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1 - Beckman Coulter

1. AcT 5diff AL Result T Analytical J Action Limit D I DiffPlot Histogram I Not Printed J Patient Limit J Not Transmitted Inc Sample ID Cass Pos Patient ID First Name Gender Date of Birth A F AUTO_SID13 9 3 Unknown CBC L _ auTo_siD14 9 4 Unknown CBC t auto_sip1s 9 5 Unknown CBC L _ auTo_sib16 9 6 Unknown CBC t fil auto_sip17 9 7 Unknown CBC t l F AUTO_SID18 9 1 Unknown CBC iT auTo_sip19 9 2 Unknown CBC t k a4uto_sip20 9 3 Unknown CBC t PF Jauto_sip21 9 4 Unknown CBC I m C _auTO_SID22 9 5 Unknown CBC t gt C _AUTO_SID23 9 6 Unknown CBC t L AUTO_SID24 9 7 Unknown CBC L _ AUTO_siD25 9 1 Unknown CBC L a T suto_sip26 9 2 Unknown CBC L _ AUTO_sID27 9 3 Unknown CBC L C auToO _sID28 9 4 Unknown CBC L C 78787 Unknown CBC I I Lourdes Unknown CBC I fC TIW1514 Unknown CBC TP itiwisi4 Unknown n 8 C 456 9 7 AUTO PIDS Werner TJ Female 08 11 1965 36 Y CBC I F 13119290P 9 6 Sierra7565 Remner Addison Female 04 11 1962 40 Y CBC I kial r iy vy wi amp B BD A vv X D Version V0 13 Supervisor 08 01 2002 20 04 40 9 If Auto Print is enabled a sample report is printed PN 624026AE 9 17 DATA REVIEW MANUALLY MATCHING SAMPLE RESULTS WITH WORKLIST ORDERS What to Do If the Correct Order is Not on the Manual Match Screen If there is a result on the Manual Match screen and the Worklist area di
2. Doma Inc Ope Date Time wec RBC HGB HCT MCV CONTROL 13 CBC OIFF E i seves oea 7o 133 lentes F Service 0970572002 183140 70 131 psa ena 75 132 Suis F Service 0970672002143355 74 131 F Reserved F Service 09 06 2002 16 11 49 72 133 A Expiration Date 09 09 2002 g z 1a Ome 73 510 W ay a3 fo Fih a c2 mo s a20 all Comment ny Analytica Error gt gt gt co fo pa cw E pa po fio C DIFF E Selected Results N E a Modified on r vec RBC HGB HCT MCV paerewa Mean 72 1313 By 250 ou 012 5 oz 62 Service A 305 1 09 05 os 03 ER Lower Limits 62 449 130 zs 82 SS Target Values j 72 464 135 39 86 21 k z Upper Limits a2 473 140 as 90 Delta Diff o0 075 03 w 5 5 g x os NersionVOTS e1 Service T Ts7iovam2 103630 Act Sdiff AL Quality Control cone PEE vorimeviven mocioni wevmeny noveove4 CONTROL 13 CBC DIFF zl ner sLveiMor Eos raas Lot Number sce z E F Reserved wec A Expiration Date 72 Se HN 09 09 2002 aa 9 EE 8 wec 10 W t RBC E64 1087p v N o RBC e neBfi35S gdl ied m p x 10 7a 015 pur 270 10 ET A Modified on ee aq 09705 2002 Nis By 133 135 l ae a le Shift Selection a
3. CEE diagnostic procedures RUO Results Result 1 1 Sample ID ese eee 123456 WBC 10374 63 E DiffPlot and Histogram Flags Cass Pos Panel vk WBC SL NL LN SL 1 IMM I C ieor e T7 Anaya Messages A Flagging Set HGB g dL 129 WBC BASO Interpretive Messages Standard Range Her z a7 NRC Collect Date Time too fh Barca crocytes Run Date Time pels Pe PLT Aggregates i 10 04 2002 14 14 52 paean Schistocyte EA Row x Miscellaneous Messages Eo Reagent expred Physician E MPV aL 81 R mm Comments ecr x Tuos tog a o G Patient ID z 1a lv Ine zaa Last Name ly on 250A ite First Name ae 5 Date of Birth Age ea ET ARER k m o2 R onn 3 Gender Toc ee A 5 C gt 2 y X Supervisor l T rovaar200e 1417 59 b Select Print or Transmit from the following window Print Transmit Print Transmit Trae Print Print displayed report Transmit displayed report _L to print or transmit 13 When you are finished analyzing the stat samples J mode 2 to exit the Manual Stat 14 Verify the Sample ID and results before reporting the results 8 6 PN 624026AE PN 624026AE SAMPLE ANALYSIS 8 RUNNING MANUAL STAT SAMPLES Procedure for Running Manual Stat Samples No Order on Worklist and You Want to Assign Demographics Do this procedure to run a manual stat sample if there is no Worklist order and you want to as
4. 4 Enter the Sample ID See Sample ID Sample ID Entering Selecting in this chapter 5 Select the desired test panel See Panel Oe Selecting CBC or CBC DIFF in this chapter 6 Select the flagging set or the flagging set will be automatically applied based on age and gender See Flagging Set Selecting in Appendix A PN 624026AE Flagging Sets Standard Range Standard Range 8 23 SAMPLE ANALYSIS RUNNING WORKLIST SAMPLES IN AUTOLOADER MODE 8 24 Enter the following demographics as required by your lab protocol Collect Date Time Entering Location Entering Selecting Physician Entering Selecting Comments Sample and Patient Entering Editing Patient ID Entering Editing Name Locating Selecting Date of Birth Entering Editing Age Entering Editing Gender Selecting If you make a mistake when entering Ux the demographics to clear the entry Sample ID Collect Date Time i EES a a Flagging Set Standard Range x CBC DIFF Oo Location Physician Comments Rerun f Patient ID Last Name aa First Name Date of Birth Age Lf fs __ Gender Unknown x s UW JAcT Sdiff AL WORKLIST a L Pe Cass NumbeO7 Colect Date Time a a Gacy zm corr AS ae Standard Range OMe ob Ee a y G lo 2 uerv ie _ O O fe leery Ej ooper IESE aer ojoj er Pat
5. 4 For details on adding editing or deleting users see e Adding Users in this chapter e Editing User Information in this chapter e Deleting Users in this chapter PN 624026AE A 116 SETUP A OPERATOR USERS SETUP Adding Users This procedure continues from Operators Users Adding Editing Deleting l 6 ia Login Name At type the Login name up to 10 alphanumeric characters Password At type the password up to 8 alphanumeric characters Note A password is not required for Operators only for Service and Supervisors Group T Operators at for the new user and select the group Operators Service or Supervisors Type the user s 3 character code This can be the user s initials a code assigned by you or any other 3 character combination that will distinguish this user from other users This code will be used for traceability purposes meaning that if a user with a code of TUW runs a Startup cycle TIW s Login name will appear in the Startup log as the user responsible for that action to save the change To see what an updated screen may look like after a user e g Matthew was added to the Supervisors group see Figure A 18 PN 624026AE A 117 SETUP OPERATOR USERS SETUP Figure A 18 Screen Showing a New User to Supervisors Group AcT 5diff AL Operators Operators A 118 PN 624026AE SETUP A OPERATOR USERS SETUP When th
6. Sample 1D 360902 ie en 23 E Analytical Messages Cass Pos Panel tii BASO C e ko _ eee Flagging Set HGB g dl CONTROL 13 Her x Collect Date Time bv a penteme _ MCH pg Run Date Time 11703 2002 10 30 52 pani ae Location pow pee Physician PLT 1077p Cv ft Comments Patient ID NE 641 Last Name wv 3 Ble gt a E s Z v X 170372002 103055 Act Sdiff AL Quality Control Inc Ope Date Time WBC RBC HGB HCT Mey JCONTROL 13 CBC DIFF I I Super 1170372000 103052 2 63 137 78 Lot Number 260902 z F Reserved A Expiration Date 11708 2002 bet w 8 wacles 10 u a PBe noem pum 5 t S yee eT gat Al Comment mm wer fae x c coc pir 5 10 7mt DIFF ea J Selected Results N 5 Modified on wec Rec HGB HeT wev 11703 2002 ea i aE 2501 E z Lower Limits 57 vi 6 Shift Selection T 3 e e 2 Upner Lin 6s a Delta Diff 00 oo o 3 AS E g qa Z 7y X Supewisor AEE 7 13 7 QUALITY ASSURANCE RUNNING CELL CONTROLS 16 1f the control lot number has been set up as reserved the Workstation identifies the sample as a control and places the results in the appropriate control file based on information entered in the Sample ID field 17 Review the control results as instructed in Reviewing Control
7. A 79 SETUP SYSTEM SETUP CO AcT 5diff AL System 3 E the Printer tab 0A aaaaqaq Adddddddad d iv K v adda adda k A 80 PN 624026AE PN 624026AE SETUP A SYSTEM SETUP 5 Type your laboratory s information a Report Header Type lab info here Type lab info here rype lab info here Type lab info here Tyne lab info here Type lab info herel Type your laboratory s name in the Header 1 field Note You can type up to 20 alphanumeric characters in each header field Press to advance to the next field Type the remainder of your laboratory s information pressing as necessary to advance to the next field s UY to save the change A 81 SETUP SYSTEM SETUP Printer The following options are available e e Add Printer e e Printer Properties e e Set Default Printer e o Delete Printer e Add Printer ATTENTION If you want to add a WindowsNT compatible printer to your system contact a Beckman Coulter representative before doing this procedure COULTER AST Sdiff AL 1 From the Main Menu screen W aE CO A 82 PN 624026AE SYSTEM SETUP SETUP 3 E the Printer tab AcT 5diff AL System Local Settings peo ber 0A 5 Espiner 6 Follow the instructions on the screen 7 u v to save the change PN 624026AE A 83 A SETUP SYSTEM SETUP e Printer Properties Do this proc
8. 7367162A Indicates the mode Autoloader or Manual in which the Reproducibility analyses will be run Displays the number of aspirations to be performed in the Autoloader mode Parameters result for each sample Use scroll bar to see additional parameters Panel selector that allows you to select CBC or CBC DIFF Calculated statistics for included MJ runs Range is the difference between the maximum O and minimum 0 values Maximum is the highest target value Minimum is the lowest target value ooo 000600089 8 Coefficient of variation of the selected Reproducibility runs displayed in red if greater than the CV defined by the operator 11 52 PN 624026AE PN 624026AE 9ee8e 8 6 DIAGNOSTICS REPRODUCIBILITY CHECK Standard deviation of the selected Reproducibility runs Mean of selected Reproducibility results The number of selected runs used in the calculations in The scroll bar that lets you scroll to see additional parameters in Date and time the Reproducibility run was done Operator who ran the Reproducibility run Allows you to include exclude a Reproducibility run for the calculations in 6 Running a Reproducibility Check in the Manual Stat Mode Do this procedure to run a Reproducibility check in the Manual Stat Mode as required by your state or regulatory agencies or for troubleshooting purposes For information on running in the Autoloader Mode see Running a
9. Details Displays details Insert Allows you to add information Delete Deletes data w Edit Allows editing PN 624026AE GETTING STARTED MENU PATH Table 5 5 Contextual Toolbar Icons Continued Icon Name Function y OK accept Saves information or validates an action Cancel Cancels unsaved changes or actions Quit Exits from the Main Menu screen to Login screen 29 Return Returns to previous screen Progress Indicator For every screen the date time software version and operator name appear in the status bar For Startup Shutdown and Calibration a progress indicator Figure 5 35 also appears in the status bar Figure 5 35 Progress Indicator i amp amp 534 C Tabs Tabs appear at the top of a window and group information related to that window For example Local Settings information is grouped in the window viewable by selecting the Local Settings tab Figure 5 36 Figure 5 36 Local Setting Tab AcT 5diff AL System Date Time Format imal Date Time Buttons There are three types of buttons used within this software e command text buttons e bitmap buttons and e radio buttons PN 624026AE 5 47 5 GETTING STARTED MENU PATH Command Buttons Command buttons contain text and appear within various windows of this software These buttons execute functions when selected See Figure 5 37 Figure 5 37 Text
10. A ae i 1 From the Main Menu screen a i wn 4 Ee ta Doo B a amp W a Y xX I 09718 2002 083213 A 20 PN 624026AE SETUP A OPERATIONAL SETUP 3 Verify the General tab is selected AcT 5diff AL Miscellaneous 0A 9 Select the desired Auto Stop for Consecutive Results with options 6 u v to save the change PN 624026AE A 21 SETUP OPERATIONAL SETUP pi Cs as needed Location Physician Adding Editing Deleting Using the Location Physician tab Figure A 4 you can add edit delete the location and physician lists stored in the database For details see e Adding Editing Physician and or Location e Deleting Physician and or Location Figure A 4 Location Physician Screen Details Gei sral ae Units Loca ion Physician BE o ie on Modified on By By rr a l Te 9 og 4 vV X D Service I Allows you to enter a new location or displays the location selected in to be edited or deleted Allows you to enter a new physician or displays the physician selected in to be edited or deleted Displays the date when the physician information was modified 6 Displays the name of the operator who modified the physician information 8 A 22 06 26 2002 09 07 13 7367111A Displays a list of all physicians in the database Displays a list of al
11. Defective power switch Contact a Beckman Coulter or blown fuse representative Log on Software fails to 1 Click Retry connect to the 2 If the software fails to connect analyzer during contact a Beckman Coulter log on representative 11 122 PN 624026AE Table 11 6 Troubleshooting Guide Continued Problem Area Situation Probable Cause DIAGNOSTICS TROUBLESHOOTING GUIDES Suggested Action Startup Startup failed 1 Verify the reagents are not three times expired Replace reagent if necessary See Replacing Reagents Procedure in this chapter 2 Do Heading 6 3 STARTUP again 3 Do Extended Cleaning Temperature not Instrument did not reach Wait 5 minutes to allow the reached operating temperature instrument to reach the operating temperature If the problem persists contact a Beckman Coulter representative Control 1 Rerun the control Ae a of 2 Runa new vial of control acceptable inite 3 Do Extended Cleaning 4 Ifthe problem persists contact a Beckman Coulter representative Sampling Sampling probe Motor Contact a Beckman Coulter not working representative properly Dilution Traverse motion Motor problem 1 Do the appropriate motor test 2 Ifthe problem persists contact a Beckman Coulter representative Sample distribution Pneumatic syringe problem Analyze a sample and check that specimen is correctly distributed into the baths See Aspir
12. 6 C y to save the change New Workday Defining New Workday 07 00 00 A Workday consists of a 24 hour period The following conditions must be considered during this period e the time between new Workdays e ifthe date has been changed between two log ins e if the defined time for a New Workday to begin has elapsed A Shutdown must be done before the New Workday becomes effective See Figure A 16 Figure A 16 Determining If a New Workday is Required Is it new calendar day since last New Workday Yes No Is current time gt New Workday start time last New Workday gt N Yes New Workday start Is current time gt New Workday start time Has New Workday been run in last 24 hours New Workday Nota New Workday A 107 A SETUP SYSTEM SETUP e Procedure for Defining a New Workday Do this procedure to define when a new workday will begin S amp S LN Nec 1 From the Main Menu screen 0 4 CO AcT 5diff AL System 3 0 the Cycle Options tab Host Ls A 108 PN 624026AE SETUP A SYSTEM SETUP OF 5 Type the New Workday start time New Workday a Double click the existing time fo7 00 00 b Type the new start time c Verify the time is correct 6 u y to save the change PN 624026AE A 109 SETUP SYSTEM SETUP A 110 Startup Automatic If you want your system to do an au
13. 8 Mix each control vial according to the instructions in the AC T 5diff Control Plus cell control package insert PN 624026AE 7 11 QUALITY ASSURANCE RUNNING CELL CONTROLS 9 Inspect the vials contents to ensure that all cells are uniformly distributed and that there is no evidence of deterioration 10 Load the control vial s with cap on in the correct cassette and position 11 Verify the control Sample ID on the tube with each tube s cassette and position on the Worklist WARNING Risk of injury biohazardous conditions if a cassette is not properly handled Do not use a cassette for storing or transporting tubes or vials To ensure tubes vials remain secured in the cassettes always keep cassettes upright and use them only for analysis as described in this manual 12 Load the cassette onto the instrument 7 12 PN 624026AE PN 624026AE RUNNING CELL CONTROLS QUALITY ASSURANCE 302 Be sure your hands are free and clear from the cassette input area before beginning analysis 14 FFE to begin analysis When analysis is complete the results are displayed in the Run in Progress screen 15 To view the results e From the Main Menu screen J to view the results that are displayed when analysis is completed OR e From either QC screen u to view the last control run not the last control run in the selected file Flags and Messages
14. OF 5 Select deselect the desired RUO RUO Parameters Parameters option C Disabled Enabled USA Enabled non USA 6 u y to save the change 7 Ifyou selected either of the Enabled options u to confirm that you have selected to report RUO parameters 8 u to print the RUO form ATTENTION Complete the form only if you selected Enabled USA Follow the instructions on the form o Ue as needed PN 624026AE A 17 SETUP OPERATIONAL SETUP A 18 Auto Stop for QA Messages Selecting Auto Stop for QA Messages allows you to select the specific messages that when generated stop the instrument automatically A ANE 1 From the Main Menu screen 0 aE 2 0ra 3 Verify the General tab is selected AcT 5diff AL Miscellaneous PN 624026AE SETUP A OPERATIONAL SETUP Oe 5 Select one or more of the desired Auto Stop for QA Messages options Auto Stop for QA Messages Stop instrument on QC Failed message I Display and Print QC Failed message I Stop instrument on XB XM Failed message 6 C y to save the change Gd 7 o w as needed PN 624026AE A 19 SETUP OPERATIONAL SETUP Auto Stop for Number of Consecutive Results With Selected Characteristics Selecting This Auto Stop feature allows you to select the number of consecutive results with certain characteristics that if occur stop the instrument automatically See Figure
15. Run new cycle while analyzer busy A new cycle was attempted while the Analyzer was busy Do Auto Clean Running Sample ID null in progress The specified sample is being analyzed Allow cycle to complete Sample probe mechanism not reaching home Sample probe mechanism not reaching home Do Auto Clean Running 2 Check the motor as instructed in Motors Checking Sample probe motor failure Sample probe motor failed Do Auto Clean Running 2 Check the motor as instructed in Motors Checking Sampling syringe mechanism not reaching home Sampling syringe mechanism not reaching home 1 Do Auto Clean Running 2 Check the motor as instructed in Motors Checking Sampling syringe motor Sampling motor failed 4 Do Auto Clean Running 2 Check the motor as instructed in Motors Checking PN 624026AE PN 624026AE Table 11 5 Error Messages Continued Message Probable Cause DIAGNOSTICS SYSTEM ERRORS Suggested Action SIL communication error A communication error occurred View the Host log for details See Viewing Logs in this chapter Startup Not Done Startup was not done Do Startup Procedure in Chapter 6 Startup Not Effective All 3 Startup attempts failed Do Startup Procedure in Chapter 6 2 Ifthe problem persists contact a Beckman Coulter representative Stop cassette input swit
16. o OY PN 624026AE SAMPLE ANALYSIS RUNNING WORKLIST SAMPLES IN AUTOLOADER MODE 8 WARNING Risk of injury biohazardous conditions if a cassette is not properly handled Do not use a cassette for storing or transporting tubes or vials To ensure tubes vials remain secured in the cassettes always keep cassettes upright and use them only for analysis as described in this manual 10 Place the cassette in the Cassette Input Tray of the Analyzer Be sure the cassette is properly positioned with the front of the cassette facing the reagent compartment See Loading Cassettes onto the Analyzer in Chapter 5 A analysis 11 u bPPP to begin analysis While analysis is in progress the red LED flashes on the front of the Analyzer Be sure your hands are free and clear from the cassette input area before beginning 12 To view the results for the last sample analyzed u 13 To view the results after all samples have been completed OE b Select the desired result to review PN 624026AE 8 15 SAMPLE ANALYSIS RUNNING WORKLIST SAMPLES IN AUTOLOADER MODE 14 To enter result comments Lin U if necessary b Select the result for which you want to add a comment Uke d Type the comment mel 15 If there is a situation where the system cannot find a Worklist order for the sample it is processing e g barcode was not read or the Worklist order is missing or incorrect the E
17. A 2 AMEX 2 From the Main Menu screen J Q Of 4 Select the desired control file UF CONTROL 13 CBC DIFF or at 370502 v b 0 the desired control 7 5 7 QUALITY ASSURANCE RUNNING CELL CONTROLS 5 u E to open the QC Data Grid screen 6 Verify that the level of control you are running matches the level you selected 7 Verify that the control material has not expired 8 Mix each control vial according to the instructions in the AC T 5diff Control Plus cell control package insert 9 Inspect the vials contents to ensure that all cells are uniformly distributed and that there is no evidence of deterioration 7 6 PN 624026AE QUALITY ASSURANCE T RUNNING CELL CONTROLS 10 Load the control vial with cap on in any cassette Be sure the barcode label is clearly visible through the opening Note You can load all levels at once into the same cassette WARNING Risk of injury biohazardous conditions if a cassette is not properly handled Do not use a cassette for storing or transporting tubes or vials To ensure tubes vials remain secured in the cassettes always keep cassettes upright and use them only for analysis as described in this manual 11 Load the cassette onto the instrument A analysis 12 0 FFE to begin analysis When analysis is complete the results are displayed in the Run in Progress screen Be sure your hands ar
18. Interpretive messages displayed if Messages is selected Histograms and DiffPlots displayed if Histograms and DiffPlots is selected Microscope examination area displayed if Microscopic Examination Area is selected 60000 800600600 8086 Raw data displayed if Raw Data is selected A 91 SETUP SYSTEM SETUP Figure A 14 Patient Report Setup Software Overview Vv M M M Vv M M M Vv M M M 7367516B A 92 PN 624026AE SETUP A SYSTEM SETUP e Enable Define Patient Report Areas M M M M M Do this procedure to define edit the areas of the patient sample report to be printed CouLTER AST Sdiff AL 1 From the Main Menu screen 0 a OC PN 624026AE A 93 SETUP SYSTEM SETUP 3 E the Printer tab a K Ki a a K K d K Ki Wada 0A 5 Select the desired Enable options M selected LI not selected To see the area of the report for each of the options see Figure A 14 6 u v to save the change A 94 PN 624026AE SETUP A SYSTEM SETUP e Display and Print Detailed or Suspect Flags Do this procedure to enable disable the printing of Detailed Flags or Suspect Flags on the patient sample report For details about each of these flag formats see Heading 9 9 ALTERNATIVE FLAG REPORTING FORMATS A 2 ANE C COoutTer AST Sdiff AL 1 From the Main Menu screen 0 a CO PN 624026AE A 95
19. Ream Flags and Messages DifiPlot and Histogram Flags WBC SL NL LN SLI IMM Analytical Messages D8 Sample 1D pec we 3 RBC 105 477 HGB g dl 129 MCT Mcv fh Basophila Microcytes i MCH pg un Date 10704 2002 14 14 52 penu Location Row x 5 Miscellaneous Messages Reagent expired TTA me Ka m Physician PLT 103 pL MPY fL T rovoa7en2 141753 b Select Print or Transmit from the following window Print Transmit Print Transmit Transmit Print Print displayed report 4 Transmit displayed report J x Cc E to print or transmit PN 624026AE SAMPLE ANALYSIS RUNNING WORKLIST SAMPLES IN AUTOLOADER MODE 8 12 Remove the sample tubes from the cassette See Removing Tubes from a Cassette in Chapter 5 13 Verify the Sample ID and results before reporting the results PN 624026AE 8 21 SAMPLE ANALYSIS RUNNING WORKLIST SAMPLES IN AUTOLOADER MODE 8 22 Worklist Cass Position Positive ID Manual Match ON ATTENTION This configuration is for labs that do not use barcoded sample tubes but require patient demographics be assigned with sample results The Worklist order can either be entered manually or downloaded from a Host computer IMPORTANT Risk of sample mis identification if you do not verify the correct cassette and position for each sample tu
20. k u to save the input l Do Heading 10 4 AUTO CALIBRATION 10 10 PN 624026AE CALIBRATION AUTO CALIBRATION 10 4 AUTO CALIBRATION Do this procedure to calibrate the instrument e During installation before analyzing samples e After a Beckman Coulter service representative has replaced an analytical component e As instructed by a Beckman Coulter representative Running Calibrator Samples Do this procedure to calibrate the instrument A 2 Nex 1 Verify the expiration date on the calibrator ATTENTION Beckman Coulter does not support the use of any material past its expiration date and does not accept any responsibility for results generated by products used past their expiration dates 2 Prime the instrument according to the instructions on the package insert 3 Verify that Heading 10 3 CALIBRATOR SETUP was completed for the calibrator that you are using 4 From the Main Menu screen Q Q r w i L te jj 4 Al bree le lo a a e e B gt Db 2 vyv XxX E j l 08719 2002 033219 PN 624026AE 10 11 CALIBRATION AUTO CALIBRATION 0G 6 Prepare and mix the calibrator according to the instructions on the package insert If analyzing the calibrator in the Manual Stat Mode be sure to mix the calibrator before each analysis 7 Analyze the calibrator e To analyze the calibrator in the Autolo
21. Inc Raka PN 624026AE 9 13 SYSTEM ICONS Icons depict executable functions or status information Table 5 6 shows some of the common icons used on this system Table 5 6 Software Icons GETTING STARTED SYSTEM ICONS 5 a iz Q 3 B m Startup Shutdown Run in Setup Reagents Logs Diagnostics Quality Progress Assurance Aaa W F 2 bh hb i Stop Worklist Start Alarm Archive Manual Stat Results Help Autoloader Mode a D E 72 IF KK Ie Print Details Insert Delete Edit OK Accept Cancel Quit Transmit ni IES re E g bie itt Return Misc QA Setup Auto System Save Restore Operators Flagging Sets Setup Functions Setup Config Setup Setup Setup IQAaP i fos amp G d R Quality Calibration Reproducibility IQAP XB XM Modify Target Download Auto Calibrate Control from Floppy Ea 0 GGO B B Calibration Quality Maintenance Reagent Patient Setup Log Host Log Errors Log Log Control Log Log Log Worklist Log Startup Log PN 624026AE 5 57 GETTING STARTED UNDERSTANDING HOW FLAGGING SETS ARE APPLIED 5 14 UNDERSTANDING HOW FLAGGING SETS ARE APPLIED 5 58 Your system can accommodate up to 20 flagging sets e 8are age and gender based see Table 5 7 and e 12 can be added see Heading A 10 FLAGGING SETS SETUP Table 5 7 Pre Defined Flagging Sets Flagging Set Name Age R
22. Worklist Match Option Barcode Manual Match OFF Sample Tubes Not Barcoded Worklist to be Used Worklist Match Option Cass Position Manual Match ON Sample Tubes Not Barcoded Worklist Not to be Used Worklist Match Option Cass Position Manual Match OFF Worklist Match Option Selecting Worklist Match Options C Barcode Cass 7 Position Do this procedure to select the Worklist Match Option primary identifier WARNING Risk of sample mis identification for Manual Match if the Sample ID is not verified at the Workstation Always verify the Sample IDs at the Workstation SS CEA y e Be fa of 2 1 From the Main Menu screen 5 oy a 4 ESH TEP ES jo a a 9 a amp D A v X E I p 0971872002 08 3213 A 10 PN 624026AE PN 624026AE OPERATIONAL SETUP SETUP Verify the General tab is selected Miscellaneous ry Ce Select the desired Worklist Match Option If tubes are to be identified with barcode labels select Barcode Otherwise select Cass Position u v to save the change At A SETUP OPERATIONAL SETUP A 12 ai 7 e as needed Manual Match Turning ON or Off Manual Match On C Off If Manual Match is ON sample results are posted to the Manual Match screen for any sample result that does not have a barcode ID but Barcode is the selected Worklist Match Option see Worklist Match and
23. _ Reserved Expiration Date QO m WBC 2 107 pL RBC 464 10 pL i a HeBhi35 gdl nuerfss z PLT 270 103 pL Modified on 09 06 2002 Service Shilt Selection 7 4 v v Db Z ie x 0971072002 Ea d p 10 7367055B Control file name cannot be edited Values for the control sample selected by vertical line Parameter tabs to display graphs Levey Jennings graphs for selected tab Levey Jennings graph for parameter Upper control limit on graph Assigned target value Lower control limit on graph Marker that is displayed when you click on a QC point in the graph Operator who ran the QC sample Date and time QC sample was analyzed Displays the QC Graphics screen for the last control run Displays QC target setup screen eeges 8GCegogoegedeaddosd amp Details the last person to set up or modify the control file data PN 624026AE Data points for each QC result Only results selected included on the control grid are displayed PN 624026AE Displays target values for control file by tab CBC displays CBC parameter target values for the file Control expiration date 8ees 8 considered a control and saved in this file Lot number of the control Understanding the QC Data Grid Screen QUALITY ASSURANCE RUNNING CELL CONTROLS DIFF displays diff parameter target
24. After rotating the tube 12 times and mixing for 30 seconds the mixer arm returns the tube to its original cassette position The cassette advances past the right grabber to the barcode reader pierce position where the barcode reader reads the tube s barcode for the first time The cassette moves back to the right grabber which picks up the tube After rotating the tube 12 times the mixer arm returns the tube to its original cassette position The cassette advances to the barcode reader pierce position where the barcode reader reads the tube s barcode a second time The piercing mechanism pierces the tube and sample analysis begins After about 1 minutes the Analyzer sends the sample results to the database The cassette advances to the end of the transfer rail and activates the stop transfer switch The ejection mechanism pushes the cassette onto the Cassette Output Tray The input mechanism is activated and attempts to push another cassette onto the transfer rail as noted in step 2 above If no other cassette is present the system returns to Ready PN 624026AE SPECIFICATIONS CHARACTERISTICS 3 1 INSTRUMENT SPECIFICATIONS Dimensions and Weight See Figure 3 1 Figure 3 1 Analyzer Dimensions and Weight WARNING Risk of operator injury if only one person lifts the instrument The instrument has lifting handles and weighs more than one person should lift Therefore to prevent injury at least 54 21c
25. PN 624026AE DATA REVIEW ALTERNATIVE FLAG REPORTING FORMATS 9 Miscellaneous Messages Miscellaneous messages Table 9 14 appear when additional information appropriate to the results occur Table 9 14 Miscellaneous Messages Message Description Manual Match Results were manually matched with a Worklist order see Heading 9 3 MANUALLY MATCHING SAMPLE RESULTS WITH WORKLIST ORDERS Unmatch Results are not matched with a Worklist order and system is expecting a match Patient Demographics Results had been matched with demographics and a subsequent modification Modified to the demographics has been made to all results Recalculated If the flagging set has been changed since the original sample was flagged the results will have been re assessed against the limits Reagent Expired Sample was run with an expired reagent PLT Concentrate Patient result flagged using extended linear and reportable range limits 9 9 ALTERNATIVE FLAG REPORTING FORMATS The system provides two formats for reporting the information in the Flags and Messages area Figure 9 12 The two formats are Suspect and Detailed e If the Detailed Flags option is selected samples are flagged using the Detailed format default e If the Detailed Flags option is not selected samples are flagged using the Suspect format See Display and Print Detailed or Suspect Flags in Appendix A for information on selecting the flagging format to
26. Save and Restore Settings 3 E the Delete Database tab alate Database a 0A 5 Select the date for which you want all prior data deleted a At the calendar select the date b Verify the date is correct For example if you want all data prior to June 26th deleted then select June 26 on the calendar s OSes 7 E y to delete the data D 16 PN 624026AE WORKLIST SCENARIOS E 1 USING WORKLISTS Overview By analyzing samples using the Worklist you will have the ability to enter demographics select flagging sets enter the Sample ID required select the panel and enter the Patient ID A Worklist contains sample and patient identification information for samples that are pending analysis Before the sample is analyzed you can enter edit patient demographics which will be saved with the sample Demographics include patient name age date of birth gender clinic location physician and comments Information downloaded from a host computer cannot be edited All patient information is printed on the final report and transmitted to the Host computer if applicable Multiple Worklist scenarios are possible with this instrument See Heading E 2 WORKLIST MATCH OPTION SCENARIOS Worklist Processing Conditions for Sample IDs e A Sample ID can only appear once on the Worklist e Ifa Sample ID already exists on the Worklist an internal order cannot be created for that Sample ID The system requi
27. USING THE ONLINE HELP SYSTEM 5 27 Accessing Online Help 5 27 SOFTWARE SCREENS 5 28 Login Names and Passwords 5 28 Access Levels and Rights 5 28 Login Screen 5 29 Selected Menu Path Icon 5 29 MENU PATH 5 30 Main Menu Screen 5 30 Setup Menu Options 5 32 Miscellaneous Setup Options 5 33 Quality Assurance Setup Options 5 33 Auto Functions Setup Options 5 34 System Setup Screen Options 5 35 Save Restore Configuration Options 5 36 Operators Setup Options 5 37 Flagging Sets Setup Options 5 38 Logs Menu Options 5 39 Diagnostics Menu Options 5 40 Quality Assurance Menu Options 5 41 QC Screen Options 5 42 Reproducibility Screen Options 5 42 Calibration Screen Options 5 43 IQAP Screen Options 5 43 XB XM Screen Options 5 44 Toolbars 5 45 e Generic Toolbar 5 45 e Contextual Toolbar 5 46 Progress Indicator 5 47 CONTENTS 5 12 5 13 5 14 Tabs 5 47 Buttons 5 47 Command Buttons 5 48 Bitmap Buttons 5 48 Radio Buttons 5 48 Fields Text Boxes 5 49 Check Boxes 5 49 Scrollable Lists 5 50 WORKING WITH THE SOFTWARE 5 51 Using the Mouse 5 51 Moving the Cursor 5 52 Viewing Tool Tips 5 52 Selecting Menu Items 5 52 Scrolling 5 52 Active Inactive Software Icons 5 53 Selecting Menu Tabs 5 53 Menu Headings Screen Names 5 54 Editing Text 5 54 Saving Changes 5 55 Cancelling Unsaved Changes 5 55 Selecting De selecting Software Features 5 55 SYSTEM ICONS 5 57 UNDERST
28. e INDEX Provides page numbers for indexed information XXX PN 624026AE INTRODUCTION CONVENTIONS CONVENTIONS This manual uses the following conventions GRAPHICS Bold font indicates a software option such as Startup Italics font indicates screen text displayed on the instrument such as Insert tube AL and instrument are used interchangeably to refer to the ACeT 5diff Autoloader hematology analyzer A Note contains supplemental information An ATTENTION contains information that is important to remember or helpful when performing a procedure Main card refers to the main circuit board card in the instrument RBC bath is sometimes referred to as RBC Plt bath The terms screen and window are used interchangeably ACeT 5diff Rinse reagent is sometimes referred to as Rinse ACeT 5diff Fix reagent is sometimes referred to as Fix ACeT 5diff Hgb Lyse reagent is sometimes referred to as Hgb Lyse A eT 5diff WBC Lyse reagent is sometimes referred to as WBC Lyse ACeT 5diff Diluent reagent is sometimes referred to as Diluent J indicates select with or click the left button on the mouse Bold italics font indicates a procedure heading All graphics including screens and printouts are for illustration purposes only and must not be used for any other purpose PN 624026AE XXxi INTRODUCTION Safety symbols alert you to potentially dangerous conditions These symbols together with text
29. o MM MO cs F lauTo_sicg 2 Unknow c c D07 02c O WV MM O a a es Io amp gt 4 v X f Supervisor 0971972002 20 14 00 PN 624026AE 9 23 9 DATA REVIEW PRINTING SAMPLE RESULTS 2 Select or deselect the results you want to transmit i ET e To select all results C E O O e To deselect all results u q To select individual results u O until M appears US 4 p the Transmit tab 5 Select the desired transmit option see Figure 9 11 ATTENTION Once transmission begins it cannot be stopped 6 u to begin transmitting PN 624026AE 9 24 9 5 PN 624026AE ARCHIVING PATIENT RESULTS Although you can choose to archive results at the Begin of Day you can also choose to archive results from the Results List screen DATA REVIEW ARCHIVING PATIENT RESULTS Do this procedure if you want to archive patient results currently on the Results List LN H AMEX OB The Results List screen appears AcT Sdiff AL Result I Analytical I Patient Limit pf al eon I Action Limit Not Printed I Not Transmitted Ela eel xi a JE amp Inc Sample ID Cass Pos Patient ID Last Name First Name Gender Date of Bith Age Panel RunDate AF DH PL AL P T I 458 Unknow cecjoo7 iojacM COM MO 44568 Unknow
30. 0 E which was flashing to indicate results are on the Manual Match screen 8 0 for the Manual Match screen 9 Results are placed on the Manual Match screen Order shows Sample ID 123 because that was the number entered on the Worklist order and Cass and Pos Results shows the Sample ID 123456 because that was the number read from the barcode label with C P 6 1 Options a Manually match the order to the result The report will automatically print Manual Match will appear in the Miscellaneous Messages section of the Flags and Messages area of the printout The Sample ID on the report will be the Sample ID entered when the Worklist order was created e g 123 Cass will be 6 and Pos will be 1 e Ifyou print from the Run in Progress screen after matching Manual Match will appear on the report even though the Run in Progress screen shows Unmatched e If you print from the Run in Progress screen before matching Unmatched will appear on the report b Print results from the Manual Match screen without matching Manual Match will appear in the Miscellaneous Messages section of the Flags and Messages area of the report See Printing from the Manual Match Screen Without Matching in this appendix PN 624026AE E 11 WORKLIST SCENARIOS WORKLIST MATCH OPTION SCENARIOS E 12 Scenario 9 Cass Position On Manual Match On Auto Print On No Worklist Order No Barcode Label Summary Resul
31. 21 22 25 2A 25 28 2 2 8 3 1 32 3 3 34 33 3 6 al 3 8 39 3 10 Dll 32 5323 5 4 22 5 6 Del Gl 9 1 OD 03 9 4 9 5 9 6 Of 9 8 oo 9 10 9 11 9 12 9 13 9 14 111 11 2 11 3 11 4 CBC Parameters 1 8 CBC DIFF Parameters 1 9 Reagent Descriptions 1 13 ACeT 5diff AL Analyzer Measurement Technologies 2 1 Technical Characteristics for Obtaining RBC and Platelet Counts 2 8 Technical Characteristics for the Measurement of the Hemoglobin 2 9 Characteristics Required to Obtain WBC BASO Results 2 10 Technical Characteristics for Acquisition of the DiffPlot 2 12 Summary of Dilutions 2 13 DiffPlot Regions Defined 2 20 Immature White Blood Cells 2 21 Reagent Consumption by Cycle 3 4 Reproducibility Specifications 3 5 Linearity Specifications 3 5 Accuracy Specifications 3 6 Carryover Specifications 3 6 Reportable Range 3 7 Reproducibility Characteristics From a Normal Sample with a Normal WBC Count 3 8 Accuracy Characteristics 3 8 Carryover Characteristics 3 9 Interfering Substances 3 10 Commonly Asked Questions 5 1 Software Menu Access by User Group 5 28 Main Screen Icons 5 30 Generic Toolbar Icons 5 45 Contextual Toolbar Icons 5 46 Software Icons 5 57 Pre Defined Flagging Sets 5 58 QA Menu Screen Icons 7 1 Patient Range Flags 9 36 Action Range Flags 9 36 Definition of DIFFPLOT Flags 9 39 Histogram Flags 9 43 WBC Interpretive Messages 9 45 RBC Interpr
32. 6 To change the reagent C to go directly to the Reagent screen b Change the reagent as described in Replacing Reagents PN 624026AE 6 4 DAILY ROUTINE SHUTDOWN 6 6 4 SHUTDOWN Perform the Shutdown procedure after every 24 hours of use to cleanse the instrument and place it in a stand by mode Automatic Shutdown If automatic Shutdown is enabled the Shutdown routine will be automatically performed at the designated time For information about automatic Shutdown see Shutdown Automatic in Appendix A Manual Shutdown Procedure If automatic Shutdown is disabled do the following procedure at the end of each workday amp lo A Ave a T CD F 1 From the Main Menu screen ro om E The instrument cycles Rinse reagent for i zi cleaning and goes into a stand by 5 is mode i e a be 4 y X i Jos71372002 093213 PN 624026AE 6 5 DAILY ROUTINE SHUTDOWN 2 When Shutdown is complete the following screen appears AcT 5diff AL Select Exit Windows C Restart Windows e Ifyou select Exit Windows the following message appears It is now safe to turn off your computer Restart is also available You can either turn the instrument off using the Powering Down the System and Logging Off procedure or select Restart to restart Windows and display the login screen e If you select Restart Windows
33. AST Sdiff AL 1 From the Main Menu screen W aE ORs AcT 5diff AL Quality Assurance 3 0 the QA Settings tab Shits A 44 PN 624026AE SETUP A QUALITY ASSURANCE SETUP 0A 5 Edit the numbers as desired a Highlight the number to edit b Type the new number c Press to advance to the next field if necessary d Repeat steps a through c as needed 6 u v to save the change 7 d as needed to return to the desired window PN 624026AE A 45 SETUP SETTING UP A CONTROL FILE A 6 A 46 SETTING UP A CONTROL FILE Before running a new set of controls you must set up the control file for each lot of controls This includes entering the values from the TABLE OF EXPECTED RESULTS the expiration date assay values etc for each lot You can enter the information e manually by typing the information from the TABLE OF EXPECTED RESULTS in the assay sheet or e by downloading the information from the assay values floppy disk Up to 24 control lots can be set up Of the 24 1 through 12 are reserved for CBC controls and 13 through 24 are reserved for CBC DIFF controls Do this procedure for each lot of new controls LN A 1 Before entering new cell control information e Keep a copy of the control data currently in the system See Printing Transmitting Saved Cell Control Results in Chapter 7 e Verify that control data currently in the system has been downloa
34. End dates you want printed 41 132 PN 624026AE DIAGNOSTICS Ji LOGS 3 Select the date range for the entries you want to print Date Range 15 2002 v x 4 Verify the printer is ready 2 u v to print 11 133 PN 624026AE DIAGNOSTICS LOGS 11 134 PN 624026AE A 1 INSTALLATION A Beckman Coulter representative will install your Analyzer Workstation software and printer A 2 DEFAULT CONFIGURATION Your instrument was configured prior to installation Table A 1 shows the default configuration information Table A 1 Instrument Default Settings Feature Default Settings To Change the Setting Auto Clean frequency 100 Do Auto Clean Frequency Setting Automatic Shutdown On Do Shutdown Automatic Automatic Startup Off Do Startup Automatic Daily workload CBC 10 Do Daily Workload Defining for CBC and CBC DIFF 40 CBC DIFF Language English Do Language Selecting Manual Match OFF Do Manual Match Turning ON or Off Reporting unit US Do Units Selecting the Reporting Unit RUO parameters enabled Disabled Do RUO Parameters Enabling Disabling Worklist Match Option Barcode Do Worklist Match and Manual Match Options XB XM Option OFF Do XB XM Options Enabling Disabling A 3 SETUP OVERVIEW Password Requirements Only Supervisors and Service have access to the Setup screen Changes to Instrument Setup Any time you change the instrument setup prin
35. INDEX Index 6 Recalculated 9 17 replacement flags 9 34 S 7 21 9 36 SCH 9 44 SCL 9 45 SL 9 38 9 39 SLI 9 38 9 39 Suspect flag format 9 51 Suspect displaying printing A 96 UM 9 38 9 40 UN 9 38 9 41 Unmatched 9 18 WBC BASO replaced by WBC flag 9 51 what triggers them 9 34 where they appear 9 37 flashing illuminated indicator lights LEDs 1 3 flashing Alarms icon 7 4 flashing Results icon 7 4 7 9 7 15 flashing Startup icon 6 2 flashing Worklist icon 8 2 flow cell lamp replacement 11 96 For Research Use Only Not for use in diagnostic procedures RUO definition A 16 G 8 definition Abbreviations 1 gal definition Abbreviations 1 Generic toolbar 5 45 GR definition Abbreviations 1 grounding requirements 3 1 H H flag definition 9 36 handling expired reagents 11 7 handling waste 11 6 Hardware Reset frequency 11 1 11 13 purpose 11 13 hardware reset function 11 13 procedure 11 13 hardware system troubleshooting 11 12 Hardware System screen 11 12 hazards list of 4 2 Het definition Abbreviations 1 interfering substances 3 11 measurement overview 2 14 Help using 5 27 Hgb definition Abbreviations 1 interfering substances 3 11 overview 2 17 Hgb Lyse reagent description 1 13 HH flag definition 9 36 HISTO flag what it replaces 9 51 Hypochroma triggering condition 9 46 Hz definition Abbreviations 1 icons Calibration Log 5 57 11 125 defin
36. L 5 p i amp gt 4 vy X Service 1172772002 8 22 40 9 10 PN 624026AE DATA REVIEW AFTER LOCATING THE SAMPLE RESULTS 9 2 AFTER LOCATING THE SAMPLE RESULTS After locating a sample result you can view print and transmit send results Note You can delete patient results from Archive only See Heading 9 6 DELETING ARCHIVED PATIENT RESULTS Understanding the Results Screen See Figure 9 7 PN 624026AE Figure 9 7 Results Screen 0898 8 O a eee eo Result 1 1 E DiffPlot and Histogram Flags e Pos WBC SL SL1 p 3 DF E Analyzer Messages 30 400 DIFF A E Interpretive Messages WBC Interpretation Not Posy i i PLT Aggregates 08 01 2002 15 15 00 E Miscellaneous Messages i Run Date Time Manual Match H 08 01 2002 20 04 16 m os 10 300 Recalculated Day 11 1962 Gender Feme v X D Service j 08702 2002 1321 25 7367517B Displays the first sample s results Displays the previous sample s results Automatically creates a re run for the displayed sample An order with the same Sample ID and demographic information is placed on the Worklist Indicates the results you are viewing out of the number of results available for that sample ID For example 1 1 means that you are viewing the first set of results out of one set available for the specific Sample ID
37. Left front door Left cover Left side panel Reagent door Removing the Left Panel Tools Needed Allen wrench 2 5 mm PN 624026AE 11 3 DIAGNOSTICS REMOVING PANELS COVERS LN 32 Nex AS Power down the system see Powering Down the System and Logging Off in Chapter 5 2 Open the reagent compartment door 0 3 Using a 2 5 mm Allen wrench loosen the hex screws in back 4 Remove the two screws in front 5 Slide the panel out Removing the Right Panel Tools Needed D door key A 3 AET DX Unfasten the screws with the door key 2 Slide the panel up 3 Pul the panel out Replacing the Right Panel Tools Needed 5 door key PN 624026AE DIAGNOSTICS REMOVING PANELS COVERS A amp Nec AX 1 Slide the panel into place 2 Tighten the screws with the door key Removing the Top Cover Tools Needed Allen wrench 2 5 mm A At AS EL 1 Power down the system see Powering Down the System and Logging Off in Chapter 5 2 Remove the left and right side panels as instructed in Removing the Left Panel and Removing the Right Panel 3 Using a 2 5 mm Allen wrench loosen the 7 hex screws that secure the top cover to the instrument frame 4 Life the cover up and back to remove it then set it aside PN 624026AE 11 5 1 DIAGNOSTICS WASTE HANDLING PROCEDURES 11 4 WASTE HANDLING PROCEDURES Consult
38. Prime Fix 1 6 mL NA NA 23 7 mL NA 1 minute 34 seconds Prime WBC Lyse 1 7 mL 23 7mL 1mL NA NA 1 minute 25 seconds Prime Hgb Lyse 2 7 mL NA NA NA 8 4 mL 1 minute 31 seconds Prime All Reagents 47 6mL 24 0mL 25 0 mL 24 0 mL 8 4 mL 7 minutes 13 seconds Startup 61 0mL 5 1 mL 2 1mL 2 0mL 1 0mL 3 minutes 35 seconds Shutdown 33 5mL 1 0 mL 19 1mL 1 0mL 0 5 mL 4 minutes Rinse Flow Cell 5 0 mL NA NA NA NA 1 minute 30 seconds Auto Clean 28 2mL 1 0 mL 1 0mL 1 0mL 0 5 mL 1 minute 33 seconds Mini Clean 10 9mL 2 0mL 1 0mL 1 0mL 0 33mL_ 38 seconds Extended cleaning 39 1mL 1 0 mL 1 0mL 1 0mL 0 5 mL 7 minutes 12 seconds Backflush NA NA NA NA NA 35 seconds For one background count only Cycle runs automatically after 5 hours 30 minutes of non use Environmental Protection Removal and recycling of this instrument must be done by a properly qualified laboratory in accordance with local legislation 3 4 PN 624026AE 3 2 PERFORMANCE SPECIFICATIONS SPECIFICATIONS CHARACTERISTICS PERFORMANCE SPECIFICATIONS Performance specifications indicate targeted performance based on established ranges and parameters The stated performance specifications apply to an instrument that has been properly maintained as indicated in Chapter 11 DIAGNOSTICS and one that uses only the recommended reagents listed in Recommended Reagents Reproducibility Reproducibility Table 3 2 is based on 20 consecuti
39. QUALITY CONTROL QC Overview Quality control includes monitoring routine performance and service in conjunction with the use of controls and calibrators Routinely check results between QC runs The combination of these methods provides the assurance of complete quality control This instrument incorporates multiple QC techniques For CBC and CBC DIFE the ACeT 5diff Autoloader uses the established technique of commercial controls The Workstation stores information about control file setup and control results in the database Your laboratory is encouraged to establish acceptance limits for control results based on the control source type and level By establishing your own limits you can better understand the control results and more quickly interpret them Beckman Coulter recommends that QC checks be performed using patient or commercial controls in the Autoloader mode and the Manual Stat mode as required according to your laboratory protocol When using a commercial control always refer to the package insert for more detailed product information and mixing instructions Failure to recover control values within your laboratory s expected ranges or the presence of unexplained shifts or trends in either mode of analysis should be investigated If control problems cannot be resolved contact your Beckman Coulter representative Note Beckman Coulter does not provide support for other vendors consumable products If the instrume
40. Startup Failed 5 7 Startup icon 5 30 5 57 what to do if flashing 5 30 Startup Not Effective 5 7 stat definition Glossary 2 stat samples procedure for running 8 2 Supervisor users access level A 115 SUSPECT definition 9 51 Suspect flag format 9 51 Suspect flags displaying printing A 95 A 96 symbols safety xxxii tab xxxii system cleaning procedure 11 68 when to do 11 68 System International unit See reporting units T TABLE OF EXPECTED RESULTS definition Glossary 2 temperature INDEX ambient operating range 3 2 instrument not achieved 11 123 thresholds A 130 description 2 4 Thrombocytopenia triggering condition 9 47 Thrombocytosis triggering condition 9 47 toolbars Contextual 5 46 Generic 5 45 transmitting cell control results 7 30 from QC Data Grid screen 7 33 transmitting options for patient results 9 22 transmitting patient results 9 23 transmitting Reproducibility results 11 05 transmitting results automatically A 67 traverse assembly function 11 79 location 11 79 treating waste for biohazards 11 6 troubleshooting 11 122 dilution problems 11 123 electrical problems 11 124 guide 11 122 mechanical problems 11 124 optical problems 11 124 pneumatic problems 11 124 power problems 11 122 printer problems 11 124 reagent problems 11 124 results problems 11 124 sampling problems 11 123 software could not connect to analyzer 11 122
41. To ensure tubes vials remain secured in the cassettes always keep cassettes upright and use them only for analysis as described in this manual Learning About the Cassettes A cassette holds the tubes and transports them through the instrument for analysis Ten cassette styles are available for use with the AL All 10 cassette styles are identical however through information encoded in the cassette label it is possible to instruct the instrument to sample differently from cassette to cassette to accommodate different tubes See Figures 5 6 through 5 9 Figure 5 6 Cassette Back View Cassette Number The number on the back identifies the cassette number The letter on the front identifies the cassette style which defines the tube type size The system is provided with two types of indicator codes A and B The sampling conditions for each are defined during initial setup of your instrument Figure 5 8 Cassette Front View Cassette Barcode Label The barcode label on the front is what the barcode reader scans to determine the cassette number and cassette style Each cassette has 10 slots and each slot is numbered This number is referred to as the position number When you see Cass Position there will be a number assigned to the cassette based on Figure 5 6 and a number assigned to the position based on Figure 5 9 When you load the cassette onto the instrument position 1 will be the first into the Ana
42. To view the next result J b 5 To view the last result W bl f J 08 02 2002 13 21 25 6 Ifa previous or next result is not available it will be grayed out like this gt l Results that appear on a red background indicate an HH or LL flag outside action limits Results that appear on a yellow background indicate an H or L flag outside patient limits See Heading 9 7 REVIEWING RESULTS for details e To mark a sample for re run l From the Results List screen Figure 9 2 click the desired result The Results Full View screen Figure 9 5 appears OS 3 See Manual Reruns in Chapter 8 for additional information 9 DATA REVIEW LOCATING SAMPLE RESULTS Locating Archived Results Understanding the Archives Screen See Figure 9 6 Figure 9 6 Archives Screen Details CEA Date lal E 02 2002 moz x Sample ID Patient ID Last Name First Name KiS oc ia 4 v x a Selects all results in the archive list 4 _ De selects all results in the archive list 5 _ Displays the run date O Procedure for Locating Archived Results Do this procedure to locate archived sample results J 09 16 2002 09 44 21 Allows you to search the archives by run date Allows you to search the archives by patient ID or last name Displays information for the selected run date A A e aS from the toolbar 9 8 PN 624
43. apply to specific procedures and appear as needed throughout this manual Warning Condition Action Biohazard Consider all materials specimens reagents controls and calibrators and so forth and areas these materials come into contact with as being potentially infectious Wear standard laboratory attire and follow safe laboratory procedures when handling any material in the laboratory Probe hazard The probe is sharp and may contain biohazardous materials such as controls and calibrators Avoid any unnecessary contact with the probe and probe area Electrical shock hazard Possibility of electrical shock when instrument is plugged in to the power source Before continuing unplug the ACeT 5diff AL analyzer from the electrical outlet Conditional hazard Possibility of a hazard based on specific conditions Pay close attention to the information provided when you see this symbol SYMBOLS SYMBOLS Safety Symbols Symbol A Ar AS Tab Symbols Tabs divide this document into five sections reference operation special procedures and troubleshooting appendices and Workstation Each tab reflects a unique symbol Symbol Definition WW Identifies the reference section Identifies the operating instructions section Eg 3 Identifies the special procedures and troubleshooting section lt a Identifies the appendices section
44. define your own users and passwords See Table 5 3 for additional information Table 5 2 Software Menu Access by User Group Menu Access amp User Group Setup QC Diagnostics Calibration Operator No Yest Yest No Supervisor Yes Yes Yes Yes Service Yes Yes Yes Yes t No access to Threshold tab on the QC modify target screen No access to Delete function on the QC Grid screen 4 No access to Service No access to Holder Adjustment and Cassette Adjustment tabs under Hardware Systems 5 28 PN 624026AE GETTING STARTED 5 SOFTWARE SCREENS Login Screen When the software initially loads a Login window Figure 5 14 appears This is where you select your Login Name and enter your password if required Figure 5 14 Login Screen Depending on when your lab s New Workday begins you may see additional options on the Login screen See Heading 5 4 NEW WORKDAY for details Selected Menu Path Icon On the menu screens you will see a pale gray icon in the upper left corner that shows the icon you selected to get to the displayed screen This icon simply serves as a snapshot of where you are in the software and how you got there For example Figure 5 15 shows the Setup icon which means that ae was last selected Figure 5 15 Selected Menu Path Icon 7367057A PN 624026AE 5 29 GETTING STARTED MENU PATH 5 11 MENU PATH Certain software screens offer
45. definition 10 2 Calibration Setup screen definition 10 4 calibrator definition Glossary 1 recommended 1 10 3 2 carryover definition Glossary 1 performance characteristics 3 9 PN 624026AE PN 624026AE performance specifications 3 6 Cass Position as Worklist Match Option A 9 cassettes back view 5 17 definition 5 17 front view 5 17 illustration 5 17 inserting tubes into 5 18 loading onto Analyzer 5 20 removing tubes from 5 19 tube position number 5 17 unloading from Analyzer 5 21 CAUTION definition 4 1 caution labels on Analyzer 1 4 CBC definition Abbreviations 1 See also test panel CBC parameters 1 8 excessive flagging what to do if 11 27 CBC DIFF parameters 1 9 excessive flagging what to do if 11 41 See also test panel A 6 cell control files deleting 7 48 setting up A 46 cell control results on Manual Match screen 7 4 7 9 7 15 out of range 7 21 cell controls definition Glossary 1 if Reserved 7 3 pre assigning in Worklist 7 3 recommended 1 10 saving results to disk for IQAP 7 39 verifying calibration 7 3 changing input locales A 76 changing language specific keyboards A 76 changing system setup who has access 5 1 changing the date time A 72 changing the date time format A 73 changing the reporting units A 27 characteristics definition Glossary 1 See also performance characteristics checking the motors 11 16 checking the printer 6 1 checking the sensors 11 22
46. e Determine Plt count e Develop the Plt histogram which is needed to obtain MPV Pct and PDW results Hgb Measurement Hemoglobin is determined from the dilution in the First Dilution Hgb bath Figure 2 9 This dilution is prepared in two stages the primary first dilution and the secondary last dilution The primary dilution is made and 42 5 pL of that dilution is removed for making the RBC Plt dilution ACeT 5diff Hgb Lyse and additional Diluent are added to make the final 1 250 dilution The Hgb concentration is based on the transmittance of light through the optical part of the First Dilution Hgb bath using a spectrophotometric technique at a wavelength of 550nm The transmittance of the sample dilution is compared to the transmittance of a reagent blank The system calculates the Hgb using the blank and sample readings Table 2 3 summarizes the technical characteristics required for measuring hemoglobin Table 2 3 Technical Characteristics for the Measurement of the Hemoglobin Dilution Characteristics Volume of whole blood 10 uL Volume ACT 5diff Diluent 1700 pL Preliminary dilution ratio 1 170 Volume of the 1 170 dilution removed 42 5 uL for making the RBC PIt dilution Volume of A T 5diff Hgb Lyse 400 uL Additional volume of ACeT 5diff Diluent 400 uL Final dilution for Hgb determination 1 250 Reaction temperature 35 C 95 F Measurement Characteristics Method of analysis Spectrophotometry Wavelength
47. e Replacement Flags Hierarchy e Parameter Flags e Patient Action Flags Hierarchy Replacement Flags Hierarchy Replacement flags are ranked in the following descending order of importance Parameter Flags Parameter flags are ranked in the following descending order of importance J lt Patient Action Flags Hierarchy Patient Limits and Action Limits are ranked in the following descending order of importance HH LL H L 9 52 PN 624026AE CALIBRATION 10 1 GENERAL Calibration is a procedure to standardize the instrument by determining its deviation if any from calibration references and to apply any necessary correction factors There are two calibration modes available on this instrument e Auto calibration which uses whole blood samples or the calibrator material See Heading 10 4 AUTO CALIBRATION e Manual calibration See Appendix C MANUAL CALIBRATION The instrument identifies a sample as a calibration sample only if the analysis is started from the Calibration screen Reproducibility is included in the calibration procedure When to Calibrate Calibrate your instrument e During installation before analyzing samples e After a Beckman Coulter service representative has replaced an analytical component e As instructed by a Beckman Coulter representative Recommended Calibration Conditions Beckman Coulter recommends that you perform the calibration procedure e At ambient operating temp
48. m o e To deselect all results C O To select individual results u O until M appears PN 624026AE 9 21 DATA REVIEW PRINTING SAMPLE RESULTS s OS 4 p the Print tab 5 Select the desired print option see Figure 9 10 Note Print Patient Report for All Rows prints a full page report for every row whether selected or not s OW Transmitting Sample Results You can transmit sample results to a Host computer if applicable Understanding the Transmit Options for Patient Results See Figure 9 11 Figure 9 11 Transmit Options for Patient Results Print T ransmit Transmit Last Result C Transmit Selected Results Transmit All Results O x 7367179A 9 22 PN 624026AE Select this to see the transmit send options Transmits only the last result to the Host computer DATA REVIEW PRINTING SAMPLE RESULTS _Iransmits the selected results to the Host computer _Transmits all results whether selected or not to the Host computer Sample results will automatically be transmitted to a host computer if the auto transmission option is selected and the settings have been defined See Auto Transmit for Patient Results in Appendix A IMPORTANT Risk of compromising system functionality if you batch print and or batch transmit while receiving a Worklist download from a host and or while analyzing samples with Auto Transmit on and Auto Print on Always allow sa
49. pass the cursor over the icon until the text appears See Figure 5 44 Figure 5 44 Tool Tip Names Print Transmit Selecting Menu Items J the item you want to select Scrolling Some windows contain information that cannot be viewed all at once on the screen For those windows horizontal and or vertical scroll bars are available to allow you to scroll across or up and down the window See Figure 5 45 To scroll do one of the following o UA To scroll o e the cursor on one of the arrows to scroll the window in the direction of the arrow or e and hold the slider box and drag it along the scroll bar or e the slider instead of dragging the slider box 5 52 PN 624026AE GETTING STARTED WORKING WITH THE SOFTWARE 5 Figure 5 45 Scroll Bars Active Inactive Software Icons Two states exist for most icons active and inactive See Figure 5 46 e Active icons appear in color and are available for use e Inactive icons are grayed out and unavailable for use Figure 5 46 Icon States Active and Inactive Active Selecting Menu Tabs Inactive Tabs Figure 5 47 group functions in the same screen C the desired tab to select Figure 5 47 Tabs AcT 5diff AL System Host Printer Cycle Options Date Time Format Local Settings one Date Time PN 624026AE 5 53 GETTING STARTED WORKING WITH THE SOFTWARE Menu Headings Screen Names Menu headings Figure 5 48 are the
50. 2 4 2 9 PN 624026AE OPERATION PRINCIPLES WBC BASO METHODOLOGY WBC BASO METHODOLOGY In the WBC BASO bath 10 pL of whole blood is mixed with 2 000 pL of AC T 5diff WBC Lyse reagent This reaction lyses the red blood cells and specifically differentiates between the basophils and other leukocytes by volume The instrument maintains the reagents and reaction at a regulated temperature of 35 C 95 F Using a constant vacuum the instrument then pulls the sample through an 80 ym aperture As each cell passes through the aperture a pulse is generated proportional to the cellular volume The total leukocyte count and basophil percentage are determined by specific thresholds on the WBC BASO histogram Figure 2 4 Figure 2 4 BASO Thresholds BA1 BA2 BA3 SAMPLE ANALYSIS OVERVIEW Aspiration When the sampling probe is immersed in a whole blood sample the sample is pulled from the tube into the sampling probe Depending on the selected panel of operation the ACeT 5diff AL analyzer aspirates either 30 pL CBC panel or 53 uL CBC DIFF panel of sample The volume of sample aspirated into the sampling probe is sufficient to make all the dilutions needed to develop parameter results in the selected panel of operation The aspirated sample is then partitioned as it is distributed into the designated baths Figure 2 5 shows the sample partitioning that occurs in the CBC DIFF panel Notice there are three aliquots of the aspirated wh
51. 22 adding a physician A 22 adding a printer A 82 adding a Worklist order 8 45 at the Worklist Cassette screen 8 47 at the Worklist Grid screen 8 45 adding comments to logs 11 129 adding demographics E 1 adding entries to the Maintenance log 11 130 adding users 5 1 A 115 agglutination definition Glossary 1 altitude range 3 2 Anemia triggering condition 9 46 Anisocytosis triggering condition 9 46 ANSI definition Abbreviations 1 anticoagulant recommended 3 3 aperture DIFF diameter 3 4 RBC diameter 3 4 WBC BASO diameter 3 4 See also blocked apertures aperture sensing system function 2 1 archive definition Glossary 1 Archive Results option 5 12 Archive Unmatched Results and Delete Worklist option 5 12 assigning different operator IDs 5 1 ASTM definition Abbreviations 1 ATL display print setup A 15 ATL flag 9 38 9 42 9 51 ATTENTION definition 4 1 Atypical Lymphocyte triggering condition 9 46 AUTO_PID definition 8 38 AUTO_SID definition 8 35 A 4 See also Auto Numbering auto calibrating the instrument 10 15 Index 1 INDEX Index 2 Auto Clean definition 11 67 frequency 11 10 procedure 11 10 setting the frequency A 102 Autoloader Test procedure 11 24 understanding the screen 11 26 automatic calibration 5 3 automatic Shutdown defining A 112 automatic Startup defining A 110 Auto Numbering definition A 4 setting the starting number A 4 Auto Stop definit
52. 39 Understanding the IQAP Download Screen 7 40 Preparing for IQAP Download 7 41 Downloading Results to Diskette for IQAP Submission 7 42 DELETING QC RUNS FILES 7 46 Deleting the Last QC Run 7 46 Deleting One or More QC Runs 7 48 XB ANALYSIS 7 51 Definition 7 51 Using XB 7 51 Reviewing XB XM Analysis Information 7 52 Reviewing XB XM Graphs Screen 7 52 Viewing XB Batch Details Screen and Including Excluding XB Data 7 54 e Procedure to View XB Batch Details Screen and to Include Exclude XB Data 7 55 SAMPLE ANALYSIS 8 1 8 1 8 2 8 3 8 4 PREPARE THE SYSTEM FOR PROCESSING 8 1 COLLECT AND MIX THE SPECIMEN 8 1 DETERMINING HOW TO RUN THE SAMPLES 8 2 RUNNING MANUAL STAT SAMPLES 8 2 Running Manual Stat Samples 8 2 Procedure for Running Manual Stat Samples Order On Worklist or Not Using Worklist 8 3 Procedure for Running Manual Stat Samples No Order on Worklist and You Want to Assign Demographics 8 7 xi CONTENTS xii 8 5 8 6 8 7 8 8 8 9 RUNNING WORKLIST SAMPLES IN AUTOLOADER MODE 8 12 Worklist Barcode Positive ID Manual Match ON 8 12 No Worklist Barcode Positive ID Manual Match OFF 8 18 Worklist Cass Position Positive ID Manual Match ON 8 22 No Worklist Cass Position Positive ID Manual Match OFF 8 29 RE RUNNING SAMPLES 8 32 Manual Reruns 8 32 Automatic Reruns 8 33 Identifying Rerun Results 8 33 ENTERING SAMPLE PATIENT INFORMATION 8 34 Required Info
53. 6 Select the control files you want to delete included O excluded Note If you want to delete many rows you do not have to select them individually there is an option called Unselected in the next screen If you choose Unselected all rows not selected will be deleted and all rows selected will not be deleted g 8 wec 17 I 46 RBC w e 5 naf oa on nerfs x c c pur 270107 e orr 09 10 2002 10 5224 O 8 0 the desired delete option e Unselected deletes rows with LJ e Selected deletes rows with M All deletes all rows ATTENTION Control data cannot be recovered once it has been deleted Therefore be certain that you want to delete erase the control data before you proceed 9 3 Vv to confirm deletion AcT 5diff AL Unselected Selected C All PN 624026AE QUALITY ASSURANCE XB ANALYSIS 7 6 XB ANALYSIS PN 624026AE Definition XB Analysis is a QC method that monitors instrument performance by comparing patient RBC indices MCV MCH and MCHC with known target values The method uses these specific indices because they tend to remain fairly stable and because their values display little variance from patient to patient XB XM analysis is most effective when large numbers of samples per day are processed Low numbers of samples may lead to inappropriate XB flags When XB is enabled the Workstation stores patient R
54. 7 times each e For tubes other than Vacutainer do Running a Reproducibility Check in the Manual Stat Mode Q EEN LN 27 7 2 Ei om pa 1 From the Main Menu screen i y m l 4 aa i W W 4 3 g amp gt amp vy X F I p 0971872002 08 3213 11 60 PN 624026AE DIAGNOSTICS l REPRODUCIBILITY CHECK CO 3 If there are existing runs the following message appears AcT 5diff AL e To delete all Reproducibility runs u Yy e To acknowledge the message and not delete the Reproducibility runs W x PN 624026AE 11 61 DIAGNOSTICS REPRODUCIBILITY CHECK 4 Before running a Reproducibility check a Print or transmit existing results as instructed in Deleting Reproducibility Results in this chapter Delete existing results as instructed in Printing Transmitting Reproducibility Results in this chapter Autoloader Mode Number of Aspirations Ine E pate Tne wec ic e Selected Results N p pec oo z Be 55 oo Rec 00 000 00 HGB oo oo w a im J CBCIDIFF O 3 A la zZ iz gd d TSi p o 00 o oo oo 3 2 a a y X Dd ovoer2002 15 2851 ATTENTION A total of at least 20 aspirations is required For example if using 3 tubes type 7 as the number of aspirations 5 For th
55. 8 PN 624026AE SETUP OPERATIONAL SETUP Worklist Match and Manual Match Options PN 624026AE Worklist The Worklist provides the ability to match additional patient demographic information to the sample when it is processed An identifier has to be defined that will be used to establish a match between the sample results and the Worklist order The link is called the positive ID and can be set to either Barcode or Cass Position cassette and position e Barcode If Barcode is selected as the Worklist Match Option primary ID when the Sample ID is identified from the barcoded tube at the time of analysis the Worklist is searched for an order that has the same Sample ID If a matching order is found the results from the sample analysis and the demographic information on the Worklist are matched together and automatically sent to the Results list e Cass Position If Cass Position is selected as the Worklist Match Option primary ID when the cassette and position are identified during analysis the Worklist is searched for an order that has the same cassette and position If a matching order is found the results from the analysis and the demographic information on the Worklist are matched together and automatically sent to the Results list Manual Match The system also offers the ability to trap results that do not have orders that match the positive identifier This ability which prevents results from being reported withou
56. A 3 Figure A 3 Auto Stop for Consecutive Results With Selected Characteristics Auto Stop for Consecutive Results with 12 se 4 5 a ADE A eS LEE E E E E Mou Ce eeg lv WBC 0 Cc CC CCO M WBC Yoteout ct tent Oe lly Sapo COCCO M RBC oteout Ct Ot tet lv sHeT O COC CC f HGB Yoteout tet E et ely Sia COCCO M HC oteout COCCO C f PLT Yoteout COCCO amp NM DIFF DIFF The above settings are interpreted below MCHC gt 38 no auto stop conditions are selected WBC Voteout 3 consecutive incidents of WBC Voteouts will automatically stop the instrument RBC Voteout 2 consecutive incidents of RBC Voteouts will automatically stop the instrument HGB Voteout no auto stop conditions are selected HCT Voteout 2 consecutive incidents of HCT Voteout will automatically stop the instrument PLT Voteout no auto stop conditions are selected DIFF DIFF 5 consecutive incidents of DIFF DIFF will automatically stop the instrument WBC 0 2 consecutive incidents of WBC results being zero will automatically stop the instrument RBC 0 3 consecutive incidents of RBC results being zero will automatically stop the instrument HCT 0 4 consecutive incidents of HCT results being zero will automatically stop the instrument PLT 0 2 consecutive incidents of PLT results being zero will automatically stop the instrument Do this procedure to define your lab s auto stop criteria SS AcT 5diff AL A f Aer
57. BASO Parameter Results 2 18 DiffPlot Regions 2 19 Sample Analysis Workflow With the Worklist 2 22 Analyzer Dimensions and Weight 3 1 Startup Status and Results Displayed on the Startup Log 5 8 Startup Status Displayed on the Background Report 5 8 New Workday Options If No Unmatched Results Exist in Manual Match Screen 5 11 New Workday Options If Unmatched Results Exist on Manual Match Screen 5 12 Label Placement on Tubes 5 15 Cassette Back View Cassette Number 5 17 Cassette Front View Cassette Style 5 17 Cassette Front View Cassette Barcode Label 5 17 Cassette Tube Position Numbers 5 17 Cassette Input Tray Pushers Location and Function 5 20 Tube Holder Door Open 5 26 Tube Holder Door Closed 5 26 Tube Holder Door Analysis in Progress 5 26 Login Screen 5 29 Selected Menu Path Icon 5 29 Main Menu Screen 5 30 PN 624026AE PN 624026AE 5 17 5 18 5 19 2 20 3 21 3 22 5 23 3 24 5 25 226 Dt 328 2 29 D250 23l 3 32 J32 5 34 D132 5 36 2 34 5 38 D159 5 40 3 41 22 a5 5 44 5 45 5 46 5 47 5 48 5 49 tl T2 Ta T4 fee 7 6 rer 8 1 5 2 8 3 8 4 8 5 8 6 8 7 8 8 9 1 9 2 Setup Menu Screen 5 32 Miscellaneous Setup Screen Options 5 33 Quality Assurance Setup Screen Options 5 33 Auto Functions Setup Screen Options 5 34 System Setup Screen Options 5 35 Save Restore Configuration Screen Options 5 36 Operators Setup Screen Options 5 37 Flagging Sets Setup S
58. CBC DIFF file The steps L t for the CBC file are the same The Pz difference is that the CBC file will only r is contain data for the CBC parameter d ze m a WBC RBC Hgb Hct MCV MCH MCHC Plt and MPV 7 22 PN 624026AE QUALITY ASSURANCE T RUNNING CELL CONTROLS 3 The QC Levey Jennings graphs screen appears 4 Select the control file to be reviewed 370502 7 W at CONTROL 13 CBC DIFF v pae J b v the desired control PN 624026AE 7 23 QUALITY ASSURANCE RUNNING CELL CONTROLS 7 24 5 The Levey Jennings QC graphs appear To see the QC Data Grid screen Om To return to the Levey Jennings QC graphs screen C EA Act Sdiff AL Quality Control Control Name Recrecnes Her imcv imon mcrcrmowier wevincney noveorea CONTROL 13 CBC DIFF xf NE ILY IMOR cor BAr Lot Number 270502 z nE F Reserved wec Expiration Date 72 Dz Ekan Die e 72 a 03 09 2002 102 7b ae 8 wac 1037 4 Rec EBE 1057p 5 HeBfi35S gat ner esx pur 270103 ub Ta gt 6 Operator a Modified on 09 06 2002 By Service Shift Selection g x 5 g Date c os osy2002 16 11 49 g amp Bence Z y X 9 NasonvoT5 iei savis T 0971072002 10 26 01 Act Sdiff AL Quality Control
59. Do this procedure to print transmit cell control results from the QC Data Grid screen 1 From the Main Menu screen 0 Q 0E PN 624026AE 7 33 QUALITY ASSURANCE RUNNING CELL CONTROLS 3 The QC Levey Jennings graphs screen appears 0 E to open the QC Data Grid screen 4 Select the control file to be reviewed Control Name W ha CONTROL 13 CBC DIFF a at or b C the desired control AcT Sdiff AL Quali Control Name recreio _Herimcv imen morcrowieer wevieny woreoea NE ILY IMOR cor Bar 5 onmo 13 cacrorr z Lot Number 60503 E Reserved Expiration Date 07 10 2002 8 weeks 1037p RBC 237 1057y 5 HeBfes gal arf x pur 73 103 ut Modified on 07 10 2002 By Service Shift Selection Tafla e 012 RBC 2ar 10 pL TSS S T HGB 64 ras ia i 4 k a v x 9 AcT Sdiff AL Quali Control Name CONTROL 18 CEC DIFF gt Lot Number Res E 07 16 2002 153211 Inc Ope Date Time wee RBC HGB HCT MEV Service 09 23 2002 15 56 32 gt el 8 weda gj 8 wecf55 10570 i rec 31057 z x me AON a yepli62 gzal CAN Comment n ner fT z C cec E rr pur 0 103 C DIFF Ei Selected Results N P aR Modified on k t EE wec R
60. FOR OPTIONAL BARCODE WAND B CONNECTING THE OPTIONAL BARCODE WAND Table B 7 Interleaved 2 of 5 Options With Fixed Length Characters Test Labels Continued n Ml 4C131616 AC111616 1234567890123452 3 to 15 or 4 to MITI T TIET 15 4C130416 AC110416 Note Variable Length Characters are NOT recommended for Interleaved 2 of 5 Barcodes To increase sample identification integrity use fixed length characters with Check Digit If the test label fails to read 1 Reset the scanner by doing Powering Down the System and Logging Off then Powering Up the System and Logging On_in Chapter 5 2 Repeat the programming sequence B 6 CONNECTING THE OPTIONAL BARCODE WAND Do this procedure to connect the barcode wand to the Workstation or to verify the connection Ds Be Power down the instrument as instructed in Powering Down the System and Logging Off in Chapter 5 2 Disconnect the Workstation s power cord PN 624026AE B 9 BARCODE SPECIFICATIONS FOR OPTIONAL BARCODE WAND CONNECTING THE OPTIONAL BARCODE WAND 3 Disconnect the keyboard from the Workstation 4 Connect the barcode wand to where the keyboard was previously connected 5 Connect the keyboard to the other barcode wand connector w RUU DA 6 Reconnect the power cord to the Workstation B 10 PN 624026AE PN 624026AE BARCODE SPECIFICATIONS FOR OPTIONAL BARCODE WAND B CONNECTING THE OPTI
61. Highlighted the order 4 Highlighted the result E 19 WORKLIST SCENARIOS WORKLIST MATCH OPTION SCENARIOS E 20 5 Ow 6 The report automatically prints The Sample ID Manual Match appeared in the Miscellaneous Messages section of the Flags and Messages area of the printout e Ifyou print from the Run in Progress screen after matching Manual Match will appear on the report even though the Run in Progress screen shows Unmatched e Ifyou print from the Run in Progress screen before matching Unmatched will appear on the report b Print the results from the Manual Match screen without matching Manual Match will appear in the Miscellaneous Messages section of the Flags and Messages area of the report See Printing from the Manual Match Screen Without Matching in this appendix Scenario 18 Cass Position On Manual Match On Auto Print On Worklist Order Cassette Position and Sample ID Barcode Label Summary Results are placed on the Manual Match screen because the Sample ID was analyzed in a different position than what was entered on the Worklist 1 Create a Worklist order with Sample ID 123456789 and C P 10 4 OE b c Type 10 as cassette number then press Enter d Select the 4th tube position e Type 123456789 as the Sample ID OM sg 03 2 Insert tube into the 1st position of cassette 10 3 Place cassette in Cassette Input Tray O i 4 PPPI 5 Sample is a
62. INDEX checking the valves 11 19 checking the waste container level 6 1 Cleaning Cycles options 1 34 cleaning procedures after running a contaminated sample 11 68 Auto Clean 11 67 extended cleaning 11 34 for inside of instrument 11 67 for outside of instrument 11 66 system cleaning 11 68 cleaning the Analyzer 11 66 cleaning the baths 11 73 cleaning the inside of the Analyzer 11 67 cleaning the outside of the Analyzer 11 66 cleaning the system after analyzing a contaminated sample 11 68 cleaning the tube holder 11 66 cm definition Abbreviations 1 CO flag 9 49 coefficient of variation CV definition Glossary 1 Cold agglutinin triggering condition 9 46 collecting the specimen 8 1 columns no longer visible 9 3 resizing the widths 9 3 comments prompted for logs A 14 components resetting to home position 11 13 components inside right illustrated 11 78 components left inside illustrated 11 76 conditions for starting a New Workday A 107 Contextual toolbar 5 46 control definition Glossary 1 recommended 3 2 control flags 9 36 control values editing A 56 controls See cell controls conventions definition Glossary 1 used in this manual xxxi Index 3 INDEX Index 4 copying settings to another flagging sets A 126 Coulter Principle 2 2 count syringe function 11 79 11 80 location 11 79 11 80 creating a report header 5 1 A 79 cursor how to move 5 52 customizing the patient
63. J the Flags and Messages tab Standard Range Action PatientL PatiemtH Action H joman we 15 so 120 wo Chil RBC 250 400 E 70 A child Chida ne 5 Mo 1 E Chida HeT 0260 0350 0550 E as Mey 7 E 100 EJ es MCH 50 250 EN Et il MCHC E 30 0 Ez RDW 70 700 Cao ao J PLT 7 750 200 EI MPV 50 60 700 125 pun Gu ecr 100 0200 0500 1800 Restore Default Values BD La B NE EN 0500 E 0850 By Set as Default Flagging Set LY AEJ E 0500 0550 Mo amo Faa 100 GEJ Default Flagging Set___ 0 noo 000 ons 7080 Standard Range a ow Mow UE mE l7 Modified on NEW IEEJ ECI 200 30 jd ive om i sm 550 a mow 000 Mon 10 110 a foe NE EE a E GS a BAR Mao Fow 02a oa Let 5 amp gt A4 y X 9 Supervisor l 0771672002 18 48 37 OF 5 J the flagging set to Copy From For example to copy from the Man flagging set select Man Note You can Copy From the Standard flagging set but you cannot Copy To it Flagging Sets Standard Range Woman Childi Child2 Child3 Child4 Childs Renal 6 Copy A 127 A SETUP FLAGGING SETS SETUP 7 Select the flagging set to Copy To ig T Copy from Man a ighli cee F b Highlight the flagging set For example to copy to the Renal flagging set select Renal vy _x 8 C Yy to copy 9 Veri
64. Match will appear in the Miscellaneous Messages section of the Flags and Messages area of the printout The Sample ID on the report will be AUTO_SID Cass will be 2 and Pos will be 1 e Ifyou print from the Run in Progress screen after matching Manual Match will appear on the report even though the Run in Progress screen shows Unmatched e Ifyou print from the Run in Progress screen before matching Unmatched will appear on the report b Print results from the Manual Match screen without matching Manual Match will appear in the Miscellaneous Messages section of the Flags and Messages area of the report See Printing from the Manual Match Screen Without Matching in this appendix A Oo Scenario 6 Cass Position On Manual Match On Auto Print On Worklist Order Cassette Position and Sample ID No Barcode Label Summary Report prints with the Sample ID cassette and position that was entered on the Worklist order 1 Create a Worklist order Cal Oi b c Type 2 as cassette number then pressed Enter d Select the 1st tube position e Type 123457 as the Sample ID OM 0S 2 Insert tube into position 1 of cassette 2 E 9 E WORKLIST SCENARIOS WORKLIST MATCH OPTION SCENARIOS E 10 3 4 5 6 Place cassette in Cassette Input Tray o m Phib Sample is analyzed Report prints with Sample ID 123457 and C P 2 1 Scenario 7 Cass Position On Ma
65. Messages Continued Message Probable Cause DIAGNOSTICS SYSTEM ERRORS Suggested Action Autoloader transfer motor failure Autoloader transfer motor failed 1 Do Hardware Reset 2 Check the motor as instructed in Motors Checking Automatic calibration failed Attempt was made to save Contact a Beckman Coulter Calibration factors out of calibration factors but one representative range or more of the factors are out of range Bath enclosure door open Bath enclosure door right 1 Close door side panel is open 2 Do Auto Clean Running Bath Enclosure Door Opened If a cycle is attempted while 1 Close the door the right side door is open 2 Do Hardware Reset this message is generated Bath enclosure temperature out of range Actual d Min d Max d The temperature in the counting bath compartment is outside of the acceptable range 1 Ensure the sure right side door is closed Wait a few minutes Ifthe problem persists contact a Beckman Coulter representative won Bath enclosure temperature out of range Actual 0 Min 0 Max 0 Bath enclosure temperature is out of range Do Hardware Reset Bath enclosure temperature sensor failure Bath enclosure temperature sensor failed Do Hardware Reset Bath enclosure temperature sensor not connected Bath enclosed temperature sensor is not connected Do Hardware Reset Calibration factors
66. Options Read ONE of the labels below to set Start Stop Equality option check F hD111 No Start Stop equality check nor transmission F hD lL les No Start Stop equality check but transmission F hDlele Start Stop equality check but no transmission F thD Lees Start Stop equality check and transmission PN 624026AE B 7 BARCODE SPECIFICATIONS FOR OPTIONAL BARCODE WAND 2 OF 5 PROGRAMMING OPTIONS AND TEST LABELS B 7 See Table B 7 2 OF 5 PROGRAMMING OPTIONS AND TEST LABELS ATTENTION Test these barcodes from the printed Instructions for Use manual If you do not have a printed copy of the manual contact your Beckman Coulter representative Table B 7 Interleaved 2 of 5 Options With Fixed Length Characters Test Labels Number of Characters Check Digit or No Check Digit With Check Digit No Check Digit Fixed Digit Test Labels Read this label first then ONE of Read this label first then ONE of the other labels below the other labels below acos AC0 i WAAL WAAL RC1L304045 R01104042 1236 E M AU S RCLS06065 RC1106065 123457 M I 4C1l130808 4 4C110808 4 12245670 E WAL WAU LI RC1L310102 R01110102 1234567895 E M I 4C1l3l l1 S RCL1L1LZ122 lz345e789012 13 or 14 il wii WALI ML l 345678901 31 B 8 PN 624026AE BARCODE SPECIFICATIONS
67. PIt Action Ranges Message Triggering Condition PANCYTOPENIA WBC lt WBC LL and RBC lt RBC LL and Pit lt PIt LL LL below the action range Table 9 9 NABCs and PLATELET AGGREGATES Interpretive Messages Message Triggering Condition PLT AGGREGATES Plt lt 150x103 mm3 and WBC voteout DB and PDW gt 20 or DB and MPV gt 10 or DB and Plt lt 150x103 mm or DB and WBC Voteout WBC and PDW gt 20 or WBC and MPV gt 10 or WBC and Plt lt 150x103 mms NRBCs SL or SL and WBC Voteout or WBC and WBC Voteout or SL1 and WBC Voteout NRBCs amp PLATELET If none of the individual conditions defined for WRBCS or PLATELET AGGREGATES AGGREGATES occur and WBC or SL1 or WBC Voteout occur PN 624026AE 9 47 DATA REVIEW FLAGS AND MESSAGES GENERATED BY THE INSTRUMENT 9 48 Analytical Messages Analytical messages are displayed when the instrument detects conditions in the analytical process that may have influenced the result generated The analytical messages are DIFF and DIFF CO DIFF Reject DB Debris BASO QA Messages small cells on Plt histogram DIFF and DIFF During the data collection for the DiffPlot the instrument also determines the WBC count from the flow cell The WBC flag DIFF or DIFF Analytical message is reported in the Analytical Messages section of the Flags and Messages area If the WBC count from the flow cell exceeds the WBC coun
68. PL JAL P T To resize column widths 1 Place the cursor exactly on the right side of the column heading you want to resize and hold the left mouse button down The cursor changes into double cross hairs F to indicate the column can be resized For example if resizing the First Name column your cursor may look like this aes Date of Bith Age Panel RunDate AF DH PL AL P 2 While continuing to press the left mouse button move the mouse to resize the column ATTENTION Use care when resizing column widths because you can make a column so narrow that the entire column disappears 3 When the column is the desired width release the left mouse button 4 Repeat steps through 3 to resize additional columns PN 624026AE 9 3 DATA REVIEW LOCATING SAMPLE RESULTS Procedure for Locating Non Archived Results Do this procedure to locate a result not previously archived The Results List screen appears AcT Sdiff AL Result I Analytical I Action Limit F p I DiffPiot Histogram I Not Printed I Patient Limit I Not Transmitted Inc Sample ID Cass Pos Patient ID Last Name First Name Gender Date of Bith Age Panel Run Date AF DH PL AL P T A Mi 4se Unknow cecjoo7 iojacM CM wo E 44568 Unknow o MM e 206502 Unknow o MM e f jauto_sico 1 Unknow c c 007 10
69. PN 624026AE SETUP A SYSTEM SETUP Figure A 13 Patient Report Areas Defined Beckman Coulter Inc Miami FL 33196 Semple D AJTO_SOE Run Datellime 1 IZO Taio Collect Date Time me 1 Pos S Flagging Set Se wart Reres Pawel CECIDIFF Rerun N watie Pirysician DiffPlot and Histogram Flags WBC SL NL LN SL1 Note When setting up the patient report see the following sections in this chapter e Report Header Entering Editing e e Enable Define Patient Report Areas e e Hematology Parameters Printed Define for Patient Report For an overview see Figure A 14 7367461B WBC BASO Metamyelocyte Anisocytosis Retics Myelocytes V DATA REPORT FOR INVESTIGATIONAL USE ONLY Operator Supervisor Report header that you can define see Report Header Entering Editing in this chapter WBC result printed if WBC is selected see e Hematology Parameters Printed Define for Patient Report in this chapter Ranges printed if Range is selected Parameter percentages printed if selected see e Hematology Parameters Printed Define for Patient Report in this chapter Parameters absolute counts printed if selected see e Hematology Parameters Printed Define for Patient Report in this chapter DiffPlot and Histogram Flags prints Detailed or Suspect flags see Display and Print Detailed or Suspect Flags in this chapter Note Detailed flags are shown in Figure A 13
70. Physician Us 2 Highlight the desired physician s name if it appears in the list Otherwise type the physician s name OM Comments Sample and Patient Entering Editing You can type comments up to 50 alphanumeric characters for a sample and or a patient AcT Sdiff AL Sample Comment l l For sample comments u appears AcT 5diff AL r For patient comments u Ed 2 Type the comment OM appears 8 37 8 SAMPLE ANALYSIS ENTERING SAMPLE PATIENT INFORMATION Patient ID Entering Editing Patient ID ATTENTION If you enter patient demographic information and do not enter a Patient ID the system automatically assigns a Patient ID when the order is saved on the Worklist The format is AUTO_PIDxxxxxxxx where each x is replaced by the next logical sequence number 4 Anchor the cursor in the first position of the field Type the Patient ID If the Patient ID entered already exists in the database the remaining fields Last Name first Name Date of Birth Age and Gender are automatically populated with any information already stored when the cursor is moved to the next field Om Name Locating Selecting Last Name e For the Last Name To locate a Last Name already in the database u E Type the patients last name As you type the records matching the information are displayed at the Last Name field Highlight
71. Press The Worklist Cassette screen appears for that cassette number There may already be Worklist orders or the Worklist for that cassette may be empty 3 Click the tube order to be deleted Verify the arrow appears next to your selection Di 5 The following message appears Warning G Delete order for Sample ID 101112 A Delete cassette and position from order with Sample ID 101112 C Delete all orders from the Worklist 6 Select the desired option e Delete the order with Sample ID will delete the entire order from the Worklist for that Sample ID e Delete cassette and position from the order with Sample ID clears the cassette and position fields for that Sample ID but leaves the order on the Worklist e Delete all orders will delete every order on the Worklist 7 p Vv to delete PN 624026AE 8 53 SAMPLE ANALYSIS WORKING WITH WORKLIST ORDERS 8 54 PN 624026AE DATA REVIEW LOCATING SAMPLE RESULTS You can view results For the last sample analyzed see Reviewing the Last Sample s Results in this chapter e For sample results on the Results screen not yet archived see Locating Results on the Results List Screen in this chapter e For sample results already archived not available on the Results screen see Locating Archived Results in this chapter Reviewing the Last Sample s Results The Run in Progress Figure 9 1 screen displays the results for t
72. Reproducibility Check in the Autoloader Mode in this chapter Supplies Needed For closed vial analysis 3 Vacutainer tubes of fresh normal whole blood samples as defined by your lab that can be aspirated a maximum of 7 times each For tubes other than Vacutainer gt have enough tubes to obtain a total of 20 aspirations gt run the samples using open vial analysis CE Z l Ge E 4 4 Yo ja OX o E 1 From the Main Menu screen Ex ma B ESI DD le fc a 3 amp B amp B Db A y X I f I 0971572002 0322 19 11 53 i DIAGNOSTICS REPRODUCIBILITY CHECK CO 3 If there are existing runs the following message appears AcT 5diff AL e To delete all Reproducibility runs u Yy e To acknowledge the message and not delete the Reproducibility runs W x 11 54 PN 624026AE PN 624026AE DIAGNOSTICS REPRODUCIBILITY CHECK Before running a Reproducibility check a Print or transmit existing results as instructed in Printing Transmitting Reproducibility Results in this chapter b Delete existing results as instructed in Deleting Reproducibility Results in this chapter CBCIDIFF O MCHC Inc Opr Date Time wec RBC I Gey Selected Results N J wec Rec CV Minimum oo 00 B oo ow HGB oo ao a lt ig oe until the desired
73. Results in this chapter and as per your lab s protocol 18 To manually de select exclude run s from the statistics as per your lab s heer i mene 11 08 2002 protocol the check box as needed om Ww rat ppc 2321087 eo woo or to de select LI Gomm oa El m ner fae z C cac z pur 10 C DIFF 2 Modified on pe ee pP a 11 03 2002 WBC RBC HGB HCT nsec Tam Valet ae ere p Upper Limits 27 244 65 0 1 84 Delta Diff 00 0 00 oo 00 o 5 Y Lz a X dv i Supervisor 1170372002 103434 19 The control file results automatically print if Auto Print is enabled If Auto Print is disabled OB b Select the print option OM For information about enabling Auto Print for control results see Auto Print Non Patient Results in Appendix A 20 Repeat steps 5 through 19 for the remaining cell control levels 7 14 PN 624026AE QUALITY ASSURANCE T RUNNING CELL CONTROLS Running Cell Controls Manual Stat Mode Do this procedure to run a QC sample cell control material in the Manual Stat Mode with the QC sample ID to be entered by you ATTENTION If there is a situation when the system cannot find a Worklist order for the sample it is processing e g the barcode was not read and Barcode was the Worklist Match option the control lot number is reserved or the Worklist entry is missing or incorrect
74. Right Components 11 78 View of the Pneumatics Area 11 79 Bath Assembly 11 80 Optical Bench and Pneumatic Assemblies 11 80 Main Card 11 81 Computer Workstation Front View 11 81 Computer Workstation Back View 11 82 Reagent Bottle Container Location 11 83 Reagent Status Screen Details 11 83 Logs Menu Screen 11 125 Understanding the Logs Alarms and Errors Log Shown Details 11 126 Maintenance Log Entry 11 132 Setup Menu Screen A 2 General Tab Settings A 3 Auto Stop for Consecutive Results With Selected Characteristics A 20 PN 624026AE A4 AJ A 6 A 7 A 8 A 9 A 10 ATI A 12 A 13 A 14 A 15 A 16 AsL A 18 A 19 A 20 D 1 D2 PN 624026AE Location Physician Screen Details A 22 Shifts Setup Screen Details A 30 QA Settings Screen A 34 Rerun Setup Screen Details A 60 Auto Print Setup Screen for Patient Results Details A 64 Auto Transmit Setup Screen A 67 Local Settings Setup Screen A 70 Printer Setup Screen A 78 Patient Report CBC DIFF A 90 Patient Report Areas Defined A 91 Patient Report Setup Software Overview A 92 Cycle Options Setup Screen A 101 Determining If a New Workday is Required A 107 Users Setup Screen A 114 Screen Showing a New User to Supervisors Group A 118 Flags and Messages Setup Screen A 120 Age Ranges Screen for Flagging Set Setup A 121 Configuration Save Restore Screen D 2 Delete Database Screen D 14 XXV xxvi TABLES lel 2 L3
75. SETUP SYSTEM SETUP 3 E the Printer tab M Ki uA K M aad a aaa E 0A 5 u the check box as needed to select or deselect the option e To display print Detailed Flags f EEEN e To display print Suspect Flags 6 u v to save the change A 96 PN 624026AE SETUP A SYSTEM SETUP e Hematology Parameters Printed Define for Patient Report Vv M M M Vv M M M v v v v kinik kk Do this procedure to select deselect the hematology parameters to be printed S LN amp Wer 1 From the Main Menu screen J 4 CO PN 624026AE A 97 SETUP SYSTEM SETUP 3 E the Printer tab a K Ki a a K K d K Ki Wada 0A 5 Select the desired Hematology Parameters Printed M selected O not selected To see the area of the report for each of the options see Figure A 14 kkk k kk k k kak kaika M M M M M M M 6 u v to save the change A 98 PN 624026AE SETUP A SYSTEM SETUP Auto Print Non Patient Results Do this procedure to define edit the following results to be printed automatically upon completion e Quality Control Results e Reproducibility Results e Calibration Results e Startup Do this procedure to enable activate or disable deactivate the Auto Print feature that automatically prints control reproducibility calibration and or Startup reports upon completion of
76. SETUP SYSTEM SETUP Auto Clean Frequency Setting The instrument automatically performs an Auto Clean after a specified number of analyses The default number of analyses is 100 You can change this number to be any number from 1 to 120 For example if you want the instrument to run the Auto Clean after 75 analyses then you would change the number to 75 Do this procedure to change the auto clean frequency amp A amp Ade 1 From the Main Menu screen 0 a COULTER Coutter AST Sdiff AL CO A 102 PN 624026AE SETUP A SYSTEM SETUP AcT 5diff AL System 3 W the Cycle Options tab 0A PN 624026AE A 103 SETUP SYSTEM SETUP 5 Type the number of cycles the system should run before it does an Auto Clean Autoclean Frequency gt 75 R The frequency range is 1 to 120 which means you can enter any number from 1 to 120 such as 75 If you enter a number outside the range the following error message appears AcT 5diff AL value out of range 1 120 C then edit the number to be any whole number from 1 to 120 6 0 Y to save the change The Auto Clean frequency is now set to the number you entered For example if you entered 75 then after 75 cycles the instrument will do an Auto Clean A 104 PN 624026AE SETUP A SYSTEM SETUP Daily Workload Defining for CBC and CBC DIFF You can specify the daily workload which is the approximate
77. Startup problems 11 123 tube holder pierce position of tube 5 24 placing tubes in holder 5 22 tube holder door closed 5 26 during analysis 5 26 open 5 26 tubes inserting into tube holder 5 23 placing in the piercing position 5 24 removing from cassette 5 19 See also tube holder turning Manual Match ON OFE A 12 Index 13 INDEX Index 14 U U S See reporting units UM flag 9 38 9 40 UN flag 9 38 9 41 units See reporting units unmatched defined 9 18 Unmatched flag 9 18 Unmatched message definition 9 51 unpriming the reservoirs 11 32 Users Setup screen A 114 using Help 5 27 V Vac definition Abbreviations 2 valve locations 11 19 Vds definition Abbreviations 2 verification definition Glossary 2 verifying calibration 10 1 viewing additional information 5 50 viewing histograms on the screen 5 2 viewing Startup results 5 7 viewing the cycle counters 11 44 viewing the logs 11 128 viewing the patient results screen 9 6 W WARNING definition 4 1 warning labels on Analyzer 1 4 waste container replacement 11 95 waste sensor 11 95 waste detector sensor location 1 4 Waste full message 11 95 waste output connector location 1 4 waste sensor function 11 95 location 11 95 waste syringe function 11 79 location 11 79 WBC definition Abbreviations 2 interfering substances 3 10 WBC count overview 2 18 WBC INTERPRETATION NOT POSSIBLE triggering condition
78. Unknow g yae CM MT r F t3wisi4 Unknow cecjbov iefacM MM ae O E t3w1s14 Unknow c D07 26 2cM CV MO le 46 z amp B gt A vyv X LB Version v0 13 Supervisor 08 01 2002 20 15 41 e To review the patient results screen l From the Results List screen Figure 9 2 0 the desired result The Results Full View Figure 9 5 screen appears 9 6 PN 624026AE PN 624026AE Figure 9 5 Results Screen DATA REVIEW LOCATING SAMPLE RESULTS AcT 5diff AL Results Mid Spl Result 1 1 bl Sample ID 23119290P WBC 109 L Cass Pos Panel 9 3 CEC DIFF RBC 1072 L Flagging Sets HGB g L WBC BASO Woman HCT L L Collect Date Time MCV fL 08 01 2002 15 15 00 Run Date Time pet ee 08 01 2002 20 04 16 pee t Location RDW Miami FL Physician PLT 1097L Dr Totino MPY fL Comments PCT iZ 7 BA ew Patient ID ratio Sierra7565 NE 0472 RL 223 Last Name LY 0 439 R Remner MO 0 071 R First Name EO a05 A Addison rie Date of Birth Age BA i 1962 J 40 ATL ns IMM Female a amp Z Flags and Messages DiffPlot and Histogram Flags WBC SL SL1 B Analyzer Messages DIFF Interpretive Messages WBC Interpretation Not Pos PLT Aggregates Miscellaneous Messages Manual Match gt Recalculated le im gt P gt Pr gt 4 gt zi Ke xX d Service l 2 To view the previous result u q a 3 To view the first result W Id 4
79. additional results Control comment entered on QC results screen Number of runs included in statistics Statistical calculations based on included runs Mean mean of selected QC results Displayed in red if greater than the high targets and displayed in yellow if lower than the low targets If a control result is out of target a QC alarm is activated 2SD standard deviation of the selected QC results CV Coefficient of variation of the selected QC results Displayed in red if greater than the define coefficient Lower Limits low target limit for the QC results Target Values target for the QC results Upper Limits high target limit for the QC results Delta Diff difference between the mean and the target Displays the QC Graphics screen for the last control run Display QC target setup screen Allows display of data by shift Details the last person to set up or modify the control file data Displays target values for control file by tab DIFF displays diff parameter target values for DIFF file only CBC displays CBC parameter target values for the file Control expiration data Reserved ID indicator when selected any sample run with the Sample ID matching the lot number is considered a control and saved in this file Lot number of control Filter options that allow you to filter the displayed data All displays all data CBC displays CBC data CBC DIFF displays CBC DIFF data PN 624026AE QU
80. analysis For information on enabling disabling Auto Print for patient sample reports see Auto Print for Patient Results in this chapter Ke LN Wer 1 From the Main Menu screen W aE OC PN 624026AE A 99 SETUP SYSTEM SETUP 3 E the Printer tab a K Ki a a K K K K Ki aaa 0A 5 Select the desired Auto Print options M selected L not selected 6 u v to save the change A 100 PN 624026AE PN 624026AE SETUP A SYSTEM SETUP Cycle Options Under the Cycles Options tab Figure A 15 you can define edit these settings Auto Clean Frequency Setting Daily Workload Defining for CBC and CBC DIFF New Workday Defining Startup Automatic Shutdown Automatic Figure A 15 Cycle Options Setup Screen 7367129A Allows you to define the Auto Clean Frequency See Auto Clean Frequency Setting in this chapter Allows you to enable disable automatic Startup See Startup Automatic in this chapter Allows you to enable disable automatic Shutdown See Shutdown Automatic in this chapter Allows you to define when a new Workday begins See New Workday Defining in this chapter Allows you to define the daily workload for CBC runs per day See Daily Workload Defining for CBC and CBC DIFF in this chapter Allows you to define the daily workload for CBC DIFF runs per day See Daily Workload Defining for CBC and CBC DIFF in this chapter A 101
81. and the RBC count and describes the average weight of hemoglobin in a red cell The calculation for MCH is Hgb RBC Note pg is the US unit format Other formats are available See Units Selecting the Reporting Unit in Appendix A MCH pg 10 e MCHC calculation MCHC Mean Cell Hemoglobin Concentration is calculated using the Hgb and Hct values and describes the average concentration of hemoglobin in the red blood cells The calculation for MCHC is _ Hgb MCHC g dL Ha 100 Note g dL is the US unit format Other formats are available See Units Selecting the Reporting Unit in Appendix A PN 624026AE 2 15 OPERATION PRINCIPLES PARAMETER DEVELOPMENT Pit Parameters Overview Platelet counting and sizing are also done in the RBC bath Thresholds separate the platelet pulses which are much smaller from the red blood cell pulses Platelets are also categorized according to size by a 256 channel pulse height analyzer A pulse height analyzer uses a number of thresholds to sort the particles into several size volume categories and to develop a size distribution curve of the particles The Plt distribution curve shows cells in their native size Figure 2 15 is an example of a Plt histogram with a normal Plt size distribution Figure 2 15 Typical Pit Histogram 30fL Interference on the Lower End of the Platelet Distribution Curve Particles that are approximately platelet size can interfere with the plate
82. and Platelet Analysis The RBC Plt dilution analyzes red blood cells and platelets This dilution is prepared in two stages the primary first dilution and the secondary last dilution The primary dilution is made in the First Dilution Hgb bath and the secondary dilution is made in the RBC bath Figure 2 9 Table 2 2 summarizes the technical characteristics required to obtain RBC and Platelet results Figure 2 9 Bath Assembly Rinse bath First Dilution Hgb bath DIFF bath RBC bath WBC BASO bath Table 2 2 Technical Characteristics for Obtaining RBC and Platelet Counts Dilution Characteristics Primary Dilution for RBC and Pit Initial volume of whole blood Volume A eT 5diff diluent Primary dilution ratio Secondary Dilution for RBC and Pit Volume of primary dilution Volume A T 5diff diluent Secondary dilution ratio Final dilution for RBC and Plt results Reaction temperature Measurement Characteristics Method of analysis Aperture diameter Count vacuum Count period 10 pL 1 700 pL 1 170 42 5 uL 2500 uL 1 58 8 1 170 x 1 58 8 1 10 000 35 C 95 F Coulter Principle 50 um 200mb 5 9 in Hg 2x5 seconds 2 8 PN 624026AE OPERATION PRINCIPLES 2 SAMPLE ANALYSIS Parameter Results Obtained from the RBC PIt Dilution This final 1 10 000 RBC Plt dilution is used to e Determine the RBC count e Develop the RBC histogram which is needed to obtain the Hct MCV and RDW results
83. bath an electric current continuously passes through the aperture Current moving between the two electrodes establishes the electronic flow through the aperture Once a sample is aspirated an aliquot of that aspirated sample is diluted with reagent an electrolyte and is delivered to the RBC or WBC BASO bath using tangential flow which ensures proper mixing of the dilution When the cells suspended in the conductive reagent are pulled through a calibrated aperture the electrical resistance between the two electrodes increases proportionately with the cell volume Figure 2 1 The resistance creates a pulse that is sensed and counted as a particle by the instrument The amount of resistance amplitude of each pulse is directly related to the size of the particle that produced it The generated pulses have a very low voltage which the amplification circuit increases so that the electronic system can better analyze the pulses and eliminate the background noise Applying the Coulter Principle The A eT 5diff AL analyzer makes several dilutions of an aspirated whole blood sample The RBC Plt dilution begins in the First Dilution Hgb bath but is actually analyzed in the RBC bath The final dilution in the RBC bath is used to determine the cell count and size of red blood cells and platelets The WBC BASO aperture sensor system is directly responsible for determining the cell count and size of white blood cells The differentiation between baso
84. be displayed printed Detailed Flags Format If the Detailed option is selected at the setup screen the flags are reported displayed and printed in the detailed format as described in previous sections Suspect Flag Format If the Detailed Flags option is not selected at the setup screen the flags are reported displayed and printed in the Suspect format as follows e DB prints as DB e The DIFFPLOT flag replaces the SL SL1 NL MN UM LN UN and NE flags e IMM prints as IMM e ATL prints as ATL e The WBC BASO flag replaces the WBC flag e The HISTO flag replaces the MICRO MACRO MIC and SCH flags e The flags will be printed on the patient report in the area labeled SUSPECT PN 624026AE 9 51 DATA REVIEW FLAG HIERARCHY 9 10 FLAG HIERARCHY There are three fields available to display the parameter and patient action flags Flags therefore are ranked so that a specific logic is consistently applied to determine which flags appear in which of the three available fields Ifa V R or is generated it will always display in the first flag field after the parameter results In addition the HH LL or H L flag can be displayed with or without the V R or If the V R or is present HH LL or H L displays in the second and third flag field If the V R or is not present HH LL or H L displays in the first and second field Here are some examples 10 3 V 5 6 L 35 0 VHH For specific flag rankings see
85. by the system See Heading 11 16 LOGS Diagnostics Opens the Diagnostics screen which allows you to perform diagnostic functions e For information about diagnostic procedures see Chapter 11 DIAGNOSTICS e For information about additional screen options available see Diagnostics Menu Options in this chapter Quality Assurance Opens the Quality Assurance screen which allows you to run various QA functions e For information about additional screen options available see Quality Assurance Menu Options in this chapter e For information about the QA functions see Chapter 7 QUALITY ASSURANCE Shutdown Initiates the Shutdown cycle See Heading 6 4 SHUTDOWN PN 624026AE 5 31 5 GETTING STARTED MENU PATH Setup Menu Options The following menu options are available from the Setup screen Figure 5 17 e Figure 5 18 Miscellaneous Setup Screen Options e Figure 5 19 Quality Assurance Setup Screen Options e Figure 5 20 Auto Functions Setup Screen Options e Figure 5 21 System Setup Screen Options e Figure 5 22 Save Restore Configuration Screen Options e Figure 5 23 Operators Setup Screen Options e Figure 5 24 Flagging Sets Setup Screen Options Figure 5 17 Setup Menu Screen AcT 5diff AL Setup 5 32 PN 624026AE PN 624026AE GETTING STARTED 5 MENU PATH Miscellaneous Setup Options See Figure 5 18 Figure 5 18 Miscellaneous Setup Screen Options 7367449A Quality Assura
86. can e Save to Hard Disk e Restore from Hard Disk e Save to Floppy Disk e Restore from Floppy Disk e Workstation Configuration Save to Hard Disk Save to Floppy Disk This procedure allows you to save the Workstation s current configuration settings to the Workstation s hard drive or to a floppy disk Once you save the settings you can restore them later if necessary See e Workstation Configuration Restore from Hard Disk Restore from Floppy Disk in this chapter Beckman Coulter recommends that you save the information to floppy disks The Beckman Coulter representative performs this procedure at installation Do this procedure if you change the Workstation s configuration AAr 3 Ey i S 5 1 From the Main Menu screen E 7 aE s Euro D 8 PN 624026AE WORKSTATION MANAGEMENT D CONFIGURATION ANALYZER AND WORKSTATION 3 the Configuration tab 0A PN 624026AE D 9 WORKSTATION MANAGEMENT CONFIGURATION ANALYZER AND WORKSTATION 5 Indicate where the settings should be saved e To save to the hard drive p Save to Hard Disk e To save to a floppy disk 1 Insert the disk into drive A 2 W Save to Floppy Disk wA 3 6 Follow the instructions on the screen 7 E to print the current settings for your records 8 u y to save the change D 10 PN 624026AE WORKSTATION MANAGEMENT D CONFIGURATION AN
87. can load up to 10 cassettes at once 5 20 PN 624026AE GETTING STARTED 5 WORKING WITH THE CASSETTES WARNING Risk of injury from the cassette pushers A The pushers move forward with force to push the cassettes into the instrument 2 When the Start Autoloader PFFF function is activated the Analyzer pushes the cassettes to the front of the instrument for processing Unloading Cassettes from the Analyzer Once the Analyzer has finished analyzing the samples in the cassette the cassette is ejected into the Cassette Output Tray on the right side of the Analyzer The Cassette Output Tray can hold up to 10 cassettes If the tray is full the Analyzer will stop until some of the cassettes are removed and the other cassette s can be ejected Do this procedure to unload the cassettes from the Analyzer LN WARNING Risk of injury biohazardous condition if the sample tube breaks Use extreme care not to break a sample tube Remove the cassette from the Cassette Output Tray PN 624026AE 5 21 GETTING STARTED WORKING WITH THE TUBE HOLDER 5 8 WORKING WITH THE TUBE HOLDER Placing the Tube Holder in the Analyzer Do this procedure to place a tube holder in the Analyzer A amp Nec 1 Bp to open the tube holder door 2 Slide the tube holder over the metal shaft and rotate tube holder slowly until it clicks into place Positioning Tubes in the Tube Holders Some procedures in this
88. close attention to the information 4 2 PN 624026AE 5 1 GENERAL GETTING STARTED This chapter provides general information on using the system 5 2 COMMONLY ASKED QUESTIONS See Table 5 1 Table 5 1 Commonly Asked Questions Area Question Answer System Access Is a password required to use the system Can additional users be added to the system The access level Operator does not require a password to operate the system However a password may be used The access levels Supervisor and Service required passwords For additional information on access rights see Access Rights in Appendix A Yes Additional users can be added For details see Operators Users Adding Editing Deleting in Appendix A Can users with Operator access change the system setup No Only users with Supervisor or Service access can change the system setup See Password Requirements in Appendix A Can assign different operator IDs to each of the operators Yes Each operator can be assigned his her own ID and password if required See Operators Users Adding Editing Deleting in Appendix A System Setup Can the system be set up to automatically re run a sample Yes You can define the criteria that the system will use to automatically re run a sample See Rerun Marking a Sample for Automatic Re run in Appendix A Can the system be set up to automatically p
89. down sequence that you must follow to prevent damaging the system When instructed in this document do this procedure to power down the system if it is on 1 From the Main Menu screen 0 t PN 624026AE 5 9 GETTING STARTED POWERING UP AND LOGGING ON POWERING DOWN AND LOGGING OFF 3 The Login screen appears Act Sdit AL This computer program is protected by x international copyright laws and unauthorized copying use distribution transfer or sale is a violation of those laws that may result in civil or criminal penalties f AcT 5dif AL Workstation Version XXX Copyright c 2002 Beckman Coulter Inc I Rights Reserved 4 J Ts to exit the system 5 When It is now safe to turn off your computer appears turn the Workstation OFE Note Do not u Restart If you do you will need to repeat this entire procedure 6 Turn the Workstation OFF a Tum off the PC b Turn off the monitor 7 Turn the Analyzer OFF ATTENTION If you are doing a replacement or maintenance procedure that requires you to open the Analyzer panels unplug the ac power cord from the ac outlet 5 10 PN 624026AE 9 4 PN 624026AE GETTING STARTED NEW WORKDAY NEW WORKDAY A workday consists of a 24 hour period and a New Workday begins for your lab based on the time defined in Procedure for Defining a New Workday in Appendix A The significance of a New Workday is that the system performs certai
90. ee ler g z ia ae EE pefos eon2 16 11 49 Perce ola g Z v x os NersionVO1S e1 Service osrov2002 10 2601 C the tab that represents the Levey Jennings control graph that you want to see To view all runs use the scroll bar at the bottom of the screen Note WBC RBC HGB is the default tab displayed PN 624026AE QUALITY ASSURANCE T RUNNING CELL CONTROLS a 7 u when you are finished Understanding the QC Results Screens There are four screens related to the QC function QC Levey Jennings Graph screen Figure 7 2 e QC Data Grid screen Figure 7 3 e QC Graphics screen Figure 7 4 Understanding the QC Levey Jennings Graph Screen The Levey Jennings Graph screen is the default screen displayed when you u kA amp Figure 7 2 shows the Levey Jennings Graph screen for the CBC DIFF file The parameters are displayed in groups of three depending on the file type CBC or CBC DIFE For CBC there are 4 groups e WBC RBC HGB e HCT MCV MCH e MCHC RDW PLT e MPV For CBC DIFE there are 7 groups e WBC RBC HGB HCT MCV MCH e MCHC RDW PLT MPV NE LY e MO EO BA e NE LY MO e E0O BA PN 624026AE 7 25 RUNNING CELL CONTROLS QUALITY ASSURANCE 7 26 Figure 7 2 QC Levey Jennings Graph Screen AcT 5di AL Quality C 0 Control ame Naracinice IN tHGB conTRoL 3 cec orr NS MO Lot Number Fut z
91. existing Patient ID will be deleted and an AUTO_PID will be assigned e Ifyou selected Delete Patient File this message appears AcT 5diff AL Delete selected Patient file from database Any existing results including archived will be updated Continue ATTENTION Once a Patient ID or a patient file is deleted it cannot be recovered 10 C y to delete PN 624026AE 9 33 DATA REVIEW REVIEWING RESULTS 9 7 REVIEWING RESULTS Introduction Patient sample results are generated from sample analysis There may be instances when a patient sample result is flagged or a parameter numeric result is replaced by a flag Carefully review all parameter results especially results with flags and or messages ATTENTION Beckman Coulter does not claim to identify every abnormality in all samples It is recommended that you use all flagging options to optimize the sensitivity of instrument results Additionally it is recommended that platelet counts less than 20 x 103 uL be reviewed IMPORTANT Risk of result inaccuracy if a transient or partial blockage is not detected by the instrument In rare instances especially for samples where fibrin or other debris is likely to occur such as pediatric or oncology samples a transient or partial blockage may not be detected by the instrument Therefore verify flagged results for accuracy and review any result that exceeds your laboratory s limits ATTENTION For QC XB XM Reproduc
92. for Cass Position Lin l the sample results will be placed on the Manual Match screen flashes to signify results are on the Manual Match screen For information on manually matching the results see Manual Match Procedure in Chapter 9 1 Are you running a new set of controls e If yes be sure the new controls have been set up as instructed in Heading A 6 SETTING UP A CONTROL FILE e Ifno go to step 2 MENIN Be a Q i oA z 2 From the Main Menu screen i T om i es PP E po vy 3 2 a gt 4 y X f 0871372002 093213 PN 624026AE 7 15 QUALITY ASSURANCE RUNNING CELL CONTROLS 0 amp AcT Sdiff AL Quality 4 The QC Levey Jennings graphs screen ee appears C E to open the QC Data Grid arm screen aeos 7 16 PN 624026AE QUALITY ASSURANCE T RUNNING CELL CONTROLS 5 Enter the control ID in the Sample ID field 0 b Type the reserved lot number for the control in the Sample ID field c u The following message appears When tube holder opens insert Sample ID X for analysis d Do NOT u X otherwise you have to begin again Note If the control s lot number has been reserved when the control file was set up manually type the reserved lot number for the control as the Sample ID at the Run screen 6 Verify the level of control you are running matches the level you select
93. hemoglobin concentration ACeT 5diff Hgb Lyse is a clear aqueous solution and is composed of potassium cyanide at 0 035 and a quaternary ammonium salt Handle as indicated in this manual Use at ambient temperature from 18 C to 25 C up to the expiration date indicated on the packaging ACT 5diff Rinse UL Used as a rinsing agent ACT 5diff Rinse is a transparent liquid composed of an enzymatic solution with proteolytic action Handle as indicated in this manual Use at ambient temperature from 18 C to 25 C up to the expiration date indicated on the packaging PN 624026AE 1 13 i USE AND FUNCTION PRINTER 1 9 PRINTER Use the printer supplied or approved by Beckman Coulter 1 10 ORDERING MATERIAL SAFETY DATA SHEETS MSDS To obtain an MSDS for Beckman Coulter reagents used on the A eT 5diff AL analyzer 1 On the Internet go to www beckmancoulter com a Select MSDS from the Customer Support drop down menu Follow the instructions on the screen c Contact your Beckman Coulter representative if you have difficulty locating the information 2 Ifyou do not have Internet access e Inthe USA either call Beckman Coulter Customer Operations 800 526 7694 or write to Beckman Coulter Inc Attn MSDS Requests PO Box 169015 Miami FL 33116 9015 e Outside the USA contact your Beckman Coulter representative 1 14 PN 624026AE OPERATION PRINCIPLES 2 1 OVERVIEW The A eT 5diff AL analyzer is a
94. included in the statistical calculations even though the parameter is shown as a non numeric flag on the table It is recommended that results in the table that have one or more non numeric flags not be selected for inclusion in the statistics When an IQAP file is created the system will only included results from the file that are selected in the control file table Review the control file for erroneous data that should not be included in the IQAP report and de select that particular run If a result with non numeric flags is selected and an IQAP file is created the value that generated the flag will be included in the file created and analyzed as part of the IQAP report It is recommended that results in the table that have one or more non numeric values not be selected PN 624026AE 7 39 QUALITY ASSURANCE DOWNLOADING CELL CONTROL RESULTS FOR IQAP Understanding the IQAP Download Screen Before you proceed with downloading the cell control information to a diskette for IQAP be sure you understand the IQAP download screen Figure 7 5 Figure 7 5 IQAP Download Screen Defined IQAP Download in Control File Lo No First Run Dejs Last Rur Date Pav CONTROL 13 370502 09 06 2002 14 29 55 09 06 1002 16 11 49 g l j v v Select files to download for IQAP a JF amp 7 o amp D A V X D 09710 2002 10 55 38 7367035A Allows you to include exclude the file 4 Date o
95. into the lymphocyte region Figure 2 18 NRBC cytoplasmic membranes lyse like those of mature erythrocytes The small nuclei that remain appear in the debris and small lymphocyte regions Figure 2 18 Monocyte Mono Monocytes are typically large cells with a kidney shaped nucleus and agranular cytoplasm These cells neither scatter nor absorb large amounts of light therefore they are positioned in the lower end of the absorbance axis Due to their size the monocytes are clearly positioned high on the volume axis Figure 2 18 Very large monocytes may be found in the IMM immature cell region Eosinophil Eos With the reagent action eosinophils are the most intensely stained for optical separation Due to the staining intensity and their size eosinophils show higher absorbance than the neutrophils but they will be of similar volume Figure 2 18 Debris Platelets and debris from erythrocyte lysis represent the background debris population located in the lower region of the DiffPlot 2 20 PN 624026AE OPERATION PRINCIPLES PARAMETER DEVELOPMENT Table 2 8 Immature White Blood Cells Immature Cell Type Definition Immature Granulocytes Immature granulocytes are detected by their larger volume and by the presence of granules that increase the intensity of the scattered light Due to their increased volume and similar absorbance promyelocytes myelocytes and metamyelocytes are located ab
96. is an acceptable alternative Note You can collect blood into a microcontainer Refer to the tube manufacturer s minimum and maximum fill volumes 2 Mix the blood specimen gently and thoroughly before analysis according to the tube manufacturer s recommendations and your laboratory s protocol PN 624026AE 8 1 SAMPLE ANALYSIS DETERMINING HOW TO RUN THE SAMPLES 8 3 DETERMINING HOW TO RUN THE SAMPLES e For stat samples see Heading 8 4 RUNNING MANUAL STAT SAMPLES For samples on the Worklist see Heading 8 5 RUNNING WORKLIST SAMPLES IN AUTOLOADER MODE e For re running samples see Heading 8 6 RE RUNNING SAMPLES IMPORTANT The Run in Progress screen Figure 9 1 is not updated to reflect when a Manual Match is performed The Run in Progress screen shows the results as analyzed only Printing prior to Manual Match from the Run in Progress screen is inhibited The final report prints from the Manual Match screen after Manual Match has been completed 8 4 RUNNING MANUAL STAT SAMPLES Do this procedure to run a stat sample for e asample ID that does not exist on the Worklist or e asample ID that already exists on the Worklist You cannot select multiple entries from the Worklist to be run as stat samples The samples are processed based on entry into the Worklist Therefore if you have more than one stat sample to process from the Worklist repeat the procedure below as required Note If you run a stat s
97. it is processing e g the barcode was not read and Barcode was the Worklist Match option the control lot number is reserved or the Worklist entry is missing or incorrect for Cass Position EEE the sample results will be placed on the Manual Match screen 4 flashes to signify results are on the Manual Match screen For information on manually matching the results see Manual Match Procedure in Chapter 9 1 Are you running a new set of controls e If yes be sure the new controls have been set up as instructed in Heading A 6 SETTING UP A CONTROL FILE e Ifno go to step 2 amp nes a Pa Le a g foe E amp 0A 5 z 2 From the Main Menu screen zy om Fe l ba a 3 a gt 4 y X f 0871372002 093213 PN 624026AE 7 9 QUALITY ASSURANCE RUNNING CELL CONTROLS 0 amp Act Sdiff AL Quality 4 The QC Levey Jennings graphs screen aS appears to open the QC Data Grid pe screen 7 10 PN 624026AE QUALITY ASSURANCE T RUNNING CELL CONTROLS 5 Manually type the control s reserved lot number as the Sample ID OF Enter the cassette number and press Enter d Type the control lot number as the Sample ID Ow f Repeat steps d and e for each control 6 Verify the level of control you are running matches the level you selected 7 Verify that the control material has not expired
98. lo J 2 3 E oT D Fe Vv x d Version v0 13 Service M aa 15 23 42 The cassette number is entered when you create edit the Worklist if Cass Position is the Worklist Match Option If any information has already been entered for this cassette it will be displayed The pos position displayed is based upon the location of the arrow In Figure 8 7 the arrow is at position 1 therefore 1 is reflected in the Pos field For example if the arrow were located next to an empty tube in position 7 7 would be reflected in the Pos field The graphic representation of the cassette is used to facilitate data entry and correct location of the samples in the cassette Any position that has information assigned to it will be indicated by a sample tube containing the Sample ID on the side See Figure 8 8 Any position that does not have information assigned to it will be indicated as EMPTY Figure 8 8 Worklist Sample ID from Worklist Cassette Screen 041162 8 44 PN 624026AE SAMPLE ANALYSIS WORKING WITH WORKLIST ORDERS 8 9 WORKING WITH WORKLIST ORDERS Receiving Worklists from a Host Computer If the Host transmission protocol is established demographics are automatically downloaded from the host computer You cannot edit any information downloaded from the host computer Adding an Order Entry PN 624026AE Worklist orders entries can be added entered at the Worklist Grid screen or at the Worklist Cassette Screen For de
99. manual require you to place a tube or vial into the tube holder and start analysis There are three factors to be aware of l The manufacturer and tube name of the cap pierceable tube vial that you are using Refer to the Hematology Tube List available on the BCI website at www beckmancoulter com The position of the tube in the tube holder See Tube Holders in Chapter 1 The position of the tube holder in the Analyzer See Position of Tube Holder in the Analyzer in this chapter Position of Tube Holder in the Analyzer There is one pierce position in the Analyzer which means that tube holder must be rotated such that the tube to be pierced is in the pierce position 12 00 o clock 5 22 PN 624026AE PN 624026AE GETTING STARTED WORKING WITH THE TUBE HOLDER A ANE 1 The tube holder door automatically opens when the system is ready 2 To avoid possible mis identification always verify the Sample ID at the Workstation with the Sample ID from the tube prior inserting the tube into the instrument Beckman Coulter recommends positive tube sample identification such as barcode labels WARNING Risk of exposure to biohazardous material 1 If you insert an uncapped tube or vial into the tube holder the contents may spill out of the tube or vial thereby creating a biohazardous condition the tube or vial can be cap pierced then ensure th the cap is secure before inserting the tube or vial into the t
100. milliliter mm millimeter MO monocyte MPV mean platelet volume MSDS material safety data sheet PN 624026AE Abbreviations 1 ABBREVIATIONS mW milliwatt n number NCCLS National Committee for Clinical Laboratory Standards NE neutrophil nm nanometer pg picogram Pit platelet RBC red blood cell RDW red cell distribution width RUO Research Use Only SD standard deviation Vac volts of alternating current Vde volts of direct current WBC white blood cell Abbreviations 2 PN 624026AE REFERENCES p LIST OF REFERENCES 1 Coulter WH High speed automatic blood cell counter and cell size analyzer Paper presented at National Electronics Conference Chicago IL 1956 October 3 2 Websters ninth new collegiate dictionary Merriam Webster Springfield MA 1989 3 Stedman s medical dictionary 21st edition Williams amp Wilkins Baltimore MD 1966 4 Bull BS and Elashoff RM et al 1974 A study of various estimators for the derivation of quality control procedures from patient erythrocyte indices Am J Clin Path 61 4 475 PN 624026AE References 1 REFERENCES References 2 PN 624026AE DEFINITIONS PN 624026AE GLOSSARY accuracy Ability of the instrument to agree with a predetermined reference value at any point within the operating range closeness of a result to the true accepted value agglutination clump archive Contains res
101. modified Run calibration Analyzer and Workstation calibration factors do not match 4 Do Edit Accept Calibration Factors to accept the calibration values 2 If the message re appears contact a Beckman Coulter representative Cassette in wrong position Cassette is not correctly positioned in the Cassette Input Tray Place cassette in correct position 2 Restart cycle Cassette moving left sensor error An error occurred with the sensor that detects cassette movement to the left Do Hardware Reset Cassette moving right sensor error An error occurred with the sensor that detects cassette movement to the right Do Hardware Reset Cassette not identified System could not read the barcode label on the cassette 1 Check the barcode label to ensure it is legible 2 Restart the cycle Cassette transfer end sensor error An error occurred with the sensor that detects the end point of cassette movement Do Hardware Reset 11 113 i DIAGNOSTICS SYSTEM ERRORS 11 114 Table 11 5 Error Messages Continued Message Probable Cause Suggested Action Check Diluent level and run a Diluent reservoir is unable Check the diluent level Do Replacing the Prime Diluent cycle to fill Diluent Reagent if necessary Diluent reagent is empty CO Resistive and analytical 1 Re run the sample pulses for a cell fail internal criteria 2 Ifthe pr
102. o MM e _ s06s02 Unknow o MM wo E autost 1 Unknow o CR CO s11s20039 2 Unknow cecoo7fjijjac oF ow OO F 311929099 4 Unknow c o07 10 2 0 MF Oo Iauto sco 5 Unknow co07 102c 0 MM Oo F lautosico 6 Unknow o MM RO autro ses 7 Unknow c o07 102c C RR OO F 311929039 1 Unknow c c 007 10 20 0 MM MO Fi 3119290P9 13 Unknow co07 102 0 CR Oo E auto_scs 4 Unknow c c D07 102c C MM RO C jautosico 5 Unknow c cjoo7 10 2 0 MR OO fF jaiise0099 6 Unknow c 007 10 20 0 FF oo M jautosics 7 Unknow c o07 10 2c 0 MM OO i fsi192003 9 1 Unknow o MR RO I 311929009 3 Unknow co07 102 0 MM OO C auTo_sSIt9 4 Unknow cegpo7 jiojac MM o o Ci jauto seo 5 Unknow c 007 10 20 0 MR OO i 311929099 6 Unknow c o07 102 0 MO Oo Ti jauto sito 7 Unknow o MR Oo P favtosico 1 Unknow cecoo7 jigjac MM e fF lautosico 2 Unknow o RR e z y amp a VY xX Supervisor I 0971972002 20 14 00 2 C y The following message appears AcT 5diff AL Archive all results _x 9 25 9 DATA REVIEW ARCHIVING PATIENT RESULTS 3 e Y to archive all results 9 26 PN 624026AE 9 6 DELETING ARCHIVED PATIENT RESULTS The delete options include e Deleting Patient Results by Run Date DATA REVIEW DELETING ARCHIVED PATIENT RESULTS e Deleting Patient ID or Patient File from Database Deleting Patient Results by Run Date Do this procedure to delete patient results by run date If you do not know the run date but PN 62402
103. obtain accurate Hgb results when increased turbidity of the blood sample occurs determine the cause of the turbidity and follow the appropriate method below e Elevated WBC An extremely elevated WBC will cause excessive light scatter If this occurs 1 Use the reference manual methods 2 Centrifuge the diluted sample 3 Measure the supernatant fluid with a spectrophotometer e Elevated lipids Elevated lipids in the blood sample will give the plasma a milky appearance This condition can occur with hyperlipidemia hyperproteinemia as in gammapathies and hyperbilirubinemia Accurate hemoglobin determinations can be achieved by using reference manual methods and a plasma bank e Increased turbidity This may be seen in cases where the RBCs are resistant to lysing This condition will cause a falsely elevated Hgb result but may be detected by observing the abnormal MCH MCHC values and the increased baseline on the leading edge of the WBC histogram Erroneous Hgb results will cause the results of MCH and MCHC to also be erroneous e Fetal bloods The mixing of fetal and maternal blood may produce a falsely elevated Hgb value Het RBC agglutination May produce erroneous Hct and MCV values RBC agglutination may be detected by observing abnormal MCH and MCHC values and by examining the stained blood film Use the manual method to obtain an accurate Hct value MCV RBC agglutination May produce an erroneous MCV value R
104. of Birth as PaO M eam o2 R onn 3 Gender ore ee A 5 y amp gt 4 v X pona T T 070472002 141753 b Select Print or Transmit from the following window Print Transmit Print Transmit ipo Print Print pa Transmit displayed report L to print or transmit 14 The manual stat mode screen remains active if you want to run another stat sample Repeat steps 2 through 7 for additional manual stat samples 8 11 SAMPLE ANALYSIS RUNNING WORKLIST SAMPLES IN AUTOLOADER MODE cd 15 When you are finished analyzing the stat samples u to exit the Manual Stat mode 16 Verify the Sample ID and results before reporting the results 8 5 RUNNING WORKLIST SAMPLES IN AUTOLOADER MODE The following procedures are provided e Worklist Barcode Positive ID Manual Match ON e No Worklist Barcode Positive ID Manual Match OFF e Worklist Cass Position Positive ID Manual Match ON e No Worklist Cass Position Positive ID Manual Match OFF To learn more about the Worklist feature see Heading E 2 WORKLIST MATCH OPTION SCENARIOS Worklist Barcode Positive ID Manual Match ON Do this procedure to analyze samples with barcoded Sample IDs from the Worklist with Manual Match on ety oP PE a b LOO oE a 1 TENE ae a i mim at Q t D A v E4 li Supervisor I ovo 8 12 PN 624026AE SAMPLE ANALYSI
105. report 5 1 A 90 CV definition Glossary 1 cycle count description 11 44 viewing 1 44 D daily routine procedures 6 1 Database Maintenance option 5 12 DB flag 9 49 9 51 debris description 2 20 deciding which Worklist Match Option and Manual Match Option to use A 9 default definition Glossary 1 default system configuration A 1 default test panel 8 35 defining a flagging set A 120 defining a New Workday A 107 defining automatic re run criteria A 60 defining flagging sets A 120 defining the daily workload A 105 defining the Host settings A 78 defining the minimum runs for auto calibration A 40 defining your lab s shifts A 31 deleting a location A 22 deleting a physician A 22 deleting a printer A 88 deleting a Worklist order 8 51 deleting cell control results 7 46 7 48 deleting patient results 9 27 deleting Reproducibility results 11 05 deleting users A 115 demographics adding to patient information E 1 Detailed flags displaying printing A 95 A 96 format 9 51 Diagnostics icon 5 31 5 57 Diagnostics screen 11 8 Diagnostics User screen 11 11 DIFF flag 9 48 Diff Reject See CO flag DIFF syringe function 11 80 location 11 80 DIFF flag 9 48 DiffPlot development overview 2 19 function 2 19 regions 2 20 DIFFPLOT flag what it replaces 9 51 Diluent reagent description 11 6 input connector location 1 4 replacement procedure 11 85 diluent reservoir functio
106. return to the desired screen 6 Resume normal operation Auto Clean Running Do this procedure to run an Auto Clean cycle A amp Nec 1 From the Main Menu screen 0 T 2 2 g to begin the cycle 11 10 PN 624026AE DIAGNOSTICS DIAGNOSTICS USER SCREEN 3 Allow the cycle to be completed 4 d as needed to return to the desired screen 11 6 DIAGNOSTICS USER SCREEN Understanding the User Screen See Figure 11 4 and Table 11 3 Figure 11 4 Diagnostics User Screen AcT 5diff AL User Diagnostics Table 11 3 Diagnostics User Screen Icons Icon Name Function v Hardware Opens the Hardware Systems menu See Hardware Systems in this a Systems chapter r Diluter Systems Opens the Diluter Systems menu See Diluter Systems in this chapter TiS Others Opens the Others menu See Others Diagnostic Functions in this chapter PN 624026AE 11 11 l DIAGNOSTICS DIAGNOSTICS USER SCREEN Hardware Systems The following options are available on the Hardware Systems screen Figure 11 5 e Hardware Reset e Motors Checking e Valves Checking e Sensors Checking e Autoloader Test Figure 11 5 Hardware Systems Screen 11 12 PN 624026AE DIAGNOSTICS l DIAGNOSTICS USER SCREEN Hardware Reset Do a Hardware Reset e if the instrument halts due to error e after an emergency stop of the instrument e when the instrument reports a faulty operation or e whe
107. sample integrity e 10 pL of sample is delivered to the First Dilution Hgb bath for use in preparing the primary RBC Plt dilution and for measuring the Hgb value e 10 pL of sample is delivered to the WBC BASO bath for the WBC BASO count e 7 pL of remaining sample is discarded into the Rinse bath CBC DIFF Panel After aspiration in the CBC DIFF panel aliquots of the whole blood sample are distributed as follows Figure 2 5 e The 3 pL sample aliquot at the tip of the probe is discarded into the Rinse bath as the exterior of the sampling probe is rinsed ensuring sample integrity e 10 pL of sample is delivered to the First Dilution Hgb bath for use in preparing the primary RBC Plt dilution and for measuring the Hgb value e 10 pL of sample is delivered to the WBC BASO bath for the WBC BASO count e 25 uL of sample is delivered to the DIFF bath for development of the DiffPlot e 5 pL of remaining sample is discarded into the Rinse bath Delivery In the CBC and the CBC DIFF panels each aliquotted sample is delivered to its appropriate bath using a tangential flow Figure 2 8 of reagent Tangential flow mixes the diluted sample and minimizes viscosity problems Figure 2 8 Sample Delivery Using Tangential Flow Probe mh Ae Reagent input Tangential flow Bath 7616002A PN 624026AE 2 7 2 OPERATION PRINCIPLES SAMPLE ANALYSIS 2 6 SAMPLE ANALYSIS RBC
108. screen with what is shown on the assay sheet Ow to save the control setup and exit the window X shout seving ee cancel without saving undo changes without saving 9 Repeat steps 2 through 8 until target values are entered for all control levels and all parameters 10 Remove the diskette when all information has been downloaded PN 624026AE A 53 SETUP SETTING UP A CONTROL FILE Reserving Control Lot Numbers Do this procedure to reserve a lot number for a specific control material This allows you to enter the lot number as the Sample ID at the Run screen The system will recognize the Sample ID as being a control and will place the control results in the correct control file ATTENTION The control must be set up before the lot number can be reserved EX AcT Sdiff AL LN ANE Socom COULTER AST Sdiff AL 1 From the Main screen J Q Of A 54 PN 624026AE SETUP A SETTING UP A CONTROL FILE 3 The QC Levey Jennings graphs screen appears 4 0 the Target tab b b i W b W W W E li 5 Select the desired control file 370502 rs W ag 13 CBC DIFF J kat J b 0 the desired control CO PN 624026AE A 55 SETUP SETTING UP A CONTROL FILE 0A 8 Select Reserved Ml to reserve the control lot number as the Sample ID for the control file selected OM Editing Control Target Values Do this procedure to change target values
109. see To mark a sample for re run in this chapter Sorting Results You can sort results in ascending or descending order The fields sort alphanumerically by character For example 10 will appear before 4 because it is being sorted by the 1 unless sorted in descending order Numbers appear in a sorted list before letters For example Sample ID 482 will appear before Sample ID N482 unless sorted in descending order To sort by Sample ID Patient ID or Run Date Time 1 Double click the desired column title Sample ID Patient ID or Run Date Time e Ifyou see next to the column title the results are sorted in ascending order e Ifyou see next to the column title the results are sorted in descending order The and appear as shown here Patient ID a Run Dates Time 2 Locate the desired result To sort by special sort criteria Scroll to the right on the Results screen to see the following columns AF DH PL AL P T OO O O 0 o See Figure 9 4 for the relationship between the sort criteria and the columns Figure 9 4 Sort Criteria Columns Defined AF DH PL AL P T Po fp of ie Analytical Action Limit M DiffPlot Histogram l Not Printed I Patient Limit M Not Transmitted PN 624026AE 9 5 DATA REVIEW LOCATING SAMPLE RESULTS 1 To select one or more sort criteria W O until M appears For example to locate all results with action limit flags
110. selected Flagging Sets Stancard Range Apply to all Flagging Sets 8 0 y to save the change PN 624026AE A 63 SETUP AUTO FUNCTIONS SETUP Auto Print for Patient Results You can enable the system to automatically print patient results when the run is completed Figure A 8 shows the Auto Print options for patient results Note For information on enabling disabling Auto Print for controls reproducibility and calibration see Auto Transmit for Patient Results in this chapter Figure A 8 Auto Print Setup Screen for Patient Results Details AcT Sdiff AL Auto Functions Rerun Auto Print Auto Transmit Auto Print Options Patient Results C All Normals g J gt C Selected Abnormals No Parameter Value With Parameter Flags With Histo and DiffPlot Flags eo __ Outside Patient Limits Outside Action Limits a tai te A ae E amp 77 S y 42 Y X Supervisor 1170972002 08 47 31 7367138A Off disables automatic printing of patient sample results upon completion of analysis All automatically prints all patient results upon completion of analysis Normals Only automatically prints only normal patient results upon completion of analysis Selected Abnormals automatically prints patient results that meet the abnormal results criteria 000000 These are the abnormal results criteria for No Parame
111. system you will be required to select if automatic Shutdown is not selected lt LN AET 1 From the Main Menu screen W ay CO AcT 5diff AL System 3 0 the Cycle Options tab Host Pinter A K A 112 PN 624026AE SETUP A SYSTEM SETUP OF Shutdown 5 e the check box next to Automatic I Automatie 18 00 00 for Shutdown as needed M enabled LI disabled 6 Type the time when Automatic Shutdown should occur a Double click the existing time b Type the new start time c Verify the time is correct 7 y to save the change PN 624026AE A 113 SETUP OPERATOR USERS SETUP A 9 OPERATOR USERS SETUP Under Operators setup Figure A 17 you can add edit delete users See Operators Users Adding Editing Deleting for details on adding editing deleting the user s e Login Name e Password e Group e Operator Code By assigning each user his her own user name there is traceability for actions performed For example when a user named Jo logs in under that name any changes made by that user to the patient or Worklist information will be noted in the Patient Worklist log Figure A 17 Users Setup Screen AcT Sdiff AL Operators 7 7 A User Details Login Name v Service p iO Operator Code ISER Perri aaas phbr Modified on cg 2 Y 42 vx vi 000000000 Service Bii i 0672672002 09 12
112. the material safety data sheets MSDS for additional reagent information To order an MSDS see Heading 1 10 ORDERING MATERIAL SAFETY DATA SHEETS MSDS Neutralizing the Waste and Treating for Biohazards Do this procedure before capping the waste container for disposal WARNING Risk of personal injury if waste is not neutralized before the waste container is capped Non neutralized waste contents may produce 50mL 250mL gas which can build up pressure in a capped container Neutralize waste contents after removing the waste container and before Capping it for disposal Sodium Hydroxide Sodium Hypochlorite Os Bex For 20L of waste liquid add the following to the waste container a 50mL of Sodium Hydroxide solution 200g L to prevent gas from forming a 250mL of Sodium Hypochlorite solution 12 available chlorine to treat waste for biohazards 2 Cap the waste container and firmly tighten the cap to prevent waste contents from escaping 11 6 PN 624026AE DIAGNOSTICS Ji WASTE HANDLING PROCEDURES 3 Dispose of the waste container according to your laboratory s guidelines Handling Expired Reagents Do this procedure to eliminate cyanides from expired ACeT 5diff Hgb Lyse gt A 2 Ar o 1 For 1L of reagent add 100mL a 50mL of Sodium Hydroxide lution 2 See 00g L Ammonium Persulfate b 100mL of freshly prepared Q Ammonium Persulfate solution ah r he 500g L or 50mL
113. the top fitting c Remove the tubing from the bottom of the filter 6 Properly dispose of the old rinse bath filter PN 624026AE 11 105 DIAGNOSTICS REPLACEMENT PROCEDURES 7 Install the new rinse bath filter a Connect the existing tubing to the Dom bottom of the new filter RWS b Grasp the upper half of filter and insert the end into the fitting c Secure the filter by turning as needed d Connect the tubing on the bottom of the filter to the rear port of valve 27 e Push the tubing down over the fitting till it is secure 8 Replace the right side panel a Slide the panel into place b Tighten the screws with the door key 11 106 PN 624026AE DIAGNOSTICS Ji REPLACEMENT PROCEDURES 9 Plug the Analyzers power cord into its power source electrical outlet 10 Power up the system as instructed in Powering Up the System and Logging On in Chapter 5 11 Cycle a sample with known results to verify instrument performance 12 After the cycle is complete a Remove the right side panel see Removing the Right Panel in this chapter b Confirm there are no leaks and that the rinse bath is empty c Replace the right side panel see Replacing the Right Panel in this chapter 7367382A 13 Resume normal operation PN 624026AE 11 107 DIAGNOSTICS OPENING THE TUBE HOLDER DOOR IF JAMMED 11 12 OPENING THE TUBE HOLDER DOOR IF JAMMED IMPORTANT Risk
114. throughout this manual Cautions Anything that can cause instrument damage is considered a caution and is noted in the text as CAUTION Cautions appear where needed throughout this manual Importants Anything that can cause misleading results or data corruption is considered important and is noted in the text as IMPORTANT Importants appear where needed throughout this manual Attention An ATTENTION provides additional information to be considered when performing a procedure 4 2 SAFETY PRECAUTIONS Electronic WARNING Risk of personal injury from electronic shock Electronic components can shock and injure you To prevent possible injury or shock do not tamper with the instrument and do not remove any components covers doors panels and so on unless otherwise instructed within this document Biological WARNING Risk of personal injury or contamination If you do not properly shield yourself while using or servicing the instrument you may become injured or contaminated To prevent possible injury or biological contamination you must wear proper laboratory attire including gloves a laboratory coat and eye protection Use care when working with pathogenic materials Be sure that you have a procedure available to decontaminate the instrument provide ventilation and dispose of waste liquid and sharps Refer to the following publications for further guidance on decontamination e Biohazards Safety Guide 1974 National Insti
115. values for the DIFF file only Reserved ID indicator when selected any sample run with Sample ID matching the lot number is The QC Data Grid screen Figure 7 3 shows the results from each QC run for the selected control file To see this screen C E at the Levey Jennings Graph screen Figure 7 2 Figure 7 3 QC Data Grid Screen A A Cont 17 CORRS Nane Inc Opr Date Time wec RBC HGB HCT MCV SWTR 13 CBC OFF FF Serice 0906 2002 142955 70 133 M Service 03 06 2002 14 31 40 7 0 131 fio S g E lenie ose 2o2143227 75 132 Z _ Service 09 06 2002 14 33 55 74 131 Reserved F Service 09 06 2002 16 11 49 72 133 A Expiration Date a ist J 2 Comment ia Analytical Error EA ver Selected Results N mi 09 06 2002 Mean By 25D Service CV Lower Limits Shift Selection 7 v Q Upper Limits Delta Diff 09 10 2002 10 36 30 7367056B Control file name cannot be edited Check box that includes or excludes results from statistical calculation and display on the Levey Jennings graphs Operator who ran the QC analysis 7 27 7 QUALITY ASSURANCE RUNNING CELL CONTROLS o000 8 86 000000 00 000 7 28 Date and time the QC analysis was done Parameter results for QC analysis If result is outside limits value is backlit in red for an H or L flag Scroll bar to display
116. 0 0 0 0 0 Failed 09 04 2002 07 53 31 Service 0 2 0 00 0 0 0 0 Failed 109 04 2002 07 54 21 Service 0 00 0 0 o Failed 09 05 2002 08 10 41 Service 0 0 0 00 0 0 1 Oc Passed A 09 06 2002 07 45 52 Service 0 0 0 00 0 0 o 0 1 Passed 09 09 2002 07 40 43 Service 0 0 0 00 0 1 o 0 04 Passed 09 09 2002 15 09 10 Supervisor 0 3 0 00 0 0 o 0 03 Passed 09 10 2002 08 32 55 Service 0 0 0 00 0 0 1 0 02 Passed Eii b i bbb W 0970372002 11 25 54 Service ta WBC 00 RBC 0 00 HGB 0 0 PLT 1 Flow Cell WBC Status Passed v x w 0971072002 12 31 53 7367522A amp Version V0 15 rt 2 gt A Sovica Background Operator Service Run Date Time 09 10 2002 12 36 18 Status Startup Passed 7367524A 5 8 The Startup Log displays the Startup status and parameter results For details on viewing the Startup Log see Viewing Logs in Chapter 11 The Background report displays the Startup status If Auto Print is enabled for Startup the Background report automatically prints For information on enabling Auto Print see Auto Print Non Patient Results in Appendix A PN 624026AE GETTING STARTED 5 POWERING UP AND LOGGING ON POWERING DOWN AND LOGGING OFF Powering Down the System and Logging Off Before performing certain replacement procedures you will be instructed to power down the system to prevent personal injury from electric shock There is a proper power
117. 0 E a mo yn os 100 500 550 ay mow 000 010 10 110 a foe NE EE a E GS supervisor _ ee fe 10 ef 5 2 3 P id 4 y x 9 Eanes T 077672002 1648 37 4 To edit an existing flagging set except Standard Range a Highlight the flagging set e g Man OF PN 624026AE A 123 SETUP FLAGGING SETS SETUP 5 To add a new flagging set n Oba Type the flagging set name up to 20 alphanumeric characters Do AcT 5diff AL Flagging Sets not use an apostrophe or any other punctuation in the flagging set al name an A E If you do not type a name on E E xxxxx will be the name B 60 pny If you type a name that already z A Restore Default Values ie a o A exists the following message eee o e MO 1 0 20 appears fr g a lt a Mo 0 00 010 bea e om ow ew a e Name already exists Saika BA 0 00 0 00 0 20 030 lE 7 a 2 24 v X Dd Serice M o e If this appears OM 2 Type anew name ATTENTION The action and patient limits applied to a new flagging set are those from the Standard Range flagging set 6 Define the patient limit ranges a Highlight the number to be changed b Type the new number c Press to move between the fields To copy setting from another flagging set go to step 5 of e Copying Settings to Another Flagging Set A 124 PN 624026AE SETUP FLAGG
118. 0 Q 7 36 PN 624026AE PN 624026AE QUALITY ASSURANCE RUNNING CELL CONTROLS The QC Levey Jennings graphs screen appears Act Sdiff AL Quality Control anne TEC TREC THOS HCT MCVIMCH McHCrRDWseLT MevinerLY woreosea CONTROL 13 CEC DIFF z NesiLveimos Eos IBAF Lot Number eee 60503 E er F Reserved wec A Expiration Date Hy 07 10 2002 1037 a i a m i B wacht 1057 ec 247 1064 012 J t RBC a wep 64 gat ni ner fies x 10 7at pur 3 103 nt Modified on u a 07 10 2002 By 64 rs Service wa Sra le Shift Selection os a z a g E ey v xX o77e72002 1832 71 Select the control file to be reviewed Control Name 7 af CONTROL 13 CBC DIFF z b the desired control From the QC Levey Jennings graph screen J to view the QC Graphics screen for the last control run not the last control run in the selected file JAcT Sdiff AL Control Gray Sample ID phics e0902 Cass Pos Panel E S eecjorrr Run Date Time 10701 2002 08 51 44 Comment Analytical Error I e E Analytical Messages BASO A Flags and Messages w m gt a la ee J v x me eee d 4 Tiraram 103006 a i
119. 026AE DATA REVIEW LOCATING SAMPLE RESULTS 2 The Archive screen appears Ale E Ine Sample ID Cass Pos Patient ID Last Name Fist Name Panel Flagg A p 4 Q 5 2 Z y X a Rie N E Nia F T 10371672002 0344 21 3 To search for a result by run date J a b At the Run Date field J E and select the run date me me c To select all results for the chosen date o w oo00 To deselect all selected results for the chosen date C 4 To search for a result by the patients ID or last name OS b Search e by Patient ID see Searching by Patient ID in this chapter or e by the patients last name see Searching by Last Name in this chapter PN 624026AE 9 9 9 DATA REVIEW LOCATING SAMPLE RESULTS Searching by Patient ID l At the Patient ID field b E 2 Select the Patient ID Searching by Last Name l At the Last Name field o po Last Name 2 At type the patient s last name As you type the indicator moves through the list to locate the last name 3 Highlight the desired patient from the list 4 C Yy The following screen appears AcT Sdiff AL Archives m 1 7 Run Date Time 11722 2002 8 53 Patient 1D WBC 103 uL OL RBC 105 4 zm T A Wemer ir y 300R 11 8RH a 183ALL tn 72 3RHH O5 ALL 06R A 23H NEH 103 uL 1 09ALL LYBE 103 uL 468R MOH 103 uL 0 03RL Ow 103 uL 004R T BA 103 aL 014
120. 1 11 2 11 3 14 M15 11 6 11 7 11 8 11 9 11 10 11 11 11 12 11 13 Let 11 15 11 16 L7 11 18 11 19 11 20 11 21 11 22 A l A 2 A 3 Results List Screen Column Headings 9 3 Sort Criteria Columns Defined 9 5 Results Screen 9 7 Archives Screen Details 9 8 Results Screen 9 11 Manual Match Screen Details 9 14 Results List Screen 9 19 Print Options for Patient Results 9 20 Transmit Options for Patient Results 9 22 Flags and Messages Collapsed View 9 38 Flags and Messages Expanded View 9 38 WBC BASO Histogram Flags CBC Panel 9 43 WBC BASO Histogram Flags CBC DIFF Panel 9 43 MICRO and MACRO Regions on RBC Histogram 9 43 Plt Flags 9 44 Mobile Threshold Positioned in the Standard Regions Between 18 fL and 25 fL 9 44 Mobile Threshold Cannot Be Positioned in the Standard Region 9 44 Mobile Threshold Cannot Be Positioned 9 44 Presence of Small Cells in the 2 fL and 3fL Regions 9 45 Calibration Screen Details 10 2 Modify Calibration Targets Screen 10 4 Calibration Runs Included and Excluded 10 15 Calibration Log Entry Forced Calibration 10 18 Analyzer Doors and Covers Right Side 11 3 Analyzer Doors and Covers Left Side 11 3 Diagnostics Menu Screen 11 8 Diagnostics User Screen 11 11 Hardware Systems Screen 11 12 Diluter Systems Screen 11 27 Bath Assembly 11 38 Others Diagnostics Screen 11 43 Reproducibility Screen Details 11 52 Inside Left Components 11 76 Inside
121. 1 2 means that you are viewing the first set of results out of a rerun 2 2 means that you are viewing the second set of results for a rerun Displays the next sample s results Displays the last sample s results Displays all generated flags and interpretive messages if any See Heading 9 7 REVIEWING RESULTS for additional information 9 DATA REVIEW AFTER LOCATING THE SAMPLE RESULTS 9 12 Allows you to scroll to view additional text in the Flags and Messages area Displays all parameter results histograms and DiffPlots Normal results within your defined patient limits and action limits appear against a white background BE results below your defined patient limits appear against a yellow background with an L ee results above your defined patient limits appear against a yellow background with an H EN results below your defined action limits appear against a red background with an LL HQ results above your defined action limits appear against a red background with an HH See Heading 9 7 REVIEWING RESULTS for additional information indicates an RUO Research Use Only parameter and is not for use in diagnostic procedures This symbol only appears when the RUO parameters are enabled See RUO Parameters Enabling Disabling in Appendix A Sample ID and demographic information based on information entered at the Sample ID screen or received from the Host allows you to enter comments abou
122. 1 37 7 QUALITY ASSURANCE RUNNING CELL CONTROLS Print Trans 8 E the desired tab e For printing options verify that the Print tab is selected e For transmitting options verify that the Transmit tab is selected This allows the control results to be sent to the Host computer if applicable 9 J the desired option 10 u y to print transmit the selected cell control results 11 Y 2 when you are finished 7 38 PN 624026AE QUALITY ASSURANCE T DOWNLOADING CELL CONTROL RESULTS FOR IQAP 7 4 DOWNLOADING CELL CONTROL RESULTS FOR IQAP Overview You can submit your control results to Beckman Coulter for inclusion in Beckman Coulter s IQAP program See IQAP Interlaboratory Quality Assurance Program in Chapter 1 for additional information The IQAP can provide statistical comparison only for parameters that have assigned assay values To process the cell control data from your instrument you must submit one output file for each cell control lot number per shift i e 0 1 2 or 3 When you download the cell control information to a diskette the instrument assigns a unique filename to that information part of the filename will be your IQAP ID Beckman Coulter recommends you submit your control data monthly Controls Processing If a result that has non numerical parameter results is manually selected for inclusion in the statistics the values that have been replaced by the non numeric flag will be
123. 1 41 run definition Glossary 2 Run in Progress icon 5 30 5 57 running Auto Clean 11 10 running calibration in the Autoloader Mode INDEX recommended 10 12 in the Manual Stat mode 10 13 running calibration samples 10 11 running cell controls in Autoloader Mode with Barcode ID 7 4 in Autoloader Mode without Barcode ID 7 9 in Manual Stat Mode 7 15 when to run 7 3 running manual stat samples if no order on Worklist and demographics are required 8 7 running Mini Clean 11 9 running non Worklist samples Cass Position is Worklist Match Option and Manual Match is Off 8 29 running non Worklist samples Barcode is Worklist Match Option and Manual Match is Off 8 18 running Reproducibility in the Autoloader Mode 11 60 in the Manual Stat Mode 11 53 running stat samples if already running Worklist samples 5 2 8 2 running Worklist samples Barcode is Worklist Match Option and Manual Match is On 8 12 Cass Position is Worklist Match Option and Manual Match is On 8 22 in Autoloader Mode 8 12 RUO definition Abbreviations 2 RUO parameters enabling disabling A 15 how to display print and transmit A 15 list of A 15 S S flag 7 21 9 36 printed on QC report 7 21 safety precautions biological 11 37 list of 4 1 while performing maintenance or service 11 37 sample analysis minimum requirements 2 23 rerunning samples 8 32 running manual stat samples 8 2 Index 11 INDEX Index 12 runnin
124. 11 110 11 14 SYSTEM ERRORS 11 112 What Error Messages Mean 11 112 11 15 TROUBLESHOOTING GUIDES 11 122 11 16 LOGS 11 124 Overview 11 124 Understanding the Logs Menu Screen 11 125 Understanding the Logs 11 126 Calibration Log 11 127 Quality Control Log 11 127 Reagent Log 11 127 Maintenance Log 11 127 PN 624026AE PN 624026AE CONTENTS Patient Worklist Log 11 127 Setup Log 11 127 Host Log 11 127 Alarms and Errors Log 11 127 Startup Log 11 128 Viewing Logs 11 128 Adding Comments to the Logs 11 129 Adding Entries to the Maintenance Log 11 130 Printing Log Entries 11 132 A SETUP A 1 A l A 2 AS AA A 5 INSTALLATION A 1 DEFAULT CONFIGURATION A 1 SETUP OVERVIEW A 1 Password Requirements A 1 Changes to Instrument Setup A 1 Understanding the Setup Screen A 2 OPERATIONAL SETUP A 3 General A 3 Auto Numbering Setting the AUTO_SID Starting Number A 4 Default Panel Selecting CBC or CBC DIFF A 6 Worklist Match and Manual Match Options A 9 Worklist A 9 e Barcode A 9 e Cass Position A 9 Manual Match A 9 Deciding Which Worklist Match and Manual Match Options to Use A 9 Possible Workflows and Configurations A 10 Worklist Match Option Selecting A 10 Manual Match Turning ON or Off A 12 Logs Comments Prompt A 14 RUO Parameters Enabling Disabling A 15 Auto Stop for QA Messages Selecting A 18 Auto Stop for Number of Consecutive Results With Selected Charac
125. 13 04 42 Note allows you to modify the XB XM Limits To do this see Setting XB XM Limits in Appendix A PN 624026AE QUALITY ASSURANCE T XB ANALYSIS Do this procedure to review the XB XM Analysis graphs amp LN AN 1 From the Main Menu screen W Q 0 Note If the icon is grayed out there is not enough control data for XB 3 The XB XM graphics screen appears e Ifyour system is setup for 3 parameters then the 3 Parameters XB screen appears e Ifyour system is setup for 9 parameters then the 9 Parameters XM screen appears shown here PN 624026AE 7 53 QUALITY ASSURANCE XB ANALYSIS Viewing XB Batch Details Screen and Including Excluding XB Data The XB Batch Details screen Figure 7 7 displays parameter values batch number and run date time Statistics includes the means of all the batches and the coefficients of variation for each If batch values or means are not within acceptable limits they are displayed in color yellow if low and red if high Figure 7 7 XB Batch Details Screen RBC HGR HCT _ MCV MCH MCHC 513 14 9 43 8 8 291 mo 466 152 445 n 313 342 5 32 15 4 45 4 29 339 7 54 PN 624026AE QUALITY ASSURANCE T XB ANALYSIS e Procedure to View XB Batch Details Screen and to Include Exclude XB Data Do this procedure to review the XB Batch Details
126. 18 Close the reagent compartment door tN a7 a Lift the door up b Lower the door until it is closed 19 Inspect the reagent lines to ensure there are no air bubbles present If air bubbles are present repeat step WE 20 Power down the system as instructed in Powering Down the System and Logging Off in Chapter 5 21 Power up the system as instructed in Powering Up the System and Logging On in Chapter 5 11 72 PN 624026AE DIAGNOSTICS Ji CLEANING THE ANALYZER Cleaning the Baths Frequency As needed Supplies Needed Q 50mL ofa 1 to 2 chlorine solution produced from high quality fragrance free sodium hypochlorite gt Ifusing 4 high quality fragrance free sodium hypochlorite dilute with an equal part of distilled water gt Ifusing 10 to 12 high quality fragrance free sodium hypochlorite dilute by adding 10 parts distilled water to 1 part of the sodium hypochlorite Q 5 lint free wipes or fabric tipped applicators Note Extended Cleaning is required after this procedure Do this procedure to clean the baths ARAR 1 Power down the system as instructed in Powering Down the System and Logging Off in Chapter 5 2 Unplug the Analyzer from its power source wall outlet PN 624026AE 11 73 DIAGNOSTICS CLEANING THE ANALYZER 3 Remove the right side panel a Loosen the screws with the door key b Pull the panel up to remove 4 Remove the bath shiel
127. 2 To download the assay values and ranges from the floppy This procedure continues from Heading A 6 SETTING UP A CONTROL FILE above ATTENTION MCVs with a decimal value of 5 or higher will be rounded up to the nearest whole number MCVs with a decimal value of 4 or lower will be rounded down to the nearest whole number 1 Insert the correct assay values diskette into the floppy drive UA 0S 4 Select the level of control Low Normal or High Select Control to Load Low Hormal OM If the system cannot detect a diskette the following error message appears There is no disk in the drive Please insert a disk into drive A If this appears insert the diskette and select Retry If you select Abort QC Target Values File not found appears if this Ow 6 Ifthe expiration date on the floppy is expired the following message appears happens AcT 5diff AL Control expired Continue PN 624026AE SETUP A SETTING UP A CONTROL FILE ATTENTION Beckman Coulter suggests that you do not use control material past its expiration date e To cancel the download Set up a current not expired control ia a Allow the download to be completed When the LED on the Workstation PC is no longer illuminated remove the disk e To download the expired control information The Expiration Date field displays the date downloaded from the floppy 7 Verify the downloaded information on the
128. 2 PN 624026AE DAILY ROUTINE 6 STARTUP 2 Allow Startup to finish When it is completed the Main Menu screen appears 3 If Auto Print is enabled the Background report automatically prints with the Startup results If Auto Print is disabled do Printing Log Entries in Chapter 11 to print See Auto Print Non Patient Results in Appendix A for details on enabling the auto print feature for Startup results For additional information see Viewing Startup Results in Chapter 5 4 Review the Startup results status e If Passed appears go to step 3 e If Failed appears go to step 5 9 If Failed appears pamon COULTER a From the Main Menu COULTER AST Sdiff AL O Ole Evaluate the numeric results d u ia to run Startup again e Ifthe Startup fails again contact a Beckman Coulter representative PN 624026AE 6 3 DAILY ROUTINE STARTUP 6 Add comments to the Background report if desired Ue b Type your comments C 0 Yy to save Reagent Expired During Startup During Startup if the system detects the reagent is expired 1 Reagent expired appears in the Miscellaneous Messages in the tree view p Bosses DA Read the log entry 5 You can change the reagent or continue running with the expired reagent Note If you continue running Reagent expired will appear in Miscellaneous Messages in the tree view for all samples run with an expired reagent
129. 26 7367331A Shows the entry that is selected and displayed in Log name A log entry The reason why the log entry was made The scroll bar which allows you to scroll right and left to see additional information such as comments 11 126 PN 624026AE oo 98 98 Date and time the system made the log entry DIAGNOSTICS LOGS Allows you to add comments to the log See Adding Comments to the Logs in this chapter This area shows the log entry information O including information that may not be easily seen on the screen without scrolling such as comments if any The operator who was logged into the system at the time the entry was made When the system makes an entry into a log the entry is posted to the appropriate log For example entries regarding reagents are made to the Reagents log See Table 11 8 for details regarding the various entries made into each log Table 11 8 Log Details Log Entries Made into the Log s Storage Capacityt Calibration Log e when calibration is done e when a target value is changed e when a calibration analysis is rejected e when analysis is started and the calibrator is expired 5 years Quality Control Log e when a QC target value is changed e when a QC analysis is rejected 1 year Reagent Log when a reagent is replaced 5 years Maintenance Log ATTENTION The system does not automatically make entries into the Maintenance log Whe
130. 26AE 11 1 GENERAL MAINTENANCE This chapter details the ACeT 5diff AL Analyzer maintenance procedures that are your responsibility Also included is a troubleshooting guide to help solve possible instrument problems Failure to properly execute the maintenance procedures in this chapter may compromise instrument performance DIAGNOSTICS Perform maintenance procedures either on a time schedule or on an instrument cycle schedule Mark the maintenance dates on your calendar CAUTION Incorrectly performed maintenance procedures can damage the ACeT 5diff AL Analyzer Do not attempt to do any procedures not included in this manual Contact a Beckman Coulter representative for service and maintenance beyond the scope of what is documented in this manual 11 2 MAINTENANCE SCHEDULE PN 624026AE See Table 11 1 Table 11 1 Maintenance Schedule Maintenance Procedure Frequency Situation Startup Daily If Automatic Startup is enabled the Startup cycle automatically run when you turn on a the instrument If Automatic Startup is disabled do Startup Procedure To enable Automatic Startup do Startup Automatic Shutdown Daily Do Heading 6 4 SHUTDOWN to clean the instrument Reproducibility check Calibration verification For troubleshooting or when required by your laboratory or regulatory agency your laboratory or regulatory agency See Heading 11 7 REPRODUCIBILITY CHECK As needed or when required
131. 2c 0 oC e a n el s11920039 2 Unknow c 007 10 20 C OR OO E F 311929099 4 Unknow c o07 10 2 C MF Oo Iauto se 5 Unknow cecpo7jiyj2ccl MM OO a F lautosico 6 Unknow o MM BO Ci lauto_sico 7 Unknow o MR Oo iiim I 311929039 1 Unknow c c o07 10 2c 0 MM MO PPP E 311929009 3 Unknow cegoo7 jiyjace CR Oo PF fautosico 4 Unknow cecoo7 jijaccl MM MO F jautosico 5 Unknow cecjoo7fjigjec MM OO fF aiisec099 6 Unknow c 007 10 2 C CF CF Oo oo F jautosico 7 Unknow c o07 10 2 C MM OO Fi fsiig20039 1 Unknow o MR RO PF jais2c0p 93 Unknow c o07 102 0 MM OO la M auTO_SIC9 4 Unknow c c D07 10 2c 0 e wR Ee Pilato sico 5 Unknow cegoo7jiojco MR OO z F 311929099 6 Unknow c o07 102c 0 MO OO MM auro swo 7 Unknow o MM Oo i jauTo sico 1 Unknow cecoo7 iojac MM BO GE f jauto_sic9 2 Unknow c c D07 10 2c C MM MO a J gt Db 4 v X dv Supervisor l 0971972002 20 14 00 2 Sort the results if necessary You can sort the results by e Sample ID e Patient ID e Run Date Time I Analytical DiffPlot Histogram Patient Limit See Sorting Results in this chapter Action Limit Not Printed Not Transmitted PN 624026AE DATA REVIEW LOCATING SAMPLE RESULTS 9 3 Once you have located the desired result you can e view the report see To review the patient results screen in this chapter e print transmit the report see Heading 9 4 PRINTING SAMPLE RESULTS e mark the result to be re run
132. 4 2 4 3 DEFINITIONS 4 1 Warnings 4 1 Cautions 4 1 Importants 4 1 Attention 4 1 SAFETY PRECAUTIONS 4 1 Electronic 4 1 Biological 4 1 Moving Parts 4 1 OPERATIONAL HAZARDS 4 2 GETTING STARTED 5 1 3l 32 5 3 5 4 GENERAL 5 1 COMMONLY ASKED QUESTIONS 5 1 POWERING UP AND LOGGING ON POWERING DOWN AND LOGGING OFE 5 3 Powering Up the System and Logging On 5 3 Viewing Startup Results 5 7 Powering Down the System and Logging Off 5 9 NEW WORKDAY 5 11 New Workday Routine 5 11 No Unmatched Results on Manual Match Screen 5 11 Unmatched Results on Manual Match Screen 5 12 New Workday Options 5 12 What Happens if No New Workday Options are Selected 5 12 PN 624026AE PN 624026AE 5 5 5 6 Dl 5 8 29 5 10 CONTENTS LOGGING ON IF SYSTEM IS ALREADY POWERED UP 5 13 WORKING WITH BAR CODE LABELS 5 15 Placing Labels on Tubes 5 15 Scanning Barcode Labels with the Optional Barcode Wand 5 16 WORKING WITH THE CASSETTES 5 17 Learning About the Cassettes 5 17 Inserting Tubes into a Cassette 5 18 Removing Tubes from a Cassette 5 19 Loading Cassettes onto the Analyzer 5 20 Procedure for Loading Cassettes onto the Analyzer 5 20 Unloading Cassettes from the Analyzer 5 21 WORKING WITH THE TUBE HOLDER 5 22 Placing the Tube Holder in the Analyzer 5 22 Positioning Tubes in the Tube Holders 5 22 Position of Tube Holder in the Analyzer 5 22 Tube Holder Door 3 Positions 5 26
133. 40 11 0 25 2LL o ney memo and Histogram Flags Lita 7367535B PN 624026AE 8 33 SAMPLE ANALYSIS ENTERING SAMPLE PATIENT INFORMATION 8 7 ENTERING SAMPLE PATIENT INFORMATION Figure 8 3 shows the patient and sample information fields Figure 8 3 Patient and Sample Information Fields Sample ID Collect Date Time aa Pe Sa e Flagging Set Standard Range CBC DIFF O e Location Physician Comments WA Rerun f Patient ID Last Name id First Name Date of Birth Age ff Gender Unknown Required Information The following information is required for every sample e Sample ID see Sample ID Entering Selecting in this chapter Panel see Panel Selecting CBC or CBC DIFF in this chapter e Flagging Set see Flagging Set Selecting in this chapter Other demographics are optional See Demographics Entering Selecting in this chapter To create a Worklist order the information must be entered manually or downloaded from a Host computer The manual entry is done using the Worklist add function For details see Adding an Order Entry in this chapter 8 34 PN 624026AE SAMPLE ANALYSIS 8 ENTERING SAMPLE PATIENT INFORMATION Sample ID Entering Selecting Sample ID A Sample ID is required for all orders You can manually enter the Sample ID at the keyboard or through scanning with the optional barcode wand The Sample ID can also be received from a Host computer If a Sampl
134. 4026AE DIAGNOSTICS l DIAGNOSTICS USER SCREEN Remove the right side panel a Loosen the screws with the door key b Pull the panel up to remove Remove the bath shield and set it aside From the Main Menu screen 0 ES Of 11 35 DIAGNOSTICS DIAGNOSTICS USER SCREEN OS 7 W Cleaning Cycles tab 8 J Extended Cleaning The following message appears AcT 5diff AL 11 36 PN 624026AE DIAGNOSTICS Ji DIAGNOSTICS USER SCREEN 9 u Y to begin the extended cleaning cycle After about a minute the following message appears AcT 5diff AL Pour 3 ml of extended cleaning reagent into baths Press OK to continue Note Do not until after you dispense the cleaning solution into the baths amp A WARNING Risk of contamination If you do not properly shield yourself while decontaminating the instrument you may become contaminated To prevent possible biological contamination you must use appropriate barrier protections safety glasses a lab coat gloves and so forth when performing this procedure 10 Dispense 3 mL of the 1 to 2 chlorine solution into each bath 11 Press OY Press Enter to continue PN 624026AE 11 37 DIAGNOSTICS DIAGNOSTICS USER SCREEN 11 38 12 Message appears on screen to pour 3 mL of extended cleaning reagent into the WBC Baso bath AcT 5diff AL Pour 3 ml of extended cleaning reagent int
135. 51 7367110A Displays the login information currently set up for your system Displays the login names of each user under each group Displays the login name highlighted in Allows you to define edit the password for the selected login name Allows you to assign the login name to a specific user group Allows you to define edit an operator code for the selected login name Displays the date and operator who last modified the operator setup information Displays the pre defined user groups under which you can assign specific login names Each person you assign will have the same access rights as the user group to which the login name belongs A 114 PN 624026AE SETUP A OPERATOR USERS SETUP Access Rights Service Users with Service access have unlimited access to the system Supervisors Users with Supervisor access can add or edit users in the Operators and Supervisors groups However users in the Supervisors group can only delete a user in the Operators group not in the Supervisors or Service group Operator Users with Operator access cannot add edit or delete other users Operators Users Adding Editing Deleting Do this procedure to add edit or delete a user A A 1 From the Main Menu screen 0 aE MD 2 ig ihe PN 624026AE A 115 SETUP OPERATOR USERS SETUP OF b JE a E e gt 4 v X 0771672002 18 30 12
136. 550nm PN 624026AE 2 9 OPERATION PRINCIPLES SAMPLE ANALYSIS WBC Count and Differential The WBC count is determined twice using two different methodologies e The reference WBC count is the count obtained in the WBC BASO bath Figure 2 10 The WBC count and the BASO count are determined simultaneously e Asecond WBC count is determined in the flow cell during acquisition of the DiffPlot The dilution analyzed in the flow cell is prepared in the DIFF bath Figure 2 10 The WBC counts from the two methodologies are compared and if they exceed the defined limits will be flagged Figure 2 10 Bath Assembly Rinse bath First Dilution Hgb bath DIFF bath RBC bath WBC BASO bath Table 2 4 summarizes the technical characteristics required to obtain WBC and BASO results Table 2 4 Characteristics Required to Obtain WBC BASO Results Dilution Characteristics Volume of whole blood 10 uL Volume A T 5diff WBC Lyse 2 000 uL Dilution ratio 1 200 Reaction temperature 35 C 95 F Measurement Characteristics Method of analysis Coulter Principle Aperture diameter 80 um Count vacuum 200 mb 5 9in Hg Count period 2x6 seconds 2 10 PN 624026AE OPERATION PRINCIPLES 2 SAMPLE ANALYSIS Parameter Results Obtained from the WBC BASO Dilution The final 1 200 dilution is used to e Determine the WBC count and e Develop the WBC BASO histogram which is needed to obtain the BASO count Differenti
137. 57 and C P 10 1 Options a Adda Worklist order and manually match the order to the result To add the Worklist order E 13 E WORKLIST SCENARIOS WORKLIST MATCH OPTION SCENARIOS E 14 ill C goooo0 1 2 Jar 3 Type 123457 as the Sample ID a OW Manually match the order to the results 3 Highlighted the order 4 Highlighted the result 5 Ow b The report automatically prints Manual Match appeared in the Miscellaneous Messages section of the Flags and Messages area of the printout The Sample ID on the report is 123457 Cass is 10 and Pos is 1 e Ifyou print from the Run in Progress screen after matching Manual Match will appear on the report even though the Run in Progress screen shows Unmatched e Ifyou print from the Run in Progress screen before matching Unmatched will appear on the report c Print the result from the Manual Match screen without matching Manual Match will appear in the Miscellaneous Messages section of the Flags and Messages area of the report See Printing from the Manual Match Screen Without Matching in this appendix Scenario 12 Cass Position On Manual Match Off Auto Print On No Worklist Order No Barcode Label Summary Results are printed with an AUTO_SID and with the cassette position of the tube when analyzed Manual Match is off no match required 1 2 Insert tube into the 1st position o
138. 5diff AL analyzer is about 40 pm in diameter Figure 2 2 Dual Focused Flow Process Optical Aperture window Sample dilution Sheath Sample stream 1 injector Sheath Sample Sheath stream 2 stream fluid DFF uses the sheath fluid to surround and force cells suspended in diluent to pass one at a time through the center of the flow cell The first sheath flow focuses the sample through the impedance aperture The second sheath flow maintains the focused flow of cells as they exit the aperture into the optical flow cell Hydrodynamic focusing in the flow cell enables accurate and rapid cell by cell measurements on a large number of individual cells Flow Cell Sequential analyses for cell volume impedance and light absorbance are performed in the flow cell A total of 72 uL of sample is injected through the flow cell for 15 seconds The flow cell incorporates a 60 pm aperture for cellular volume analysis and a 42 pm measurement area for light absorbance 2 3 2 OPERATION PRINCIPLES ACV TECHNOLOGY 2 4 Focused Flow Impedance Focused flow impedance technology measures the electrical resistance of a cell as it passes through the aperture in the flow cell The change in resistance is directly proportional to the volume of the cell Absorbance Cytochemistry As a cell passes through the optical portion of the flow cell light is scattered in all directions A sensor detects only forward scattered light The optical measurem
139. 6 PN 624026AE PN 624026AE DIAGNOSTICS l DIAGNOSTICS USER SCREEN LN ANE NE 1 From the Main Menu screen 0 OA 11 17 DIAGNOSTICS DIAGNOSTICS USER SCREEN 4 e Motors tab Flowcell Syringes Cassette Input Mechanism Traverse Motor Counting Syringe Cass Transfer Mechanism Sampling Syringe Draining Syringe 2 Tube Mixing Mechanism Draining Syringe 1 Ua Je s ilaro Fesoni T Joav2av2002 173956 5 b the desired motor to be checked 6 Open the Errors log see Viewing Logs to verify that the motor s activity did not P 8 g Log y y generate an error message 7 Repeat steps 5 through 6 for each additional motors Ue as needed to return to the desired screen Valves Checking Overview Solenoid valves are devices that allow or stop the flow of a pressurized medium Check any of the following blocks of valves e Valves 1 to 12 e Valves 13 to 19 e Valves 20 to 23 11 18 PN 624026AE PN 624026AE DIAGNOSTICS DIAGNOSTICS USER SCREEN e Valves 24 to 30 e Valves 31 to 37 Valve Locations Valves LV1 through LV19 are grouped into two blocks of solenoid valves in the left compartment see Figure 11 10 e IVI to LV12 are in a horizontal block at the DIFF and reagent syringes assemblies e LV13 to LV19 are in a vertical block next to the DIFF syringe assembly Valves LV20 through LV37 are grouped
140. 6AE you know the Patient ID do Deleting Patient ID or Patient File from Database LN ANE 1 Oral The Archives screen appears AcT Sdiff AL Archives a m Run Date E 11 22 2002 x pL H Inc Sample ID Cass Pos Patient ID LastName Fist Name Panel Flagg A m E 7565_001 Werner Jo CBC DIFF_ WOM _auro_sio70 CBC DIFF STAN Ci as RemO01 Remson 1 CEC DIFF_ WOM E__ auto_sioz1 CBC DIFF STAN i F__jauto_sio72 cec orrr stan calaway cc so I Johnson CBC DIFF STAN p W i B E a va gt B 2 aA wv XX d Service j 1172772002 1309 Of 9 27 9 DATA REVIEW DELETING ARCHIVED PATIENT RESULTS 3 Select the run date for the result s you want to delete KE November 2002 D Sun Mon Tue Wed Thu Fri Sat W Run Date a M at 11 22 2002 1 2 to open the calendar 3 45 6 7 8 9 10 11 12 13 14 15 16 b Select the run date 17 18 19 20 21 23 25 26 GD 28 29 30 1 0 E to advance to the correct month 2 b the correct date 4 The archived results appear for the selected run date AcT 5diff AL Archives 2 2 ee To Inc Sample ID Cass Pos _ Patient ID Last Name First Name Panel I im 123 7565_001 Werner Jo CBC DIFF im AUTO_SID70 CBC DIFF C 456 Rem001 Remson TJ CBC DIFF a AUTO_SID71 CBC DIFF al AUTO_SID72 C
141. 70 dilution 1 58 8 Note The primary from the 1 170 x dilution 1 170 is made First 1 58 8 in the First Dilution Hgb Dilution Hgb Final bath a 1 10 000 2 13 OPERATION PRINCIPLES PARAMETER DEVELOPMENT 2 7 2 14 PARAMETER DEVELOPMENT RBC Parameters Hct Measurement Hct measurement Hct hematocrit is the sum of all the digitized pulses Hct is displayed and printed as percentage Note is the US unit format Other formats are available See Units Selecting the Reporting Unit in Appendix A The height of the pulse generated by the passage of a cell through the aperture is directly proportional to the volume of the analyzed red blood cell RBC Count The instrument uses duplicate counting criteria voting criteria and proprietary flagging information to confirm the parameter result prior to reporting it To obtain an RBC count result the instrument compares the data from the two 5 second count periods then votes and rejects any questionable data RBC count Number of cells counted per unit volume x Calibration factor The RBC count is displayed and printed as RBC N x 10 cells pL Note cells yL is the US unit format Other formats are available See Units Selecting the Reporting Unit in Appendix A RBC Histogram In addition to being counted red blood cells RBCs are categorized according to size from 30 fL to 300 fL by a 256 channel pulse height analyzer The pulse height analy
142. 8 PN 624026AE GETTING STARTED 5 MENU PATH Logs Menu Options See Figure 5 25 Figure 5 25 Logs Menu Options AcT 5diff AL Error Logs Date Time gt 7 10 2 12 5 E AcT 5diff AL Setup Logs Date Time By d AcT 5diff AL Maintenance Logs Date Time Be AcT 5diff AL Reagent Logs Ei AcT 5diff AL Quality Control Logs AcT 5diff AL Calibration Logs gt 0 2002 11 5 i L A fl 07 10 2002 11 39 4 Service Lot Number CX321 Expiration Date 07 11 2002 Not ft 7367450A PN 624026AE 5 39 GETTING STARTED MENU PATH Diagnostics Menu Options See Figure 5 26 Figure 5 26 Diagnostics Menu Screen Options Act 5diff AL User Diagnostics 5 40 PN 624026AE GETTING STARTED 5 MENU PATH Quality Assurance Menu Options The following screens are available from the QA screen Figure 5 28 QC Screen Options Figure 5 29 Reproducibility Screen Options Figure 5 30 Calibration Screen Options Figure 5 31 IQAP Screen Options Figure 5 32 XB XM Screen Options Figure 5 27 Quality Assurance Screen AcT 5diff AL Quality Assurance PN 624026AE 5 41 GETTING STARTED MENU PATH QC Screen Options See Figure 5 28 Figure 5 28 QC Screen Options CONTROL 13 CBC DIFF BAcT Sdiff AL Quality Control onor is err a i AcT 5diff AL Quality Control a CONTROL 13 CBC DIFF Nerva wor __consear AcT 5diff AL Quality Control fomo cemr
143. 9 46 WBC Lyse reagent description 1 13 whole blood definition Glossary 2 workflow definition 2 22 workflow and configuration possibilities A 10 Worklist definition 2 23 match options A 9 purpose A 9 Worklist Cassette screen 8 43 Worklist Grid screen 8 41 Worklist Match Option Barcode A 9 Cass Position A 9 overview A 9 selecting A 10 Worklist orders 8 45 Worklist scenarios Barcode scenarios E 2 Cass Position scenarios E 5 Worklist screens definition 8 40 right side of each 8 40 Workstation definition Glossary 2 illustrated 11 81 Workstation connector location 1 4 X XB definition 7 51 A 35 Glossary 2 selecting the option A 35 XB XM Off A 35 XM defined A 35 PN 624026AE INDEX definition Glossary 2 selecting the option A 35 XM analysis definition 7 51 PN 624026AE Index 15 INDEX Index 16 PN 624026AE BECKMAN COULTER INC CUSTOMER END USER LICENSE AGREEMENT This Product contains software that is owned by Beckman Coulter Inc or its suppliers and is protected by United States and international copyright laws and international trade provisions You must treat the software contained in this Product like any other copyrighted material This license and your right to use the Product terminate automatically if you violate any part of this agreement This is a license agreement and not an agreement for sale Beckman Coulter hereby licenses this Software to you under the follow
144. 98 4 44 134 0 360 28 6 9 2 a VY X d Supervisor 07 25 2002 13 41 58 elf a Hle eol Selecting the Results to be Used for Auto Calibration Review the calibration results to determine if you want to remove one or more calibration runs from the calibration table Remember the instrument requires at least 5 runs to calculate the calibration statistics 1 Verify the desired parameters WBC RBC HBG HCT or PLT are selected for inclusion in the calibration calculation e Toselecta E a O until M appears For example all parameters selected appears like this WBC IV RBC JV HGB JV HCT Jv PLT IV e To deselect a parameter u until LJ appears For example if you deselect RBC and PLT the options appear like this WBC RBC HGR MHT PLT T 2 Once you have selected 5 or more results print the calibration table see Printing Calibration Results in this chapter and keep a copy for your records Calibration passes when e the CV is within the limits defined in Heading 10 3 CALIBRATOR SETUP and PN 624026AE 10 15 i CALIBRATION AUTO CALIBRATION e the new calibration factors are within 20 of the old calibration factors Calibration fails when e the CV is not within the limits defined in Heading 10 3 CALIBRATOR SETUP and e the new calibration factors are greater than 20 of the old calibration factors Note If the following message appears and you Y y the existing calib
145. A 78 Printer A 78 Report Header Entering Editing A 79 Printer A 82 e Add Printer A 82 e Printer Properties A 84 e Set Default Printer A 86 e Delete Printer A 88 Patient Report Setup A 90 e Enable Define Patient Report Areas A 93 e Display and Print Detailed or Suspect Flags A 95 e Hematology Parameters Printed Define for Patient Report A 97 Auto Print Non Patient Results A 99 Cycle Options A 101 Auto Clean Frequency Setting A 102 Daily Workload Defining for CBC and CBC DIFF A 105 New Workday Defining A 107 e Procedure for Defining a New Workday A 108 Startup Automatic A 110 Shutdown Automatic A 112 A 9 OPERATOR USERS SETUP A 114 Access Rights A 115 Service A 115 Supervisors A 115 Operator A 115 xviii PN 624026AE PN 624026AE CONTENTS Operators Users Adding Editing Deleting A 115 Adding Users A 117 Editing User Information A 119 Deleting Users A 119 A 10 FLAGGING SETS SETUP A 120 Flags and Messages A 120 e Adding Editing a Flagging Set Range A 122 e Copying Settings to Another Flagging Set A 126 e Setting a Default Flagging Set A 129 e Restoring Default Values A 130 Flag Sensitivity and Thresholds A 130 BARCODE SPECIFICATIONS FOR OPTIONAL BARCODE WAND B 1 B I B 2 B 3 B 4 B 5 B 6 B 7 B 8 OVERVIEW B 1 Definition B 1 BARCODE LABELS B 1 Symbologies B 1 BARCODE SPECIFICATIONS B 1 BARCODE LABEL TEST PAGES B 3 OPTIONAL BA
146. AE CONTENTS e To review the patient results screen 9 6 e To mark a sample for re run 9 7 Locating Archived Results 9 8 Understanding the Archives Screen 9 8 Procedure for Locating Archived Results 9 8 Searching by Patient ID 9 10 Searching by Last Name 9 10 AFTER LOCATING THE SAMPLE RESULTS 9 11 Understanding the Results Screen 9 11 MANUALLY MATCHING SAMPLE RESULTS WITH WORKLIST ORDERS 9 13 Overview 9 13 Conditions for Results Going to Manual Match Screen 9 13 Understanding the Manual Match Screen 9 14 Manual Match Procedure 9 15 What to Do If the Correct Order is Not on the Manual Match Screen 9 18 Moving Unmatched Results to the Results List 9 18 Adding a Worklist Order for the Result 9 18 PRINTING SAMPLE RESULTS 9 19 Understanding the Results List Screen 9 19 Understanding the Printing Options for Patient Results 9 20 Printing Procedure 9 21 Transmitting Sample Results 9 22 Understanding the Transmit Options for Patient Results 9 22 Transmission Procedure 9 23 ARCHIVING PATIENT RESULTS 9 25 DELETING ARCHIVED PATIENT RESULTS 9 27 Deleting Patient Results by Run Date 9 27 Deleting Patient ID or Patient File from Database 9 30 REVIEWING RESULTS 9 34 Introduction 9 34 Flags and Messages Defined 9 34 FLAGS AND MESSAGES GENERATED BY THE INSTRUMENT 9 35 Parameter Flags 9 35 Results Exceeding Capacity 9 35 Hemoglobin Flags 9 35 e Hgb Blank Error 9 35 e Hgb Read Error 9 36 Vo
147. ALITY ASSURANCE SETUP 5 Edit the desired fields Click the field you want to edit a b Type the new value c Press as needed to move to the next field d Repeat steps b and c until you are finished editing the XB XM limits Ww ae 6 C to accept the new limits peas _ ale A The XB XM screen appears we 30 il 200 RBC p u 1067p iu SS se ae a a ay x HGB in le oal I es CS RAES a v Xx d Supervisor T 0771672002 1516 51 a 4 as needed to return to the desired window PN 624026AE A 39 SETUP QUALITY ASSURANCE SETUP Minimum Runs Required for Auto Calibration Defining Do this procedure to define the minimum runs required for Auto Calibration EA AcT 5diff AL LN NET Serco COULTER COULTER AST Sdiff AL 1 From the Main Menu screen 0 a CR AcT 5diff AL Quality Assurance 3 C the QA Settings tab shits A 40 PN 624026AE SETUP A QUALITY ASSURANCE SETUP Oe 5 Edit the number Minimum Runs for Automatic Calibration a Double click the existing number b Type anew number B 6 0 to save the change io 7 as needed to return to the desired window PN 624026AE A 41 SETUP QUALITY ASSURANCE SETUP IQAP ID Entering Editing If your laboratory participates in Beckman Coulter s IQAP your IQAP ID which you should have receive
148. ALITY ASSURANCE T RUNNING CELL CONTROLS Understanding QC Graphics Screen The QC Graphics screen Figure 7 4 displays the last QC result Access the QC Graphics screen from either the Levey Jennings Graph screen or the QC Data Grid screen by selecting Figure 7 4 QC Graphics Screen SSSEEE SS Sa Control Sample ID e 502 E Analyzer Messages gt 7 2 fal Analyzer Messages Cass Pos Panel BASO rc O eor Run Date Time 547 H UON EN i 133 Comment Analytical Error 8 L MCH pg 243 L 09 10 2002 10 41 19 7367054A Control file information The Sample ID is the Lot Number QC results Histograms of QC results Click to enlarge Analyzer messages DiffPlot of QC results Click to enlarge 9000000 Comment field where you can enter comments up to 50 characters For details on adding or editing a comment see Adding Editing QC Result Comments in this chapter The comment will appear in the Comment area of the QC Data Grid screen Figure 7 3 PN 624026AE 7 29 QUALITY ASSURANCE RUNNING CELL CONTROLS Adding Editing QC Result Comments Do this procedure to add edit a comment at the QC Graphics screen Oe 2 Anchor the cursor in the Comment field l From the QC Graphics screen 3 Type your comments up to 50 alphanumeric characters 4 u to save the comment which now appears on the QC Data Grid screen Pr
149. ALYZER AND WORKSTATION e Workstation Configuration Restore from Hard Disk Restore from Floppy Disk Do this procedure if you want to restore previously saved Workstation settings to be the current settings L COETS T 1 From the Main Menu screen 0 a Coutter AST Sdiff AL PN 624026AE D 11 WORKSTATION MANAGEMENT CONFIGURATION ANALYZER AND WORKSTATION 3 J the Configuration tab Bim En OF IMPORTANT Workstation configuration restore is not recommended if the database contains patient results After a restore the range values in the Workstation Flagging Sets are replaced by the range values from the restored Flagging Sets Existing patient samples remain flagged with the range values as analyzed However the Flagging Set ranges reported are changed to the values from the restored Flagging Sets Verify Flagging Set range values after restore and prior to reporting patient results 5 Indicate from where the settings should be restored e To restore from the hard drive W Restore from Hard Disk e To restore from a floppy disk 1 Insert the proper disk into drive A 2 J Restore from Floppy Disk OM PN 624026AE D 12 WORKSTATION MANAGEMENT D CONFIGURATION ANALYZER AND WORKSTATION 6 Follow the instructions on the screen 7 E to print the current settings for your records 8 u Y to save the change 9 Prior to reporting patient results verify
150. AND WORKSTATION D 3 CONFIGURATION ANALYZER AND WORKSTATION Under the Configuration tab Figure D 1 the following options are available Analyzer Configuration and Workstation Configuration Figure D 1 Configuration Save Restore Screen D 2 PN 624026AE WORKSTATION MANAGEMENT D CONFIGURATION ANALYZER AND WORKSTATION Analyzer Configuration Under Analyzer Configuration you can e Save to Hard Disk e Restore from Hard Disk e Save to Floppy Disk e Restore from Floppy Disk e Analyzer Configuration Save to Hard Disk Save to Floppy Disk This procedure allows you to save the Analyzer s current configuration settings to the Workstation s hard drive or to a floppy disk Once you save the settings you can restore them later if necessary See Analyzer Configuration Restore from Hard Disk Restore from Floppy Disk in this chapter Beckman Coulter recommends that you save the information to floppy disks The Beckman Coulter representative performs this procedure at installation Do this procedure if you change the Analyzer s configuration SEN Yao l Ek Q x z la 02 S 1 From the Main Menu screen a y g 4 z a N fo a a p amp A v x E f 0971872002 08 3213 PN 624026AE D 3 WORKSTATION MANAGEMENT CONFIGURATION ANALYZER AND WORKSTATION OB 3 W the Configuration tab 0A D 4 PN 624026AE WORK
151. ANDING HOW FLAGGING SETS ARE APPLIED 5 58 DAILY ROUTINE 6 1 6 1 6 2 6 3 6 4 WASTE CONTAINER LEVEL CHECK 6 1 PRINTER CHECK 6 1 STARTUP 6 1 Overview 6 1 Background Counts 6 1 Startup Procedure 6 2 Reagent Expired During Startup 6 4 SHUTDOWN 6 5 Automatic Shutdown 6 5 Manual Shutdown Procedure 6 5 QUALITY ASSURANCE 7 1 fl 2 INTRODUCTION 7 1 Understanding the QA Menu Screen 7 1 QUALITY CONTROL QC 7 2 Overview 7 2 QC Techniques 7 2 Controls Processing 7 3 How QC Runs are Analyzed 7 3 PN 624026AE PN 624026AE T2 7 4 7 5 7 6 CONTENTS QC Screens 7 3 RUNNING CELL CONTROLS 7 3 Running Cell Controls Autoloader Mode With Barcode ID 7 4 Running Cell Controls Autoloader Mode Without Barcode ID 7 9 Running Cell Controls Manual Stat Mode 7 15 Reviewing Control Results 7 20 Displaying QC Results 7 22 Understanding the QC Results Screens 7 25 Understanding the QC Levey Jennings Graph Screen 7 25 Understanding the QC Data Grid Screen 7 27 Understanding QC Graphics Screen 7 29 Adding Editing QC Result Comments 7 30 Printing Transmitting Saved Cell Control Results 7 30 Printing Control Results from the QC Levey Jennings Graphs Screen 7 30 Printing Transmitting Control Results from the QC Data Grid Screen 7 33 Printing Control Results from the QC Graphics Screen 7 36 DOWNLOADING CELL CONTROL RESULTS FOR IQAP 7 39 Overview 7 39 Controls Processing 7
152. ANT Risk of instrument error if the reagent tubing is pinched or twisted Pinched or twisted tubing prevents a proper flow of the reagent To ensure that the reagent flows properly through the tubing ensure that the tubing is not pinched or twisted 11 Verify that the tubing is not pinched or twisted 2 UM The system updates the reagent information primes the reagent and updates the level indicator Note Due to priming the reagent level may not be displayed as 100 ATTENTION If an instrument error occurs during the reagent replacement procedure the reagent s may not be fully primed If an error occurs a Acknowledge and resolve the error b Do Hardware Reset in this chapter c Do Prime Reagents to manually prime the reagent s Replacing Reagents Fix WBC Lyse Hgb Lyse or Rinse Reagents Do this procedure to replace either Fix WBC Lyse Hgb Lyse or Rinse reagents To replace only the Diluent do Replacing the Diluent Reagent in this chapter PN 624026AE 11 89 DIAGNOSTICS REPLACEMENT PROCEDURES 11 90 A Wer 1 From the Main Menu screen E i AcT Sdiff AL A S Bry COULTER AST Sdiff AL Double click the level indicator for desired reagent WBC Lyse is shown At the Reagent screen enter the reagent information a Type or scan the lot number from the reagent container b Select the expiration date 1 Y E at the Expiration Date field 2 0 to adv
153. B A xD PN 624026AE C 3 MANUAL CALIBRATION CALCULATING NEW CALIBRATION FACTORS C 4 PN 624026AE WORKSTATION MANAGEMENT DE D 1 DATABASE MANAGEMENT A database stores all archives If the database has been backed up you can restore patient information from the backup Database Compacting Cleaning The database can store 10 000 results To optimize performance the system compacts the database at every 1 000 results The database compacting process begins when you log out and log in again after 1 000 results are stored The following process occurs l At intervals of 1 000 samples during the display of the system s title screen Database cleaning appears You will be prompted to log out and log in again At this point the system compacts cleans the database 2 After 10 000 results have been stored the system automatically deletes the oldest results having the oldest activity by Sample ID leaving a maximum of 9 500 results 3 After the results are deleted the system compacts the database to allow additional results to be stored Every time you logout of the system it performs a database compact and cleaning procedure D 2 CONFIGURATION SAVE RESTORE SETUP Two tabs are available under this option Configuration and Delete Database For additional information see e Heading D 3 CONFIGURATION ANALYZER AND WORKSTATION Heading D 4 DELETE DATABASE PN 624026AE D 1 WORKSTATION MANAGEMENT CONFIGURATION ANALYZER
154. BC DIFF al Callaway CBC C Johnson CBC DIFF ajaj ES H g a y X 11 27 2002 9 13 09 9 28 PN 624026AE DATA REVIEW DELETING ARCHIVED PATIENT RESULTS 9 5 Select the result s you want to delete me W 2 To select all results wf O m e To deselect all results u q e To select individual results u O until M appears s Ow The following window appears AcT 5diff AL Selected All 7 Select the desired delete option e Selected deletes only the selected results e All deletes all results for that particular run date ATTENTION Once a result is deleted it cannot be recovered 8 C y to delete the results Deletion in progress appears while the results are being deleted PN 624026AE 9 29 DATA REVIEW DELETING ARCHIVED PATIENT RESULTS 9 30 Deleting Patient ID or Patient File from Database Do this procedure to delete a Patient ID or a patient file from the database Note To delete patient results by run date do Deleting Patient Results by Run Date A amp Nec 1 C The Archives screen appears AcT Sdiff AL Archives ro pn Run Date i E 11 22 2002 5 pL S Inc Sample ID Cass Pos _ Patient ID Last Name Fist Name Panel Flagg A m EE 7565_001 Wemer Jo CBC DIFF WOM al AUTO_SID70 CBC DIFF STAN me 56 RemO01 Remson i CBC DIFF WOM I auto s1071 CBC DIFF_STAI i Jauto_sip72 C
155. BC DIFF stan E__ calaway a sTo I Johnson CBC DIFF STAN m ooo Lat as va 9 Z v X al Service 1172772002 9 13 09 PN 624026AE DATA REVIEW e DELETING ARCHIVED PATIENT RESULTS OS The following screen appears 3 0 a to search for the desired result by last name The following screen appears AcT 5diff AL Find Patient PN 624026AE 9 31 DATA REVIEW DELETING ARCHIVED PATIENT RESULTS Last Name 4 At type the patient s last name As you type the indicator moves through the list to locate the associated Patient IDs 5 Highlight the desired result Note If only one result appears it is automatically highlighted s Ow The following window appears AcT 5diff AL Delete Patient ID for Selected Entry Delete Patient File x 7 Select the desired delete option e Delete Patient ID for Selected Entry deletes the Patient ID from the database for the selected result e Delete Patient File deletes the selected patient file from the database s OM 9 32 PN 624026AE DATA REVIEW DELETING ARCHIVED PATIENT RESULTS 9 9 A specific message appears based on the option you selected e Ifyou selected Delete Patient ID for Selected Entry this message appears AcT 5diff AL Delete selected Patient ID from database Any existing results including archived will be updated Continue If you continue with this option the
156. BC Ge HCT Mov 09 23 2002 250 z ervice A I Lower Limits 130 473 156 se 30 Sai Target Values 155 493 162 I a BF k Upper Limits 180 513 168 se 8 Delta Diff 60 0s 35 se is 5 or g amp x os T oavan 2002 161451 Lot Number 270502 at gt US 7 34 PN 624026AE QUALITY ASSURANCE RUNNING CELL CONTROLS 6 e the desired tab e For printing options verify that the Print tab is selected e For transmitting options verify that the Transmit tab is selected This allows the control results to be sent to the Host computer if applicable 7 the desired option Transmit Print Selected Results Print All Results C Print Statistics Only v _x Print Transmit Print Transmit i Transmit Selected Results C Transmit All Results CAREA 8 u to print transmit the selected cell control results ap 9 When you are finished 0 as needed to return to the desired screen PN 624026AE 7 35 7 QUALITY ASSURANCE RUNNING CELL CONTROLS Printing Control Results from the QC Graphics Screen Do this procedure to print cell control results from the QC Graphics screen for the last control run Dm Bex Is the Graphics screen displayed for the the control results you want printed e Ifyes 0 Es and y e Ifno go to step 2 2 From the Main Menu screen
157. BC agglutination may be detected by observing abnormal MCH and MCHC values and by examining the stained blood film Use the manual method to obtain an accurate MCV value Excessive numbers of large platelets This condition and or the presence of an excessively high WBC count may interfere with the accurate determination of the MCV value Carefully examine the stained blood film to detect the problem MCH MCH is determined according to the Hgb value and the RBC count which means that anything listed as an interfering substance for Hgb and or RBC will impact MCH and may cause erroneous MCH values MCHC MCHC is determined according to the Hgb and Hct values which means that anything listed as an interfering substance for Hgb and or Hcet will impact MCHC and may cause erroneous MCHC values RDW RDW is determined according to the RBC count and may be impacted by the following conditions e Agglutinated RBCs May cause a falsely low RBC count and erroneous RDWs Blood samples containing the agglutinated RBC may be detected by observing abnormal MCH and MCHC values and by examining the stained blood film e Nutritional deficiency or blood transfusion May cause elevated RDW results due to iron cobalamin and or folate deficiencies PN 624026AE 3 SPECIFICATIONS CHARACTERISTICS INTERFERING SUBSTANCES Table 3 10 Interfering Substances Continued Parameter Interfering Substance Pit Very small RBCs mi
158. BC results RBC Hgb Hct MCV MCH and MCHC after the samples are run A result will be excluded from the XB XM analysis if one of the appropriate parameters e isan incomplete e is above the linear range e has an SCL MIC or SCH flag When a batch of 20 acceptable samples has been collected the Workstation does the XB Analysis calculations for the batch means of MCV MCH and MCHC The batch value for each point is the mean of the results of the last 20 analyses contained in the batch The number of parameters tracked for XB Analysis calculation depends upon your lab s preferences Three parameters for XB is called XB Nine parameter for XB is called XM For details see XB XM Options Enabling Disabling and Setting XB XM Limits in Appendix A and XB Analysis in the Analyzer in this chapter Using XB When using XB Analysis be sure to process samples randomly instead of in a group For example if you process chemotherapy or neonate patient samples as a group the results may cause the XB to be OUT because the XB calculations will be based on those sample results When XB analysis is enabled the Workstation compares the mean values with the target values and the percent limits If the mean values are within the percent limits of the target values then XB will be IN Investigate any batch that is OUT of the XB limits and record the information in your logbook The Workstation also displays the batch means for e
159. Button Accept Values Bitmap Buttons Bitmap buttons Figure 5 38 function the same as command buttons and appear in popup windows Figure 5 38 Bitmap Button Drop down Box Radio Buttons Radio buttons Figure 5 39 which appear within various windows of this software allow you to choose one of the options presented For additional information see Selecting De selecting Software Features in this chapter Figure 5 39 Radio Buttons Off All C Normals C Selected Abnormals 5 48 PN 624026AE GETTING STARTED 5 MENU PATH Fields Text Boxes Fields Figure 5 40 which appear within various windows of this software are rectangular areas where you can input or display data or other information Fields are editable when they appear in white You can move the cursor to the next field by pressing when ina field See Editing Text in this chapter for additional information Figure 5 40 Fields Check Boxes Check boxes which appear within various windows of this software allow you to select include or deselect exclude options See Figure 5 41 Figure 5 41 Boxes Raak PN 624026AE 5 49 GETTING STARTED MENU PATH Scrollable Lists Scrollable lists Figure 5 42 are lists of information that require you to scroll to see all available entries Figure 5 42 Scrollable List ene 41 33 5 33 9 33 3 33 7 33 1 33 4 ut 33 2 33 4 33 2 33 5 z TE U4 Note In some cases you may have to before you can s
160. C P 10 1 Sijil 8 i The Worklist order is still there for 123456789 because it was not matched to a result To delete the order a Highlight the order Ola Cl PN 624026AE PN 624026AE WORKLIST SCENARIOS E WORKLIST MATCH OPTION SCENARIOS d e Y to delete Scenario 15 Cass Position On Manual Match Off Auto Print On Worklist Order Cassette Position and Sample ID Barcode Label Summary Results are placed on the Manual Match screen because the Sample ID read off the barcode label was different from the Sample ID in the Worklist order 1 Create a Worklist order OW Type 10 as cassette number then press Enter Select the ist tube position Type 132 as the Sample ID even though the barcode label was 123456789 2 Insert tube into the 1st position of cassette 10 3 Place cassette in Cassette Input Tray at 4 Phib 5 Sample is analyzed 0 gt Oo aQ 90 Fr to see the Run in Progress screen which shows Sample ID as 123456789 and C P 10 1 La re 7 J aa which was flashing to indicate results are on the Manual Match screen for the Manual Match screen 9 Results are placed on the Manual Match screen Order shows Sample ID 132 Cass Pos Results shows Sample ID 123456789 C P 10 1 10 Manually matched the order to the results Prior to matching you may want to edit the Worklist order as required To manually match 3 Highl
161. COULTER A eT 5diff Autoloader Hematology Analyzer Instructions for Use CE PN 624026AE May 2013 Manufactured for B Beckman Coulter Inc 250 S Kraemer Blvd OULTER Brea CA 92821 U S A WARNINGS AND PRECAUTIONS READ ALL PRODUCT MANUALS AND CONSULT WITH BECKMAN COULTER TRAINED PERSONNEL BEFORE ATTEMPTING TO OPERATE INSTRUMENT DO NOT ATTEMPT TO PERFORM ANY PROCEDURE BEFORE CAREFULLY READING ALL INSTRUCTIONS ALWAYS FOLLOW PRODUCT LABELING AND MANUFACTURER S RECOMMENDATIONS IF IN DOUBT AS TO HOW TO PROCEED IN ANY SITUATION CONTACT YOUR BECKMAN COULTER REPRESENTATIVE HAZARDS AND OPERATIONAL PRECAUTIONS AND LIMITATIONS WARNINGS CAUTIONS and IMPORTANTS alert you as follows WARNING Can cause injury CAUTION Can cause damage to the instrument IMPORTANT Can cause misleading results BECKMAN COULTER INC URGES ITS CUSTOMERS TO COMPLY WITH ALL NATIONAL HEALTH AND SAFETY STANDARDS SUCH AS THE USE OF BARRIER PROTECTION THIS MAY INCLUDE BUT IT IS NOT LIMITED TO PROTECTIVE EYEWEAR GLOVES AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS OR ANY OTHER AUTOMATED LABORATORY ANALYZER WARNING Risk of operator injury if e All doors covers and panels are not closed and secured in place prior to and during instrument operation e The integrity of safety interlocks and sensors is compromised e Instrument alarms and error messages are not acknowledged and acted upon e You contact moving p
162. Calibration QC and or Reproducibility Figure A 6 QA Settings Screen AcT Sdiff AL Qua if To i LLL EEEEREREFEUEGEER GEC 73671058B Allows you to enable disable select the XB XM Analysis See XB XM Options Enabling Disabling in this chapter Displays the Calibration CV Limits which you can edit See CV Limits for Calibration QC and or Reproducibility in this chapter Displays the QC CV Limits which you can edit See CV Limits for Calibration QC and or Reproducibility in this chapter Displays the Reproducibility CV Limits which you can edit See CV Limits for Calibration QC and or Reproducibility in this chapter Displays your lab s IQAP ID which you can edit See IQAP ID Entering Editing in this chapter Displays the minimum number of runs required for Auto Calibration See Minimum Runs Required for Auto Calibration Defining in this chapter A 34 PN 624026AE PN 624026AE SETUP A QUALITY ASSURANCE SETUP XB XM Options Enabling Disabling XB XM Options XB 3 Parameters C XM 9 Parameters XB analysis is a method of monitoring your automated hematology analyzer Similar to XB analysis XM analysis uses a weighted moving average of patient sample results You cannot edit or exclude XM values from the current batch or batch details XB analysis can be set to monitor either three parameters or nine parameters Your laboratory must establish its own mean values For d
163. Cass Position Then set the Manual Match option to OFF These conditions are set on the General settings screen See Worklist Match and Manual Match Options and Manual Match Turning ON or Off in Appendix A Under these conditions when a sample is processed there will be no Worklist interaction and the results will be placed on the Results list and be reported according the instrument configuration Figure 2 19 shows the sample analysis workflow for this instrument Figure 2 19 Sample Analysis Workflow With the Worklist F lt we Clo e As illustrated in Figure 2 19 An order is placed onto the Worklist by manual entry or by Host download The order appears on the Worklist The sample is analyzed for that order in the Autoloader mode or the Manual Stat mode The sample results are generated The order is removed from the Worklist if the results are matched to a Sample ID The results are archived at the start of a New Workday AL OO E we You can search archived results by Patient ID or run date PN 624026AE OPERATION PRINCIPLES 2 WORKFLOW AND WORKLISTS Order An order is a request for analysis entered into the instrument for a specific sample Each order is by a unique Sample ID Order information consists of three categories e Patient information e Sample information e Laboratory information Orders can be entered manually or received from the Host The minimum requirements for sample analysis include
164. Clean See Startup Procedure in Chapter 6 or Mini Clean Running in Chapter 11 14 To check the status of the reagents and to see the analysis capacity based on the current reagent levels do Viewing Reagent Levels in Chapter 11 Viewing Startup Results In addition to checking the limits of the parameters the system also checks the Hgb Blank and Read voltages The following status messages may appear e Passed which indicates that all checks passed the limits e Failed which indicates that one or more of the checks failed the limits If all parameter values are within limits the Hgb Blank and Read check failed The following messages may also print on patient sample reports e Startup Failed which means that the patient sample was analyzed after Startup failed e Startup Not Effective which means that the Startup was not completed while at the Service access level After Startup is completed you can view the Startup results and status Passed Failed For details see e Figure 5 1 Startup Status and Results Displayed on the Startup Log Figure 5 2 Startup Status Displayed on the Background Report 5 7 5 GETTING STARTED POWERING UP AND LOGGING ON POWERING DOWN AND LOGGING OFF Figure 5 1 Startup Status and Results Displayed on the Startup Log AcT 5diff AL Startup Logs Date Time By WBC RBC Br b o9 o3 2002 11 25 54 Service o0 0 00 1 r Passed 09 04 2002 07 52 41 Service 0 0 0 0
165. D E EZ CBC DIFF jing Set Standard Range z eel 0 W E s le e 2 Highlight the desired order sample to be edited OF PN 624026AE 8 49 SAMPLE ANALYSIS WORKING WITH WORKLIST ORDERS 8 50 Make the desired changes if any for Collect Date Time Entering Panel Selecting CBC or CBC DIFF Flagging Set Selecting Location Entering Selecting Physician Entering Selecting Comments Sample and Patient Entering Editing Patient ID Entering Editing Name Locating Selecting Date of Birth Entering Editing Age Entering Editing Gender Selecting Sample ID Collect Date Time i CE f Flagging Set Standard Range x CBC DIFF Oe Location Physician Comments A Rerun f Patient ID Last Name ga First Name Date of Birth Age Lf fs __ Gender Unknown x Om The Worklist is updated to reflect your changes You may need to scroll to view everything PN 624026AE SAMPLE ANALYSIS WORKING WITH WORKLIST ORDERS Deleting a Worklist Order Entry Worklist orders can be deleted at the Worklist Grid screen or at the Worklist Cassette Screen ATTENTION If you delete a Worklist order for a new Patient ID any entered demographic information will be deleted If the order has a Patient ID already in the system prior to this Worklist order then the demographic information for this Patie
166. E Documentation Instructions for Use PN 624026A e Host Transmission Specification PN 4277065 e Training Guide PN 177196 e Hematology Tube List PN A70017 EC REP Beckman Coulter Ireland Inc Mervue Business Park Mervue Galway Ireland 353 91 774068 Copyright Beckman Coulter Inc 2003 2013 All Rights Reserved Use and Function Operation Principles Specifications Characteristics Precautions Hazards Running Samples Reviewing Results Calibration Diagnostics Instrument Setup Barcode Specifications e Log Sheets Manual Calibration e Workstation Management Worklist Scenarios References e Glossary Abbreviations Index Requirements for interfacing the system with a host computer Training information for using the AL system Tube List information Come visit us at www beckmancoulter com COULTER
167. E 20 Printing from the Manual Match Screen Without Matching E 21 ABBREVIATIONS Abbreviations 1 LIST OF ABBREVIATIONS Abbreviations 1 REFERENCES References 1 LIST OF REFERENCES References 1 GLOSSARY Glossary 1 DEFINITIONS Glossary 1 INDEX Index 1 BECKMAN COULTER INC CUSTOMER END USER LICENSE AGREEMENT i TRADEMARKS iii PN 624026AE xxii ILLUSTRATIONS lel 1 2 13 1 4 13 1 6 alee 1 8 1 9 1 10 2 1 2 2 23 24 2 5 2 6 2T 2 8 29 2 10 211 2 12 213 2 l4 pis 2 16 27 2 18 2 19 3 1 5 1 2 2 D3 5 4 5 5 5 6 Det 5 8 29 5 10 2 11 5 12 5 13 JAg J3 5 16 ACeT 5diff AL Analyzer 1 1 AL System 1 2 Overview of Analyzer 1 3 Analyzer Back Panel 1 4 Warning and Caution Labels Analyzer 1 4 Tube Holder 1 1 5 Tube Holder 2 1 5 Tube Positions in the Tube Holders 1 6 Workstation PC 1 7 Back of Workstation 1 7 Coulter Principle 2 2 Dual Focused Flow Process 2 3 Signal Processing 2 4 BASO Thresholds 2 5 Sample Partitions Inside the Probe CBC DIFF Panel 2 6 Sample Partitions Inside the Probe CBC Panel 2 6 Bath Assembly 2 6 Sample Delivery Using Tangential Flow 2 7 Bath Assembly 2 8 Bath Assembly 2 10 Flow Cell Operation 2 11 DiffPlot Regions 2 12 Normal DiffPlot 2 12 Typical RBC Histogram 2 14 Typical Plt Histogram 2 16 Area of the Plt Histogram Used to Determine the PDW Parameter Result 2 17 Areas Used to Determine WBC and
168. ESSAGES GENERATED BY THE INSTRUMENT Table 9 3 Definition of DIFFPLOT Flags Continued DiffPlot Region Suspected Flag DiffPlot Region Affected Description Flags Abnormalities MN Occurs when the R next to Monocytes with number of particles ATL ATL granules or inthe MN IMM IMM hyperbasophilic separation region is NE NE monocytes above the limits set MO and MO Immature Default values 100 or 120 particles MN is displayed and printed in the DiffPlot and Histogram section of the Flags and Messages area neutrophils with non segmented nuclei band cells UM Occurs when the R next to Large monocytes number of particles 7 Hyperbasophilic in UM region is Bee NEF j e MO MO monocytes above the limits set a i IMM and Myelocytes Default values IMM 1 1 or 999 Promyelocytes particles Bit aiopiayen Large blasts i and printed in the DiffPlot and Histogram section of the Flags and Messages area LN Occurs when the R next to all Neutrophil number of particles WBC DIFF degradation due inthe LN region is parameters to improper Debris DB Absorbance above the limits set Default values 2 5 or 999 LN is displayed and printed in the DiffPlot and storage or sample age Pit aggregates particles Histogram RBCs resistant to section of the lysis stroma Flags and Messages area Reagent contamination 9 40 PN 624026AE DATA REVIEW F
169. ESULTS 9 9 4 PRINTING SAMPLE RESULTS You can print from either the Results List screen Figure 9 2 or from the Results Full View screen Figure 9 5 Understanding the Results List Screen See Figure 9 9 Figure 9 9 Results List Screen lal 7 Y S A y X D Version v0 12 Service 07 09 2002 14 44 48 7367181B idii 2 _ Selects deselects all results in the list opens the Manual Match screen Figure 9 8 i selects all itt deselects all a archives the results See Heading 9 5 ARCHIVING PATIENT RESULTS for details Allows you to sort by analytical message meaning that any result with an analytical message will be listed For additional information see Figure 9 4 PN 624026AE 9 19 DATA REVIEW PRINTING SAMPLE RESULTS 9 20 8 O Allows you to sort by DiffPlot Histogram meaning that any result with a DiffPlot Histogram will be listed For additional information see Figure 9 4 Allows you to sort by patient limit meaning that any result with a patient limit flag will be listed For additional information see Figure 9 4 Allows you to sort by action limit meaning that any result with an action limit flag will be listed For additional information see Figure 9 4 Allows you to sort by not printed status meaning those results not printed will be listed For additional information see Figure 9 4 Allows you to sort by not t
170. F ratio DIFF 103 uL 109 L 109 L 103 uL 109 L PN 624026AE A 27 SETUP OPERATIONAL SETUP Changing Reporting Units Do this procedure to select one of the desired reporting units ATTENTION If you change the reporting unit the system automatically restarts to implement the change max AcT 5Sdiff AL LN NE Sore COULTER AST Sdiff AL 1 From the Main Menu screen 0 ay diff AL Miscellaneous 3 C the Units tab A 28 PN 624026AE SETUP OPERATIONAL SETUP 5 Select the desired reporting unit format US v INTERNATIONAL SYSTEM 1 a INTERNATIONAL SYSTEM 2 j i INTERNATIONAL SYSTEM 3 INTERNATIONAL SYSTEM 4 b g the desired reporting unit After you select the reporting unit the l screen displays the reporting unit format for each parameter For example if you selected INTERNATIONAL SYSTEM 2 that name is displayed 6 W y to save the change 7 E as needed PN 624026AE A 29 SETUP QUALITY ASSURANCE SETUP A 5 QUALITY ASSURANCE SETUP Two tabs are available under this option Shifts and Units For details see e Shifts Defining e QA Settings Defining Shifts Defining Under the Shifts tab Figure A 5 you can define edit your lab s shifts See Selecting Shifts in this chapter Figure A 5 Shifts Setup Screen Details Quality Assurance 73671044 Shift 0 The 24 hour shift which is the default Allows you t
171. GING SETS SETUP If a sample is re run how will know if the results are for the rerun There are two ways to know if the results you are viewing are for a sample that has been re run e Yes will appear next to Rerun on the patient sample report See Identifying Rerun Results in Chapter 8 e The Result will be identified as 1 1 1 of 1 1 2 1 of 2 2 2 2 of 2 on the Results screen See Understanding the Results Screen in Chapter 9 Can the Analyzer read barcodes Yes The Analyzer has an internal barcode reader that reads barcode labels There is also an optional barcode wand that you can use See Appendix B BARCODE SPECIFICATIONS FOR OPTIONAL BARCODE WAND 5 2 PN 624026AE 5 3 PN 624026AE POWERING UP AND LOGGING ON POWERING DOWN AND LOGGING OFF GETTING STARTED Table 5 1 Commonly Asked Questions Continued Area Question Answer How many times is the barcode label read in the Autoloader mode Twice once before mixing and once before piercing See Heading 2 9 CASSETTE TRANSFER CYCLE a Can I automatically download my Yes See Heading 7 4 DOWNLOADING CELL CONTROL IQAP data onto a diskette RESULTS FOR IQAP Does the instrument automatically Yes With the ACeT 5diff Control Plus cell control the system 2 verify that my daily controls are automatically checks the reference ranges and flags any within range parameters on the control sample that are out of ran
172. HG GAASS RBA T A S Figure 1 10 Back of Workstation Monitor connector Power supply cord connector PC Host communications connector Printer connector Analyzer connector Keyboard connector Mouse connector 0o00 0000o Power supply cord connector monitor Note Your configuration may vary from what is shown here PN 624026AE 1 7 i USE AND FUNCTION PANELS 1 3 PANELS You can run samples in either the CBC panel or CBC DIFF panel For information on the parameters of each panel see Heading 1 4 PARAMETERS For information on selecting the default panel see Default Panel Selecting CBC or CBC DIFF in Appendix A 1 4 PARAMETERS CBC Panel Table 1 1 lists the 12 parameters analyzed in the CBC panel Table 1 1 CBC Parameters Parameter Definition WBC White Blood Cell or leukocyte count RBC Red Blood Cell or erythrocyte count Hgb Hemoglobin concentration Het Hematocrit relative volume of erythrocytes within the whole blood sample MCV Mean Corpuscular erythrocyte Volume MCH Mean Corpuscular erythrocyte Hemoglobin MCHC Mean Corpuscular erythrocyte Hemoglobin Concentration RDW Red Cell erythrocyte Distribution Width Plt Platelet or thrombocyte count MPV Mean Platelet thrombocyte Volume PDWt Platelet Distribution Width Pett Plateletcrit tPct and PDW are derived parameters an
173. ING Risk of personal injury due to hot surfaces within the instrument Use care when working in this area Some of the surfaces may be very hot and can burn you Allow the lamp to cool sufficiently before proceeding 6 Disconnect the lamp from the Power Supply a Locate the lamp and the connector on the left side of the optical bench Disconnect the lamp from the Power Supply Note how the existing lamp is seated e The metal bracket holding the lamp is keyed to ensure proper positioning e There are two different notches one is a semi circle that matches a circular raised area and the other is a square notch that matches a raised square PN 624026AE DIAGNOSTICS REPLACEMENT PROCEDURES 7 Remove the lamp a Usea2 mm hex key to loosen the two screws a few turns b Separate the metal bracket from the lamp and cable assembly J 0 wae 8 Discard the old lamp assembly c Save the metal bracket and screws d Turn the lamp counterclockwise to remove it from its housing PN 624026AE 11 99 DIAGNOSTICS REPLACEMENT PROCEDURES IMPORTANT Risk of compromising output of the new lamp if the surface is smudged Fingerprints or other smudges on the lamp can affect output Do not touch the surface of the lamp 9 Using care not to touch the surface of the lamp a Insert the new lamp assembly inside the housing Place the bracket with wings u
174. ING SETS SETUP A 7 Define the action limit ranges a Highlight the number to be changed b Type the new number c Press to move between the fields To copy setting from another flagging set go to step 5 of e Copying Settings to Another Flagging Set 8 To edit the patient age for the selected CEES flagging set Child 1 through Child 5 only Flags and Messages Flag Sensitivity and Thresholds Age Ranges a u the Age Ranges tab if available b b the slider box until the desired age appears Set as Default Flagging Set Gris Default Flagging Set g tandadrane oo To adjust the age by one day press Modi on i or You cannot make the next flagging set amp Bebe v x vi younger than the former For example Saves I a 738 Child 2 cannot be younger than Child 1 See Figure A 20 for details if necessary 9 C Y to save the change s PN 624026AE A 125 SETUP FLAGGING SETS SETUP e Copying Settings to Another Flagging Set Do this procedure to copy action limits and patient limits from one flagging set to another existing flagging set A flagging set must already be created before you can copy to it See e Adding Editing a Flagging Set Range in this chapter JAcT Sdiff AL Ly A x2 ANE Spa COULTER 1 From the Main Menu screen W a COULTER AST Sdiff AL 2 OM A 126 PN 624026AE PN 624026AE FLAGGING SETS SETUP SETUP 3
175. INSTRUCTIONS FOR USE MANUAL Use this manual to find information about e getting started e running your instrument e reviewing results e performing special procedures such as cleaning replacing or adjusting an instrument component e troubleshooting problems e determining what the instrument does e understanding how to safely operate the instrument e powering up the instrument e customizing the setup and e running controls and samples ABOUT THIS MANUAL The information in this manual is organized as follows e Chapter 1 USE AND FUNCTION Contains the intended use of the instrument a brief history of the methods used by the instrument the reagents calibrators and controls used a brief description of the major components and how to work with the software e Chapter 2 OPERATION PRINCIPLES Contains the descriptions for cell counting and voting and how the parameters are derived e Chapter 3 SPECIFICATIONS CHARACTERISTICS Details instrument specifications characteristics and interfering substances e Chapter 4 PRECAUTIONS HAZARDS Provides information about key safety issues and contains information on biological hazards and hazards pertaining to moving parts e Chapter 5 GETTING STARTED Provides information on using the system s software and Workstation PN 624026AE Xxix INTRODUCTION ABOUT THIS MANUAL e Chapter 6 DAILY ROUTINE Provides information on doing daily procedures such as Startup
176. IPTIONS Tube Holders Two interchangeable tube holders Figures 1 6 and 1 7 are available for accommodating various sizes of specimen tubes microcollection devices and control vials Each tube holder contains four slots in which you can place an open or closed tube vial It is important to note that there is a single point of aspiration at the 12 o clock position referred to as the pierce position on the Analyzer To position the desired tube slot in the 12 o clock pierce position manually rotate the tube holder clockwise or counterclockwise as needed See Positioning Tubes in the Tube Holders in Chapter 5 for additional information on the pierce position Figure 1 6 Tube Holder 1 Slot Designations for Tube Holder 1 Position 1 Position 2 Position 3 Position 4 Note Tube Holder 1 has one dot in the center Slot Designations for Tube Holder 2 Position 1 Position 2 Positions Position 4 Note Tube Holder 2 has two dots in the center Each tube vial has an assigned slot in a tube holder Refer to the Hematology Tube List available on the BCI website at www beckmancoulter com Beckman Coulter does not guarantee the performance of any other tube on this system Figure 1 8 shows examples of tubes in their correct slot and tube holder PN 624026AE 1 5 USE AND FUNCTION DESCRIPTIONS Figure 1 8 Tube Positions in the Tube Holders al Tube Holder 1 Tube Holder 2 7367456A The follo
177. LAGS AND MESSAGES GENERATED BY THE INSTRUMENT Table 9 3 Definition of DIFFPLOT Flags Continued DiffPlot Region Suspected Flag DiffPlot Region Affected Description Flags Abnormalities UN Occurs when the R next to Large neutrophils number of particles NE NE Immature in the UN regionis IMM IMM granulocytes above the limits set ao D iauit vaike UN is displayed Metamyelocytes ult values z dele 0r 399 the DiffPlotand id particles Histogram romyelocytes section of the Flags and Messages area NE Occurs when the R next to Young eosinophils number of particles IMM and Giant the NE separation IMM hypersegmented region is above the neutrophils Hai eplaces MEYE ecinophils with Default values NE E0 and ow 3 1 1 or 60 EO with Debris DB Absorbance particles NE is displayed and printed in the DiffPlot and Histogram section of the Flags and Messages area intracytoplasmic material agranular eosinophils PN 624026AE 9 41 DATA REVIEW FLAGS AND MESSAGES GENERATED BY THE INSTRUMENT 9 42 Table 9 3 Definition of DIFFPLOT Flags Continued DiffPlot Region Suspected Flag DiffPlot Region Affected Description Flags Abnormalities ATL Occurs when a ATLis displayed Large significantly large and printed in lymphocytes population is the DiffPlot and Reactive located in the ATL Histogram lymphocytes o region section of the E T F
178. M M M DOD E 306502 Unknow cec D07 10 2c O M M M DO D JAUTO_SIC9 1 Unknow cBc D07 10 2c0 O M O DO r al 311929039 2 Unknow cBc D07 10 2C0 O M O DO D Ii 311929099 4 Unknow cBc D07 10 2C 0 M OO O D r JAUTO_sIC9 5 Unknow cBc D07 10 2c0 M M ODD 2 AUTO_SIC9 6 Unknow cec Dov 1o vece MMM Oo Mauros 7 Unknow c c D07 10 20 0 MM OO m 311929039 1 Unknow cBc D07 10 2C0 M M MDDr M _ 3119290P9 3 Unknow cBc D07 10 200 O M O OD AUTO_sIC9 4 Unknow cBc D07 10 2C0 M M MDDr JAUTO_sIC9 5 Unknow cBc D07 10 200 M M O DOD AR fT 311929099 6 Unknow cBc D07 10 20 0 O O Pe T auTo_sicg 7 Unknow cec D07 10 200 M M O DOD M 311929039 1 Unknow cBc D07 10 2c0 M M MDD 3119290P 9 3 Unknow cec D07 10 20 0 M M OP LE JAUTO_sICg 4 Unknow cBc D07 10 200 M M O Dr jaAuTo_sicg 5 Unknow cBc D07 10 2c O VM M OF D fomm 311929099 6 amp 6 Unknow cBc D07 10 20 0 M O O DODO jauTo_sicg 7 Unknow c c D07 10 20 0 M M O O D javTo_sicg 1 Unknow cBc D07 10 2c O VM M M OO El D avTo_sicg 2 Unknow cBc D07 10 2C O M M M DO D g a S amp S amp A v X Supervisor fo 5719 2002 20 14 00 If all the column headings Figure 9 3 do not appear on your screen you can scroll to the right to see the remaining columns You can also resize the column widths to fit more on the screen Figure 9 3 Results List Screen Column Headings Inc SampleID Cass Pos Patient ID Last Name First Name Gender Date of Birth Age Panel RunDate AF DH
179. Manual Match Off Auto Print On Worklist Order Exists with Same Sample ID as on Barcode Label E 3 Scenario 4 Barcode On Manual Match Off Auto Print On Worklist Order Exists but Worklist Sample ID Differs from the Sample ID on the Barcode Label E 3 Scenario 5 Barcode On Manual Match On Auto Print On Worklist Order Exists but Worklist Sample ID Differs From the Sample ID on the Barcode Label E 3 Scenario 6 Barcode On Manual Match On Auto Print On No Worklist Order E 4 Scenario 7 Barcode On Manual Match Off No Worklist Order E 4 Cass Position Scenarios E 5 Scenario 1 Cass Position On Manual Match On Auto Print On Worklist Order Cassette Position and Sample ID No Barcode Label E 6 Scenario 2 Cass Position On Manual Match OFE Auto Print On Worklist Order Cassette Position and Sample ID No Barcode Label E 7 Scenario 3 Cass Position On Manual Match On Auto Print On Worklist Order Cassette Position and Sample ID Barcode Label E 7 Scenario 4 Cass Position On Manual Match Off Auto Print On Worklist Order Cassette Position and Sample ID Barcode Label E 8 Scenario 5 Cass Position On Manual Match On Auto Print On Worklist Order Cassette and Position only Barcode Label E 8 Scenario 6 Cass Position On Manual Match On Auto Print On Worklist Order Cassette Position and Sample ID No Barcode Label E 9 Scenario 7 Cass Position On Manual Match Off A
180. Manual Match Options in this chapter Once a set of results is on the Manual Match screen you can match them to the Worklist order See e If Auto Print is enabled see Auto Print for Patient Results in this chapter the sample report automatically prints e If Auto Print is disabled the sample results are placed on the Results list If Manual Match is OFE the sample results do not post to the Manual Match screen If Manual Match is OFF and Cass Position is the Worklist Match Option primary identifier you must positively identify the sample unless a Worklist order exists and does not match the processed cassette Do this procedure to turn Manual Match ON recommended or OFE A p A E ae a 1 From the Main Menu screen J ales e a vy X I p 0971872002 08 3213 PN 624026AE SETUP A OPERATIONAL SETUP 2 Oe 3 Verify the General tab is selected Miscellaneous 0A 9 Select the desired Manual Match option ON is recommended 6 Y v to save the change 7 E d as needed PN 624026AE A 13 SETUP OPERATIONAL SETUP Logs Comments Prompt When calibration is performed or when reagents are replaced a Comments window can be enabled to automatically appear so you can enter comments Do this procedure to enable disable the Comments prompt for the Calibration Log or Reagent Log amp LN AT 1 From the Ma
181. NOSTICS USER SCREEN Unprime Do this procedure to unprime any of the following reservoirs e Diluent Reservoir e All reservoirs A amp Ar 1 From the Main Menu screen 0 r 2 UA 11 32 PN 624026AE DIAGNOSTICS l DIAGNOSTICS USER SCREEN OR 4 W Unprime tab 5 C the desired unprime option 6 Allow the Analyzer to complete the unprime function Repeat step 5 as needed 7 0 as needed to return to the desired screen PN 624026AE 11 33 DIAGNOSTICS DIAGNOSTICS USER SCREEN 11 34 Cleaning Cycles The following cleaning functions are available Extended Cleaning Backflush Rinse Flow Cell Extended Cleaning Do this procedure to clean the baths with a 1 to 2 solution of sodium hypochlorite if e You suspect a clog or fibrin e Directed by a Beckman Coulter representative Supplies needed Q One 5mL syringe Q 50mL ofa 1 to 2 chlorine solution produced from high quality fragrance free sodium hypochlorite De Oe Prepare a 1 to 2 chlorine solution using high quality fragrance free sodium hypochlorite 500mL For example e Ifusing 4 high quality fragrance free sodium hypochlorite dilute with an equal part of distilled water e Ifusing 10 to 12 high quality fragrance free sodium hypochlorite dilute by adding 10 parts distilled water to 1 part of the 10 to 12 high quality fragrance free sodium hypochlorite PN 624026AE PN 62
182. NTO THE ANALYZER Due to the Analyzer s weight four lifting handles are provided to allow at least two people to safely move the instrument Do this procedure before moving the instrument Supplies Needed Lifting handles 4 LN 2 Nex 1 Power down the System as instructed in Powering Down the System and Logging Off in Chapter 5 11 110 PN 624026AE DIAGNOSTICS Ji INSTALLING THE LIFTING HANDLES INTO THE ANALYZER 2 Unplug the Analyzer from its power source wall outlet 3 Locate the openings for the four lifting handles 4 Insert the four handles into their corresponding openings a Insert the appropriate end of the handle into the opening and push in as far as possible b Rotate the handle clockwise until it locks in the lifting position c Ensure that the handle is securely in place d Repeat steps a through c until all four handles are in place PN 624026AE 11 111 DIAGNOSTICS SYSTEM ERRORS WARNING Risk of operator injury if only one person lifts the instrument The instrument has lifting handles and weighs more than one person should lift Therefore to prevent injury at least two people following appropriate safety precautions and using the lifting handles should lift the instrument together 5 With at least one person on each side of the Analyzer grasp the handles and safely lift the Analyzer to move it 11 14 SYSTEM ERRORS 11 112 What Error Mess
183. ONAL BARCODE WAND Power up the system as instructed in Powering Up the System and Logging On in Chapter 5 The power on sequence should now perform a startup and background cycle if Auto Startup is selected Program the barcode wand to the default configuration as instructed in Heading B 5 OPTIONAL BARCODE WAND CONFIGURATION B 11 BARCODE SPECIFICATIONS FOR OPTIONAL BARCODE WAND CONNECTING THE OPTIONAL BARCODE WAND B 12 PN 624026AE MANUAL CALIBRATION C 1 ANALYSIS PROCEDURE Do this procedure if you do not know the new calibration factors Use a material with known reference values as your calibrator 1 Be sure you have done Heading 10 2 PRE CALIBRATION CHECKS 2 Prepare your material as needed 3 Insert the tube into the tube holder and close the door for analysis to begin 4 Record the results on the calibration worksheet CALIBRATION WORKSHEET Sample Number WBC RBC Hgb Het Pit ee a o on a eo rm 9 10 11 TOTAL MEAN A ASSIGNED VALUE B ABSOLUTE DIFFERENCE C CALIBRATION REQUIRED CURRENT CALIBRATION FACTOR D NEW CALIBRATION FACTOR E C B A E B A xD 5 Repeat steps 3 and 4 ten more times for a total of 11 runs 6 Do Heading C 2 CALCULATIONS PROCEDURE PN 624026AE C 1 MANUAL CALIBRATION CALCULATIONS PROCEDURE C 2 CALCULATIONS PROCEDURE 1 Calculate the mean for ea
184. ONS FOR OPTIONAL BARCODE WAND Bo B 1 OVERVIEW Use the information in this appendix to test troubleshoot and reprogram the optional barcode wand IMPORTANT Risk of sample mis identification if your barcode labels do not meet the specifications stated in this appendix Use only barcode labels that meet the stated specifications Note These specifications are for the optional barcode wand During installation and setup of your system Barcode Setup should have been done to match these specifications so the internal barcode reader in the Analyzer can read the barcodes your lab uses Definition A barcode consists of black lines bars and white lines spaces called elements ATTENTION Beckman Coulter recommends that you verify each barcode reading to ensure correct sample identification B 2 BARCODE LABELS Symbologies The ACeT 5diff AL analyzer accepts six barcode symbologies e Code 128 e Code 39 e Codabar e Interleaved 2 of 5 e EAN 8 and e EAN 13 ATTENTION The scanner uses Code 128 symbology for programming and the symbol for entering the programming mode Therefore the following Code 128 characters must not be used in any combination of the barcodes used to identify the sample and B 3 BARCODE SPECIFICATIONS Barcode labels to be used with the ACT 5diff AL analyzer must meet the following specifications e Maximum number of usable characters in barcode label 16 e Minimum PCS Print Contrast Si
185. On Manual Match Off Auto Print On Worklist Order Cassette Position and Sample ID Barcode Label Scenario 16 Cass Position On Manual Match Off Auto Print On Worklist Order Sample ID only No Barcode Label Scenario 17 Cass Position On Manual Match Off Auto Print On Worklist Order Cassette Position and Sample ID Barcode Label Scenario 18 Cass Position On Manual Match On Auto Print On Worklist Order Cassette Position and Sample ID Barcode Label Scenario 1 Cass Position On Manual Match On Auto Print On Worklist Order Cassette Position and Sample ID No Barcode Label Summary Report prints with the Sample ID cassette and position information that was entered on the Worklist order 1 Create a Worklist order Om oE Type 06 as cassette number then pressed Enter Select the 1st tube position Type 123 as the Sample ID OM 02 Insert tube into position 1 of cassette 6 Place cassette in Cassette Input Tray ooo O Select PREF Sample is analyzed Report prints with Sample ID 123 cassette 6 and position 1 which is exactly what was entered for the Worklist order PN 624026AE PN 624026AE WORKLIST SCENARIOS E WORKLIST MATCH OPTION SCENARIOS Scenario 2 Cass Position On Manual Match OFF Auto Print On Worklist Order Cassette Position and Sample ID No Barcode Label Summary Report prints with the Sample ID cassette and position information that was
186. PN 4277065 Printer Under the Printer tab Figure A 11 you can define edit these settings Report Header Entering Editing e Printer e Add Printer e Printer Properties e Set Default Printer e Delete Printerr e Patient Report Setup e Enable Define Patient Report Areas e Display and Print Detailed or Suspect Flags e Hematology Parameters Printed Define for Patient Report e Auto Print Non Patient Results Figure A 11 Printer Setup Screen a Host io Cycle Options Report Header p Enable Printed O pme List Range Vv WBC Vv OKIPAGE 142 z RBC K he i ai 5 nen ud Dae Microscopic Examinat n Area Iv HCT v JOKIPAGE 14e one F MCY 7 J MCH M Histograms and DiffPlot Vv MCHC Vv QoQ Add Printer rea a aN RDW Vv PLT Vv Quality Control Results MPV Iv CO Pmerome Reproducibility Results Calibration Results Startup Display and Print IL Delete Printer Detalied Flags B e Supervisor aaa x RU URC adadda xX a _ 1120872002 08 53 54 7367107A A 78 PN 624026AE 0o00 00090 12 SETUP A SYSTEM SETUP Allows you to define edit the report header See Report Header Entering Editing in this chapter Allows you to select deselect the parameter results to be printed on the patient sample report See Patient Report Setup and e Hematology Parameters Printed Define for Patient Report in this chapter Allows you
187. PN 624026AE SETUP A AUTO FUNCTIONS SETUP Auto Transmit for Patient Results Automatic transmission sending of patient results to the host computer depends upon the settings defined in Auto Transmit Refer to the Host Transmission Specification manual for details on configuring the host communication protocol Figure A 9 shows the Auto Transmit options for patient results Figure A 9 Auto Transmit Setup Screen AcT 5diff AL Auto Functions Rerun Auto Print Auto Transmit Auto Transmit Options Patient Results ___ au C All B e gt C Normals Only a Normals and Selected Abnommals be gt No Parameter Value With Parameter Flags With Histo and DiffPlot Flags O Outside Patient Limits Outside Action Limits SA a SA ta E d E s 7 S B BD A v X dil Version V0 15r01 Supervisor J 1170972002 08 43 00 7367137A Off disables automatic transmission so that patient results are not automatically sent to the Host computer upon completion of analysis All automatically transmits all patient results to the Host computer upon completion of analysis Normals Only automatically transmits only normal patient results to the Host computer upon completion of analysis Normals and Selected Abnormals automatically transmits to the Host computer all normal patient results and selected abnormal results that you select from 88 These
188. RCODE WAND CONFIGURATION B 4 CODE 39 AND CODABAR BARCODE SCANNER OPTIONS B 6 I 2 OF 5 PROGRAMMING OPTIONS AND TEST LABELS B 8 CONNECTING THE OPTIONAL BARCODE WAND B 9 MANUAL CALIBRATION C 1 Cl C2 C3 ANALYSIS PROCEDURE C 1 CALCULATIONS PROCEDURE C 2 CALCULATING NEW CALIBRATION FACTORS C 2 Calibration Worksheet C 3 WORKSTATION MANAGEMENT D 1 D 1 D2 D3 DATABASE MANAGEMENT D 1 Database Compacting Cleaning D 1 CONFIGURATION SAVE RESTORE SETUP D 1 CONFIGURATION ANALYZER AND WORKSTATION D 2 Analyzer Configuration D 3 e Analyzer Configuration Save to Hard Disk Save to Floppy Disk D 3 e Analyzer Configuration Restore from Hard Disk Restore from Floppy Disk D 6 xix CONTENTS D4 Workstation Configuration D 8 e Workstation Configuration Save to Hard Disk Save to Floppy Disk D 8 e Workstation Configuration Restore from Hard Disk Restore from Floppy Disk D 11 DELETE DATABASE D 14 Understanding the Delete Database Screen D 14 Procedure to Delete Existing Database D 15 WORKLIST SCENARIOS E 1 E 1 E2 USING WORKLISTS E 1 Overview E 1 Worklist Processing Conditions for Sample IDs E 1 WORKLIST MATCH OPTION SCENARIOS E 2 Barcode Scenarios E 2 Scenario 1 Barcode On Manual Match On Auto Print On No Worklist Order E 2 Scenario 2 Barcode On Manual Match On Auto Print On Worklist Order Exists With Same Sample ID as on Barcode Label E 3 Scenario 3 Barcode On
189. RFORMANCE SPECIFICATIONS Accuracy Accuracy Table 3 4 is assessed by duplicate analysis of morphologically normal non flagged specimens when compared to an automated hematology analyzer that has been properly calibrated and maintained according to the manufacturer s recommendation Table 3 4 Accuracy Specifications Parameter Correlation r WBC gt 0 95 RBC gt 0 95 Hgb gt 0 95 Het gt 0 95 Plt gt 0 95 Carryover Carryover Table 3 5 is assessed by analyzing whole blood with high values followed by a whole blood sample with low values Each sample is run consecutively in triplicate Carryover is calculated as follows Low 1 Low 3 Michaelowi Carryover Table 3 5 Carryover Specifications 3 6 Parameter Carryover WBC lt 2 0 RBC lt 2 0 Pit lt 2 0 Hgb lt 2 0 SPECIFICATIONS CHARACTERISTICS 3 PERFORMANCE SPECIFICATIONS Reportable Range The reportable range Table 3 6 is the range of results that the instrument displays prints and transmits Results between the linear range and the reportable range will be flagged Table 3 6 Reportable Range Parameter Units Reportable Range WBC 103 uL 0 0 150 0 RBC 106 yL 0 00 18 00 Pit 103 uL 0 0 1900 0 0 0 2800 0 Het 0 0 80 0 Hgb g dL 0 0 30 0 whole blood An extended platelet linear range and reportable range can be applied if the Platelet Concentrate exten
190. Reset Mixer incorrect grabber position Tube mixer arm is in the wrong position 1 Do Hardware Reset 2 Check the motor as instructed in Motors Checking s Mixer mechanism not reaching home Tube mixer mechanism not reaching home 1 Do Hardware Reset 2 Check the motor as instructed in Motors Checking Mixer motor failure Tube mixer motor failed 1 Do Hardware Reset 2 Check the motor as instructed in Motors Checking Motor 0 is active The specified motor is Do Hardware Reset active PN 624026AE PN 624026AE Table 11 5 Error Messages Continued DIAGNOSTICS SYSTEM ERRORS Message Probable Cause Suggested Action Name Already Exists The name you typed already exists 7 y l 2 Type another name No Cassette s There are no cassettes in 1 Load cassettes 2 the Cassette Input Tray Restart cycle No communication with hardware No communication between hardware and software Do Hardware Reset No Tube Holder Tube holder door was closed without a tube holder in place Tube holder not in 12 o clock pierce position 1 Insert the tube holder 2 Verify that the tube holder is in the pierce position for the desired tube 3 Close the tube holder door One or more calibration factors Calibration factors were not Contact a Beckman Coulter failed criteria Save within the limits representative calibration Output Area Full Cassett
191. S RUNNING WORKLIST SAMPLES IN AUTOLOADER MODE 8 2 Use 3 Enter the Sample ID See Sample ID Sample ID Entering Selecting in this chapter 4 Select the desired test panel See Panel Selecting CBC or CBC DIFF in this Eee chapter 5 Select the flagging set or the flagging Flagging Sets set will be determined by age and Standard Range gender Standard Range See Flagging Set Selecting in this chapter PN 624026AE 8 13 SAMPLE ANALYSIS RUNNING WORKLIST SAMPLES IN AUTOLOADER MODE 8 14 Enter the appropriate demographics as required by your lab protocol Collect Date Time Entering Location Entering Selecting Physician Entering Selecting Comments Sample and Patient Entering Editing Patient ID Entering Editing Name Locating Selecting Date of Birth Entering Editing Age Entering Editing Gender Selecting If you make a mistake when entering Ux the demographics to clear the entry Sample ID Collect Date Time ad ff Flagging Set Standard Range x CBC DIFF O e Location Physician Comments Rerun f Patient ID Last Name aa First Name Date of Birth Age Hf fs Gender Unknown Load the tubes into the cassette IMPORTANT Risk of sample mis identification if you do not verify the Sample ID displayed at the Workstation with the Sample ID on the tube prior to analysis 8 Verify the correct Sample ID for each barcoded tube
192. S sample results are placed on the Manual Match screen flashes when this happens For details see Manual Match Procedure in Chapter 9 16 When all samples have been processed the instrument ejects the cassette into the Cassette Output Tray 17 Remove the cassette from the instrument See Unloading Cassettes from the Analyzer in Chapter 5 8 16 PN 624026AE SAMPLE ANALYSIS 8 RUNNING WORKLIST SAMPLES IN AUTOLOADER MODE 18 Results are printed transmitted according to your system setup If Auto Print is enabled results comments will not be included To print transmit a sample report with the results comments included a p 5 from the Results screen SEA Result 171 gt Sample ID Cal Riad 123456 f 03 63 E DiffPlot and Histogram Flags wec 10 aL Cass Pos Panel WBC SL NL LN SLL IMM i oo pe Analytical Messages td 100200 300 DB A Flagging Set HGB gdl hiad WBC BASO Interpretive Messages Standard Range ner a7 RBCS Collect Date Time tee fh Basophila Microcyt Run Date Time MCH pg f PLT Aarogates w 10 04 2002 14 14 52 pae a 7 Schistocyte ena Row x 5 Miscelaneous Messages ls p Reagent expred Physician a FL qt o 81 R PEPY Comments rct x paa lp zi Ui le a a y XxX 2a J 10 04 2002 14 17 59 Supervisor b Select Print or Transmit from the following window Print Transmit Print Transmit ipo Print Pri
193. STATION MANAGEMENT D CONFIGURATION ANALYZER AND WORKSTATION 5 Indicate where the settings should be saved e To save to the hard drive o Save to Hard Disk e To save to a floppy disk 1 Insert the disk into drive A 2 W Save to Floppy Disk wA 3 6 Follow the instructions on the screen 7 0 to print the current settings for your records 8 u y to save the change PN 624026AE D 5 WORKSTATION MANAGEMENT CONFIGURATION ANALYZER AND WORKSTATION D 6 e Analyzer Configuration Restore from Hard Disk Restore from Floppy Disk Do this procedure if you want to restore previously saved Analyzer settings to be the current settings H LN Ar 1 From the Main Menu screen aE PN 624026AE WORKSTATION MANAGEMENT D CONFIGURATION ANALYZER AND WORKSTATION 3 u the Configuration tab 7 u amp gt A A 2 3 Ema 0841 20 US 5 Indicate from where the settings should be restored e To restore from the hard drive W Restore from Hard Disk e To restore from a floppy disk 1 Insert the proper disk into drive A 2 u Restore from Floppy Disk 0M 6 Follow the instructions on the screen 7 E to print the current settings for your records PN 624026AE D 7 WORKSTATION MANAGEMENT CONFIGURATION ANALYZER AND WORKSTATION 8 u Y to save the change Workstation Configuration Under Workstation Configuration you
194. Storing Specimens Analyze specimens as soon as possible for optimum accuracy Note For more information on handling and processing blood specimens refer to NCCLS publication H18 A 6 Altitude Range The instrument can be operated at any altitude up to 3 000 meters 9 800 feet Recommended Location Place the instrument indoors on a clean level bench or table top Allow at least 20cm 8 in of space behind the instrument and the Workstation for ventilation Do not expose the instrument or the Workstation to sunlight Electromagnetic Environment Check The instrument is designed to produce less than the acceptable level of electromagnetic interference when properly placed Electromagnetic interferences are limited to levels that allow the correct operation of other instruments conforming to their placement If there is a problem ensure that the instrument is not placed near electromagnetic fields or short wave emissions such as radar X ray machines scanners and so forth Recommended Reagents Beckman Coulter recommends these reagents e ACeT 5diff Diluent e ACeT 5diff Fix e ACeT 5diff WBC Lyse e ACeT 5diff Hgb Lyse and e ACeT 5diff Rinse See Heading 1 8 REAGENTS for additional information about these reagents Recommended Controls A eT 5diff Control Plus is the recommended control See Heading 1 7 QUALITY ASSURANCE CONTROLS CALIBRATORS AND IQAP for additional information Recommended Calibrator A eT 5d
195. T Plt count Number of cells counted per unit volume x Calibration factor Plt count is displayed and printed as Plt Nx10 cells pL Note cells yL is the US unit format Other formats are available See Units Selecting the Reporting Unit in Appendix A e MPV Measurement MPV Mean Platelet Volume is measured directly from analysis of the platelet distribution curve MPV is displayed and printed in femtoliters fL e Pct Calculation Pct plateletcrit is calculated according to the formula Pit 10 uL x MPV fL 10 000 e PDW Calculation PDW Platelet Distribution Width is calculated from the Plt histogram as the width of the curve between S1 and S2 Pct As shown in Figure 2 16 S1 and S2 are placed so that gt 15 of the platelets occur between 2fL and S1 gt 15 of the platelets occur between S2 and the variable upper threshold gt The PDW result is determined on the platelets between S1 and S2 Figure 2 16 Area of the Pit Histogram Used to Determine the PDW Parameter Result A 15 7615002A Hgb Determination The hemoglobin Hgb released by the lysis of the red blood cells combines with the potassium cyanide to form a stable cyanmethemoglobin compound This compound is measured through the optical part of the First Dilution Hgb bath using a spectrophotometric technique at a wavelength of 550nm Transmittance of the sample dilution is compared with the transmittance of a reagent
196. TERIAL SAFETY DATA SHEETS MSDS 1 14 2 OPERATION PRINCIPLES 2 1 2 1 2 2 23 2 25 26 Zt vi OVERVIEW 2 1 MEASUREMENT PRINCIPLES 2 1 Coulter Principle 2 1 Aperture Sensor System 2 1 Overview 2 1 Particle Sensing 2 1 Applying the Coulter Principle 2 2 ACV TECHNOLOGY 2 3 Overview 2 3 Dual Focused Flow DFF 2 3 Flow Cell 2 3 Focused Flow Impedance 2 4 Absorbance Cytochemistry 2 4 Signal Processing 2 4 Overview 2 4 Thresholds 2 4 WBC BASO METHODOLOGY 2 5 SAMPLE ANALYSIS OVERVIEW 2 5 Aspiration 2 5 Dilution 2 6 CBC Panel 2 7 CBC DIFF Panel 2 7 Delivery 2 7 SAMPLE ANALYSIS 2 8 RBC and Platelet Analysis 2 8 Parameter Results Obtained from the RBC Plt Dilution 2 9 Hgb Measurement 2 9 WBC Count and Differential 2 10 Parameter Results Obtained from the WBC BASO Dilution 2 11 Differential 2 11 Parameter Results Obtained from the DIFF Dilution 2 12 Dilution Summary 2 13 PARAMETER DEVELOPMENT 2 14 RBC Parameters 2 14 Hct Measurement 2 14 RBC Count 2 14 RBC Histogram 2 14 PN 624026AE PN 624026AE 2 8 2 9 CONTENTS Parameter Results Obtained Using the RBC Histogram 2 15 MCH and MCHC Calculations 2 15 Plt Parameters 2 16 Overview 2 16 Interference on the Lower End of the Platelet Distribution Curve 2 16 Microcytic Interferences on the Upper End of the Platelet Distribution Curve 2 16 Parameter Results Obtained Using the Plt Histogram 2 16 Hgb De
197. To control the performance of the instrument Beckman Coulter recommends the use of the ACT 5diff Control Plus cell control which is available in three levels low normal and high For each set of controls received be sure that the cell control information and assay values selected and entered into the instrument are correct for the lot and level of control For details see Heading A 6 SETTING UP A CONTROL FILE The Workstation allows you to set up files to store control results for CBC and or CBC DIFF analysis Before you can store control results in a file the file must be setup for the appropriate information such as control name Sample Lot ID assay values expected ranges and so forth For control material details refer to the package insert Note The instrument identifies a control sample through the use of the Control lot number and Sample ID In the control file if the Reserved box is checked the system automatically assigns any results with the Sample ID matching the lot number into the appropriate file Asa result it is not necessary to have the control file open to have the results correctly assigned You can preassign controls on the Worklist if required 7 3 7 QUALITY ASSURANCE RUNNING CELL CONTROLS 7 4 You can safely run a patient sample when a control file is open because patient sample results do not go into the control database they go into the patient results database You can run QC samples i
198. You can manually select the sample to be re run see Manual Reruns in this chapter e Ifthe sample meets the defined criteria for an automatic re run a new Worklist order is created and the instrument will automatically re analyze the sample Both the original and re run results will be available for view For information on automatic re runs see Defining Automatic Rerun Criteria By Flags and or by Parameters in Appendix A and see Automatic Reruns in this chapter Manual Reruns Do this procedure to re analyze a sample that was not automatically selected to be rerun 1 Locate the results of the sample you want to rerun See Heading 9 1 LOCATING SAMPLE RESULTS for details 2 From the Results List screen Figure 9 2 click the desired result The Results screen Figure 9 5 appears 3 C The following message appears A rerun order was created on the Worklist Verify that the Sample ID in the message is correct OY The system automatically creates an order Figure 8 1 on the Worklist and allows the sample to be processed as a rerun The sample is marked to be re run and the Rerun icon is grayed out Figure 8 1 Rerun Order on Worklist AcT Sdiff AL WORKLIST Note Reruns of AUTO_SIDs o with Cass Position as the Sample ID sp Sano Cass Pos ene Busco SSS primary identifier require AUTO S105 1 3 ee os re ent
199. You must use a blank formatted diskette otherwise the download will not be complete and Operation Failed will appear 4 Inserta blank formatted diskette into the drive A of the Workstation s PC PN 624026AE 7 43 QUALITY ASSURANCE DOWNLOADING CELL CONTROL RESULTS FOR QAP 5 C to begin the download The following message appears AcT 5diff AL Insert blank diskette Click OK to begin IQAP download e If the IQAP ID is valid the system downloads the selected control data to the diskette The progress indicator in the status bar indicates the progress e Ifthe IQAP ID is not valid the following message appears AcT 5diff AL Invalid IQAP number IQAP number must be entered before download can occur OM 2 Verify that the correct IQAP ID was entered into the system See IQAP ID Entering Editing 3 Repeat steps 1 through 4 e Ifthe diskette is not blank and formatted Operation Failed appears Repeat the procedure with a blank formatted disk 6 Allow the IQAP download to be completed Wait for the green LED on the Workstation to stop illuminating before removing the diskette 7 Remove the diskette 7 44 PN 624026AE QUALITY ASSURANCE T DOWNLOADING CELL CONTROL RESULTS FOR IQAP 8 Apply a label provided by Beckman Coulter s IQAP department to the disk The label identifies the owner of the submission in case the disk becomes corrupted 9 Insert the disk into a r
200. ach parameter in graph form The lines on the graph are from point to point but when printed a horizontal bar represents each mean You can delete individual samples from the batch You may want to do delete a result s if from review of the data it represents a non random sample population or has parameter results that are exceptionally abnormal When you delete a sample from the batch it is excluded from the calculations for that parameter The total number of deletes in a batch cannot exceed 5 because the XB Analysis requires at least 15 MCV MCH and MCHC values in a batch for a valid calculation ATTENTION Remember that abnormal samples should be processed randomly 7 51 7 QUALITY ASSURANCE XB ANALYSIS 7 52 Reviewing XB XM Analysis Information The Workstation displays the batch means for each parameter in graph form You can exclude individual samples from the batch However you can only exclude a maximum of 5 samples Reviewing XB XM Graphs Screen XB graphs Figure 7 6 shows each parameter in reference to the XB limits The graphics contain the values of the XB batches Sixty full points are displayed and printed Figure 7 6 XB XM Graphs Screen 9 Parameters XM is Shown AcT 5diff AL XB XM Operator 9 Parameters XM ne WBC 7 RBC 7 HGB HCT 7 MCY 7 MCH MCHC RDW 7 PLT Batch Date js 17 2002 12 58 50 WBC 57 1077uL re B E A Yy X J 09 19 2002
201. additional menu options From the Main Menu screen Figure 5 16 the following screens are available and offer additional menu options e Figure 5 17 Setup Menu Screen e Figure 5 26 Diagnostics Menu Screen Optionss e Figure 5 27 Quality Assurance Screen Main Menu Screen The Main Menu screen Figure 5 16 appears after you log in and Startup is completed See Table 5 3 for details about each icon Figure 5 16 Main Menu Screen c BECKMAN COULTER COULTER A T Sdiff AL Table 5 3 Main Screen Icons Icon Name Function a Startup Initiates the Startup cycle See Startup Procedure in Chapter 6 eres Run in Progress Opens the Run in Progress screen which allows you to view the results l E R A A EE for the last sample analyzed See To review the patient results screen in Chapter 9 Setup Opens the Setup screen which allows you to define system settings ae e For information about additional screen options available under the Setup screen see System Setup Screen Options in this chapter e For information about setting up the system see Appendix A 8 SYSTEM SETUP 5 30 PN 624026AE GETTING STARTED MENU PATH Table 5 3 Main Screen Icons Continued Icon Name Function Reagents Opens the Reagents screen which allows you to view the existing reagent levels and to change reagents See Replacing Reagents in Chapter 11 Logs Opens the Logs screen which allows you to view log entries made
202. ader Mode do Analyzing the Calibrator in the Autoloader Mode Recommended in this chapter e To analyze the calibrator in the Manual Stat Mode do Analyzing the Calibrator in the Manual Stat Mode in this chapter Analyzing the Calibrator in the Autoloader Mode Recommended Note This procedure requires a cap pierceable calibrator that can be analyzed with the cap on This procedure continues from Running Calibrator Samples above Number of Aspirations 5 l At on the Calibration screen define the number of aspirations runs to be done with the calibrator Type at least 5 but no more than 11 10 12 PN 624026AE CALIBRATION AUTO CALIBRATION O a 2 PPIP A message similar to this appears AcT 5diff AL Place calibrator CALI 1 Lot No CX321 in cassette je 3 Verify that the Lot Number is correct for the Calibrator you are using 4 Insert the calibrator with cap on into the cassette WARNING Risk of injury biohazardous conditions if a cassette is not properly handled Do not use a cassette for storing or transporting tubes or vials To ensure tubes vials remain secured in the cassettes always keep cassettes upright and use them only for analysis as described in this manual 5 Load the cassette onto the instrument 6 C y to begin analysis 7 Do Auto Calibrating the Instrument in this chapter Analyzing the Calibrator in the Manual Stat Mode Note You can use an open vial or cap pierc
203. ages Mean Table 11 5 lists errors messages that may appear on the instrument Table 11 5 Error Messages Message Probable Cause Suggested Action X Not Reaching Home Motor did not reach home 1 Do Auto Clean Running Note X name of motor Sensor 2 Ifthe problem persists contact a Beckman Coulter representative X value cannot be less than The value entered is less Enter a value of at least Y Y value than Y X value out of range Y Z The value entered is out of Enter a value within the range Y Z range A Communication Error The Analyzer and 1 Verify that the cables are properly Occurred Workstation are not connected communicating na If the problem persists contact a Beckman Coulter representative Alarm Cycle in Progress Another function was attempted while the cycle was in progress 1 Allow the cycle to be completed 2 Do Hardware Reset Alarm Diagnostic Menu must be A function was attempted 1 Exit from the Diagnostic menu closed while the Diagnostic menu 9 Do Hardware Reset is ope Alarm Remote connection Connection with Host Do Hardware Reset needed computer was lost Autoloader Transfer Mechanism Autoloader transfer mechanism not reaching home 1 Do Hardware Reset 2 Check the motor as instructed in Motors Checking PN 624026AE PN 624026AE Table 11 5 Error
204. ages area Figure 9 12 of the Run in Progress screen See Understanding the Flags and Messages Area in this chapter Flags and messages are displayed for patient samples as well as for QC calibration and reproducibility For additional information see Flags and Messages for Patient Samples and Flags and Messages for QC Calibration and Reproducibility Samples Flags and Messages for Patient Samples For patient samples the following categories of flags and messages are displayed printed in tree view format e DiffPlot and Histogram Flags e Interpretive Messages e Analytical Messages e QA Messages e Miscellaneous Messages Flags and Messages for QC Calibration and Reproducibility Samples For QC calibration and reproducibility samples the following categories of flags and messages are displayed printed in tree view format e Analytical Messages e QA Messages e Miscellaneous Messages Understanding the Flags and Messages Area If a sample is flagged that information appears under the category name to which it applies See Figure 9 13 e To see the details for each category u to expand the list see Figure 9 13 To see only the category names again u E to collapse the list You may need to scroll to view all the messages 9 37 9 DATA REVIEW FLAGS AND MESSAGES GENERATED BY THE INSTRUMENT 9 38 Figure 9 12 Flags and Messages Collapsed View Flags and Messages Diffplot an
205. ain Menu are screen appears COULTER AST Sdiff AL PN 624026AE 5 5 GETTING STARTED POWERING UP AND LOGGING ON POWERING DOWN AND LOGGING OFF 9 If Auto Print is enabled the Background report automatically prints with the Startup results If Auto Print is disabled do Printing Log Entries in Chapter 11 to print See Auto Print Non Patient Results in Appendix A for details on enabling the auto print feature for Startup results 10 Review the Startup results status e If Passed appears go to step 9 e If Failed appears go to step 11 11 If Failed appears on any Startup result mem a W Bb Ve fa a From the Main Menu w iT b u ay a zi c Evaluate the numeric results S OS a d to run Startup again 9 amp gt bb 7z v Xx e Ifthe Startup fails again contact a T TEE Beckman Coulter representative 12 Add comments to the Background report if desired 0 b Type your comments C C Y to save 5 6 PN 624026AE GETTING STARTED POWERING UP AND LOGGING ON POWERING DOWN AND LOGGING OFF IMPORTANT Risk of inaccurate results if the Analyzer is not properly prepared Follow the prompts if any on the screen to perform either a Startup or Mini Clean to prepare the Analyzer It is not necessary to do both 13 Ifthe system has remained idle for a certain period of time you will be prompted to do a Startup or a Mini
206. al Twenty five microliters 25 pL of whole blood are delivered to the DIFF bath in a flow of ACeT 5diff Fix reagent which e lyses the red blood cells e stabilizes the WBC in their native forms and e stains the lymphocytes monocytes neutrophils and eosinophils differentially with eosinophils staining most intensely The solution is then stabilized with Diluent for three seconds and transferred to the measuring bath See Figure 2 11 Each cell is measured in absorbance cytochemistry and resistivity volume 2 Second focused flow for optical detection Dir ZEN Figure 2 11 Flow Cell Operation 1 Primary focused flow for impedance OPERATION PRINCIPLES SAMPLE ANALYSIS Table 2 5 summarizes the technical characteristics required for acquisition of the DiffPlot Table 2 5 Technical Characteristics for Acquisition of the DiffPlot Dilution Characteristics Volume of whole blood Volume ACT 5diff Fix Volume A T 5diff Diluent Final dilution ratio Reaction temperature Incubation duration Measurement Characteristics Method of analysis Aperture diameter Diameter of the flow Injection duration Data accumulated Volume injected 25 uL 1 000 uL 1 000 pL 1 80 35 C 95 F 12 seconds Impedance with hydrofocus 60 um 42 um 15 seconds 12 seconds 72 uL Parameter Results Obtained from the DIFF Dilution From the measurements described above a DiffPlot is developed with optical transmission absorbance on t
207. amp in Service PO 10672672002 09 21 55 7367109A Displays the existing flagging sets Displays the action limits for the selected flagging set See Action Range Flags in Chapter 9 Displays the patient limits for the selected flagging set See Patient Range Flags in Chapter 9 Allows you to set the age for the selected flagging set See Figure A 20 A 120 PN 624026AE PN 624026AE 88 6 SETUP A FLAGGING SETS SETUP Displays the date and operator who last modified the selected flagging set Displays the default flagging set See Setting a Default Flagging Set in this chapter Allows you to make the selected flagging set the default See Setting a Default Flagging Set in this chapter Allows you to restore the default values for the selected flagging set as long as you have not saved the changes See Restoring Default Values in this chapter Allows you to copy the values from one flagging set to another See e Copying Settings to Another Flagging Set in this chapter Figure A 20 shows the Age Ranges screen where you can set the age for the selected flagging sets Figure A 20 Age Ranges Screen for Flagging Set Setup AcT 5diff AL Flagging Sets z Man a 5 7367131A 0 and drag right to increase or left to decrease the age displayed in Note To increase or decrease the age by one day at a time press or as needed Displays the age selected by the slider box You
208. ample while the Autoloader mode is in progress flashes after the stat sample is analyzed u Fkk and the system will continue processing any additional cassettes already loaded Running Manual Stat Samples e If there is an order on the Worklist or if you are not using Worklist do Procedure for Running Manual Stat Samples Order On Worklist or Not Using Worklist e If there is not an order on the Worklist and you want to assign demographics do Procedure for Running Manual Stat Samples No Order on Worklist and You Want to Assign Demographics PN 624026AE 8 2 SAMPLE ANALYSIS RUNNING MANUAL STAT SAMPLES 8 Procedure for Running Manual Stat Samples Order On Worklist or Not Using Worklist Do this procedure to run a manual stat sample if there is a Worklist order for this sample or if you do not use the Worklist A s ANE 1 Of 2 Enter the Sample ID up to 16 Sample ID alphanumeric characters into the Stat window or E Pih to search for the sample Worklist order Highlight to select Note If data is already on the Worklist it will automatically populate the fields and can be confirmed by u E 3 Select the desired test panel CBC or CBC DIFF See Panel Selecting CBC or CBC DIFF in this chapter oe PN 624026AE 8 3 SAMPLE ANALYSIS RUNNING MANUAL STAT SAMPLES 4 Select the flagging set See Flagging Set Flagging Sets Selecting in this chapt
209. amples have been analyzed The instruments autocalibration module calculates statistics on these results to obtain the best possible calibration factors Do Auto Calibrating the Instrument in this chapter After you analyze the last calibrator sample calibrator into the holder when prompted to insert the PN 624026AE CALIBRATION AUTO CALIBRATION Auto Calibrating the Instrument After you analyze the calibrator and have at least 5 results you can select the results to be used to auto calibrate the instrument The results obtained from analyzing the calibrator appear on the Calibration screen Figure 10 3 shows 7 results 5 of which are selected If a result is greater than its defined CV the result is displayed in red Figure 10 3 Calibration Runs Included and Excluded CaN Dpr Date Time Superv 07 25 2002 13 34 04 Supery 07 25 2002 13 36 22 Supery 07 25 2002 13 37 42 Superv 07 25 2002 13 38 56 Superv 07 25 2002 13 33 41 Superv 07 25 2002 13 40 26 Supery 07 25 2002 13 41 12 Ale Lot Number fexaai Expiration Date 07 11 2002 wec 38 109 L Rec fiss 10727 Hep 134 g L Hct 030 La ptt 28 1997 Selected Results N 5 Number of Aspirations 3 Minimum Runs Required For Automatic Calculation 5 aaa Modified on WBC Iv RBC W HGB HCT PLT iv 07 10 2002 Mean By New Cal Factor ence Old cal Factor 128 41 156 76 42 07 168 14 207 99 Cv Target Values
210. an only be closed into sampling position when zi has been selected For details about the various positions of the tube holder door see Tube Holder Door 3 Positions in this chapter PN 624026AE GETTING STARTED 5 WORKING WITH THE TUBE HOLDER 6 When the LED is green and the tube holder door opens remove the tube vial PN 624026AE 5 25 GETTING STARTED WORKING WITH THE TUBE HOLDER 5 26 Tube Holder Door 3 Positions e Figure 5 11 Tube Holder Door Open e Figure 5 12 Tube Holder Door Closed e Figure 5 13 Tube Holder Door Analysis in Progress Figure 5 11 Tube Holder Door Open The tube holder door is open and ready to accept tubes for analysis Figure 5 12 Tube Holder Door Closed Close the tube holder door when not in use Figure 5 13 Tube Holder Door Analysis in Progress When processing manual stat samples you will be prompted to close the tube holder door When you do gently push the door as far in as possible Sample analysis begins only when the door is recessed into the instrument as shown PN 624026AE GETTING STARTED 5 USING THE ONLINE HELP SYSTEM 5 9 USING THE ONLINE HELP SYSTEM Your COULTER ACeT 5diff AL system provides an online Help system that allows you to search for information on specific system related topics The Help system is an electronic version of the Instructions for Use manual and includes a table of contents an index for finding information quick
211. ance a month or return to a previous month 3 C the correct day 05 17 2002 Sun Mon Tue Wed Thu Fri 29 30 1 2 3 4 6 7 8 9 10 11 12 13 14 15 16 gt 18 19 20 21 22 23 24 25 26 27 28 29 30 31 2 4 J 0 J a 03 28 2001 PN 624026AE DIAGNOSTICS Ji REPLACEMENT PROCEDURES 4 Open the reagent compartment door ie ae then gradually lower it until it stops eee 9 Remove the appropriate reagent bottle from the reagent compartment WBC Lyse is shown 6 Remove the bottle stopper assembly from the reagent you are replacing PN 624026AE 11 91 DIAGNOSTICS REPLACEMENT PROCEDURES 7 Place the stopper assembly on a clean surface to prevent contamination 8 Uncap a new reagent bottle 9 Put the cap from the new container onto the empty container 10 Properly dispose of the empty bottle 11 92 PN 624026AE PN 624026AE REPLACEMENT PROCEDURES DIAGNOSTICS 11 Insert the stopper assembly tube into the new bottle 12 Tighten the stopper assembly onto the bottle to ensure an adequate seal 13 Put the new reagent bottle in the reagent compartment WEC Lyse is shown 11 93 l DIAGNOSTICS REPLACEMENT PROCEDURES IMPORTANT Risk of instrument error if the reagent tubing is pinched or twisted Pinched or twisted tubing prevents a proper flow of the reagent To ensure that the reagent flows properly through the tubing ensure th
212. and Shutdown e Chapter 7 QUALITY ASSURANCE Provides information on how to run quality control material to verify calibration e Chapter 8 SAMPLE ANALYSIS Provides information on how to run patient blood samples e Chapter 9 DATA REVIEW Provides information on reviewing sample results including flagged results e Chapter 10 CALIBRATION Provides procedures for calibrating the instrument including manually adjusting the calibration factors e Chapter 11 DIAGNOSTICS Provides information about special procedures and troubleshooting procedures for the instrument Includes topics such as a maintenance schedule cleaning and replacement procedures and what error messages mean e Appendix A SETUP Provides procedures on customizing the instrument s settings such as date time reporting units laboratory limits and others e Appendix B BARCODE SPECIFICATIONS FOR OPTIONAL BARCODE WAND Provides a procedure for testing troubleshooting and reprogramming the barcode scanner e Appendix C MANUAL CALIBRATION Provides a procedure for manually calibrating the instrument e Appendix D WORKSTATION MANAGEMENT Provides information about archive and database management e Appendix E WORKLIST SCENARIOS Provides information and flowcharts regarding Worklist scenarios e REFERENCES Lists references used in this manual e GLOSSARY Defines terminology used in this manual e ABBREVIATIONS Defines abbreviations used in this manual
213. and or to edit a clerical error A AET 1 From the Main screen J Q A 56 PN 624026AE SETUP A SETTING UP A CONTROL FILE 0 amp CETE 3 The QC Levey Jennings graphs screen Sata appears JAcT Sdiff AL Modify Vi 4 0 the Target tab PN 624026AE A 57 SETUP SETTING UP A CONTROL FILE A 58 5 Select the desired control file Control Name b i the desired control s Ue Lot Number J CONTROL 13 CBC DIFF 270502 x at or at OF 8 Edit the control information as needed OM 10 Ifyou modified the target values and there are no results in the control files the changes are saved and an entry is made into the QA log PN 624026AE SETUP A SETTING UP A CONTROL FILE 11 If you modified the target values and the control file contains results the following message appears AcT 5diff AL Target Modified Delete All Results y x a E the desired option e Ifyou select Delete All Results the changes made to the target values will be saved and all results stored in the control file will be deleted All stored control data for that specific control will be deleted and cannot be recovered e Ifyou select Recalculate Using New Target recommended the new target values are saved and all results in the control file will be recalculated and re flagged using the new target values b C to perform the selected
214. and with DiffPlot Histogram flags select the criteria as shown I Analytical P V DiffPlot Histogram I Not Printed J Patient Limit Not Transmitted To locate all results with action limits flags select the criteria as shown Analytical I DiffPlot Histogram Not Printed J Patient Limit T Not Transmitted 2 Once you select a criteria the sorted results are displayed For example this screen shows the results sorted by Action Limit AL AcT Sdiff AL Result a I Analytical I DiffPlot Histogram I Not Printed I Not Transmitted I Patient Limit Inc Sample ID Cass Pos Patient ID Last Name First Name Gender Date of Birth Age Panel Run Date AF DI EJE A 458 Unknow cecjbovjiojjaceM DO OM BM DD I 44568 Unknow c D07 10 2c 0 A e e O 306502 Unknow c c Do7 10 2c 0 e MM OD F jauto_sico 6 Unknow c D07 102c 0 MRR OO aj M1929039 1 Unknow c D07 10 2c C hh wo M auto sio 4 Unknow c c D07 10 2c 0 MR wo Fijsiis20039 1 Unknow c Do7 10 2c 0 hh e O p M javtosico9 1 Unknow c D07 10 2c 0 MR e O Fjautosico 2 Unknow caqioovjinjec MR RO ia m jauto_sicg 1 Unknow c D07 10 20 0 MR RO rrr M jauto_sico 2 Unknow c D07 10 2c 0 MM RO M javtosico 1 Unknow cecibovjiojac M MM OD F auto sito 2 Unknow c D07 10 2c 0 MM BO aR 78787 Unknow cecjbov iojaceM CO OM BM DD Lourdes
215. ange Standard Range Man gt 14 years Woman gt 14 years Child 1 Editable see e Adding Editing a Flagging Set Range in Appendix A Child 2 Editable see e Adding Editing a Flagging Set Range in Appendix A Child 3 Editable see e Adding Editing a Flagging Set Range in Appendix A Child 4 Editable see e Adding Editing a Flagging Set Range in Appendix A Child 5 Editable see e Adding Editing a Flagging Set Range in Appendix A No defined range When your instrument is installed Standard Range is established as the default flagging set However you can change the default flagging set to meet your laboratory s needs For details see Setting a Default Flagging Set in Appendix A You can edit the patient limit ranges and action limit ranges for existing flagging sets except Standard If a result is outside the patient limit range the result will be flagged in yellow e H for results above the upper patient limit and e L for results below the lower patient limit See Adding Editing a Flagging Set Range in Appendix A for additional information If a result is outside the action limit range the result will be flagged in red e HH for results above the upper action limit and e LL for results below the lower action limit Figure 5 49 shows the flagging set selection and update process PN 624026AE PN 624026AE GETTING STARTED 5 UNDERSTANDING HOW FLAGGING SETS ARE APPLIED Fig
216. ar results when a sample is repeatedly run Precision of the instrument is a CV or an SD for DIFF parameters based on replicate determinations of the same sample Precision shows the closeness of test results when repeated analyses of the same material are performed quality control QC A comprehensive set of procedures a laboratory establishes to ensure that the instrument is working accurately and precisely reportable range The lowest to highest concentration that can be reported without dilution or other modifications to the sample reproducibility This procedure checks that the system gives similar results within established limits every time it measures the same sample A so called precision results Numeric values and or codes flags derived from analyzing a sample run An analysis that provides results for hematology parameters SD standard A measure of variation within a group of samples or within a population deviation shutdown cycle Cleans the instrument s fluidic lines and apertures to help prevent residue buildup specifications See performance specifications startup cycle Ensures that the instrument is ready to run includes performing a background test stat See statim statim At once or immediately Commonly referred to as stat TABLE OF Assigned values for a control material used for quality control parameters Usually EXPECTED reported on pac
217. ardware Reset Error on raw results An error occurred when Do Hardware Reset transmitting raw results Error on start internal clock Internal clock start failure Do Hardware Reset Flow cell syringe mechanism Flow cell syringe 1 Do Auto Clean Running motor failure mechanism failed 2 Check motor in Diagnostics Flow cell syringe motor not Flow cell syringe 1 Do Auto Clean Running reaching home mechanism not reaching 2 Check the motor as instructed in home Motors Checking Front cover open Front cover is open 1 Close front covers 2 Do Hardware Reset Hbg blank error Hgb reference value was Do Auto Clean Running not within range 2 5 to 4 99 V Holder sensor 1 incorrect Holder 1 sensor is in the Do Hardware Reset position incorrect position Holder sensor 2 incorrect Holder 2 sensor is in the Do Hardware Reset position incorrect position PN 624026AE 11 115 DIAGNOSTICS SYSTEM ERRORS 11 116 Table 11 5 Error Messages Continued Message Probable Cause Suggested Action Holder sensor 3 incorrect position Holder 3 sensor is in the incorrect position Do Hardware Reset Holder sensor 4 incorrect position Holder 4 sensor is in the incorrect position Do Hardware Reset Home motor 0 error Home motor error Do Hardware Reset Host Communication Error ACK There is a problem with the communication or handshaking to the host computer Verify th
218. are doing this procedure because you received the Calibration factors modified Run calibration message do not enter new calibration factors Go to step 7 9 Enter the desired calibration factors Highlight the number to edit a b Type the new number c Press to advance to the next field if necessary d Repeat steps a through c as needed 6 Verify the calibration factors are correct 7 C Accept Values to save the new calibration factors 0a 8 as needed to return to the desired screen PN 624026AE 11 51 DIAGNOSTICS REPRODUCIBILITY CHECK 11 7 REPRODUCIBILITY CHECK Reproducibility sometimes referred to as precision measures the instrument s ability to reproduce similar results within established limits when a sample is consecutively run The closeness of the results for the same sample indicates the instrument s precision Understanding the Reproducibility Screen See Figure 11 9 Figure 11 9 Reproducibility Screen Details ps Reproducibility N n Autoloader Mode Number of Aspirations E 4 CBCs DIFF Oee D Opr __ Date Time a RBC HGB HCT HCY MCH MCHC o wW j i s Selected Results N 5 D WBC RBC HGB HCT MCY MCH MCHC O Nex 5 25D fe Nf p Minimum 00 oo oo oo o oo oo Maximum 00 0 00 00 00 0 00 00 o 00 0 00 oo 00 0 oo 00 3 7 amp B BD Av X DI Supervisor Jj 0770872002 15 23 51
219. are indicated in text by a bar in the margin of the amended page This document applies to the latest software listed and higher versions When a subsequent software version changes the information in this document a new issue will be released to the Beckman Coulter website For labeling updates go to www beckmancoulter com and download the most recent manual or system help for your instrument REVISION STATUS iv PN 624026AE CONTENTS E WARNINGS AND PRECAUTIONS ii REVISION STATUS iii CONTENTS v INTRODUCTION xxix OVERVIEW xxix USING YOUR A T 5diff AL HEMATOLOGY INSTRUCTIONS FOR USE MANUAL xxix ABOUT THIS MANUAL xxix CONVENTIONS xxxi GRAPHICS xxxi SYMBOLS xxxii Safety Symbols xxxii Tab Symbols xxxii 1 USE AND FUNCTION 1 1 1 1 INTENDED USE 1 1 General 1 1 Purpose 1 1 System Overview 1 2 1 2 DESCRIPTIONS 1 2 ACeT 5diff AL Analyzer 1 2 Overview of Analyzer 1 2 Back Panel 1 4 Warning and Caution Labels 1 4 Tube Holders 1 5 Workstation PC 1 7 1 3 PANELS 1 8 1 4 PARAMETERS 1 8 CBC Panel 1 8 CBC DIFF Panel 1 9 1 5 FEATURES 1 9 1 6 REPORTS 1 10 1 7 QUALITY ASSURANCE CONTROLS CALIBRATORS AND IQAP 1 10 Cell Controls 1 10 Calibrator 1 10 IQAP Interlaboratory Quality Assurance Program 1 10 XB Analysis in the Analyzer 1 11 1 8 REAGENTS 1 12 PN 624026AE V CONTENTS 1 9 Recommended Reagents 1 12 Reagent Descriptions 1 13 PRINTER 1 14 1 10 ORDERING MA
220. are now available on the Results screen and the Run in Progress screen PN 624026AE E 1 WORKLIST SCENARIOS WORKLIST MATCH OPTION SCENARIOS E 2 E 2 WORKLIST MATCH OPTION SCENARIOS Depending upon your lab s Worklist Match Option setting various sample analysis scenarios can occur If your Worklist Match Option is Barcode see Barcode Scenarios in this chapter If your Worklist Match Option is Cass Position see Cass Position Scenarios in this chapter ATTENTION For all scenarios Auto Print for patient sample results was ON In some scenarios actual cassette and positions were entered as well as specific Sample IDs This specific information is provided to help explain the scenarios so you can better understand the process Your cassette position and Sample ID information will differ from what is included in these scenarios Barcode Scenarios If your Worklist Match Option is Barcode see the following scenarios Scenario 1 Barcode On Manual Match On Auto Print On No Worklist Order Scenario 2 Barcode On Manual Match On Auto Print On Worklist Order Exists With Same Sample ID as on Barcode Label Scenario 3 Barcode On Manual Match Off Auto Print On Worklist Order Exists with Same Sample ID as on Barcode Label Scenario 4 Barcode On Manual Match Off Auto Print On Worklist Order Exists but Worklist Sample ID Differs from the Sample ID on the Barcode Label Scenario 5 Barcode On Manual Match On Au
221. are the abnormal results criteria for No Parameter Value allows all patient results without a value to be automatically sent to the Host computer upon completion of analysis With Parameter Flags allows all patient results with a parameter flag to be automatically sent to the Host computer upon completion of analysis With Histo amp DiffPlot Flags allows all patient results with a histogram flag and a DiffPlot flag to be automatically sent to the Host computer upon completion of analysis Outside Patient Limits allows all patient results outside patient limits flagged with H or L to be automatically sent to the Host computer upon completion of analysis A 67 SETUP AUTO FUNCTIONS SETUP Setting the Auto Transmit Options for Patient Results Do this procedure to define the auto transmission settings for transmitting patient results to a Host computer ES AcT 5diff AL LN 3 A Seco COULTER Coutter AST Sdiff AL 1 From the Main Menu screen 0 aE OF Sdiff AL Auto Functions 3 0 the Auto Transmit tab Auto Print Auto Transmit is A 68 PN 624026AE SETUP A AUTO FUNCTIONS SETUP OF 5 Select the desired Auto Transmit option for patient results For Normals and Selected Abnormals be sure to select the criteria for abnormals No Parameter Value Iv With Parameter Flags Iv With Histo and DiffPlot Flags Vv Outside Patient Limits Vv Outside Action Limits VV 6 u y to save t
222. arts e You mishandle broken parts e Doors covers and panels are not opened closed removed and or replaced with care e Improper tools are used for troubleshooting To avoid injury e Keep doors covers and panels closed and secured in place while the instrument is in use e Take full advantage of the safety features of the instrument Do not defeat safety interlocks and sensors e Acknowledge and act upon instrument alarms and error messages e Keep away from moving parts Report any broken parts to your Beckman Coulter Representative Open remove and close replace doors covers and panels with care Use the proper tools when troubleshooting CAUTION System integrity might be compromised and operational failures might occur if e This equipment is used in a manner other than specified Operate the instrument as instructed in the Product Manuals e You introduce software that is not authorized by Beckman Coulter into your computer Only operate your system s computer with software authorized by Beckman Coulter e You install software that is not an original copyrighted version Only use software that is an original copyrighted version to prevent virus contamination IMPORTANT If you purchased this product from anyone other than Beckman Coulter or an authorized Beckman Coulter distributor and if it is not presently under a Beckman Coulter service maintenance agreement Beckman Coulter cannot guarantee that the product is fitted with
223. assette moved to the right Do Hardware Reset Incorrect pos motor counting 0 Min 0 Max 0 Counting motor is in the wrong position Do Hardware Reset Incorrect pos motor diff 0 Min 0 Max 0 Diff motor is in the wrong position Do Hardware Reset Incorrect pos motor diluter 0 Min 0 Max 0 Diluter motor is in the wrong position Do Hardware Reset Incorrect pos motor drain 1 0 Min 0 Max 0 Drain 1 motor is in the wrong position Do Hardware Reset PN 624026AE PN 624026AE Table 11 5 Error Messages Continued Message Probable Cause DIAGNOSTICS SYSTEM ERRORS Suggested Action Incorrect pos motor drain 2 0 Min 0 Max 0 Drain 2 motor is in the wrong position Do Hardware Reset Incorrect pos motor loader 0 Min 0 Max 0 Loader motor is in the wrong position Do Hardware Reset Incorrect pos motor mixer 0 Min 0 Max 0 Mixer motor is in the wrong position Do Hardware Reset Incorrect pos motor needle 0 Min 0 Max 0 Needle motor is in the wrong position Do Hardware Reset Incorrect pos motor sampling 0 Min 0 Max 0 Sampling motor is in the wrong position Do Hardware Reset Incorrect pos motor transfer 0 Min 0 Max 0 Transfer motor is in the wrong position Do Hardware Reset Incorrect pos motor traverse 0 Min 0 Max 0 Traverse motor is i
224. at the tubing is not pinched or twisted 14 Verify that the tubing is not pinched or twisted OOS 15 Close the reagent compartment door ee a Lift the door up b Lower the door until it is closed 6 UY The system updates the reagent information primes the reagent and updates the level indicator Note Due to priming the reagent level may not be displayed as 100 ATTENTION If an instrument error occurs during the reagent replacement procedure the reagent s may not be fully primed If an error occurs a Acknowledge and resolve the error b Do Hardware Reset in this chapter c Do Prime Reagents to manually prime the reagent s 11 94 PN 624026AE DIAGNOSTICS REPLACEMENT PROCEDURES Replacing the Waste Container As the waste container fills there is a float on the waste sensor in the cap that triggers an alarm in the software and a Waste Full error message Do this procedure to replace the waste container if the Waste Full message appears ce A 1 Carefully remove the waste container cap with waste sensor attached Ae 2 Replace the waste container according to your laboratory s guidelines WARNING Risk of personal injury if waste is not neutralized before the waste container is capped Non neutralized waste contents may produce gas which can build up pressure in a capped container Neutralize waste contents after removing the waste container and before capping it for
225. at the input window Maintenance Log Input Action Performed Duration of Action _ Comment v x Action Performed 35 characters available Duration of Action 10 characters available Comment 50 characters available For example if you cleaned the tube holder door and it took one minute to do your input may be something like this Cleaned tube holder door in Action Performed 1 minute in Duration of Action Cleaned tube holder door as instructed in the Operator s Guide in the Comment field OM c View the log to verify the entry was added Figure 11 22 shows what the entry would be using the above example PN 624026AE 11 131 DIAGNOSTICS LOGS Figure 11 22 Maintenance Log Entry AcT 5diff AL Maintenance Logs By Description S Service Group Service Action Clean Exterior of instrument Duration 5 minutes All user must ensure instrur gt Printing Log Entries Do this procedure to print log entries from any log 1 Ifthe log is not already open im a From the Main Menu screen a b U the icon for the log you want to open 2 After the desired log opens u D ATTENTION All logs retain at least one year s worth of entries some retain five year s worth Keep in mind that a week s worth of entries on the Startup log will probably be more than a week s worth of entries on the Reagents log Therefore specify the exact Start and
226. at the protocol set up in the host transmission screen matches the protocol expected by the host computer Host Communication Error Chars There is a problem with the communication or handshaking to the host computer Verify that the protocol set up in the host transmission screen matches the protocol expected by the host computer Host Communication Error ENQ There is a problem with the communication or handshaking to the host computer Verify that the protocol set up in the host transmission screen matches the protocol expected by the host computer Host Communication Error Timeout There is a problem with the communication or handshaking to the host computer Verify that the protocol set up in the host transmission screen matches the protocol expected by the host computer Host Communication Error Timeout There is a problem with the communication or handshaking to the host computer Verify that the protocol set up in the host transmission screen matches the protocol expected by the host computer Host Communication Error Write There is a problem with the communication or handshaking to the host computer Verify that the protocol set up in the host transmission screen matches the protocol expected by the host computer Incorrect cassette transfer movement left Cassette moved to the left Do Hardware Reset Incorrect cassette transfer movement right C
227. ates and NRBCs may be found in this region WBC is displayed and printed in the DiffPlot and Histogram section of the Flags and Messages area Default value 3 5 or 999 particles MB Mono Baso Figure 9 15 WBC BASO Histogram Flags CBC DIFF Panel Generated when the percentage of basophils found in the BA channel is above the percentage of the LY MO NE raw count found on the DIFF channel MB is displayed and printed in the DiffPlot and Histogram section of the Flags and Messages area MICRO and or RBC Figure 9 16 MICRO and MACRO Regions on RBC Histogram MACRO 1 1 MICRO 1 RBC1 RBC2 1 1 MACRO MICRO and MACRO flags are generated when the percentage of cells counted in the microcytic MICRO and macrocytic MACRO regions compared to the total number of RBCs are above the established limits set by your laboratory See Figure 9 16 Thresholds RBC1 and RBC2 define the MICRO and MACRO regions and are calculated based on the standard deviation of anormal RBC population MICRO and or MACRO are displayed and printed in the DiffPlot and Histogram section of the Flags and Messages area Default value 5 for MICRO and 7 5 for MACRO 9 43 9 DATA REVIEW FLAGS AND MESSAGES GENERATED BY THE INSTRUMENT Table 9 4 Histogram Flags Continued Histogram Flag Illustrations of Histogram Flags Description Pit MIC Figure 9 17 Plt Flags The Plt histo
228. ation in Chapter 2 Drain and rinse Pneumatic syringe problem 1 Drain the baths See Drain Baths in this chapter 2 Rinse the baths See Backflush in this chapter 3 Ifthe problem persists contact a Beckman Coulter representative 11 123 l DIAGNOSTICS LOGS Table 11 6 Troubleshooting Guide Continued Problem Area Situation Probable Cause Suggested Action Results Poor Bent sampling probe Contact a Beckman Coulter reproducibility representative No parameter Bent sampling probe Contact a Beckman Coulter results No sample aspiration representative Reagent problem Excessive Collection and or mixing Contact a Beckman Coulter flagging problem with sample representative Reagent problem Printer Printer does not Printer may be turned off Turn the printer on work Printer may not be setup Refer to the printer user s manual or connected properly Reagents Level low Not enough reagent in Do Replacing Reagents Procedure the bottle container Waste sensor Waste container is full Do Replacing the Waste Container alarm beeps Waste sensor battery is Replace the battery low Incorrect mechanical Defective stepper Motor alarms are Do Hardware Reset Operation motors triggered Current cycle stops Incorrect pneumatic Leaks or Reagent alarms are 1 Do Hardware Reset operation blockages triggered 2 Do Prime Reagents Current cycle stops Incorre
229. ation runs 21 Expiration date of the calibrator material D Lot number of the calibrator material only the lot numbers defined in the Modify Calibration Targets screen will be displayed in the drop down list Understanding the Calibration Setup Screen Figure 10 2 shows the Calibration Setup screen details To access the screen l From the Main Menu screen C Q PN 624026AE 10 3 CALIBRATION GENERAL Figure 10 2 Modify Calibration Targets Screen Calibrator Lot Number Expiration Date A pnya Modified on Jo7 10j2002 a a ta eae a 3 5 e A v X D Supervisor D y maaan 7367384A 1 Calibrator information lot number expiration date date modified and name of operator who modified the information 2 Target values and limits This information can be downloaded or entered manually The information entered here appears on the Calibration Screen see in Figure 10 1 Allows you to download target values from a floppy disk 10 4 PN 624026AE CALIBRATION Ji PRE CALIBRATION CHECKS 10 2 PRE CALIBRATION CHECKS Before beginning calibration it is important that you do these pre calibration checks 1 Determine if there is enough of each reagent to complete the entire procedure e Ifnot do Replacing Reagents Procedure e Ifso go to step 2 2 Verify that the instrument has been shut down for at least 30 minutes duri
230. automated quality control evaluation automated patient data storage closed vial sampling aspiration with probe wipe cell control download for IQAP 12 or 26 parameter analysis with histograms and DiffPlots and manually entered autonumbered or barcoded patient sample identification 1 9 i USE AND FUNCTION REPORTS 1 6 1 7 REPORTS Sample result reports are printed based on your instrument setup See Enable Define Patient Report Areas in Appendix A for details For instructions on how to use the printer refer to the printer s instruction manual In addition to sample reports the instrument also generates other reports such as e Worklist reports e results list reports e control reports including Levey Jennings e reproducibility reports e calibration reports e XB XM reports including Levey Jennings e log reports e background Startup reports and e setup reports QUALITY ASSURANCE CONTROLS CALIBRATORS AND IQAP Cell Controls Controls are substances used to monitor instrument performance By comparing the control results against the assay known value you can determine your instrument s accuracy and reproducibility ACeT 5diff Control Plus is available in three levels low normal and high to provide a stable reference control for use with this instrument Refer to the control material package inserts for additional information including stability for open and closed vial us
231. automatically re run Patient ID Figure 8 6 Only available if the Cass Position is the Worklist Match Option Cassette number for sample highlighted in Find search icon for the Patient ID Cassette position number for sample highlighted in Sample ID Patient s last name Patient s first name 8 41 8 SAMPLE ANALYSIS UNDERSTANDING THE WORKLIST SCREENS Collection date and time of sample Patient s age Flagging set Patient s date of birth Find search icon for the Sample ID Patient s gender Location Patient ID Test panel Position Physician Cassette number If is displayed it means the system could not determine the cassette number Opens the Sample comment window Sample ID If is displayed it means the system could not determine the tube s position Opens the Patient comment window Worklist orders 8 49 PN 624026AE SAMPLE ANALYSIS 8 UNDERSTANDING THE WORKLIST SCREENS Understanding the Worklist Cassette Screen On the Worklist Cassette screen Figure 8 6 the entered information is shown on the left of the screen and is representative of a cassette to facilitate data entry and location of tubes within the cassette This screen is only available if Cass Position is the selected Worklist Match Option positive ID The Worklist Cassette screen is the primary screen used when entering Worklist information when the Work
232. be The use of the cassette and position as the positive identifier is not as secure as the use of barcodes and is not a recommended method of sample identification operation If you choose to analyze samples in this manner you must verify that the sample tube s are placed in the correct cassette and in the correct position Do not use this method of operation if you are using barcoded tubes The barcode label in this case is additional sample information and not the primary sample identifier If a barcode label is not read the results will be reported using the Worklist entry information Do this procedure to analyze samples without barcoded Sample IDs from the Worklist with Manual Match on ay Ge Be E oeo pEi E 1 WE i TENEIRE gt er KIM 2i 9 amp gt l amp v x j Tena T A 2 If manually entering the Worklist orders u Note If the Worklist orders were downloaded by a Host computer verify that they have been received PN 624026AE RUNNING WORKLIST SAMPLES IN AUTOLOADER MODE SAMPLE ANALYSIS 8 3 Type the cassette number 1 to 10 from the back of the cassette and press Enter AcT Sdiff AL_ WORKLIST Z i Sampie 10 Collect Date Tir EJ ime Cass numborf07 Ea A CBC ninna CBC DIFF DIFF O Standard Range z m El Comments CRCHOMORCRONCRONORGH CROMONCRORORONORCES
233. blank The system calculates the Hgb using both the blank and sample readings The final Hgb result represents absorbance value obtained x factor of calibration Hgb is displayed and printed as Hgb N g dL Note g dL is the US unit format Other formats are available See Units Selecting the Reporting Unit in Appendix A 2 OPERATION PRINCIPLES PARAMETER DEVELOPMENT WBC Count BASO Count and DiffPlot Development WBC Count The instrument uses duplicate counting criteria voting criteria and proprietary flagging information to confirm the parameter result prior to reporting it To obtain an WBC white blood cell count result the instrument compares the data from the two 5 second count periods then votes and rejects any questionable data This is the reference WBC count which is reported A second WBC count is determined in the flow cell during acquisition of the DiffPlot WBC count Number of cells per volume x calibration factor BASO Count Differentiation between basophils and other leukocytes is obtained by means of the ACeT 5diff WBC Lyse specific lytic action In Figure 2 17 basophils are located in the area between the thresholds labeled and One hundred percent 100 of the leukocytes is represented by the total number of nucleated particles plus the basophils within the area between the thresholds labeled and The basophil percentage is calculated from the number of particles existing in the area bet
234. by See Chapter 10 CALIBRATION Replace reagents When empty or when there is not enough to complete your daily workload Reagent s Low Insufficient Reagents to Complete Daily Workload appears See Replacing Reagents Procedure in this chapter Extended cleaning As needed Poor instrument performance See Extended Cleaning in this chapter Hardware Reset After an emergency stop of the instrument or when a faulty operation has been detected See Hardware Reset in this chapter DIAGNOSTICS REMOVING PANELS COVERS Table 11 1 Maintenance Schedule Continued Maintenance Procedure Frequency Situation Replace Rinse Drain Filter When instructed by a Beckman Coulter representative DRAIN SENSOR TIMEOUT may indicate a possible filter restriction See Replacing the Rinse Bath Drain Filter in this chapter Shut down Windows NT Monthly See Heading 11 8 SHUTTING DOWN WINDOWS NT RECOMMENDED 11 3 REMOVING PANELS COVERS Occasionally you may be instructed to open a door or remove a cover panel on the Analyzer See Figures 11 1 and 11 2 For details regarding specific panels covers see e Removing the Left Panel e Removing the Right Panel e Replacing the Right Panel e Removing the Top Cover PN 624026AE DIAGNOSTICS Ji REMOVING PANELS COVERS Figure 11 1 Analyzer Doors and Covers Right Side Right side panel Right cover Right front door
235. c power cord is plugged into a power source e Ifthe ac power cord is unplugged plug the cord into the instrument at the back panel in the lower left comer and or into an appropriate ac wall outlet e Ifyour system is plugged into a line conditioner and not directly plugged into a wall outlet verify all system components are plugged into the same source 4 Turn the Workstation computer on a Turn the PC on b Turn the monitor on Allow sufficient time for the computer to complete its internal checks 5 At the Analyzer a Turn the power ON OFF switch ON b Verify that the red LED remains illuminated 5 4 PN 624026AE GETTING STARTED 5 POWERING UP AND LOGGING ON POWERING DOWN AND LOGGING OFF AcT Sdiff AL 6 Log in to the system a Select the Login Name name p Us 2 Highlight your choice b Type your password only required if you log in as Supervisor or pace roren ropna PaE n that may result in civil or criminal penalties Service ee ee c Read the license agreement scroll down by v E a 0 7 Ifautomatic Startup is enabled Startup automatically runs If automatic Startup is disabled a will flash u rs to run a Startup For details on enabling automatic Startup see Startup Automatic in Appendix A The progress bar shows the progress of the Startup routine 8 Allow Startup to finish When it is completed the M
236. cannot type the age in this field you can only select the age with the slider box A 121 SETUP FLAGGING SETS SETUP e Adding Editing a Flagging Set Range You can create up to 12 additional flagging sets for a total of 20 flagging sets for your system or to edit existing flagging sets Twelve are already pre defined and installed Do this procedure to create a new flagging set or to edit an existing flagging set ATTENTION e The Standard Range flagging set cannot be edited The age range can only be edited for Child 1 Child 2 Child 3 Child 4 and Child 5 flagging sets IMPORTANT Due to the system s calculation methods for determining the age from the date of birth the precision of the age calculation is limited to 1 day When the age is close to the limit of a flagging range the adjoining flagging range may be selected amp S LN Ne 1 From the Main Menu screen C a OM PN 624026AE A 122 SETUP FLAGGING SETS SETUP A 3 he FI dM b E up e Flags and Messages tab ee a ee chi RBC 250 a0 E 70 cs na 5 Cio cE A a a EJ B FEET rer P E aa w m PP a5 F A Restore Default Value hosii E REN om fom i Mo amo Faa 100 GEJ Default Flagging Set E0 ao aoo 0060 0 080 oy Standard Range pa oo o T0 TE di Modified on nes 150 2
237. cation Do this procedure to delete a physician and or location 1 From the Main Menu screen 0 4 3 W the Location Physician tab PN 624026AE A 25 SETUP OPERATIONAL SETUP 4 Highlight the physician or location from the list For example to delete Dr Villanueva from the list of physicians highlight Dr Villanueva in the list If deleting a location this message appears If deleting a physician this message appears 6 E v to delete A 26 PN 624026AE SETUP A OPERATIONAL SETUP Ce as needed Units Selecting the Reporting Unit Under the Units tab you can select the reporting units in which results are displayed and printed By selecting a reporting unit you are selecting the format in which numeric results are reported You can choose from these reporting units Unit Selection US INTERNATIONAL SYSTEM 1 INTERNATIONAL SYSTEM 2 INTERNATIONAL SYSTEM 3 INTERNATIONAL SYSTEM 4 Table A 3 shows the reporting unit formats for each parameter Table A 3 Reporting Unit Format Reporting Unit Parameter US SI 1 SI 2 13 S14 WBC 103 uL 109 L 109 L 103 uL 109 L RBC 106 uL 1012 L 1012 L 106 uL 1012 L Plt 108 uL 109 L 109 L 108 uL 109 L Het L L L L L L L L Hgb g dL g L g L g dL mmol L MCV fL fL fL fL fL MCH pg pg pg pg fmol MCHC g dL g L g L g dL mmol L RDW MPV fL fL fL fL fL Pct PDW DIF
238. ch detected Stop cassette input switch was detected but should not have been k Do Hardware Reset 2 Check the motor as instructed in Motors Checking Stop cassette input switch not detected Stop cassette input switch was not detected but should have been Do Hardware Reset 2 Check motor in Diagnostics Stop cassette transfer sensor detected Stop cassette transfer sensor was detected but should not have been Do Hardware Reset 2 Check the motor as instructed in Motors Checking Stop cassette transfer sensor not detected Stop cassette transfer sensor not detected but should have been Do Hardware Reset 2 Check the motor as instructed in Motors Checking Traverse mechanism not Traverse mechanism not Do Auto Clean Running reaching home reaching home 2 Check the motor as instructed in Motors Checking Traverse motor failure Traverse motor failed 1 Do Auto Clean Running 2 Check the motor as instructed in Motors Checking Tube detection sensor incorrect position Tube detection sensor is in wrong position Do Hardware Reset Tube holder mechanism failure Tube holder mechanism failed Do Hardware Reset Restart cycle Tube too high in cassette Tube is too high in the cassette 1 2 1 Open left front cover 2 Move cassette from input area 3 Close left front cover 4 Restart cycle Tw
239. ch On Auto Print On Worklist Order Exists With Same Sample ID as on Barcode Label Summary Report prints with the barcode Sample ID 1 Insert tube into cassette 2 Place cassette in Cassette Input Tray 0 umi 3 PPP 4 Sample is analyzed 5 Report automatically prints with the barcode Sample ID Scenario 3 Barcode On Manual Match Off Auto Print On Worklist Order Exists with Same Sample ID as on Barcode Label Summary Report prints with the barcode Sample ID 1 Insert tube into cassette 2 Place cassette in Cassette Input Tray i 3 Tis 4 Sample is analyzed 5 Report automatically prints with the barcode Sample ID Scenario 4 Barcode On Manual Match Off Auto Print On Worklist Order Exists but Worklist Sample ID Differs from the Sample ID on the Barcode Label Summary Report prints with the barcode Sample ID but the Worklist order remains until deleted because the Sample ID for the Worklist order differs from what was read off the barcode label 1 Insert tube into cassette 2 Place cassette in Cassette Input Tray U i PPIP Sample is analyzed Report automatically prints with the barcode Sample ID Since the Sample ID for the Worklist order differs from what the Analyzer read off the sample tube the Worklist order remains there until it is deleted or until it is matched with sample results oo Seo Scenario 5 Barcode On Manual Match On Auto Print On Worklist Order Exists but Worklist Sa
240. ch parameter A 50 If manually entering the values from the assay sheet do To manually enter the assigned values and expected ranges If downloading the values from the assay values floppy diskette do To download the assay values and ranges from the floppy PN 624026AE SETUP A SETTING UP A CONTROL FILE To manually enter the assigned values and expected ranges This procedure continues from Heading A 6 SETTING UP A CONTROL FILE above ATTENTION Decimals cannot be entered for MCV values Therefore round up to the nearest whole number for a decimal value of 5 or higher and round down to the nearest whole number for a decimal value of 4 or lower oer ee aE Anchor the cursor in the desired field Enter the value Press to move to the next field Continue until all values and ranges are entered Ow e Ifthe value entered is not within the parameter s range the following message appears AcT 5diff AL to save the control setup Incorrect input for WBC Possible reasons value set to zero value out of range Ow e Ifthe value entered is not valid Invalid Input on X parameter appears Enter a correct value and sl cancel without saving undo changes without saving Repeat steps 1 through 5 until target values are entered for all control levels and all parameters 0 to print a copy of the control setup information for your records A 51 SETUP SETTING UP A CONTROL FILE A 5
241. ch parameter using samples 2 through 11 on the worksheet Write this number into row A on the worksheet 2 Copy your calibrator material s assigned value to the worksheet Write this number into row B on the worksheet 3 Calculate the absolute difference between the assigned value and the mean value calculated in step 1 Write this number into row C of the worksheet 4 Determine if calibration is necessary by comparing the absolute difference from row C to your materials calibration criteria table e If the absolute difference is less than the value in your material s calibration criteria table no calibration is required e If the absolute difference is between the values found in your material s calibration criteria table do Heading C 3 CALCULATING NEW CALIBRATION FACTORS e Ifthe absolute difference is greater than the value found in your material s calibration criteria table eliminate possible instrument problems and possible calibrator deterioration If you determine calibration may be needed contact a Beckman Coulter Representative before calibrating C 3 CALCULATING NEW CALIBRATION FACTORS 1 Record the new factors into row D on the worksheet see Calibration Worksheet 2 After you complete the worksheet contact a Beckman Coulter representative C 2 PN 624026AE MANUAL CALIBRATION C CALCULATING NEW CALIBRATION FACTORS Calibration Worksheet Sample Number TOTAL A samples 2 through 11 C B A E
242. creen Options 5 38 Logs Menu Options 5 39 Diagnostics Menu Screen Options 5 40 Quality Assurance Screen 5 41 QC Screen Options 5 42 Reproducibility Screen Options 5 42 Calibration Screen Options 5 43 IQAP Screen Options 5 43 XB XM Screen Options 5 44 Generic Toolbar 5 45 Contextual Toolbar 5 46 Progress Indicator 5 47 Local Setting Tab 5 47 Text Button 5 48 Bitmap Button Drop down Box 5 48 Radio Buttons 5 48 Fields 5 49 Boxes 5 49 Scrollable List 5 50 Mouse 5 51 Tool Tip Names 5 52 Scroll Bars 5 53 Icon States Active and Inactive 5 53 Tabs 5 53 Screen Name System is Shown 5 54 Flagging Set Selection and Update Process 5 59 QA Menu Screen 7 1 QC Levey Jennings Graph Screen 7 26 QC Data Grid Screen 7 27 QC Graphics Screen 7 29 IQAP Download Screen Defined 7 40 XB XM Graphs Screen 9 Parameters XM is Shown 7 52 XB Batch Details Screen 7 54 Rerun Order on Worklist 8 32 Rerun Indicator on Patient Sample Report 8 33 Patient and Sample Information Fields 8 34 Right Side of the Worklist Screens 8 40 Worklist Grid Screen 8 41 Worklist Cassette Screen 8 43 Worklist Cassette Screen Cass Position Details 8 44 Worklist Sample ID from Worklist Cassette Screen 8 44 Run in Progress Screen 9 1 Results List Screen 9 3 xxiii xxiv o gt 9 4 99 9 6 o 9 8 99 9 10 9 11 9 12 9 13 9 14 9 15 9 16 9 17 9 18 9 19 9 20 9 21 10 1 102 10 3 10 4 11
243. crocytes RBC fragments schistocytes and WBC fragments May interfere with the proper counting of platelets and cause elevated Pit counts Agglutinated RBCs May trap platelets causing an erroneously low Plt count The presence of agglutinated RBCs may be detected by observing abnormal MCH and MCHC values and by examining the stained blood film Excessive numbers of large platelets May cause an erroneously low Plt count since these large platelets may exceed the upper threshold for the Plt parameter are not counted Chemotherapy Cytotoxic and immunosuppressive drugs may increase the fragility of these cells which may cause low Plt counts Use the manual reference method to obtain an accurate Plt count Elevated triglycerides and or cholesterol May interfere with the proper counting of platelets Hemolysis Hemolysed specimens contain RBC stroma which may elevate the Plt count ACD acid citrate dextrose blood Blood anticoagulated with ACD may contain clumped platelets which could depress the Plt count Note that in some patients platelets can aggregate in the presence of EDTA because of the occurrence of platelet specific antibodies This may cause and erroneously low or decreased platelet count Plt Agglutination Clumped platelets may cause a decreased Plt count and or elevated WBC count WBC SL and SL1 flags may be generated Reanalyze the specimen as follows 1 Recollect the specimen in sodium citrate anticoagulant to
244. croll 5 50 PN 624026AE GETTING STARTED WORKING WITH THE SOFTWARE 5 12 WORKING WITH THE SOFTWARE When working with the instrument s software be sure you understand the basics of e Using the Mouse e Moving the Cursor e Viewing Tool Tips Selecting Menu Items e Scrolling e Active Inactive Software Icons e Selecting Menu Tabs e Menu Headings Screen Names Editing Text e Saving Changes e Cancelling Unsaved Changes and e Selecting De selecting Software Features Using the Mouse PN 624026AE A mouse Figure 5 43 is connected to your Workstation and allows you to navigate through the software and to select certain software functions Figure 5 43 Mouse Throughout this manual you will be instructed to select a software option by clicking on it with the mouse Do this procedure to learn how 1 Place the cursor over the item you want AcT 5diff AL System to select Local Host Printer Cycle Options Date Time Format pam Date Time 2 Click press and release the left mouse button v Note If the selection is not made try again check the connection if necessary If the problem persists contact a Beckman Coulter representative 5 51 5 GETTING STARTED WORKING WITH THE SOFTWARE Moving the Cursor To move the software cursor e move Q or e press Tab Viewing Tool Tips To see the function name of a specific icon without clicking the mouse button
245. ct optical Defective optical Specific flags 1 Do Hardware Reset operation parts Hgb blank cycle 2 Do Prime Reagents Dirty optical measurements are parts outside acceptable limit Incorrect electrical Incorrect main Instrument would not Ensure correct voltage from power operation supply voltage initialize source means not applicable 11 16 LOGS Overview Logs contain information regarding specific events performed by the system during operation That information in the log is called an entry Entries to the logs are made automatically by the system except for the Maintenance log which requires you to manually add the entry Logs or log entries cannot be deleted or edited However you can add comments to any of the logs which include e Calibration Log e Quality Control Log 11 124 PN 624026AE PN 624026AE e Reagent Log e Maintenance Log e Patient Worklist Log e Setup Log e Host Log e Alarms and Errors Log e Startup Log DIAGNOSTICS LOGS Understanding the Logs Menu Screen See Figure 11 20 and Table 11 7 Figure 11 20 Logs Menu Screen aap 8 E m A 3 4 wm g a vy X D Ba P Table 11 7 Logs Screen Icons Icon Name Function fa Calibration Log Opens the Calibration log See Calibration Log in this chapter Quality Control Log Opens the QC log See Quality Control Log in this chapter Reagent Log Opens the reagents log See Reagent Log
246. d 5 Apply a liberal amount of the solution to a lint free wipe or fabric tipped applicator ATTENTION Do not wipe contaminants into the baths 6 Use the wipe or applicator to clean the top of a bath With an outward motion slowly and carefully wipe around the top of the bath 11 74 PN 624026AE DIAGNOSTICS Ji CLEANING THE ANALYZER 7 Using a new wipe or applicator for each bath repeat steps 5 and 6 until all baths are cleaned 8 Replace the bath shield 9 Replace the right side panel a Slide the panel into place b Tighten the screws with the door key 10 Plug the Analyzers power cord into its power source electrical outlet 11 Power up the system as instructed in Powering Up the System and Logging On in Chapter 5 PN 624026AE 11 75 DIAGNOSTICS COMPONENT LOCATIONS 12 Drain the Rinse bath as instructed in Drain Baths in this chapter 13 To remove any debris or contaminants from the baths do Extended Cleaning in this chapter 14 Cycle a sample with known results to verify instrument performance 11 10 COMPONENT LOCATIONS See the following figures for component locations e Figure 11 10 Inside Left Components e Figure 11 11 Inside Right Components e Figure 11 12 View of the Pneumatics Area Figure 11 13 Bath Assembly e Figure 11 14 Optical Bench and Pneumatic Assemblies e Figure 11 15 Main Card e Figure 11 16 Computer Worksta
247. d 5upervisor T 0771672002 154633 A 48 PN 624026AE SETUP A SETTING UP A CONTROL FILE 9 Enter the control material lot number Anchor the cursor in the Lot Number field b Locate the lot number of the control material vial c Enter the lot number e manually up to 16 alphanumeric characters with no spaces or e scan the barcode label with the barcode wand d Verify the lot number is correct If you enter a lot number that already exists in a different control filename the following message appears AcT 5diff AL Lot Number already exists in CONTROL 13 10 Beckman Coulter recommends that you select Reserved J Reserved When using a control with a barcode label select For more information on reserving control lot numbers see Reserving Control Lot Numbers in this chapter PN 624026AE A 49 SETUP SETTING UP A CONTROL FILE 11 Select the control s expiration date scouts ig Expiration Date Jos 7 2002 x a I at the Expiration Date field EE May 2002 to open the calendar that shows Sun Mon Tue Wed Thu Fri 1 2 3 4 the current date oe a b Select the expiration date 13 14 15 16 E 18 20 21 22 23 24 25 27 28 29 30 31 1 b TA to advance to the gt Today 03 28 2001 correct month 2 C the correct date 12 From the TABLE OF EXPECTED RESULTS enter the assigned values and expected ranges for the ACeT 5diff Control Plus control for ea
248. d Histogram Flags Interpretive Messages Figure 9 13 Flags and Messages Expanded View Flags and Messages fig Diffplot and Histogram Flags IMM E Interpretive Messages Leukocytosis Neutrophilia ATTENTION In rare instances an unusually high number of flags and messages may appear in the Flags and Messages area which will expand the printout to two pages DiffPlot and Histogram Flags DiffPlot Flags When populations in the DiffPlot exceed the limits set for that region a review R flag will occur on the DIFF parameter related to that region and either DiffPlot and Histogram flags or Analytical Messages will occur and indicate the area within the DiffPlot that is affected If the R flag occurs on a DIFF parameter it is suggested that the result be reviewed according to your laboratory defined protocol Ten different flags may occur related to the position of the populations within the DiffPlot See Table 9 3 for additional information SL small lymphocytes SL1 small lymphocytes 1 NL neutrophil lymphocyte MN monocyte neutrophil UM upper monocyte LN lower neutrophil UN upper neutrophil NE neutrophil eosinophil ATL atypical lymphocytes IMM immature cells PN 624026AE DATA REVIEW FLAGS AND MESSAGES GENERATED BY THE INSTRUMENT Table 9 3 Definition of DIFFPLOT Flags DiffPlot Region Suspected Flag DiffPlot Region Affected Description Flags Abnormalities SL Occurs
249. d Increased Plt count in the DB region printed in the exceeds the DB Analytical RBCs resistant to 2 limit Messages lysis stroma 3 Default values section inthe NRBCs z 100 or 120 Flags and Reagent Absorbance particles Messages area contamination 9 49 DATA REVIEW FLAGS AND MESSAGES GENERATED BY THE INSTRUMENT BASO See Table 9 12 Table 9 12 Definition of Analytical Message BASO DiffPlot Region Suspected Flag DiffPlot Region Affected Description Flags Abnormalities BASO If the BASO BASO is exceeds 50 a displayed and BASO flag is printed in the generated The Analytical basophils are not Messages taken away from section in the the DiffPlot Flags and LY MO NE Messages area populations displayed and printed instead of the BA and BA and BASO is displayed and printed in the Analytical Messages section of the Flags and Messages area QA Messages QA messages Table 9 13 appear when conditions relating to the analysis of a control occurs The QA message is removed only after the condition has been corrected Any sample analyzed after a QA message has occurred will be reported with the QA message Table 9 13 QA Messages Message Description QC Failed Patient sample was run after a QC sample that exceeded limits had been run QC Expired Patient sample was run after an expired QC had been run 9 50
250. d L This computer progam is protected by unauthorized copying use distribution if you log 1n as Supervisor or transfer or sale is a violation of those laws 4 that may result in civil or criminal penalties Service g 7 AcT 5diff AL Workstation Version XX Copyright c 2002 Beckman Coulter Inc All Rights Reserved OM PN 624026AE 5 14 GETTING STARTED 5 WORKING WITH BAR CODE LABELS 5 6 WORKING WITH BAR CODE LABELS Placing Labels on Tubes Your lab may use barcode labels or identification labels on the sample tubes To maintain a high read rate keep the barcode label free from blood scratches excessive powder from gloves and anything else that may interfere with the label s readability When placing barcode labels on a tube e Center the label on the tube between the bottom of the stopper and the bottom of the tube e Place the label parallel to the stopper If the label is skewed the scanner may not read it e Place the label smooth and flat against the tube Gaps and wrinkles may cause the tube to jam in the Autoloader e Do not place excessive labels on the tubes as the labels may cause the tube to jam in the cassette or in the tube holder See Figure 5 5 Figure 5 5 Label Placement on Tubes Correct The label is properly placed Incorrect The label is too far down on the tube and does not lie flat against the tube Incorrect The label is twisted 2 Incorrect The label is wri
251. d are For Research Use Only Not for use in diagnostic procedures 1 8 PN 624026AE 1 5 PN 624026AE CBC DIFF Panel USE AND FUNCTION FEATURES Table 1 2 lists the 26 parameters analyzed in the CBC DIFF panel Table 1 2 CBC DIFF Parameters Parameter Definition WBC White Blood Cell or leukocyte count NE Neutrophil percentage NE Neutrophil number LY Lymphocyte percentage LY Lymphocyte number MO Monocyte percentage MO Monocyte number E0 Eosinophil percentage EO Eosinophil number BA Basophil percentage BA Basophil number IMMt Immature cell percentage IMM t Immature cell number ATLT Atypical lymphocyte percentage ATL t Atypical lymphocyte number RBC Red Blood Cell or erythrocyte count Hgb Hemoglobin concentration Het Hematocrit relative volume of erythrocytes within the whole blood sample MCV Mean Corpuscular erythrocyte Volume MCH Mean Corpuscular erythrocyte Hemoglobin MCHC Mean Corpuscular erythrocyte Hemoglobin Concentration RDW Red Cell erythrocyte Distribution Width Pit Platelet or thrombocyte count MPV Mean Platelet thrombocyte Volume PDWt Platelet Distribution Width Pett Plateletcrit tDerived parameters are For Research Use Only Not for use in diagnostic procedures For additional RUO information see RUO Parameters Enabling Disabling in Appendix A FEATURES Instrument features include Autoloader sampling automated calibration
252. d by the instrument e Results Exceeding Capacity e Hemoglobin Flags e Voteout Flag e Patient Range Flags e Action Range Flags e Control Flags e Platelet Concentrate Extended Range Flag Hemoglobin Hematocrit Ratio Flag H amp H Flag Results Exceeding Capacity If a result exceeds instrument capacity the result will be indicated as follows e If the result is below the lower limits of the instrument the result will be reported as 0 gt WBC reported as 0 if WBC lt 0 1 x 107 uL and RBC is less than 0 01 x 10 pL gt RBC reported as 0 if RBC lt 0 01 x 10 pL gt Hgb reported as 0 if Hgb lt 0 1 g dL gt Het reported as 0 if Hct lt 0 1 e Ifthe result is outside the limits at which the parameter can be calculated the result is replaced by e Ifthe result is above the instrument s linear range Table 3 3 the result is flagged with or if the result is above the instrument s reportable range Table 3 6 the result is replaced by Additionally related parameters may also be flagged or replaced Hemoglobin Flags e Hgb Blank Error The instrument establishes a reference blank reading and compares each sample blank to the reference result If the blank differs from the reference by more than an allowable amount the Hgb MCH and MCHC results are flagged with a review R flag If three consecutive samples produce a Hgb blank error the Hgb MCH and MCHC results are replaced by on
253. d calibration results for the selected calibrator Check box that allows you to select deselect the run to be included excluded in the calibration data statistics Operator who analyzed the calibrator Date and time the calibrator was analyzed Parameter results for the analyzed calibrator Number of selected calibration runs to be included in the calibration statistics Mean for each parameter using selected calibration results New calibration factor is the calibration factor based on calculations from the new calibration data PN 624026AE CALIBRATION Ji GENERAL 11 Old calibration factor is the current calibration factor Coefficient of variation for each parameter 13 Target value for each parameter The values that appear here are those that are entered during calibrator setup see Figure 10 2 Q Updates the calibration factors based on the current calibration runs If differences exceed the defined limits you will have the option to calibrate which is called forced calibration 15 Opens the Modify Calibration Targets screen 16 Operator who modified the calibration target values 17 Date when the operator modified the calibration target values Calculated calibration results based on the individual calibrator runs to be included MJ in 19 Allows you to select the parameters for which you want to accept the new calibration factor next to the parameter indicates it is selected D Number of selected calibr
254. d so they can be read 6 mm The system moves the cassette to detect if tubes are present mixing and if the barcode is being read PN 624026AE 11 25 DIAGNOSTICS DIAGNOSTICS USER SCREEN 7 View the Autoloader Test screen e Ifa tube is detected the respective Present box on the Autoloader Test screen changes to a teal color e Ifa barcode is present and read the Sample ID is displayed in the Sample ID field as shown below e Ifa barcode is not present or is not read no Sample ID appears See position 4 on the screen shown below AcT 5diff AL Hardware Systems BEER EERE 8 Confirm that the positions indicated on the screen are the correct positions of the tubes and barcodes in the cassette 9 Confirm that the cassette number and type are correct 10 If there is a problem contact your local Beckman Coulter representative 11 26 PN 624026AE DIAGNOSTICS l DIAGNOSTICS USER SCREEN Diluter Systems This option allows you to Drain Baths Prime Reagents Unprime Cleaning Cycles See Figure 11 6 Figure 11 6 Diluter Systems Screen AcT 5diff AL Diluter System Drain Baths If you suspect a draining problem with the baths or if there is excessive flagging on CBC parameters do this procedure to drain any of the following baths PN 624026AE Rinse Bath HGB Bath DIFF Bath RBC PLT Bath WBC BASO Bath All Baths 11 27 DIAGNOSTICS DIAGNOSTICS USER SCREEN Once the se
255. d with your enrollment confirmation information must be entered into the system You only need to do this once unless your IQAP ID changes or if required after a software upgrade For details on what IQAP is see IQAP Interlaboratory Quality Assurance Program in Chapter 1 Your IQAP ID should be in the following format XXXXX X XX where X is the assigned number from Beckman Coulter Do this procedure to enter or edit your lab s IQAP ID ES AcT 5diff AL AN i A Sec COULTER COULTER AST 5diff AL 1 From the Main Menu screen W Gi A 42 PN 624026AE SETUP A QUALITY ASSURANCE SETUP AcT 5diff AL Quality Assurance Shifts QA Settings 3 J the QA Settings tab OG 5 Type your IQAP ID number a Anchor the cursor in the IQAP ID iaaP iD fizaa5_ fi Ni field b Type your IQAP ID number 6 E y to save the change Ho 7 as needed to return to the desired window PN 624026AE A 43 SETUP QUALITY ASSURANCE SETUP CV Limits for Calibration QC and or Reproducibility Do this procedure to edit the CV coefficient of variation limits for Calibration QC and Reproducibility e The CV limits for Calibration are what the values calibration results are compared against e The CV limits for QC are what the values in the control files are compared against e The CV limits for Reproducibility are what the values reproducibility results are compared against A p ANE Ses COULTER
256. ded for IQAP if your lab participates in Beckman Coulter s IQAP See Heading 7 4 DOWNLOADING CELL CONTROL RESULTS FOR IQAP e Delete the previous cell control data as instructed in Heading 7 5 DELETING QC RUNS FILES 2 From the Main Menu screen Q amp Tee s ile ce ol PN 624026AE SETUP A SETTING UP A CONTROL FILE 0 amp CETE 4 TheQC Levey Jennings graphs screen TEENE appears CELETTE W E contor 18 oc z to open the QC Data Grid screen PN 624026AE A 47 SETUP SETTING UP A CONTROL FILE 5 Select the desired control file Control Name Lot Number ig T CONTROL 13 CBC DIFF 270502 a at or at b Select the desired control s Cle JAcT Sdiff AL Modify Values Target Threshold 7 W h T t b f EBC Values DIFF Values the larget tab 1 necessary wee r pe Oa e 2 po x Lot Number A 60503 Rec o7 2 wosa Ly 75 sz 70 x F Reserved nop p fe wa mo f en fra x r al ncr fies eft Eo By aps az al Ekan Date mv fe ae fa n BA pr for x z 07 10 2002 zl om MCH 59 20 po NEw iso 7 0 40 108 u PPP Modified Fame mene 50 0 grat Lya ovo 00 1037 i mow pfe mpo a mos foo 0 10 a y Service pur fa f 107 uL E08 o0 7 00 1037 uyv E upo a Bas 0 ez 0 0 ly j Download Target Values faa a E a 5 5 9 amp gt 4 vyv Xx p
257. ded range mode is active and the sample result for Hgb lt 2 0 g dL and Pit gt 15 0 x 103 uL If these conditions are met the Pit result is flagged using the extended linear and reportable range limits Additionally the use of the extended linear and reportable ranges is indicated by a C flag next to the Pit result and the message PLT Concentrate appears in the Tree View Flags and Messages PN 624026AE 3 7 SPECIFICATIONS CHARACTERISTICS PERFORMANCE CHARACTERISTICS 3 3 3 8 PERFORMANCE CHARACTERISTICS Performance characteristics indicate actual performance The data presented was collected at an internal lab of Beckman Coulter Reproducibility Reproducibility was measured to show precision for a normal WBC count Table 3 7 shows the precision values based on 20 replicate samples that were analyzed consecutively on the same instrument from one normal fresh whole blood sample with a normal WBC and without flags Table 3 7 Reproducibility Characteristics From a Normal Sample with a Normal WBC Count Parameter Mean Standard Deviation SD CV WBC 6 27 0 08 1 25 RBC 5 38 0 04 0 74 Hgb 15 84 0 055 0 35 Het 45 72 0 275 0 6 Plt 313 7 178 2 48 Pit 1 564 14 6 0 93 NE 56 2 0 8 1 42 LY 30 4 0 66 2 17 MO 7 7 0 46 6 01 E0 4 6 0 32 7 07 BA 1 1 0 12 11 1 Platelet Concentrate Mode Accuracy Accuracy Table 3 8 for the CBC and DIFF parameters was defined as a
258. ders or the Worklist for that cassette may be empty 4 Click the EMPTY slot that corresponds to the desired position number If you select 1 as the position be sure to insert the tube into slot 1 of the cassette 5 Enter all required Worklist information for this sample 6 Enter the information on the right side of the screen e Sample ID Entering Selecting e Flagging Set Selecting e Panel Selecting CBC or CBC DIFF e Demographics as required by your lab protocol 8 48 Collect Date Time Entering Location Entering Selecting Physician Entering Selecting Comments Sample and Patient Entering Editing Patient ID Entering Editing Name Locating Selecting Date of Birth Entering Editing Age Entering Editing Gender Selecting Sample ID Collect Date Time fi A i oo Flagging Set Standard Range CBC DIFF O e Location Physician Comments A Rerun f Patient ID Last Name aa First Name Date of Birth ff _ Gender B Unknown he PN 624026AE SAMPLE ANALYSIS 8 WORKING WITH WORKLIST ORDERS 1 OM The Worklist is updated to reflect your changes You may need to scroll to view everything Editing a Worklist Order Entry Do this procedure to edit a Worklist order before analysis Note Everything except the Sample ID can be changed FX AcT 5diff AL WORKLIST Ce a Cass Pos er z C4 Sample ID a Pe 1
259. disposal 3 Insert the waste sensor float into the new waste container and properly secure the cap PN 624026AE 11 95 DIAGNOSTICS REPLACEMENT PROCEDURES 4 Acknowledge the Waste Full error CON b Review and acknowledge the message 5 Do Neutralizing the Waste and Treating for Biohazards in this chapter Replacing the Flow Cell Lamp Do this procedure e when the flow cell lamp fails or e when instructed by a Beckman Coulter representative Tools Supplies needed e Hex keys 2 mm and 3 mm e Flow Cell lamp Note For any part that you use from your spare parts kit be sure to record the part number for reordering ARAS Power down the instrument as instructed in Powering Down the System and Logging Off in Chapter 5 2 Unplug the Analyzer from its power source wall outlet 11 96 PN 624026AE DIAGNOSTICS REPLACEMENT PROCEDURES 3 Remove the left side panel a Open the reagent compartment door b Loosen the back screws c Remove the two front screws and slide the panel out 4 Remove the right side panel a Loosen the screws with the door key b Pull the panel up to remove PN 624026AE 11 97 DIAGNOSTICS REPLACEMENT PROCEDURES 11 98 5 Remove the top cover a Loosen the 7 hex screws that secure the top cover to the instrument frame Carefully remove the top cover and set it aside WARN
260. e An invalid date was entered Enter a valid date Invalid Input Invalid data was entered Enter valid data Invalid Lot Number Entered Enter Correct Lot Number An invalid lot number was entered 1 Verify that the correct reagent is selected for replacement 2 Re enter the lot number Invalid Password Entered Try again An invalid password was entered Enter a valid password Invalid Reagent Lot Number Entered Enter Correct Reagent Lot Number An invalid lot number was entered 1 Verify that the correct reagent is selected for replacement 2 Re enter the lot number LIS communication module closed Communication failed between system and Host Do Hardware Reset Low diluent in reservoir Diluent level low 1 Check the Diluent level as instructed in Viewing Reagent Levels 2 Prime the Diluent as instructed in Prime Reagents Lower piercing sensor incorrect position Lower piercing sensor is in the wrong position Do Hardware Reset Minimum of 5 Selected Results Required to Calibrate At least 5 calibration runs are required to save calibration factors and less than 5 are included Include at least 5 calibration runs before saving the calibration factors Mismatch between first and second barcode readings on cass X pos X The internal barcode reader read the same barcode label differently the first and second time Do Hardware
261. e eeren eree AcT 5diff AL Quality Control CONTROL 13 CBC DIFF l GETTE fonra seor z AcT 5diff AL Quality Control onmo corr oa as iz amp be 260503 Reproducibility Screen Options See Figure 5 29 Figure 5 29 Reproducibility Screen Options AcT 5diff AL Reproducibility 7367454A 5 42 PN 624026AE GETTING STARTED 5 MENU PATH Calibration Screen Options See Figure 5 30 Figure 5 30 Calibration Screen Options 7367455A IQAP Screen Options See Figure 5 31 Figure 5 31 IQAP Screen Options 7367452A PN 624026AE 5 43 GETTING STARTED MENU PATH XB XM Screen Options See Figure 5 32 Figure 5 32 XB XM Screen Options 7367451A 5 44 PN 624026AE PN 624026AE GETTING STARTED MENU PATH Toolbars There are two distinct toolbars on the Main screen e the main generic toolbar Figure 5 33 and e the contextual toolbar Figure 5 34 e Generic Toolbar The generic toolbar Figure 5 33 always resides on the right of each screen This toolbar contains the most frequently used functions and the main cycle launch functions If an icon is grayed out it is unavailable for use on that particular screen See Table 5 4 for a description of each icon Figure 5 33 Generic Toolbar E yi v v vi a E amp Table 5 4 Generic Toolbar Icons Icon Name Function Stop Stops the Analyzer at a time you specify immediately af
262. e 9 6 Table 9 6 RBC Interpretive Messages Message Triggering Condition ANEMIA Hgb lt Hgb LL ANISOCYTOSIS RDW gt RDW HH HYPOCHROMIA MCHC lt MCHC LL COLD AGGLUTININ MCHC gt MCHC HH MICROCYTOSIS MCV lt MCV LL MACROCYTOSIS MCV gt MCV HH ERYTHROCYTOSIS RBC gt RBC HH MICROCYTES MICRO gt MICRO Flag Sensitivity limit MACROCYTES MACRO gt MACRO Flag Sensitivity limit RBC One or more analytical alarms occurred for RBC INTERPRETATION NOT POSSIBLE HH above the action range LL below the action range 9 46 PN 624026AE DATA REVIEW FLAGS AND MESSAGES GENERATED BY THE INSTRUMENT 9 Pit Interpretive Messages See Table 9 7 Table 9 7 Pit Interpretive Messages Message Triggering Condition THROMBOCYTOSIS Plt gt Plt HH THROMBOCYTOPENIA Pit lt PIt LL MACROPLATELETS MPV gt 11 MICROCYTES Derived from Pit histogram SCHISTOCYTE Derived from Pit histogram SMALL CELL SCL Derived from Plt histogram PLT INTERPRETATION One or more analytical alarms occurred for PLT NOT POSSIBLE HH above the action range LL below the action range Combination WBC RBC PIit Interpretive Messages e Table 9 8 lists interpretive messages from a combination of WBC RBC PIlt Action Ranges e Table 9 9 lists conditions causing NRBCS and PLATELET AGGREGATES interpretive messages Table 9 8 Interpretive Messages from a Combination of WBC RBC
263. e Analyzer Be sure your hands are free and clear from the cassette input area before beginning PN 624026AE SAMPLE ANALYSIS RUNNING WORKLIST SAMPLES IN AUTOLOADER MODE 8 5 To view the results for the last sample analyzed u 6 To view the results after all samples have been completed OB b Select the desired result to review 7 To enter result comments U a H if necessary b Select the result for which you want to add a comment Ue d Type the comment mel 8 If there is a situation where the system cannot read the barcode the sample results are Le Lk placed on the Manual Match screen even though the Manual Match is OF EBE flashes when results are placed on the Manual Match screen For details see Manual Match Procedure in Chapter 9 9 When all samples have been processed the instrument ejects the cassette into the Cassette Output Tray PN 624026AE 8 19 SAMPLE ANALYSIS RUNNING WORKLIST SAMPLES IN AUTOLOADER MODE 10 Remove the cassette from the instrument See Unloading Cassettes from the Analyzer in Chapter 5 11 8 20 Results are printed transmitted according to your system setup If Auto Print is enabled results comments will not be included To print transmit a sample report with the results comments included a U 5 from the Results screen Act 5diff AL For Research Use Only Not for use in diagnostic procedures RUD Results
264. e ID is not entered when the order is saved on the Worklist the system automatically assigns a Sample ID in the format of AUTO_SIDxxxxxxxx where each x is replaced by the next logical sequence number The AUTO_SID can be set to reset and start at a given number as party of the New Workday process To select the starting number for the Auto Numbering sequence see Auto Numbering Setting the AUTO_SID Starting Number in Appendix A Siiil UW Oka 3 To locate a Sample ID already on the Worklist do one of the following a C hh at the Sample ID b Type the Sample ID As you type each number the Sample IDs matching the information are displayed c Highlight the desired Sample ID and u The information is placed on the Worklist entry screen and with the fields populated with any information associated with the Sample ID OR a Type the Sample ID in the Sample ID field up to 16 alphanumeric characters Move the cursor to another field If any information is associated with that Sample ID it is displayed OM Panel Selecting CBC or CBC DIFF oee to select the desired panel CBC or CBC DIFF Verify the correct panel is displayed OM 4 The default panel will automatically be run if no change is made i Ww PN 624026AE 8 35 SAMPLE ANALYSIS ENTERING SAMPLE PATIENT INFORMATION 8 36 Flagging Set Selecting Flagging Sets Standard Range Standard Range The flagging set can be sel
265. e Input Tray o m 4 Phib 5 Sample is analyzed 6 0 ro to see the Run in Progress screen which shows Sample ID as AUTO_SID and C P 10 1 7 The report prints E 18 PN 624026AE PN 624026AE WORKLIST SCENARIOS E WORKLIST MATCH OPTION SCENARIOS Scenario 17 Cass Position On Manual Match Off Auto Print On Worklist Order Cassette Position and Sample ID Barcode Label Summary Results are placed on the Manual Match screen because the Sample ID was analyzed in a different position than what was entered on the Worklist 1 Create a Worklist order with Sample ID 123456789 and C P 10 4 il Cl OE Type 10 as cassette number then press Enter Select the 4th tube position Type 123456789 as the Sample ID OM 02 2 Insert tube into the 1st position of cassette 10 3 Place cassette in Cassette Input Tray 0 i 4 PPPI 5 Sample is analyzed 6 U Fr to see the Run in Progress screen which shows Sample ID as AUTO_SID and C P 7 E which flashes to indicate results are on the Manual Match screen for the Manual Match screen 9 Results are placed on the Manual Match screen Order shows Worklist Sample ID 123456789 Cass Pos Results shows Sample ID AUTO_SID with barcode ID C P 10 1 10 Two options are available a Manually match the order to the results Prior to matching you may want to edit the Worklist order as required To manually match ooo o py
266. e Output area is full 1 Unload cassettes and additional cassettes cannot be ejected 2 Restart cycle Output sensor incorrect position Output sensor is in the wrong position Do Hardware Reset Patient Demographics Received Modified From Host Order cannot be saved Attempt was made at the Workstation to modify patient demographics received from a host computer None Patient demographics received from a host computer cannot be modified at the Workstation Piercing mechanism incorrect position Piercing mechanism is in incorrect position Do Auto Clean Running 2 Check the motor as instructed in Motors Checking Please check printer is connected on line and has paper Continue An error indication has been sent from the Printer to the instrument usually a paper out message Ensure there is paper in the printer and that the printer is ready 2 Refer to the Printer user s manual for additional information PLT Interpretation Not Possible Multiple analytical alarms e g Voteout occurred Re run the sample 2 Ifthe problem persists contact your local Beckman Coulter representative Printer error Printer not ready 1 Check the printer 2 Retry printing Printer module closed Printer module closed 1 Do Hardware Reset 2 Retry printing 11 119 i DIAGNOSTICS SYSTEM ERRORS 11 120 Table 11 5 Error Messages Cont
267. e Sample ID entered manually downloaded from the Host or scanned by barcode wand e Flagging Set selected from list of existing flagging sets e Panel CBC or CBC DIFF If a Sample ID is not entered or received an AUTO_SID will be assigned to the order and the flagging set and test panels will be assigned according to the default settings It is recommended that you enter as much information for a sample as possible More information makes it easier to match a result with a Sample ID Worklist A Workilist is a list of pending orders to be analyzed for the workday Once a Worklist order is analyzed e the order is removed from the Worklist e the results are associated with matched to the order e the report is printed if Auto Print is On e the results are transmitted to the Host if Auto Transmission is ON and e the results are archived in the database and can be searched by Patient ID or last name Note If the system is configured to Manual Match ON and a sample analysis is done without a Worklist order or if the Worklist Match Option is Barcode and the tube does not have a barcode label the results are unmatched This means that you will need to associate match the results with a Sample ID See Heading 9 3 MANUALLY MATCHING SAMPLE RESULTS WITH WORKLIST ORDERS If you want to add demographic information for a patient you must do so before the sample is analyzed The information you enter is printed on the final rep
268. e and for a list of measured parameters Calibrator A calibrator is a substance traceable to reference methods for the preparation of material used to calibrate a measurement on an instrument ACeT 5diff Cal Calibrator is a recommended alternative to the whole blood reference method of calibration and is traceable to reference methods and materials Use ACeT 5diff Cal Calibrator to ensure accurate instrument measurements for WBC RBC Plt Hct and Hgb IQAP interlaboratory Quality Assurance Program Quality Assurance QA includes routine maintenance and service in conjunction with the use of controls and calibrators The combination of these methods assures complete quality control and should be applied separately or in combination according to your laboratory state and federal protocols For information on determining laboratory procedures you can purchase the Physician s Office Laboratory Guideline POL2 T from the National Committee for Clinical Laboratory Standards NCCLS at 940 West Valley Road Wayne PA 19087 1898 USA PN 624026AE USE AND FUNCTION Ji QUALITY ASSURANCE CONTROLS CALIBRATORS AND IQAP Participation in Beckman Coulter s IQAP helps you interpret control results and correlate them with your other internal quality control techniques Your IQAP report will show how your laboratory performed in comparison with other laboratories The AL instrument allows you to save your cell control data to diskette for sub
269. e free and clear from the cassette input area before beginning PN 624026AE 7 7 QUALITY ASSURANCE RUNNING CELL CONTROLS 7 8 13 To view the results e From the Main Menu screen 0 bbb to view OR From either QC screen 0 run in the selected file to view the last control run not the last control 14 Review the control results as instructed in Reviewing Control Results in this chapter and as per your lab s protocol 15 To manually de select exclude run s from the statistics as per your lab s protocol the check box as needed to de select O 16 If you did not load all control levels in the same cassette for analysis repeat steps 6 through 15 for the remaining cell control levels 17 The control file results automatically print if Auto Print is enabled If Auto Print is disabled OB b Select the print option OM For information about enabling Auto Print for control results see Auto Print Non Patient Results in Appendix A PN 624026AE QUALITY ASSURANCE T RUNNING CELL CONTROLS Running Cell Controls Autoloader Mode Without Barcode ID Do this procedure to run a QC sample cell control material in the Autoloader Mode with the QC sample ID to be entered by you Note The control s lot number must be reserved See Reserving Control Lot Numbers in Appendix A ATTENTION If there is a situation when the system cannot find a Worklist order for the sample
270. e new Reproducibility check type the number of aspirations to be done for each tube i O Autoloader Mode Number of Aspirations At each tube type the desired number of aspirations for Verify that the number is correct Each tube in the cassette will be aspirated that number of times until the desired panel CBC or CBC DIFF appears 7 Prepare and mix fresh normal whole blood samples as defined by your laboratory guidelines WARNING Risk of injury biohazardous conditions if a cassette is not properly handled Do not use a cassette for storing or transporting tubes or vials To ensure tubes vials remain secured in the cassettes always keep cassettes upright and use them only for analysis as described in this manual 11 62 PN 624026AE DIAGNOSTICS REPRODUCIBILITY CHECK 8 Insert the tube s into the cassette a Insert the tube b Push the tube into the cassette If you insert more than one tube into the cassette each tube will be analyzed aspirated the number of times you entered in step 5 9 Load the cassette onto the instrument A analysis n OF Be sure your hands are free and clear from the cassette input area before beginning PN 624026AE 11 63 DIAGNOSTICS REPRODUCIBILITY CHECK 11 After all runs are done remove the cassette from the Cassette Output Tray 12 e the check box next to the run to be included in the calculati
271. e possible fragility of the leukocytes some of these cells may be destroyed during counting WBC fragments will also interfere with the WBC DIFF parameters Chemotherapy Cytotoxic and immunosuppressive drugs may increase the fragility of the leukocytes which may cause falsely low WBC counts Cryoglobulins Increased levels of cryoglobulin that may be associated with myeloma carcinoma leukemia macroglobulinemia lymphoproliferative disorders metastatic tumors autoimmune disorders infections aneurysm pregnancy thromboembolic phenomena diabetes and so forth can elevate the WBC RBC or Plt counts and the Hgb concentration The specimen must be warmed to 37 C 99 F in a water bath for 30 minutes and reanalyzed immediately analyzer or manual method Agglutinated WBCs Leukoagglutination RBCt Agglutinated RBCs May cause a falsely low RBC count Blood samples containing the agglutinated RBCs may be suspected by elevated MCH and MCHC values and shown by examination of the stained blood film Cold agglutinins IgM immunoglobulins elevated in cold agglutinin disease may falsely lower RBC and Plt counts and falsely increase MCV 3 10 PN 624026AE SPECIFICATIONS CHARACTERISTICS INTERFERING SUBSTANCES Table 3 10 Interfering Substances Continued Parameter Interfering Substance Hgb Turbidity of the blood sample Any number of physiologic and or therapeutic factors may produce falsely elevated Hgb results To
272. e printout for your records as required 3 To transmit the results to a Host computer a Select the Send tab b Select the desired send option e Send selected results e Send all results Of Deleting Reproducibility Results This procedure continues from either of the running Reproducibility procedures l From the Reproducibility Data Grid screen u the check box next to the result you want to delete selected LI not selected O 3 Select the delete option e Delete selected results e Delete unselected results e Delete all results 5 Ifrunning a new Reproducibility check e For Manual Mode return to step 5 of Running a Reproducibility Check in the Manual Stat Mode e For Autoloader Mode return to step 5 of Running a Reproducibility Check in the Autoloader Mode PN 624026AE 11 65 i DIAGNOSTICS SHUTTING DOWN WINDOWS NT RECOMMENDED 11 8 SHUTTING DOWN WINDOWS NT RECOMMENDED It is recommended that you shut down Windows NT at least monthly When Windows NT shuts down it does an automated system maintenance procedure 1 Power down the system and log off as instructed in Powering Down the System and Logging Off in Chapter 5 2 To resume normal operation power up the system and log on again as instructed in Powering Up the System and Logging On in Chapter 5 11 9 CLEANING THE ANALYZER WARNING Risk of biohazardous conditions Utilize appropriate barrier protection when performing
273. e read Bar codes with S and will sound multiple beeps when read Other codes will only sound a single beep ATTENTION Test these barcodes from the printed Instructions for Use manual If you do not have a printed copy of the manual contact your Beckman Coulter representative Table B 4 Barcode Scanner Configuration Sheet f ABIL Sab tolls F CPSoO0s ACLISLZ1zZ S4 cCpsovs Hi B 4 PN 624026AE BARCODE SPECIFICATIONS FOR OPTIONAL BARCODE WAND B OPTIONAL BARCODE WAND CONFIGURATION Table B 4 Barcode Scanner Configuration Sheet S ER11942 M 401214070316 AZOAAS PN 624026AE B 5 BARCODE SPECIFICATIONS FOR OPTIONAL BARCODE WAND CODE 39 AND CODABAR BARCODE SCANNER OPTIONS B 6 CODE 39 AND CODABAR BARCODE SCANNER OPTIONS For Code 39 see Table B 5 Code 39 Barcode Scanner Options For Codabar see Table B 6 Codabar Barcode Scanner Options ATTENTION Test these barcodes from the printed Instructions for Use manual If you do not have a printed copy of the manual contact your Beckman Coulter representative Table B 5 Code 39 Barcode Scanner Options Read ONE of the labels below to set Check Digit control option hB115 Code 39 No Check Digit control AB13 Code 39 Check Digit control B 6 PN 624026AE BARCODE SPECIFICATIONS FOR OPTIONAL BARCODE WAND B CODE 39 AND CODABAR BARCODE SCANNER OPTIONS Table B 6 Codabar Barcode Scanner
274. e user logs into the system the Login name appears at the bottom of the screen COULTER COULTER AS T Sdiff AL wu Editing User Information This procedure continues from Operators Users Adding Editing Deleting l Edit the information 2 u v to save the change Deleting Users This procedure continues from Operators Users Adding Editing Deleting 1 Highlight the user name to delete The following message appears 3 0 y to delete the selected user 4 C y to save the change PN 624026AE A 119 SETUP FLAGGING SETS SETUP A 10 FLAGGING SETS SETUP Two tabs are available under this option Flags and Messages and Flag Sensitivity and Thresholds For additional information see e Flags and Messages e Flag Sensitivity and Thresholds Flags and Messages Under the Flags and Messages tab Figure A 19 you can e create a new flagging set e copy settings to another flagging set except to the Standard Range which is the default and cannot be edited e set a default flagging set e edit existing flagging sets Figure A 19 Flags and Messages Setup Screen iff AL Flagging Sets Flagging Sets Standara Range Child2 childs ue hi J 35 0 ild5 B0 mn ao 10 0 150 Qo mm i a Qo Default Values ao A Set as Default Flagging Set 25 0 Qo 20 Default Flagging Set D0 potandard Range 00 ey Modified on J 200 rc 1 00 0 10 o Ho ao 0 00 g B
275. eT 5diff Diluent is clear and odorless Composed of stabilized saline solution containing an organic buffer and less than 0 1 sodium azide ACeT 5diff Diluent e Dilutes whole blood samples e Stabilizes cell membranes for accurate counting and sizing e Conducts aperture current and e Rinses instrument components between analyses Handle as indicated in this manual Use at ambient temperature from 18 C to 25 C up to the expiration date indicated on the packaging ACT Odiff Fix Le Used to lyse erythrocytes fix leukocytes and differentially stain granules of monocytes neutrophils and eosinophils ACeT 5diff Fix is a deep blue aqueous solution that smells like alcohol ACeT 5diff Fix is composed of an alcohol solution containing propylene glycol a formic dye buffers alkaline salts wetting agents and an aldehyde preservative Handle as indicated in this manual Use at ambient temperature from 18 C to 25 C up to the expiration date indicated on the packaging ACT Sdiff WBC Lyse L WBC Lyse Used to lyse red blood cells for the leukocyte count and to differentiate poly nuclear basophils ACeT 5diff WBC Lyse is a colorless aqueous solution It is composed of an acidic solution containing a lytic agent Handle as indicated in this manual Use at ambient temperature from 18 C to 25 C up to the expiration date indicated on the packaging ACT 5diff Hgb Lyse Used to lyse blood cells and to determine
276. eable calibrator for this procedure This procedure continues from Running Calibrator Samples above 0 A message similar to this appears AcT 5diff AL Place calibrator CALI 1 Lot No CX321 in tube holder and close door 2 Verify that the Lot Number is correct for the Calibrator you are using 3 Mix the calibrator according to the package insert PN 624026AE 10 13 AUTO CALIBRATION CALIBRATION CAUTION Risk of damage to the instrument if the calibrator cap is not removed prior to analysis in the Manual Stat mode 4 5 6 7 8 If the calibrator is in a vial with a non pierceable cap remove the cap from the vial Je Insert the calibrator vial into the correct position of the proper tube holder Refer to the Hematology Tube List available on the BCI website at www beckmancoulter com Note Do not O X now or you will have to begin again Verify the tube holder is in the 12 00 o clock pierce position Close the tube holder door to begin analysis When the tube holder door opens remove the vial IMPORTANT Risk of erroneous results if the calibrator is not thoroughly mixed between each analysis Mix according to the instructions in the calibrator material s package insert 9 10 ll 12 13 10 14 If the cap has been removed replace the cap on the calibrator vial Mix as needed for the next analysis Repeat steps 5 through 9 until at least 5 calibrator s
277. ected manually or automatically if the Age Date of Birth Gender information is entered The system has the Standard Range set as the default and this will be used if no other information is entered For details on changing the range to be used as the default see Setting a Default Flagging Set in Appendix A Us 2 Highlight the desired flagging set as required OM Demographics Entering Selecting Although Sample ID panel and flagging set are required for every sample the following demographics are optional collection date time see Collect Date Time Entering location see Location Entering Selecting physician see Physician Entering Selecting comments about the sample see Comments Sample and Patient Entering Editing comments about the patient see Comments Sample and Patient Entering Editing patient ID see Patient ID Entering Editing patient name see Name Locating Selecting date of birth see Date of Birth Entering Editing age see Age Entering Editing gender see Gender Selecting Collect Date Time Entering Collect Date Time 1 Anchor the cursor in the first position of the field wes Type the date Type the time me PN 624026AE SAMPLE ANALYSIS ENTERING SAMPLE PATIENT INFORMATION Location Entering Selecting Location Us 2 Highlight the desired location if it appears in the list Otherwise type the location name OM Physician Entering Selecting
278. ed 7 Verify that the control material has not expired 8 Mix each control vial thoroughly according to the instructions in the ACeT 5diff Control Plus cell control package insert PN 624026AE 7 17 QUALITY ASSURANCE RUNNING CELL CONTROLS 7 18 9 Inspect the vials contents to ensure that all cells are uniformly distributed and that there is no evidence of deterioration IMPORTANT Risk of erroneous results and or instrument damage if tubes vials with hard caps are processed with the caps on Always remove hard caps from tubes vials before processing A 10 Insert the tube vial correctly into gt e slot 1 of Tube Holder 1 or Sy e slot 4 of Tube Holder 2 For information about the correct slot for each tube vial refer to the Hematology Tube List available on the BCI website at www beckmancoulter com IMPORTANT Risk of erroneous results if the desired sample tube vial is not positioned in the j pierce position 12 o clock in the Analyzer A B 11 Ensure that the tube is in the pierce position within the tube holder e If the tube is in the pierce position B A 12 00 o clock within the holder do step 12 e If the tube is not in the pierce position within the holder rotate the holder until the tube is in the pierce position QUALITY ASSURANCE T RUNNING CELL CONTROLS 12 Close the tube holder door and push it into the Analyzer to beg
279. edure if you want to e select a paper size US or A4 e select the print quality 300 or 600 e select the number of copies to be automatically printed Actual printer setup information may vary depending on the printer used EN AcT 5diff AL COULTER COULTER AST Sdiff AL 1 From the Main Menu screen J Hi OC A 84 PN 624026AE SETUP A SYSTEM SETUP AcT 5diff AL System aea Cycle Options Date Time Format 3 e the Printer tab Local Settings Date Time Time os 16 09 C 5 ig Printer Properties 6 Select the paper size source orientation number of copies and so forth 7 E 4 to save the change PN 624026AE A 85 SETUP SYSTEM SETUP e Set Default Printer Do this procedure to select a default printer AN amp Aer pm COULTER AST Sdiff AL 1 From the Main Menu screen 0 4 CO 3 0 the Printer tab aaqa aaaaa aaaaq A 86 PN 624026AE SETUP A SYSTEM SETUP OF 5 Select the desired printer to be the default a J E at the Printer List field Printer List OKIPAGE 14e b 0 the desired printer c Ifthe printer you want does not appear in the list you can add the printer See e Add Printer in this chapter for details ATTENTION Use printers available in this field only because these printers and their drivers have been validated for use with the ACeT 5diff AL system Default Print
280. ent is derived as a function of the amount of light lost due to diffraction and absorbance as compared to full transmission when no cell is present The collected signals are converted into voltage pulses and are processed The magnitude of the voltage pulses are proportional to the physical and chemical characteristics of the cells being analyzed Light absorbance is related to cellular contents granularity nuclear content and so forth after cytochemical staining These measurements provide the information for lymphocytes monocytes neutrophils eosinophils and their precursors Signal Processing Overview The signals from the flow cell aperture and from the optical measurement are correlated by a window of time The optical pulse must be detected within 100 to 300 microseconds of the impedance pulse otherwise the signal is rejected The output signals from the focused flow impedance and the light absorbance measurements are combined to define the WBC differential population clusters See Figure 2 3 Figure 2 3 Signal Processing Volume Thresholds Most of the population partition thresholds are fixed and give the limits of the morphological normality of leukocytes Changes in the morphology of a population are expressed on the DiffPlot by a shifting of the corresponding population Volume and absorbance thresholds are used to detect shifting populations Absorbance Debris gt A ETA PN 624026AE
281. entered on the Worklist order 1 Create a Worklist order a ooo o f g ill Ua OE Type 06 as cassette number then pressed Enter Select the ist tube position Typed 123 as the Sample ID Ow 0a 2 Insert tube into position 1 of cassette 6 3 Place cassette in Cassette Input Tray 0 i 4 PPPI 5 Sample is analyzed 6 Report prints with Sample ID 123 cassette 6 and position 1 which is exactly what was entered for the Worklist order Scenario 3 Cass Position On Manual Match On Auto Print On Worklist Order Cassette Position and Sample ID Barcode Label Summary Report prints with the Sample ID cassette and position information that was entered on the Worklist order 1 Create a Worklist order ooo F f g Type 06 as cassette number then pressed Enter Select the 1st tube position Type 123456 from the label as the Sample ID Ow Us 2 Insert tube into position 1 of cassette 6 E 7 WORKLIST SCENARIOS WORKLIST MATCH OPTION SCENARIOS E 8 3 Place cassette in Cassette Input Tray o a 4 Phib 5 Sample is analyzed 6 Report prints with Sample ID 123456 cassette 6 and position 1 which is exactly what was entered for the Worklist order Scenario 4 Cass Position On Manual Match Off Auto Print On Worklist Order Cassette Position and Sample ID Barcode Label Summary Report prints with the Sample ID cassette and
282. ents e ACeT 5diff Diluent e ACeT 5diff Fix e ACeT 5diff WBC Lyse e ACeT 5diff Hgb Lyse and e ACeT 5diff Rinse These reagents are manufactured by for Beckman Coulter Inc Miami Florida USA and distributed by Beckman Coulter France SA 33 rue des Vanesses BP 50359 Villepinte 95942 Roissy CDG Cedex All stated performance characteristics in this manual are based on the use of the instrument with the above referenced reagents Before using the reagent refer to the reagents bottle container label for detailed information such as stability ATTENTION The open container stability on the reagent labeling applies only to the reagent when connected to the instrument with approved reagent pickups and caps For information on handling reagent waste see Heading 11 4 WASTE HANDLING PROCEDURES and Replacing the Waste Container in Chapter 11 1 12 PN 624026AE Reagent Descriptions See Table 1 3 USE AND FUNCTION REAGENTS Table 1 3 Reagent Descriptions Reagent Description ACT Sdiff Diluent WARNING Risk of explosion if sodium azide is not properly flushed down the drain with large volumes of water Sodium azide preservative may form explosive compounds in metal drain lines See National Institute for Occupational Safety and Health Bulletin Explosive Azide Hazards 8 16 76 When disposing of reagents down the drain flush with large volumes of water Used for counting and differentiating blood cells AC
283. er d Verify your selection is displayed OKIPAGE 14e in the Default Printer field 6 Set Default Printer 7 u y to save the change PN 624026AE A 87 SETUP SYSTEM SETUP e Delete Printer Do this procedure to delete a printer from the list of printers available for use with your system lan SELS T A Nex Saggy COULTER 1 From the Main Menu screen 0 aE Coutter AST Sdiff AL CO 3 0 the Printer tab Ki K d M sd aaqaaqaaqaaqaaaqaaaq adda A 88 PN 624026AE SETUP A SYSTEM SETUP 0A 9 Select the desired printer to be deleted Oa a E at the Printer List field OKIPAGE 14e b u the desired printer c Verify the correct printer is selected 6 u Delt Panter The following message appears 7 0 v to delete the printer PN 624026AE A 89 SETUP SYSTEM SETUP Patient Report Setup You can define the areas of the patient report to be printed Figure A 12 shows a CBC DIFF report You can define certain areas of the report see Figure A 13 For an overview of the software options required to setup the patient report see Figure A 14 Figure A 12 Patient Report CBC DIFF A 90 Beckman Coulter Inc Miami FL 33196 Semple ID AUTO_SIDE Crass 1 Pos 5 Location Sample Com ment Fwient ID Lost Nome First Na me Palier Comment 103 yL 3 62 1068 yL MPV PCT PDW 11 4H 0 283 17 0 Result Comment v Neutrophi
284. er Standard Range Z Standard Range 0M A message appears prompting you to insert the tube into the holder AcT 5diff AL When tube holder opens insert Sample ID XXXXX for analysis IMPORTANT Risk of sample mis identification if you do not verify the Sample ID displayed at the Workstation with the Sample ID on the tube prior to analysis 6 When the tube holder door opens confirm the Sample ID e Ifthe Sample ID is correct place the tube in the correct position of the appropriate holder Ox e Ifthe Sample ID is incorrect to exit 7 Ifthe information is correct close the tube holder door to begin analysis 8 4 PN 624026AE SAMPLE ANALYSIS RUNNING MANUAL STAT SAMPLES 8 8 After analysis is completed the results are displayed for review 9 Repeat steps 2 through 8 for each stat sample 10 To view the results after all samples have been completed OF b Select the desired result to review 11 To enter result comments u z U if necessary b Select the result for which you want to add a comment Ue d Type the comment OM PN 624026AE 8 5 SAMPLE ANALYSIS RUNNING MANUAL STAT SAMPLES 12 Results are printed transmitted according to your system setup If Auto Print is enabled results comments will not be included To print transmit a sample report with the results comments included C E from the Results screen
285. erature of 16 C to 34 C 61 F to 93 F e Using A eT 5diff Cal Calibrator as an alternative to whole blood When to Verify Calibration Verify calibration of your instrument e As required by your laboratory procedures and as required by local or national regulations e When cell controls such as ACeT 5diff Control Plus exceed the manufacturer s defined acceptable limits In the normal process of tracking data for an extended period of time your laboratory can decide to recalibrate the instrument for a given parameter Never adjust to a specific value based on an individual sample result For calibration QC and reproducibility rejected results are displayed in the file and are automatically de selected excluded from the statistics PN 624026AE 10 1 CALIBRATION GENERAL Understanding the Calibration Screen Figure 10 1 shows the Calibration screen details To access the screen l From the Main Menu screen 0 Q 0G Figure 10 1 Calibration Screen Details 6000000 60080 8 Supery 07 25 2002 13 37 42 FZ Superv 07 25 2002 13 38 56 Superv 07 25 2002 13 39 41 F Superv 07 25 2002 13 40 26 I Superv 07 25 2002 13 41 12 wec V RBC IV HGB HCT Version v0 13 Supervisor 7367041A Calibrator information entered at the Modify Calibration Targets screen Figure 10 2 A calibration run processed at the date and time shown with parameter results All save
286. es passing through the aperture within a given time period Aperture Sensor System Overview The RBC Plt aperture sensor system determines the cell count and size of red blood cells and platelets The WBC BASO aperture sensor system determines the cell count The differentiation between basophils and other white blood cells is related to the ACeT 5diff WEC Lyse specific lytic action on the white blood cells in WBC BASO bath Particle Sensing To sense particles using the Coulter Principle Figure 2 1 a current flow is established so changes in that flow can be monitored In this sensing system an electrode is located on each side of the aperture The most visible electrode is referred to as the counting head These electrodes are the conductive metallic housings attached to the front of the RBC and WBC BASO baths The second electrode referred to as the bath electrode is not as noticeable it is located inside the bath The aperture is located between the counting head and the bath electrode PN 624026AE 2 1 OPERATION PRINCIPLES MEASUREMENT PRINCIPLES 2 2 Figure 2 1 Coulter Principle Solution to be analyzed Vacuum constant Current constant v Analyzing electronic circuit Electrodes gt Time 7650331A When the count circuit is activated and an electronically conductive reagent is in the RBC or WBC BASO
287. esence of large lymphocytes atypical lymphocytes blasts and an excessive number of basophils may interfere with an accurate monocyte count Interfering substances pertaining to WBC also pertain to the MO and MO 3 12 PN 624026AE PN 624026AE SPECIFICATIONS CHARACTERISTICS INTERFERING SUBSTANCES Table 3 10 Interfering Substances Continued Parameter Interfering Substance EO E0 The eosinophil absolute cell count is derived from the WBC count The presence of abnormal granules degranulated areas toxic granules and so forth may interfere with the eosinophil count Interfering substances pertaining to WBC also pertain to the EO and EO BA BA The basophil absolute cell count is derived from the WBC count Interfering substances pertaining to WBC also pertain to the BA and BA tThe RBC dilution contains all formed elements in the blood erythrocytes leukocytes and platelets During the counting of the RBCs platelets are not counted if their size falls below the RBC minimum threshold Blood samples collected in EDTA will not maintain a stable MPV because platelets swell depending on the time post collection and storage temperature 3 13 3 SPECIFICATIONS CHARACTERISTICS INTERFERING SUBSTANCES 3 14 PN 624026AE PRECAUTIONS HAZARDS 4 1 DEFINITIONS Warnings Anything that can cause user injury is considered a hazard and is noted in the text as WARNING Warnings appear where needed
288. esence of schistocytes and or the presence of Plt aggregates See Figure 9 20 The Pit result is not reliable It is recommended that you verify the result by an alternative method as defined by your laboratory protocol 9 44 PN 624026AE DATA REVIEW FLAGS AND MESSAGES GENERATED BY THE INSTRUMENT 9 Table 9 4 Histogram Flags Continued Histogram Flag Illustrations of Histogram Flags Description Pit SCL Figure 9 21 Presence of Small Cellsin SCL small cell indicates the continued the 2 fL and 3fL Regions presence of small cells in the 2fL and 3fL regions See Figure 9 21 MPV Pct and PDW reported as If Plt lt 5 0 x 10 uL the SCL flag is not reported Rerun the sample and verify the results Interpretive Messages ATTENTION Interpretive messages indicate a possible pathological disorder and should be used to assist with quick and efficient screening of abnormal samples and for diagnosis It is recommended that your laboratory use suitable reference methods to confirm diagnosis The interpretive messages print in the Flags and Messages area Figure 9 13 on the patient report Tables 9 5 through 9 9 list interpretive messages and triggering conditions Only one DIFF interpretive message can be displayed for each DIFF parameter The message generated from the absolute count for that parameter takes priority For example if a relative LYMPHOPENIA LY lt LY LL a
289. etails on setting the XB limits see Setting XB XM Limits in this chapter Do this procedure to enable activate or disable deactivate the XB XM options e Off default e XB 3 Parameters monitors MCV MCH and MCHC e XM 9 Parameters monitors WBC RBC HGB HCT MCV MCH MCHC RDW and PLT AcT Sdiff AL LN 32 ANE CF BY 9 0 1 From the Main Menu screen a fy 7 aE s Euro A 35 SETUP QUALITY ASSURANCE SETUP CR 3 W the QA Settings tab AcT 5diff AL Quality Assurance OF 5 At the XB XM option field select the desired option 6 u v to save the change A 36 PN 624026AE PN 624026AE SETUP QUALITY ASSURANCE SETUP ai 7 b 2 as needed e Setting XB XM Limits Do this procedure to set the limits for XB Analysis If any point calculated from the last batch is out of limits an XB alarm occurs If Auto Print is enabled the appropriate message is printed The flag can also be transmitted to the Host if this option has been enabled during Host setup SS A NET 1 From the Main Menu screen W Q AGT Saif AL a f aluro we IN lt x a A 37 A SETUP QUALITY ASSURANCE SETUP 0 C 3 to open the XB XM Limits screen You can also select this option from the XB Data Grid screen 0A PN 624026AE A 38 SETUP A QU
290. etive Messages 9 46 Plt Interpretive Messages 9 47 Interpretive Messages from a Combination of WBC RBC PIt Action Ranges 9 47 NRBCs and PLATELET AGGREGATES Interpretive Messages 9 47 Definition of Analytical Message CO 9 49 Definition of Analytical Message DB 9 49 Definition of Analytical Message BASO 9 50 QA Messages 9 50 Miscellaneous Messages 9 51 Maintenance Schedule 11 1 Diagnostics Menu Screen Icons 11 8 Diagnostics User Screen Icons 11 11 Analyzer Motors Function and Location 11 15 PN 624026AE 11 5 Error Messages 11 112 11 6 Troubleshooting Guide 11 122 11 7 Logs Screen Icons 11 125 11 8 Log Details 11 127 A l Instrument Default Settings A 1 A 2 Setup Screen Icons A 2 A3 Reporting Unit Format A 27 A 4 Daily Workload Runs per Panel A 105 BA Default Barcode Settings B 2 B 2 Test Labels With the Check Digit Checksum B 3 B 3 Test Labels Without the Check Digit B 4 B4 Barcode Scanner Configuration Sheet B 4 B 5 Code 39 Barcode Scanner Options B 6 B 6 Codabar Barcode Scanner Options B 7 B 7 Interleaved 2 of 5 Options With Fixed Length Characters Test Labels B 8 PN 624026AE xxvii xxviii PN 624026AE INTRODUCTION D OVERVIEW This introductory section contains the following topics e USING YOUR ACof 5diff AL HEMATOLOGY INSTRUCTIONS FOR USE MANUAL e ABOUT THIS MANUAL e CONVENTIONS GRAPHICS and e SYMBOLS USING YOUR A eT 5diff AL HEMATOLOGY
291. eturn mailer and mail it to Beckman Coulter s IQAP department ATTENTION Beckman Coulter suggests that if possible until you receive an IQAP report for a particular set of data you do not delete that data There may be times when you need to provide additional information for the IQAP report in those instances you may need to refer to the control data 10 Delete the cell control files from the system according to your laboratory s protocol See Heading 7 5 DELETING QC RUNS FILES 11 Enter your next set of controls assay values expected ranges lot numbers and expiration dates for all three levels of controls as instructed in Heading A 6 SETTING UP A CONTROL FILE PN 624026AE 7 45 QUALITY ASSURANCE DELETING QC RUNS FILES 7 5 DELETING QC RUNS FILES ATTENTION QC files are made up of individual QC runs The following control data delete options are available e Deleting the Last QC Run e Deleting One or More QC Runs Deleting the Last QC Run Do this procedure to delete the last QC result A amp ANE ATTENTION Control data cannot be recovered once it has been deleted Therefore be certain that you want to delete erase the control data before you proceed 1 Is the last QC result displayed on the QC Graphics screen e If yes o Oi U 2 b Y to confirm deletion e Ifno go to step 2 nem scx DA 2 From the Main Menu screen Q 5 2 7 igi lity Ey Soe B Ea i
292. ext sample tube into the cassette 4 Repeat step 3 as needed Removing Tubes from a Cassette A WARNING Risk of injury biohazardous condition if the sample tube breaks Use extreme care not to break a sample tube when loading unloading them into from a cassette 1 Pull the top of the tube out and away from the cassette 2 Pull the tube completely out of the cassette PN 624026AE 9 19 GETTING STARTED WORKING WITH THE CASSETTES Loading Cassettes onto the Analyzer You can load up to 10 cassettes at once A When the Start Autoloader PFFF function is selected use care when working around the cassette input tray pushers Figure 5 10 They move forward with a fair amount of force to push the cassettes toward the instrument Figure 5 10 Cassette Input Tray Pushers Location and Function Procedure for Loading Cassettes onto the Analyzer WARNING Risk of injury biohazardous conditions if a cassette is not properly handled Do not use a cassette for storing or transporting tubes or vials To ensure tubes vials remain secured in the cassettes always keep cassettes upright and use them only for analysis as described in this manual LN WARNING Risk of injury biohazardous condition if the sample tube breaks Use extreme care not to break a sample tube 1 With the back of the cassette facing the front of the Analyzer place the cassette upright on the Cassette Input Tray You
293. ext to the desired flag s selected O not selected If you want to define rerun criteria by parameter s go to step 6 If you are finished go to step 7 PN 624026AE SETUP A AUTO FUNCTIONS SETUP 6 To define rerun criteria by parameter s a the check box next to the desired parameter s b To select all the boxes under a column heading e g Voteout p the column heading selected O not selected eT Seif AL Auto Functio By Flag s By Parameter s Flagging Sets Standard Range M Apply to all Flagging Sets r wae F su Voteout uj ma H m A B we r x T o RBC r x x r DES HEB r x r a T o Her r r Fil im mcv x x a r i C UM McH x x T a 5 C UN MCHC r F F m DB RDW x E m LES PLT r r r r F micro MPV r r r r I macro NE r r r aq F set vy x x r F mic Mo x r x r I SCH E0 x C L le I DIFF BA F r i T DIFF NER r un E C T T DIFF Reject Ly rT rT C i a MOR rT E p cow r r r m 5 BAN r r r 7 x z 5 gt 4 y X li Supervisor j 11709 2002 08 43 28 7 Select the desired flagging set to which the rerun criteria should be applied e To apply the rerun criteria to only one flagging set 1 u E at the Flagging Set field 2 C the desired flagging set To apply the rerun criteria to all flagging sets u LI Apply to All Flagging Sets as needed selected LI not
294. f cassette 10 Place cassette in Cassette Input Tray o ad oe Sample is analyzed b ro to see the Run in Progress screen which shows Sample ID as AUTO_SID and C P 10 1 Report prints with AUTO_SID and C P 10 1 PN 624026AE PN 624026AE WORKLIST SCENARIOS E WORKLIST MATCH OPTION SCENARIOS Scenario 13 Cass Position On Manual Match On Auto Print On Worklist Order Sample ID only Barcode Label Summary Results are placed on the Manual Match screen because the Worklist order did not have a cassette and position with sample results to match 1 10 Create a Worklist order and entered only the Sample ID 123456789 C f d Type the Sample ID as 123456789 OM Insert tube into the 1st position of cassette 10 Place cassette in Cassette Input Tray 0 i Ts Sample is analyzed u to see the Run in Progress screen which shows Sample ID as AUTO_SID and C P 10 1 Iz ta which was flashing to indicate results are on the Manual Match screen J for the Manual Match screen Results are placed on the Manual Match screen Order shows Sample ID 123456789 Results shows Sample ID AUTO_SID and barcode Sample ID from the sample tube Manually match the order to the results Cc oF C 2 3 Highlighted the order 4 Highlighted the result 5 Verified the cassette position 6 Or E 15 WORKLIST SCENARIOS WORKLIST MATCH OPTION SCENARIOS E 16 a The rep
295. f the first run in the control file Control file name 5 Date of the last run in the control file Control material lot number Note Only files that have lot numbers in the same format as A eT 5diff Control Plus control material and files with at least one selected result are displayed for inclusion in the IQAP download 7 40 PN 624026AE QUALITY ASSURANCE DOWNLOADING CELL CONTROL RESULTS FOR IQAP Preparing for IQAP Download Do this procedure to prepare for downloading saving your cell control results to diskette for IQAP use After you do this procedure do Downloading Results to Diskette for IQAP Submission 1 Verify that your IQAP ID has been entered into your instrument Without the IQAP ID your data cannot be downloaded to diskette See IQAP ID Entering Editing in Appendix A for details 2 Review the control summary profile which shows the individual control runs mean 2SD and number of runs Os OS ATTENTION Incorrect runs will misrepresent the true mean and standard deviation SD of that summary data Therefore be sure that the runs you submit are correct 3 Verify that the data you want to submit is correct If necessary delete any data runs not intended for IQAP submission such as a control that was analyzed in the wrong file IMPORTANT If you analyzed a control in the wrong file that run must be excluded from the statistics If the run is not excluded the summary data fo
296. finition 3 8 Glossary 2 reproducibility 3 8 performance specifications accuracy 3 6 carryover 3 6 definition 3 5 Glossary 2 linearity 3 5 reproducibility 3 5 p8 definition Abbreviations 2 pierce position of tube 5 24 placing labels on tubes 5 15 Platelet Concentrate Extended Range flag defined 9 37 Plt count determination 2 16 interfering substances 3 12 parameter overview 2 16 Plt aggregate triggering condition 9 47 PLT Concentrate defined 3 5 3 7 9 51 next to PLT result 3 9 PLT INTERPRETATION NOT POSSIBLE triggering condition 9 47 pneumatics area illustrated 11 79 positioning tubes in the tube holder 5 22 power consumption 3 1 power problems 11 122 power supply 3 1 cord connector location 1 4 powering down the system 5 9 powering up the system 5 3 precision definition Glossary 2 See alsoReproducibility preparing the system for sample analysis 8 1 primary ID See Worklist Match Option priming reagents procedure 11 30 when to do 11 30 priming the reagents 11 30 Index 9 INDEX Index 10 printer prints incorrectly what to do if 11 124 required model 1 14 printing calibration results 10 17 printing cell control results 7 30 from QC Data Grid screen 7 33 from QC Graphics screen 7 36 from QC L J Graphs screen 7 30 printing from the Run in Progress screen 8 2 9 1 printing log entries 11 132 printing options for cell control results 7 35 7 38 for patient results 9 20 p
297. fully automated hematology analyzer providing a complete WBC five part differential which is determined simultaneously by the ACV Absorbance Cytochemistry and Volume Technology and WBC BASO methodologies The ACV Technology uses absorbance cytochemistry and focused flow impedance The WBC BASO methodology uses differential lysis impedance technology and differential thresholds See Table 2 1 Table 2 1 ACeT 5diff AL Analyzer Measurement Technologies Fluid Dynamics Technology Measurements Output Dual Focused Flow ACV Technology Light absorbance of Lymphocytes monocytes cytochemically stained neutrophils eosinophils cells immature cells and atypical lymphocytes Volume aperture Differential lysis using the Volume and count WBC count basophil Coulter Principle percentage and basophil count Volume aperture Coulter Principle Volume and count RBC count platelet count and hematocrit 2 2 MEASUREMENT PRINCIPLES Coulter Principle In the ACeT 5diff AL analyzer the Coulter Principle is used to analyze the final RBC Plt dilution and the WBC BASO dilution This electronic method of counting and sizing particles is based on the fact that cells which are poor conductors of electricity will interrupt a current flow The impedance variation generated by the passage of non conductive cells through a small calibrated aperture is used to determine the count number of particles and size volume of the particl
298. fy that the limit ranges have been copied correctly a Highlight the flagging set you copied to b Verify the action and patient limits are the same as those of the flagging set you copied from 10 Ifyou are creating a new flagging set return to step 9 of that procedure A 128 PN 624026AE SETUP A FLAGGING SETS SETUP e Setting a Default Flagging Set Do this procedure to select a default flagging set COULTER AST Sdiff AL 1 From the Main Menu screen 0 4 Olt 3 W the Flags and Messages tab PN 624026AE A 129 SETUP FLAGGING SETS SETUP Oe 9 Highlight the flagging set you want to set as the default e g Man 6 W Set as Default Flagging Set Flagging Sets Standard Range 7 u Y to save the change 8 Verify that The flagging set you selected is now the default flagging set e Restoring Default Values To restore the default values for a specific flagging set u Restore Default Values before saving the changes Once you save you cannot restore the previous default values Flag Sensitivity and Thresholds The options under the Flag Sensitivity and Thresholds are for Service use only IMPORTANT Do not make any adjustments without first consulting a Beckman Coulter representative Otherwise your system may not perform to specifications Any change to thresholds or sensitivity affect overall system performance A 130 BARCODE SPECIFICATI
299. g PN 624026AE 8 25 SAMPLE ANALYSIS RUNNING WORKLIST SAMPLES IN AUTOLOADER MODE 15 To view the results for the last sample analyzed u 16 17 18 If there is a situation where the system cannot find a Worklist order for the sample it is processing e g Worklist order is missing or is incorrect the sample results are placed ra La on the Manual Match screen ESE flashes when this occurs For details see Manual Match Procedure in Chapter 9 To view the results after all samples have been completed Of b Select the desired result to review To enter result comments Lin 0 a if necessary b Select the result for which you want to add a comment Uke d Type the comment mel pe 19 8 26 When all samples have been processed the instrument ejects the cassette into the Cassette Output Tray PN 624026AE SAMPLE ANALYSIS 8 RUNNING WORKLIST SAMPLES IN AUTOLOADER MODE 20 Remove the cassette from the instrument See Unloading Cassettes from the Analyzer in Chapter 5 21 Results are printed transmitted according to your system setup If Auto Print is enabled results comments will not be included To print transmit a sample report with the results comments included a W from the Results screen AcT 5diff AL For Research Use Only Not for use in diagnostic procedures RUD Results Microcytes PLT Aggre
300. g fc I 5 S amp a wv X e I p I I 0971572002 09 2219 7 46 PN 624026AE QUALITY ASSURANCE T DELETING QC RUNS FILES Of 4 The QC Levey Jennings graphs screen appears AcT Sidi AL_ Control Graphics 5 u to view the QC Graphics screen for the last run PN 624026AE 7 47 QUALITY ASSURANCE DELETING QC RUNS FILES ATTENTION Control data cannot be recovered once it has been deleted Therefore be certain that you want to delete erase the control data before you proceed w 6 0 which immediately deletes the control data Deleting One or More QC Runs Do this procedure to delete one or more control runs A Ar ATTENTION Control data cannot be recovered once it has been deleted Therefore be certain that you want to delete erase the control data before you proceed 1 Ensure that you have control summary data to fulfill your regulatory requirements prior to deleting control files sem acen OR 2 From the Main Menu screen Q o D 4 2 Ei iT y A Ea 3 is fc gE p amp Db A x W I I 0971572002 09 2219 7 48 PN 624026AE QUALITY ASSURANCE T DELETING QC RUNS FILES 4 The QC Levey Jennings graphs screen eet te appears 5 Y R to view the QC Data Grid screen PN 624026AE 7 49 QUALITY ASSURANCE DELETING QC RUNS FILES 7 50
301. g Worklist samples in the Autoloader mode 8 12 sample results flagged or outside range what to do if 3 9 importance of verifying flagged results 9 34 reviewing 9 2 selecting results to view 9 8 sorting 9 5 samples entering IDs 3 3 number processed per hour 3 3 stability of 3 3 sampling probe if not working 11 123 sampling syringe function 11 79 location 11 79 saving software changes 5 55 SCH flag 9 44 Schistocyte triggering condition 9 47 SCL flag 9 45 scrolling how to scroll 5 52 through lists 5 50 to view all information 5 50 SD standard deviation definition Glossary 2 searching for sample results 5 2 9 1 selecting a default flagging set A 129 selecting a default printer A 86 selecting a flagging set 8 36 selecting a language A 74 selecting a paper size A 84 selecting a test panel 8 35 selecting Auto Stop messages for QA A 18 selecting parameters for patient report A 97 selecting results for auto calibration 10 15 selecting the Auto Stop criteria for patient results A 20 selecting the default test panel A 6 selecting the number of copies to automatically print A 84 selecting the print quality A 84 selecting the Worklist Match Option A 10 selecting the XB XM option A 35 serial number label location 1 4 Service users access levels A 115 setting Auto Print for patient results A 64 setting the AUTO_SID starting number A 4 setting the Auto Clean frequency A 102 setting the XB XM
302. gates Schistocyte Miscellaneous Messages SO Reagent expired PLT 103 B RO MPY IL 81 R PPP omment PCT x Powz 135 R ej z 1m v a on a 3 Z X gt d T 1070472002 141753 b Select Print or Transmit from the following window Print Transmit Print Transmit i Transmit Print Print Print displayed report Transmit displayed report ATTENTION It is important that you verify all results as being correctly associated with the correct patient demographics before reporting UY to print or transmit PN 624026AE 8 27 SAMPLE ANALYSIS RUNNING WORKLIST SAMPLES IN AUTOLOADER MODE 22 Remove the sample tubes from the cassette See Removing Tubes from a Cassette in Chapter 5 23 Verify the Sample ID and results before reporting the results 8 28 PN 624026AE PN 624026AE SAMPLE ANALYSIS RUNNING WORKLIST SAMPLES IN AUTOLOADER MODE 8 No Worklist Cass Position Positive ID Manual Match OFF Note This configuration is for labs that do not use barcoded sample tubes and do not require that patient demographics be assigned with sample results With this configuration there is no positive identification and results will be printed with an AUTO_SID unless a Sample ID is read from the sample tube LN ANE 1 Load the sample tubes into the cassette WARNING Risk of injury biohazardous conditions if a cassette is not properly handled Do no
303. ge The 8 system also generates Levey Jennings graphs and statistical printouts Ss Does the instrument have Yes The instrument automatically updates the calibration E automatic calibration factors at the end of the successful calibration run The 2 system also does a Reproducibility check See Heading 10 4 S AUTO CALIBRATION Fe What is the purpose of the logs The logs contain entries made by the system You can view 3 the log entries to get information on various topics For detailed information see Heading 11 16 LOGS POWERING UP AND LOGGING ON POWERING DOWN AND LOGGING OFF To ensure the correct operation of the system it is important that the power up and power down sequences be done in the proper order Powering Up the System and Logging On When instructed in this document do this procedure to power up the system if it has been powered down Note If the background fails the limits the system automatically repeats the background up to a maximum of 3 times All results will be posted to the Startup log Check the waste container to determine if it needs to be replaced If so do Replacing the Waste Container in Chapter 11 Verify that the printer is ready and has paper Refer to the printer manual for details Note Your printer may be different from what is shown here 5 3 5 GETTING STARTED POWERING UP AND LOGGING ON POWERING DOWN AND LOGGING OFF 3 Verify that the Analyzers a
304. ge in which you want the instrument s software to be displayed The system will automatically reboot after you change the language S amp S LN 2 Aer 1 From the Main Menu screen 0 aE OC A 74 PN 624026AE SETUP A SYSTEM SETUP 3 W the Local Settings tab 0A 5 Select the desired language 6 u v to save the change The system automatically reboots PN 624026AE A 75 SETUP SYSTEM SETUP Changing Input Locales Note If you want to change input locales such as language specific keyboards contact a Beckman Coulter representative before doing this procedure a LN ANE 1 From the Main Menu screen 0 aE COULTER Coutter AST Sdiff AL CO 3 0 the Local Settings tab A 76 PN 624026AE SETUP A SYSTEM SETUP 0A CC 6 Make the desired changes by following Keyboard Properties the instructions on the screen W EN English United States Note If you Properties you can select a language specific keyboard Input Locale Properties 7 E Apply 8 u v to save the change PN 624026AE A 77 SETUP SYSTEM SETUP Host Defining Host Communication Settings Changing the LIS HIS communication settings affects what information is sent to and received from a host computer Typically this information is already defined in your system by a qualified technician using the information in the Host Transmission Specification manual
305. gnal 15 at 670 nm e Maximum resolution of scanner 0 1 mm 4 mils e Maximum label length 66 mm 2 6 inches e Code 128 barcode labels must meet European Standard EN 799 e Code 39 barcode labels must meet European Standard EN 800 e Codabar barcode must meet European Standard EN 798 e Interleaved 2 of 5 I 2 of 5 barcode labels must meet European Standard EN 801 e EAN 8 barcode labels must meet EAN European Article Numbering Specifications e EAN 13 barcode labels must meet EAN European Article Numbering Specifications PN 624026AE B 1 BARCODE SPECIFICATIONS FOR OPTIONAL BARCODE WAND BARCODE SPECIFICATIONS Table B 1 shows default barcode settings for each symbology Table B 1 Default Barcode Settings Setting Code 128 Code 39 Codabar 1 2 of 5 EAN 8 EAN 13 Character Length 1 to 16 1 to 16 3 to 16 118 7 12 Check Digit Checksum Always Enabled Not Enabled Always Always Enabled Available Enabled Enabled Start Stop Equality Check Not Not Enabled Not Not Not Available Available Available Available Available Start Stop Equality Output Not Not Disabled Not Not Not Available Available Available Available Available Code 128 provides excellent density alphanumeric characters and good security Recommend using this symbology if using barcodes for the first time and if compatible with other bar code systems used in your lab For increased sample identification in
306. gram has 256 channels and A between 2 fL and 30 fL A mobile SCH threshold at 25 fL by default gt 3 25u 30 Figure 9 18 Mobile Threshold Positioned in the Standard Regions Between 18 fL and 25 fL A 1 i 2 18 25y 30 Figure 9 19 Mobile Threshold Cannot Be Positioned in the Standard Region A 3 18 25u 30 Figure 9 20 Mobile Threshold Cannot Be Positioned A 2 18 25u 30 Figure 9 17 moves according to the presence of microcytic RBCs present in the Pit analysis region Plt flags generate when the following three conditions occur 1 Ifthe mobile threshold can be positioned in the standard region between 18 fL and 25 fL MIC microcytes is displayed and printed in the DiffPlot and Histogram section of the Flags and Messages area See Figure 9 18 The Plt result is reliable 2 Ifa valley is not detected by the 18 fL threshold the threshold is placed at the 18 fL position and MIC is displayed and printed in the DiffPlot and Histogram section of the Flags and Messages area If the interference is significant the Plt count will also be flagged with R 3 Ifthe mobile threshold cannot be positioned between 18 fL and 25 fL the threshold is placed at the 18 fL position SCH schistocytes is displayed and printed in the DiffPlot and Histogram section of the Flags and Messages area and the Plt count is flagged with R Suspected abnormalities include the pr
307. greement between the comparator instrument and the ACT 5diff AL analyzer using clinical specimens covering the expected range of performance Table 3 8 Accuracy Characteristics Parameter Correlation r WBC 0 9995 RBC 0 9979 Hgb 0 9991 Het 0 9977 Plt 0 9972 Pit 0 9879 NE 0 9917 LY 0 9929 PN 624026AE SPECIFICATIONS CHARACTERISTICS LIMITATIONS Table 3 8 Accuracy Characteristics Continued Parameter Correlation r M0 0 9539 E0 0 9841 Platelet Concentrate Mode Carryover Carryover Table 3 9 was assessed by analyzing whole blood with high values followed by a whole blood sample with low values Each sample was run consecutively in triplicate Carryover is calculated as follows Low 1 Low3 3 4 Carryover Hiha Lond x 100 Table 3 9 Carryover Characteristics Parameter Units Low Level High Level Carryover WBC 108 uL 0 80 38 50 0 00 RBC 106 uL 1 67 6 48 0 35 Plt 103 uL 20 0 892 3 0 19 Pit 103 uL 149 0 1 126 0 68 Hgb g dL 5 8 17 10 0 00 Platelet Concentrate Mode LIMITATIONS Maintenance Failure to properly execute the maintenance procedures in Chapter 11 DIAGNOSTICS may compromise the instrument s reliability Blood Specimens If any abnormal test result including flagged results or results outside the normal range occur use reference methods or other standard laboratory procedures to verify the results For additional informat
308. gt Worklist Match option is set to Barcode indicating a barcode Sample ID is expected but no Sample ID is obtained from the tube Lia lk If a result is placed on the Manual Match screen ESE flashes It is not possible to have a re run performed on an unmatched results PN 624026AE 9 13 9 DATA REVIEW MANUALLY MATCHING SAMPLE RESULTS WITH WORKLIST ORDERS Understanding the Manual Match Screen 9 14 See Figure 9 8 Figure 9 8 Manual Match Screen Details Run Date Ti 09 16 2002 07 10 2002 almi 3 B Db A v X B Version v0 15rc2 Service oo 097162002 09 26 30 7367410A Duplicate of the Worklist Grid screen and contains all entries currently on the Worklist Sample ID as entered on the Worklist Cassette number entered when the Worklist order was created Position of the tube in the cassette entered when the Worklist order was created Patient ID entered when the Worklist order was created Last Name of patient entered when the Worklist order was created eoo00o00 08 8 8 Displays information from the order selected on the Worklist Sample ID Flagging Sets Collect Date Time Location Physician Patient ID Last Name First Name Date of Birth Age and Gender and the cassette and position and Run Date Time from the selected unmatched result Lists all samples not yet matched with entries on the Worklist Scroll bars that allow you to scr
309. h diluent Waste 2 PN 624026AE DIAGNOSTICS Ji COMPONENT LOCATIONS Figure 11 15 Main Card Main card e amplifies processes and counts the resistive signals and DIFF optical signals the RBC signal the Plt signal and the WBC BASO signal measures hemoglobin controls the motorized components processes data and calculates results and e communicates with the Workstation N ATTENTION When opening the Main card support panel use care not to disconnect or damage the electric cables Figure 11 16 Computer Workstation Front View Monitor Monitor power ON OFF switch Mouse Workstation power ON OFF switch Note Your configuration may vary from that shown here PN 624026AE 11 81 DIAGNOSTICS REPLACEMENT PROCEDURES Figure 11 17 Computer Workstation Back View Host communications connection Power supply connection PC Monitor connection Printer connection Analyzer connection Keyboard connection Monitor connection 000000000 Power supply connection monitor Note Your configuration may vary from that shown here 11 11 REPLACEMENT PROCEDURES Overview This section contains the following replacement procedures e Replacing Reagents Replacing the Waste Container e Replacing the Flow Cell Lamp Replacing Reagents Reagent Location Figure 11 18 shows the location of the
310. he X axis and volume on the Y axis Figure 2 12 shows the DiffPlot regions From the DiffPlot four out of five leukocyte white blood cell populations are determined lymphocytes monocytes neutrophils and eosinophils In a typical whole blood sample the basophil population determined in the WBC BASO bath is very small compared to the other four white blood cell populations Figure 2 13 shows a normal DiffPlot generated by the system Figure 2 12 DiffPlot Regions Absorbance 2 12 Figure 2 13 Normal DiffPlot PN 624026AE OPERATION PRINCIPLES 2 SAMPLE ANALYSIS Dilution Summary Table 2 6 summarizes the dilution characteristics required to obtain CBC and CBC DIFF parameter results Table 2 6 Summary of Dilutions Technical Whole Blood Reagent Dilution Reaction Characteristics Volume Reagent s Volume Ratio Temperature WBC Count and BASO 10 pL ACeT 5diff WBC Lyse 2 000 pL Final 35 C 95 F Count 1 200 in the WBC BASO bath Differential Acquisition 25 uL ACeT 5diff Fix 1 000 pL Final 35 C 95 F with Differential WBC ACeT 5diff Diluent 1 000 uL 1 80 Count in the DIFF bath Hgb Measurement 10 uL ACeT 5diff Diluent 1700 uL Preliminary 35 C 95 F in the First After removin 1 170 nae g dilution Final ACsT Sdiff Diluent 400 pL 1 290 ACeT 5diff Hgb Lyse 400 uL RBC and Plt Count 42 5 uLofthe ACeT Sdiff Diluent 2 500 yL Secondary 35 C 95 F in the RBC bath 1 1
311. he change PN 624026AE A 69 SETUP SYSTEM SETUP A 8 SYSTEM SETUP Four tabs are available for this option e Local Settings e Host Defining Host Communication Settings e Printer e Cycle Options Local Settings Under the Local Settings tab Figure A 10 you can define edit these settings e e Changing the Date Time e e Changing the Date Time Format e Language Selecting e Changing Input Locales Figure A 10 Local Settings Setup Screen For Research Use Only Not for use in diagnostic procedures RUD System A 70 PN 624026AE SETUP A SYSTEM SETUP Changing the Current Date Time and Date Time Format Do this procedure to change the current date and time and or the format for each 1 From the Main Menu screen 0 4 CO 3 W the Local Settings tab PN 624026AE A 71 SETUP SYSTEM SETUP Oe s 0 Change Date Time 6 To change the date time do Changing the Date Time To change the date time format do e Changing the Date Time Format e Changing the Date Time 1 To change the date a b c d Select the month Select the year Select the day Verify the date is correct 2 To change the time a a b Highlight the hour minute or second E to change as desired Verify the time is correct 0 OK If you want to change the date time format do e Changing the Date Time Format If you are finished u A 72 Date Ti
312. he instrument See Defining Automatic Rerun Criteria By Flags and or by Parameters in this chapter Allows you to select the parameter characteristics which if met causes the sample to be automatically re run by the instrument See Defining Automatic Rerun Criteria By Flags and or by Parameters in this chapter Allows you to select the specific flagging set for which you want to define the automatic rerun criteria Allows you to apply the rerun criteria to all flagging sets which means that you would not select a specific set in See Defining Automatic Rerun Criteria By Flags and or by Parameters in this chapter Headings for the parameter criteria If selected all check boxes related to that specific heading will be selected deselected A 60 PN 624026AE SETUP A AUTO FUNCTIONS SETUP Defining Automatic Rerun Criteria By Flags and or by Parameters Do this procedure to define the flag s and or parameter s to cause the sample to be automatically re run by the instrument Samples meeting the defined criteria will automatically be placed on the Worklist A Nex Seca COULTER COULTER AST 5diff AL 1 From the Main Menu screen 0 ay OF 3 W the Rerun tab PN 624026AE A 61 AUTO FUNCTIONS SETUP SETUP A 62 0A pT TT TT EEE mamanmi momonon K pT TD TD YY YD DT DTT TTT 9 To define the rerun criteria by flag s a C E the check box n
313. he last sample analyzed IMPORTANT The Run in Progress screen Figure 9 1 is not updated to reflect when a Manual Match is performed The Run in Progress screen shows the results as analyzed only Printing prior to Manual Match from the Run in Progress screen is inhibited The final report prints from the Manual Match screen after Manual Match has been completed Figure 9 1 Run in Progress Screen Flags and Messages Sample ID 123456 WBC 103 uL 52 E DiffPlot and Histogram Flags Cass Pos Panel WBC SL NL LN SL1 MACF fi fi CBC DIFF RBC 108 uL 845 HS ig Analyzer Messages 100 200 300 400 DB A Flagging Set HGB g dL 13 0 WBC BASO Interpretive Messages Standard Range HCT Lymphocytosis Collect Date Time MCV fL Neutropenia NRBCs m Run Date Time Men am Basophilia a Il 09709 2002 14 16 47 MEHE 9 Macrocyte Location RDW Hypochromia E a Schistocyte PLT 103 pL Miscellaneous Messages Bhesiciay MPY fL Unmatched mm Comments a a i w 4 Patient ID 103 pL ne E e Last Name LY 566 RHH 295 R 3 MO __ EEE EO 43 R 022 R s REY m Date of Birth Age Gender El JUnknown Y 3 P a y X d 09 09 2002 14 17 07 DATA REVIEW LOCATING SAMPLE RESULTS Locating Results on the Results List Screen 9 2 Procedure for Viewing the Last Sample s Results Do this procedure to view the results from the last sample on the Run in Progres
314. hen back up to home Right compartment see Figure 11 11 Sampling syringe The sampling syringe makes a full stroke and returns to home Right compartment see Figure 11 11 11 15 i DIAGNOSTICS DIAGNOSTICS USER SCREEN Table 11 4 Analyzer Motors Function and Location Continued Motor Component Action Component Location Traverse assembly The horizontal traverse assembly moves the vertical Right compartment traverse assembly to the rear of the Analyzer then see Figure 11 11 back completing a full cycle Tube mixing The tube mixing mechanism moves the tube mixer Lower front compartment mechanism arm in and out to the left of and behind the Note To observe the tube mixer arm movement tube holder open the left front door and look into the lower front compartment on the left of the tube holder Procedure for Checking Motors Do this procedure to activate any of the following motors e Diluter Syringes motor e Flow Cell Syringes motor e Counting Syringe motor e Draining Syringe 1 motor e Draining Syringe 2 motor e Piercing Mechanism motor e Cassette Input Mechanism motor e Cass cassette Transfer Mechanism motor e Tube Mixing Mechanism motor e Sampling Probe e Traverse Motor e Sampling Syringe ATTENTION Motors must be checked individually If you need to check more than one select one motor and verify it s operation before proceeding to the next one 11 1
315. hese settings Auto Numbering Setting the AUTO_SID Starting Number Default Panel Selecting CBC or CBC DIFF Worklist Match Option Selecting Manual Match Turning ON or Off Logs Comments Prompt RUO Parameters Enabling Disabling Auto Stop for QA Messages Selecting Auto Stop for Number of Consecutive Results With Selected Characteristics Selecting Figure A 2 General Tab Settings PN 624026AE gt io qaqa K M v Vv Vv iv 7367103A A 3 SETUP OPERATIONAL SETUP A 4 Allows you to enter the Auto Numbering starting number See Auto Numbering Setting the AUTO_SID Starting Number in this chapter Allows you to define the default panel CBC DIFF or CBC See Default Panel Selecting CBC or CBC DIFF in this chapter Allows you to enable disable RUO Parameters See RUO Parameters Enabling Disabling in this chapter Allows you to select the Worklist match options See Worklist Match and Manual Match Options in this chapter Allows you to turn Manual Match ON OFF See Manual Match Turning ON or Off in this chapter Allows you to select the sample criteria that if met automatically stop the system See Auto Stop for Number of Consecutive Results With Selected Characteristics Selecting in this chapter 08 8 Allows you to select the QA messages that if generated automatically stop the system and allows you to display print the QC Failed message See Auto Stop for QA Mes
316. ibility and Calibration only one character is displayed for flags For example you may see a V or R against a red background to indicate the value is out of range If the results background is white the value in within range Flags and Messages Defined 9 34 Flags and messages are symbols sets of symbols letters or text generated by the instrument to signal that parameter s may need additional review Flags and messages are linked to results in a number of ways e Linked to a result when it exceeds the defined limits e g H or L e Linked to a problem in the morphology of the blood cell population e g R Linked to instrument operation e g DIFF For details see Heading 9 8 FLAGS AND MESSAGES GENERATED BY THE INSTRUMENT Flags and messages may be displayed as e Replacement flags also called codes replace a parameter s numeric results e Non replacement flags appear next to the parameter results Up to three of these flags can be displayed for a parameter e DiffPlot and Histogram flags appear in the Flags and Messages box in the upper right corner of the Results screen PN 624026AE 9 8 DATA REVIEW FLAGS AND MESSAGES GENERATED BY THE INSTRUMENT FLAGS AND MESSAGES GENERATED BY THE INSTRUMENT The following sections define the flags and messages generated by the instrument e Parameter Flags e Tree View Flags and Messages Parameter Flags This section defines the parameter flags that can be generate
317. iff Cal Calibrator is the recommended calibrator See Heading 1 7 QUALITY ASSURANCE CONTROLS CALIBRATORS AND IQAP for additional information 3 2 PN 624026AE SPECIFICATIONS CHARACTERISTICS 3 INSTRUMENT SPECIFICATIONS Recommended Anticoagulant The recommended anticoagulant is KzEDTA with the proper proportion of blood to anticoagulant as specified by the tube manufacturer K EDTA is an acceptable alternative Sample Volume Aspirated e 30 pL of whole blood is aspirated in the CBC mode e 53 uL of whole blood is aspirated in the CBC DIFF mode Slightly higher volumes may be used depending on such variables as tube fill volume sample viscosity and the amount of pressure vacuum in the tube Dilution Ratios WBC BASO 1 200 DIFF 1 80 RBC PIt 1 10 000 Hgb 1 250 Throughput The instrument can process up to 80 samples per hour for CBC or CBC DIFEF The instrument achieves nominal throughput when used in a routine laboratory environment with samples having normal hematology parameters Depending on sample mix and workflow conditions e g running Stat samples lower throughput may be observed Sample Stability Sample stability is based on an average of at least 10 clinical normal and abnormal whole blood samples e CBC parameters are stable up to 48 hours at room temperature e DIFF parameters are stable up to 24 hours at room temperature Sample Identification You can manually enter a sample ID setup the instrument t
318. ighted the order 4 Highlighted the result WORKLIST SCENARIOS WORKLIST MATCH OPTION SCENARIOS 5 Ow a The report automatically prints Manual Match appeared in the Miscellaneous Messages section of the Flags and Messages area of the printout The Sample ID on the report was 132 which was the Sample ID entered when the Worklist order was created Cass was 10 and Pos was 1 e Ifyou print from the Run in Progress screen after matching Manual Match will appear on the report even though the Run in Progress screen shows Unmatched e Ifyou print from the Run in Progress screen before matching Unmatched will appear on the report b Print the result from the Manual Match screen without matching Manual Match will appear in the Miscellaneous Messages section of the Flags and Messages area of the report See Printing from the Manual Match Screen Without Matching in this appendix Scenario 16 Cass Position On Manual Match Off Auto Print On Worklist Order Sample ID only No Barcode Label Summary Report prints with an AUTO_SID and the cassette position of the tube when analyzed There was a Sample ID conflict because the ID read off the barcode label was different from the Sample ID in the Worklist order 1 Create a Worklist order with Sample ID 123 only d Type 123 as the Sample ID OW 2 Insert tube into the 1st position of cassette 10 3 Place cassette in Cassett
319. in Menu screen 0 aE COULTER COULTER AST Sdiff AL A 14 PN 624026AE SETUP A OPERATIONAL SETUP 3 Verify the General tab is selected AcT 5diff AL Miscellaneous General Location Physician Units OF 5 Select one or both Prompt for Comments Logs options Prompt for Comments I Calibration Log Reagents Log 6 E to save the change ai 7 i we as needed RUO Parameters Enabling Disabling RUO Parameters Disabled Enabled USA Enabled non USA The RUO parameters for this instrument include PCT PDW ATL and IMM When USA is the selected country these parameters are defined as For Research Use Only Not for use in diagnostic procedures If you want the results for the RUO parameters displayed printed and or transmitted you must enable the RUO parameter feature as described below PN 624026AE A 15 SETUP OPERATIONAL SETUP Note Whenever an RUO parameter label is displayed printed and or transmitted the following message will be displayed printed and or transmitted For Research Use Only Not for use in diagnostic procedures RUO Do this procedure to enable disable the reporting of the RUO parameters CA AcT 5diff AL 7 A 2 AET See COULTER AST Sdiff AL 1 From the Main Menu screen J 4 3 Verify the General tab is selected AcT 5diff AL Miscellaneous A 16 PN 624026AE SETUP A OPERATIONAL SETUP
320. in analysis The red and green LEDs flash e When the red LED remains illuminated the system is busy analyzing the sample e When the green LED remains illuminated the instrument is ready for the next analysis 13 When the LED is green and the tube holder door opens remove the tube vial If the control lot number has been set up as reserved the Workstation identifies the sample as a control and places the results in the appropriate control file based on information entered in the Sample ID field 14 Review the control results as instructed in Reviewing Control Results in this chapter and as per your lab s protocol 15 To manually de select exclude run s from the statistics as per your lab s protocol the check box as needed to de select LI PN 624026AE 7 19 QUALITY ASSURANCE RUNNING CELL CONTROLS 16 The control file results automatically print if Auto Print is enabled If Auto Print is disabled OB b Select the print option OM For information about enabling Auto Print for control results see Auto Print Non Patient Results in Appendix A 17 Repeat steps 5 through 16 for the remaining cell control levels Reviewing Control Results Do this procedure immediately following QC analysis to review the control results For details about the QC results screens see Understanding the QC Results Screens in this chapter LN amp Nec 1 Review the control res
321. in this chapter Maintenance Log Opens the maintenance log See Maintenance Log in this chapter Patient Worklist Log Opens the patient Worklist log See Patient Worklist Log in this chapter ae m p we i Setup Log Opens the setup log See Setup Log in this chapter 11 125 l DIAGNOSTICS LOGS Table 11 7 Logs Screen Icons Continued Icon Name Function Host Log Opens the host log See Host Log in this chapter L5 Alarms and Errors Log Opens the alarms and errors log See Alarms and Errors Log in this z chapter Startup Log Opens the Startup log See Startup Log in this chapter Understanding the Logs The format of each log is the same regarding the Date Time By Description and Comment columns However the types of entries differ for each log See Figure 11 21 for details on reviewing log entries Figure 11 21 Understanding the Logs Alarms and Errors Log Shown Details i aaa gt 10 2002 12 54 46 Service Section Miscellaneous Message Sample ID 31192903 in progress 107 10 2002 13 18 37 Service Section Miscellaneous Message Sample ID 31192903 in progress 07 15 2002 16 12 37 Supervisor Section Autoloader Message Front cover open 07 16 2002 15 33 21 Supervisor Section Autoloader Message Front cover open 07 16 2002 19 09 46 Supervisor Section Operator Message Instrument stopped by user 07 22 2002 10 27
322. ing terms and conditions You May 1 Use this software in the computer supplied to you by Beckman Coulter 2 Maintain one copy of this software for backup purposes the backup copy shall be supplied by Beckman Coulter 3 After written notification to Beckman Coulter transfer the entire Product to another person or entity provided you retain no copies of the Product software and the transferee agrees to the terms of this license agreement You May Not 1 Use copy or transfer copies of this Software except as provided in this license agreement 2 Alter merge modify or adapt this Software in any way including disassembling or decompiling 3 Loan rent lease or sublicense this Software or any copy Limited Warranty Beckman Coulter warrants that the software will substantially conform to the published specifications for the Product in which it is contained provided that it is used on the computer hardware and in the operating system environment for which it was designed Should the media on which your software arrives prove defective Beckman Coulter will replace said media free of charge within 90 days of delivery of the Product This is your sole remedy for any breech of warranty for this software Except as specifically noted above Beckman Coulter makes no warranty or representation either expressed or implied with respect to this software or its documentation including quality performance merchantability or fitness f
323. inges 11 46 Traverse Service Position 11 48 Edit Accept Calibration Factors 11 49 11 7 REPRODUCIBILITY CHECK 11 52 Understanding the Reproducibility Screen 11 52 Running a Reproducibility Check in the Manual Stat Mode 11 53 CONTENTS XV CONTENTS xvi 11 9 Supplies Needed 11 53 Running a Reproducibility Check in the Autoloader Mode 11 60 Supplies Needed 11 60 Printing Transmitting Reproducibility Results 11 65 Deleting Reproducibility Results 11 65 SHUTTING DOWN WINDOWS NT RECOMMENDED 11 66 CLEANING THE ANALYZER 11 66 Cleaning the Tube Holder 11 66 Cleaning the Outside of the Analyzer 11 66 Cleaning the Inside of the Analyzer 11 67 Auto Clean 11 67 Shutdown 11 67 System Cleaning After Analyzing a Contaminated Sample 11 68 Cleaning the Baths 11 73 11 10 COMPONENT LOCATIONS 11 76 11 11 REPLACEMENT PROCEDURES 11 82 Overview 11 82 Replacing Reagents 11 82 Reagent Location 11 82 Understanding the Reagent Status Screen 11 83 Replacing Reagents Procedure 11 84 Viewing Reagent Levels 11 84 Replacing the Diluent Reagent 11 85 Replacing Reagents Fix WBC Lyse Hgb Lyse or Rinse Reagents 11 89 Replacing the Waste Container 11 95 Replacing the Flow Cell Lamp 11 96 Replacing the Rinse Bath Drain Filter 11 103 Purpose 11 103 Supplies Needed 11 103 Procedure 11 103 11 12 OPENING THE TUBE HOLDER DOOR IF JAMMED 11 108 11 13 INSTALLING THE LIFTING HANDLES INTO THE ANALYZER
324. int sample results A s A OB The Results List screen appears AcT 5diff AL Result T Analytical I Action Limit 5 DB I DiffPlot Histogram I Not Printed I Patient Limit I Not Transmitted Inc Sample ID Cass Pos Patient ID Last Name First Name Gender Date of Birth Age Panel RunDate AF DH PL AL P T A m kr cecjoo7 iojacM COM MO P 44568 Unknow c c D07 10 20 C WM wR EC s06s02 Unknow o MM BO Pijavtosics 1 Unknow ceyoo7jig2c OR Ooo el P js11920039 2 Unknow c 007 10 20 0 CR OO E T 311929099 4 Unknow cegoo7 igjac e EF Oe Fi jauto sco 5 Unknow o eR OO Ie T ljauto sco 6 Unknow o MM RO C auto sito 7 Unknow cegoo7jojaco MR O iim 311929039 1 Unknow c c 007 10 20 0 MM MO Pr T _ 3119290P 9 3 Unknow c D07 10 20 0 O e EF Oe m auto sco 4 Unknow c c D07 10 20 0 MM e E auto sco 5 Unknow o e Roo 31192909 9 6 Unknow c amp c 007 10 201 0 O ao ano ano A Ffauto_ses 7 Unknow o wR oo F 31192903 9 1 Unknow cecjoo7 iojac WM RM e o Tf 3119290P9 3 Unknow o MM OO la T auto sts 4 Unknow o MR Oo m autost 5 Unknow e MO pe 311929099 6 Unknow o wo oo oo Tjauto sico 7 Unknow cec oo7 jigjacl BM RM OOP Pi auros 1 Unknow o MM e El F lauto_sico 2 Unknow c D07 02c 0 A e MF al 7 gt 4 v X I Supervisor I EJ 2 Select or deselect the results you want to print me ES e To select all results u ET
325. inting Transmitting Saved Cell Control Results Prior to entering new cell control information print the stored cell control results for your files You can print transmit the cell control results from the following screens as noted e QC Levey Jennings Graphs Screen Figure 7 2 print e QC Data Grid Screen Figure 7 3 print and transmit e QC Graphics Screen Figure 7 4 print Printing Control Results from the QC Levey Jennings Graphs Screen Do this procedure to print cell control results from the QC Levey Jennings Graphs screen LN amp ANE 1 Is the Levey Jennings graph you want to print transmit already displayed e If yes u D e Ifno go to step 2 7 30 PN 624026AE PN 624026AE QUALITY ASSURANCE RUNNING CELL CONTROLS From the Main Menu screen u Q S econ COULTER COULTER AST Sdiff AL C The QC Levey Jennings graphs screen appears 7 31 7 QUALITY ASSURANCE RUNNING CELL CONTROLS 5 Select the control file to be reviewed Control Name Lot Number ig T CONTROL 13 CBC DIFF 270502 a at or at gt b J the desired control 6 C D to print transmit the selected control results 7 The following message appears AcT 5diff AL Print Levey Jennings graphs 8 u Y to print Ce when you are finished 7 32 PN 624026AE QUALITY ASSURANCE T RUNNING CELL CONTROLS Printing Transmitting Control Results from the QC Data Grid Screen
326. into the RBC bath Waste syringe e drains the baths e bubbles the mixtures and e transfers the DIFF specimen to the flow cell Diluent reservoir e holds the necessary diluent for an analysis cycle e prevents diluent degassing as it is being aspirated by the syringes and e is vacuum filled by the count syringe Bath assembly receives the different rinsings and dilutions Tube holder holds the tubes vials PN 624026AE 11 79 1 DIAGNOSTICS COMPONENT LOCATIONS 11 80 Figure 11 13 Bath Assembly Figure 11 14 Optical Bench and Pneumatic Assemblies lt Rinse bath First Dilution Hgb bath DIFF bath RBC bath WBC BASO bath Optical bench ensures the support and adjustment of the flow cell lamp and optical and electronic elements Reagent syringe assembly e ensures correct reagent delivery gt Lysing reagent for Hgb A T 5diff Hgb Lyse gt Rinsing reagent A T 5diff Rinse gt Lysing reagent for DIFF ACeT 5diff Fix Lysing reagent for WBC BASO ACeT 5diff WBC Lyse gt Diluent AC T 5diff Diluent DIFF syringe assembly e injects the diluted sample into the flow cell and e injects the interior and exterior sheath into the flow cell Solenoid valves LV x through LV x Count syringe e ensures the vacuum for the WBC and BASO counts ensures the vacuum for the RBC and Pit counts and ensures the vacuum for filling the diluent reservoir wit
327. into three blocks of solenoid valves in the right compartment see Figure 11 11 e LV20 through LV23 are in a horizontal block at the tope of the traverse assembly above the sampling syringe assembly e LV24 to LV30 are in a vertical block beside the Draining Syringe 1 e LV31 to LV35 are in a horizontal block below the baths assembly in the baths enclosure area e LV 36 to LV 37 are in front of the baths assembly in the bath enclosure area Procedure for Checking Valves Tools Needed Q Allen wrench 3 0 mm for accessing valves in the left compartment Q Straight blade screwdriver for accessing valves in the right compartment Do this procedure to verify a valve s operation is smooth and regular When you use activate a block all valves in that block should be energized amp LN Ar NS EL 1 Power down the system the Analyzer and the Workstation See Powering Down the System and Logging Off in Chapter 5 2 Determine the location of the solenoid you need to check 11 19 i DIAGNOSTICS DIAGNOSTICS USER SCREEN 3 Remove the necessary panels covers See Heading 11 3 REMOVING PANELS COVERS 4 Power up the system See Powering Up the System and Logging On in Chapter 5 5 From the Main Menu screen 0 EE gt OR 11 20 PN 624026AE DIAGNOSTICS l DIAGNOSTICS USER SCREEN 8 E Valves tab 9 u the range of valves to check As the solenoids are fired l
328. inued Message Probable Cause Suggested Action RBC Interpretation Not Possible Multiple analytical alarms e g Voteout occurred 1 Re run the sample 2 Ifthe problem persists contact your local Beckman Coulter representative Reagent level low Insufficient for daily workload This message is given at the end of Startup following a new Workday if there is not enough reagent remaining to complete the daily workload that has been set up Do Replacing the Diluent Reagent and or Replacing Reagents Fix WBC Lyse Hgb Lyse or Rinse Reagents Reagent level low Insufficient to run analysis There is not enough reagent to continue Change the reagent as instructed in Replacing Reagents Procedure 2 Restart the cycle Reagent level low Insufficient to run cassette There is not enough reagent to continue Change the reagent as instructed in Replacing Reagents Procedure 2 Restart cycle Reagent temperature out of range Actual 0 Min 0 Max 0 Reagent temperature is out of range Do Hardware Reset Reagent temperature sensor failure Reagent temperature sensor failed Do Hardware Reset Reagent temperature sensor not connected Reagent temperature sensor is not connected Do Hardware Reset Result not stored The result was not stored Do Auto Clean Running RS232 error Communication error with Host Check Host connection
329. ion A 18 for QA messages A 18 for sample analyses with certain characteristics A 20 BA interfering substances 3 13 backflush function 11 39 procedure 11 39 backflushing to remove blockages 11 39 background count definition Glossary 1 background count limits 6 1 band cells description 2 21 barcode definition B 1 Barcode as Worklist Match Option A 9 barcode labels default settings B 2 specifications B 1 symbologies list of B 1 barcode wand optional specifications B 1 using 5 16 BASO count calculation overview 2 18 overview 2 18 basophil overview 2 18 percentage 2 18 See also BA Basophilia triggering condition 9 46 bath assembly illustrated 11 38 11 80 baths cleaning bleaching procedure 11 34 location illustration 11 38 11 80 blank cycle definition Glossary 1 blast cells description 2 21 Blasts triggering condition 9 46 bleaching See cleaning procedures blocked apertures removing blockage 11 39 bps definition Abbreviations 1 C C flag next to Plt result 3 5 3 7 3 9 calibration auto calibration 10 11 conditions for fail 10 16 conditions for pass 10 15 definition Glossary 1 frequency 11 1 manual C 1 passing requirements 10 17 pre calibration checks 10 5 requirements 10 1 setup procedures 10 6 verification out of limit what to do if 11 123 calibration factors definition Glossary 1 editing 11 49 Calibration Log icon 11 125 Calibration screen
330. ion Use the PC only as intended with this system Figu re 1 2 AL System ait DESCRIPTIONS ACeT 5diff AL Analyzer The Analyzer is further detailed in the following illustrations Figure 1 3 shows an overview of the Analyzer Figure 1 4 shows the back panel of the Analyzer Figure 1 5 shows the warning and caution labels on the Analyzer Figure 1 6 shows Tube Holder 1 Figure 1 7 shows Tube Holder 2 Figure 1 8 shows the position of tubes in the tube holders Overview of Analyzer WARNING Risk of operator injury when covers and doors are not closed and secured in place before you oper instr ate the instrument Ensure that all covers and doors are closed and secured before operating the ument PN 624026AE PN 624026AE Figure 1 3 Overview of Analyzer USE AND FUNCTION l DESCRIPTIONS Top cover Front cover Right panel Right cover ON OFF switch Cassette output tray Right front door ooo 000080 6 Indicator lights Note During analysis the lights are illuminated eeeoeesee e Tube holder door Tube holder Left front door Cassette input tray Left cover Left panel Reagent compartment Reagent door 1 3 USE AND FUNCTION DESCRIPTIONS Back Panel Figure 1 4 shows the Analyzers back panel Figure 1 4 Analyzer Back Panel Gi Serial number label Power supply cord connector o o o aXe Warning and Caut
331. ion see Heading 3 5 INTERFERING SUBSTANCES Platelet Concentrate Extended Linear and Reportable Ranges The instrument can be configured to allow the software to classify the sample as a platelet concentrate based on the Hgb value and the Plt count When the Platelet Concentrate extended range ability is activated by Service if the sample result for Hgb is less than 2 0 g dL and the result for Plt is greater than 15 0x107 nL the instrument considers the sample a Plt Concentrate The Plt result is then flagged using the extended linear and reportable range limits a C flag appears next to the Plt result and PLT Concentrate appears in the Tree View Flags and Messages PN 624026AE 3 9 3 SPECIFICATIONS CHARACTERISTICS INTERFERING SUBSTANCES 3 5 INTERFERING SUBSTANCES Table 3 10 shows a list of known limitations of automated blood cell counters that use impedance and light absorbance as measurement principles Table 3 10 Interfering Substances Parameter Interfering Substance WBC Unlysed RBCs In rare instances the erythrocytes in the blood sample may not completely lyse and are detected on the WBC histogram with an WBC flag or as an elevated baseline on the lymphocytes Non lysed RBCs will cause a falsely elevated WBC count Multiple myeloma The precipitation of proteins in multiple myeloma patients may cause falsely elevated WBC counts Leukemia A falsely low WBC count may result in this disease state due to th
332. ion Labels Pay close attention to the labels on the Analyzer Figure 1 5 For warning and caution labels on the Workstation PC refer to the manufacturer s manuals Waste detector sensor cable connector Waste output connector Diluent input connector e9o0o00eo 08 8 8 Workstation connector Figure 1 5 Warning and Caution Labels Analyzer 100 240 50 60 VOLTS nz ADEMA een iT a OOR PENNS AUTOMATED DIFFERENTIAL CELL COUNTER FOR IN VITRO DIAGNOSTIC USE m CAUTION jI TO REDUCE THE RISK OF ELECTRICAL SHOCK DO NOT REMOVE THE COVER CK REFER SERVICING TO QUALIFIED SERVICE PERSONNEL ELECTRIC SHOCK HAZARD DISCONNECT UNIT FROM POWER SOURCE PRIOR TO SERVICING FOR CONTINUED PROTECTION AGAINSTR FIRE HAZARD REPLACE ONLY WITH SAME TYPE AND RATING OF FUSE FOR SAFETY REASONS EQUIPMENT REQUI4RES CONNECTION TO PROTECTIVE EARTH GROUND ATTENTION POUR EVITER LES RISQUES DE CHOC ELECTRIQUE NE PAS OTERE LES CAPOTS APPELER UN REPARATEUR QUALIFIE RISQUE DE CHOC ELECTRIQUE DEBRANCHER LE CABLE D ALIMENTATION N c RISQUES D INCENDIE N UTILISER QUE DES FUSIBLES DE MEME TYPES ET DE MEME CALIBRES POUR DES RAISONS DE SECURITE LA MACHINE DOIT ETRE RELIEE A LA CAUTION ALL COVERS PANELS MUST BE SECURED IN PLACE PRIOR TO INSTRUMENT OPERATION REFER TO PRODUCT REFERENCE MANUAL FOR PROPER INSTALLATION 2429555 7616155D 1 4 PN 624026AE USE AND FUNCTION Ji DESCR
333. iration Date 05 17 2002 EE May 2002 a Type or scan the lot number from the reagent container Sun Mon Tue Wed Thu Fri irati 1 2 3 4 b Select the expiration date TEREF 13 14 15 16 E 18 W 7 20 21 22 23 24 25 1 at the Expiration Date 27 28 29 30 31 field gt Today 03 28 2001 2 J Le to advance a month 4 or ml return to a previous month 3 e the correct day 4 Remove the stopper assembly from the container 11 86 PN 624026AE DIAGNOSTICS REPLACEMENT PROCEDURES 5 Uncap a new diluent container 6 Put the cap from the new container onto the empty container 7 Properly dispose of the empty container GENTAN PN 624026AE 11 87 DIAGNOSTICS REPLACEMENT PROCEDURES IMPORTANT Risk of instrument error if the diluent container is further than 80cm 31 5 in below the instrument Be sure the diluent container is no more than 80cm 31 5 in below the instrument 8 Put the new container no more than 80 cm 31 5 in below the instrument Note If the system is installed at an altitude of 1 000 meters 3 280 feet or greater it is recommended that you place the Diluent 15 cm to 30 cm 6 in to 12 in off the floor 9 Insert the stopper assembly tube into the new container 10 Tighten the stopper assembly onto the container to ensure an adequate seal 11 88 PN 624026AE DIAGNOSTICS REPLACEMENT PROCEDURES IMPORT
334. ired screen Rinse Flow Cell This procedure rinses the Analyzers flow cell with Diluent reagent Do this procedure e to remove bubbles from the flow cell or e if there is excessive flagging on DIFF parameters A amp Nec 1 From the Main Menu screen 0 T PN 624026AE 11 41 DIAGNOSTICS DIAGNOSTICS USER SCREEN 2 0A OR 4 W Cleaning Cycles tab 11 42 PN 624026AE DIAGNOSTICS l DIAGNOSTICS USER SCREEN 5 K Rinse Flow Cell 6 Allow the Analyzer to complete the rinse flow cell function 7 6 3 as needed to return to the desired screen Others Diagnostic Functions This option allows you to e View the Cycles Counter e Park the Syringes e Traverse Service Position e Edit Accept Calibration Factors Supervisor or Service Use Only See Figure 11 8 Figure 11 8 Others Diagnostics Screen AcT Sdifl AL Dthers PN 624026AE 11 43 DIAGNOSTICS DIAGNOSTICS USER SCREEN View the Cycles Counter The instrument counts the number of cycles run after the software is installed for e CBC e CBC DIFFE e Startup e Shutdown e Auto Clean Do this procedure to view the number of cycles analyzed by the instrument Ge AcT Sdiff AL A ANE aces Courter AST Sdiff AL 1 From the Main Menu screen 0 2 UA 11 44 PN 624026AE DIAGNOSTICS l DIAGNOSTICS USER SCREEN 0E 4 View the cycle count information 5 E ee as needed to re
335. is entered Figure 8 4 Right Side of the Worklist Screens Collect Date Time Standard Range EE ae SS es C T m ES p 07 09 2002 14 54 23 7367605A 8 40 PN 624026AE PN 624026AE SAMPLE ANALYSIS UNDERSTANDING THE WORKLIST SCREENS Understanding the Worklist Grid Screen The Worklist Grid screen Figure 8 5 shows entered information in tabular or grid format on the left of the screen This screen is available when either Barcode or Cass Position is the defined Worklist Match Option positive ID The Worklist Grid screen is the primary screen used for entering Worklist order information when the Worklist Match Option is Barcode When operating with Worklist Match Option set to Barcode it is neither possible nor necessary to enter a cassette and position because the information is matched based on the sample s barcode The cassette and position information is obtained and provided with the results when the sample is analyzed Figure 8 5 Worklist Grid Screen fact Neral 1WORKLISTI X Az E Sample ID Cass Pos AUTO_SID1 AUTO_SID2 AUTO_SID3 AUTO_SID4 AUTO_SIDS AUTO_PID1 Standard Range _ _ Location displays the Worklist Cassette screen SS eS MA MM a yY B Version v0 12 Servicr displays the Worklist Grid screen 7367177A Allows you to select the sample to be
336. isten to the cadence to determine if a solenoid is defective 10 Check the Errors log see Viewing Logs in this chapter for any error messages 11 When the valve performance is acceptable close all doors and replace all panels covers PN 624026AE 11 21 DIAGNOSTICS USER SCREEN DIAGNOSTICS 11 22 12 Repeat step 9 as needed 13 0 d as needed to return to the desired screen Sensors Checking Do this procedure to check any of the following sensors Input Area Sensors Output Area Sensors Cass cassette Transfer Sensors Cover Sensors Waste Sensor A A Sec COULTER AS T Sdiff AL 1 Of From the Main Menu screen F PN 624026AE DIAGNOSTICS DIAGNOSTICS USER SCREEN 2 0A 4 E Sensors tab Ifa sensor indicator is red contact your local Beckman Coulter representative PN 624026AE 11 23 l DIAGNOSTICS DIAGNOSTICS USER SCREEN 5 E gt as needed to return to the desired screen Autoloader Test Do this procedure to test the Autoloader function to ensure that the system detects the tubes in the correct position and with the correct barcode if applicable LN ke A ir COULTER COULTER AST Sdiff AL OE 1 From the Main Menu screen oo 2 UA 11 24 PN 624026AE DIAGNOSTICS l DIAGNOSTICS USER SCREEN 4 E the Autoloader Test tab 5 Place tubes in the cassette If using barcoded tubes be sure the barcode labels are positione
337. ithin the acceptable ranges a Ensure proper mixing and control material integrity then rerun the control If results are still outside the acceptable ranges do step b b Analyze a new cell control vial If the results are still outside the acceptable ranges do step c c Clean the system see Extended Cleaning in Chapter 11 and rerun the control d Review the results e If the results are still outside the acceptable ranges contact a Beckman Coulter representative An out of range control result will appear with an H or L flag e If results are within the acceptable ranges you are ready to analyze patient samples See Chapter 8 SAMPLE ANALYSIS PN 624026AE 7 21 QUALITY ASSURANCE RUNNING CELL CONTROLS 4 The control file results automatically print if Auto Print is enabled If Auto Print is disabled OB b Select the print option OM For information about enabling Auto Print for control results see Auto Print Non Patient Results in Appendix A Us when finished Displaying QC Results Do this procedure to display the QC results in either the Levey Jennings Control Graphs screen or the QC Data Grid screen For details about the QC results screens see Understanding the QC Results Screens in this chapter AcT 5diff AL So l ae Ner e CF Doe A S OX 5 1 From the Main Menu screen E ia Note The following describes the 4 display of a
338. ithout Matching 1 If the Manual Match screen is not already open ra a U to open the results list OE 2 Highlight the desired result to be printed Of The following message appears Report selected results using AUTO_SID OY 4 To print the results without matching them to a Worklist order with the assigned AUTO_SID The results will be printed If you are uncertain about printing the unmatched results 0 gt This leaves the results on the Manual Match screen thus allowing you to match them later to a Worklist order PN 624026AE E 21 E WORKLIST SCENARIOS WORKLIST MATCH OPTION SCENARIOS E 29 PN 624026AE LIST OF ABBREVIATIONS pL microliter ACD acid citrate dextrose ANSI American National Standards Institute ASTM American Society for Testing and Materials BA basophil bps bits per second CBC complete blood count cm centimeter CV coefficient of variation DIFF differential dL deciliter EDTA ethylenediaminetetraacetic acid EO eosinophil fL femtoliter ft foot or feet g gram gal gallon GR granulocyte Het hematocrit Hgb hemoglobin Hz hertz L liter LCD liquid crystal display LED light emitting diode LIS laboratory information system LY lymphocyte m meter Misc miscellaneous MCH mean corpuscular hemoglobin MCHC mean corpuscular hemoglobin concentration MCV mean corpuscular volume mL
339. ition 5 57 Diagnostics 5 31 5 57 grayed out 5 45 5 46 5 53 knowing where you are 5 29 Logs 5 31 5 57 QA 5 31 5 57 Reagents 5 31 5 57 Run in Progress 5 30 5 57 Setup 5 30 5 57 Shutdown 5 31 5 57 software 5 57 Startup 5 30 5 57 identifying rerun results 5 2 8 33 IMM description 2 21 display print setup A 15 IMM flag 9 38 9 42 9 51 immature granulocytes See IMM IMPORTANT definition 4 1 installing the lifting handles 11 110 PN 624026AE PN 624026AE installing the system A 1 instrument component locations 11 76 dimensions 3 1 features 1 9 illustration 1 1 intended use 1 1 limitations 3 9 placement 3 2 purpose l 1 setup changes what to do after A 1 weight 3 1 instrument technology overview 2 1 interference on the Plt distribution curve 2 16 Interlaboratory Quality Assurance Program See IQAP interpretive messages definition 9 45 triggering conditions 9 45 IQAP definition 1 11 downloading to diskette 7 39 enrollment 1 11 entering your IQAP ID A 42 K keyboards changing for a specific language A 76 knowing when to calibrate 10 1 L L definition Abbreviations 1 L flag definition 9 36 laboratory limits description A 122 setup procedure A 122 lamp See flow cell lamp Large immature cell triggering condition 9 46 LCD definition Abbreviations 1 LED definition Abbreviations 1 Left Shift triggering condition 9 46 INDEX Leukoc
340. kage insert shipped with the control material can be a separate RESULTS assay sheet verification Procedure to analyze cell controls or whole blood with known values to determine if your results are within expected range whole blood Non diluted blood blood and anticoagulant only Workstation The personal computer and software used for data analysis and results storage XB X bar B A method of quality control based on the stability of the RBC indices in a patient population XM A group of quality control methods used on a patient population PN 624026AE PN 624026AE Symbols definition 9 48 BASO definition 9 50 WBC flag 9 43 replaces WBC BASO flag 9 51 definition 9 5 definition 9 5 definition 8 42 definition A 16 uL definition Abbreviations 1 A abbreviations list of Abbreviations 1 ACeT 5diff Cal Calibrator See calibrators ACeT 5diff Control Plus See cell controls ACeT 5diff Diluent See diluent reagent See reagents ACeT 5diff Fix See Fix reagent 1 12 See reagents ACeT 5diff Hgb Lyse See Hgb Lyse reagent See reagents ACeT 5diff Rinse See reagents See Rinse reagent ACeT 5diff WBC Lyse See reagents See WBC Lyse reagent A eV technology overview 2 3 access rights A 115 accuracy characteristics 3 8 definition Glossary 1 specifications 3 6 ACD definition Abbreviations 1 action range flags 9 36 INDEX a adding a flagging set A 122 adding a location A
341. l locations in the database Displays the date when the location information was modified Displays the name of the operator who modified the location information PN 624026AE SETUP A OPERATIONAL SETUP Adding Editing Physician and or Location Do this procedure to add or edit a physician or location amp A Ar 1 From the Main Menu screen J aE 2 Olea AcT 5diff AL Miscellaneous 3 0 the Location Physician tab PN 624026AE A 23 SETUP OPERATIONAL SETUP A 24 4 To adda physician or location up to 20 characters each n Oba b Type the physician or location in the proper field u The location or physician e g Dr Villanueva now appears in the list AcT 5diff AL For Research Use Only Not for use in diagnostic procedures RUO Miscellaneous General Location Physician Units Location Physician E Pr Villanueva gt Modified on Modified on 9 23 2002 13 59 42 os 26 2002 14 49 39 By vice ER IcU Peds B v y M vl ad b amp B gt BD A v X di Version V1 0 Service Ya 726r2002 148048 5 To edit a physician or location a Anchor the cursor in the desired field CE c Select the physician or location to be edited d Edit the information is s 6 e D as needed PN 624026AE SETUP A OPERATIONAL SETUP Deleting Physician and or Lo
342. lags and Stimulated ATL flag is triggered lymphocytes gt from the Patient Messages area Limits and the May be Plasma cells interpretive displayed and message Atypical printed as Lymphocyte are ATL and Absorbance triggered fromthe ATL Action Limits Default values 2 or 0 2x109 L IMM Occurs when a IMM is Large monocytes significantly large displayed and Hyperbasophilic population of cells printed in the monocytes is located in UN DiffPlot and UM and channel Histogram Myelocytes o 127 regions section of the D dee 3 IMM flag is lags and eae gt triggered from the Messages area Large blasts Patient Limits and May be Large neutrophils Debris the interpretive displayed and DB message Large printed as Absorbance Immature Cell is IMM and triggered from the IMM Action Limits Default values 2 or 0 2x109 L PN 624026AE PN 624026AE Histogram Flags FLAGS AND MESSAGES GENERATED BY THE INSTRUMENT DATA REVIEW When histogram populations exceed defined limits a flag or message will be displayed See Table 9 4 Table 9 4 Histogram Flags Histogram Flag Illustrations of Histogram Flags Description WBC BASO WBC Figure 9 14 WBC BASO Histogram Flags CBC Panel Determined from the ratio of the cells counted between the 0 channel and BAI Indicates the presence of an abnormal number of cells in comparison to leukocytes Plt aggreg
343. latelets Viewing Reagent Levels Do this procedure to view a reagent level so you can determine when replacement may be necessary A Aer CF 2 Yo hj 5 i iy 2 Ey m AT i 1 From the Main Menu screen fe ay If a reagent level indicates 0 you e must replace that reagent Do 3 e Do Replacing Reagents Fix WBC ee Lyse Hgb Lyse or Rinse Reagents or e Do Replacing the Diluent Reagent 11 84 PN 624026AE DIAGNOSTICS Ji REPLACEMENT PROCEDURES 2 View the Cycles Remaining see Figure 11 19 to determine how many CBC and CBC DIFF runs can be processed using the existing reagents e Ifthe Diluent reagent is too low do Replacing the Diluent Reagent in this chapter e Ifa reagent other than the Diluent is too low do Replacing Reagents Fix WBC Lyse Hgb Lyse or Rinse Reagents in this chapter 3 0 d to exit this screen Replacing the Diluent Reagent Do this procedure to replace the Diluent reagent To replace either Fix WBC Lyse Hgb Lyse or Rinse reagents do Replacing Reagents Fix WBC Lyse Hgb Lyse or Rinse Reagents EA AcT Sdiff AL A s Nex s SBN COULTER AST 5diff AL 1 From the Main Menu screen 0 Ty PN 624026AE 11 85 DIAGNOSTICS REPLACEMENT PROCEDURES 2 Double click the level indicator for Diluent F l l _ 3 At the Reagent screen enter the reagent information eel Exp
344. lected bath is drained it will be rinsed with Diluent reagent ee LN A 1 From the Main Menu screen 0 UA OM 11 28 PN 624026AE DIAGNOSTICS Ji DIAGNOSTICS USER SCREEN 4 p Drain Baths tab Rinse Bath RBC PLT HGB WBC BASO ales f la 6 5 C the desired bath to drain 6 Allow the Analyzer to complete the drain function 7 Repeat step 5 as needed Ho 8 as needed to return to the desired screen PN 624026AE 11 29 DIAGNOSTICS DIAGNOSTICS USER SCREEN 11 30 Prime Reagents The function primes reagents into the instrument Do this procedure only after service has been performed on the instrument ATTENTION This function does not reset the reagent cycle Do not do this procedure when replacing reagents the system automatically primes each reagent after it has been replaced Do this procedure to prime any of the reagents e Diluent reagent e Rinse reagent e Fix reagent e WBC Lyse reagent e HGB Lyse reagent e All Reagents amp LN ANex 1 From the Main Menu screen C dal OA PN 624026AE DIAGNOSTICS l DIAGNOSTICS USER SCREEN 4 E Prime Reagents tab 5 C the desired reagent prime option 6 Allow the Analyzer to complete the prime function Repeat step 5 as needed 7 0 as needed to return to the desired screen PN 624026AE 11 31 DIAGNOSTICS DIAG
345. let histogram and count Small particles such as micro bubbles can interfere at the low end If the number of pulses in the 2 to 3 fL region is higher than the predefined limits an SCL flag appears to alert the operator that a significant number of small cells or interference such as micro bubbles are present Interference that blends in with the lower area of the platelet distribution curve so there is no clear distinction between ten platelets and the interference suggests the presence of very small cells debris bubbles or electronic noise The SCL small cell flag appears indicating the present of particles in the 2 fL and 3 fL regions Microcytic Interferences on the Upper End of the Platelet Distribution Curve Microcytic red blood cells can intrude at the upper end of the platelet distribution curve If the sample contains microcytes the instrument may be able to successfully eliminate the influence of this interference by repositioning the variable threshold and excluding the microcytes Parameter Results Obtained Using the Plt Histogram e Plt Count The instrument uses duplicate counting criteria voting criteria and proprietary flagging information to confirm the parameter result prior to reporting it To obtain a Plt platelet count result the instrument compares the data from the two 5 second count periods then votes and rejects any questionable data 9 16 PN 624026AE PN 624026AE OPERATION PRINCIPLES PARAMETER DEVELOPMEN
346. limits A 37 setting up a cell control file A 46 setting up a flagging set A 120 setting up shifts A 30 setting up the patient report layout A 90 setting up users A 114 Setup icon 5 30 5 57 Setup Menu screen A 2 shifts setting up A 30 Shift 0 definition A 30 Shutdown cycle definition Glossary 2 frequency 11 1 procedure 6 5 Shutdown automatic defining A 112 Shutdown icon 5 31 5 57 shutting down Windows frequency 11 2 shutting down Windows NT 11 66 SI 1 See reporting units SI 2 See reporting units SI 3 See reporting units SI 4 See reporting units SL flag 9 38 9 39 SL1 flag 9 38 9 39 Small cell triggering condition 9 47 software access 5 28 check boxes 5 49 fields 5 49 icons 5 57 knowing where you are 5 29 menu path 5 30 options selecting deselecting 5 55 overview 5 28 scrollable lists 5 50 toolbars 5 45 software buttons 5 47 software cursor See cursor software fields See fields software icons list of 5 57 software screens PN 624026AE PN 624026AE overview 5 28 software tabs 5 47 sorting sample results 9 5 specifications See performance specifications specimen limitations 3 9 specimen collection requirements 8 1 specimen mixing requirements 8 1 starting a New Workday 5 11 Startup failure 11 123 frequency 6 2 11 1 if Failed 6 2 overview 6 1 viewing results and status 5 1 Startup automatic defining A 110 startup cycle definition Glossary 2
347. list Match Option is Cass Position When operating with the Worklist Match Option set to Cass Position you must enter a cassette and position to indicate the location of the sample tube to match with the demographics Figure 8 6 Worklist Cassette Screen y Car ee pe pen __ ce oe Dp SG 2 per O O 3 mT O El Z Rerun O Patient ID Olle Last Name o O First Name a8 2 2 Date of Birth Age O79 jj Oo oO Gender Unknown v amp E gt A Y X d Version v0 13 Service 10771172002 15 26 47 7367201A Test panels Information for the tubes currently entered in the Worklist for the cassette number shown in Cassette number field where you type the _ Patient sample information for the tube where cassette number is pointing Cassette number indicator that reflects Pointer that indicates the tube for which what is typed in information appears in Position number in the cassette of the Selected test panel indicator that shows which test tube where is pointing has been selected oe with For a better understanding of cassette and position numbers see Figure 8 7 PN 624026AE 8 43 SAMPLE ANALYSIS UNDERSTANDING THE WORKLIST SCREENS Figure 8 7 Worklist Cassette Screen Cass Position Details AcT 5diff AL WORKLIST Eo A O w oN o lo olo m olo olo o lo olo ta o lo fe o
348. ls Bands Lymphocytes Monocyte Eosinophils Basophils Comments Run Date Time Flagging Set Physician Range 40 110 4 00 6 20 110 188 35 0 550 8 100 26 0 34 0 31 0 350 10 0 20 0 Test Lab Phone 305 380 3800 Building 2 Fax 305 380 3800 11 30 2902 17 430 Se ward Ranca Collect Date Time Pane Operator CSODIF Rerun Service Sata of Sirih Flags and Messages DiffPlot and Histogram Flags MICRO MACRO Analyzer Messages DIFF BASO Interpretive Messages WBC Interpretation Not Possible Anemia Anisocytosis Microcyte Macrocyte Microcytosis Macroplatelets 103 pL 103 pL 103 pL 103 pL 103 uL 103 pL 103 pL i 50100 200 Metamyelocyte Myelocytes Promyelocytes Blast Atyp Lymph NRBCs 300 WBC BASO Too 200 300 400 Microscopic Examination Anisocytosis Hypochromia Polychromasia Poikilocytosis Microcytosis Macrocytosis Retics Sed Rate Requested by wect RBC1 HCT1 PLT1 HGBB 5408 16060 705886 11082 3283 Raw Data Out of Action Range Printed on WBec2 RBC2 HCT2 PLT2 HGBM 5419 16003 705901 11089 2414 MO NE EO DB E Out of Patient Range Reviewed by 157 SL o 93 aml 7 207 uM 5 25 LN 18 20 c127 2 XXX FNL FMN FNE UN IMM RAW DATA REPORT FOR INVESTIGATIONAL USE ONLY For Research Use Only Not for use in diagnostic procedures RUO 08 01 2002 15 28 03 Operator Service PN 624026AE
349. ly and a glossary of definitions Accessing Online Help From the system software u amp to access the online Help system If you cannot access the online Help system contact your Beckman Coulter Representative Once the online Help is opened E for instructions on using Help PN 624026AE 5 27 GETTING STARTED SOFTWARE SCREENS 5 10 SOFTWARE SCREENS The Workstation software is based on Windows NT Although familiarity with Windows conventions and use would be beneficial it is not required Login Names and Passwords When you log on to the system you are required to select a Login Name If you are logging on as a Supervisor or Service you must enter a password If logging on as an Operator a password is not required Access Levels and Rights Access to software functions is determined by user group access rights There are three levels of user groups e Service password required e Supervisor password required default is 123 e Operators no password required unless one was entered with the Operator ID When the software is first installed the system is set up with default users for the 3 groups e The Operator group user is Opr1 e The Supervisor group user is Supervisor e The Service group user is Service At initial logon you are required to select one of the default user groups Logging in as the Supervisor user allows access to the Setup area of the software and access to the ability to
350. lyzer PN 624026AE 5 17 5 GETTING STARTED WORKING WITH THE CASSETTES Inserting Tubes into a Cassette If the Worklist Match Option is Barcode it is important that you load the cassettes correctly so the Analyzer can read the barcode labels IMPORTANT Risk of sample mis identification if a tube is skipped The Autoloader will process all tubes in a cassette If the bar code label is missing or cannot be read an AUTO_SID will be assigned Ensure that all sample tubes in a cassette have a legible bar code label attached See Heading 5 6 WORKING WITH BAR CODE LABELS WARNING Risk of injury biohazardous condition if the sample tube breaks Use extreme care not to break a sample tube when loading unloading it into or removing it from a cassette CAUTION Risk of instrument damage too if the wrong tube is used in the cassette Verify the tube is correct for the cassette being processed LN 1 Load the sample tubes into the cassette a 5 18 Ensure that the tubes are clean and dry Position the tube with the bar code label clearly visible through the opening Insert the tube bottom first into the cassette Push the top of the tube into the holder until the tube snaps into place PN 624026AE GETTING STARTED 5 WORKING WITH THE CASSETTES 2 Ensure that the bottom of the tube is resting on the bottom inside of the cassette 3 Insert the n
351. m two people following appropriate 21 5 in safety precautions and using the lifting handles should lift the instrument together 55 0 kg For details on using the lifting handles see Heading 11 13 INSTALLING THE LIFTING HANDLES INTO THE ANALYZER 57 73 cm 22 5 in 81 45 cm 32 3 in For the dimensions and weight of the Workstation refer to the PC printer and monitor documentation from the respective manufacturers Power Supply e From 100 Vac to 240 Vac excluding the printer which is voltage specific e g 100 to 120 Vac or 220 to 240 Vac e From 50 Hz to 60 Hz Consumption Maximum of 800 VA for the Analyzer Workstation and printer Installation Category The instrument is designed to be safe for transient voltages according to Installation Category II and Pollution Degree 2 Grounding Requirements AN NN ZL To protect against electrical shock the wall ground earth plug must be correctly connected to the laboratory grounding electricity installation PN 624026AE 3 1 SPECIFICATIONS CHARACTERISTICS INSTRUMENT SPECIFICATIONS Ambient Temperature and Humidity Operate the system in a room with an ambient temperature between 16 and 34 C 61 F to 93 F and humidity no higher than 85 without condensation Note If the instrument is kept at a temperature of less than 10 C 50 F allow the instrument to remain idle for one hour at the correct room temperature before use
352. me Properties x Date amp Time Time Zone m Date Te Octobe 2002 Peres ra f a 12 3 456789910 s 5 1112 13 14 16 17 a 18 19 20 21 22 23 24 ie ag 25 26 27 28 29 30 31 1 05 20Pm Current time zone Eastern Standard Time Cancel Apply to save the change PN 624026AE SETUP A SYSTEM SETUP e Changing the Date Time Format Do this procedure to change the format for how the system time is displayed The available formats and how each displays time are shown below hh mm ss ampm 05 30 12 am or pm h mm ss ampm 5 30 12 am or pm H mmi ss 5 30 12 HH mm ss 05 30 12 Do this procedure to change the format for how the system date is displayed The available formats and how each displays the date are shown below MM dd yyyy 04 11 2002 dd MM yyyy 11 04 2002 yyyy MM dd 2002 04 11 1 To change the time format Current Date Time Format a 0 E at the Time format field b W the desired format The system updates the format in the Current time field 2 To change the date format a C E at the Date format field b 0 the desired format The system updates the format in the Current date field 3 W y to save the change PN 624026AE A 73 SETUP SYSTEM SETUP Language Selecting Note Currently English is the only available language The other languages are scheduled for future release Do this procedure to select the langua
353. ment door b Remove the pickup tube assemblies 4 Place all reagent pickup tube assemblies in the chlorine solution PN 624026AE 11 69 DIAGNOSTICS CLEANING THE ANALYZER 5 Prime All Reagents as instructed in Prime Reagents in this chapter Chlorine solution will now be pulled into the instrument through the reagent pickup tubes 6 When priming is complete remove the reagent pickup tube assemblies from the chlorine solution and wrap the tubes in absorbent paper 7 Prime all reagents as instructed in Prime Reagents in this chapter The chlorine solution will now be drained from the system 8 Place the container with the distilled water in front of the reagent compartment 9 Place all pickup tube assemblies into the distilled water container H 0 10 Prime all reagents as instructed in Prime Reagents in this chapter The distilled water will be pulled in to rinse the system 11 70 PN 624026AE DIAGNOSTICS Ji CLEANING THE ANALYZER 11 Runa blank cycle 12 Remove all pickup tubes from the container 13 Repeat step 10 14 Reconnect the reagent pickup tube assemblies to their respective containers 15 Be sure each pickup tube cap is properly tightened 16 Place the reagent containers in their respective locations PN 624026AE 11 71 DIAGNOSTICS CLEANING THE ANALYZER 17 Prime all reagents as instructed in Prime Reagents in this chapter
354. mission to IQAP See Heading 7 4 DOWNLOADING CELL CONTROL RESULTS FOR IQAP for details For additional information on IQAP including how to enroll contact your Beckman Coulter representative XB Analysis in the Analyzer Studies indicate that the red cell indices MCV MCH and MCHC of patient populations are stable over time This stability characteristic of the indices is the basis of a quality control technique called XB Analysis In a mutually implemented system population means target values are established by analyzing as large a sample population as possible at least 250 but ideally 1 000 blood samples The XB analysis feature of this instrument does all the calculations automatically Once the target values have been established the XB Analysis can be applied using small batches i e 20 patient samples per batch from the patient population The instrument is considered in control when the batch means are within established limits of the target values XB Analysis detects the direction and amount of change due to instrument reagent or sample handling See Heading 7 6 XB ANALYSIS for additional information The system also offers XM analysis which extends the statistical process of XB from 3 parameters MCV MCH and MCHC to 9 parameters WBC RBC Hgb Hct MCV MCH MCHC RDW and Plt PN 624026AE 1 11 USE AND FUNCTION REAGENTS 1 8 REAGENTS Recommended Reagents Beckman Coulter recommends these reag
355. mple ID Differs From the Sample ID on the Barcode Label Summary Results are placed on the Manual Match screen due to the Sample ID conflict 1 Insert tube into cassette 2 Place cassette in Cassette Input Tray E 3 E WORKLIST SCENARIOS WORKLIST MATCH OPTION SCENARIOS E 4 C a LLL Sample is analyzed Results are placed on Manual Match screen due to the Sample ID conflict Options a Add a Worklist order with the correct Sample ID and manually match to the result The report will automatically print with the Worklist Sample ID from the order Manual Match will appear in the Miscellaneous Messages section of the Flags and Messages area of the printout e Ifyou print from the Run in Progress screen after matching Manual Match will appear on the report even though the Run in Progress screen shows Unmatched e Ifyou print from the Run in Progress screen before matching Unmatched will appear on the report Print results from the Manual Match screen without matching Manual Match will appear in the Miscellaneous Messages section of the Flags and Messages area of the report See Printing from the Manual Match Screen Without Matching in this appendix Scenario 6 Barcode On Manual Match On Auto Print On No Worklist Order Summary An AUTO_SID is assigned results are placed on the Manual Match screen with the AUTO_SID 1 2 Dao amp Insert tube into cassette Place cassette in Casset
356. mple analysis and or the host download to complete before batch printing and or batch transmitting Transmission Procedure Do this procedure to transmit send patient results to the Host computer A amp Nec 1 0 The Results List screen appears AcT 5diff AL Result T Analytical I Action Limit B DittPtowttistogram I Not Printed T Patient Limit I Not Transmitted Inc Sample ID Cass Pos Patient ID Last Name First Name Gender Date of Birth Age Panel Run Date AF DH PL AL P T A iias Unknow cecjoo7 iojacM COM Mo T 44568 Unknow c c D07 10 20 C WM wR O 1 s06502 Unknow o MM BO m lauto scg 1 Unknow c D07 102c 0 CRM CO Ei s11s20039 2 Unknow cegoo7 igj2c CR OO E C 31192909 9 4 Unknow cegoo7 igjac e O ao no a MM auto_sc9 5 Unknow o RR OO Ie mauto sco 6 Unknow o MM e C auto sco 7 Unknow cegoo7jojaco MR O iiim I 311929039 1 Unknow c c o07 10 2c 0 MM MO rrr s119200P9 3 Unknow cecbovjigjacl oO oR OP m auto sco 4 Unknow c c 007 10 20 0 MM RO m jauTo_sico 5 Unknow o e Roo j311929099 6 Unknow c c 007 10 2c C O O O eo m jauTo_sico 7 Unknow cecoo7 iojac MM OO F 31192903 9 1 Unknow c D07 10 2c 0 e Mw o s119200P 9 3 Unknow o MM OO la F auto st9 4 Unknow cagoo7jigec MR oo C Pi jauto seo 5 Unknow o RM OO fp 311929099 6 Unknow cecoo7fiojacl MO Oo auTo_sicg Z Unknow c c D07 10 20 0 WM Ee e i jauTo sico 1 Unknow
357. n 11 79 location 11 79 Diluter Systems screen 11 27 dilution ratios 3 3 summary overview 2 13 displaying cell control results 7 22 displaying printing detailed flags A 95 displaying printing suspect flags A 95 dL definition Abbreviations 1 doing a Hardware Reset 11 13 doing an Autoloader Test 11 24 downloading calibrator values from disk 10 9 downloading control values from disk A 52 downloading IQAP data 5 3 7 39 draining the baths 11 27 E editing a flagging set A 122 editing a location A 22 editing a physician A 22 editing a Worklist order 8 49 editing calibration factors 11 49 editing control target values A 56 editing CV limits A 44 editing text 5 54 PN 624026AE PN 624026AE editing users A 115 EDTA definition Abbreviations 1 enabling Auto Print for non patient results A 99 enabling Auto Transmit for patient results A 67 enabling RUO parameters A 15 entering a patient ID 8 38 entering a patient s age 8 39 entering a patient s date of birth 8 39 entering a patient s gender 8 39 entering a patient s location 8 37 entering a patient s name 8 38 entering a physician s name 8 37 entering a report header A 79 entering a Sample ID 8 35 entering a sample s collection date time 8 36 entering calibrator information manually 10 10 entering patient demographics 8 36 entering patient information 8 34 entering patient sample comments 8 37 entering sample informati
358. n Worklist Order Cassette Position and Sample ID Barcode Label Scenario 4 Cass Position On Manual Match Off Auto Print On Worklist Order Cassette Position and Sample ID Barcode Label Scenario 5 Cass Position On Manual Match On Auto Print On Worklist Order Cassette and Position only Barcode Label Scenario 6 Cass Position On Manual Match On Auto Print On Worklist Order Cassette Position and Sample ID No Barcode Label Scenario 7 Cass Position On Manual Match Off Auto Print On Worklist Order Cassette Position and Sample ID No Barcode Label Scenario 8 Cass Position On Manual Match On Auto Print On Worklist Order Cassette Position and Sample ID Barcode Label Scenario 9 Cass Position On Manual Match On Auto Print On No Worklist Order No Barcode Label Scenario 10 Cass Position On Manual Match Off Auto Print On No Worklist Order No Barcode Label E 5 E WORKLIST SCENARIOS WORKLIST MATCH OPTION SCENARIOS E 6 Scenario 11 Cass Position On Manual Match On Auto Print On No Worklist Order Barcode Label Scenario 12 Cass Position On Manual Match Off Auto Print On No Worklist Order No Barcode Label Scenario 13 Cass Position On Manual Match On Auto Print On Worklist Order Sample ID only Barcode Label Scenario 14 Cass Position On Manual Match Off Auto Print On Worklist Order Sample ID only Barcode Label Scenario 15 Cass Position
359. n Coulter suggests that you do not use calibration material past its expiration date e To cancel the download u Set up a current not expired calibrator as instructed in Heading 10 3 CALIBRATOR SETUP Ow e Allow the download to be completed When the LED on the Workstation PC is no longer illuminated remove the disk e To download the expired calibrator information The Expiration Date field displays the date downloaded from the floppy f Do Heading 10 4 AUTO CALIBRATION g Verify the values have been downloaded and are correct PN 624026AE 10 9 CALIBRATION CALIBRATOR SETUP 8 To manually enter the calibrator information and values Enter the lot number of the calibrator a b Press Teb c Enter the expiration date from the calibrator s label d C E at the Expiration Date field e Select the date from the calendar Note If the calibrator is expired Invalid Date appears ATTENTION Beckman Coulter suggests that you do not use calibration material past its expiration date 1 C 4 to acknowledge the message 2 Do Heading 10 3 CALIBRATOR SETUP to set up a current not expired calibrator Enter the target values and limits from the calibrator s assay sheet Anchor the cursor in the desired field pga rm Type the corresponding number from the assay sheet Press to move the cursor the next field Repeat steps h and i until all target values and limits are entered jats
360. n X Copyright c 2002 Beckman Coulter Inc All Rights Reserved T Archive Unmatched Results and Delete Worklist I Reset Auto Numbering Archive Results Database Maintenance 5 GETTING STARTED NEW WORKDAY 5 12 Unmatched Results on Manual Match Screen If there are unmatched results in the Manual Match screen at the beginning of the New Workday other options appear at the Login screen See Figure 5 4 Figure 5 4 New Workday Options If Unmatched Results Exist on Manual Match Screen AcT 5diff AL Login Name Supervisor he Password This computer program is protected by international copyright laws and unauthorized copying use distribution transfer or sale is a violation of those laws that may result in civil or criminal penalties xl AcT Sdiff AL Workstation Version x x Copyright c 2002 Beckman Coulter Inc All Rights Reserved T Archive Unmatched Results and Delete Worklist I Reset Auto Numbering Archive Results Database Maintenance New Workday Options e Erase Worklist erases the Worklist e Reset Autonumbering resets the Auto Numbering to the starting number defined in Auto Numbering Setting the AUTO_SID Starting Number in Appendix A Archive Results archives any results on the results list Archived results are accessible when aS is selected Archive Unmatched Results and Delete Worklist places all unmatched results from the Manual Match screen into the archive a
361. n one of three ways e Running Cell Controls Autoloader Mode With Barcode ID e Running Cell Controls Autoloader Mode Without Barcode ID e Running Cell Controls Manual Stat Mode Note If A flashes at any time during cell control analysis click the icon to open the Alarms and Errors Log Running Cell Controls Autoloader Mode With Barcode ID Do this procedure to run a QC sample cell control material in the Autoloader Mode with the QC sample ID being scanned by the barcode reader If the control lot number has been reserved the Workstation identifies the sample as a control and places the results in the appropriate control file based on information entered in the Sample ID field ATTENTION If there is a situation when the system cannot find a Worklist order for the sample it is processing e g the barcode was not read and Barcode was the Worklist Match option the control lot number is reserved or the Worklist entry is missing or incorrect for Cass Position EEE the sample results will be placed on the Manual Match screen flashes to signify results are on the Manual Match screen For information on manually matching the results see Manual Match Procedure in Chapter 9 1 Are you running a new set of controls e If yes be sure the new controls have been set up as instructed in Heading A 6 SETTING UP A CONTROL FILE e Ifno go to step 2 PN 624026AE PN 624026AE QUALITY ASSURANCE RUNNING CELL CONTROLS
362. n operations when a power up login occurs on a New Workday ATTENTION For the system to check for a New Workday you must quit LF the system software If the system determines that the conditions for a New Workday have been met a number of options are presented on the login window See New Workday Routine in this chapter If it is determined that the conditions for a New Workday have not been met the normal login window is displayed New Workday Routine If the system determines a New Workday specific conditions occur when Startup begins When a New Workday occurs certain options appear on the Login screen The options are determined by whether there are unmatched results on the Manual Match screen e See No Unmatched Results on Manual Match Screen in this chapter e See Unmatched Results on Manual Match Screen in this chapter No Unmatched Results on Manual Match Screen If there are no unmatched results in the Manual Match screen at the beginning of the New Workday certain options appear at the Login screen See Figure 5 3 Figure 5 3 New Workday Options If No Unmatched Results Exist in Manual Match Screen AcT 5diff AL Login Name Supervisor Password _ This computer program is protected by international copyright laws and unauthorized copying use distribution transfer or sale is a violation of those laws that may result in civil or criminal penalties xl AcT Sdiff AL Workstation Versio
363. n prompted by the instrument Hardware Reset e performs a general rinse draining and initialization of mechanical assemblies and e resets instrument components such as motors and valves to a normal or home position Ge AcT Sdiff AL LN amp Aer e COULTER COULTER AST Sdiff AL a 1 From the Main Menu screen 0 W A fAcT Saif AL Diagnostics fl PN 624026AE 11 13 DIAGNOSTICS DIAGNOSTICS USER SCREEN 4 E Hardware Reset tab s Oan The instrument resets components to a home position Motors Checking Overview Motors are used in the Analyzer to e move the traverse assembly e activate all syringes e activate the piercing mechanism e move the cassettes forward in the cassette input tray 11 14 PN 624026AE PN 624026AE e index the cassettes to the sampling station and e activate the tube mixing arm To verify a motor s function you will have to e activate the motor and DIAGNOSTICS DIAGNOSTICS USER SCREEN e check the Errors log for error messages generated by the motor s activity For information on motor functions and locations see Table 11 4 Table 11 4 Analyzer Motors Function and Location Motor Component Action Component Location Cassette input The cassette input mechanism moves the cassette Rear of the cassette input mechanism pushers a short distance forward from the rear of tray the cassette input
364. n the wrong position Do Hardware Reset Input left sensor error Input left sensor error Do Hardware Reset Input mechanism motor not Input mechanism not 1 Do Hardware Reset reaching home reaching home 2 Check the motor as instructed in Motors Checking Input motor failure Input motor failed 1 Do Hardware Reset 2 Check the motor as instructed in Motors Checking Input right sensor error Input right sensor error Do Hardware Reset Instrument stopped by user User immediately stopped the instrument Do Hardware Reset Instrument stopped by user at the end of cassette User selected to stop the instrument when the cassette in progress finished Do Hardware Reset Instrument stopped by user at the end of cycle User selected to stop the instrument when the cycle in progress finished Do Hardware Reset Insufficient Disk Space Insufficient disk space to backup data to the selected drive 1 Select a drive D with sufficient space to back up the data 2 If necessary delete the old database backup then retry Internal barcode error Internal barcode reader failed Do Hardware Reset 11 117 i DIAGNOSTICS SYSTEM ERRORS 11 118 Table 11 5 Error Messages Continued Message Probable Cause Suggested Action Internal synchronization failed Internal synchronization failed Do Auto Clean Running Invalid dat
365. n you perform any maintenance operation document the maintenance information in the log as instructed in Adding Entries to the Maintenance Log 5 years Patient Worklist Log e when a patient file is modified manually or by the Host when there is a mismatch of a sample s cassette position and order and the information appears on the Manual Match screen e when you match an order and a result on the Manual Match screen 1 year Setup Log when a setting is modified 1 year Host Log Alarms and Errors Log when a file from the Host is rejected e g when an order is pending a re run or when the cassette on which the tube is found is in progress of analysis when A flashes 1 year 1 year PN 624026AE 11 127 l DIAGNOSTICS LOGS Table 11 8 Log Details Log Entries Made into the Log s Storage Capacityt Startup Log when a Startup is run 1 year gt the entry line is green if Startup passed gt the entry line is red if Startup failed or Startup is out of limits tPrior entries to the logs are deleted based on first in first out as the capacity is exceeded Viewing Logs Do this procedure to view a log AT 6 Y 2 f COULTER COULTER AST Sdiff AL 1 From the Main Menu screen W i 2 W the icon for the log you want to view See Table 11 7 for icon details A PN 624026AE 11 128 DIAGNOSTICS Ji LOGS 3 When the log opens
366. nalyzed 6 U to see the Run in Progress screen which shows Sample ID as AUTO_SID and C P O E sien tases o na 7 which flashes to indicate results are on the Manual Match screen 8 C for the Manual Match screen 9 Results are placed on the Manual Match screen Order shows Worklist Sample ID 123456789 Cass Pos PN 624026AE WORKLIST SCENARIOS WORKLIST MATCH OPTION SCENARIOS Results shows Sample ID AUTO_SID with barcode ID C P 10 1 10 Two options are available a Manually match the order to the results Prior to matching you may want to edit the Worklist order as required To manually match 3 Highlighted the order 4 Highlighted the result 0m 6 The report automatically prints The Sample ID Manual Match appeared in the Miscellaneous Messages section of the Flags and Messages area of the printout e Ifyou print from the Run in Progress screen after matching Manual Match will appear on the report even though the Run in Progress screen shows Unmatched e Ifyou print from the Run in Progress screen before matching Unmatched will appear on the report b Print the results from the Manual Match screen without matching Manual Match will appear in the Miscellaneous Messages section of the Flags and Messages area of the report See Printing from the Manual Match Screen Without Matching in this appendix Printing from the Manual Match Screen W
367. nalyzing the Calibrator in the Autoloader Mode Recommended 10 12 Analyzing the Calibrator in the Manual Stat Mode 10 13 Auto Calibrating the Instrument 10 15 Selecting the Results to be Used for Auto Calibration 10 15 Printing Calibration Results 10 17 HOW CALIBRATION SAMPLES ARE INCLUDED EXCLUDED 10 17 PN 624026AE PN 624026AE 11 DIAGNOSTICS 11 1 11 1 GENERAL MAINTENANCE 11 1 11 2 MAINTENANCE SCHEDULE 11 1 11 3 REMOVING PANELS COVERS 11 2 Removing the Left Panel 11 3 Removing the Right Panel 11 4 Replacing the Right Panel 11 4 Removing the Top Cover 11 5 11 4 WASTE HANDLING PROCEDURES 11 6 Neutralizing the Waste and Treating for Biohazards 11 6 Handling Expired Reagents 11 7 11 5 DIAGNOSTICS MENU SCREEN 11 8 Understanding the Diagnostics Menu Screen 11 8 Mini Clean Running 11 9 Auto Clean Running 11 10 11 6 DIAGNOSTICS USER SCREEN 11 11 Understanding the User Screen 11 11 Hardware Systems 11 12 Hardware Reset 11 13 Motors Checking 11 14 Overview 11 14 Procedure for Checking Motors 11 16 Valves Checking 11 18 Overview 11 18 Valve Locations 11 19 Procedure for Checking Valves 11 19 Sensors Checking 11 22 Autoloader Test 11 24 Diluter Systems 11 27 Drain Baths 11 27 Prime Reagents 11 30 Unprime 11 32 Cleaning Cycles 11 34 Extended Cleaning 11 34 Backflush 11 39 Rinse Flow Cell 11 41 Others Diagnostic Functions 11 43 View the Cycles Counter 11 44 Park the Syr
368. nce Setup Options See Figure 5 19 Figure 5 19 Quality Assurance Setup Screen Options AcT 5diff AL Quality Assurance AcT 5diff AL Quality Assurance Shits aa 7367448A 5 33 GETTING STARTED MENU PATH Auto Functions Setup Options See Figure 5 21 Figure 5 20 Auto Functions Setup Screen Options 5diff AL Auto Functions AcT 5diff AL Auto Fui 7367447A 5 34 PN 624026AE GETTING STARTED 5 MENU PATH System Setup Screen Options See Figure 5 21 Figure 5 21 System Setup Screen Options AcT 5diff AL System AcT 5diff A AcT 5diff AL System PN 624026AE 5 35 GETTING STARTED MENU PATH Save Restore Configuration Options See Figure 5 22 Figure 5 22 Save Restore Configuration Screen Options AcT 5diff AL Save and Restore Settings AcT 5Sdiff AL Save and R June 2002 Sun Mon Tue Wed Thu 26 27 28 29 30 4 6 11 12 13 18 19 20 25 Gm 27 1 2 3 4 Co tToday 06 26 2002 wn Q o oaBNR hoe 7367445A PN 624026AE 5 36 PN 624026AE Operators Setup Options See Figure 5 23 Figure 5 23 Operators Setup Screen Options AcT 5diff AL Operators E Advanced Operators Opri Supervisors be Supervisor GETTING STARTED 5 MENU PATH 7367443A 5 37 GETTING STARTED MENU PATH Flagging Sets Setup Options See Figure 5 24 Figure 5 24 Flagging Sets Setup Screen Options AcT 5diff AL Flagging Sets 5 3
369. nd an absolute LYMPHOCYTOSIS LY gt LY HH occur only the LYMPHOCYTOSIS message will be displayed The following sections define e WBC Interpretive Messages e RBC Interpretive Messages e Plt Interpretive Messages and e Combination WBC RBC Plt Interpretive Messages WBC Interpretive Messages See Table 9 5 Table 9 5 WBC Interpretive Messages Printed Message Triggering Condition LEUKOCYTOSIS WBC gt WBC HH LEUKOPENIA WBC lt WBC LL LYMPHOCYTOSIS LY gt LY HH or LY gt LY HH LYMPHOPENIA LY lt LY LL or LY lt LY LL NEUTROPHILIA NE gt NE HH or NE gt NE HH NEUTROPENIA NE lt NE LL or NE lt NE LL EOSINOPHILIA EO gt EO HH or E0 gt E0 HH PN 624026AE 9 45 DATA REVIEW FLAGS AND MESSAGES GENERATED BY THE INSTRUMENT Table 9 5 WBC Interpretive Messages Continued Printed Message Triggering Condition MONOCYTOSIS MO gt MO HH or MO gt M0 HH BASOPHILIA BA gt BA HH or BA gt BA HH LARGE IMMATURE IMM gt IMM HH or IMM gt IMM HH CELLS ATYPICAL ATL gt ATL HH or ATL gt ATL HH LYMPHOCYTE MYELEMIA NE gt NE HH and IMM gt IMM HH BLASTS BA gt BA HH and IMM gt IMM HH and UM LEFT SHIFT MN or NL and UN WBC One or more analytical alarms occurred for WBC INTERPRETATION NOT POSSIBLE HH above the action range LL below the action range RBC Interpretive Messages See Tabl
370. nd deletes the current Worklist Unmatched will appear in the Miscellaneous Messages section of the Flags and Messages area of the report for the unmatched results e Database Maintenance deletes patient records that do not have corresponding results compacts the database stores the last 1 000 raw results and backs up the database What Happens if No New Workday Options are Selected Regardless of the selections you make the system automatically e Deletes as many old records as necessary until the database totals 9 500 This happens only if the database exceeded 10 000 records at Startup e Checks all reagent volumes to ensure there is enough reagent to process the day s work e Saves a backup of the database in a different directory PN 624026AE GETTING STARTED 5 LOGGING ON IF SYSTEM IS ALREADY POWERED UP 5 5 LOGGING ON IF SYSTEM IS ALREADY POWERED UP If someone else is already logged onto the system and you need to log on the existing user must be logged off before you can log on under your Login Name Do this procedure to log on if someone else is already logged on 1 From the Main Menu screen 0 t The existing user will be logged off and the Login screen appears PN 624026AE 5 13 GETTING STARTED LOGGING ON IF SYSTEM IS ALREADY POWERED UP AcT Sdiff AL 3 Log in a Select your Login Name name p Us 2 Highlight your choice i Eni Ths is protected b Type your password only require
371. ng condition 9 45 New Workday conditions for starting A 107 defining A 107 definition 5 11 options on Login screen 5 11 5 12 routine 5 11 NL flag 9 38 9 39 nm definition Abbreviations 2 NRBCs amp PLATELET AGGREGATES PN 624026AE PN 624026AE triggering condition 9 47 Nucleated RBC triggering condition 9 47 number of orders on Worklist 5 45 number of results in Results list 5 46 0 opening the Manual Match screen 9 19 opening the tube holder door if jammed 11 108 operating range definition Glossary 1 Operator users their access A 115 optical bench function 11 80 illustrated 11 80 location 11 80 order definition 2 23 Others Diagnostics screen 11 43 P Pancytopenia triggering condition 9 47 panel default test for sample analysis A 6 definition Glossary 2 parameter results from Plt histogram 2 16 from RBC histogram 2 15 parameters definition Glossary 2 how they are determined 2 14 parameters analyzed CBC 1 8 CBC DIF 1 9 parking the syringes 11 46 particles how they are detected 2 1 Passed Startup results 5 7 password for Supervisor 5 28 password requirements 5 1 A 115 Patient Demographics Modified definition 9 51 patient range flags 9 36 patient report setup software overview A 92 INDEX PC See Workstation Pct plateletcrit calculation overview 2 17 PDW calculation overview 2 17 performance characteristics accuracy 3 8 carryover 3 9 de
372. ng results 9 15 marking samples for automatic re run A 60 material safety data sheet See MSDS MB flag 9 43 definition 9 43 MCH calculation overview 2 15 interfering substances 3 11 MCHC calculation overview 2 15 interfering substances 3 11 MCV calculation overview 2 15 interfering substances 3 11 mean definition Glossary 1 menu path icon 5 29 MIC flag 9 44 MICRO flag 9 43 Microcytes triggering condition 9 46 9 47 Microcytic RBCs interference on Plt distribution curve 2 16 Microcytosis triggering condition 9 46 Mini Clean frequency 11 9 procedure 11 9 minimum specimen volume 5 2 Misc definition Abbreviations 1 mixing the specimen 8 1 mL definition Abbreviations 1 mm definition Abbreviations 1 MN flag 9 38 9 40 MO description 2 20 interfering substances 3 12 mode definition Glossary 1 monocyte See MO Monocytosis triggering condition 9 46 motors function 11 15 location 11 15 purpose 11 14 mouse moving the cursor 5 52 using to edit text 5 54 MPV interfering substances 3 12 measurement overview 2 17 MSDS definition Abbreviations 1 ordering 1 14 mW definition Abbreviations 2 Myelemia triggering condition 9 46 n definition Abbreviations 2 NCCLS definition Abbreviations 2 NE description 2 20 interfering substances 3 12 NE flag 9 38 9 41 neutralizing waste 11 6 Neutropenia triggering condition 9 45 neutrophil See NE Neutrophilia triggeri
373. ng the past 24 hours e Ifnot perform an Extended Cleaning e Ifso go to step 3 3 Do Heading 6 3 STARTUP PN 624026AE 10 5 CALIBRATION CALIBRATOR SETUP 10 3 CALIBRATOR SETUP Supplies Needed A eT 5diff Cal Calibrator Access Level Supervisor or Service Do this procedure to prepare the instrument before you run calibration samples amp S A 2 Nex 1 From the Main Menu screen 0 Q 06 10 6 PN 624026AE CALIBRATION l CALIBRATOR SETUP M 3 E at the Calibration screen 4 The Calibration Setup screen appears pera t PN 624026AE 10 7 CALIBRATION CALIBRATOR SETUP gt OE Note If calibration results exist the following message appears AcT 5diff AL OY to delete the existing calibration results 6 Enter the calibration information target values and limits e To download the information do step 7 e To manually enter the information do step 8 10 8 PN 624026AE CALIBRATION Ji CALIBRATOR SETUP 7 To download the calibrator information and values from a floppy disk a C E The following message appears AcT 5diff AL Insert floppy disk into drive A x b Insert the correct floppy disk drive A of the Workstation UM d Ifthe expiration date on the floppy is expired the following message appears to download the values AcT 5diff AL Calibrator expired Continue ATTENTION Beckma
374. nkled and does not lie flat against the tube P o 6868 00 Incorrect The label extends beyond the diameter of the tube O Orr PN 624026AE 5 15 GETTING STARTED WORKING WITH BAR CODE LABELS Scanning Barcode Labels with the Optional Barcode Wand If your system is equipped with the barcode wand you scan the barcode label to enter information into the system 1 Anchor the cursor in the field where you want to enter information 2 Locate the barcoded label IMPORTANT Risk of sample mis identification if the entire barcode is not captured with the barcode reader especially with the Interleaved 2 of 5 barcode format Position the barcode reader such that you capture the entire barcoded Sample ID Otherwise part of the Sample ID may be not scanned resulting in mis identification Verify the Sample ID was captured correctly 3 Position the barcode reader over the barcode label and squeeze the trigger button If the barcode label was successfully read the barcode reader beeps the LED e illuminates on the reader and the i cursor advances to the next field 4 Verify that the information was scanned correctly and placed in the correct field 5 16 PN 624026AE GETTING STARTED WORKING WITH THE CASSETTES 5 7 WORKING WITH THE CASSETTES WARNING Risk of injury biohazardous conditions if a cassette is not properly handled Do not use a cassette for storing or transporting tubes or vials
375. nt ID on the Worklist not in the database will be deleted when you delete the order Do this procedure if you want to delete an order from the Worklist f AcT Sdiff AL WORKLIST YY e Sampei Pos Paier a a Collect Date Time SS CBC DIFF jing Set standard Range 7 ove WE ii Se b F s 2 Open the desired screen to open the Worklist Grid screen Do To Delete a Worklist Order from the Worklist Grid Screen E to open the Worklist Cassette screen Do To Delete a Worklist Order from the Worklist Cassette Screen PN 624026AE 8 51 8 SAMPLE ANALYSIS WORKING WITH WORKLIST ORDERS e To Delete a Worklist Order from the Worklist Grid Screen This procedure continues from Deleting a Worklist Order Entry 1 Highlight the order to be deleted C 2 The following message appears AN Delete order for Sample ID AUTO_SID6 Delete all orders from the Worklist 3 Select the desired option Delete the order with Sample ID will delete the entire order from the Worklist for that Sample ID Delete all orders will delete every order on the Workilist 4 b Y to delete 8 52 PN 624026AE SAMPLE ANALYSIS 8 WORKING WITH WORKLIST ORDERS e To Delete a Worklist Order from the Worklist Cassette Screen This procedure continues from Deleting a Worklist Order Entry Cass Number 1 Type the cassette number at 2
376. nt determines a control run has an analytical error then the control run will be rejected A rejected analysis will be stored and a notification will be sent to the QC log with an automatic comment of Analytical Error Samples with analytical errors are deselected by default For each hematology parameter the mean values target values standard deviation SD and coefficient of variation CV will be calculated from the set of selected analyses The results will be validated and the data saved for up to 24 control lots There is no limit on the number of analyses saved per control file The grid and graphic data of the last control valid or rejected will be saved When the QC result is displayed in the Run in Progress screen the calculations will be made according to the rules that apply to the QC You cannot select to rerun a QC QC Techniques Your laboratory can use these QC techniques with the A eT 5diff AL instrument e Daily instrument checks e Commercial controls e Patient controls e XB Analysis PN 624026AE QUALITY ASSURANCE RUNNING CELL CONTROLS Controls Processing If a result that has non numerical parameter results is manually selected for inclusion in the statistics the values that have been replaced by the non numeric flag will be included in the statistical calculations even though the parameter is shown as a non numerical flag on the table It is recommended that results in the table that have one or m
377. nt pa Transmit displayed report Cc u to print or transmit 19 Remove the sample tubes from the cassette See Removing Tubes from a Cassette in Chapter 5 20 Verify the Sample ID and results before reporting the results PN 624026AE 8 17 RUNNING WORKLIST SAMPLES IN AUTOLOADER MODE SAMPLE ANALYSIS 8 18 No Worklist Barcode Positive ID Manual Match OFF Do this procedure to analyze samples with barcoded Sample IDs with no Worklist demographic functions and Manual Match off LN Nex IMPORTANT Risk of sample mis identification if you do not verify the Sample ID displayed at the Workstation with the Sample ID on the tube prior to analysis 1 Load the barcoded sample tubes into the cassette 2 Verify the correct Sample ID for each tube WARNING Risk of injury biohazardous conditions if a cassette is not properly handled Do not use a cassette for storing or transporting tubes or vials To ensure tubes vials remain secured in the cassettes always keep cassettes upright and use them only for analysis as described in this manual 3 Place the cassette in the Cassette Input Tray of the Analyzer Be sure the cassette is properly positioned with the front of the cassette facing the reagent compartment See Loading Cassettes onto the Analyzer in Chapter 5 A analysis 4 p PREP to begin analysis While analysis is in progress the red LED flashes on the front of th
378. ntil Q appears The instrument recalculates the batch statistics based on the number of selected analyses b View the number of selected analyses to confirm you deleted the correct number of results If you try to exclude more than 5 the following message appears AcT 5diff AL For the last batch no more than 5 results may be unselected 7 To print the results list for the batch being reviewed J E The following message appears AcT 5diff AL Print XB XM results x u to print the XB XM Results List report Ai 8 u when you are finished PN 624026AE 7 57 QUALITY ASSURANCE XB ANALYSIS 7 58 PN 624026AE SAMPLE ANALYSIS 8 IMPORTANT Risk of inaccurate results if the Analyzer is not properly prepared Follow the prompts if any on the screen to perform either a Startup or Mini Clean to prepare the Analyzer It is not necessary to do both A amp Nec If the system has remained idle for a certain period of time the system will prompt you to do a Startup or a Mini Clean 8 1 PREPARE THE SYSTEM FOR PROCESSING 8 2 COLLECT AND MIX THE SPECIMEN A amp Nec IMPORTANT Risk of erroneous results if the specimen collection tube is not filled to the quantity required by the tube manufacturer Fill the specimen collection tube as required 1 Using K EDTA as the anticoagulant collect the required amount of venous specimen according to the tube manufacturer s requirements K EDTA
379. nual Match Off Auto Print On Worklist Order Cassette Position and Sample ID No Barcode Label Summary Results print with the Sample ID and cassette position from the Worklist order because Manual Match is off 1 5 6 Create a Worklist order Of o b c Type 2 as cassette number then press Enter d Select the ist tube position e Type 123457 as the Sample ID OM a 02 Insert tube into position 1 of cassette 2 Place cassette in Cassette Input Tray it oe Sample is analyzed Report prints with the Sample ID from the Worklist as Manual Match was OFF Scenario 8 Cass Position On Manual Match On Auto Print On Worklist Order Cassette Position and Sample ID Barcode Label Summary Results are placed on the Manual Match screen because there was a Sample ID conflict between what was read off the barcode label and what was entered in the Worklist order 1 Create a Worklist order a Oe OF PN 624026AE WORKLIST SCENARIOS E WORKLIST MATCH OPTION SCENARIOS d Type 06 as cassette number then press Enter e Select the ist tube position f Type 123 as the Sample ID even though the barcode label was 123456 Or g l p h u d 2 Insert tube into the ist position of cassette 6 3 Place cassette in Cassette Input Tray ah 4 Phib 5 Sample is analyzed 0 gt gt gt to see the Run in Progress screen which shows Sample ID 123456 C P 6 1 Ee 7
380. number of CBC and CBC DIFF analyses that you expect your laboratory to run each day The system uses the daily workload settings to perform a reagent capacity check at the end of Startup The purpose is to determine if there is enough of each reagent to last throughout a workday Table A 4 shows the default values Table A 4 Daily Workload Runs per Panel Panel Default Minimum Maximum CBC 10 1 500 CBC DIFF 40 1 500 If the system determines that there is insufficient reagent to complete the day s work Reagent s Low Insufficient Reagents To Complete Daily Workload appears You can either determine which reagent is low and change it or you can continue working until the specific Reagent Low message appears then change the reagent Do this procedure to change the daily workload settings JAcT 5diff AL F3 YU Yo A W T T 1 From the Main Menu screen a ty a EE Pi le a 2 gt amp v x I 0971872002 093219 PN 624026AE A 105 SETUP SYSTEM SETUP CO W the Cycle Options tab Of A 106 Type the desired Daily Workload for CBC DIFF and or CBC a Double click the number you want to change b Type the new number Note You can type any whole number from 1 to 5000 If typing thousands do not insert a comma if you do the number will not be accepted PN 624026AE PN 624026AE SETUP SYSTEM SETUP
381. o autonumber the IDs or scan the tube s barcode label with the optional hand held barcode reader Database Storage The system can store up to 10 000 files Flagging Sets The system can accommodate 20 flagging sets e 8 are predefined e 12 can be added see Heading A 10 FLAGGING SETS SETUP Output The instrument can transmit sample data to a Host computer The Sample Results screen shows the sample identification information sample results and any result flags PN 624026AE 3 3 SPECIFICATIONS CHARACTERISTICS INSTRUMENT SPECIFICATIONS Measurements and Computation Impedance is used to determine WBC Plt RBC and BA e Photometry using cvanmethemoglobin method with 550nm diode light source is used to determine Hgb Impedance and light absorbance are used to determine NE LY MO EO ATL and IMM e Data that was directly measured is used to compute Hct MCV MCH MCHC RDW MPV Pct and PDW Counting Aperture Diameters WBC BASO 80 pm DIFF 60 um RBC Plt 50 pm Reagent Consumption Table 3 1 shows the instrument s reagent consumption by cycle Table 3 1 Reagent Consumption by Cycle Reagents WBC Cycles Diluent Lyse Rinse Fix Hgb Lyse Duration CBC 276mL 2 1 mL 1 4mL NA 0 45 mL_ 45 seconds CBC DIFF 276mL 2 0mL 1 4mL 1 0mL 0 45mL 45 seconds Prime Diluent 47 6mL NA NA NA NA 3 minutes Prime Rinse 1 7 mL NA 24 7 mL NA NA 1 minute 24 seconds
382. o caseties with same ID 0 in Two cassettes with the Verify each cassette s ID transfer mechanism same ID are in the cassette transfer mechanism Unable to launch LIS Communication not made Do Hardware Reset communication module with Host Unable to launch print module Printer module could not be launched Do Hardware Reset Upper piercing sensor incorrect position Upper piercing sensor is in the wrong position Do Hardware Reset 11 121 i DIAGNOSTICS TROUBLESHOOTING GUIDES Table 11 5 Error Messages Continued Message Probable Cause Suggested Action Valve already activated The specified valve is Do Hardware Reset already activated Waste full Waste container is full Do Replacing the Waste Container Restart WBC Interpretation Not Possible Multiple analytical alarms e g Voteout occurred Re run the sample If the problem persists contact your local Beckman Coulter representative 11 15 TROUBLESHOOTING GUIDES Troubleshoot instrument problems by using Table 11 6 Table 11 6 Troubleshooting Guide Problem Area Situation Probable Cause Suggested Action Power Power will not Power cord loose or not Ensure that the power cords are turn on securely connected properly connected Workstation turned off Turn the Workstation on No voltage or wrong Ensure the voltage is on and that voltage at laboratory the outlet is the correct Vac power outlet
383. o define the times for the multiple shifts Allows you to choose a shift option A 30 PN 624026AE SETUP A QUALITY ASSURANCE SETUP Selecting Shifts Do this procedure to define your laboratory s shifts to be either a 24 hour shift or multiple shifts amp LN ANE 1 From the Main Menu screen C aE PN 624026AE A 31 SETUP QUALITY ASSURANCE SETUP AcT 5diff AL Quality Assurance 3 E the Shifts tab OF 5 At the Shift Selection field select the desired option Note If you select 24 Hour Shift the system defaults are applied which means no additional shift settings are required A 32 PN 624026AE SETUP A QUALITY ASSURANCE SETUP 6 For Multiple Shifts option type the If you enter an incorrect time the following From for each shift message appears The To is automatically completed when the From times are entered The system automatically prevents the Overlap or gap in Shifts Shifts will be automatically adjusted times from overlapping AcT 5diff AL OY e The system automatically adjusts the time 7 C to save the change Ue as needed PN 624026AE A 33 SETUP QUALITY ASSURANCE SETUP OA Settings Defining Under the QA settings tab Figure A 6 you can define edit these settings e XB XM Options Enabling Disabling e Minimum Runs Required for Auto Calibration Defining IQAP ID Entering Editing e CV Limits for
384. o the WBC BASO bath Press OK to continue 13 Dispense 3mL of the 1 to 2 chlorine solution into the WBC Baso bath Figure 11 7 Bath Assembly Rinse bath First Dilution Hgb bath DIFF bath RBC bath WBC BASO bath closest to the rear of the instrument 14 Replace the bath shield PN 624026AE DIAGNOSTICS Ji DIAGNOSTICS USER SCREEN 15 Replace the right side panel a Slide the panel into place b Tighten the screws with the door key w UW OR Press Enter to initiate the cycle 17 Allow the Analyzer to complete the cleaning procedure Note It takes about 5 minutes for the cycle to complete The system will automatically flush to remove the chlorine solution that you dispensed in step 10 0a 18 as needed to return to the desired screen Backflush The backflush feature pushes pressure through the rear of the apertures to remove blockages Do this procedure if you suspect blocked apertures 5 MENIN mmn A Ar R z oY js id ss b 1 From the Main Menu screen py zi bs Po 3 2 gt Bb 7 vyv x f 0871372002 093213 11 39 PN 624026AE DIAGNOSTICS DIAGNOSTICS USER SCREEN 2 0A OR 4 W Cleaning Cycles tab 11 40 PN 624026AE DIAGNOSTICS l DIAGNOSTICS USER SCREEN 5 E Backflush 6 Allow the Analyzer to complete the backflush function 7 6 3 as needed to return to the des
385. oblem persists contact your local Beckman Coulter representative COM error on slave 0 Communication error Do Hardware Reset Communication with mechanical part lost Communication between software and hardware was lost Do Hardware Reset Counting syringe mechanism not reaching home Counting syringe mechanism not reaching home Do Auto Clean Running 2 Check the motor as instructed in Motors Checking Counting syringe motor failure Counting syringe motor failed 1 Do Auto Clean Running Check the motor as instructed in Motors Checking Da Database restore in progress Attempt was made to restore the database while the system is busy Make sure Analyzer is idle before attempting to restore the database Diff Syringes Mechanism Not Reaching Home Diff syringes mechanism not reaching home 1 Do Auto Clean Running 2 Check the motor as instructed in Motors Checking Diff Syringes Motor Failure Diff syringes motor failed 1 Do Auto Clean Running Check the motor as instructed in Motors Checking DIFF transfer sensor timeout DIFF transfer sensor timed out Do Auto Clean Running Diluter syringes mechanism not reaching home Diluter syringe mechanism not reaching home 1 Do Auto Clean Running 2 Check the motor as instructed in Motors Checking Diluter syringes motor failure Diluter syringe mo
386. of Sodium 500mL Sodium Hypochlorite 1L 7650043A 2 Dispose of expired reagents according Hydroxide solution 500g L 50mL to your laboratory s guidelines c 500mL of Sodium Hypochlorite PN 624026AE 11 7 solution 30 available chlorine Sodium Hydroxide DIAGNOSTICS DIAGNOSTICS MENU SCREEN 11 5 DIAGNOSTICS MENU SCREEN Understanding the Diagnostics Menu Screen See Figure 11 3 and Table 11 2 Figure 11 3 Diagnostics Menu Screen AcT 5diff AL Diagnostics Table 11 2 Diagnostics Menu Screen Icons Icon Name Function Mini Clean Launches the Mini Clean function See Mini Clean Running in this coy chapter Auto Clean Launches the Auto Clean function See Auto Clean Running in this chapter User Opens the User menu See Heading 11 6 DIAGNOSTICS USER SCREEN aq Service Opens the Service menu Only accessible by Service personnel 11 8 PN 624026AE DIAGNOSTICS l DIAGNOSTICS MENU SCREEN Mini Clean Running Do this procedure e Ifthe system has been idle between 2 and 4 hours e Ifthe Analyzer has been turned off then on again A Nex Seow COULTER Courter AST Sdiff AL 1 From the Main Menu screen 0 T 2 g to begin the cycle 3 Allow the cycle to be completed 4 Cycle a sample with known results to verify instrument performance PN 624026AE 11 9 DIAGNOSTICS DIAGNOSTICS MENU SCREEN 5 E gt as needed to
387. of instrument damage if this procedure is done prematurely Do this procedure only when the system fails to automatically open the tube holder door If the system shuts off before the tube holder door opens do this procedure to manually open the door A a Ber 0 If the tube holder door fails to open go to step 3 2 Do Hardware Reset in this chapter If the tube holder door fails to open go to step 3 3 Power down the System as instructed in Powering Down the System and Logging Off in Chapter 5 4 Unplug the Analyzer from its power source wall outlet 11 108 PN 624026AE DIAGNOSTICS Ji OPENING THE TUBE HOLDER DOOR IF JAMMED 5 Pull the right front door open 6 Insert the key into the hole on the right of the instrument near the tube holder door until the door releases Note If the door fails to open or if it becomes jammed again contact a Beckman Coulter representative 7 Close the right front door PN 624026AE 11 109 DIAGNOSTICS INSTALLING THE LIFTING HANDLES INTO THE ANALYZER 8 Plug the Analyzer into its power source 9 Power up the system as instructed in Powering Up the System and Logging On in Chapter 5 10 Do Hardware Reset in this chapter If the tube holder door fails to open contact a Beckman Coulter representative 11 If the tube holder door opens verify system performance and resume normal operation 11 13 INSTALLING THE LIFTING HANDLES I
388. ole blood sample that will be used to make dilutions Figure 2 6 shows the sample partitioning that occurs in the CBC panel Notice there are only two aliquots of the aspirated whole blood sample that will be used to make dilutions in this panel of operation The DIFF aliquot is not needed in the CBC panel To ensure sample integrity the sample aliquot at the tip of the probe is never used to make a dilution it is discarded into the Rinse bath 2 5 2 OPERATION PRINCIPLES SAMPLE ANALYSIS OVERVIEW Figure 2 5 Sample Partitions Inside the Probe Figure 2 6 Sample Partitions Inside the Probe CBC DIFF Panel CBC Panel Diluent Air bubble Diluent Not used Air bubble DIFF dilution Not used WBC BASO dilution WBC BASO dilution RBC PLT HGB first dilution RBC PLT HGB first dilution Not used Not used 7616001A 7616056A Dilution Using the Sequential Dilution System SDS technique the instrument makes a series of dilutions in a series of baths Figure 2 7 Figure 2 7 Bath Assembly Rinse bath First Dilution Hgb bath DIFF bath RBC bath WBC BASO bath 2 6 PN 624026AE OPERATION PRINCIPLES SAMPLE ANALYSIS OVERVIEW CBC Panel After aspiration in the CBC panel aliquots of the whole blood sample are distributed as follows Figure 2 6 e The 3 pL sample aliquot at the tip of the probe is discarded into the Rinse bath as the exterior of the sampling probe is rinsed ensuring
389. oll right to see additional information The selected order is indicated by highlight PN 624026AE DATA REVIEW e MANUALLY MATCHING SAMPLE RESULTS WITH WORKLIST ORDERS Manual Match Procedure Do this procedure to match a Worklist order to an instrument generated result LN 2 Nec Obs The Results List screen with all matched results appears AcT Sdiff AL Result cBcjD 07 10 20 0 cpcyo07 10 2 CBC D07 10 20 CBC D07 10 2C CC D07 10 2C C cpcyo07 10 2 F cagoo7 1ojac A A cBC D07 10 cecfoo7 1ojac OM e r cacjoo7 1o 2c 7 2 0A The Match screen appears PN 624026AE 9 15 DATA REVIEW MANUALLY MATCHING SAMPLE RESULTS WITH WORKLIST ORDERS 3 Highlight the required order e g 311929OP from the Worklist area of the Match screen The information from the selected order on the Worklist is displayed on the right of the screen in fields with a gray background Sample ID Panel Flagging Sets Collect Date Time Location Physician Patient ID Last Name First Name Date of Birth Age and Gender Note If the appropriate order does not appear see What to Do If the Correct Order is Not on the Manual Match Screen in this chapter for your options 4 Highlight the desired result to be matched with the order previously selected The information from the selected result that will be used in the final report is displayed on the right of the screen in fields
390. om the Worklist Yes You can run stat samples even if you are already running samples from the Worklist See Heading 8 4 RUNNING MANUAL STAT SAMPLES When are results placed on the Manual Match screen Results are placed on the Manual Match screen for a number of reasons The main reasons are e The Manual Match option is ON and there is no order on the Worklist that matches the Sample ID of the sample analyzed The positive identifier Worklist Match option is set to Barcode and the system is unable to read a barcode on the sample analyzed The results will automatically be placed on the Manual Match screen even if Manual Match is OFF For additional information see Heading 9 3 MANUALLY MATCHING SAMPLE RESULTS WITH WORKLIST ORDERS Does the Manual Match option have to be ON for results to be placed on the Manual Match screen No See the above response For additional information on Manual Match see Manual Match Turning ON or Off in Appendix A Can review the WBC RBC and PLT histograms on the screen Yes You can also enlarge the view by clicking on the image How do search the database for sample results You can search the database by run date or by Patient ID See Heading 9 1 LOCATING SAMPLE RESULTS Does the system have patient flagging ranges Yes They are called flagging sets There are 8 ranges based on age and gender and 12 user definable ranges See Heading A 10 FLAG
391. on 16 After all runs are done a Remove the tube when the tube holder door opens OM 11 58 PN 624026AE PN 624026AE DIAGNOSTICS REPRODUCIBILITY CHECK 17 E the check box next to the runs to be included in the calculation included O excluded AcT 5diff AL Reproducibility 054 ar 0 48 575 164 500 sse 165 508 18 Review the data Compare the results to the CV limits E e e r p po poe Results that exceed the limits appear io e a e a e against a red background e ea es f me or a ae m e oe ST wees BE OT T E 05 on 01 as 0 04 04 19 Repeat as needed Contact a Beckman Coulter representative if results continue to exceed limits l DIAGNOSTICS REPRODUCIBILITY CHECK 20 To complete the Reproducibility check and exit the Reproducibility Data Grid screen 0a Running a Reproducibility Check in the Autoloader Mode Do this procedure to run a Reproducibility check in the Autoloader Mode e as required by your state or regulatory agencies or q yy g y ag e for troubleshooting purposes For information on running in the Manual Stat Mode see Running a Reproducibility Check in the Manual Stat Mode in this chapter Supplies Needed e 3 Vacutainer tubes of fresh normal whole blood samples as defined by your lab that can be aspirated a maximum of
392. on included O excluded i 13 Review the data es Number of aaprettns fi CBCIDIFF 4 eae EX Compare the results to the CV limits ET a e ee i i iE FF Lourde 11 05 2002 14 24 12 165 579 165 502 a 2 5 328 JZ Lourde 11 05 2002 14 24 57 163 586 165 508 87 28 2 325 A i4 Z Merin 11 05 2002 14 27 01 161 561 164 503 7 28 3 32 7 Results that exceed the limits appear eae s yf see ef mi mane 159 577 164 50 1 87 284 327 fi b 14348 16 580 165 502 8 TI 229 j Ste tet eae against a red background mn SSS 2 SS oe ae 574 165 47 7 ar a 11 05 2002 14 34 49 l 161 576 164 501 87 B5 328 mnt 1170572002143534 s7 sm 164 ss a7 se soi Selected Results N F a Mean 22 250 Nh Mnimum Maximum Range Fesoni famy T 17052002 143614 14 Repeat as needed Contact a Beckman Coulter representative if results continue to exceed limits 15 To complete the Reproducibility check and exit the Reproducibility Data Grid screen 0a 11 64 PN 624026AE DIAGNOSTICS REPRODUCIBILITY CHECK Printing Transmitting Reproducibility Results This procedure continues from either of the running Reproducibility procedures From the Reproducibility Data Grid screen u D 2 To print the results a Select the Print tab b Select the desired print option e Print selected results e Print all results e Print statistics only COM d Keep a copy of th
393. on 8 34 entering your IQAP ID A 42 entering your lab s IQAP ID A 42 environmental protection requirements 3 4 EO description 2 20 interfering substances 3 13 eosinophil See EO Eosinophilia triggering condition 9 45 Erase Worklist option 5 12 error messages definition 11 112 list of 11 112 Erythrocytosis triggering condition 9 46 expiration date definition Glossary 1 extended cleaning frequency 11 1 procedure 11 34 F Failed Startup results 5 7 femtoliter definition Glossary 1 field INDEX definition Glossary 1 fields selecting deselecting 5 55 Fix reagent description 1 13 flag sensitivity A 130 flagged sample results 9 34 flagging sets how they are selected 8 36 list of pre defined 5 58 overview 5 58 setting up A 120 flags 9 48 WBC 9 43 action range 9 36 alternative reporting formats 9 51 appearing in the Flags and Messages area 9 37 ATL 9 38 9 42 9 51 BASO 9 50 CO 9 49 DB 9 49 9 51 definition Glossary 1 detailed flags format 9 51 Detailed displaying printing A 96 DIFF 9 48 DIFF 9 48 DIFFPLOT 9 51 DiffPlot 9 38 DiffPlot and Histogram flags 9 34 for controls 9 36 H 9 36 HH 9 36 HISTO 9 51 IMM 9 38 9 42 9 51 L 9 36 LL 9 36 LN 9 38 9 40 MACRO 9 43 Manual Match 9 17 MB 9 43 MIC 9 44 MICRO 9 43 MN 9 38 9 40 NE 9 38 9 41 NL 9 38 9 39 non replacement flags 9 34 patient range 9 36 R on diff parameters 9 38 Index 5
394. option c An entry is made into the QA log PN 624026AE A 59 SETUP AUTO FUNCTIONS SETUP A 7 AUTO FUNCTIONS SETUP Three tabs are available for this option Rerun Auto Print and Auto Transmit For additional information see e Rerun Marking a Sample for Automatic Re run e Auto Print for Patient Results e Auto Transmit for Patient Results Rerun Marking a Sample for Automatic Re run Under the Rerun tab Figure A 7 you can define edit the requirements that mark a sample for automatic rerun You can define the rerun criteria by flag s and or by parameters You can also apply the rerun criteria to specific or all flagging sets Figure A 7 Rerun Setup Screen Details eT Sdiff AL Auto Functions Wo Auto Transmit ee By Flag s By Parameter s Flagging Sets Standard Rande F Apply to all Flagging Sets F WBC r su Voteozt x a wee r C a r T a RBC r E a C L NE HGB E x x I q CMN HCT r r a P L IN MCY r C UM MCH r X C J UN MCHC r a im j T DB RDW r 5 r E me PLT a C C C MICRO MPV r r r r M MACRO NE L E r r m se LY m a E E M MIC MO r E E I I SCH FO x C x C I DIFF BA C r r DIFF NEW B 5 r r I DIFF Reject yt r r r Moe r A r r EOOH 5 r r r BAH B E m a z amp 2 4 v X D I Supervisor j 1170972002 08 42 28 7367106A Allows you to select the flag s which if generated causes the sample to be automatically re run by t
395. or a particular purpose No Liability for Consequential Damages In no event shall Beckman Coulter or its suppliers be liable for any damages whatsoever including without limitation damages for loss of profits business interruption loss of information or other pecuniary loss arising out of the use of or inability to use the Beckman Coulter Product software Because some states do not allow the exclusion or limitation of liability for consequential damages the above limitation might not apply to you General This agreement constitutes the entire agreement between you and Beckman Coulter and supersedes any prior agreement concerning this Product software It shall not be modified except by written agreement dated subsequent to the date of this agreement signed by an authorized Beckman Coulter representative Beckman Coulter is not bound by any provision of any purchase order receipt acceptance confirmation correspondence or otherwise unless Beckman Coulter specifically agrees to the provision in writing This agreement is governed by the laws of the State of California c B COULTER TRADEMARKS co Beckman Coulter the stylized logo and COULTER are trademarks of Beckman Coulter Inc and are registered with the USPTO All other trademarks service marks products or services are trademarks or registered trademarks of their respective holders Find us on the World Wide Web at www beckmancoulter com Made in USA PN 624026A
396. ore non numeric flags not be selected for inclusion in the statistics When an IQAP file is created the system will only include results from the file that are selected in the control file table If a result with non numeric flags is selected an IQAP file created the value that generated the flag will be included in the file created and analyzed as part of the IQAP report It is recommended that results in the table that have one or more non numeric values not be selected How QC Runs are Analyzed Once the QC run is completed the instrument completes the necessary calculations and compares the results to the corresponding target values entered when you set up a control file in Heading A 6 SETTING UP A CONTROL FILE The instrument then determines if the result is within the expected range If the value is outside the target range the result will be flagged H or L and highlighted against a red background If the control is out of range the QC alarm is triggered Until a QC analysis of the same lot is run and is within limits all analyses performed when the QC alarm is activated will have QC limit flags on the printed transmitted results to indicate the sample was run when the QC alarm was activated QC Screens 7 3 PN 624026AE See Understanding the QC Results Screens in this chapter RUNNING CELL CONTROLS Run cell controls before analyzing patient samples to confirm that the system is operating within acceptable limits
397. ort and transmitted to the Host computer if available Note You cannot modify demographics received from a Host computer For Worklist setup information see Heading E 1 USING WORKLISTS For details on various Worklist scenarios see Appendix Heading E 2 WORKLIST MATCH OPTION SCENARIOS PN 624026AE 2 23 OPERATION PRINCIPLES CASSETTE TRANSFER CYCLE 2 9 CASSETTE TRANSFER CYCLE For a better understanding of what happens when a sample is analyzed in the Autoloader mode read the following explanation Note For ease of understanding this explanation details the process for only one sample tube in the cassette the process is slightly different for 2 or more tubes 10 11 12 13 14 15 16 17 18 19 2 24 When FFP is selected the cassette transfer cycle begins The input mechanism pushes the cassette onto the transfer rail The cassette input stop switches are activated signaling that a cassette is present and ready to be processed The transfer mechanism pulls the cassette into the instrument The cassette passes the tube position sensor The cassette stops in a specific position where the left grabber of the mixer mechanism picks up the tube The mixer rotates the tube while the cassette is advanced to allow the cassette barcode to be read After the cassette barcode is read the cassette returns to the position where the left grabber will place the tube back into the original cassette position
398. ort automatically prints Manual Match appeared in the Miscellaneous Messages section of the Flags and Messages area of the printout The Sample ID on the report is 123456789 Cass is and Pos is 10 e Ifyou print from the Run in Progress screen after matching Manual Match will appear on the report even though the Run in Progress screen shows Unmatched e Ifyou print from the Run in Progress screen before matching Unmatched will appear on the report b Print results from the Manual Match screen without matching Manual Match will appear in the Miscellaneous Messages section of the Flags and Messages area of the report See Printing from the Manual Match Screen Without Matching in this appendix Scenario 14 Cass Position On Manual Match Off Auto Print On Worklist Order Sample ID only Barcode Label Summary Results printed with an AUTO_SID and cassette position of the tube when analyzed because Manual Match is off The Worklist order with the Sample ID was not linked to the cassette position 1 Create a Worklist order and entered only the Sample ID 123456789 d Type the Sample ID as 123456789 Cl 2 Insert tube into the 1st position of cassette 10 3 Place cassette in Cassette Input Tray at 4 PPPI 5 Sample is analyzed 6 gt gt gt to see the Run in Progress screen which shows Sample ID as AUTO_SID and C P 10 1 7 Report prints with AUTO_SID and
399. ove the neutrophil population and are typically counted as IMM cells IMM cells are included in the reported neutrophil value See Figure 2 18 Band Cells Band cells are typically larger or of similar size to the neutrophils however due to their low level of cellular complexity they absorb less light As a result band cells tend to appear in the region between the neutrophils and the monocytes Blast Cells Blast cells are generally larger than monocytes and have similar absorbance When blast cells are present they are generally located above the monocytes which means they will be included in the IMM cell count Small blasts will be located between the normal lymphocyte and monocyte populations PN 624026AE 2 21 2 OPERATION PRINCIPLES WORKFLOW AND WORKLISTS 2 8 2 22 WORKFLOW AND WORKLISTS Overview Workflow is the sequence of tasks required to analyze samples and generate patient reports Simply stated it is how work flows through your laboratory Using the Worklist feature of this instrument you can optimize your lab s workflow for efficiency based on any combination of workflow scenarios See Appendix Heading E 1 USING WORKLISTS The following sections describe the workflow based on instrument operation using the Worklist which is optional and not required for sample analysis To operate without the Worklist define what the primary sample identification mode is going to be either Barcode or
400. owing procedure 7 oes Yeo a The instrument cycles Rinse reagent for LF cleaning and goes into a stand by cr LJ mode a ay Lu 4 z i Do e 5 yg amp gt 4 y X E I I 0871972002 03 32 13 2 When Shutdown is complete e Allow the instrument to remain in stand by mode OR e Do Powering Down the System and Logging Off to turn the system off Note After doing Shutdown a Startup must be done before operating the instrument again PN 624026AE 11 67 i DIAGNOSTICS CLEANING THE ANALYZER System Cleaning After Analyzing a Contaminated Sample Do this procedure to clean the system after analyzing a contaminated sample according to your lab procedure Supplies Needed Q 500mL of a 1 to 2 chlorine solution produced from high quality fragrance free sodium hypochlorite Q Absorbent paper m Distilled water L 2 containers such as beakers or flasks that can each hold more than 500mL of liquid and can be placed in front of the reagent compartment when the door is open LN 2 Net 1 Do Extended Cleaning in this chapter 2 Prepare the 2 containers a Pour 500mL of distilled water into the one container b Pour the chlorine solution into the other container 500mL 11 68 PN 624026AE DIAGNOSTICS Ji CLEANING THE ANALYZER 3 Remove all reagent pickup tube assemblies from their containers including Diluent a Open the reagent compart
401. p on the housing Turn the lamp assembly clockwise until secure Reinstall the two screws removed in step 7 Reconnect the lamp to the Power Supply 10 Plug the Analyzers power cord into its power source electrical outlet 11 Power up the system as instructed in Powering Up the System and Logging On in Chapter 5 The power on sequence will do a Startup and background cycle if Auto Startup is enabled 11 100 PN 624026AE DIAGNOSTICS REPLACEMENT PROCEDURES 12 Verify correct operation a If Startup was not automatically done u ay b Verify that the new lamp is lighted e Ifitis go to step 13 e Ifitis not then troubleshoot the system to determine the problem 13 When the Startup routine is done a Turn the instrument off b Unplug it from the power outlet 14 Replace the top cover a Place the top cover on the instrument b Tighten the 7 hex screws to secure the cover to the instrument frame PN 624026AE 11 101 DIAGNOSTICS REPLACEMENT PROCEDURES 15 Re attach the left side panel a Slide the left side panel into placed b Tighten the two hex screws then the other two hex screws to secure the door to the instrument frame 16 Replace the right side panel a Slide the panel into place b Tighten the screws with the door key 17 After closing all doors and replacing all covers plug the instrument into the powe
402. panel CBC or CBC DIFF appears Prepare a fresh normal whole blood sample as defined by your laboratory guidelines Mix the sample as required by your lab Ca 11 55 i DIAGNOSTICS REPRODUCIBILITY CHECK 9 The following message appears AcT 5diff AL Insert tube in holder and close door Note Do not u unless you want to cancel otherwise you will have to begin again 10 Are you using a Vacutainer tube e Ifyes go to step 11 e Ifno carefully remove the cap from the tube then go to step 11 11 Insert the tube into the correct slot of the tube holder Refer to the Hematology Tube List available on the BCI website at www beckmancoulter com 11 56 PN 624026AE DIAGNOSTICS l REPRODUCIBILITY CHECK 12 Close the tube holder door for analysis to begin The LED lights will illuminate when analysis is in progress 13 When analysis is completed the results are displayed 17 5 5 82 16 6 50 5 87 28 4 32 8 l 16 4 5 78 165 50 3 87 28 6 32 8 oo 0o00 ao 00 o oo oo oo 000 ao 0 0 0 oo o0 oo 0 00 0 0 00 a 00 ao PN 624026AE 11 57 DIAGNOSTICS REPRODUCIBILITY CHECK 14 When analysis is completed and the tube holder door opens remove the a tube Replace the cap if necessary 15 Repeat step 7 through 14 until 20 aspirations have been analyzed Remember to mix the sample before the next aspirati
403. phils and other white blood cells is also related to the ACeT 5diff WBC Lyse specific lytic action on these white blood cells Thresholds which are electronically set size limits exclude unwanted particles such as debris from the analysis Particles above the threshold are analyzed and particles below the threshold are excluded PN 624026AE OPERATION PRINCIPLES ACV TECHNOLOGY 2 3 ACV TECHNOLOGY Overview In the DIFF bath 25 pL of whole blood is mixed with 1 000 uL of ACeT 5diff Fix reagent for 12 seconds then stabilized with 1 000 pL of ACT 5diff Diluent for an additional 3 seconds This reaction lyses the red blood cells preserves the leukocytes at their original size and differentially stains the lymphocytes monocytes neutrophils and eosinophils with eosinophils staining most intensely The instrument maintains the reagents and reaction at a regulated temperature of 35 C 95 F The lymphocytes monocytes neutrophils and eosinophils each have a unique nuclear and morphologic structure and staining intensity therefore each absorbs light differently Each stained cell is individually focused by the Dual Focused Flow DFF system and transported through the flow cell using sample pressure and diluent sheath flow Dual Focused Flow DFF PN 624026AE DFF Figure 2 2 fluid dynamics uses a hydrodynamic focusing process to focus individual cells or particles in a stream of diluent The focused sample stream of the ACeT
404. position information that was entered on the Worklist order 1 Create a Worklist order ooo O f g OE Type 06 as cassette number then pressed Enter Select the 1st tube position Type 123456 from the label as the Sample ID Ow Us 2 Insert tube into position 1 of cassette 6 3 Place cassette in Cassette Input Tray at 4 Phib 5 Sample is analyzed 6 Report prints with Sample ID 123456 cassette 6 and position 1 which is exactly what was entered for the Worklist order Scenario 5 Cass Position On Manual Match On Auto Print On Worklist Order Cassette and Position only Barcode Label Summary Results are placed on the Manual Match screen because a Sample ID was not entered on the Worklist order but a barcode Sample ID was read 1 Create a Worklist order CHI Type 2 as cassette number then pressed Enter Select the 1st tube position PN 624026AE PN 624026AE WORKLIST SCENARIOS WORKLIST MATCH OPTION SCENARIOS e Did not enter a Sample ID f C y An AUTO_SID was assigned Ld oe 2 Insert tube into position 1 of cassette 2 3 Place cassette in Cassette Input Tray o a Phib Sample is analyzed Run in Progress screen shows Sample ID 123457 C P 2 1 Results are placed on the Manual Match screen Order shows AUTO_SID C P Results shows123457 with C P 2 1 Options a Manually match the order to the result The report will automatically print Manual
405. prevent platelet agglutination 2 Reanalyze the specimen for only the Plt count 3 Correct the final Plt result for the effect of the sodium citrate dilution MPV Giant platelets May exceed the upper threshold of the Pit parameter and may not be counted as platelets Consequently these larger platelets will not be included in the instrument s calculation of MPV Very small RBCs microcytes RBC fragments schistocytes and WBC fragments May interfere with the proper counting of platelets Agglutinated RBCs May trap platelets causing an erroneous MPV result You may be able to detect the presence of agglutinated RBCs by observing abnormal MCH and MCHC values and by examining the stained blood film Chemotherapy May also affect the sizing of platelets NE NE The neutrophil absolute cell count is derived from the WBC count The presence of excessive eosinophils metamyelocytes myelocytes promyelocytes blasts and plasma cells may interfere with an accurate neutrophil count Interfering substances pertaining to WBC also pertain to the NE and NE LY LY The lymphocyte absolute cell count is derived from the WBC count The presence of erythroblasts certain parasites and RBCs that are resistant to lysis may interfere with an accurate LY count Interfering substances pertaining to WBC also pertain to the LY and LY MO MO The mononuclear absolute cell count is derived from the WBC count The pr
406. r up to 8 numeric characters For example to begin at 1 type 1 The first Sample ID will automatically be number 1 the next will be number 2 and so forth Note If you type leading zeros the system removes them i e 001 becomes 1 c Verify the number is correct 7 u y to save the change 8 At the Login screen for a New Workday select Reset Autonumbering Note Delete Worklist is automatically selected when you select Reset Autonumbering 9 Log in to the system The new starting number for AUTO_SID is effective Default Panel Selecting CBC or CBC DIFF Default Panel CBC DIFF C CBC The default panel is the default test CBC or CBC DIFE to be performed on a sample By selecting a default panel you are pre defining the test for each sample If you want to change the test for a particular sample you can do so when entering the sample information For details about which parameters are analyzed with each panel see Heading 1 4 PARAMETERS Do this procedure to select the default test panel for sample analysis PN 624026AE SETUP A OPERATIONAL SETUP amp LN amp A 1 From the Main Menu screen J aE 3 Verify the General tab is selected AcT 5diff AL Miscellaneous on OF PN 624026AE A 7 SETUP OPERATIONAL SETUP 5 Select the desired default panel Default Panel CBC DIFF CBC 6 E 4 to save the change Us 7 to return to the Setup screen A
407. r One quadrillionth 1015 of a liter field An area on a screen for entering data flags On printouts letters or symbols that appear next to parameter results to indicate specific conditions For additional information see Heading 9 7 REVIEWING RESULTS LIS laboratory information system A laboratory s computer system that stores patient information and analysis results linearity The ability of an instrument to recover expected results reference values or calculated values for such parameters as WBC RBC Hgb and Pit at varying levels of concentration of these parameters within specified limits lot number A manufacturer s code that identifies when the product such as a reagent was manufactured mean Arithmetic average of a group of data mode The analysis either CBC or CBC DIFF performed by the instrument operating range Range of results over which the instrument displays prints and transmits data Glossary 1 GLOSSARY Glossary 2 panel Specifies the group of tests CBC or CBC DIFF ordered for the patient parameter A component of blood that the instrument measures and reports performance Actual performance of the instrument characteristics performance specifications Targeted performance of the instrument based on established ranges and parameters precision A measure of reproducibility precision is the ability of the instrument to reproduce simil
408. r source 18 Verify instrument performance by running a fresh whole blood sample 11 102 PN 624026AE DIAGNOSTICS REPLACEMENT PROCEDURES Replacing the Rinse Bath Drain Filter Purpose Do this procedure when instructed by a Beckman Coulter representative Supplies Needed I door key a filter assembly Note For any part that you use from your spare parts kit be sure to record the part number for reordering Procedure Do this procedure to replace the Rinse bath drain filer AAN a 1 Power down the system as instructed in Powering Down the System and Logging Off in Chapter 5 2 Unplug the Analyzer from its power source wall outlet PN 624026AE 11 103 DIAGNOSTICS REPLACEMENT PROCEDURES 3 Remove the right side panel a Loosen the screws with the door key b Pull the panel up to remove 4 Locate the filter between the rinse bath and valve 27 11 104 PN 624026AE DIAGNOSTICS Ji REPLACEMENT PROCEDURES IMPORTANT Risk of leakage from the rinse bath filter if the gasket is lost The rinse bath filter has an upper half and a lower half When replacing the filter keep the new filter together so that the small gasket inside the filter stays in place 5 Remove the rinse bath filter AC 1 a Remove the tubing from of the a aS rear port of valve 27 b Grasp the upper half of the filter and twist it until it is completely loosened from
409. r that control file will be inaccurate Reminder To deselect a control run a u until LJ appears b Repeat step a until you have deselected the runs you want excluded from the Statistics PN 624026AE 7 41 7 QUALITY ASSURANCE DOWNLOADING CELL CONTROL RESULTS FOR QAP 4 Print a copy of the control file data for your records See Printing Transmitting Saved Cell Control Results in this chapter Downloading Results to Diskette for IQAP Submission After Preparing for IQAP Download in this chapter do this procedure to download the results Supplies Needed U Formatted blank diskette you provide 0 IQAP labels provided by Beckman Coulter in your IQAP packet U 5 to 6 5 board stock return mailers provided by Beckman Coulter in your IQAP packet 1 From the Main Menu screen 0 Q amp Q 7 42 PN 624026AE QUALITY ASSURANCE T DOWNLOADING CELL CONTROL RESULTS FOR IQAP Control files with one or more records will be displayed for the past three months which is determined from today s date to the First Run date For example if today s date is May 11 control files having February 11 or later as the First Run date will be displayed 3 Toselect a control file to be downloaded a C O until M appears b Repeat step a until only the files you want to include in the download are selected ATTENTION
410. ransmitted status meaning that those results not transmitted will be listed For additional information see Figure 9 4 Allows you to include exclude listed results for printing transmitting Understanding the Printing Options for Patient Results See Figure 9 10 Figure 9 10 Print Options for Patient Results Pinson oO 27 O Q meee Print i Transmit J Print Summary List for Seleted pae C Print Summary List for All Rows C Print Patient Report for Selected Rows 9 C Print Patient Report for All Rows Print Last Patient Report _ vix f 7367178A Displays the print options Prints the summary list for all selected rows Prints the summary list for all rows whether selected or not Prints the patient report for the selected rows Prints the patient report for all rows whether selected or not ATTENTION Because this option prints a full report for every row be sure this is the option you want before selecting OK Prints a report for the last patient result PN 624026AE DATA REVIEW e PRINTING SAMPLE RESULTS IMPORTANT Risk of compromising system functionality if you batch print and or batch transmit while receiving a Worklist download from a host and or while analyzing samples with Auto Transmit on and Auto Print on Always allow sample analysis and or the host download to complete before batch printing and or batch transmitting Printing Procedure Do this procedure to pr
411. ration results will be deleted AcT 5diff AL je a 3 W amp to initiate auto calibration The following message appears AcT 5diff AL To print the current calibration values on the Calibration List printout auto calibrate and delete the calibration table 0 v 4 Do Heading 7 3 RUNNING CELL CONTROLS in this chapter to verify calibration e Ifthe control is within expected ranges run samples e Ifthe control is not within expected ranges call your Beckman Coulter representative 10 16 PN 624026AE CALIBRATION HOW CALIBRATION SAMPLES ARE INCLUDED EXCLUDED Printing Calibration Results l Print Transmit 2 3 4 From the Calibration screen 0 c active only when data is available Print Print Selected Results Print All Results Print Statistics Only iva se Select the desired print option e Print Selected Results prints only the selected results e Print All Results prints every result whether selected or not e Print Statistics Only prints the calibration table only C Y to print Keep a copy of the printout for your records 10 5 HOW CALIBRATION SAMPLES ARE INCLUDED EXCLUDED PN 624026AE l After a calibration sample is analyzed the instrument saves the data as calibration data not as results data If a calibration run is accepted e the results will be displayed and saved e the calibration run will be selected by default If a calib
412. ration run has an Analytical Message the run will be displayed deselected Once the calibration run is completed the instrument completes the necessary calculations and compares all directly measured parameters coefficients of variation CVs to the corresponding target values entered in CV Limits for Calibration QC and or Reproducibility in Appendix A and all calibration coefficients to internal acceptance criteria A CV greater than the limit value is displayed in red A new calibration coefficient with a difference of more than 20 relative to the current coefficient will be highlighted red If new calibration factors have been manually entered the Calibrator Log will indicate Forced calibration See Figure 10 4 Note Calibration results are not sent to the Host computer 10 17 i CALIBRATION HOW CALIBRATION SAMPLES ARE INCLUDED EXCLUDED Figure 10 4 Calibration Log Entry Forced Calibration Lot Number Lot Number CX321 Expiration Date 07 11 2002 Change Calibrator expired Lot Number CX321 Expiration Date 07 11 2002 Change Calibrator expired Lot Number CX321 Expiration Date 07 11 2002 Change Calibrator expired Lot Number CX321 Expiration Date 07 11 2002 Change Calibrator expired 21 Expiration Date 07 11 2002 Change Calibrator expired Expiration Date 07 26 2002 Change Target values modified EY 129 95 RBC 145 7 HGB 40 52 HCT 159 56 PLT 19 10 18 PN 6240
413. reagent bottles containers 11 82 PN 624026AE PN 624026AE DIAGNOSTICS l REPLACEMENT PROCEDURES Figure 11 18 Reagent Bottle Container Location Understanding the Reagent Status Screen See Figure 11 19 Figure 11 19 Reagent Status Screen Details AcT 5diff AL Reagent Status 7367176A Reagent level indicators double click when replacing a reagent Reagent names 11 83 DIAGNOSTICS REPLACEMENT PROCEDURES Number of CBC cycles that can be analyzed based on current reagent levels Number of CBC DIFF cycles that can be analyzed based on current reagent levels Replacing Reagents Procedure If the instrument determines that there is insufficient reagent to complete the daily workload Reagent s Low Insufficient Reagents To Complete Daily Workload appears after Startup Specific reagent low messages appear for each reagent when applicable For details about daily workload see Daily Workload Defining for CBC and CBC DIFF in Appendix A Replace the reagent as instructed in Replacing Reagents Fix WBC Lyse Hgb Lyse or Rinse Reagents in this chapter or Replacing the Diluent Reagent in this chapter IMPORTANT Risk of instrument error if reagent is poured from one container to another Never pour reagents from one container to another Particles at the bottom of the old container can contaminate the new reagent which will cause unacceptable background results especially for p
414. res an order be placed on the Worklist for all samples processed If a worklist order is not found the software automatically generates an order places it on the Worklist and removes it when the sample has been processed This order is called the internal order e A set of results with a barcoded Sample ID cannot be matched to a Worklist order with a different Sample ID e When a set of results is matched to a Worklist order the report will show the Sample ID from the Worklist order along with the associated Patient ID and demographics if applicable e The relationship between the Sample ID and the Patient ID in an order cannot be broken The Workstation matches sample results with the additional information entered based on sample ID The Worklist order is removed upon analysis when the workstation has matched the results to the pre assigned data You can add demographic information e by manually entering the information or e by receiving downloaded information from a Host computer Once the information is present on the Worklist it will be added to the sample results when the system matches the Sample ID of the added information with the Sample ID of the processed sample The Worklist displays a listing of all samples that have had additional information entered into the system but have not been processed Once a sample that has matching information on the Worklist has been processed the Worklist order is removed The results
415. rint transmit patient results Yes You can enable an auto function feature to automatically print and or transmit patient sample results See Auto Print for Patient Results and Auto Transmit for Patient Results in Appendix A Can create a header with my lab s information that will appear on all reports Can the patient report be customized Yes You can create a 2 line report header See Report Header Entering Editing in Appendix A Yes You can define certain areas of the patient sample report to be printed See Patient Report Setup in Appendix A Startup Where can find Startup results You can find Startup results in two places on the Background report and in the Startup Log See Viewing Startup Results in this chapter PN 624026AE 5 1 GETTING STARTED COMMONLY ASKED QUESTIONS Table 5 1 Commonly Asked Questions Continued Area Question Answer Sample Analysis and Data Review Is there a list of the possible Worklist scenarios that can view Yes Because each lab s configuration differs there are several Worklist Match Option scenarios available See Heading E 2 WORKLIST MATCH OPTION SCENARIOS What is the minimum specimen volume required Refer to documentation from the tube manufacturer and refer to the Hematology Tube List available on the BCI website at www beckmancoulter com Can run stat samples if am running other pre assigned samples fr
416. rinting patient results 9 21 printing Reproducibility results 11 05 printing results automatically A 64 printing the calibration table statistics 10 17 printing the Workstation Setup report A 2 printing transmitting results automatically 5 1 progress indicator 5 47 prompting for log comments A 14 putting the Traverse assembly in service position 11 48 Q QA definition 7 1 settings A 34 setup A 34 QA icon 5 31 5 57 QA messages automatically stopping instrument A 18 QC definition 7 2 running cell controls 7 3 setting up a control file A 46 techniques 7 2 OC Expired definition 9 50 QC Failed definition 9 50 quality assurance definition 1 10 See also QA quality control definition Glossary 2 See also QC R R flag description 9 38 on diff parameters 9 38 RBC count determination 2 14 histogram determination 2 14 interfering substances 3 10 RBC INTERPRETATION NOT POSSIBLE triggering condition 9 46 RDW calculation overview 2 15 interfering substances 3 11 Reagent Expired definition 9 51 during Startup 6 4 reagent syringe function 11 80 location 11 80 reagents consumption by cycle 3 4 expired how to handle 11 7 location 11 83 priming procedure 11 30 recommended 1 12 3 2 replacement procedures 11 84 Reagents icon 5 31 5 57 Recalculated flag 9 17 Recalculated message definition 9 51 removing panels covers 11 2 removing the left panel 11 3 remo
417. rmation 8 34 Sample ID Entering Selecting 8 35 Panel Selecting CBC or CBC DIFF 8 35 Flagging Set Selecting 8 36 Demographics Entering Selecting 8 36 Collect Date Time Entering 8 36 Location Entering Selecting 8 37 Physician Entering Selecting 8 37 Comments Sample and Patient Entering Editing 8 37 Patient ID Entering Editing 8 38 Name Locating Selecting 8 38 Date of Birth Entering Editing 8 39 Age Entering Editing 8 39 Gender Selecting 8 39 UNDERSTANDING THE WORKLIST SCREENS 8 40 Overview 8 40 Understanding the Worklist Grid Screen 8 41 Understanding the Worklist Cassette Screen 8 43 WORKING WITH WORKLIST ORDERS 8 45 Receiving Worklists from a Host Computer 8 45 Adding an Order Entry 8 45 Adding an Order at the Worklist Grid Screen 8 45 Adding an Order at the Worklist Cassette Screen 8 47 Editing a Worklist Order Entry 8 49 Deleting a Worklist Order Entry 8 51 e To Delete a Worklist Order from the Worklist Grid Screen 8 52 e To Delete a Worklist Order from the Worklist Cassette Screen 8 53 9 DATA REVIEW 9 1 9 1 LOCATING SAMPLE RESULTS 9 1 Reviewing the Last Sample s Results 9 1 Procedure for Viewing the Last Sample s Results 9 2 Locating Results on the Results List Screen 9 2 Understanding the Results List Screen 9 2 Procedure for Locating Non Archived Results 9 4 Sorting Results 9 5 PN 624026AE 9 2 9 3 94 9 5 9 6 9 7 9 8 PN 624026
418. ry on the Worklist 3119290P Sierra7565 DUE eee CBC DIFF or Flogging Sete a sae because the cassette position Mee is not updated to the Worklist Mme o A up a Praeiian with rerun Dr Tatino 5 Comments 1 Rerun 7 Patient ID nj Sierra7S65 Last Name emner ma al Addison Date of Birth Age 04 11 1962 4Y Gender Female z Er E 3 amp B amp B gt 7 v X v Service 08 02 2002 13 24 46 7 Analyze the sample from the Worklist 8 32 PN 624026AE SAMPLE ANALYSIS 8 RE RUNNING SAMPLES Automatic Reruns The criteria for automatically marking samples to be re run are defined in Defining Automatic Rerun Criteria By Flags and or by Parameters Appendix A If a sample meets the defined criteria a Worklist order is created You can then analyze the sample as needed Identifying Rerun Results When a patient sample report is printed Yes will appear near to Rerun on the report See Figure 8 2 Figure 8 2 Rerun Indicator on Patient Sample Report Beckman Coulter Inc Test Lab Miami FL 33196 Phone 305 380 3800 Sample ID SID1 Run Date Time 08 01 2002 15 18 59 Collect Date Time Cass Pos Flagging Set Standard Range Panel CBC DIFF Location Location Physician Physician Sample Comment Sample Comment Operator Service Patient ID PID1 Last Name Last Name Date of Birth 01 01 1985 Age 17Y Gender Unknown First Name First Name Patient Comment Patient Comment Range Flags and Messages 103 pL
419. s Flag Description HH Result is above the action limit set by your laboratory and may generate an interpretive message on the printout LL Result is below the action limit set by your laboratory and may generate an interpretive message on the printout Control Flags The BA and BA from the A eT 5diff Control Plus cell control are reported into the control file with an S flag to indicate that these would normally have been suppressed if it was a patient sample The high and low flags indicate recovery outside the expected ranges Analytical errors other than BASO may require review PN 624026AE PN 624026AE DATA REVIEW FLAGS AND MESSAGES GENERATED BY THE INSTRUMENT Platelet Concentrate Extended Range Flag If the Platelet Concentrate extended range flagging mode is active and the instrument determines that the sample result for Hgb is less than 2 0 g dL and for Plt is greater than 15 0x107 nL the Plt result is flagged using the extended linear and reportable range limits resulting in a C flag next to the Plt result Hemoglobin Hematocrit Ratio Flag H amp H Flag If the Hgb g dL x 3 Hct is lt 0 8 or gt 1 2 the RBC Hgb MCV Hct MCH MCHC Plt MPV Pct and PDW will be flagged with The presence of this flag indicates that there may have been an error in the analytical process Tree View Flags and Messages This section defines the flags and messages displayed in the Flags and Mess
420. s chapter Flagging Sets Standard Range gt Standard Range Enter the appropriate demographics as required by your lab protocol Collect Date Time Entering Location Entering Selecting Physician Entering Selecting Comments Sample and Patient Entering Editing Patient ID Entering Editing Name Locating Selecting Date of Birth Entering Editing Age Entering Editing Gender Selecting If you make a mistake when entering Ux the demographics to clear the entry Sample ID Collect Date Time ii ff tt Flagging Set Standard Range x CBC DIFF O e e Location Physician Comments Rerun Patient ID Last Name aa First Name Date of Birth A ff Gender Unknown x PN 624026AE SAMPLE ANALYSIS RUNNING MANUAL STAT SAMPLES 8 OM A message appears prompting you to insert the tube into the tube holder for analysis AcT 5diff AL When tube holder opens insert Sample ID 789 for analysis of Patient ID No Merlint Berg Merlin 8 Verify the Sample ID and other information If any of the information is incorrect u to exit IMPORTANT Risk of sample mis identification if you do not verify the Sample ID displayed at the Workstation with the Sample ID on the tube prior to analysis 9 If the information is correct insert the tube into the tube holder 10 Close the tube holder door for analysis to begin After analy
421. s enabled results comments will not be included To print transmit a sample report with the results comments included a U from the Results screen Sample 1D ese wc 53 com Cass Pos Panel ks Flag Standard Range HCT ar Collect Date Time Run Time ee MCHC gdl RBC 108 nL aa HEB g dL eg Mey tL oF MCH pg BA RDW j DifPiot and Histogram Flags WBC PLT 1034 MPV f pct z Last Name First Name Date of Biith LA Flags and Messages SL NL LN SLL IMM Micocytes PLT Aogregates Schistecyte Miscellaneous Messages Re aE e b E s X 10704 2002 14 17 53 Print Transmit Transmit Print Print displayed report Select Print or Transmit from the following window Print Transmit Transmit displayed report ATTENTION It is important that you verify all results as being correctly associated with the correct patient demographics before reporting UY to print or transmit 10 Remove the sample tubes from the cassette See Removing Tubes from a Cassette in Chapter 5 11 Verify the Sample ID and results before reporting the results 8 31 SAMPLE ANALYSIS RE RUNNING SAMPLES 8 6 RE RUNNING SAMPLES There may be instances when you will want to rerun a sample for example you may want to rerun a sample to confirm a suspect result e
422. s screen Figure 9 1 LN 2 Nec 1 From the Main Menu screen C to display the last sample s results AcT Sdiff AL LA ales yv X Jos71s72002 093213 2 Verify that the results displayed correspond to the desired Sample ID you want to view pec 1z RBC 10 L Flags and Messages gg DifiPiot and Histogram Flags WC LN PPP SL1 MACF A w om ig 7 E v x Jos7osv2002 141707 There are two screens with the title of Results one lists the results by Sample ID and another that displays the results based on what is selected from the Results List screen Understanding the Results List Screen The Results screen Figure 9 2 displays results that are ready to be or already have been reported Results not ready for reporting because they are not matched to a Sample ID are located on the Match screen Figure 9 8 PN 624026AE DATA REVIEW e LOCATING SAMPLE RESULTS Figure 9 2 Results List Screen AcT 5diff AL Result Action Limit I Not Printed Not Transmitted Sample ID Cass Pos Patient ID Last Name First Name Gender Date of Birth Age Panel Run Date AF DH PL AL P T A T 458 Unknow cec D07 10 2cM FM M DO D 44568 Unknow cec D07 10 2c O
423. sages Selecting in this chapter Allows you to select if you want the system to prompt you for comments in the Calibration Log and or Reagents Log when an error messages posts to the log s See Logs Comments Prompt in this chapter Auto Numbering Setting the AUTO_SID Starting Number AUTO_SID f Auto Numbering is always on and cannot be turned off However you can set the starting number where Auto Numbering will begin The auto numbered Sample ID is preceded by AUTO_SID for example an auto numbered Sample ID of 101 will appear as AUTO_SID 101 The AUTO_SID is automatically incremented by 1 from the previously assigned number each time a sample is analyzed For Auto Numbering to start on the initial number the Worklist from the previous Workday must be erased Do this procedure to set the Auto Numbering starting number The new starting number becomes effective when Reset Autonumbering is selected at the Login screen when a New Workday begins PN 624026AE SETUP A OPERATIONAL SETUP amp LN amp A 1 From the Main Menu screen J aE 3 Verify the General tab is selected AcT 5diff AL Miscellaneous on OF PN 624026AE A 5 SETUP OPERATIONAL SETUP A 6 5 Click the number in the AUTO_SID z AUTO_SID fi field and type a new number a 6 Type the number where you want the autonumbering to begin a Click the number in the AUTO_SID field b Type the new starting numbe
424. screen which allows you to display details for a specific batch you select and to exclude up to 5 results from one batch for XB Analysis calculations Note You can edit only the most current XB batch A 2 Ar See CouLTER AST Sdiff AL 1 From the Main Menu screen W Q O amp PN 624026AE 7 55 QUALITY ASSURANCE XB ANALYSIS 3 The XB XM graphics screen appears cea WUE e Ifyour system is setup for 3 parameters then the 3 Parameters XB screen appears e Ifyour system is setup for 9 parameters then the 9 Parameters XM screen appears shown here 0 5 W Zs to display the Batch Details E 1 42 513 149 438 5 231 340 2 4 96 152 445 3 3 3 342 fi screen 3 52 52 154 454 85 289 333 a 77 465 44 a5 83 30 347 5 53 44 136 398 2 EKI 342 e 53 an 129 37 2 32 41 7 54 424 123 358 84 289 43 e 60 an 125 320 8 231 339 s 52 535 155 453 85 290 43 to 52 533 155 455 85 292 341 u az 533 155 452 85 231 43 12 52 526 154 4g 85 293 343 13 52 532 154 454 85 230 340 u 60 433 126 370 85 231 340 15 75 580 149 as M 335 w s2 517 43 441 5 289 339 7 495 154 443 E 38 pO 18 52 52 153 445 5 291 43 19 78 4 85 145 M6 83 310 348 2 52 440 136 406 2 303 336 7 56 PN 624026AE QUALITY ASSURANCE T XB ANALYSIS 6 To exclude up to five results from the batch a b the box next to the desired result s u
425. screen names that appear on the current screen so you know the menu item you selected to get to the current screen Figure 5 48 Screen Name System is Shown Local Setting Hoe A Printer Cycle Options Date Time Format on Date Time Editing Text There may be times when you need to edit text ia as 2 Move the cursor to where you want to edit information 3 u the left mouse button to anchor the cursor 4 Edit the text 5 E y to save the changes 5 54 PN 624026AE GETTING STARTED 5 WORKING WITH THE SOFTWARE Saving Changes Throughout the procedures you will be instructed to save information a y to save Cancelling Unsaved Changes As you are making changes you can cancel without saving them UX C2 Selecting De selecting Software Features Some software screens allow you to select activate or de select deactivate certain software features to cancel all unsaved changes and to remain at the same screen to cancel all unsaved changes and to return to the previous screen 1 0S 2 To select options using radio buttons Off C desired radio button C All selected not selected Normals C Selected Abnormals PN 624026AE 5 55 GETTING STARTED WORKING WITH THE SOFTWARE 5 56 To select check boxes ig the check box to select deselect or include exclude the corresponding feature selected included O not selected excluded
426. sign demographics i AcT 5diff AL For Research Use Only Not for use in diagnostic procedures RUD Manual Mode x Sample 1D Flags and Messages foaaa ec n C3 Cass Pos Panel I r T f pi Rec Flagging Set HGB Standard Range HCT jl ime aA vy x Bupewisor T Fravoar200 141022 Fal A Ela e AcT Sdiff AL For Research Use Only Not for use in diagnostic procedures RUO Manual Mode Sample ID Sample 1D 123456 i Pog Collect Date Time BS Cass Pos Panel ICBC DIFF Flagging Set Standard Range WBC BASO standard Range z Collect Date Time CBC DIFF o el ETT oe un Dai ne 0 04 2002 14 14 52 PoE cet Locati RBC Praa m E Physician Comments 1 PPP e ao 7 F Patient ID z 10 lv Patient 1D 293 R Last Name ly 0A 2R Last Name a la Mo E fi First Name C ENNE First Name A E5 Date of Birth As BA M Date of Birth Age eam 02 A om R Jj Gender Gender 5 Unknown r imm 36 RH 02 RH A Unknown x 4 ps V amp gt Dd 4 v X j Tera T AA 3 Enter the Sample ID up to 16 Sample ID alphanumeric characters into the Stat window 4 Select the desired test panel See Panel Selecting CBC or CBC DIFF in this chapter SAMPLE ANALYSIS RUNNING MANUAL STAT SAMPLES 8 8 Select the flagging set See Flagging Set Selecting in thi
427. sis is completed the results are displayed for review PN 624026AE 8 9 SAMPLE ANALYSIS RUNNING MANUAL STAT SAMPLES 11 To view the results after all samples have been completed OB b Select the desired result to review 12 To enter result comments U a H if necessary b Select the result for which you want to add a comment Uke d Type the comment mel 8 10 PN 624026AE SAMPLE ANALYSIS RUNNING MANUAL STAT SAMPLES 8 13 Results are printed transmitted according to your system setup If Auto Print is enabled results comments will not be included To print transmit a sample report with the results comments included a p 5 from the Results screen AcT Sudiff AL For Research Use Only Not for use in diagnostic procedures RUO Results Result 1 1 Sample ID FORE ed 123456 f 03 63 E DiffPlot and Histogram Flags wec 10 70 Cass Pos Pi WBC SL NL LN SLL IMM f C ecm fee 1p 477 anaes Messages Flagging Set HGB gdl Jee Interpretive Messages A Standard Range ner a7 RBCS Collect Date Time MCV fl ar Basophlia 5 Micocytes z EAI Run Date Time pau os PLT Aggregates il 10 04 2002 14 14 52 pepi Schistocyte ena Row x 174 5 Miscelaneous Messages ls Reagent expred Physician a FL qt MPV AL 81 R PPP Comments erct x AE B ew E Patient ID x wm v Last Name ly 0A 25 A a i uo 002 FL a First Name re is Date
428. splayed on the Manual Match screen does not contain the correct order you have two options e Moving Unmatched Results to the Results List e Adding a Worklist Order for the Result Moving Unmatched Results to the Results List An unmatched result is one that is not matched to a Worklist order Do this procedure if you want to move unmatched results from the Manual Match screen to the Results List 1 At the Manual Match screen select the desired result without selecting an order 2 u y The following message appears AcT 5diff AL Move selected results to Results List C Move all results to Results List 3 u the desired option 4 J to move the results Note The results will be reported with the Sample ID and flagging set as analyzed and marked with the Unmatched flag Adding a Worklist Order for the Result Do this procedure if you want to add a Worklist order appropriate for a result on the Manual Match screen Uo 2 Add an order to the Worklist that is appropriate for the result that is on the Manual Match screen See Adding an Order Entry in Chapter 8 to exit from the Manual Match screen or i j 3 Return to the Manual Match screen E c The new Worklist order is now available to match with the results 4 Match the results with the order For details on how to do this begin at step 3 of the Manual Match Procedure above 9 18 PN 624026AE DATA REVIEW PRINTING SAMPLE R
429. st Name aa First Name Date of Birth Age Hf fs Gender Unknown x 4 To add another order C i and enter the information Repeat this step until all orders have been entered Note If you Ux only the information currently displayed will be cleared 5 When you are finished adding all the orders The Worklist is updated to reflect your changes You may need to scroll to view everything Cm SAMPLE ANALYSIS WORKING WITH WORKLIST ORDERS Adding an Order at the Worklist Cassette Screen Requirements The Worklist Match Option must be Cass Position See Worklist Match and Manual Match Options in Appendix A Do this procedure to add an order to the Worklist Cassette screen for analysis Minimum requirements include e Sample ID e Flagging Set e Panel CBC or CBC DIFF A S ze E E Sample ID Cass Pos Pase 1D F l amp vyv X vw J Ct ae 2 to open the Worklist Cassette Cass NumbeO7 2 furry 3 EMPTY 5 furry 6 furry 7 EMPTY y 5 I Supervisor 1070472002 15 20 26 screen i og 38 OOO O1O O70 CIO OLOTOO OLCOTT OO 1O76 PN 624026AE 8 47 SAMPLE ANALYSIS WORKING WITH WORKLIST ORDERS Cass Number 3 Type the cassette number at and press Enter The Worklist Cassette screen appears for that cassette number There may already be Worklist or
430. t 1 O O Zz E O E 8 Furry gt __ _ Gender o lo 0 Every e B gt Bb amp y x l Supervisor i 10704 2002 15 2371 9 Repeat steps 4 through 8 for each tube PN 624026AE SAMPLE ANALYSIS RUNNING WORKLIST SAMPLES IN AUTOLOADER MODE 8 WARNING Risk of injury biohazardous conditions if a cassette is not properly handled Do not use a cassette for storing or transporting tubes or vials To ensure tubes vials remain secured in the cassettes always keep cassettes upright and use them only for analysis as described in this manual 10 Load the tube s into the correct cassette positions IMPORTANT Risk of sample mis identification or incorrect demographic assignment if the tubes are not located in the correct cassette and position Prior to analysis verify that all tubes are located in the correct cassette and position as they are entered on your Worklist 11 Verify the correct identification for each tube 12 Place the cassette in the Cassette Input Tray of the Analyzer Be sure the cassette is properly positioned with the front of the cassette facing the reagent compartment See Loading Cassettes onto the Analyzer in Chapter 5 302 A analysis 14 0 FEEF to begin analysis While analysis is in progress the red LED flashes on the front of the Analyzer Be sure your hands are free and clear from the cassette input area before beginnin
431. t a setup report for your records See Analyzer Configuration and Workstation Configuration in Appendix D for details PN 624026AE A 1 SETUP SETUP OVERVIEW Understanding the Setup Screen See Figure A 1 Figure A 1 Setup Menu Screen AcT 5diff AL Setup Table A 2 Setup Screen Icons Icon Name Function Miscellaneous Opens the Miscellaneous setup screens See Heading A 4 wee N OPERATIONAL SETUP Quality Assurance Opens the QA setup screens See Heading A 5 QUALITY ASSURANCE ak Setup SETUP Auto Functions Opens the auto functions e g Auto Print Auto Clean etc setup screen See Heading A 7 AUTO FUNCTIONS SETUP System Opens the System setup screen See Heading A 8 SYSTEM SETUP Save Restore Conf Opens the Configuration Save Restore screen See Heading D 2 CONFIGURATION SAVE RESTORE SETUP i in Operators Opens the Operators setup screen See Heading A 9 OPERATOR e DA USERS SETUP Flagging Sets Opens the Flagging Sets setup screen See Heading A 10 FLAGGING itt SETS SETUP Note S Prints the Workstation Setup Report A 2 PN 624026AE SETUP A OPERATIONAL SETUP A 4 OPERATIONAL SETUP Three tabs are available for this option General Location Physician and Units For additional information see General General Location Physician Adding Editing Deleting Units Selecting the Reporting Unit Under the General tab Figure A 2 you can define edit t
432. t from the WBC BASO bath by more than a predefined amount DIFF is displayed If the WBC count from the flow cell is less than the WBC count from the WBC BASO bath by more than a predefined amount DIFF is displayed When a DIFF or a DIFF flag occurs the WBC count and all DIFF parameters are flagged with an Note The comparison between the WBC count from the WBC BASO bath and the WBC count from the flow cell will not be performed when the sample is analyzed in the CBC mode or when this option is disabled in setup PN 624026AE CO DIFF Reject See Table 9 10 DATA REVIEW FLAGS AND MESSAGES GENERATED BY THE INSTRUMENT Table 9 10 Definition of Analytical Message CO DiffPlot Region Suspected Flag DiffPlot Region Affected Description Flags Abnormalities CO The system detects CO Diff Diff a problem with Reject is Reject volume and displayed and absorbance printed in the measurements in Analytical the flow cell Messages G More than 50 of Section in the a the pulses were Flags and rejected because Messages area Debris they do not have optical pulses that Absorbance meet internal Criteria 100 to 300 microseconds DB Debris See Table 9 11 Table 9 11 Definition of Analytical Message DB DiffPlot Region Suspected Flag DiffPlot Region Affected Description Flags Abnormalities DB Occurs when the DB Debris is Plt aggregates number of pulses displayed an
433. t the result Comments appear on the printed report PN 624026AE DATA REVIEW MANUALLY MATCHING SAMPLE RESULTS WITH WORKLIST ORDERS 9 3 MANUALLY MATCHING SAMPLE RESULTS WITH WORKLIST ORDERS Overview The system provides the ability to trap results under certain conditions and hold them before reporting This function is primarily controlled by the Manual Match configuration If Manual Match is ON and the system is unable to automatically identify the correct Worklist order for the analyzed sample the results will be held on the Manual Match screen and will not be reported automatically Results can be held at the Manual Match screen even if Manual Match is OFF For details see Conditions for Results Going to Manual Match Screen in this chapter Conditions for Results Going to Manual Match Screen If Manual Match is ON the following are some of the conditions that cause results to be posted to the Manual Match screen e Barcode Sample ID from tube is not found on the Worklist due to gt Sample ID not entered on Worklist gt Sample ID from the barcode was not read and an AUTO_SID was assigned e Cassette and position not found on the Worklist due to gt cassette and position not entered on Worklist gt partial match where cassette and position are located but the Sample ID information is inconsistent If Manual Match is OFF the following is one of the conditions that causes results to be posted to the Manual Match screen
434. t their required demographic information is called the Manual Match option If Manual Match is ON any positive ID for a sample that does not have a matching Worklist order will not be reported it will be sent to the Manual Match screen for action If Manual Match is OFF the result for any Worklist order that is not found no match is reported as analyzed Deciding Which Worklist Match and Manual Match Options to Use There are two questions to answer 1 How are the sample tubes identified 2 Will the functionality of the Worklist be used If all or most of your sample tubes are barcoded set the Worklist Match Option to Barcode regardless if the Worklist will be used or not If you want to use the functions of the Worklist to assign demographics set Manual Match to ON so that any no matches are held prior to reporting this allows you to manually assign the appropriate demographics to the results If your sample tubes are not barcoded set the Worklist Match Option to Cass Position If you want to use the functions of the Worklist to assign demographics set Manual Match to ON so that any no matches are held prior to reporting this allows you to manually assign the appropriate demographics to the results A 9 A SETUP OPERATIONAL SETUP Possible Workflows and Configurations Sample Tube Barcoded Worklist to be Used Worklist Match Option Barcode Manual Match ON Sample Tubes Barcoded Worklist Not to be Used
435. t use a cassette for storing or transporting tubes or vials To ensure tubes vials remain secured in the cassettes always keep cassettes upright and use them only for analysis as described in this manual 2 Place the cassette in the Cassette Input Tray of the Analyzer Be sure the cassette is p y y properly positioned with the front of the cassette facing the reagent compartment See Loading Cassettes onto the Analyzer in Chapter 5 A analysis 3 C FFE to begin analysis While analysis is in progress the red LED flashes on the front of the Analyzer Be sure your hands are free and clear from the cassette input area before beginning 4 To view the results for the last sample analyzed u 8 29 SAMPLE ANALYSIS RUNNING WORKLIST SAMPLES IN AUTOLOADER MODE 5 To view the results after all samples have been completed OB b Select the desired result to review 6 To enter result comments Lin U if necessary b Select the result for which you want to add a comment 0U d Type the comment Of 7 When all samples have been processed the instrument ejects the cassette into the Cassette Output Tray 8 Remove the cassette from the instrument See Unloading Cassettes from the Analyzer in Chapter 5 8 30 PN 624026AE PN 624026AE SAMPLE ANALYSIS 8 RUNNING WORKLIST SAMPLES IN AUTOLOADER MODE Results are printed transmitted according to your system setup If Auto Print i
436. tails e See Adding an Order at the Worklist Grid Screen in this chapter e See Adding an Order at the Worklist Cassette Screen in this chapter The following information cannot be edited results and demographics downloaded from the Host computer Adding an Order at the Worklist Grid Screen Do this procedure to add an order to the Worklist Grid screen for analysis Minimum requirements include e Sample ID e Flagging Set e Panel CBC or CBC DIFF l Ee A Collect Date Time TEMEER cprr A Se Eii 1 u EIl ie el pen r j eae a L First Name le pam e an i GE aiaj 9 5 gt a Z v Xx d panna T Fravoaomn2 14304 Ue 8 45 8 SAMPLE ANALYSIS WORKING WITH WORKLIST ORDERS 8 46 3 Enter the information on the right side of the screen Sample ID Entering Selecting Flagging Set Selecting Panel Selecting CBC or CBC DIFF Demographics as required by your lab protocol Collect Date Time Entering Location Entering Selecting Physician Entering Selecting Comments Sample and Patient Entering Editing Patient ID Entering Editing Name Locating Selecting Date of Birth Entering Editing Age Entering Editing Gender Selecting Sample ID Collect Date Time aa EES a a Flagging Set Standard Range x CBC DIFF o e e Location Physician Comments Rerun f Patient ID La
437. tching Unmatched will appear on the report c _ Print the result from the Manual Match screen without matching Manual Match will appear in the Miscellaneous Messages section of the Flags and Messages area of the report See Printing from the Manual Match Screen Without Matching in this appendix Scenario 10 Cass Position On Manual Match Off Auto Print On No Worklist Order No Barcode Label Summary Results are printed with an AUTO_SID and the cassette position of the tube when analyzed 1 2 3 4 5 Insert tube into the 1st position of cassette 10 Place cassette in Cassette Input Tray o m bheb Sample is analyzed Report prints with AUTO_SID and C P 10 1 Scenario 11 Cass Position On Manual Match On Auto Print On No Worklist Order Barcode Label Summary Results are placed on the Manual Match screen because a barcode label was read but the system was trying to match to the cassette and position 1 2 Insert tube into the 1st position of cassette 10 Place cassette in Cassette Input Tray o a Phib Sample is analyzed J F to see the Run in Progress screen which shows Sample ID as 123457 which was read from the barcode label and C P 10 1 J Ea which was flashing to indicate results are on the Manual Match screen U for the Manual Match screen Results are placed on the Manual Match screen Order None existed for this sample Results shows Sample ID as 1234
438. te Input Tray O a LLL Sample is analyzed An AUTO_SID is assigned Results are placed on Manual Match screen with the AUTO_SID if the Sample ID on the label could not be read or if there is no Worklist order Options a Add a Worklist order and manually match to the result The report will automatically print Manual Match will appear in the Miscellaneous Messages section of the Flags and Messages area of the printout e Ifyou print from the Run in Progress screen after matching Manual Match will appear on the report even though the Run in Progress screen shows Unmatched e Ifyou print from the Run in Progress screen before matching Unmatched will appear on the report Print results from the Manual Match screen without matching Manual Match will appear in the Miscellaneous Messages section of the Flags and Messages area of the report See Printing from the Manual Match Screen Without Matching in this appendix Scenario 7 Barcode On Manual Match Off No Worklist Order Summary An AUTO_SID is assigned results are placed on the Manual Match screen with the AUTO_SID 1 2 Insert tube into cassette Place cassette in Cassette Input Tray O i 3 Ts PN 624026AE PN 624026AE WORKLIST SCENARIOS WORKLIST MATCH OPTION SCENARIOS Sample is analyzed An AUTO_SID is assigned Results are placed on Manual Match screen with the AUTO_SID if the Sample ID on the label could not be read Op
439. tegrity always use Check Digit Checksum Number of characters for 2 of 5 can be programmed for other lengths including variable length However the variable length is NOT recommended for 2 of 5 due to the possibility of capturing a partial read of the bar code label B 2 PN 624026AE BARCODE SPECIFICATIONS FOR OPTIONAL BARCODE WAND B 4 BARCODE LABEL TEST PAGES See Tables B 2 and B 3 BARCODE LABEL TEST PAGES B ATTENTION Test these barcodes from the printed Instructions for Use manual If you do not have a printed copy of the manual contact your Beckman Coulter representative Table B 2 Test Labels With the Check Digit Checksum 1Z345aBCDE 1234567 Code 128 EAN 8 Reads 12345670 123ABC 234567 990128 Code 39 EAN 13 If this label is read with Check Digit disabled the last character is also displayed Reads 1234567890128 L23456789012 Interleaved 2 of 5 Reads 11 characters with Check Digit or reads 12 characters without Check Digit PN 624026AE B 3 BARCODE SPECIFICATIONS FOR OPTIONAL BARCODE WAND OPTIONAL BARCODE WAND CONFIGURATION Table B 3 Test Labels Without the Check Digit l 34BC Code 39 Label will not read if scanner is programmed to default condition A123123A Codabar B 5 OPTIONAL BARCODE WAND CONFIGURATION To restore the barcode scanner to default settings read each bar code from top to bottom on each column of Table B 4 until all bar codes ar
440. teout Flag 9 36 Patient Range Flags 9 36 Action Range Flags 9 36 Control Flags 9 36 Platelet Concentrate Extended Range Flag 9 37 Hemoglobin Hematocrit Ratio Flag H amp H Flag 9 37 Tree View Flags and Messages 9 37 xiii CONTENTS Xiv 10 9 9 9 10 Flags and Messages for Patient Samples 9 37 Flags and Messages for QC Calibration and Reproducibility Samples 9 37 Understanding the Flags and Messages Area 9 37 DiffPlot and Histogram Flags 9 38 DiffPlot Flags 9 38 Histogram Flags 9 43 Interpretive Messages 9 45 WEC Interpretive Messages 9 45 RBC Interpretive Messages 9 46 Plt Interpretive Messages 9 47 Combination WBC RBC Plt Interpretive Messages 9 47 Analytical Messages 9 48 DIFF and DIFF 9 48 CO DIFF Reject 9 49 DB Debris 9 49 BASO 9 50 QA Messages 9 50 Miscellaneous Messages 9 51 ALTERNATIVE FLAG REPORTING FORMATS 9 51 Detailed Flags Format 9 51 Suspect Flag Format 9 51 FLAG HIERARCHY 9 52 Replacement Flags Hierarchy 9 52 Parameter Flags 9 52 Patient Action Flags Hierarchy 9 52 CALIBRATION 10 1 10 1 10 2 10 3 10 4 10 5 GENERAL 10 1 When to Calibrate 10 1 Recommended Calibration Conditions 10 1 When to Verify Calibration 10 1 Understanding the Calibration Screen 10 2 Understanding the Calibration Setup Screen 10 3 PRE CALIBRATION CHECKS 10 5 CALIBRATOR SETUP 10 6 AUTO CALIBRATION 10 11 Running Calibrator Samples 10 11 A
441. ter Value allows all patient results without a value to be automatically printed upon completion of analysis With Parameter Flags allows all patient results with a parameter flag to be automatically printed upon completion of analysis With Histo amp DiffPlot Flags allows all patient results with a histogram flag and a DiffPlot flag to be automatically printed upon completion of analysis Outside Patient Limits allows all patient results outside patient limits flagged with H or L to be automatically printed upon completion of analysis Outside Action Limits allows all patient results outside action limits flagged with HH or LL to be automatically printed upon completion of analysis A 64 PN 624026AE SETUP A AUTO FUNCTIONS SETUP Setting the Auto Print Options for Patient Results Do this procedure to enable or disable the Auto Print print options for patient results A h ANE pm Coutter AST 5diff AL 1 From the Main Menu screen 0 aE OF AcT iff AL Auto Functions 3 0 the Auto Print tab Auto Print Auto Transmit is PN 624026AE A 65 SETUP AUTO FUNCTIONS SETUP Oe 5 Select the desired Auto Print option for patient results For Selected Abnormals be sure to select the criteria for abnormals Selected Abnormals No Parameter Yalue m With Parameter Flags Iv r Outside Patient Limits Vv Outside Action Limits Vv 6 u y to save the change A 66 PN 624026AE
442. ter a cycle is completed or after cassette analysis is completed Alarm Flashes when a problem is detected and opens the Alarm screen when you AN click the flashing icon Sij Worklist Launches the Worklist screen and closes all others ll The number of orders samples to be processed are indicated below the icon m 5 45 5 GETTING STARTED MENU PATH 5 46 Table 5 4 Generic Toolbar Icons Continued Icon Name Function m Start Starts analyzing the samples in the loaded cassette Autoloader Y il P Flashes after you run a manual stat sample while the Autoloader mode is in progress Manual Stat Mode Allows you to run a manual stat sample Results Archive Displays the Results screen flashes when results have been placed on the Manual Match screen The number of results in the list are indicated under the Results icon EE i Displays the Archive screen e Contextual Toolbar The contextual toolbar Figure 5 34 is located across the bottom of every screen If an icon is grayed out it is unavailable for use on that particular screen See Table 5 5 for a description of each icon Figure 5 34 Contextual Toolbar 2 t amp 8 2 wv Kx dD Table 5 5 Contextual Toolbar Icons icon Re Name Help Function Opens the online Help Print Transmit Prints data to a printer or transmits data to the Host computer la
443. teristics Selecting A 20 Location Physician Adding Editing Deleting A 22 Adding Editing Physician and or Location A 23 Deleting Physician and or Location A 25 Units Selecting the Reporting Unit A 27 Changing Reporting Units A 28 QUALITY ASSURANCE SETUP A 30 Shifts Defining A 30 Selecting Shifts A 31 QA Settings Defining A 34 XB XM Options Enabling Disabling A 35 e Setting XB XM Limits A 37 xvii CONTENTS Minimum Runs Required for Auto Calibration Defining A 40 IQAP ID Entering Editing A 42 CV Limits for Calibration QC and or Reproducibility A 44 A 6 SETTING UP A CONTROL FILE A 46 To manually enter the assigned values and expected ranges A 51 To download the assay values and ranges from the floppy A 52 Reserving Control Lot Numbers A 54 Editing Control Target Values A 56 A 7 AUTO FUNCTIONS SETUP A 60 Rerun Marking a Sample for Automatic Re run A 60 Defining Automatic Rerun Criteria By Flags and or by Parameters A 61 Auto Print for Patient Results A 64 Setting the Auto Print Options for Patient Results A 65 Auto Transmit for Patient Results A 67 Setting the Auto Transmit Options for Patient Results A 68 A 8 SYSTEM SETUP A 70 Local Settings A 70 Changing the Current Date Time and Date Time Format A 71 e Changing the Date Time A 72 e Changing the Date Time Format A 73 Language Selecting A 74 Changing Input Locales A 76 Host Defining Host Communication Settings
444. termination 2 17 WBC Count BASO Count and DiffPlot Development 2 18 WBC Count 2 18 BASO Count 2 18 DiffPlot Development 2 19 WORKFLOW AND WORKLISTS 2 22 Overview 2 22 Order 2 23 Worklist 2 23 CASSETTE TRANSFER CYCLE 2 24 SPECIFICATIONS CHARACTERISTICS 3 1 3 1 INSTRUMENT SPECIFICATIONS 3 1 Dimensions and Weight 3 1 Power 3 1 Supply 3 1 Consumption 3 1 Installation Category 3 1 Grounding Requirements 3 1 Ambient Temperature and Humidity 3 2 Storing Specimens 3 2 Altitude Range 3 2 Recommended Location 3 2 Electromagnetic Environment Check 3 2 Recommended Reagents 3 2 Recommended Controls 3 2 Recommended Calibrator 3 2 Recommended Anticoagulant 3 3 Sample Volume Aspirated 3 3 Dilution Ratios 3 3 Throughput 3 3 Sample Stability 3 3 Sample Identification 3 3 Database Storage 3 3 Flagging Sets 3 3 Output 3 3 Measurements and Computation 3 4 Counting Aperture Diameters 3 4 Reagent Consumption 3 4 Environmental Protection 3 4 vii CONTENTS viii 32 3 3 oat 3 5 PERFORMANCE SPECIFICATIONS 3 5 Reproducibility 3 5 Linearity 3 5 Accuracy 3 6 Carryover 3 6 Reportable Range 3 7 PERFORMANCE CHARACTERISTICS 3 8 Reproducibility 3 8 Accuracy 3 8 Carryover 3 9 LIMITATIONS 3 9 Maintenance 3 9 Blood Specimens 3 9 Platelet Concentrate Extended Linear and Reportable Ranges 3 9 INTERFERING SUBSTANCES 3 10 PRECAUTIONS HAZARDS 4 1 4 1
445. that have a teal background Cassette Position and Run Date Time 5 C A confirmation message appears the Sample ID for the order you selected and the Sample ID for the result you selected are referenced in the message AcT 5diff AL Match order for Sample ID 3119290P with result from tube with 3119290P _ ATTENTION When manually matching an order and results the final report will ALWAYS use the Sample ID from the Worklist order even if a barcode has been read on the tube 9 16 PN 624026AE DATA REVIEW e MANUALLY MATCHING SAMPLE RESULTS WITH WORKLIST ORDERS 6 Verify the order and result information 0 Vv to match the order with the result u X and repeat steps 3 through 5 When a Manual Match is performed the results are always marked with the Manual Match flag If the order that the results are matched with has a flagging set different from the one the sample was processed with the results will be ola ated using the flagging set of the order and the results will be marked with the Recalculated flag e Ifthe information is correct e Ifthe information is incorrect IMPORTANT Risk of sample mis identification if the order Sample ID is not correctly matched to the sample result It is recommended that you created a new Worklist order 7 Verify the Sample ID 8 The order and result are matched and the information appears on the Results List screen
446. the Flagging Set range values PN 624026AE D 13 WORKSTATION MANAGEMENT DELETE DATABASE D 4 DELETE DATABASE Under the Delete Database tab Figure D 2 you can delete all or part of the patient database Understanding the Delete Database Screen See Figure D 2 Figure D 2 Delete Database Screen AcT 5diff AL S store Settings m D 14 EE June 2002 Sun Mon Tue Wed Thu Fri 6 2 0 31 2345 67 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 Gm 27 28 29 312 3 4 5 6 SD Today 06 26 2002 Allows you to select the run date for which all patient data prior to then will be deleted Displays details about the last deletion completed Displays details about the current database Displays the date selected in and the number of results that will be deleted 7367108A Deletes all patient data on prior to the date selected in For example if the selected date is June 26 2002 all patient data analyzed up to and including June 26 2002 will be deleted PN 624026AE WORKSTATION MANAGEMENT D DELETE DATABASE Procedure to Delete Existing Database Do this procedure if you want to delete the existing database from the Workstation s hard drive A amp ANE ATTENTION You cannot recover a deleted database A 1 From the Main Menu screen W aE SF BECKMAN COUuLTER AST Sdiff AL PN 624026AE D 15 WORKSTATION MANAGEMENT DELETE DATABASE AcT 5diff AL
447. the desired record The information is placed on the Worklist entry screen and the fields are populated with any information associated with the Last Name For the First Name l 2 8 38 First Name paree o ooo Type the name at Cm PN 624026AE SAMPLE ANALYSIS 8 ENTERING SAMPLE PATIENT INFORMATION Date of Birth Entering Editing Date of Birth a 1 Anchor the cursor in the first position of the field 2 Type the patient s date of birth OM Age Entering Editing Age ro If a date of birth has been entered the patient s age is automatically entered If a date of birth is unavailable enter the patients age 1 Anchor the cursor in the first position of the field Type the patient s age To indicate the age use Y for years M for months W for weeks and D for days For example 40 years should be entered as 40Y CO Gender Selecting Gender unknown Re Unknown Male Us 2 Highlight the patients gender OM PN 624026AE 8 39 SAMPLE ANALYSIS UNDERSTANDING THE WORKLIST SCREENS 8 8 UNDERSTANDING THE WORKLIST SCREENS Overview There are two screens available for entering and displaying Worklist information a Worklist Grid screen and a Worklist Cassette screen e See Figure 8 5 Worklist Grid Screen e See Figure 8 6 Worklist Cassette Screen TE The right side of both screens is the same Figure 8 4 and contains the fields where the information
448. the login screen appears Om Select the desired option and 3 After doing Shutdown a Startup Procedure is required before operating the instrument again 6 6 PN 624026AE 7 1 INTRODUCTION Quality Assurance includes routine maintenance and service in conjunction with the use of controls and calibrators The combination of these methods provides the assurance of complete quality control and should be applied separately or in combination according to your laboratory state and federal protocols QUALITY ASSURANCE For information on setting up the control files see Heading A 6 SETTING UP A CONTROL FILE Understanding the QA Menu Screen See Figure 7 1 and Table 7 1 Figure 7 1 QA Menu Screen AcT 5diff AL Quality Assurance A m b E a KS X Table 7 1 QA Menu Screen Icons 03 19 2002 14 14 35 icon Name Function amp Quality Control Opens the QC screen See Heading 7 3 RUNNING CELL CONTROLS Calibration Opens the calibration screen See Chapter 10 CALIBRATION Reproducibility Opens the reproducibility screen See Heading 11 7 REPRODUCIBILITY CHECK ioar IQAP Opens the IQAP Download screen See Heading 7 4 DOWNLOADING CELL CONTROL RESULTS FOR IQAP e XB XM Opens the XB XM screen See Heading 7 6 XB ANALYSIS PN 624026AE 7 1 QUALITY ASSURANCE QUALITY CONTROL QC 7 2 Tee
449. the most current mandatory engineering revisions or that you will receive the most current information bulletins concerning the product If you purchased this product from a third party and would like further information concerning this topic call your Beckman Coulter Representative PN 624026AE REVISION STATUS Initial Issue 9 03 Software Version 1 20 Complies with the EU IVD Directive 98 79 EC Issue AA 5 10 Software Version 1 20 Updates were made to the company corporate address Note Changes that are part of the most recent revision are indicated in text by a bar in the margin of the amended page Issue AB 08 12 Software Version 1 2 4 Changes were made to e Ambient Temperature and Humidity e Storing Specimens e Reagent Consumption e SHUTDOWN e Extended Cleaning steps 8 16 e Refer to the Hematology Tube List on the BCI website Issue AC 01 13 Software Version 1 2 4 Changes were made to the graphic in step 8 under Extended Cleaning Note Changes that are part of the most recent revision are indicated in text by a bar in the margin of the amended page Issue AD 02 13 Software Version 1 2 4 Changes were made to the graphic in step 8 under Procedure for Checking Valves Issue AE 05 13 Software Version 1 2 4 Changes were made to enable the display settings in the Help files to default to Always on Top and Maximum to Full Screen Note Changes that are part of the most recent revision
450. the third sample PN 624026AE 9 35 9 DATA REVIEW FLAGS AND MESSAGES GENERATED BY THE INSTRUMENT 9 36 e Hgb Read Error The instrument reads each sample three times If the difference among the three readings exceeds a predefined limit the Hgb MCH and MCHC results are flagged with a voteout V flag Voteout Flag The instrument performs two counts on the WBC RBC Hct and Plt If the results for the two counts differ by more than a predefined limit the WBC RBC Hct and Plt results are flagged with a voteout V flag e Ifthe WBC result is flagged with a V then the DIFF number results are also flagged with a V e Ifthe RBC result is flagged with a V then the MCV MCH MCHC and RDW results are replaced by e Ifthe Hct result is flagged with a V then the MCV and MCHC results are replaced by e Ifthe Plt counts votes out then the Plt result is flagged with a V Patient Range Flags Sample results that appear on a yellow background indicate an H or L flag See Table 9 1 Table 9 1 Patient Range Flags Flag Description H Result is above the patient limit set by your laboratory and may generate an interpretive message on the printout L Result is below the patient limit set by your laboratory and may generate an interpretive message on the printout Action Range Flags Sample results that appear on a red background indicate an HH or LL flag See Table 9 2 Table 9 2 Action Range Flag
451. these procedures as the instrument may contain biohazardous material Cleaning the Tube Holder ARALAS CAUTION Risk of damage to tube holder if it is exposed to temperatures of 70 C 158 F or higher Do not heat sterilize the tube holder or subject it to temperatures of 70 C 158 F or higher Clean the tube holder with a damp cloth and distilled water You can also use a 1 to 2 chlorine solution made from distilled water and high quality fragrance free sodium hypochlorite Cleaning the Outside of the Analyzer ARALAS Clean the outside of the Analyzer with a damp cloth and distilled water to prevent the buildup of corrosive deposits Pay particular attention to the sampling probe area Clean up spills promptly PN 624026AE 11 66 DIAGNOSTICS CLEANING THE ANALYZER Cleaning the Inside of the Analyzer LN Ae VQ If corrosive deposits are evident clean the inside of the Analyzer with a damp cloth and distilled water Be careful not to wipe contaminants into the baths Auto Clean An auto clean automatic cleaning is performed by the instrument after a specified number of samples are analyzed You can set the frequency from 1 to 120 See Auto Clean Frequency Setting in Appendix A Shutdown At the end of each day do Shutdown to rinse the instrument and place it in a stand by mode If Automatic Shutdown is enabled Shutdown is done automatically However if Automatic Shutdown is not enabled do the foll
452. tion Front View Figure 11 17 Computer Workstation Back View Figure 11 10 Inside Left Components 11 76 PN 624026AE 7367440A Flow cell lamp assembly Optical preamplifier card Optical bench Reagent syringes assembly DIFF syringe assembly PN 624026AE 00009 DIAGNOSTICS COMPONENT LOCATIONS Valves LV13 to LV19 Count syringe assembly Valves LV1 to LV12 Waste syringe 2 Fan 11 77 DIAGNOSTICS COMPONENT LOCATIONS 11 78 Figure 11 11 Inside Right Components 7367441A Main card Power supply Traverse card Horizontal traverse assembly Valves LV20 to LV23 Vertical traverse assembly Sampling syringe Waste syringe 1 Valves LV24 to LV29 Diluent reservoir eeqgoqgqgo 00060009 9 Bath shield 9eeeeed6e68 8 8 Bath assembly Valves LV31 to LV35 Interlock Counting heads Drain de bubble baths Hgb photometer Rinse bath First Dilution Hgb bath DIFF bath RBC bath WBC BASO bath PN 624026AE DIAGNOSTICS COMPONENT LOCATIONS Figure 11 12 View of the Pneumatics Area Traverse assembly e ensures probe positioning for the sample stages and distribution and e supports the sampling syringe Sampling syringe e aspirates sample e distributes portions of the specimen into the dilution baths and e takes the sample from the first dilution and distributes it
453. tions a Adda Worklist order and manually match to the result The report will automatically print Manual Match will appear in the Miscellaneous Messages section of the Flags and Messages area of the printout e Ifyou print from the Run in Progress screen after matching Manual Match will appear on the report even though the Run in Progress screen shows Unmatched e Ifyou print from the Run in Progress screen before matching Unmatched will appear on the report b Print the result from the Manual Match screen without matching Manual Match will appear in the Miscellaneous Messages section of the Flags and Messages area of the report See Printing from the Manual Match Screen Without Matching in this appendix Cass Position Scenarios When using the Cass Position Worklist Match Option note that A cassette and position can only appear once on the Worklist The cassette and position cannot be received as part of an order from the Host The cassette and position cannot be added to an order from a Host If your Worklist Match Option is Cass Position see the following scenarios Scenario 1 Cass Position On Manual Match On Auto Print On Worklist Order Cassette Position and Sample ID No Barcode Label Scenario 2 Cass Position On Manual Match OFF Auto Print On Worklist Order Cassette Position and Sample ID No Barcode Label Scenario 3 Cass Position On Manual Match On Auto Print O
454. to Print On Worklist Order Exists but Worklist Sample ID Differs From the Sample ID on the Barcode Label Scenario 6 Barcode On Manual Match On Auto Print On No Worklist Order Scenario 7 Barcode On Manual Match Off No Worklist Order Scenario 1 Barcode On Manual Match On Auto Print On No Worklist Order Summary Report prints with the Sample ID cassette and position information entered for the Worklist order 1 2 Insert tube into cassette Place cassette in Cassette Input Tray O a LLL Sample is analyzed Results are placed on Manual Match screen because there was no Worklist order Options a Add a Worklist order and manually match to the result Manual Match will appear in the Miscellaneous Messages section of the Flags and Messages area of the printout e Ifyou print from the Run in Progress screen after matching Manual Match will appear on the report even though the Run in Progress screen shows Unmatched e Ifyou print from the Run in Progress screen before matching Unmatched will appear on the report PN 624026AE PN 624026AE WORKLIST SCENARIOS WORKLIST MATCH OPTION SCENARIOS b Print results from the Manual Match screen without matching Manual Match will appear in the Miscellaneous Messages section of the Flags and Messages area of the report See Printing from the Manual Match Screen Without Matching in this appendix Scenario 2 Barcode On Manual Mat
455. to select deselect certain areas of the patient sample report to be printed See Patient Report Setup and Enable Define Patient Report Areas in this chapter Allows you to enable disable non patient sample results to be printed automatically See Auto Print Non Patient Results in this chapter Allows you to enable disable Detailed flags on the patient sample report If this option is not selected only Suspect flags will be printed See Patient Report Setup and Display and Print Detailed or Suspect Flags in this chapter Allows you to delete a printer from the list in See Delete Printer in this chapter Allows you to set the default printer from the list in See Set Default Printer in this chapter Allows you to define printer properties for the selected printer See Printer Properties in this chapter Allows you to add a printer See e Add Printer in this chapter Displays the default printer e Set Default Printer in this chapter Displays the available printers Displays the various printer settings Report Header Entering Editing Do this procedure to enter edit your laboratory s information such as lab name address and so forth that you want printed on the top of each patient sample report SS AcT 5diff AL j LN 82 Nec gt Gago 4 Oh 33 a 1 From the Main Menu screen N i mny i 4 zz GE a gt 7 v xXx I li i 12 09 3219 PN 624026AE
456. tomatic startup default after you log in do not disable the Automatic Startup feature It is recommended that you leave Automatic Startup enabled If you do not want your system to do an automatic startup after you log in disable the Automatic Startup feature Keep in mind that if you disable this feature then you will have to select the Startup option every time you log in e Ifthe option is selected Startup automatically runs when you power up the system e Ifthe option is deselected Startup will not automatically run when you power up the system you will be required to select rs if automatic Startup is not selected Do this procedure to enable disable Automatic Startup A e A a COULTER AST Sdiff AL 1 From the Main Menu screen J aE W Er AcT Sdiff AL Setup PN 624026AE SETUP A SYSTEM SETUP AcT 5diff AL System Local Settings Host Printer Cycle Options Date Time Format 3 C the Cycle Options tab Date Time Time s 16 09 DUA Startup 5 the check box next as needed M enabled DO disabled V Automatic 6 E Y to save the change PN 624026AE A 111 SETUP SYSTEM SETUP Shutdown Automatic Do this procedure to turn on or off the automatic Shutdown feature If the option is selected Shutdown automatically runs when you power down the system If the option is deselected Shutdown will not automatically run when you power down the
457. tor failed 1 Do Auto Clean Running Check the motor as instructed in Motors Checking NS Drain 1 sensor timeout Drain 1 sensor timed out Do Auto Clean Running Drain 1 syringe mechanism not reaching home Drain 1 syringe mechanism not reaching home 1 Do Auto Clean Running 2 Check the motor as instructed in Motors Checking PN 624026AE DIAGNOSTICS SYSTEM ERRORS Table 11 5 Error Messages Continued Message Probable Cause Suggested Action Drain 1 syringe motor Drain 1 syringe motor failed 1 Do Auto Clean Running 2 Check the motor as instructed in Motors Checking Drain 2 sensor timeout Drain 2 sensor timed out Do Auto Clean Running Drain 2 syringe mechanism not Drain 2 syringe mechanism 1 Do Auto Clean Running reaching home not reaching home 2 Check the motor as instructed in Motors Checking Drain 2 syringe motor failure Drain 2 syringe motor failed 1 Do Auto Clean Running 2 Check the motor as instructed in Motors Checking Drain 3 sensor timeout Drain 3 sensor timed out Do Auto Clean Running Drain Timeout Problems with draining 1 Do Hardware Reset Rinse bath filter may be 2 Do Replacing the Rinse Bath Drain clogged Filter 3 Ifthe problem persists contact a Beckman Coulter representative Error management failure Error management failed Do Hardware Reset Error on cycle 0 A cycle error occurred Do H
458. tray and then retracts them It does not complete a full cycle Cassette transfer The cassette transfer mechanism moves a short Lower front compartment mechanism distance from left to right and then returns It does to the right of the cassette not complete a full cycle Note To observe the cassette transfer mechanism movement open the left front door and look into the lower front compartment on the right of the cassette input tray input tray Counting syringe The counting syringe makes a full stroke and returns to home Left compartment see Figure 11 10 Dilution syringes The dilution reagent syringes assembly makes a full stroke and returns to home Left compartment see Figure 11 10 Draining syringe 1 The draining waste syringe 1 makes a full stroke and returns to home Right compartment see Figure 11 11 Draining syringe 2 The draining waste syringe 1 makes a full stroke and returns to home Left compartment see Figure 11 10 Flowcell syringes The DIFF syringe assembly makes a full stroke and returns to home Left compartment see Figure 11 10 Piercing mechanism The piercing mechanism extends the needle then retracts it to home Note To observe the needle movement open the left front door and look into the left side of the sampling station Upper front compartment Sampling probe The vertical traverse assembly moves the sampling probe down t
459. ts are placed on the Manual Match screen because an AUTO_SID was assigned and the results could not be matched to a Worklist order 1 Insert tube into the 1st position of cassette 10 2 Place cassette in Cassette Input Tray i 3 PPPI 4 Sample is analyzed 0 PPP to see the Run in Progress screen which shows Sample ID as AUTO_SID C P 10 1 Ee 6 0 E which was flashing to indicate results are on the Manual Match screen 7 p for the Manual Match screen 8 Results are placed on the Manual Match screen Order None existed for this sample Results shows Sample ID as AUTO_SID and C P 10 1 Options a Adda Worklist order and manually match the order to the result To add the Worklist order 2 Ose To manually match the order to the results 1 Ole a 3 Highlighted the order 4 Highlighted the result 5 OF b The report automatically printed Manual Match appeared in the Miscellaneous Messages section of the Flags and Messages area of the printout PN 624026AE PN 624026AE WORKLIST SCENARIOS WORKLIST MATCH OPTION SCENARIOS The Sample ID on the report will be the Sample ID entered when the Worklist order was created Cass will be 10 and Pos will be 1 e Ifyou print from the Run in Progress screen after matching Manual Match will appear on the report even though the Run in Progress screen shows Unmatched e Ifyou print from the Run in Progress screen before ma
460. turn to the desired screen PN 624026AE 11 45 DIAGNOSTICS DIAGNOSTICS USER SCREEN Park the Syringes Do this procedure to park the syringes if the instrument will be transported or will not be used for a long time ES JAcT Sdiff AL S LN 2 NET Seco COULTER COouLTeR AST Sdiff AL B 1 From the Main Menu screen 0 2 0A PN 624026AE 11 46 DIAGNOSTICS l DIAGNOSTICS USER SCREEN 0E 4 0 Run Park Syringes 5 Allow the Analyzer to complete the function 6 Y as needed to return to the desired screen PN 624026AE 11 47 DIAGNOSTICS DIAGNOSTICS USER SCREEN Traverse Service Position Do this procedure to put the traverse assembly in a service position for easy access LN se AMEX Sra COULTER COULTER AST Sdiff AL 1 From the Main Menu screen 0 OFF Ow 11 48 PN 624026AE DIAGNOSTICS l DIAGNOSTICS USER SCREEN 4 C Run Traverse Service Pos 5 Allow the Analyzer to complete the function 6 o d as needed to return to the desired screen Edit Accept Calibration Factors Note For Supervisor or Service use only Do this procedure to edit accept the calibration factors A amp Nec E COULTER COULTER AST Sdiff AL PN 624026AE 11 49 DIAGNOSTICS DIAGNOSTICS USER SCREEN 2 0A Om OF 11 50 PN 624026AE DIAGNOSTICS Ji DIAGNOSTICS USER SCREEN ATTENTION If you
461. tute of Health e Classifications of Etiological Agents on the Basis of Hazards 3d ed June 1974 Center for Disease Control U S Public Health Service Moving Parts WARNING Risk of personal injury Operating the instrument with doors and or covers open can cause personal injury When you operate the instrument be sure all covers and doors are closed PN 624026AE 4 1 PRECAUTIONS HAZARDS OPERATIONAL HAZARDS 4 3 OPERATIONAL HAZARDS Safety symbols alert you to potentially dangerous conditions These symbols together with text apply to specific procedures and appear as needed throughout this manual Symbol Warning Condition Action Biohazard Consider all materials Wear standard laboratory attire and follow be specimens reagents controls safe laboratory procedures when handling any calibrators and so forth and areas material in the laboratory these materials come into contact with as being potentially infectious Probe hazard The probe is sharp Avoid any unnecessary contact with the probe and may contain biohazardous and probe area materials such as controls and calibrators electrical shock when instrumentis analyzer from the electrical outlet plugged into the power source WA Electrical shock hazard Possibility of Before continuing unplug the ACeT 5diff AL hazard based on specific conditions provided when you see this symbol Conditional hazard Possibility ofa Pay
462. ube holder 2 If you insert a tube or vial upside down into the tube holder Always insert the tube bottom first int the holder 3 Insert the tube vial into the appropriate 12 00 o clock pierce position in the tube holder For information on the correct position of each tube within the tube holder refer to the Hematology Tube List available on the BCI website at www beckmancoulter com 9 23 5 GETTING STARTED WORKING WITH THE TUBE HOLDER 5 24 IMPORTANT Risk of erroneous results if the sample tube is not placed in the holder correctly and if the tube holder is not positioned correctly in the instrument Ensure that the tube is placed in the 12 00 o clock pierce position within the tube holder 4 Ensure that the tube is in the pierce position 12 00 o clock within the tube holder e Ifthe tube is in the pierce position within the holder do step 5 e If the tube is not in the pierce position within the holder rotate the holder until the tube is in the pierce position If the tube holder is not in the correct position when you close the door an error message will appear 5 Close the tube holder door by pushing it gently into the instrument as shown The red and green LEDs flash during analysis e When the red LED remains illuminated the system is busy analyzing the sample e When the green LED remains illuminated the instrument is ready for the next analysis Note The door c
463. ults and runs that can be reviewed by the user based on patient or date background count Measure of the amount of electrical or particle interference blank cycle Runs diluent through the system to clean it out calibration A procedure to standardize the instrument by determining its deviation from calibration references and applying any necessary correction factors calibration factors These are correction factors that the system uses to fine tune instrument accuracy calibrator A substance traceable to a reference method for preparation or material used to calibrate graduate or adjust measurement carryover The amount in percent of blood cells of Hgb remaining in diluent following the cycling of a blood sample cell control A preparation made of human blood with stabilized cells and surrogate material used for daily instrument quality control characteristics See performance characteristics coefficient of variation An expression in percent of data SD spread related to the mean CV SD mean x100 control A substance used for monitoring the performance of an analytical process or instrument conventions A standard style or format used in a manual CV See coefficient of variation default An original factory setting expiration date The last day that you can use that specific lot number of reagent control or calibrator femtolite
464. ults to ensure they are within the acceptable ranges before analyzing patient samples e If the parameter values of the control results are within the acceptable ranges you are ready to analyze patient samples See Heading 8 SAMPLE ANALYSIS e If one or more parameter results are out of the control range the out of range result is backlit in red and the result is flagged with an H or L The data should be reviewed according to your laboratory protocol or go to step 2 7 20 PN 624026AE QUALITY ASSURANCE T RUNNING CELL CONTROLS ATTENTION A eT 5diff Control Plus cell control is analyzed as a patient sample Due to the technology used and the nature of the control material the basophil analysis generates a BASO analytical alarm and will cause the BA and the BA to be inhibited on the Run in Progress screen just as a patient sample would if the same result was obtained However to permit the performance of the BA parameter to be assessed the BA and BA from the ACeT 5diff Control Plus cell control are reported into the control file with an S flag to indicate that these would normally have been suppressed if it was a patient sample The S flag prints on the QC report when printed from the QC Data Grid screen 2 To manually reject results from the control file de select exclude the run s you want to exclude from the statistics selected included O de selected excluded 3 When control results are not w
465. ure 5 49 Flagging Set Selection and Update Process Current No Flagging set Yes Default Flagging Set Current No Flagging set based Yes gt on Age or Gender 2 No Age Yes lt 14yr Anabi Select child range Flagging set remains as selected Te amp 7367518B 5 59 GETTING STARTED UNDERSTANDING HOW FLAGGING SETS ARE APPLIED 5 60 PN 624026AE DAILY ROUTINE 6 6 1 WASTE CONTAINER LEVEL CHECK At the beginning of each day check the waste container to determine if it needs to be replaced If so follow instructions in the Replacing the Waste Container in Chapter 11 6 2 PRINTER CHECK At the beginning of each day or shift be sure the printer is ready to print 1 Be sure there is an adequate paper supply in the printer e Ifso go to step 2 e Ifnot add paper according to the printer s user manual 2 Tuam the printer on 3 Be sure the printer is ready See your printer manual for details 6 3 STARTUP Overview The Startup cycle takes about 3 minutes to be completed If Automatic Startup is enabled Startup automatically runs if the instrument is powered up from a powered down state If Automatic Startup is disabled on your instrument see Startup Automatic Appendix A for details Startup results automatically display on the Run in Progress screen During the first Startup after a New Workday the system checks to see if there is enough reagent to complete the day s
466. uto Print On Worklist Order Cassette Position and Sample ID No Barcode Label E 10 Scenario 8 Cass Position On Manual Match On Auto Print On Worklist Order Cassette Position and Sample ID Barcode Label E 10 Scenario 9 Cass Position On Manual Match On Auto Print On No Worklist Order No Barcode Label E 12 PN 624026AE Scenario 10 Cass Position On Manual Match Off Auto Print On No Worklist Order No Barcode Label Scenario 11 Cass Position On Manual Match On Auto Print On No Worklist Order Barcode Label E Scenario 12 Cass Position On Manual Match Off Auto Print On No Worklist Order No Barcode Label E 13 13 E 14 CONTENTS Scenario 13 Cass Position On Manual Match On Auto Print On Worklist Order Sample ID only Barcode Label E 15 Scenario 14 Cass Position On Manual Match Off Auto Print On Worklist Order Sample ID only Barcode Label E 16 Scenario 15 Cass Position On Manual Match Off Auto Print On Worklist Order Cassette Position and Sample ID Barcode Label E 17 Scenario 16 Cass Position On Manual Match Off Auto Print On Worklist Order Sample ID only No Barcode Label E 18 Scenario 17 Cass Position On Manual Match Off Auto Print On Worklist Order Cassette Position and Sample ID Barcode Label E 19 Scenario 18 Cass Position On Manual Match On Auto Print On Worklist Order Cassette Position and Sample ID Barcode Label
467. ve replicate runs from one normal fresh whole blood sample without flags Table 3 2 Reproducibility Specifications Parameter CV Test Level WBC lt 2 0 10 0x103 uL RBC lt 2 0 5 00x106 uL Hgb lt 1 0 15 0 g dL Het lt 2 0 45 0 Plt lt 5 0 300 0x108 uL Linearity Linearity is assessed using a commercially available low range and full range linearity test kit When analyzed and results computed according to the manufacturer s instructions the results will be within the limits in Table 3 3 Table 3 3 Linearity Specifications Difference Parameter Units Linearity Range Whichever is Greater WBC 103 uL 0 4 to 120 0 0 3 or 7 0 RBC 106 uL 0 3 to 8 0 0 07 or 5 0 Plt 103 uL 10 0 1 000 10 0 or 10 0 100 0 1 900 Hgb g dL 1 3 to 24 0 0 3 or 2 0 Het 2 0 67 0 2 0 or 3 0 whole blood An extended platelet linear range and reportable range can be applied if the Platelet Concentrate extended range mode is active and the sample result for Hgb lt 2 0 g dL and Pit gt 15 0 x 103 uL If these conditions are met the Pit result is flagged using the extended linear and reportable range limits Additionally the use of the extended linear and reportable ranges is indicated by a C flag next to the Plt result and the message PLT Concentrate appears in the Tree View Flags and Messages PN 624026AE 3 5 3 SPECIFICATIONS CHARACTERISTICS PE
468. ving the right panel 11 4 removing the top cover 11 5 reordering parts 11 103 replacing reagents frequency 11 1 replacing the flow cell lamp 11 96 replacing the right panel 11 4 replacing the Rinse bath drain filter 11 103 reportable range definition Glossary 2 Het 3 7 Hgb 3 7 Plt 3 7 RBC 3 7 WBC 3 7 PN 624026AE PN 624026AE reporting units available formats A 27 selection procedure A 27 reporting unmatched results without a Worklist order 9 18 Reproducibility definition Glossary 2 frequency 11 1 if poor 11 124 overview 11 52 specifications 3 5 reproducibility characteristics 3 8 Reproducibility screen 11 52 rerunning samples 8 32 automatically 5 1 8 33 in a Worklist 8 32 manually 8 32 marking for automatic re run A 60 reruns of AUTO_SID and Cass Position 8 32 reserving cell control lot numbers 7 4 reserving control lot numbers A 54 Reset Autonumbering option 5 12 restoring default flagging set values A 130 results definition Glossary 2 on the Manual Match screen 5 2 9 13 results exceeding instrument capacity 9 35 Results List screen 9 19 results reported as 0 Het 9 35 Hgb 9 35 RBC 9 35 WBC 9 35 Results screen 9 11 review flag description 9 38 reviewing cell control results 7 20 reviewing flagged results 9 34 reviewing platelet counts 9 34 reviewing XB Batch Details screen 7 55 Rinse reagent description 1 13 rinsing the flow cell 1
469. ween the thresholds labeled and Figure 2 17 Figure 2 17 Areas Used to Determine WBC and BASO Parameter Results Q WBC basophils BASO count Number of cells per volume x factor of calibration in percentage relative to the number of counted cells BASO plus WBC nuclei BASO BASO count WBC x WBC count 2 18 PN 624026AE OPERATION PRINCIPLES 2 PARAMETER DEVELOPMENT DiffPlot Development The instrument s DiffPlot analysis is based on three essential principles l Dual Focused Flow DFF fluid dynamics which is a process by which individual cells or particles are focused in a stream of diluent hydrodynamic focusing For additional information see Dual Focused Flow DFF in this chapter 2 The volume measurement Coulter Principle For additional information see Coulter Principle in this chapter 3 The measurement of transmitted light with zero degree 0 angle which permits a response proportional to the internal structure of each cell and its absorbance For additional information see Absorbance Cytochemistry in this chapter From these measurements a DiffPlot is developed with optical transmission absorbance on the X axis and volume on the Y axis See Figure 2 18 Figure 2 18 DiffPlot Regions Absorbance The study of the DiffPlot permits the clear differentiation of four out of five leukocyte populations In a typical whole blood sample the basophil population is very small
470. when compared with the other four white cell populations For additional DiffPlot information see the following tables e Table 2 7 defines the DiffPlot regions e Table 2 8 defines immature white blood cells PN 624026AE 9 19 OPERATION PRINCIPLES PARAMETER DEVELOPMENT Table 2 7 DiffPlot Regions Defined Region Definition Neutrophil Neut Neutrophils with their cytoplasmic granules and segmented nuclei scatter light according to their morphological complexity A hypersegmented neutrophil gives an increased optical response when compared to a young neutrophil population The higher the complexity of the cell the further to the right they appear in the DiffPlot Figure 2 18 Lymphocyte Lymph Lymphocytes typically being small with regular shape are e smaller in volume and lower in absorbance than the other cells and e positioned in the lower region of the DiffPlot Figure 2 18 Normal lymphocyte populations typically have a homogeneous volume with a Gaussian bell shaped distribution Large lymphocytes reactive lymphoid forms stimulated lymphocytes and plasma cells are found in the upper portion of the lymphocyte region Figure 2 18 The lower area of the lymphocyte zone is normally empty however when small lymphocytes are present a population may exist in this area Figure 2 18 The presence of platelet aggregates is indicated by a distribution pattern that moves from the DiffPlot origin
471. when the R next to Small number of particles NE NE lymphocytes counted inthe SL Ly LY Pit aggregates region are higher MO MO than the SL limit coo gog NRBCs Default values ATL ATL RBCs resistant to 100 or 50 IMM IMM ysis stroma particles SL displayed and printed in DiffPlot and Histogram section of the Flags and Messages area SL1 Occurs when the May trigger Pit aggregates number of particles interpretive NRBCs inthe SL region is messages higher than the SL1 NRBCs Plt RBCs resistant to number limit and aggregates and YSIS stroma when the NRBCs plus Pit Small abnormal percentage of aggregates lymphocytes particles inthe SL 14 js region relative to displayed and the lymphocyte printed in the region exceeds the DiffPlot and Absorbance SL percentage Histogram limit section of the Default values 5 Flags and or 45 particles Messages area NL Occurs when the R next to Small Neutrophils number of particles NE NE without granules Volume Debris DB Absorbance in the NL separation region is above the limits set Default values 3 or 120 particles LY and LY NL is displayed and printed in the DiffPlot and Histogram section of the Flags and Messages area and or slight nuclear segmentation Lymphocytes with segment nuclei Neutrophils with weak membranes smudge smear cells PN 624026AE 9 39 DATA REVIEW FLAGS AND M
472. wing list provides an overview of the tube holders and the tubes vials they accommodate Refer to the Hematology Tube List available on the BCI website at www beckmancoulter com Tube Holder 1 Types of Collection Devices or Control Vials Position Most 13 mm x 75 mm evacuated specimen tubes containing either K3EDTA or K EDTA for collecting whole blood volumes of 2to5 mL e COULTER A eT 5diff Control Plus control tubes Position COULTER ACeT 5diff Cal Calibrator vial Position Sarstedt Monovette 11 5 mm x 66 mm specimen tube collecting 2 7 mL of whole blood Position O Becton Dickinson Microtainer for collection of 0 25 to 0 50 mL of whole blood Tube Holder 2 Position 1 Becton Dickinson Microtainer for collection of 0 25 to 0 50 mL of whole blood Position Becton Dickinson 10 25 mm x 64 mm Vacutainer for collecting 3 mL of whole blood Position RAM Scientific microcollection device for collecting 125 pL of whole blood Position 13 mm x75 mm specimen tube with multiple labels 1 6 PN 624026AE USE AND FUNCTION DESCRIPTIONS Workstation PC Use the Workstation Figure 1 9 to set up and operate the instrument e Figure 1 9 shows the Workstation e Figure 1 10 shows the back of the Workstation Figure 1 9 Workstation PC Monitor Monitor power ON OFF button Mouse PC power ON OFF button Note Your monitor may differ from what is shown a aana Sees anna B
473. work If there is not enough reagent to complete the day s work Reagent s Low Insufficient Reagent to Complete The Daily Workload appears If this occurs e Identify the low reagent and change it according to the Replacing Reagents Procedure in Chapter 11 OR e Continue and change the reagent when the specific reagent low message is displayed Background Counts If the background counts are not within acceptable limits after the first Startup cycle the instrument automatically performs Startup up to two more times If Startup fails after the third attempt a STARTUP FAILED message appears on the screen and on the report PN 624026AE 6 1 DAILY ROUTINE STARTUP Background limits are fixed and cannot be changed The acceptable background limits are WBC lt 0 3 x 103 pL3 RBC lt 0 03 x 10 pL3 Hgb lt 0 3 g dL Plt lt 7 0 x 107 pL3 Flowcell WBC lt 0 3 x 107 nL3 Startup Procedure Do this procedure e If Automatic Startup is disabled and you powered up the system e If you want to run Startup again e Tf a flashes The Startup cycle runs for approximately 3 minutes on m A Aer 7 1 From the Main Menu screen 0 at When Startup begins the progress appears in the status bar Startup will be completed in about 3 minutes Q 7 a JE s Juro N lt 3X 3 amp The progress bar shows the progress of the Startup routine Startup BANANEN 6
474. ya Identifies the Workstation management section xxxii PN 624026AE USE AND FUNCTION 1 1 INTENDED USE General The COULTER ACeT 5diff Autoloader Figure 1 1 ACeT 5diff AL Analyzer AL hematology analyzer Figures 1 1 is a 26 parameter fully automated hematology analyzer including a five part leukocyte differential counter capable of analyzing samples in a closed vial Autoloader mode or a Manual Stat mode open or closed vial Of the 26 reported parameters e 20 parameters are For In Vitro Diagnostic Use WBC RBC Hgb Hct MCV MCH MCHC RDW Plt MPV NE NE LY LY MO MO EO EO BA and BA e 6 parameters are qualitative and are For Research Use Only Not for use in diagnostic procedures They are Pct PDW IMM IMM ATL and ATL Purpose The purpose of the AC T 5diff AL hematology analyzer is to identify normal patient results with all normal system generated parameters and to flag or identify patient results that require additional studies PN 624026AE 1 1 USE AND FUNCTION DESCRIPTIONS 1 2 1 2 System Overview The AL system Figure 1 2 consists of the the Analyzer the Workstation PC monitor keyboard mouse and software a printer a barcode wand optional IMPORTANT Risk of instrument damage and or erroneous results if you install additional software onto the PC or if you use the PC for anything other than stated within this documentat
475. you may need to scroll down to locate the entry you want to view Once you locate the desired entry scroll right to see additional information 4 To add comments to the log do Adding Comments to the Logs in this chapter 9 To print log entries do Printing Log Entries Adding Comments to the Logs For the Reagents log or Calibration log you may be prompted to enter a comment at the time the system makes the entry if that option is selected in Logs Comments Prompt Do this procedure to add comments to any of the logs after the entry is made 1 Ifthe log is not already open a From the Main Menu screen 0 b u the icon for the desired log 3 Type your comment up to 50 characters in the comment window AcT 5diff AL 4 J to save the comment 5 View the log to verify that the comment was added Remember you may need to scroll to the right to see the comment PN 624026AE 11 129 DIAGNOSTICS LOGS Adding Entries to the Maintenance Log Except for the Maintenance log the system automatically makes the entries to the appropriate log For the Maintenance log you must manually add the entry to detail the maintenance you performed on the system Do this procedure to manually add an entry to the Maintenance log 1 If the log is not already open a From the Main Menu screen o b 0 as to open the log 11 130 PN 624026AE DIAGNOSTICS Ji LOGS Oba a Type the entry information
476. ytosis triggering condition 9 45 Leukopenia triggering condition 9 45 linearity definition Glossary 1 specifications 3 5 LIS definition Abbreviations 1 Glossary 1 LL flag definition 9 36 LN flag 9 38 9 40 locating Startup results 5 1 location of system components 11 76 logging off 5 9 logging on 5 3 login access levels 5 28 name 5 28 passwords 5 28 Login screen 5 29 New Workday options 5 11 5 12 logs adding comments A 14 being prompted for comments A 14 overview 11 126 purpose 5 3 11 124 Logs icon 5 31 5 57 Logs Menu screen 11 125 lot number definition Glossary 1 LY description 2 20 interfering substances 3 12 lymphocytes See LY Lymphocytosis triggering condition 9 45 Lymphopenia triggering condition 9 45 m definition Abbreviations 1 MACRO flag definition 9 43 Macrocytes triggering condition 9 46 Macrocytosis triggering condition 9 46 Macroplatelets triggering condition 9 47 Main card function 11 81 location 11 81 Main Menu screen 5 30 maintenance schedule 11 1 Index 7 INDEX Index 8 Manual Match matching Sample IDs to results A 12 OFF A 12 ON A 12 overview A 9 Manual Match flag 9 17 Manual Match message 9 51 Manual Match option turning on or off A 12 turning ON OFF A 12 Manual Match screen 9 14 opening 9 19 when are results placed there 5 2 9 13 manually entering control values A 51 manually matching cell control results 9 15 manually matchi
477. zer uses a number of thresholds to sort the particles into several size volume categories and to develop a size distribution curve of the particles The RBC distribution curve shows cells in their native size Figure 2 14 is an example of an RBC histogram with a normal RBC size distribution Figure 2 14 Typical RBC Histogram 30 300 7616036A PN 624026AE OPERATION PRINCIPLES 2 PARAMETER DEVELOPMENT Parameter Results Obtained Using the RBC Histogram e MCV calculation MCV Mean Cell Volume is calculated using the Hct and the RBC count The MCV is displayed and printed in femtoliters fL Note fL is the US unit format Other formats are available See Units Selecting the Reporting Unit in Appendix A e RDW calculation RDW Red cell Distribution Width is an index of the variation or spread in the size of the red blood cells The study of the RBC distribution detects erythrocyte anomalies linked to anisocytosis and enables the clinician to follow the evolution of the width of the curve relative to the cell number and average volume Displayed and printed as a percentage RDW is calculated using the standard deviation SD of the RBC population and the MCV RDW KSD MCV where K System constant SD Calculated standard deviation based on the red cell distribution MCV Mean Cell Volume of the red cells MCH and MCHC Calculations e MCH calculation MCH Mean Cell Hemoglobin is calculated from the Hgb value

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