Operation (OPE)
Contents
1. OPE 27 Software HI EDIF instruments OPE 28 5 Choose a category Test Calibration QC to add that item to a selected sheet Identify the item For calibration select sele bath SSS ol standard or reagent blank P e and a method this includes and a method a complete list of tests se dae Penri at EEJIFIE For quality control select one or more QC listings and a method For a test Sarp le lis Mii Pela ss Select a method Select a method Method groups Touch select a method code to add that item to the selected page of tests Method profiles Touch select a profile to add the page selected to the complete list of tests linked to that item Blue test not programmed Green test programmed Software HI Test management WOL continued Departments This panel appears above the Sample list when departments have been set up by the administrator Only the samples in checked categories will appear in the Sample list thus reducing user search and find operations Depari Undefined Calibrator Control Surgery If a listing is not required click to remove that checkmark Undefined W Calibrator Control lw Surgery The administrator of your laboratory has managed method profiles for this instrument to simplify work routine Users can add a complete list of tests to a worksheet Hethod p oMr Profile 1 Profile 2 Profile 3 Profile2. is displayed where required Software HI EDIF instruments OPE 8 Software HI REAGENTS MONITOR SAMPLES WORKLIST METHODS Main pag e continued Work forms Sample tray 0PE 25 ae SAMPLE TRAY L l of sen gee lagan kapy E aril ds A 759820 q e d kon on e oe eee r i l i j a m ae yen F ALA ki i E Th BUHE i a I j F r L 3 a Sample inspection 0P 23 SAMPLE INSPECTION Cal ee ee dT a i r Mi C EL i i E seri th METHOD FIELDS tage ji p sli a MM MN i mja i E i kone l ja Yi Pwan onn EE ai oun E rp ee MA mail pumy e MM ann OO van Ey n li E Method fields nam wamm orp F OPE 36 Inspect test a Asami 1 es lie I Test ee eee Cee Work forms are provided for specific functions inspection a sona SERI YE FIF WETE NTSETEIES where access to more detailed information a 30 A is required to complete operational tasks ad e g sample lists and status test lists and results ee a eee e e oe ae Work modules are provided for the special management EI RET IDEE features that are independent and more complex in nature i e test count patient information l SS test sorting review and storage i EE E a new lots and links with methods ta e quality control assignment and results OPE 39
3. Calibration ADD CALIBRATION TESTS kenn kit pwos M N nen heat n Mafi barpl 0 ppi tu liegt gut Do you want to automatically Ma CRP Ihen BLANK EE add all needed test s to sa CRP went 5 i Not scheduled E proceed with a calibration gt iH CRF CaP a ANA 53 e L Mon nati Y i pi HE DEP CoCaLo 4 Li Ma kihid see also OPE 19 The three part diagram above shows one example of how Rapid access can simplify required operational tasks When either Missing or Expired is selected Calibration column in Method status the message box ADD CALIBRATION TESTS is displayed and following an OK click the entire list of tests required for calibration is automatically added to the Worksheet panel The color coded buttons below show typical examples of additional Rapid access functions Additional information Error detection Completed in Solutions to problems Resources missing Provide a new bottle of GLU 1 Reag 1 empty Sample empty Technical assistance required EDIF instruments OPE 1 3 Software HI REAGENTS tab REA Save assigned positions and file bottle panel for reuse Retrieve and load a bottle panel from saved file Clear displayed bottle panel 1 To manually assign reagents to bottle positions click on the method then the reagent listed and touch select an empty bottle to transfer
4. EDIF instruments Sample list management 3 Continue until all sample data required for the current work schedule has been entered and transferred to the sample list To delete a line Item 4 ID Position change an entry Item 5 NOM p inspect a sample Item 6 or print test results Item 7 PRAET AN ki 0002 1 0001 2 first touch select 0003 9 the line in question oa pe and then perform the operation There are no reserved positions Urgencies Samples Calibrators and Controls are positioned together in normal tube configuration and in any sequence assigned by the operator in the course of programming work When no designation is indicated in the Type column the sample type has not been specified 4 To delete an entire line from the sample list x touch select that line and press the Remove icon OPE 22 amp Click for Rapid access to related sections Software HI SAM continued Initially all categories are checked samples calibrators controls If not required click to remove that checkmark Sample list k Samples Calibrators M Controls Type Urgent Sample status Nature Tube Department Control Serum Cup Calibrator Yes EE Serum Tube Male Yes Serum Tube Pediatry Female amp __ Completed Serum Cup Serum Tube Surgery Control Serum Cup 5 To change an incorrect entry in the sample list touch select that line make the necessary adjustment and pres
5. GPT 2 Click to transfer an individual missing code to a bottle position 3 Select Auto to assign Missing reagents to empty bottle positions and to remove those Not needed automatically Initially all sheets in the Worksheet list are checked and reagent requirements will be inventoried If the inventory of a sheet is not required click to remove that checkmark Reagents that are Missing and those Not needed are shown Touch select Place to transfer all missing reagents to empty bottle positions and Remove to delete those not needed 4 When all positions have been assigned load the bottles of liquid reagents needed to positions indicated on the reagent tray Note It is possible to load multiple bottles of the same reagent Bottles which contain small amounts of liquid reagent remaining from previous tests can be used when loading the reagent tray All bottles will be used beginning with the least full then the next and finally the full bottles Any number of methods may employ the same bottle of reagent EDIF instruments OPE 15 Software HI EDIF instruments REA continued When various size bottles i e large small or cups are assigned to positions on the Methods and reagents panel they are displayed in the Bottle positions panel Reagent placement Methods and reagents Method Reagent 1 Reagent 2 ALB JALB 1 ari J ALP2
6. Mechanical problem Reag 2 empty Reagent assigned insufficent ke ie a kisa DYSE Cover opened during run Sample provided insufficent Reading failed Diluent empty Diluent provided insufficent WOL continued Worksheet management 1 To create a new sheet of tests 2 To remove a sheet of tests activate touch select Plus and activate that sheet and touch select Minus the NEW SHEET window na 3 To run a sheet of tests other designation zan kok ao ig tee he ene te suitable to identify sales E ouch select Execute the new page and m Lan and then press OK EDIF instruments 4 To print a sheet of tests activate that sheet and touch select Print Sheet status Not scheduled Worksheets F Stack sheet Worksheets are Scheduled pages of tests Inspect test lt See OPE 29 Test n Method Sample ID Type Dil OD1 OD Result Date Executing 1 CRE Diluent BLANK 1 gt cxe No Completed For testing convenience the WORKLIST can be broken down When a sheet to create individual Worksheets of tests for specifc user purposes IS removed e g all glucose all samples of a specific department the tests of that Aborted all tests of the same sample all tests by the same analyst sheet will be lost Click any Sample ID to display the Message boxes showing Click for Rapid access relevant sample and patient information see Items 4 and 5 OPE 12 to related sections
7. see OPE 11 the Communication error box shown below will be displayed Check the communcation cable and press Retry Communication error COMS port is not accessible Serial port COM3 w Feri ki D F If the problem persists the error may also be caused by the erroneous configuration of the serial communcation port In this case select the appropriate port from the list provided and press Retry Message boxes 3 CLEAR SAMPLE LIST 2 Sample list will be 1 DAILY START UP d proceed COMMUNICATI Daily start up procedure has The instrument is n not been done execute now Check the cable lf problem pers technical ass 1 Error Problem 2 Confirmation required 3 Warning possible lose of data CONTROL 1G METLI Mi D6SIGZ Poufan Y CALIBRATOR Males Sern Container Tube ee PATIENT 10 MULTICAL OJ43UJE Pautan 60 Type Control Mature Derin Lingent Ma Tant oman Contain Tubt Depim Type Here Type Calibrator Tabus Not scheduled Linger Pii 4 Sample information 5 Patient information To Rapid access relevant current data and information and working functions available in the system select any color coded item under solution or status REAGENTS MONITOR SAMPLES WORKLIST We Rapid access ll Worksheet panel Saa eo Sheet a Sheet a Sheed a LAKraton Method status
8. 4 Profile 5 4 Select a profile with a single click avoiding long programming sessions Note that method groups and profiles are available in all panel variations Worksheets Ten a Sheet 6 Test status Net scheduled scheduled Kot scheduled MILT LI M OU326L MULTICALO343UE m Stack sheet Ie 6 Activate any test line s on a worksheet of tests to either Remove Execute or Inspect the line s indicated and then touch select the required option gt Execute test Inspect test Game Delete selected test s Note when a test is removed it will be lost EDIF instruments When Execute test is activated e Non scheduled tests will be scheduled and added to the work queue e Completed tests will be copied replicated The copies will be inserted in the worksheet possibly diluted and executed e Tests in error will be run again Access Test inspection work form see OPE 30 OPE 29 WOL continued DILUTIONS If more than one dilution is available for the method selected a box will be shown for the selection of the dilution rate Test proposed Method ALP Sample 0001 Nature Serum Check dilutions to apply Rates that are checked will be inserted in the current worksheet NOTE If the result of a test is unusable it may be possible that the sample is too concentrated When this is the case the test should be replicated with an appropriate di
9. OK LIS information will be transferred to a normal worksheet and executed Once completed the results will be sent automatically to the central computer Reactions are accurately followed by readings taken every machine cycle for each test during the entire testing process EDIF instruments OPE 31 Software HI EDIF instruments OPE 32 Software HI METHODS tab MET REAGENTS MOM TOR SAMPLES WORKLIST METHODS Access the Enn METHOD FIELDS Designations Ho e i No a work form to check Information ene the working parameters pertaining to the Ganera Amezi i E ee of the selected method TOTES ARLE twill method selected see OPE 36 z T Ea paf ka yo p aa aa pe ka aa kn a an a onn e Sandands MAZO wor alter OO i eet a Calibration L5 l e Information L O e kep ee anana a eee used to build i C DO n E e DO calibration tests L Access the see OPE 33 I Select any method QUALITY CONTROL to apply available work module Correlation information Information used to to the three o h ik a delika adjust results with acjacent paneis SA an S ie a ES check QC results see OPE 35 See also OPE 35 for a special note T XE TI 1 Select a method in the Method list and the appropriate data will be displayed The methods that are installed on this instrument w PON PW w PW have been set by your administrator under Desi
10. PATIENT MANAGEMENT a 1368 li x OPE 46 Eg d Ek tf a EB Ey a begets Access modules A aay Meer 4 w a per OPE 44 OPE 38 z 2 a W O r k ee OPE 40 modules EDIF instruments OPE 9 Software HI EDIF instruments can The state of the analyzer can be monitored or controlled using the icons in the upper right corner of the main page Icons for additional services and information be found at the bottom of the main page OPE 11 State of the analyzer WARM UP Approximately 20 to 30 minutes of warm up time are required before testing is possible warm up status bar shown in lower left panel When warm up has finished the analyzer automatically reaches the STOPPED state STOPPED Analyzer is completely stopped There are no mechanical movements Testing temperature is maintained START UP Upon start up the analyzer begins by executing a prime of the hydraulic system a wash cycle and the optical calibration of the reaction cells CHECKING LEVELS Indicates that reagent liquid levels are being monitored after a request while in STOPPED state RUNNING The analyzer is running The reagent sampling arm is in motion Tests problems and liquid levels are constantly being monitored OPE 10 Software HI COVER OPEN Principal f controls PAUSE of RUN Sphera STOP COVER OPEN If the cover is opened during the running state the analyzer will suspend t
11. method e Exit METHOD FIELDS work form A list of sample types may be set up by the administrator In the test reports if a result is lower than the minimum normal value L is indicated If a result is higher than the maximum normal value gt H is indicated Minimum and maximum normal reference values are expressed in primary units 9 Pathological ranges Sample types Maximum Man Woman Child Dialysate man Minimum Dialysate woman OPE 37 EDIF instruments MANAGEMENT OF PATHOLOGICAL RANGES AND LIMITS To add a new Sample type press Add select from the list I of previously added types or enter a new value for specific use with the maximum and minimum range then press OK Add pathological value To remove a type select a line item and press Remove To modify a type select a line item press Edit change the information and press OK Software HI EDIF instruments Tests retrieved from ARCHIVES for use in the management of patients OPE 40 QC results and statistics of single methods Performance report of the entire system OPE 46 OPE 38 Work modules se count q System quality control 10 09 43 Press to display available special management features Cumulative listing of the number of tests executed for each method programmed
12. saved file di or samples calibrators and controls Clear displayed bottle positions Employed to check reagent liquid levels when the analyzer is STOPPED see OPE 17 for complete information Display work form for sample report Display work form for sample inspection Add Remove a sample Apply modified data to selected sample 4 WORKLIST tab WOL 090 Save and file all worksheets for reuse with related samples Retrieve and load worksheets from saved file with related samples Clear all worksheets without related samples E Create a new worksheet gt Remove worksheet selected A Run all tests of the worksheet selected kai Print a report of the worksheet selected Before continuing users are urged to experiment with the main page command structure Using the graphics on these two pages as a guide access each of the numbered tabs above several times and run through the secondary commands at random A bit of practice early on will ensure a more complete understanding of how to operate this instrument and illustrate just how user friendly it is EDIF instruments OPE 7 5 METHODS tab MET Access method fields work form to check the working parameters of the analysis that can be performed Access quality control work module to assign controls to each method and check QC results es ff ff 1 erie e 6 6 6 6 reorer nce rer mC OMe er ce A touch screen Keyboard
13. the designated reagent code to that position OPE 14 EDIF instruments REAGENTS MONITOR SAMP ES WORKLIST i E 20 Bec tthe paalt ioma In case of an error _ in reagent placement double click to clear that bottle position ami On 0 rmi Ifi irn i mi Dmi Ami Bottle blinking yellow see Item 2 TJ CO i Manual assignment of reagent bottle positions Software HI 2 Check liquid levels of panel displayed Assign bottle positions by either Manual or Auto means Manual Assign reagent code s to bottle positions manually see Items 1 and 2 Assign reagent code s to bottle positions automatically see Item 3 2 When a method requires a second reagent click again and transfer it to an empty position Note If a reagent code has already been assigned that position in the bottle panel will blink yellow Worksheet list All worksheets currently listed in the Worklist tab see OPE 26 An inventory is made of all sheets checked to monitor the status of reagent resources on board and to compare them with current worklist requirements Reagent list Reagents are identified as Missing or Not needed of those inventoried Auto assignment of reagent bottle positions Reagent placement Sheet list Sheet 1 Sheet 2 Calibration Sheet 3 Reagent list Missing aa Not needed CRE 1 GOT 1 CRE 2 GOT 2 FE 1 GLU 1
14. E 11 Blank Calibration Missing Has not been executed Expired No longer valid Valid Has been executed and is still valid Invalid Unusable Reagent BLANK Calibration User s may elect to apply quality controls at any time EDIF instruments OPE 18 Software HI REAGENTS MONITOR SAMPLES WORKLIST METHODS Problems and solutions Item type Problem Date Solution GLU 1 reagent Empty 3 16 2009 4 21 26 Probl ems Waste weekly maintenance Tank full 3 16 2009 4 21 26 Wash station instrument Mechanical error 3 16 2009 4 21 26 a nd sol uti o ns Identifies problems concerning the instrument and indicates possible solutions for the user si qui GLUP method Incorrect field value 3 16 2009 4 21 26 f Administrator assistance required Method status Provides information for each method programmed Method status Method Avail tests Prog tests Sched tests Blank Calibration Calibrators Quality control 1 Quality control 2 Quality control 3 au L 2 o f vaia f Missing Noton board Notion board Indicates scheduled and aN i OR e en n available tests and the GOT 54 51 7 valid Valid status of reagent blank calibration calibrators and quality control ie a ey Method status Rapid access Specified and present d Specified but no longer valid Specified but not present Not specified in method to monitor the a
15. ITY Number of cycles that are skipped in the work queue to avoid contamination owing to incompatible reagent proximity OPE 36 4 To inspect or adjust a method item press Fields to display the METHOD FIELDS work form Then select the desired line from the method list to automatically apply the relevant information which will define all testing procedures METHOD FIELDS Digrii Methad lha LI ko L tas mn niri ii em RANNMAN ki ini Sample types t va Man coy on a MNS o Woman Hapi 7E O an Britka Hig pe l E irag dan YN 2 OD Lay an Fon O e at ane man Aa ti an bul vial a f We Di E pase za Urgere ma L pi Bep l aza amenmen Kwa II L i Do r F races Sa Dibad E wa 7 L E y Diiia a Nn a a Tm maal lege A YON k Lie ea ken F 2 mani L W ia E ii Min L ME E ijan 4 E i Ei E rin E iii E prai 1 Pipetting Select SETEL Large M Suitable bottle size Reag 2 bottle Reagent 1 ID GLU 1 or cup Method fields Software HI LIMITS Working limits for results validity AUTODILUTION Dilution rate used in the event of automatic test repetition DILUTIONS Serum and urine rates PATHOLOGICAL RANGES Min Max values for various sample types RESULT UNITS Allows access to appropriate measurement units for the analysis being performed Print report of selected
16. Jamy1 ep1 B02 eti BT2 caLa 1 chout ck ekm1 exn1 OPE 16 Reagents on board Bottle positions Liquid levels The illustration below shows an enlarged version of how the actual liquid levels of reagents on board appear in the Bottle positions panel Bottle positions in the current display can be used as a guide when actually loading bottles or cups on the reagent tray M Full a Approximate 10 or less Q 2 2 op O m T zi y Fi Pi a NO 44 1 ml 17 6 ml 16 2ml 2 5 ml 33 5 ml 4 2 ml The exact positions on the tray and the use of the correct bottle sizes are manditory to ensure the accurate measurement of the volume of reagent liquid levels on board Software HI NOTES Liquid levels shown on the Bottle positions panel are constantly updated to permit real time evaluation of reagents available on board Bottle sizes are normally assigned by the administrator However this can also be done by the operator during routine work by adjustments to Pipetting OPE 36 in method fields Normal reagent liquid volumes are 50 and 24 mi for large and small bottles 1 3 ml for cups 5 Monitoring Checking liquid levels of reagents currently on board di RUNNING While the analyzer is RUNNING reagent liquid levels of tests being executed are constantly monit
17. OPE 39 All functions dealing with the management of calibrator and control lots OPE 44 Access modules Software HI Test count Select this module to review the number of tests recorded per method Print a report of current listings EDIF instruments Test count module This special management feature provides a continually updated record of all testing activities executed including liquid quantities of reagents that have been used e Number of tests counted per method e Print a report of tests counted Exit TEST COUNT module W ni report 2 OPE 39 Software HI EDIF instruments OPE 40 Software HI The Linked patient box G If New lower right corner of the SAMPLE tab pea in Linked patient per mits the user to quickly link key indentifying word has been selected samples with patients during routine Name Family name Type ID this panel will be displayed sample creation or editing OPE 21 to initiate a search in the archive NEW PATIENT PATIENT SEARCH RE Smith Annie Smith John Smith Paul New Gates Paul Mart Bob Smith John Add new patient A A patient selected Enter the required information Menn TA ai and Add the new patient o the selected sample Execute word match on items in archive During the test execution when a test linked to a patient is compl
18. b OPE 26 In this case it will be necessary to build new calibration tests for the required method to be executed I Polylinear Linear regression Cubic spline Four parameters Interpolation type Reagent Blank Validity Frnt Curre OTO pe O T ron fey MET continued Result correlation This operation configured by the administrator of the laboratory is used to align the result obtained during testing with other results statistically obtained from instruments of reference This process may help to improve the accuracy level of the instrument in certain cases A special note on The Tan one module HE quality performs a dual function it control see OPE 46 control This module can be accessed from the METHODS tab It can also be accessed to monitor to assign the controls that are used during the overall status of the entire system the execution of QC tests and to monitor their status e g accuracy and performance indicators EDIF instruments OPE 35 Software HI EDIF instruments MET continued e PIPETTING Codes of reagents and diluents to be used Bottle sizes Liquid volumes pipetted TIME The time scheduled for the test reaction i e between sampling and reading WAVELENGTHS Each method requires specific wavelength s for the reading s to be performed WASHING Programmed intensity of washings required for each test sequence INCOMPATIBIL
19. be executed monthly to avoid a shift of test results or the deterioration of critical parts Listed are 1 Sampling needle rinse 2 Special cuvette wash 3 Testing pumps Note It is advised that instrument performance tests be run during the course of each month to monitor possible problem development ADDITIONAL TOOLS Power on Power off PC with Start up Shut down analyzer Exit software A Information Warm up status bar Verification of connections Special maintenance An occasional procedure should be executed to monitor the remaining life of certain parts Listed are 1 Reaction cuvettes 2 Pumps 3 Halogen lamp 4 Filters 5 Sampling needle Additional tools Procedures possible to help save time during testing This includes the use of the manual dilution tool for preparing a sample dilution to be added to the test mix as a supplement to normally scheduled dilutions Principal services Connecting A Connected PC is trying to connect PC connection established A Not connected Problem s detected Some reasons Work i Analyzer not turned on modules ii Analyzer not connected to PC iii Connecting cable damaged iv PC communication port in use s OPE 11 Time 09 35 04 Software HI EDIF instruments OPE 12 Software HI MONITOR SAMPLES METHODS REAGENTS WORKLIST If the PC and the analyzer are Not connected for any reason
20. ccuracy of ongoing analyses Possible drift in chemical characteristics of reagent MON continued Problems and solutions Item type Problem Date Solution GLU 1 reagent Empty 3 16 2009 4 21 26 Waste weekly maintenance Tank full 3 16 2009 4 21 26 Wash station instrument Mechanical error 3 16 2009 4 21 26 GLUP method Incorrect field value 3 16 2009 4 21 26 Type of Nature of Date and time since problem problem problem was detected Solutions provided with analyzer or designated by administrator See OPE 11 for a diagram of a Rapid access function Method status Quality control 2 Quality control 3 Calibrators Method Avail tests Prog tests Sched tests Blank Calibration Quality control 1 GLU 15 2 0 BUN 103 3 0 GOT 54 51 7 E Recorded status of blank calibration calibrators and quality controls Tests scheduled Tests programmed Approximate number of tests possible with reagent liquid levels available amp Click for Rapid access to related sections EDIF instruments OPE 1 9 Software HI EDIF instruments OPE 20 Software HI SAMPLES tab Dimp cai os lan Ia Peyi lye Lirg rt Di an ati ie l L suet Eagar Save and file MONTOR SAMPLES WORKLEST METHODS J KILA E 1 3 Add Remove a sample SAM arcode scan GT eLA LE avance a sample list for reuse sann Sim Tike without related
21. d solutions n 19 A special note on quality control Method status eresesesersesasasesesesononos 19 Method fieldS rrrrereserereerenesesesosonooo SAMPLES tab SAM ererereresesoreronons OPE 20 Work modules r rerrrrerererererererone Sample list management 008 22 TeSt COUN 8e A A DO Sample INSPECTION n 23 Patient management reerererereneronnens Sample report oeereeererrssesonssresosonsanos 24 Lot management ererererrerarasonononnens SdIMpPle tay EEEE 25 Quality control management 085 EDIF instruments OPE 2 Software HI The Galt line of analyzers features an twnovative software based ou the minimal number of operational commands needed to accommodate in depth and comprehensive testing with maximum ef tetewoy tt caw be employer tmmentately oy Laboratory technicians at all levels of proficiency from the beginner on The manual begins with a brief but complete overview of the entire work process OPE to 13 followed by descriptions of the five Prima ry tabs OPE 14 to 27 which include a complete step by step explanation of the entire hiera reny of testing actions and fnally a discussion of the Work modules covering the use of special management features OPE 38 to 47 Readers are urged to Switch ow OPE 3 and experiment while following these instructions page by page Switch on Log in Start up 1 To begin opening procedures 4 Upon entry and confirmatio
22. e optical calibration at Start up has failed Error in calibration curve standards One or more standards of the curve are invalid Error in reagent BLANK ranges Blank calibration values are out of range Error in calibration curve ODs The OD values of calibration are out of range Software HI EDIF instruments OPE 34 Software HI Calibration continued MET continued Lot currently in use for the selected calibrator Primary concentration of the selected lot Final concentration used for the standard OD value of the last calibration in absorbances Abs Date of execution of the last calibration Calibrator used for the standard Dilution rate to be applied to the standard Single Calibrator Dilution yes Primary Final OD ae Final concentration Primary concentration ko Dilution rate 2 ii 8 ei ee ee eee Touch select curve chart access listings Blank ue an lect interpolation ty ako me enn select interpolation type L ii L to be used for calculations Blank correction used in result calculation if checked Print a report showing Validity of the blank in hours the current Blank OD values in absorbances Abs calibration FE E Date of execution of the last blank correction status and chart If the calibration of a method is no longer valid the user will be alerted both in the MONITOR tab OPE 18 and in the test creation process in the WORKLISt ta
23. es listed to any empty tray positions temove all 4 Remove all samples from the tray EDIF instruments 8 This work form shows the positions assigned to f Sample urgencies samples calibrators and controls with the color coded status of each It can be displayed by pressing Sample tray SAMPLE IAAT List of sample Positions not on tray nimi e CALSIPATOM C 0 AAA Status key HOT BCHEDAREC CHE DULG O CELOU TEA O CAMA T TEL BAM PLE EMPTY O TEST ABORTED Sample tray This effective management tool makes it is possible to remove or place samples and monitor type location and status of tests displayed OPE 25 Type kay Color coded key permits identification of the position of samples urgencies calibrators controls and the status of each in the testing process Code examples SAMPLE orange ring COMPLETED green center SAMPLE COMPLETED Orange and green see descriptions of Sample status OPE 20 8 Exit SAMPLE TRAY work form Software HI EDIF instruments OPE 26 Software HI WORKLIST tab ano vovo SAMPLES WORST ie FOS a Ka Create a new worksheet Worksheets di apea Save and file Shest Armyiwa a GOT Anylana 2 heat n keyiasa a GOT Amytant a Calbrabon Tests all worksheets for reuse a ILP O lt MW i Tests Testad with
24. eted a new item will be recorded in the archive making It possible to search for old tests executed or to track the progress over time of individual patients Patient management module This module provides information and procedures for the optimum operation and the efficiency of patient management e g List of pattents patient searches tests organized OU date or analysis stored test features Patient management A List patients and Enter Key indentifying words Access Detailed search search for individual i e Name Family name Type ID to identify patients to search for patients in archive by entering key words patient records Display Complete list of patients in archive Add a new patient to the list In this panel a list e Edit selected line item of patients is displayed The list may be complete 6 or partial i e the result of a search PATIENT MANAGEMENT Access Patient test list panel OPE 42 Select any line item in the list of patients to display Exit additional data in this panel e g Date of birth Email Type PATIENT MANAGEMENT module This feature can be used to inspect or edit patient information and to show tests of a selected item recorded in the archive EDIF instruments OPE 41 Software HI EDIF instruments OPE 42 Software HI Patient management module continued 2 Sort tests S
25. ey Jen n i ngs 2009 11 01 16 50 MTCL1 N 25 4 mg dl z 2009 11 01 17 12 MTCL1 N 0 1 mg dl g Fa ph IC of 2009 11 01 17 24 MTCL1 N 25 8 mg dl yi 2009 11 01 17 31 MTCL1 N 25 6 mg dl e jini all QC resu its 2009 11 01 17 43 MTCL1 N 26 4 mg dl k A executed over time 2009 11 01 17 55 MTCLI N 27 1 mg dl y D t etermines accuracy level of the instrument Prints a report of quality controls e 4 Reference values Calculated values It j ibl t IS possible to for mean and CV for mean and CV Levey Jennings select the period taken from control using all items checked graphic of QC of control evaluation results with dated lot data OPE 44 in test results list Item 3 using the From and reference lines To date selections List of tests executed 5 in the selected period see item 4 Access list and select a Control for each of the three QC operations to be used for the selected method and control Any items that remain unchecked If more than one Control Concentration Minimum Maximum will be excluded QC test has been gt DD ON me ie executed per day le to OH E HE calculated an only the final test es E o ie om Che will be checked oi EH Y E Z graphic chart List of Print daily report of the Exit methods available quality control selected QUALITY CONTROL for current method module EDIF instruments OPE 47 So
26. ftware HI EDIF instruments OPE 48 Software HI Power off Shut down Switch off 1 To begin closing procedures first click the Power off button to access the options required Options gt gt DOI If testing is to be Te resumed shortly a final wash of the reaction cuvettes l is not required at this time In this case press Exit and the programme will close immediately Power on Power off ADDITIONAL INFORMATION CONCERNING SHUT DOWN Each day following the completion of the work scheduled a Shut down procedure is required to initiate the cleaning of the reaction cuvettes before switching off the analyzer If this procedure is neglected any test residue remaining may damage the cuvette walls This will reduce testing accuracy and possibly require earlier replacement of cuvettes 2 To continue closing procedures select the Shut down option to access the final shut down procedure Execute final shut down procedure Proceed Shut down options Check to programme the following options Check automatic actions Exit after shut down to be run after shut down Tum off PE after strut here i exit software ioganmanod restart li turn off PC ENE 5 001 write PS DANE e iii restart when required e g next morning iv automatic start up following restart M Automate start up 3 Switch off the PC and the touch screen monitor 4 Sw
27. gations Calibration and Correlation Vissis Iuses test Haake tor nec eee week During the testing process if there is any doubt concerning the quality of the reagent used critical for testing e g readings and calculations bring this to the attention of your administrator interpolations testing processes timings volumes This information forms the basis for functions Calibration Calibrations are the means by which the instrument transforms ODs optical density values into interpretable results concentrations It can be a linear function factor or it can be a non linear function described by multiple points standards To ensure accurate results it is mandatory to execute a calibration of the method each time it is requested by the system Number of standards to be used for the calibration Factor of multiplication for result concentration Validity of the calibration expressed in hours Interpolation type used for calculation Calibration Number of standards Facto validitu Sa Interpolaton type pro Standards Current calibration Single Calibrat ary Primary Final oD Date L A EE EE kk Click Single and the calibrator in position 1 will be repeated in all other positions EDIF Instruments OPE 33 MET continued METHOD ERRORS Invalid filter A filter with the wavelength inserted is not mounted on the instrument Invalid calibration of method filters Th
28. he sampling of new tests Dispensations will be skipped until the cover is closed and all tests requiring a second dispensation will be aborted Tests requiring no dispensations will continue PAUSE REQUESTED PAUSED A pause may be requested at any time and reached PAUSED when the current sampling runs have been completed The instrument cover can then be opened to permit the user to perform on board functions Reagents and samples on board can be removed or added during which time the reading process continues PROBLEM Indicates that the analyzer has stopped and testing can not continue without user or technical intervention SHUT DOWN The analyzer begins closing procedures by executing the necessary wash cycles When these are completed the instrument can be switched off OPE 48 Service EDIF instruments MAINTENANCE Daily maintenance Two procedures should be executed each day 1 Start up Recommended daily to ensure that calibration of the optical group is renewed 2 Shut down Required to initiate the cleaning of the reaction cells before switching off the analyzer but only if tests have been executed Weekly maintenance Four procedures are recommended once each week 1 Empty waste tank 2 Fill common resource tanks water cleaning solution 3 Prime hydraulic system this is to ensure the removal of any air trapped in the tubing Monthly maintenance Three procedures should
29. in 24 hours from test execution and thus were adjusted it is possible to request Mn Aa da if either calibration or Se blank were faulty a new result calculation Q 8 9 with the latest calibration Test inspection 9 An overview of test information with a graphic SU EST ANRO of test readings and result considerations work form A recalculation of test results is possible WOL continued followed by the instrument for a single test xX K xX Operators familiar with the trends normally associated with the reaction curves of analyses may be in a unique position to contribute their insight regarding the validity of tests executed on specific samples This can provide a valuable asset which is particularly effective when testing samples with specific pathological characteristics Method Sample ID ALP 0001 N OD UR LIS WORKSHEET Incubation Incubation Reading Incoming worksheet has been time 1 time 2 time received from the server Do you want to accept it If software for the management of the laboratory LIS has been set up to work in tandem with the instrument it is possible to receive worksheet data from the central computer When this happens a message box Time requesting confirmation by the operator will be displayed in the middle of the screen A 2 2 5 4 Pe S amp S SE 4 A et Se a se Ss o N a A N gt FG O YN DAH KE U N gt O O i j i a ee GOU W w dB a BG Few eww vu w n Bon Upon
30. information about the test i e Test ID Date of execution Result Dilution Logged operator Patient ID EDIF instruments W resi stored 5 Access a single test showing system status e g method calibration sample information precisely at the moment of execution of that test TEST STORED METHOD Sample information upon which the archived test has been executed Calibration curve used to calculate the result of the archived test Method parameters employed to execute the archived test Exit TEST STORED panel Q OPE 43 Software HI EDIF Instruments OPE 44 Lot management module To simplify the information Loading and monitoring process this module has been designed to manage the calibrators and control lots tw a single database Lot LOT MANAGEMENT management Load new lots of calibrators and controls Link methods to lots Inspect the current listings Meth hiiio ey i With this module users can add new lots and specify multiple methods Each lot can be linked to as many methods as required a and once a lot method d i complete decriptions below linkage has been established it need never be recorded again PHOS WAA UREA ALB 50 FT CALA fi Unused lots can be deactivated Software HI o This panel deals with all lot functions This panel deals with method selection e g entering recording stor
31. ing and the linkage of methods to lots Enter the name of a new lot Select the method required select calibrator or control and enter code for linkage from choices and date of expiration in text boxes in the list provided See additional commands below See additional commands below Link method chosen to Add lot entered to record file the lot selected in panel 1a Remove lot displayed AA H m Rom t cord fil Remove link selected Apply adjustments made Apply adjustments to method displayed made to lot displayed Activate Stored Indicates the lot status active Active or stored Click to change List of all methods currently lots with same name cannot linked with the selected lot be activated at the same time name and code indicated List of lots currently recorded Exit LOT MANAGEMENT module EDIF instruments OPE 45 Software HI EDIF instruments OPE 46 Software HI Quality control management module This module has been designed to control the quality of the system by monitoring the QC results of methods and extracting information regarding the accuracy of the instrument QUALITY CONTROL System uality control Assigns controls to methods up to three conrols per method 2009 11 01 16 10 MTCL1 N 25 1 mg dl ma ear i si 2009 11 01 16 20 MTCLI N 24 1 mg dl ZAN Provides a 2009 11 01 16 30 MTCL1 N 24 3 mg dl 7 P Lev
32. itch off the analyzer Switch for reagent a main refri eke a i ao si g switch plate W Danm Ii If for any reason If Programmed restart the analyzer is to be has been checked switched off but the during Shut down do not reagent trays are to remain turn off the main power switch on board be sure to leave and the instrument will hybernate the refrigeration plate on until the selected Date and time EDIF instruments Notes OPE 49 Edif Instruments would welcome receiving any comments or feedback from the operator so that over time le improvements d if can be made INSTRUMENTS Software HI EDIF instruments OPE 50 Software HI SAMPLES REAGENTS OO e ao ED ia Po A fax The approach taken in the design of Edif products and the Edif line of analyzers is simplicity itself Edif INSTRUMENTS Edif Instruments S r l via Ardeatina 132 00179 Rome Italy Phone 39 06 5127161 Fax 39 06 5127550 Web www edif it Email info edif it
33. lution rate based on the previous result Software HI EDIF instruments WOL continued e A line item selected in the WORKLIST tab OPE 26 will be entered here under Information Other relative data will be displayed throughout the current work form QG Subsequent selections of other tests can be accessed here without returning to the WORKLIST tab G Next test Previous test 9 Test result readings in Abs with a graphic representation Readings plotted here represent the trend of ODs during test execution OPE 30 Software HI 4 To inspect the result of a test on a sheet a 5 select that test line Inspect test Additional useful and press Inspect test ki ki sesa e to display the work form includes ODs date and eventual listings of issues TEST INSPEC TOH Tes hisi Tas miini ian encountered Sample il 277 e ANOS Hevea during testing n 7 7 maid Hmmp fen Man delinita Result maa kat hod narnia hilirtsoe Saa Cam plied Print test report I Lie f i OT Albee 11 Oe Abe i OO E l 0 14 Aba 12 OS Abe ESS a ay KA Gs MN MA ee i a ee iM Abe TE 04016 Ahs ea AAA ER BEBEP os S RSE ane Access LI a IA pe ti L n Eli taxi iJ SAMPLE INSPECTION D JEIDA Th 64198 Aha 0 31S Abs Ti C4740 Abs PSE Ed DO N fee Be 1 ee pit i ate OSS Alb M 0 4S Abs P l DIM Aka lik Or Re L ji iii iii pil l lir iii a 0 0719 Aba Ak OAIT Aba With
34. n switch on the analyzer of the appropriate name and password Instrument warm up will begin see also OPE 10 the REAGENTS tab will appear see also OPE 14 Switch Main for reagent power refrigeration plate switch 2 Switch on the PC and the touch screen monitor For an outline of the message boxes available see OPE 12 DAILY START UP 3 Click on the HI icon to access the Log in window Daily start up procedure has ne not been done execute now pote Reminder and press OK ser ERAD If start up has not been executed Mo a in within the last 24 hours the DAILY START UP Name a m Password Goes message box will appear If tests are scheduled to be run ae man Touch press OK to activate this procedure Then upon completion AM In B screen of warm up a prime of the hydraulic system a wash cycle and keyboard optical calibration will be executed and test execution can begin provided EDIF instruments OPE 3 Software HI EDIF instruments OPE 4 Software HI REAGENTS MONITOR SAMPLES WORKLIST METHODS Main page With only two clicks the user is into the very heart of the testing process giving immediate access to all working functions at any time during laboratory routine work Monitor tab i REY EAN TA EY mi kagi RCTS Problems and solutions 2 MONITOR e Identify and manage problems e e Provide solu
35. n i n t O F ma hi fa 1e SSN ke s t Operation OPE e Main page e Primary tabs e Secondary commands e e State of the analyzer e Controls e Services e e REAGENTS e MONITOR e SAMPLES e e WORKLIST METHODS e Work modules e Human Interface manual xii 2010 Complete descriptions of the working parameters required for a routine testing session prepared by Edif n INSTRUMENTS This manual has been the collaborative action of all the Edif Instruments staff Software version 0 37b First printed iii 2007 Revisions made vi 2007 iii 2009 ii 2010 xii 2010 EDIF INSTRUMENTS 2010 Contents Operation OPE Switch on Log in Start up Main page Primary tabs Secondary commands Work forms and modules OPE 4 State of the analyzer Controls Services Message boxes Rapid access 10 REAGENTS tab REA vrerererererereses OPE 14 WORKLIST tab WOL 008 Manual assignment reeeererererenononnens 14 Worksheet Management rerererereones Auto assignment re 15 Test management sssssssssssrrnerrrnnen Reagents on board reeeerererereononoens 16 Test INSPECTION ccccevaeeeeeeeeeeavavaeeees Monitoring Checking liquid levels 17 METHODS tab MET asasesesessess MONITOR tab MON ececeeeeeees OPE 18 EalibkatiO n e n OVENVIEW leeeeresonresonsasesonsasonsesonsasons 18 Result correlation eeeroerenoeresonrosonos Problems an
36. ored The user can touch select any Bottle position in the panel at any time to request a liquid level check of that bottle NOTE When the instrument detects a bottle or cup of reagent that has been newly replaced on the reagent tray one found previously insufficient all of the tests that were stopped for the lack of that specific reagent will be automatically rescheduled During the course of these procedures the liquid level of the diluent bottle is also measured EDIF instruments REA continued l Yi STOPPED When the analyzer is STOPPED choose any reagent bottle in the Bottle positions panel that you would like to verify then touch select Check levels to measure that liquid level If no bottle selection is made and Check levels is requested the liquid levels of all reagents currently on board will be measured REAGENT BARCODES Reagent bottles with barcodes can be scanned using an external reader recognized by the software HI and displayed in a special window provided in the REAGENT tab Users have only to click on an empty bottle position to trasfer that reagent barcode Software HI OPE 17 MONITOR tab MON OVERVIEW Constant monitoring of the status of all critical items that may interrupt the normal testing process Once an anomaly is identified a solution may be provided by using the Rapid access function see also OP
37. ort tests Test information OO w n by date by method Partial information of execution of analysis about the selected test i ID Method Date Result Access the patient list of tests organized by date or by analysis and print reports G Graphic showing the evolution of test results over time Select Sort by method 1b and then the method name son by dat e Test information in the list to plot the graphic Sinr d test far controle CAP LIS pi Miei a ape MN ii 4 4 a F a p Sa a a Print a report of the tests FA 2157 C0P 2m ____ previously checked in the list p22 4 cnP 2mqrd il th m 2243 ZAN 2ma dl a 12571 CRP Pm F 5 ap vie E py SRP ml z l EE 11 1 Ht Se For detailed information MITES UHP Smp VA about the selected test a BIS rM33 cnn 2m ki SE access the Test stored form g 15 31 200 2mg dl di 547 200 2mq d next page Treeview of patient tests 6 organized by date or by method as requested Exit a i T PATIENT TEST LIST panel PATIENT TEST LIST The information provided nere will allow the operator to retrieve data trom past situations to Ldentify previous testing anomalies that may have occurred Equipped with this kaowledge the operator ts LW a position to apply the work practices that are expected from a modern Laboratory wattowal or international standaras man apply e General
38. panel will be required Sample information Calibrator information Control information e ee on L Select a patient from the list z to link it with the sample currently being added thus permitting Linked paten a the recording of related tests New Gates Paul Mart Bob Smith John Thomson Henry in the patient archive OPE 40 EDIF instruments OPE 21 i NA SAM continued Sample identification ID If an ID has been provided with the sample click on the ID field and enter it using the touch screen Keyboard If no ID is provided press Auto and the next available ID number will be entered Calibrator Control identification ID Access the list z and select from those provided Position Press Auto for next available position Enter specific positions using the touch screen Keyboard Urgent To identify samples or controls of an urgent nature Calibrators are always urgent and are auto tagged as such Tube Cup Identify sample container to be used Reference Enter a reference name for identification convenience Department Type Access the list vi and select from those provided Nature Select serum or urine sample calibrator control sample only 2 To add a new sample after data fields are complete press the Plus icon to transfer that information Software HI
39. related samples n Revove teit Gwodetest Insonct et worksheet selected Tete Feta Sena l Tie Tt thet af Bry aed Plante el APCAL A FS a Ta TH Ba MENI fi I p Sa ki A ka po kan W ji 1 Transferred from Retrieve and load Da URSA Mer fa li i SAMPLE tab mi worksheets from saved file e poudi kon area Mi ZE 5 with related samples yji UREA Dbent BLANK i iiai GWD L m imi Seow OS 1L mea mo ee l ni jim ie i E acas TEEF Run all tests F DEA MCL L Laan Lil LAO OA Hi UREA MALLS Si l LAMA ODL DANIA aa emu pom eur es on the worksheet 3a LEA MCL 5a a completed LISE ee er ee Brize selected JIJ Men MA Leese Sa i Hei 1 LIEN ijay 2S EL Clear all worksheets a ea a at l wan e TEST meet ee En without related samples 4 eS Sng Can fi Compia ed LAA 3r 7 eo Ae FE Print a report of the worksheet Unlimited worklists can be managed Hi selected simultaneously Routine a Resource errors Not Scheduled Test programmed Waiting for confirmation Test status Scheduled Test confirmed Waiting for execution Rapid access Reag 1 missing Not assigned on reagent panel Test in process _ Reag 2 missing Not assigned on reagent panel Instrument errors Reag blank error Reagent usability range exceeded Completed Test result usable a i i Predilution failed Reag 1 empty Reagent assigned insufficent Result unusable Test result unusable i i
40. s Apply to add it SAM continued 6 To access accurate information of a sample select that line in the sample list a Additional useful A I tem selected the and press the Inspect icon information SAMPLE tab OPE 20 to display the SAMPLE INSPECTION work form will be entered here under Information l l gt 3500 ul full Other relative data will seni ke be displayed throughout DH Information mile Stas Nit pdwdied the current work form 0002 pos 2 es Poet 6 A Graphic display Subsequent selections showing of other samples can sample be accessed here volume to the SAMPLE tab Next sample Previous sample Oo Tests listed showing information on method code dilution CRE 1 0 0133 0 0133 Olaa 5 0 0133 O 0b33 Level too low insufficient E for testing OD result status date Access a SAMPLE REPORT Q Sample inspection 8 O An overview of sample information featuring click for Rapid access a graphic display showing the remaining sample volume SAMPLE INSPECTION a cla for easy monitoring of the current level work form EDIF instruments OPE 23 Software HI EDIF instruments SAM continued A line item selected in the SAMPLE tab OPE 20 will be entered here under Information Other relative data will be displayed throughout the current work form G Subsequent selections of other sample
41. s can be accessed here without returning to the SAMPLE tab Next sample Previous sample o Checked tests will be included in the report Tests listed that have been completed showing information on method code dilution result status date OPE 24 7 If a printout of test results is required select that line in the sample list and press the Print icon to display the SAMPLE REPORT work form SAMPLE REPORT Infarmatsan 6 Add Prearranged comments Ogis 00133 ONI 0033 ONI O 0133 Click for Rapid access to inspect a test OPE 30 Sample report With this form it is possible to select the results to be shown and to insert additional comments in the printout Software HI Space reserved for comments and observations Prearranged comments can be selected and added to the Comments box by pressing Add Print sample report Preview the report Check to automatically print report when all tests for that sample have been completed Date and time Name of analyst 2 Exit SAMPLE REPORT work form SAM continued oo Touch select any tray position to display color coded information panels Commands to remove a sample or display the SAMPLE INSPECTION work form List of samples with no assigned tray positions Activate any item and touch select a tray position to place that item Auto placement of sampl
42. tests E Completed Sen Tube CRACAL OUE ay ret Not ereid Serum Lag Ert Completed g rum ube Sample horri Apply modified data to selected sample in list MTOI NORM ii PATOL 1 2 zi Retrieve and load pata a sample list from saved file E baa without related tests mo Display work form Le for sample report Ser urn Cuc PTL eS ai Cirig Mit afraid Faruri Tucker Samples listed here are L iriki patient Ca ai e Display work form with related tests i for sample inspection Sample tray 1 m 51 Sample status Rapid access Display work form showing Routine Linked patient tray positions for samples One or more tests of that sample are waiting for confirmation Establish links between calibrators and controls All tests of that sample have been scheduled patients and samples One or more tests of that sample are being executed for analyzer archives All tests of that sample have been completed and are correct See OPE 40 for a Sample errors description of how Execute a complete Sample remaining is insufficient for testing this feature works scan of sample barcodes One or more tests of the sample have been aborted 1 Identify a category Sample Calibrator Control and enter data required see adjacent list Choose the category Calibrator Touch select either calibrator or control when required In most cases only the sample information
43. tions for problems identified e e Review method status e 1 REAGENTS e Assign and adjust bottle positions e e Manage listings e e Check liquid levels e Samples tab fan kof n LA ann Methods tab ALAM a De KANPE AA An kat iran p JA anno ky e mo Worklist tab see mand Cd 3 SAMPLES e Manage samples 5 METHODS an pou a make n r amp a e Set and monitor calibrations e A aa ae ka e Assign quality controls QC e PER PES S 4 WORKLIST e Access QC results e e Request and print reports e e Create and manage test lists organized in sheets by groups e e Run zoom rerun tests e EDIF instruments OPE 5 Software HI EDIF Instruments OPE 6 Software HI WORKLIST METHODS Main pag e continued Secondary commands This level of the command structure l U 3 SAMPLES tab SAM is the link to the core functions that give access to the range of testing options provided with this analyzer amp Save and file a sample list for reuse without related tests 1 REAGENTS tab REA Retrieve and load a sample list from saved file without related tests Clear displayed sample list with related tests Barcode Execute a complete O scan d scan of sample barcodes Save assigned positions and file bottle panel for reuse l work form oeg aj kn Retrieve and load a bottle panel from
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