedure the copy function begins 5 If the backed up files are on more than one disk select Continue 6 At the ADVIA Backup window select Exit select Restore then select OK 7 At the ADVIA Backup window select Cancel 8 Re...

Page 145: ...at might fall 3 Lift and manually rotate the probe to an accessible location Probe Accessible Location Sample probe SPP Over the dilution tray DTT Reagent probe 1 RPP1 Over reagent tray 1 RTT1 Reagent probe 2 RPP2 Over reagent tray 2 RTT2 4 Loosen but do not remove the setscrews on each side of the probe cover Lift the cover off the probe 5 Using pliers or your fingers loosen the knurled fitting 3...

Page 146: ...ing new probe CAUTION To avoid damaging the threads or introducing leaks or air bubbles do not cross thread or force the knurled fitting in too far 5 Replace the probe arm cover and tighten the two probe cover screws 6 Lift up the probe arm to the end of its travel Manually rotate the probe over the probe wash cup but not within the wash port 7 Put the system in Operating mode 8 At the Menu Panel ...

Page 147: ...r mode STANDBY BIOHAZARD Wear personal protective equipment Use universal precautions 1 Dilution Probe DPP 2 Sample Probe SPP 3 Reagent Probe 1 RPP1 4 Reagent Probe 2 RPP2 Figure 5 31 Dilution probe location Removing the DPP probe 1 Put the system in Standby mode CAUTION Manually support the probe and be careful not to strike it against anything on the analyzer to avoid damaging the probe tip when...

Page 148: ...UTION Be careful not to damage the flare end or kink the tube 8 Loosen but do not remove the locking screw 11 9 Loosen but do not remove the probe wire screw 3 then remove the orange probe wire from the post 10 CAUTION Do not force the wire or bend excessively to avoid breaking the wire off of the probe body mount 10 Securely hold the probe arm 9 and open the 2 spring clips 2 by grasping each at t...

Page 149: ... screw To prevent damaging the wire avoid flexing the wire more than necessary CAUTION If the screw does not fully tighten or the standoff spins tighten the screw on the probe arm base until the standoff no longer spins otherwise the liquid level sensing capability may be adversely affected 6 Reconnect the orange probe and preamp wires to the post 10 7 Carefully flex the tubing 5 and slip the flar...

Page 150: ...e proper water flow through the probe NOTE Make sure that no water is leaking from the joint connector 4 Replenishing the RRV reaction bath oil bottle Materials required RRV reaction bath oil REF 09323099 PN B01 4180 01 Time 10 minutes Analyzer mode READY BIOHAZARD Wear personal protective equipment Use universal precautions 1 ISE buffer bottle 2 RRV Reaction bath oil bottle 3 Isotonic saline dilu...

Page 151: ...asten the cap NOTE Make sure that the filter holder is located at the bottom of the bottle Preventive cleaning of the wash station lines Materials required 5 reagent containers empty 70 mL optional Probe Wash 1 Probe Wash 2 10 Cuvette Wash solution 5 Probe Wash 3 solution 70 mL reagent container REF 06397121 PN 073 0373 02 Wash solution labels REF 00153468 PN 073 0406 02 Deionized water Time 45 mi...

Page 152: ...ed volume is 100 mL Probe Wash 3 plus 900 mL of distilled or deionized water Alternate Solution Prepare a 20 solution of household bleach by diluting 1 part of bleach with 4 parts of distilled or deionized water The prepared solution is stable for one week when stored at room temperature Minimum recommended volume is 200 mL bleach plus 800 mL of deionized distilled water NOTE The remainder of this...

Page 153: ...stic tray on top of the paper towels NOTE Use a shallow tray for washing the nozzles A tray with a depth of 35 40 mm is most suitable Trays with higher sides may require additional wash solution e Place the dryer nozzle outside the tray 1 and all the other nozzles inside the tray Figure 5 35 WUD and DWUD dryer nozzle ...

Page 154: ... the WUD DWUD wash head into the tray and fill the tray with 10 Probe Wash 3 solution preferred or 20 bleach solution alternate 9 Pour enough wash solution into the tray so the center nozzle yellow labeled overflow nozzle is in liquid without overflowing the tray 10 Repeat steps 4 and 5 to clean the WUD DWUD lines with the 10 Probe Wash 3 or 20 bleach solution 11 Repeat steps 4 and 5 until the lin...

Page 155: ...E lines Materials required 2 clean empty buffer bottles Probe Wash 3 solution Dummy electrode Phillips head screwdriver Time 15 minutes Analyzer mode Manual operation BIOHAZARD Wear personal protective equipment Use universal precautions 1 At the Menu Panel select Maint then select ISE Operation 2 In the Period wash area select OFF then select Set 3 Open the front doors and replace the buffer solu...

Page 156: ...wash 3 solution 2 At the ISE Operation window in the Bufferprime area enter 50 in the Times field 3 Select Execute 4 When prompted select Yes to execute the buffer prime Rinsing the lines 1 Replace the probe wash 3 solution bottle with a bottle of deionized water 2 In the Bufferprime area enter 50 in the Times field then select Execute 3 Remove the dummy electrode 4 Reinstall the Na K and Cl elect...

Page 157: ...e day before you need to use it A new electrode may take a long time to stabilize 1 Prepare a 1 4 dilution of pool serum using ISE buffer solution 2 Remove the new electrode from its case NOTE The ion electrode contains an inner solution which can be confirmed by shaking the electrode This solution decreases little by little with time If you do not feel any response in your shaking measure its wei...

Page 158: ...required Electrodes Cl REF 07097504 PN 073 0049 01 K REF 06135445 PN 073 0050 01 Na REF 03092699 PN 073 0051 01 Reference REF 00311764 PN 073 0653 01 O rings 3 REF 09955206 PN 073 0071 01 Philips screwdriver Time 5 minutes Analyzer mode Manual operation BIOHAZARD Wear personal protective equipment Use universal precautions Replace the Na K and the Cl electrodes if the slope is incorrect or calibra...

Page 159: ...re the reference electrode refer to Storing the Reference Electrode on page 160 1 Assemble the new electrodes in the correct order 2 Set the electrodes in place paying careful attention not to leave a space between them Make sure there is an 0 ring between each electrode and that the ridges on the side of each electrode fits into the depressions on the side of the electrode next to it 3 Tighten th...

Page 160: ...it in place with the Phillips screw 10 At the ISE Operation window in the Initialize area select Execute then select Yes NOTE The ISE wash is automatically turned on 11 After initialization is complete select Exit then select Yes Calibrating the ISEs 1 At the Operation Panel select Initialize 2 At the Menu Panel select Maint then select ISE Operation 3 At the ISE Operation window in the Calibratio...

Page 161: ... reaches approximately a 90 angle then gently lift the tab of the DPP shield and remove 5 Loosen the thumb screws then remove the ISE cover 6 Loosen the screw retaining the stainless steel cover at the top of the ISE unit and remove that cover by sliding it toward you 7 At the ISE Operation window next to Final operation type 16 in the field next to Pure water position 8 Select container 1 setting...

Page 162: ...to execute a buffer prime Cleaning the waste drain nozzle CAUTION Be careful not to scratch the nozzle Damaging the nozzle may cause inaccurate results 1 Using a blunt object such as a pipette carefully scrape the crystals that are attached to the waste drain nozzle 1 Figure 5 40 Location of waste drain nozzle 2 At the ISE Operation window enter 5 in the Bufferprime Times box then select Execute I...

Page 163: ...ontrols Recovering from a power failure Preparing the system for an expected power outage If you know in advance of an upcoming power outage 1 Turn off the workstation and analyzer power by performing the normal shutdown operation 2 If you expect the power supply to be off for a long period of time refrigerate the reagents 3 When the power returns perform the normal startup operation Preparing the...

Page 164: ...lost while system was on 1 If the Startup window is open select Shutdown and perform the normal shutdown operation 2 Turn off the workstation power and turn the Operate Standby switch on the analyzer to Standby 3 Wait approximately 20 seconds 4 Perform the normal startup operation and open the Startup window 5 At the Startup window enter a password 6 Select Re Start then select OK 7 If possible re...

Page 165: ...Maintenance 165 ...

Page 166: ...e events listed below refer to the Troubleshooting section of the online Operator s Guide System error messages NOTE The error message log on the analyzer also has information to guide you through resolving error messages Sample dilution checking DPP waveform Reagents RPP reagent detection ...

Page 167: ...Troubleshooting 167 ...

Page 168: ...t job as follows a At the Windows taskbar select Start then select Settings b Select Printers and Faxes c At the Printers and Faxes window right select the printer marked with a checkmark default printer d Select Cancel All Documents e When prompted select Yes f Close the Printer and the Printer and Fax windows 9 Turn the printer on 10 Copy the file to a CD or a DVD as follows a Place a formatted ...

Page 169: ... can open the file using a spread sheet program such as Microsoft Excel You can save the file to a diskette CD or to the system PC hard drive Saving test data 1 Verify that the analyzer is in READY or WAIT mode 2 Insert a formatted CD or DVD into the CD DVD ROM drive 3 Select the Drag to Disc icon located to the left of the time display in the lower right corner of the window 4 Select Request then...

Page 170: ...the time display in the lower right corner of the window 4 Select Request then Review Edit and make a note of the filing date of the samples you want to save Saving by order number works best but you can use sample Based on when you performed a New Start the system stores data for 7 filing dates After that the data with the oldest filing date is deleted 5 Select Request then Reaction Monitor 6 Sel...

Page 171: ...save all 7 filing dates at one time weekly and create a system backup at the same time 1 Verify that the analyzer is in READY or WAIT mode 2 Place a formatted CD or DVD into the DVD CD RW drive on your PC 3 Select Request then select Review Edit and note the filing date of the samples to save The system stores data for 7 filing dates based on when a New Start is performed After that the data with ...

Page 172: ...DVD into the DVD CD RW drive on your PC 3 Select Request then select Review Edit 4 Select Archive from the filing option in the pull down menu The Filing button becomes active 5 Select the Filing button and select the CD DVD 6 Select on the file date of the data to view 7 Follow the same steps to view the reaction data at the Reaction Monitor window ...

Page 173: ...System Setup 173 ...

Page 174: ...or boxes in the Analytical Parameters Serum window to designate the test for the determination of serum indices Use the Serum indices area on the System Specifications Set window to determine when the serum blank assay is run Refer to the System Configuration section of the online Operator s Guide for further information Connecting to your host computer 1 Have your laboratory computer professional...

Page 175: ...ray For the current analysis you can override the settings in the Temp cup tube select window 1 Log on as supervisor 2 At the Menu Panel select Request then select Cup Tube Assign 3 At the Cup Tube Assign window assign the containers as follows a Select the arrow in the Status Container field for a position b From the list select a container type to assign it to the position Container Types are de...

Page 176: ...e Real time correction formula 1 At the Process Sequence window set the processing and print order for electrolyte tests 124 126 2 At the QC Sample Definition window add electrolyte tests to existing controls or define additional controls for the tests 3 At the Test Select window select electrolyte tests to run on routine sample controls and calibrators 4 At the Sample Select window select CTT pos...

Page 177: ...System Setup 177 ...

Page 178: ... Third Edition 2005 CLSI Document M29 A3 This document contains complete information on user protection and it can be used as reference material for instructions on laboratory safety Electrical warning ELECTRICAL WARNING To avoid exposure to shock hazards and or damage to the instrument while performing this procedure power off the analyzer before proceeding Laser warning LASER WARNING To avoid da...

Page 179: ...r The prepared solution is stable for one week when stored at room temperature To prepare a 25 solution of household bleach dilute one part of bleach with three parts of clean distilled water or clean deionized water The prepared solution is stable for one week when stored at room temperature Regulatory compliance Laser information The chemistry system complies with CDRH laser radiation Class 1 an...

Page 180: ...tray barcode readers RTT1 RTT2 are classified as Class I LED devices having a maximum power output of 25 5 mW at a wavelength of 655 nm and a pulse duration of 200 ns 1 Sample Barcode Reader STT 2 Reagent Barcode Reader RTT2 3 Reagent Barcode Reader RTT1 ...

Page 181: ...Appendix 181 ...

Page 182: ...182 ADVIA 2400 Operator s Guide ...

Page 183: ... or authorized distributor will inform the customer of the type of service available for the customer s instrument and will instruct the customer as to how to obtain that service CAUTION Please observe the warning and hazard statements appearing throughout the online operator s guide If the ADVIA 2400 Chemistry system is used in a manner not specified by Siemens the protection provided by the equi...

Page 184: ...rized distributor Service performed outside normal hours is subject to a surcharge unless the customer has in place a service product option that provides service at the time s requested Replacement of parts In performing service Siemens or its authorized distributors will provide appropriate parts to repair the instrument or will arrange for the exchange of the instrument or affected parts at no ...

Page 185: ...sed by water from any source external to the instrument 9 The customer has purchased an alternative agreement whose terms of warranty or service supersede these provisions Siemens or its authorized distributors will invoice customers at current standard labor and parts rates for instruments repaired to correct damage or malfunctions due to any of the reasons listed above OTHER THAN AS STATED ABOVE...

Page 186: ...cation the customer must provide the Siemens representative with adequate facilities that comply with the regulations of the Secretary of Labor under the Occupational Safety and Health Act OSHA of 1970 as amended Software License No title or ownership of software is transferred to the customer The software component of this Siemens system and any of its modules are merely licensed to the customer ...

Page 187: ... located in the United States you can contact the Customer Service Department by calling toll free 1 877 229 3711 If you are located outside the United States please contact the Siemens office nearest you Siemens Worldwide www siemens com diagnostics ...

Page 188: ...ectrode Na ISE 073 0051 01 03092699 Filter 10 R 073 0033 01 08602474 Water tank cuvette conditioner saline and wash bottles Filter 18 R 073 0034 01 01448895 Pure water bottle Guide sample cup STT CTT 073 0346 01 08056461 ISE cell base assembly 094 0024 01 07096842 ISE dummy electrode 073 0646 01 05938765 ISE ground assembly 094 B015 01 04412484 ISE screw probe guide 094 0089 01 06616737 ISE screw ...

Page 189: ...8 01 08163594 RRV Guide reagent bottle 20 mL 073 0345 02 00771668 RRV Reference Electrode ISE 073 0653 01 00311764 Sample cup 1000 PKG 073 0157 02 01390706 Screw thumb cuvettes 4x6 073 0384 01 07199951 Screw thumb 3x6 073 0385 01 02291299 Shield DPP 073 0951 01 04457097 Splash cover RPP1 073 0632 01 04084266 Splash cover RPP2 073 0633 01 03482527 Splash cover SPP 073 0634 01 06657492 Waste bottle ...

Page 190: ...cup STT only Hitachi 2 mL sample cups and Ez Nest 2 mL sample cups in 7 mL 16 x 75 mm collection tubes URH or STT sample adapter dead volume for sample cups is 50 µL Trays STT Used for general samples and calibrators for multipoint calibration assays Two lines outer and inner of 42 samples each Total positions in STT tray 84 Sample barcode 13 digits Code 39 Codabar and Interleaved 2 of 5 Code 128 ...

Page 191: ... and 14 C Container capacity 20 or 70 mL 40 mL with adapter Refrigerator Recirculated liquid Reagent volume item 10 to 100 µL 0 1 µL increments Dilution reagent volume 10 to 100 µL 0 1 µL increments Reagent inventory Computed by the liquid level sensing Barcode Interleaved 2 of 5 JSCLA standard Reaction Reaction tray RRV Turntable system Number of cuvettes 340 20 sets of 17 cuvettes RRV cuvette ma...

Page 192: ... Sample blank correction Reassay mechanism Automatic or manual selectable Automatic correction Blood serum blank cell blank measurement point change sample volume change in reassay ISE Method Na K Cl ion selective electrolyte assay Dilution measurement method Analysis item Simultaneous 3 item measurement of Na K and Cl Electrode Na Crown ether membrane K Crown ether membrane Cl Super layer solid m...

Page 193: ...single phase 2 pole 3 wire configuration with Class III grounding Can be tapped the following input voltages 100 V 115 V 200 V 220 V or 230 V Maximum current draw at in rush is 26 amps at 115 V or 14 amps at 220 V Cooling ventilation requirements Ventilation sufficient to maintain 18 C to 30 C operating temperature The maximum temperature change the system can accommodate is 2 C hour Maximum relat...

Page 194: ... indicates a moving component that can cause injury This symbol alerts you to a potential electrical hazard This symbol alerts you to the risk of exposure to lasers The onboard sampler is equipped with a laser barcode reader When covers are opened there is a risk of radiation exposure Do not stare into the beam This symbol alerts you to a potential biohazard Biohazard labels are also placed on the...

Page 195: ...mbol Some parts of the system are on Some parts of the system are off Alarm symbol Stop button Reset button Prime button Error log Indicates consult online instructions Operator s guide Wash button I indicates closed circuit or On O indicates open circuit or Off ...

Page 196: ...ed States Revision letter of a part or product Serial number of part or product Number used for ordering a part or product An in vitro diagnostic device Product is a Class 1 laser product under the provisions of 21 CFR 1040 10 The WEEE symbol indicates that this equipment is classified as Waste Electrical and Electronic Equipment under the European WEEE Directive It must be recycled or disposed of...

Page 197: ...mputer monitor Computer workstation Vacuum pump pressure gage Reagent tray 1 Reagent tray 2 Controls and calibrators tray Sample tray Use these arrow symbols to align the tray covers Ancillary reagent symbols Deionized water symbol on the reagent and sample trays 10 cuvette wash Probe wash 1 Probe wash 2 ISE detergent ...

Page 198: ...le sensor connector System packaging label symbols Contents of the package is fragile Packaging is recyclable Expiration date for the package Lot number of the package Minimum and maximum storage temperature for the package The specified range may vary Contents of the package should be protected from heat and light Product or container should be oriented in the direction of the arrows Package is p...

Page 199: ...Appendix 199 Number of tests available from the contents of this package Packaging materials can be or are recovered and recycled ...

Page 200: ...M2400 JEOL Ltd 1 2 Musashino 3 Chome Akishima Tokyo 196 8558 Japan Tel 81 42 542 2303 Fax 81 42 542 3132 Manufacturer of ADVIA 2400 System Siemens Healthcare Diagnostics Inc 511 Benedict Avenue Tarrytown NY 10591 5097 USA Tel 914 524 3001 Fax 914 524 2088 ...

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