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11 - Beckman Coulter

1. Figure 1 9 Back of Workstation e006 08 8 6 e 1 6 Monitor Monitor power ON OFF button Mouse PC power ON OFF button Power supply cord connector monitor Power supply cord connector PC Mouse connector Keyboard connector Analyzer connector Printer connector Monitor connector Host communications connector Note Configurations may vary from what is shown here PN 624021CA 1 3 PANELS USE AND FUNCTION 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 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 Hct 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 Volume PDWt Platelet Distribution Width Pett Plateletcrit PN 624021CA tPct and PDW are derived parameters and are For Research Use Only Not for use in diagnost
2. 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 4ACDZ 4ACD Ill MAII 404 1 404 236 MANI 242130606 RC01106065 123457 Ill AAA S RCL30808s 242110808 12345670 i 10 11010 lz34567855 Ill WALL A CI3121z ACIIlZl1z lz34567859012 Ill ll 1 1414 111414 12345678901231 PN 624021CA B 7 BARCODE SPECIFICATIONS CONNECTING THE OPTIONAL BARCODE READER Table B 7 Interleaved 2 of 5 Options With Fixed Length Characters Test Labels Continued TACIS3l1616z 111616 lz34567880123452 15 4 1304165 4 1104165 B 8 B 8 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 Power Down the System then Power Up the System 2 Repeat the programming sequence CONNECTING THE OPTIONAL BARCODE READER Do this procedure to connect the barcode reader to the Workstation or to verify the connection 5 Power down the instr
3. Worklist Run Results Quality Assurance Reagent Status Reagent RINSE Fx HGB LYSE WECLYSE DILUENT Lot Number 100202 02367 100802 00117 100202401700 100402800176 100302000068 Opened Date 09 04 2001 09 04 2001 09 04 2001 09 04 2001 09 04 2001 Expiration Date 13 10 2001 08 08 2001 05 10 2001 23 08 2001 11 08 2001 Admin Admin Admin Admin Administrato ree mmm 3 HGB Passed J 11704 2001 121341 PM 3 IfFailed appears on any Startup result a Startup Log tab and evaluate the numeric results Or U Cycles gt Startup to initiate another Startup routine c Ifthe Startup continues to fail contact a Beckman Coulter representative Note the Run tab to view the Startup results A gu aD ed niodo w zug wd vi 20 ost Results Quality Assurance AnalyzerLogs Startup Date Time wec nec PLT Status JEomment 04 18 2001 09 04 19 AM 00 0 00 0 1 Passed 04 17 2001 06 14 49 PM 00 0 00 0 1 Passed 04 17 2001 06 09 47 PM O Feld 04 05 2001 08 43 37 AM 00 000 0 T Passed 04 04 2001 09 04 41 AM 00 0 00 0 1 Passed 04 03 2001 081801 00 000 o 1 Passed 04 02 2001 09 09 23 AM 00 000 0 1 Passed 03 30 2001 08 13 30 AM 00 000 0 1 Passed 03 30 2001 080325 00 000 0 Passed 03 29 2001 08 51 19 AM 00 000 0 1 Passed 03 23 2001 08 45 13
4. All Reagents EN SEQ 72 Ele Cycles Diagnosics Selup Help A 7217 1 E wer zii v 3 Worklist Run Results Quality Assuran p Reagent Status i BE RINSE Fx WBCLYSE DILUENT 1 the Analyzer Logs tab to display the Lot Number 0010201441 00402 00005 0020200846 00402801284 0302000035 H d Opened Date 03 27 2001 03 27 2001 03 27 2001 03 27 2001 03 27 2001 eagent win OW Expiration Date 03 30 2001 04 20 2001 10 05 2001 08 23 2001 08 11 2001 Operator Administrato Administrato Administrato Administrato 1 r Stertup System Background WBC PBC HGB PLT Resuts Corecin Reagents ReagentLog Startup Loa J_ ErorLoa J Calibration Loa Maintenance Los Service Log J I 03 27 2001 1617 06 LN Net 2 Remove the stopper assembly from the container PN 624021 11 51 DIAGNOSTICS REPLACEMENT PROCEDURES 3 Uncapa new diluent container 4 Putthe cap from the new container onto the empty container 9 Properly dispose of the empty container 6 Insert the stopper assembly tube into the new container 11 52 PN 624021CA DIAGNOSTICS REPLACEMENT PROCEDURES 1 Tighten the stopper assembly onto the container to ensure an adequate seal IMPORTANT Risk of instrument error if the diluent container is further than 80cm 31 5 in below the instrument Be sure the diluent
5. T1 at Room Parameter Temperature T4 T8 T24 T48 WBC Mean x103 uL 6 52 6 60 6 54 6 38 5 92 RBC Mean x106 uL 4 620 4 610 4 604 4 606 4 618 HGB Mean Hgb 13 70 13 64 13 64 13 64 13 64 Mean 95 41 04 40 82 40 70 40 70 40 66 MCV Mean fL 88 60 88 40 88 40 88 20 87 80 RDW Mean 96 13 08 13 28 13 28 13 72 13 66 PLT Mean x103 uL 355 4 352 0 352 2 342 6 350 4 MPV Mean fL 8 18 8 34 8 42 8 78 8 82 Mean 54 10 54 46 54 00 53 98 51 48 LY Mean 31 96 31 66 32 02 31 76 32 94 MO Mean 7 60 7 32 7 02 7 40 8 30 E096 Mean 5 64 5 78 6 14 6 06 6 30 Mean 0 70 0 78 0 82 0 80 0 98 NEZ Mean x103 uL 3 60 3 67 3 61 3 51 3 15 LY Mean x103 uL 2 02 2 02 2 03 1 95 1 85 MO Mean x103 uL 0 49 0 48 0 45 0 46 0 49 EO Mean x103 uL 0 38 0 39 0 41 0 41 0 38 BA Mean x103 uL 0 04 0 05 0 05 0 05 0 05 LIMITATIONS Maintenance Failure to properly execute the maintenance procedures in Chapter 11 DIAGNOSTICS may compromise the instruments reliability Blood Specimens PN 624021CA 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 information see Heading 3 5 INTERFERING SUBSTANCES SPECIFICATIONS CHARACTERISTICS INTERFERING SUBSTANCES 3 5 INTERFERING SUBSTANCES Table 3 12 shows a list of known limitations of automated blood cell counters t
6. Table 9 1 Definition of DIFF Flags Continued DiffPlot Region Suspected Flag DiffPlot Region Affected Description Flags Abnormalities SL1 Occurs when the May trigger aggregates number of interpretive NRBCs particles in the SL messages region is higher NRBCs Plt RBCs resistant to than the SL1 aggregates and ysis stroma number limit NRBCs plus Pit Small abnormal E when the aggregates lymphocytes gt percentage of SL4 is displayed particles in the SL ang printed in region relative to the DiffPlot and the lymphocyte Histogram Absorbance region exceeds section of the theSLt Flags and percentage limit Messages area Default values 5 or 45 particles NL Occurs when the R next to Small Neutrophils number of NE without granules particles in the NL LY and LY and or slight separation region FEM nuclear is above the limits NL Is displayed segmentation 2 set and printed in ith 2 j the DiffPlot and YMPnocyles wi 9 efault values 3 Histogram segment nuclei or 120 particles section of the Neutrophils with Flags and weak membranes Messages area smudge smear cells Absorbance MN Occurs when the R next to Monocytes with number of ATL ATL granules or particles in the MN IMM IMM E hyperbasophilic separation region NE NE monocytes is above the limits woo and MO Immature Volume Absorbance
7. 1 Prepare the Workstation for sample processing a b 8 28 the Results tab Verify that the active archive is open white background on Worklist and Results list If an old archive is open green background File gt gt Close Archive If according to your laboratory protocol it is time to create a new archive File New Archive Note You cannot create a new archive until any previously opened archive if any is closed PN 624021CA RUNNING PATIENT SAMPLES WITHOUT USING THE WORKLIST SAMPLE ANALYSIS 8 2 the Run tab Jd AOL T zs vj 2 gs Quali Analyzer Logs 27 Patient Name Gender Date of Bith Panel Unknown f cec lun Date Ti Comment 63 27 2001 111242 wee foo v msc oo v 00 uer v pur fi v Sample ID isos 123 Nest 124 03 28 2001 1400 06 3 Enter the Sample ID by typing it or scanning it from the barcode label Ifscanning the Sample ID go to step 4 If typing the Sample ID 1 2 3 4 3 6 PN 624021CA in the Sample ID Next field Type the Sample ID Press Verify that the Sample ID in the Sample ID Next field is correct Press to move the cursor to the Panel field Go to step 5 SampeID Pane Patient 1D 123 124 CBC DIFF 8 29 SAMPLE ANALYSIS RUNNING PATIEN
8. Sal dD Ed cde wi zE UM 2l Bs the Quality Assurance window 39 440 135 363 257 2 100 442 135 356 255 2 39 443 135 358 251 39 440 135 364 253 39 440 135 358 264 ECAE 100 437 134 355 E 100 438 134 356 253 Eaton Date ss 440 135 355 248 2 101 435 134 352 253 Mean 99 440 134 357 58 New Cal Factor 124 201 36 4265 20008 2658 Old Cal Factor 12281 201 7 4278 20038 267 83 1 37 083 05 09 278 Reference Values 100 438 134 356 255 Setup Calibration Select Parameters 2 L2 mem Com Repduc iy Calibration 03 28 2001 21448 FM 3 Setup Calibration 4 Enter lot number from the package insert PN 624021CA 10 3 CALIBRATION AUTO CALIBRATION 10 4 Press to move the cursor to the Expiration Date field Enter the expiration date from the calibrators label nme a at the Expiration Date field b Select the date from the calendar 3l 2 15 ed J dA 2 a Workist Fun Results Quality Assurance Ansiyzer L as Calibrator Details E h E E m 255 h fio 357 258 Ql SO ell Setup Calibration 15 16 17 18 19 20 21 papas BBNBRTB 29 30 HEE Z Today 03 28 2001 ontrols ieproi Calibration GNZ 201 2185
9. to save and exit the PN 624021CA SETUP A QUALITY ASSURANCE SETUP Reproducibility Run Results Do this procedure to run reproducibility A Ne 1 the Quality Assurance tab 2 the Reproducibility tab at the bottom of the window Eag Reproducibility Taras 03 09 2001 15 49 58 3 Select the panel CBC or CBC DIFF a the Panel field Select the desired panel CBC or CBC DIFF a A 83 PN 624021CA SETUP QUALITY ASSURANCE SETUP A 84 4 Runreproducibility samples IMPORTANT Risk of erroneous results if sample is not properly mixed before analysis Mix the blood specimen gently and thoroughly before analysis according to the tube manufacturer s recommendations and your laboratory protocol a Prepare and mix fresh normal whole blood samples as defined by your laboratory guidelines b Insert the tube vial into the correct slot of the tube holder c Close the tube holder door analysis begins IMPORTANT Do not log out of the Workstation while the Analyzer is running a cycle Logging out during an Analyzer cycle will cause problems with the Analyzer Workstation communication d Remove the tube vial when the door opens IMPORTANT Risk of erroneous results if sample is not properly mixed between analyses Mix the blood specimen gently and thoroughly before ea
10. e Use the Search Results tab view to search for and delete sample results from either the current or closed archives 2 Select each sample result that you want to delete a Press the key and on each sample you want to delete b Verify that a black dot p or P appears in the far left column of each selected sample and that the row is highlighted PN 624021CA 9 13 DATA REVIEW REVIEWING FLAGGED RESULTS 9 3 9 14 5diff Vorklist Run Results Seq Sample ID ma Patient ID m 3460 js 12349 Ja 12348 la 123457 a Ux The system deletes the selected results REVIEWING FLAGGED RESULTS Ac T Workstation Information Delete All Selected Items Cancel IMPORTANT Beckman Coulter Inc does not claim to identify every abnormality in all samples Beckman Coulter suggests using all available flagging options to optimize the sensitivity of instrument results All flagging options include Patient Limits H L Action Limits HH LL Parameter Flags Interpretive Messages and Analytical Alarms Beckman Coulter recommends avoiding the use of single messages or outputs to summarize specimen results or patient conditions 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 especial
11. 1 Repeat steps 4 through 6 to delete additional physician or location names When finished v to save and exit the window Changing the Reporting Unit By selecting a reporting unit you are selecting the format in which numeric results are reported You can choose from these reporting units US e SII e SI2 e 53 e 514 Table A 2 shows the reporting unit formats for each parameter Table A 2 Reporting Unit Format Reporting Unit Parameter US 11 12 13 14 WBC 103 uL 109 L 109 L 103 uL 109 L RBC 106 uL 1012 L 1012 L 106 uL 1012 1 Pit 103 uL 109 L 109 L 103 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 DIFF 96 ratio DIFF 103 uL 109 L 109 L 103 uL 109 L PN 624021CA SETUP A SYSTEM SETUP Do this procedure to select a reporting unit format ATTENTION If you change the reporting unit the system automatically restarts to implement the change A amp Nec 1 Setup gt gt System 2 Typethe password and vj 3 Units tab PN 624021CA A 9 SETUP SYSTEM SETUP Select the desired reporting unit a at Unit Selection field b Highlight your choice US SII SI2 e 53 e 514 After you select the reporting unit the screen displays the re
12. HGB Ww F HT RW F i r Ditiplot Thresholds fe hee Histogram Thresholds F PLT F d 5 Raw Values 4 Select the desired format option a at the Report Format field b Highlight the desired option Optian 2 9 Save the changes W to save and exit from the window OR to save and remain at this window to continue setting up the Patient report A 62 624021CA SETUP PATIENT SETUP A Figure A 2 Sample Results Report Areas Defined YOUR LABORATORY NAME 4 CITY STATE ZIP Sample ID e Patient Name Run D ime 04 01 04 30 55 PN Pati 39 OPR Admin YOUR LABORATORY ADDRESS 1 LAB PHONE NUMBER YOUR LABORATORY ADDRESS 2 LAB FAX NUMBER Collect Date Time Physician Location 17 Flagging Set Standard Range Co Flags and Messa WBC 69 10e3 uL 40 11 0 RBC 4 74 10e6 uL 3 80 6 50 HGB 146 gid HCT 432 MCV 91 fL MCH 308 Pg 270 32 0 31 0 35 0 2 E MO 0 34 10e3 uL 0 20 0 80 10e3 pL 0 04 0 40 10e3jgL 0 02 0 10 150 400 EOR 0 13 60 100 BA 0 03 0 150 0 300 150 1170 Vol Microscopic Examination Neutrophils Metamyelocytes Anisocytosis Retics Bands Myelocytes Hypochromia Sed Rate Lymphocytes Promyelocytes Polychromasia Monocytes Bla
13. oN Ac T 9 Ele Cycler Diagnostics Setup er Sra hil M ax Wels w SEI 9 d oie R Results E Patient IP Seq H Sample ID Patient Name Panel Ta eim Erm 42 0162 CBC DIFF 08 A0 0152 CBC DIFF 08 1 the Results tab at the top and then s os EX E the Results tab at the bottom A list of x jus exam 35 o132 CBC DIFF 08 the samples analyzed in the current jus Eu 7 archive is displayed Results can be com e a i 30 fo cec p1rF 08 viewed by scrolling ET Lu 2 ar e s e te standar e andar e lt lt SO 2 Toview detailed results e Double click the desired result OR el to view the details The data is displayed as it was on the Run screen with results and DiffPlots 3 Toreturn to the list PN 624021CA 9 1 DATA REVIEW LOCATING SAMPLE RESULTS 9 2 Advanced Search A the Results tab at the top then the mE File Cycles Diagnostics Setup Helo sel iE El zum 15 2 oe oH halt Assurance Areheitons Search C Sample ID G Patient ID C Patient Name 1 SS Search Results tab at the bottom IST 3 He 2 search Fesuts 2 Setup the search Seach Curent Archive C Closed Archive Search criteria a Current Archive or Closed Sample ID Pa
14. set 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 PN 624021CA 9 21 9 DATA REVIEW REVIEWING FLAGGED RESULTS Table 9 1 Definition of DIFF Flags Continued DiffPlot Region Suspected Flag DiffPlot Region Affected Description Flags Abnormalities UM Occurs when the R next to Large monocytes number of Hyperbasophilic particles UM monocytes region is above the and Myelocytes limits set IMMZ Promyelocytes 5 values UM displayed o 1 1 or 999 d printed i Large blasts gt articles and printed in p the DiffPlot and Histogram section of the Flags and Messages area LN Occurs when the R next to all Neutrophil number of WBC DIFF degradation due to particles in the LN parameters improper storage or region is above the LN is displayed sample age limits set and printed in Plt aggregates Pat values the DiffPlot and RBCs resistant to 2 5 To or 999 Histogram lysis stroma particles section of the Flags and Reagent Messages area contamination UN Occurs when the R next to Large neutrophils number of NE NE Immature particles in the UN IMM IMM granulocytes Volume Debris DB Absorbance region is above the limits set
15. Patient Identification Patient ID 112760 fl Patient Name Date of Birth Physician Location Autonumbering M On 12345 Apply 2 amp H x 17 Press to move the cursor to the Location field 18 PN 624021CA Enter the patient s location up to 15 alphanumeric characters and spaces manually enter the location or E and select the location from the existing list of locations if applicable Patient Identification PatientID 112760 Patient Jene Doe Date of Birth R 35 Gender X Physician Location Autonumbering On 12345 8 SAMPLE ANALYSIS RUNNING PATIENT SAMPLES USING THE WORKLIST 8 18 19 W 2 to save the information and clear the box for additional entries 20 When the last entry is added 0 D to save and exit the window 21 the Run tab The Sample ID for the next sample to be processed is identified in the Next Sample ID field Fle Cycles D o He 3 9 ve A i Zn 5 nalyzer Logs Gender Date of Bith Panel Unknown f cec un ime Patient ID Sample ID 123 124 03 28 2001 14 00 06 IMPORTANT Risk of erroneous results if sample is not properly mixed before analysis Mix the blood specimen gently and thoroughly before analysis according to the tube manufacturer s
16. W File gt gt Close archive Note You cannot create a new archive until any previously opened archive if any is closed 2 0 File New archive 3 Resume normal operation using the new archive which is now your current active archive PN 624021CA E 1 WORKSTATION MANAGEMENT ARCHIVE MANAGEMENT E 2 Opening a Saved Archive Do this procedure to open a saved archive File gt gt Open archive 2 Highlight the archive to open from the Date 1 dI c cecor 4 2 _ 03 08 2001 12 44 58 PM list and 4 03 08 2001 12 45 46 5 03 08 2001 12 47 23 PM Note The Worklist and results list for an old archive will be colored light green If an old archive has Worklist entries without results never analyzed the entries will be displayed in white The current active archive background is white and in this view no statistics appear for the active archive Printing a Worklist from a Previous Archive Do this procedure to print Worklist orders that are not in the current active archive 1 Open the archive where the Worklist orders are located File gt gt Open archive The date displayed indicates when the archive was created Select the correct archive to open e PN 624021CA WORKSTATION MANAGEMENT E ARCHIVE MANAGEMENT 2 the Worklist tab 3 Select each order you want to print eeu Run a Press the key and on each
17. 6 4 SHUTDOWN At the end of each day do this procedure to cleanse the instrument shut down the computer and power off the analyzer and PC IMPORTANT Do not log out of the Workstation while the Analyzer is running a cycle Logging out during an Analyzer cycle will cause problems with the Analyzer Workstation communication Ba The instrument cycles Rinse reagent for cleaning and goes into a stand by mode The Reagent window is displayed during Shutdown 2 When Shutdown is complete a message box appears Shutdown cycle completed Press OK to Shutdown computer During computer Shutdown Switch off Analyzer a U to shut down the computer b Turn off the Analyzer power switch c Wait the It is now safe to turn off computer message to appear d Turn off the PC power switch CAUTION Wait at least 30 seconds before performing the Power Up and Log On procedures IMPORTANT After doing Shutdown you must do a Power Up and Startup before operating the instrument again PN 624021CA 6 5 DAILY ROUTINE SHUTDOWN 6 6 624021CA QUALITY ASSURANCE 7 1 RUNNING CELL CONTROLS Do this procedure before analyzing patient samples to ensure that the system is within acceptable operating limits Beckman Coulter recommends that you analyze three levels low normal and high of cell control material The cell control for the 5diff CP hematology analyzer is AC T 5diff Co
18. B 3 BARCODE SPECIFICATIONS Barcode labels to be used with the 5diff CP analyzer must meet the following specifications Maximum number of usable characters in barcode label 16 Minimum PCS Print Contrast Signal 1596 at 670 nm Maximum resolution of scanner 0 1 mm 4 mils Maximum label length 66 mm 2 6 inches e Code 128 barcode labels must meet European Standard EN 799 Code 39 barcode labels must meet European Standard EN 800 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 624021CA B 1 BARCODE SPECIFICATIONS BARCODE SPECIFICATIONS Table B 1 shows default barcode settings for each symbology Table B 1 Default Barcode Settings Setting Code 1289 Code 39 Codabar 1 2 of 5 EAN 8 EAN 13 Character Length 1 to 16 1 to 16 3 to 16 119 7 12 Check Digit Checksum 9 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 9 Code 128 provides excellent density alphanumeri
19. Default values 1 1 or 999 particles UN is displayed and printed in the DiffPlot and Histogram section of the Flags and Messages area Metamyelocytes Myelocytes Promyelocytes 9 22 624021 DATA REVIEW REVIEWING FLAGGED RESULTS Table 9 1 Definition of DIFF Flags Continued DiffPlot Region Suspected Flag DiffPlot Region Affected Description Flags Abnormalities NE Occurs when the R next to Young eosinophils number of IMM and Giant particles the NE hypersegmented separation region neutrophils is above the limits Replaces Eosinophils with set NEE EOY and wit Default values EO with Debris DB Absorbance 1 1 or 60 particles NE is displayed and printed in the DiffPlot and Histogram section of the Flags and Messages area intracytoplasmic material agranular eosinophils PN 624021CA 9 23 DATA REVIEW REVIEWING FLAGGED RESULTS Table 9 1 Definition of DIFF Flags Continued DiffPlot Region Suspected Flag DiffPlot Region Affected Description Flags Abnormalities ATL Occurs when a ATLis displayed Large lymphocytes significantly large and printed in Reactive population is the DiffPlot and lymphocytes located in the ATL Histogram region section of the Stimulated 5 ATL flag is Flags and MEUS g triggered from the Messages area Plasma cells Patient Limits and May be the inter
20. and or batch transmitting IMPORTANT Risk of failure to print and or transmit all requested results Do not delete result s until printing and or transmitting are complete Allow all results to complete printing and or transmitting before using the delete function LN 1 the Results tab at the top and then the Results tab at the bottom if necessary XE File Cycles Diagnostics Setup ial MA s 8 gt ve Results aliy Assurance Analyze 1 Seq Sample ID Patient IP Patient Name Panel Flagging Set 14 0172 ES Stendard Range 087 43 017 CBC DIFF Standard Range 08 42 0162 CBC DIFF Standard Range 08 AL 016 CBC DIFF Standard Range 08 40 0152 CBC DIFF Standard Range 08 as 015 cec brFF Standard Range 08 38 014 CBC DIFF Standard Range 08 3 0142 CBC DIFF Standard Range 08 26 o133 CBC DIFF Standard Range 08 as 0132 CBC DIFF 34 013 ICEC DIFF 33 0122 BC DIFF 32 012 ICBC DIFF En 30 0112 m ICEC DIFF CBC DIFF 0102 010 CBC DIFF CBC DIFF 0092 CBC DIFF Standard Range Standard Range Standard Range Standard Range Standard Range Standard Range Standard Range Standard Range Standard Range 087 087 08 08 08 08 08 08 08 RET 2 Select each sample result that
21. lt patient demographics in the Demo 7 Worklist were modified by the host Host Mod Sample ID None gt Demo If Patient ID is not available the patient demographics in the Worklist were modified by the host Incorrect Date Entry Value entered is not a valid date Enter a valid date Incorrect Reagent Type Entered Please Enter Correct Reagent Lot Number The reagent lot number for the is invalid for the selected reagent 1 Verify that the correct reagent is selected for replacement 2 Re enter the lot number Incorrect Time Entry Time entered is not a valid time Enter a valid time Insufficient Disk Space To Insufficient disk space to backup 1 Select a drive D with sufficient Backup Restore data to the selected drive space to back up the data Selected Database 2 If necessary delete the old database backup then retry Invalid Input Invalid data was entered Enter valid data Invalid Password Entered An invalid password was entered Enter a valid password Access Denied Invalid Reagent Entered An invalid lot number was entered 1 Verify that the correct reagent is Please Enter Correct selected for replacement Reagent Lot Number 2 Re enter the lot number Invalid Reagent Lot An invalid lot number was entered 1 Verify that the correct reagent is Number Entered Please selected for replacement Enter Correct R
22. 72 624021 SETUP A QUALITY ASSURANCE SETUP 9 For the Multiple Shifts option type the From for each shift The To is automatically completed when the From times are entered The system automatically prevents the times from overlapping 6 Vv to save and exit the window Setting Up a Control File Upload from Control Disk LN 1 the Quality Assurance tab 2 the Controls tab at the bottom of the window PN 624021CA A 73 SETUP QUALITY ASSURANCE SETUP A 74 3 Select the control to set up a At the Select Control field b Select the desired control file from the list nU 1 Ex Diagnostics Setup Help gt 2221 Ale SHY ud 2l 9e iN Results Quality Assurance AnalyzerLogs Include Date Time wec wer wv nf E sy inm SS Add Comment E Shit dab hos Setup Conto ir Bomoi WBC RBC HGB MCV MCH MCHC ROW 7 PLT MPV NE LY MO EO 7 NER 7 LYn Eon WBC Control Data REC Contro Data I 07 18 2004 12 19 18 PM 4 Setup Control File Cycles Diagnostics Setup Help Spg 3 38 15 201 Cle Se wd 9 99 Worklist Pun Resubs QueliyAssurence Analyzerfiogs incude DateTime wec Hcr wv
23. BAR Abnorm F No Parameter Value RW FE Wi 2 Bi 2 2 64 624021 PN 624021CA SETUP PATIENT SETUP rEnable 4 the box next to the desired features 3 a ange in the Enable field Messages Detailed Flags E Diffplot Thresholds Iv Histogram Thresholds v Raw Values 9 Save the changes J to save and exit from the window OR zi to save and remain at this window to continue setting up the Patient report Selecting the Parameters to Print Do this procedure to select which parameters to print LN Ne 1 Setup gt Patients Ac T 5diff System A 65 A SETUP PATIENT SETUP 2 Typethe password and U amp 3 the Reports tab 9 aaa 4 the box next to the parameters you want to appear on the printout lt 4 A AIAI 4 66 624021 SETUP A QUALITY ASSURANCE SETUP 9 Save the changes W to save and exit from the window O R il to save and remain at this window to continue setting up the Patient report A 5 QUALITY ASSURANCE SETUP Enabling Disabling Autoprint for Controls Reproducibility and Calibration Do this procedure to enable activate or disable deactivate the Autoprint feature that automatically prints co
24. CONVENTIONS GRAPHICS and e SYMBOLS USING YOUR A eT 5diff CP HEMATOLOGY ANALYZER OPERATOR S GUIDE Use this Operators Guide to find information about getting started running your instrument reviewing results performing special procedures such as cleaning replacing or adjusting an instrument component troubleshooting problems determining what the instrument does understanding how to safely operate the instrument powering up the instrument customizing the setup and running controls and samples ABOUT THIS MANUAL The information in this manual is organized as follows 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 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 Chapter 5 GETTING STARTED Provides information on using the system s software and Workstation 624021CA xxi INTRODUCTION ABOUT THIS MANUAL
25. Connected Disconnected Lu Logout Exit 9 10 PRINTING Overview The first print job after initial Startup takes a few seconds to print Subsequent print jobs print without delay There are several ways to print information On most of the screens appears at the bottom of the window By selecting that icon only the information pertaining to the open window prints 8 also appears in the tool bar This particular printer icon does not print the information pertaining to the open window However it provides general printing options for the primary windows Worklist Run Results Quality Assurance and Analyzer Logs This means for example that you can print information from the Worklist without having to be in the Worklist screen For details see Printing Using the Printer in the Tool Bar Primary Windows Only PN 624021CA 5 37 GETTING STARTED PRINTING Printing Using the Printer in the Tool Bar Primary Windows Only Primary window Worklist Run Results Quality Assurance and Analyzer Logs information can be printed by using e in the tool bar Note Empty logs Reagent Startup Error and so forth do not print because there is no information in them 1 U in the tool bar from primary window 2 the desired tab to select the item s you want to print For example if you want to print a Reagent Log 0 Analyzer Logs for options Worklist Run Resul Re
26. Table 9 11 Plt Interpretive Messages from the Histogram MESSAGE Triggering Condition MICROCYTES Derived from Pit histogram SCHISTOCYTE Derived from histogram 9 30 624021CA DATA REVIEW REVIEWING FLAGGED RESULTS Table 9 11 Plt Interpretive Messages from the Pit Histogram Continued MESSAGE Triggering Condition SMALL CELL Derived from Plt histogram PLT INTERPRETATION One or more analytical alarms occurred for PLT NOT POSSIBLE Combination WBC RBC PIt Interpretive Messages Table 9 12 lists interpretive messages from a combination of WBC RBC PIt Action Ranges Table 9 13 lists conditions causing NRBCS and PLATELET AGGREGATES interpretive messages Table 9 12 Interpretive Messages from a Combination of WBC RBC PIt Action Ranges Message Triggering Condition PANCYTOPENIA WBC lt WBC LL and RBC lt RBC LL and Plt lt Pit LL LL below the action range Table 9 13 NABCs and PLATELET AGGREGATES Interpretive Messages Message Triggering Condition PLT AGGREGATES NRBCS NRBCS amp PLATELET AGGREGATES Plt lt 150x103 mm and WBC voteout DB and PDW gt 20 or DB and MPV gt 10 or DB and Plt lt 150x103 mm3 or DB and WBC Voteout WBC and PDW gt 20 or WBC and MPV gt 10 or WBC and lt 150x103 mm SL or SL and WBC Voteout or WBC and WBC Voteout or SL1 and WBC Voteout If none of the individual condition
27. in the RBC bath 1 170 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 path 9 1 10 000 2 13 OPERATION PRINCIPLES PARAMETER DEVELOPMENT 2 1 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 96 is the US unit format Other formats are available See Changing the Reporting Unit 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 obtain count result the instrument compares the data from the two 5 second count periods then votes and rejects any questionable data count Number of cells counted per unit volume x Calibration coefficient The RBC count is displayed and printed as RBC N x 106 cells pL Note cells pL is the US unit format Other formats are available See Changing the Reporting Unit 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 analyzer
28. 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 15 3 SPECIFICATIONS CHARACTERISTICS INTERFERING SUBSTANCES 3 16 624021CA 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 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 yo
29. 2 Referto the Printer user s manual for additional information Reagent s Low This message is given at the end Do Changing the Diluent Reagent Insufficient Reagents To of startup if there is not enough and or Changing One Reagent Fix Complete Daily reagent remaining to complete the WBC Lyse Hgb Lyse or Rinse Workload daily workload that has been set Reagents up Reserved Barcode May Attempt was made to add create 1 Verify that the Sample ID is correct ID that matches a reserved control Result Could Not Be Non numeric blank results exist Repeat analysis Saved No Results in the control file Available Attempt was made to modify iuis iain pleb the lt patient demographics cannot be 4 Analyzing Cant Patient demographics whilethe from the Worklist Mod sample is being analyzed 11 84 PN 624021CA Table 11 2 Error Messages Continued Message Probable Cause DIAGNOSTICS SYSTEM ERRORS 11 Suggested Action Sample ID Already Exists on Pending Worklist Attempt was made to add create a Worklist entry with a Sample ID Verify that the Sample ID is correct e f Sample ID is incorrect enter the Must Use Edit to Modify that already exists in a pending correct Sample ID An Existing Worklist Worklist t Entry ample ID is correct U EET to modify the existing Worklist entry Sample ID Required Attempt was made to analyze a 1 Enter the next Sam
30. 3 3 date format selecting A 2 setup procedure 2 debris description 2 20 default configuration instrument A 1 definition GLOSSARY 1 delete Physician or Location names A 6 sample results 9 13 demographics adding to patient information 5 42 description 2 22 editing 5 48 storage 2 23 DIFF diameter of aperture 3 5 DIFF syringe function 11 29 location 11 29 DiffPlot development overview 2 19 function 2 19 regions 2 20 Diluent reagent description 1 11 input connector location 1 3 replacement procedure 11 51 diluent reservoir draining procedure 11 34 function 11 28 location 11 28 diluter system troubleshooting procedures 11 32 INDEX 3 INDEX INDEX 4 dilution ratios 3 3 summary overview 2 13 dL definition ABBREVIATIONS 1 Do 7 1 download control results for IQAP 7 11 DRAIN TIMEOUT 11 82 draining procedures baths 11 34 diluent reservoir 11 34 duplicate sample ID 2 22 E editing text using the mouse 5 34 EDTA 8 2 definition ABBREVIATIONS 1 electromagnetic interference 3 2 environmental protection requirements 3 5 EO description 2 20 interfering substances 3 15 eosinophil See EO Eosinophilia triggering condition 9 29 error messages definition 11 81 list 11 81 See also individual messages Erythrocytosis triggering condition 9 30 expiration date definition GLOSSARY 1 F femtoliter definition GLOSSARY 1 field definition GLOSSARY 1 how t
31. 5 7 PLACING THE TUBE HOLDER IN THE ANALYZER 5 8 POSITIONING TUBES IN TUBE HOLDERS 5 9 Position of Tube Holder in the Analyzer 5 9 PN 624021CA PN 624021CA 5 6 5 8 5 9 5 10 CONTENTS USING THE ONLINE HELP SYSTEM 5 13 Accessing Online Help 5 14 Moving Resizing the Help Screen 5 14 Opening Closing the Topics Pane 5 15 Viewing Help Topics 5 16 sing the Contents Option 5 17 sing the Index Option 5 18 sing the Tables Option 5 19 sing the Illustrations Option 5 19 sing the Search Option 5 20 rinting Help Information Printing the Operators Manual 5 21 Iq rg t USING YOUR 5diff CP HEMATOLOGY ANALYZER OPERATOR MANUALS CD ROM 5 22 Minimum System Requirements for Using the CD ROM 5 22 Launching the Manual from the CD ROM 5 22 SOFTWARE DETAILS 5 24 Overview 5 24 Initial Windows NT Logon 5 24 User Names and Passwords 5 24 Operator ID Logon 5 24 Change Operator ID 5 25 Logout 5 25 Software Passwords 5 26 Primary Windows 5 26 Menu Bar 5 28 Pull down Menus 5 28 Tool Bar 5 28 Tabs 5 29 Buttons 5 29 Command Buttons 5 29 Bitmap Buttons 5 29 Radio Buttons 5 30 Fields Text Boxes 5 30 Check Boxes 5 30 Scrollable Lists 5 31 WORKING WITH THE SOFTWARE 5 32 Using the Mouse 5 32 Moving the Cursor 5 33 Selecting Menu Items 5 33 Scrolling 5 34 Editing Text 5 34 Saving Changes 5 35 Selecting Deselecting Software Fields 5 35 SYSTEM ICONS
32. ATL atypical lymphocytes IMM immature cells 9 19 9 DATA REVIEW REVIEWING FLAGGED RESULTS 9 20 Table 9 1 Definition of DIFF Flags DiffPlot Region Suspected Flag DiffPlot Region Affected Description Flags Abnormalities CO The system CO Diff Reject Diff detects aproblem is displayed and Reject with volume and printed in the absorbance Analytical measurements in Alarms in the e the flow cell Flags and More than 50 of Messages area the pulses were rejected because they do not have optical pulses that meet internal criteria 100 to 300 microseconds DB Occurs when the DB Debris is Plt aggregates number of pulses displayed and Increased Plt count in the DB region printed in the exceeds the DB Analytical RBCs resistant to limit Alarms in the _ lysis stroma Default values Flags and NRBCs 100 or 120 Messages area Reagent particles contamination SL Debris DB Absorbance Occurs when the number of particles counted in the SL region are higher than the SL limit Default values 100 or 50 particles R next to NE NE LY LY MO MO EO ATL ATL IMM IMM SL displayed and printed in Diffplot and Histogram section of the Flags and Messages area Small lymphocytes aggregates NRBCs RBCs resistant to lysis stroma PN 624021CA REVIEWING FLAGGED RESULTS DATA REVIEW
33. ATL 07 96 0 0 20 MCH 308 pg 270 32 0 09 00 20 MCHC 33 8 g dL 31 0 35 0 48 10e3 uL 200 750 aui MOM 034 1Oe3 uL 0 20 0 80 259 10e3 uL 150 400 EO 013 10e3 pL 0 04 0 40 76 fL 60 100 BA 003 1Oe3 uL 0 02 0 10 0 196 6 0 150 0 300 ATL 0 05 1Oe3 uL 0 00 0 20 n IMM 0 06 10eS uL 0 00 0 20 Vol Neutrophils Bands Lymphocytes Monocytes Eosinophils Basophils Comment Metamyelocytes Myelocytes Promyelocytes Blast Atyp Lymph NRBC s Abs Microscopic Examination Anisocytosis Hypochromia Polychromasia Poikilocytosis Microcytosis Macrocytosis Requested by Out of Action Range For Research Use Only Not for use in diagnostic procedures RI of Patient Range XX Reviewed by Retics Sed Rate Printed 14 03 2001 11 08 10 AM PN 624021CA SPECIFICATIONS CHARACTERISTICS 3 INSTRUMENT SPECIFICATIONS Measurements and Computation Impedance is used to determine WBC Plt RBC and BA e Photometry using cyanmethemoglobin method with 550nm diode light source is used to determine Hgb Impedance and light absorbance are used to determine NE LY MO EO AIL and IMM Data that was directly measured is used to compute Hct MCH MCHC RDW MPV Pct and PDW Counting Aperture Diameters WBC BASO 80 um DIFF 60 um RBC PIt 50 um Reagent Consumption Table 3 1 shows the instruments reagent consumption b
34. Chapter 6 DAILY ROUTINE Provides information on doing daily procedures such as Startup and Shutdown 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 Chapter 9 DATA REVIEW Provides information on reviewing sample results including flagged results Chapter 10 CALIBRATION Provides procedures for calibrating the instrument including manually adjusting the calibration factors 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 instruments settings such as date time reporting units laboratory limits and others Appendix B BARCODE SPECIFICATIONS 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 TUBE LIST Lists the tubes for use with the CP system e Appendix E WORKSTATION MANAGEMENT Provides information about archive and database management e REFERENCES Lists references used in this manual e GLOSSARY Defines terminology used in this manual e ABBREVIATIONS Defines a
35. DEFINITIONS agglutination clump background count Measure of the amount of electrical or particle interference blank cycle Runs diluent through the system to clean it out calibration 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 An expression in percent of data SD spread related to the mean variation 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 fL Abbreviation for femtoliter femtoliter One quadrillionth 1015
36. Net ve jorklist Rur Results elit ance Analyze l Seq ti Sample ID Patient Name Panel Flagging Set 12 gt 44 0172 Standard Range 08 43 017 ICBC DIFF Standard Range 08 42 0162 CBC DIFF Standard Range 08 Al 016 CBC DIFF Standard Range 08 40 0152 ICBC DIFF Standard Range 08 1 the Results tab at the top and then 5 jus Umm Range 06 38 014 ICBC DIFF Standard Range 08 Y 37 0142 CBC DIFF Standard Range 08 the Results tab at the bottom if m E D 3 35 0132 ICBC DIFF Standard Range 08 necessary 34 us cecorrF Standard Renge 08 0122 cec p1FF Standard Range 08 32__ 012 CBC DIFF Standard Range 08 31 forz CBC DIFF Standard Range 08 30 fou CBC DIFF Standard Range 08 29 __ 0102 CBC DIFF Standard Range 08 28 CBC DIFF Standard Range 08 6032 cBC DIFF Standard Range 08 IM Bess 5 hne 0 10 624021CA DATA REVIEW AFTER LOCATING THE SAMPLE RESULTS 2 Select each sample result that you want to transmit a Press the key and 0 on each sample you want to transmit b Verify that a black dot p or LA appears in the far left column of each selected sample and that the row is highlighted t8 4 U The selected results 5 Dx The system transmits the selected results to the host computer Validating Sample Results The validation feature provides
37. RBC1 RBC2 1 1 1 MICRO MACRO 1 9 26 PN 624021CA Pit Histogram Flags and Analytical Alarms See Table 9 4 Table 9 4 Histogram Flags and Analytical Alarms DATA REVIEW REVIEWING FLAGGED RESULTS Histogram Flag Illustrations of Histogram Flags Description PIt MIC Figure 9 6 Flags The Plt histogram has 256 channels and between 2 fL and 30 fL A mobile SCH threshold at 25 fL by default 3 25 30 Figure 9 7 Mobile Threshold Positioned in the Standard Regions Between 18 fL and 25 fL gt 2 18 25u 30 Figure 9 8 Mobile Threshold Cannot Be Positioned in the Standard Region Figure 9 9 Mobile Threshold Cannot Be Positioned 1 1 2 18 25u 30 Figure 9 6 moves according to the presence of microcytic RBCs present in the 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 7 The 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 co
38. Table 9 7 WBC Interpretive Messages from DiffPlot Message Triggering Condition LEFT SHIFT MN or NL and UN 9 29 9 DATA REVIEW REVIEWING FLAGGED RESULTS RBC Interpretive Messages Table 9 8 lists RBC interpretive messages from Action Ranges Table 9 9 lists RBC interpretive messages from Flag Sensitivity Table 9 8 RBC Interpretive Messages from Action Ranges Message Triggering Condition ANEMIA Hgb Hgb LL ANISOCYTOSIS RDW RDW HH HYPOCHROMIA MCHC MCHC LL COLD AGGLUTININ MCHC gt MCHC HH MICROCYTOSIS MCV MCV LL MACROCYTOSIS MCV gt MCV HH ERYTHROCYTOSIS gt HH RBC One or more analytical alarms occurred for RBC INTERPRETATION NOT POSSIBLE HH above the action range LL below the action range Table 9 9 RBC Interpretive Messages from Flag Sensitivity Message Triggering Condition MICROCYTE MICRO gt MICRO Flag Sensitivity limit MACROCYTE MACRO gt MACRO Flag Sensitivity limit Pit Interpretive Messages Table 9 10 lists platelet interpretive messages from Action Ranges Table 9 11 lists platelet interpretive messages from the Plt histogram Table 9 10 Plt Interpretive Messages from Action Ranges Message Triggering Condition THROMBOCYTOSIS Plt gt THROMBOCYTOPENIA Pit lt PIt LL MACROPLATELETS MPV gt 11 HH above the action range LL below the action range
39. Workstation connector Power supply cord connector Waste output connector eoo0c0c009 9 Diluent input connector Warning and Caution Labels Pay close attention to the labels on the Analyzer Figure 1 4 For warning and caution labels on the Workstation refer to the manuals from the PC manufacturer for details Figure 1 4 Warning and Caution Labels Analyzer MO STER Mad ACT Sdiff CP ASSY M EA XXXXXX Hz VOLTS AMPS WATTS MANUFACTURED FOR BECKMAN COULTER INC 250 S Kraemer Blvd Brea CA 92821 U S A PATENTS ISSUED AND OR PENDING MADE IN FRANCE AUTOMATED DIFFERENTIAL CELL COUNTER FOR IN VITRO DIAGNOSTIC USE KON LISTED EQUIMENI TO REDUCE THE RISK OF ELECTRICAL SHOCK DO NOT REMOVE THE COVER OR BACK REFER SERVICING TO QUALIFIED SERVICE PERSONNEL ELECTRIC SHOCK HAZARD DISCONNECT UNIT FROM POWER SOURCE PRIOR TO SERVICING FOR CONTINUED PROTECTION AGAINST FIRE HAZARD REPLACE ONLY WITH SAME TYPE AND RATING OF FUSE FOR SAFETY REASONS EQUIPMENT REQUIRES CONNECTION TO PROTECTIVE EARTH GROUND ATTENTION POUR EVITER LES RISQUES DE CHOC ELECTRIQUE NE PAS OTER LES CAPOTS APPELER UN REPARATEUR QUALIFIE RISQUE DE CHOC ELECTRIQUE DEBRANCHER LE CABLE D ALIMENTATION SECTEUR AVANT TOUTE INTERVENTION POUR UNE PROTECTION CONTRE LES RISQUES D INCENDIE N UTILISER QUE CAUTION DES FUSIBLES DE MEME TYPES ET DE MEME CALIBRES CAUTION 1 POUR
40. You can change this number to be any number from 1 to 75 For example if you want the instrument to run the autoclean after 50 analyses then you would change the number to 50 Do this procedure to change the auto clean frequency A Ne File Cycles Diagnostics Be n e Patients Setup gt gt System Quality Assurance 2 Type the password and 0 3 W the Cycle Option tab CBC DiFFRunsPerDey 40 10 2 Per Dey A 20 624021CA PN 624021CA SETUP SYSTEM SETUP 4 Typethe number of cycles the system EEEN should run before it does an autoclean 79 The frequency range is 1 to 75 If you enter a number outside the range an EE E ET d error message appears If this happens icis then edit the number to be any whole number from 1 to 75 5 to save and exit the window The autoclean frequency is now set to the number you entered For example if you entered 50 then after 50 cycles the instrument will do an autoclean A 21 SETUP SYSTEM SETUP Enabling Disabling Automatic Startup If you want your system to do an automatic 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
41. You must use a different PC Minimum System Requirements for Using the CD ROM DO NOT USE THE CD ROM ON YOUR WORKSTATION PC You can use this CD ROM on any PC that meets these minimum requirements e Microsoft Internet Explorer 4 0 or higher for displaying the HTML files An IBM PC or compatible with a CD ROM drive Microsoft operating system Windows 95 Windows 98 Windows 2000 Windows ME or Windows NT 4 0 or higher e 32 MB e Display settings 800x600 and 256 colors Launching the Manual from the CD ROM The contents of the CD ROM will not be installed on your PC You will view and print directly from the CD ROM ATTENTION If you cannot access the Operators Guide on this CD ROM contact your Beckman Coulter Representative The contents of this CD ROM will not automatically install on your PC PN 624021CA GETTING STARTED 5 USING YOUR 5diff CP HEMATOLOGY ANALYZER OPERATOR MANUALS CD ROM 1 Tumon your PC and allow it to boot up Refer to the PC manual for instructions 2 Insert the CD ROM into the CD ROM drive e If Autorun is enabled on your PC the PC automatically launches the Operators Guide e If Autorun is disabled on your PC do steps 3 through 4 3 Locate the Start HTM file CD ROM drive letter NStart HTM a J the Windows Start button b W Run J Browse and locate the CD ROM drive d Double click the CD ROM drive letter usual
42. e 3 H el x 47 SETUP PATIENT SETUP ATTENTION The action and patient limits applied to a new flagging set are those from the Standard Range flagging set Remember that the age range cannot be edited 8 Edit the limits ranges if necessary a Highlight the number to be changed Note You cannot enter age ranges for the flagging sets b Typethe new number c Press to move between the fields For an alternative method see Copying Action Limits and Patient Limits to Another Flagging Set 9 v to save and exit the window The new flagging set is created and now appears in the list of defined flagging sets Flag Sensitivity and Thresholds The options under the Flag Sensitivity and Thresholds tab 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 48 624021 SETUP A PATIENT SETUP Copying Action Limits and Patient Limits 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 A Ne 1 Setup gt gt Patients 2 the password and 2 3 the Flagging and Messaging tab 4 Select an empt
43. hierarchy see Figure 5 15 8 Enter the date and time that the specimen was collected a Enter the complete date Enter the time c Press to move the cursor to the Comments field Add Edit Worklist Sample Identification Ad Sample ID Panel Flagging Set 5 18 Collect Date Time Comment rPatient Identification Add Edit Worklist Kil gt Sample Identification Opr Admin Sample ID 1234 Panel CBC DIFF Flagging Set Collect Date Time 04 19 2001 05 50 PM Comment Patient Identification 9 your comments optional and press to move to the Patient ID field Add Edit Worklist Xp r Sample Identification Admin Sample ID fiz Panel ceciorr Flagging Set 2 a Collect Date T Comment Patient Identification 8 15 8 SAMPLE ANALYSIS RUNNING PATIENT SAMPLES USING THE WORKLIST 10 Enter the Patient ID up to 25 alphanumeric characters and no spaces Manually enter the ID or Scan the ID from the barcode if applicable or s 0 E and select the ID from the existing list of Patient IDs if applicable Patient Identific PatientID N Patient Name Date of Birth J Age Gender Female X Physician Location m On 23 Apply D S sp e x 11 Press t
44. 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 3 REVIEWING FLAGGED RESULTS LIS laboratory A laboratory s computer system that stores patient information and analysis information system results linearity The ability of an instrument to recover expected results reference values or calculated values for such parameters as WBC Hgb and 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 PN 624021CA 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 similar resul
45. recommendations and your laboratory protocol 22 Mix the specimen gently and thoroughly PN 624021CA SAMPLE ANALYSIS 8 RUNNING PATIENT SAMPLES USING THE WORKLIST 23 If the specimen tube does not have a pierceable stopper remove the stopper 24 Verify that the Sample ID in the Sample ID Next field matches the sample to be processed 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 25 Insert the tube into the correct position of the correct tube holder 26 Close the tube holder door to begin analysis IMPORTANT Do not log out of the Workstation while the Analyzer is running a cycle Logging out during an Analyzer cycle will cause problems with the Analyzer Workstation communication 624021CA 8 19 SAMPLE ANALYSIS RUNNING PATIENT SAMPLES USING THE WORKLIST 8 20 21 Remove the tube when the tube holder door automatically opens after aspiration The red LED is still illuminated which means the Analyzer is busy processing the sample 28 Wait for the green LED to illuminate which indicates the system is ready for the next sample Information for the next sample to be processed is displayed in the Sample ID Next field SampeiD Pane Patient ID 123 124 CBC DIFF 29 Verify that the current sample results appear in the Run
46. that will distinguish you from other users This code is used for traceability purposes For example if a user with a code of LTS changes a reagent and updates the Reagent log LTS will appear in the Reagent log as the user responsible for that action 5 24 PN 624021CA GETTING STARTED 5 SOFTWARE DETAILS Change Operator ID You do not have to log out completely to change Operator IDs 2 Ch th ID ange tae Open tor Workstation Logout DE X a Select Change Operator b Typethe new Operator ID in the box c Press Enter 0 D Duit Application 3 The next operator is now logged in with their Operator ID Logout Do this procedure to log out and quit the application PN 624021CA 5 25 GETTING STARTED SOFTWARE DETAILS Select Quit Application then press Enter awoikstanon 1505 D Quit Application C Change Operator BCI e x Software Passwords Various Workstation software areas such as setup and calibration require you to enter an Administrator password before permitting access When the Administrator password is requested type 123 to gain access to that particular software screen Other Workstation software areas such as service diagnostics requires you to enter a Service password before permitting access The Service password is for use by Beckman Coulter representatives Primary Windows
47. up to 30 alphanumeric characters and spaces and press to move to the date of birth field Patient Identification Patient ID Patient Name Date of Birth Gender Female gt Physician z Location po sg E o El ela 5 45 5 GETTING STARTED USING WORKLISTS 12 Enter the patients date of birth and press Patient Identification The system automatically calculates the Patient ID patient s age and populates the age field based on the date of birth you entered Date of Birth Physician Note If you do not enter the year Location an invalid date message appears Autcrunberng rofos appv 9 S el e xl If you prefer to enter the age rather than the date of birth use the following designators They must be lower case d day w week m month year 13 Press to move to the patient s gender field 14 Select the patient s gender Patient Identification Patient ID pao x Patient Jane Doe b Select the gender Date of Birth a Age 35 Genc Female Physician c Press to move the cursor to das L 3 the physician s name field m rojas w 9 S el e 5 46 624021 GETTING STARTED USING WORKLISTS 15 Enter the physician s name up to 30 alphanumeric characters and spaces manually enter the physician s name or zi an
48. window to a new location e Release the mouse button 3 To resize the Help window a Move the cursor over the border until the arrows appears b 0 and drag to resize it c Release the mouse button 5 14 PN 624021CA GETTING STARTED 5 USING THE ONLINE HELP SYSTEM Opening Closing the Topics Pane To maximize the contents pane where text and graphics appear you may want to close the topics pane where topics appear Do the following procedure to open close the topics pane 1 Access online Help 2 W the arrows to close the topics pane 3 0 any of the following option to re open the topics pane me ou 50l omens I engen Tanes pes e Contents e index e Tables e illustrations or e Search PN 624021CA 5 15 GETTING STARTED USING THE ONLINE HELP SYSTEM Viewing Help Topics Do this procedure to view topics within the Help system 1 Access online Help 2 Navigate through Help as needed Home Contents Index Illustrations Tables Search eo 4444 W Contents to browse through topics by heading Index to see a list of index entries 0 Tables to see list of tables 0 Illustrations to see list of illustrations W Search to search for words or phrases Home to return to main Help screen 3 through topics as needed to display the previous topic in t
49. you may want to rerun a sample to confirm a suspect result Due to the duplicate ID feature rerunning a sample requires using the system s Rerun feature If the ID of the sample to be repeated was manually re entered into the instrument a Duplicate Sample ID message is displayed and the sample cannot be processed You can indicate you want to rerun any sample from the Results screen or the Detailed Results screen From the Run screen you can indicate you want to rerun the last sample LN e Nec 1 Locate the results of the sample you want to rerun See Heading 9 1 LOCATING SAMPLE RESULTS for details ATTENTION If you are in the Results List view verify that the correct result is selected OB The system automatically places the Sample ID onto the worklist and allows it to be processed as a rerun A red square indicating that the sample is a re run appears at the top right of the screen if you are in the Detailed Results view 3 the Run tab 8 38 624021CA PN 624021CA SAMPLE ANALYSIS RERUNNING SAMPLES 8 4 Verify that the correct Sample ID is displayed SampeiD Panei PeatentiD 123 124 CBC DIFF 9 specimen gently and thoroughly according to your laboratorys protocol 6 Ifthe specimen tube does not have pierceable stopper remove the stopper 1 Verify that the Sample ID in the Sample ID Next field matches th
50. 1 H H amp H Flag 9 18 H flag definition 9 28 hardware reset function 11 36 procedure 11 36 hardware system troubleshooting 11 36 hazards operational list 4 2 Hct definition ABBREVIATIONS 1 interfering substances 3 13 measurement overview 2 14 Help Contents menu option 5 14 Print Manual menu option 5 21 printing Help information 5 21 searching topics 5 16 using the online Help system 5 13 hemoglobin hematocrit ratio flag 9 18 Hgb definition ABBREVIATIONS 1 interfering substances 3 13 overview 2 17 Hgb Lyse reagent description 1 11 replacement procedure 11 63 HH flag definition 9 28 hierarchy of flags 9 32 Host Communication Error ACK 11 82 Host Communication Error ENQ 11 82 Host Communication Error Write 11 83 Hypochromia triggering condition 9 30 Hz definition ABBREVIATIONS 1 INDEX icons definition 5 37 for saving information 5 35 grayed out 5 28 software 5 37 identification of samples 3 3 IMM description 2 21 display print setup A 51 immature granulocytes See IMM important definition 4 1 INCORRECT DATA ENTRY 11 83 INCORRECT TIME ENTRY 11 83 installation category 3 1 instrument component locations 11 28 default configuration A 1 description 1 1 dimensions 3 1 features 1 8 illustration 1 1 intended use 1 1 limitations 3 11 purpose 1 1 reported parameters 1 1 setup changes what to do after A 1 specifications 3 1 technolog
51. 1 or slot 4 of Tube Holder 2 IMPORTANT Risk of erroneous results if the calibrator is not positioned in the pierce position 12 o clock in the Analyzer S 9 Ensure that the tube is in the pierce N osition within the tube holder i 4 gt lt e the tube is in the pierce position gt 12 00 o clock within the holder M do step 6 If the tube is not in the pierce position within the holder rotate o the holder until the tube is in the pierce position 10 6 624021 PN 624021CA CALIBRATION AUTO CALIBRATION 6 Close the tube holder door to begin analysis IMPORTANT Do not log out of the Workstation while the Analyzer is running a cycle Logging out during an Analyzer cycle will cause problems with the Analyzer Workstation communication 7 When the LED is green 8 and the tube holder door opens remove the tube The results are displayed 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 8 Repeat steps 3 through 7 until at least 5 but no more than 11 calibrator samples have been analyzed The instruments autocalibration module calculates statistics on these results to obtain the best possible calibration factors 10 7 0 CALIBRATION AUTO CALIBRATION 9 Review the data to determine if you
52. 11 3 Troubleshooting Guide Problem Area Situation Probable Cause Suggested Action Power Power will not Power loose or Ensure that the power cords are properly turn on not securely connected connected Workstation turned Turn the Workstation on off No voltage or wrong Ensure the voltage is on and that the outlet voltage at laboratory is the correct Vac power outlet Defective power Contact a Beckman Coulter representative switch or blown fuse Log on Software fails to 1 Click Retry connect to the analyzer during A Could Not Connect To Analyzer log on H Cancel 2 fthe software fails to connect contact a Beckman Coulter representative Startup Startup failed 1 Verify the reagents are not expired three times Replace reagent if necessary See Changing Reagents 2 Do Heading 6 1 STARTUP again 3 Do Extended Cleaning Procedure Temperature not Instrument did not Wait 5 minutes to allow the instrument to reached reach operating reach the operating temperature temperature If the problem persists contact a Beckman Coulter representative Control 1 Rerun the control 2 Runa new vial of control 3 Do Extended Cleaning Procedure 4 Ifthe problem persists contact a Beckman Coulter representative Sampling Sampling probe Motor Contact a Beckman Coulter representative not working properly 11 86 PN 624021CA PN 624021CA Table 11 3 Tr
53. 5 and will sound multiple beeps when read Other codes will only sound a single beep Table B 4 Barcode Scanner Configuration Sheet ES dd ABISAB ll6 F CPSO0s AClI3121z S CPR507 n1 4EAll842 ADlzZlAD 0316 FH d A FDAA3 4 624021 BARCODE SPECIFICATIONS B 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 Table B 5 Code 39 Barcode Scanner Options Read ONE of the labels below to set Check Digit control option 4811 Code 39 No Check Digit control 4ABl3 Code 39 Check Digit control PN 624021CA B 5 BARCODE SPECIFICATIONS CODE 39 AND CODABAR BARCODE SCANNER OPTIONS Table B 6 Codabar Barcode Scanner Options Read ONE of the labels below to set Start Stop Equality option check LADlllz No Start Stop equality check nor transmission 801125 No Start Stop equality check but transmission LADIZIT Start Stop equality check but no transmission F thD lees Start Stop equality check and transmission B 6 PN 624021CA B 7 See Table B 7 2 0F 5 PROGRAMMING OPTIONS AND TEST LABELS 2 OF 5 PROGRAMMING OPTIONS AND TEST LABELS Table B 7 Interleaved 2 of 5 Options With Fixed Length Characters Test Labels BARCODE SPECIFICATIONS B
54. 5 37 PRINTING 5 37 Overview 5 37 Printing Using the Printer in the Tool Bar Primary Windows Only 5 38 CONTENTS 5 11 ENTERING INFORMATION USING THE BARCODE SCANNER 5 39 5 12 UNDERSTANDING HOW FLAGGING SETS ARE APPLIED 5 40 5 13 USING WORKLISTS 5 42 Overview 5 42 Adding Entries To Creating a Worklist 5 43 Downloading Worklists from a Host Computer 5 48 Editing Worklist Entries 5 48 Deleting Worklist Entries 5 50 DAILY ROUTINE 6 1 6 1 STARTUP 6 1 6 2 WASTE CONTAINER LEVEL CHECK 6 3 6 3 PRINTER CHECK 6 4 6 4 SHUTDOWN 6 5 QUALITY ASSURANCE 7 1 7 1 RUNNING CELL CONTROLS 7 1 Displaying Levey Jennings Control Graphs 7 7 Adding QC Result Comments 7 9 7 2 SUBMITTING CONTROL RESULTS FOR IQAP INTERLABORATORY QUALITY ASSURANCE PROGRAM 7 11 Preparing for IQAP Download 7 12 Downloading Results to Diskette for IQAP Submission 7 12 The IQAP Download Screen 7 13 Download Procedure 7 14 7 3 DELETING CONTROL FILES 7 16 SAMPLE ANALYSIS 8 1 8 1 OVERVIEW 8 1 8 2 PREPARE THE SYSTEM FOR PROCESSING 8 1 8 5 SPECIMEN COLLECTION AND MIXING 8 2 8 4 RUNNING PATIENT SAMPLES USING THE WORKLIST 8 3 Running Worklist Samples Autonumbering On 8 3 Running Worklist Samples Autonumbering Off 8 12 8 5 RUNNING PATIENT SAMPLES WITHOUT USING THE WORKLIST 8 22 Running Samples Autonumbering On 8 22 Running Samples Autonumbering Off 8 28 8 6 RUNNING STAT SAMPLES FROM WORKLIST ENTRIES 8 34 8 7 RERUNNING
55. 624021CA OPERATION PRINCIPLES 2 PARAMETER DEVELOPMENT DiffPlot Development The instruments DiffPlot analysis is based on three essential principles 1 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 17 Figure 2 17 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 when compared with the other four white cell populations For additional DiffPlot information see the following tables Table 2 7 defines the DiffPlot regions e Table 2 8 defines immature white blood cells 624021CA 2 19 OPERATION PRINCIPLES PARAMETER DEVELOPMENT Table 2 7 DiffPlot Regions Defined Region Definition Ne
56. 8 SAMPLE ANALYSIS RUNNING PATIENT SAMPLES USING THE WORKLIST 8 Type your comments optional and press to move to the Patient ID ly field Sample Identification Opr Admin Sample ID 12345 Panel CBC DIFF Flagging Set 2 a Collect Date T fF 04 19 2007 05 PM Comment Patient Identificatio 9 Enter the Patient ID optional up to 25 alphanumeric characters and no Patient Identific spaces Patient ID s manually enter the Patient ID or Patient Name e scan the Patient ID from the Date of Birth Age Gender Female M sician oF barcode if applicable or mee Location Autonumbering or 9 l bal Ol XI and select the Patient ID from the existing list of Patient IDs if applicable 10 Press to move to the Patient Name field 11 Enter the patients name up to 30 8 6 alphanumeric characters and spaces and press to move to the date of birth field Patient Identification Patient ID Patient Name Date of Birth Gender Female Physician Location ff Autonumbering V 1234 Apply D amp sp x PN 624021CA SAMPLE ANALYSIS 8 RUNNING PATIENT SAMPLES USING THE WORKLIST 12 Enter the patients date of birth and press Tab The system automatically calculates the patient s age and populates the age field Patient Identification Patient ID Patient Name based on the date of birth you e
57. 9 8 WORKING WITH THE SOFTWARE When working with the instruments software be sure you understand the basics of e Using the Mouse Moving the Cursor Selecting Menu Items e Scrolling Editing Text e Saving Changes and Selecting Deselecting Software Fields Using the Mouse A mouse Figure 5 13 is connected to your Workstation and allows you to navigate through the software and to select certain software functions Figure 5 13 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 to select Setup Control 2 Click press and release the left mouse button W Note If the selection is not made try again check the connection if necessary If the problem persists contact a Beckman Coulter representative 5 32 624021 GETTING STARTED WORKING WITH THE SOFTWARE 5 Moving the Cursor To move the software cursor move the mouse or press Tab Selecting Menu Items There are two ways to select a menu item as defined below 1 the item OR 2 Press and simultaneously press the underlined letter of the menu item For example to select File press and release both keys after the menu item is selected 3 Oncea pull down menu is open Cycles Diagnostic You can press 1 or 4 to highlight a menu op
58. AM 00 0 00 0 T Passed 03 28 2001 05 04554M 00 000 0 1 Passed Iz 04 18 2001 06 16 05 PM PN 624021CA DAILY ROUTINE 6 WASTE CONTAINER LEVEL CHECK 4 TheStartup log automatically prints in tabular format if Auto Print is enabled If Auto Print is disabled oS b Verify that the Analyzer Logs tab is selected C Startup Log Note The Startup log maintains the most recent 50 entries 9 Add comments to the Startup log if desired Add Comment a If the Add Comments box appeared Type your comment here automatically type your Comment comments To access the Add Comments box x W Startup Log tab gt gt Add Comments button then type your comments b 0 D to save your comments 6 2 WASTE CONTAINER LEVEL CHECK At the beginning of each day check the waste container to determine if it needs to be replaced If so do Replacing the Waste Container 624021 6 3 DAILY ROUTINE PRINTER CHECK 6 3 PRINTER CHECK At the beginning of each day or shift be sure the printer is ready to print 1 Besure there is an adequate paper supply in the printer e 50 go to step 2 Ifnot add paper according to the printers user manual 2 Turn the printer on 3 Besure the printer is ready See your printer manual for details 6 4 PN 624021CA DAILY ROUTINE SHUTDOWN 6
59. CONTROL 14 z WBC RBC HGB HCT 7 RDW 7 PLT MPV 7 NE 7 LY EO 7 NE LY EO gt WOC Conr Data REC Contr Data Conti Data 07 18 2004 12 19 18 PM 9 Insert the correct assay values diskette into the floppy drive PN 624021CA QUALITY ASSURANCE SETUP SETUP 6 Select the Download Values button ry Select the control level then 8 8 Select Commercial as the source of the control material if it is not already displayed at the Source field b Select Commercial PN 624021CA 75 SETUP QUALITY ASSURANCE SETUP 9 0 e to print a copy of the control setup information for your records 10 0 to save the control setup and exit the window Setting Up a Control File Manual Method AN Ne 1 the Quality Assurance tab 2 the Controls tab at the bottom of the window A 76 624021CA SETUP QUALITY ASSURANCE SETUP 3 Select the control to set up a Atthe Select Control field Og b Select the desired control file from the list 4 Setup Control 5 Enter the lot number of the control material a Locate the lot number on the control materials vial b Enter the lot number up to 10 alphanumeric characters with no spaces into the Lot N
60. Cell Operation 2 11 DiffPlot Regions 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 BASO Parameter Results 2 18 DiffPlot Regions 2 19 Database Archive and Worklist Relationships 2 23 Analyzer Dimensions and Weight 3 1 Sample Report Report Format Option 1 3 4 Help Screen 5 13 Primary Window Analyzer Logs 5 27 Menu Bar 5 28 Pull Down Menu Options 5 28 Tool Bar 5 28 Worklist Tab 5 29 Text Button 5 29 Bitmap Button Drop down Box 5 29 Radio Buttons 5 30 Fields 5 30 Boxes 5 30 Scrollable List 5 31 Mouse 5 32 Scroll Bars 5 34 Flagging Set Hierarchy 5 41 Flags Messages Collapsed View 9 15 Flags Messages Expanded View 9 15 WBC BASO Histogram Flags CBC Panel 9 25 WBC BASO Histogram Flags CBC DIFF Panel 9 25 xvii B MICRO and MACRO Regions on RBC Histogram 9 26 9 6 Plt Flags 9 27 9 7 Mobile Threshold Positioned in the Standard Regions Between 18 fL and 25 fL 9 27 9 8 Mobile Threshold Cannot Be Positioned in the Standard Region 9 27 9 9 Mobile Threshold Cannot Be Positioned 9 27 9 10 Presence of Small Cells in the 2 fL and Regions 9 28 11 View of the Pneumatics Area 11 28 11 2 Bath Assembly 11 29 11 3 View Behind Main Card Left Side 11 29 11 4 Main 11 30 11 5 Computer Workstation Front View 11 30 11 6 Computer Workstati
61. DES RAISONS DE SECURITE LA MACHINE DOIT ETRE RELIEE A LA X TERRE ALL COVERS PANELS MUST BE SECURED IN PLACE PRIOR TO INSTRUMENT OPERATION REFER TO PRODUCT REFERENCE MANUAL FOR PROPER INSTALLATION 2429555 7650010A PN 624021CA 1 3 USE AND FUNCTION DESCRIPTION Tube Holders Two interchangeable tube holders Figures 1 5 and 1 6 are available for accommodating various size specimen tubes microcollection devices and control vials Each tube holder contains four slots in which you can place an open or closed 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 Figure 1 5 Tube Holder 1 Slot Designations for Tube Holder 1 Q Position 1 Position 2 4 Position 3 Position 4 Note Tube Holder 1 has dot in the center Figure 1 6 Tube Holder 2 Slot Designations for Tube Holder 2 Q Position 1 Position am N Position 3 Q Position 4 Note Tube Holder 2 has two dots in the center e As detailed in Appendix D TUBE LIST each tube vial has an assigned slot in a tube holder Beckman Coulter does not guarantee the performance of any other tube on this system other than those listed in Appendix D Figure 1 7 shows examples of tubes in their corre
62. DETAILS Radio Buttons Radio buttons which appear within various windows of this software allow you to choose one of the options presented See Figure 5 9 Figure 5 9 Radio Buttons Auta Print C All C Normals C Abnormals Fields Text Boxes Fields which appear within various windows of this software are rectangular areas where you can input or display information See Figure 5 10 Figure 5 10 Fields Reagent Status Reagent RINSE FIX LYSE wec LYSE DILUENT Lot Number 0020202367 00802600117 00202401700 00402800176 00302000068 Opened Date 05 04 2001 05 04 2001 09 04 2001 09 04 2001 09 04 2001 Expiration Date fi 3 10 2001 08 08 2001 0571 0 2001 23 08 2001 fi 1 08 2001 Operator Admin Admin Admin Admin Administrato Change All Reagents Change Ragen Check Boxes Check boxes which appear within various windows of this software allow you to select include or deselect exclude options See Figure 5 11 Figure 5 11 Boxes Include Date Time rj I 2 I 12 18 00 8 52 GETTING STARTED 5 SOFTWARE DETAILS Scrollable Lists Scrollable lists are lists of information that require you to scroll to see all available entries See Figure 5 12 Figure 5 12 Scrollable List 33 5 33 3 33 3 33 7 33 1 33 4 4 33 2 33 4 33 2 33 5 HE PN 624021CA 5 31 GETTING STARTED WORKING WITH THE SOFTWARE
63. Down the System 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 down sequence that you must follow to prevent damaging the system 1 Log out of the Workstation ta b Select Quit Application Press Enter D d Wait while the Workstation closes its program Workstation Logout iof x D 2 When the Begin Logon box appears simultaneously press Ctrl At Delete 3 Shut Down 4 Verify that only Shut Down is selected 5 Dx It is now safe to turn off your computer appears PN 624021CA 5 7 GETTING STARTED PLACING THE TUBE HOLDER IN THE ANALYZER 6 Turn off the Workstation Note Do not U Restart Turn off the Analyzer ATTENTION If you are doing a replacement or maintenance procedure that requires you to open the Analyzer panels unplug the ac power cord Either remove the cord from the instrument at the back panel in the lower right corner or unplug it from the ac outlet 5 3 PLACING THE TUBE HOLDER IN THE ANALYZER Do this procedure to place a tube holder in the Analyzer A 1 Slide the tube holder over the metal shaft in the Analyzer 2 Rotate the tube holder until it is properly seated 5 8 624021CA GETTING STARTED 5 POSITIONING TUBES IN TUBE HOLDERS 5 4 POSITIONING TUBES I
64. FLAGGING SETS ARE APPLIED Figure 5 15 Flagging Set Hierarchy Modification Mode Flagging Set is modified Flagging Set remains as selected Newborn 30 Days Add Mode Flagging Set Default Flagging Flagging Set remains as selected Yes Select child range Infant 1 month Child gt 6 Yrs to 6 Years to 12 Yrs Gender known Gender man Flagging Set Man GETTING STARTED Host entry 15 Flagging Set empty Is Flagging Set known Current Flagging Set is updated in the order with the Flagging Set received Current Flagging Set Default for a new entry Flagging Set Woman 4021048A 5 41 5 GETTING STARTED USING WORKLISTS 9 13 USING WORKLISTS 5 42 Overview 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 The Workstation matches sample results with the additional information entered based on sample ID The Worklist entry is removed upon analysis when th
65. Help 4 T WERE System 1 Setup gt gt Patients e 2 Typethe password and ML 3 the Parameters tab NER Lys RBC MCHC ROW 5 HGB MF HCT 5 uud EOR MCV r ewm mr GIMM Enable RUO Parameters Changing Selected Parameters f quires restarting the application F mv F enw PN 624021CA A 51 SETUP PATIENT SETUP A 52 4 Enable RUO Parameters Note If Enable RUO Parameters is not available then the RUO parameters are already enabled and you do not have to continue with this procedure Enable 8 Parameters 5 and select one of the following U S A e Non U S A e None 6 W Yes to confirm that you have selected to report RUO parameters ATTENTION If you selected U S A you must complete the RUO Certification form that automatically prints Follow the instructions on the form RUO Parameters You Have Selected To Report Parameters That Are RUO In The USA Continue No 1 Verify that the printer is ready 8 0 to confirm that you will be automatically logged out 9 wait while the systems logs out PN 624021CA PN 624021CA SETUP PATIENT SETUP 10 Login again a When the Begin Logon box appears simultaneously press ci at Delete b Type User name and press Tab c
66. LOCATIONS 11 28 11 10 SYSTEM TROUBLESHOOTING PROCEDURES 11 32 Diluter System 11 32 Backflush 11 32 Rinse Baths and Flow Cell 11 32 Draining the Baths and or the Diluent Reservoir 11 34 Hardware Systems 11 36 Hardware Reset 11 36 Sampling Probe Test 11 37 Traverse Test 11 38 Sampling Syringe Test 11 39 Draining Syringe Test 11 40 Counting Syringe Test 11 41 Flow Cell Syringes Test 11 42 Dilution Syringe Test 11 43 Piercing Mechanism Test 11 44 Valves Test 11 45 Traverse Service Position 11 46 Parking the Syringes 11 47 11 11 REPLACEMENT PROCEDURES 11 49 Changing Reagents 11 49 Viewing Reagent Levels 11 50 Changing the Diluent Reagent 11 51 Changing One Reagent Fix WBC Lyse Hgb Lyse or Rinse Reagents 11 57 Changing Reagents 11 63 Priming the Reagents 11 72 Replacing the Waste Container 11 73 Replacing the Flow Cell Lamp 11 75 11 12 SYSTEM ERRORS 11 81 What Error Messages Mean 11 81 11 13 TROUBLESHOOTING GUIDES 11 86 11 14 SYSTEM LOGS 11 89 Viewing System Logs 11 89 Adding Comments to the Logs 11 90 Adding Comments After Log Entry 11 90 Adding Comments Before Log Entry 11 92 11 15 OPENING THE TUBE HOLDER DOOR IF JAMMED 11 93 xiii CONTENTS xiv A SETUP A 1 A 2 A3 AA INSTALLATION A 1 DEFAULT CONFIGURATION A 1 Changes to Instrument Setup A 1 SYSTEM SETUP A 2 Activating Autonumbering and Setting The Starting Number A 2 Sample I
67. Notice there are three aliquots of the aspirated whole 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 L 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 624021CA 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 The3 pL sample aliquot at the tip of the probe is discarded into the Rinse bath as t
68. Password 123 Press 0 OK Logon Information Enter a user name and password that is valid for this system User name Password Cancel Help Shutdown PN 624021CA GETTING STARTED POWER UP POWER DOWN 5 Type your Operator ID and 9 AC T Sdiff press or ES Note Your Operator ID is a 3 character alphanumeric code that identifies you as the operator Use your initials or any other 3 character combination that will distinguish you from other users 8 Workstation a Wait for the Analyzer Logs window to appear b Wait about 30 seconds for the Analyzer and Workstation to communicate and to connect PN 624021CA 5 3 GETTING STARTED POWER UP POWER DOWN 9 verify that the Analyzer and Workstation connection is made Ele Cycles Diagnostics Setup Help AID sd AIC Wl zb wi i Mis Results Quality Assures Anelyzertogs P4 Reagent Status x a Verify that appears in the Reagent RINSE Fix HGB LYSE WBC LYSE DILUENT s Lot Number lower right corner of the screen mu Expiration Date Operator pct ea pa pa Note indicates that the NEE NES E Analyzer and Workstation Startup connection is not made If the rJ e E Analyzer and Workstation fail to connect repeat steps 1 through 7 sss Conta
69. Reagent 00402 00121 3 13 00 15 Press to move the cursor to the expiration date field PN 624021CA 11 61 DIAGNOSTICS REPLACEMENT PROCEDURES 11 62 16 select the reagents expiration date Expiration Date 05 17 2001 at the Expiration Date fiel EE May 2001 ield to open the calendar that Sur Mon Tue iod Tur Td shows the current date 1 2 3 4 M 6 7 8 9 10 11 b Select the expiration date 13 14 15 16 B 18 20 21 22 23 24 25 27 28 29 30 31 1 1 as needed to C Today 03 28 2001 advance to the correct month Note To return to a previous EN d m 2 the correct day 17 A to save the reagent information The system now primes the reagent and updates the level indicator Note Due to priming the reagent level may not be displayed as 10096 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 Heading 11 7 SYSTEM RESET CYCLE c Do Priming the Reagents to manually prime the reagent s PN 624021CA PN 624021CA DIAGNOSTICS REPLACEMENT PROCEDURES 18 Close the reagent compartment door Changing All Reagents Do this procedure to replace all the reagents at the same time LN 1 the Analyzer Log tab to display the Reagent window Sdiff File Cycles Diagnostics Setup
70. Reagent Log Startup Log Calibration Log Maintenance Log e Error Log There are two ways that you can add comments to the logs by Adding Comments After Log Entry or by Adding Comments Before Log Entry Adding Comments After Log Entry Do this procedure to add a comment to an existing log entry 1 the Analyzer Logs tab 11 90 PN 624021CA DIAGNOSTICS SYSTEM LOGS l l 2 the desired log at the bottom of the screen Reagent Log e Startup Log e Calibration Log e Maintenance Log Error Log Ac T Ele Cycles Diagnostics Setup Help ez i BD ie wi gt WH 9l 5 Warklist Results Quality Assurance Analyzer Logs Reagent Status Reagent RINSE Fx Jace LYSE WBC LYSE DILUENT Lot Number Opened Date Expiration Date Operator pct pa pa NE NS NK NE ChangeAllReagens Change Reagent Startup System RBC HGB PLT Anal Results Passed Passed Passed Passed Connection Status Reagents ReanentLoa Loa J_Enorloa J Calibration Lea Lou Sewice Log 03 09 2001 155858 3 Highlight the entry for which you want to add a comment 4 Add Comments 9 Type your comment Add Comment Type your comment here Comment x 6 to save PN 624021CA 11 91 DIAGNOSTI
71. The 5diff CP analyzer is a 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 CP 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 AC T 5diff CP analyzer the Coulter Principle is used to analyze the final RBC PIt 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 part
72. The primary windows are those displayed after you select one of the following tabs e Worklist e Run e Results Quality Assurance e Analyzer Logs After you log on the Analyzer Log window Figure 5 2 appears 5 26 624021CA GETTING STARTED 5 SOFTWARE DETAILS Figure 5 2 Primary Window Analyzer Logs ser rere fumum Bm P Bm Each menu item offers additional software choices For additional information see Pull down Menus PN 624021CA 5 27 GETTING STARTED SOFTWARE DETAILS Menu Bar The menu bar which appears across the top of a window contains the pull down text menus for the system s software See Figure 5 3 Figure 5 3 Menu Bar Ac T 5diff File Cycles Diagnostics Setup Help Pull down Menus Figure 5 4 shows the software options available for each pull down menu Figure 5 4 Pull Down Menu Options 5diff File Cycles Diagnostics Setup Help Mew archive Open archive lose archive Syst et Cycle E inem Hee e About Backup database scolis e Backflush Restore database Delete Database Ext CRESCE Logout Tool Bar tool bar Figure 5 5 appears below the menu bar and displays icons that when selected execute the function they represent If an icon is grayed out it is unavailable for use Figure 5 5 Tool Bar Sm 40 82 T ve Note The tool bar disappears if a secon
73. archive monthly since small archives are easier to navigate through and easier to manage than large ones PN 624021CA OPERATION PRINCIPLES 2 WORKLISTS If your laboratory does not repeat the sequence of sample IDs meaning that the sample IDs are always unique archiving is not required However for practical purposes it is recommended that you archive monthly Small archives are easier to navigate through and easier to manage than large ones Demographics Storage The Worklist allows you to add patient information such as patient name age date of birth gender and so forth This information is included with in the sample results If information pertaining to age and or gender is added the system automatically selects the appropriate flagging range For additional information on flagging ranges see Heading 9 3 REVIEWING FLAGGED RESULTS 1f the Patient ID is added the information is stored relative to that Patient ID The entered information can be retrieved by entering the Patient ID Database Archive and Worklist Relationships On this system the database is the larger electronic storage cabinet on the Workstation s hard drive Within the database the archive is a file cabinet and the worklist is a folder within the file cabinet See Figure 2 18 Figure 2 18 Database Archive and Worklist Relationships Database Ne Worklist WS gt Archive The worklist and the results ar
74. at the Time format field b the desired format The system updates the format in the Current time field 9 Save the change w to save and exit from the window OR il to save and remain at this window to change the date format Go to step 4 of Changing the Date Format Changing the Date Format 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 03 08 2001 dd mm yyyy 08 03 2001 yyyy mm dd 2001 03 08 Ne File Cycles Diagnostics amp 92 E i Patients Quality Assurance 1 Setup gt gt System 16 624021CA SETUP SYSTEM SETUP 2 Typethe password and 0 v 3 B Date Time Current Date Time Format Time hh mm ss EH Date MMiddiyyyy Change Date Time 4 Select the date format Current Date Time Format Time hh mm ss ampm Date MM ddivyyy dd MMA A a at the Date format field b the desired format The system updates the format in the Current date field PN 624021CA 17 SETUP SYSTEM SETUP A 18 9 Save the change Vv to save and exit from the window OR il to save and remain at this window to change the time format Go to step 4 of Changing the Time Format Changing the Dail
75. 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 lower RBC and counts and increase MCV 3 12 PN 624021CA SPECIFICATIONS CHARACTERISTICS INTERFERING SUBSTANCES Table 3 12 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 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 va
76. field select the control lot that you want to reserve a the box in the Reserved column that corresponds to the desired control lot b Verify that appears next to the desired control lot 5 v to save and exit the window Setting Up the IQAP ID As soon as you are enrolled in the IQAP program set up your IQAP ID in the workstation as follows This must be done before you download control data to disk to submit to IQAP A 1 Setup gt gt Quality Assurance 2 the password and 0 vj PN 624021CA A 81 SETUP QUALITY ASSURANCE SETUP A 82 3 the General tab if necessary Geies 1 Reserved Lot Number Reserved Name LotNumber Level Source Panel Parameter pro Cali cv a Jl XM Options C 3Pmam C 08 Repro Calibration aro Con off Con of Con Got poses 07 18 2004 11 43 17 AM 4 Atthe IQAP ID field type in your IQAP ID General fs Reserved Lot Number CV Limits Reserved Lot Number Level Source Panel Parameter QC CV Repro Cali r 5 2 25 2 25 1 1 4 2 3 15 25 15 25 15 5 25 10 5 5 8 5 10 3 10 5 5 15 40 25 wo 4 50 3 ha UTRUM MEUS Corto Repo Calibration Con Co Con Co Con CO pssp m 3 2 D H x 0771872004 11 43 17 AM
77. from the electrical outlet instrument is plugged into the power source 4 2 624021CA 9 1 GENERAL 9 2 POWER UP POWER DOWN Power Up the System PN 624021CA GETTING STARTED After your system is set up and configured at installation use this section as an overview 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 Check the waste container to determine if it needs to be replaced If so do Replacing the Waste Container Verify that the printer is ready and has paper Refer to the printer manual for details if necessary Note Your printer may be different from what is shown here Verify that the Analyzers ac power cord is plugged into a power source If the ac power cord is unplugged plug the cord into the instrument at the back panel in the lower right corner and or into an appropriate ac wall outlet Turn the Workstation computer on a the PC on b Turn the monitor on Allow sufficient time for the computer to complete its internal checks 5 1 GETTING STARTED POWER UP POWER DOWN 9 At the Analyzer a Turn the power ON OFF switch ON Verify that the red LED remains illuminated 6 Logon to the Workstation a 5 2 When the Begin Logon box appears simultaneously press ctn At t Delete Type User name and press Tab Type
78. has been Database Backup Successful saved to the file you named above If the database could not be backed up an error message will appear Restoring a Database Do this procedure if you want to restore a database from a backup copy previously saved to the Workstation s hard drive The default directory is DABackup Note password is required WARNING Current data is deleted when a backed up database is restored 1 File Restore database 2 Typethe password and 0 3 Locate and highlight the database you want to restore to the hard drive Maec ias 2x Firme Files of type Database files mdb x Cancel 624021 5 WORKSTATION MANAGEMENT DATABASE MANAGEMENT 4 5 OK to log out 6 Login again to the Workstation and resume normal operation Deleting a Database Do this procedure if you want to delete the existing database from the Workstation s hard drive ATTENTION You cannot recover a deleted database 1 Backup the database before deleting it See Backing Up the Database for details 2 U File Delete database 3 Type the password and v E 6 PN 624021CA WORKSTATION MANAGEMENT E DATABASE MANAGEMENT 4 YES to confirm that you want to delete the database AN Are You Sure You Want To Delete The Database The database is deleted 5 W OK to log out Database Has Been Deleted Use
79. have to select the Startup option every time you log in A Setup gt gt System Type the password and 0 Vj W Cycle Option tab Daily Workload CBC DiFFRunsPerDay 40 CBC Runs Per Day A 22 the box next to Automatic to either enable or disable the feature PN 624021CA SETUP A SYSTEM SETUP 5 U v to save and exit Viewing Editing the Analyzer s Serial Number SN LN Nex 1 Setup gt gt System 2 Typethe password and 0 vj 3 Analyzer tab S N AD43004 4 Edit the serial number if necessary PN 624021CA A 23 SETUP SYSTEM SETUP A 24 9 window Selecting a Language Do this procedure to select the language in which you want the instruments software to be displayed Select from English French Italian German Spanish LN 1 Setup gt gt System gt gt General Ac T 5diff File Cycles Diagnostics Help THY Patients aja in i117 Quality Assurance 2 W the Language tab SEET General Date Time hysicien Location Commu Printer Cycle Option Units azer Con s EY Modified On 07 16 2004 Englis EMG Change Input Locales Changing the Lanquage Options requires restarting the application PN 624021CA PN 624021CA SETUP SYSTEM SETUP Language Options 3 the desired language C French C G
80. instrument for a given parameter Never adjust to a specific value based on an individual sample result 10 2 PRE CALIBRATION CHECKS Before beginning calibration it is important that you do these pre calibration checks 1 Determine if there is enough reagents to complete the entire procedure Ifnot do Changing Reagents e 50 go to step 2 PN 624021CA 10 1 CALIBRATION PRE CALIBRATION CHECKS Verify that the instrument has been shut down for at least 30 minutes in the past 24 hours e Ifnot do Extended Cleaning Procedure e 50 go to step 3 Do Heading 6 1 STARTUP Do Heading 7 1 RUNNING CELL CONTROLS to verify calibration If the control is within expected ranges run samples Calibration is not necessary if the cell control is within the expected ranges If the control is not within expected ranges do Heading 10 3 AUTO CALIBRATION Calibration is required if the cell control is not within the defined limits PN 624021CA 10 3 AUTO CALIBRATION CALIBRATION 0 AUTO CALIBRATION When calibration verification fails or when instructed by a Beckman Coulter representative calibrate the instrument using this procedure Setup Calibration Do this procedure to prepare the instrument to run calibration A Aer 1 the Quality Assurance tab 2 the Calibration tab at the bottom of m
81. maintenance procedure Do this procedure to shutdown Windows NT 1 Log out of the Workstation Workstation Logout c Begin b Select Quit Application C Change perator BCI d Wait while the Workstation closes its program D Pile ES x PN 624021CA DIAGNOSTICS CLEANING PROCEDURES 2 When the Begin Logon box appears simultaneously press Ctrl ait Delete 3 Shut Down 4 Verify that only Shut Down is selected 5 Dx The Workstation automatically shuts down and informs you that the system is ready to be powered off or restarted 11 6 CLEANING PROCEDURES WARNING Risk of biohazardous conditions Utilize appropriate barrier protection when performing these procedures as the instrument may contain biohazardous material Cleaning the Tube Holder MN Ber 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 gel free bleach 5 to 6 solution of sodium hypochlorite available chlorine Cleaning the Outside of the Instrument MN Ber AD Clean the outside of the instrument with a damp cloth and distilled water to prevent the buildup of corrosive depo
82. 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 v B COULTER TRADEMARKS MEN AC T Beckman Coulter and the Beckman Coulter logo are trademarks of Beckman Coulter Inc All other trademarks service marks products or services are trademarks or registered trademarks of their respective holders PN 624021CA Documentation COULTER ACeT 5diff CP Hematology Analyzer Documentation Instructions For Use PN 624021 Host Transmission Specification PN 4277065 Training Guide PN 4277205 Daily Operations Quick Reference PN 4277315 EC Beckman Coulter Ireland Inc Mervue Business Park Mervue Galway Ireland 353 91 774068 E qc Printed on Recycled Paper Copyright Beckman Coulter Inc 2003 2005 2010 All Rights Reserved Use and Function Operation Principles Specifications Characteristics e Precautions Hazards Running Samples Re
83. order you want to print b Verify that a black dot Or P appears in the far left column of the selected order s and that the entire row is highlighted m 4 to display the print menu 9 Select the desired print format To print one or more selected TOWS U Print Selected Rows To print all orders Print All Rows PN 624021CA E 3 WORKSTATION MANAGEMENT DATABASE MANAGEMENT E 2 E 4 DATABASE MANAGEMENT A database stores all archives If the database has been backed up you can restore patient information from the backup This section describes how to manage your database including backing up restoring and deleting It also describes when and why the system compacts the database Backing Up the Database Do this procedure if you want to make a backup copy of your patient database and save it to the Workstation s hard drive The default directory is DABackup Note A password is required 1 U File Backup database 2 the password and D 3 Enter a file name such as the current Backup Database date using standard file naming Save in a Backup amp e 8 conventions Save type Database files Cancel 4 The file extension MDB is automatically applied to the filename PN 624021CA WORKSTATION MANAGEMENT DATABASE MANAGEMENT 5 OK backup copy of the database
84. procedure to print calibration results if you are not currently running calibration LN 2 Nex 1 the Setup gt gt Quality Assurance 2 Typethe password and 0 D 3 the Calibration tab at the bottom of the Quality Assurance setup window 4 Print the calibration results os b Select the items you want to print 9 Keep a copy of the calibration printout for your records 624021CA 10 13 CALIBRATION PRINTING CALIBRATION FACTORS 10 14 PN 624021CA 11 1 GENERAL MAINTENANCE This chapter details the AC T 5diff CP 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 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 ACT 5diff CP 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 624021CA See Table 11 1 Table 11 1 Maintenance Schedule Maintenance Procedure Frequency Situation Startup Daily Automatically occurs when you turn i on the instrument if auto
85. ro iioc Physician yes 48 70 BA Ld Yes PLT 88 PCT wec Messages 88 Location ve 68 QALT MPV Yes RBC Messages 988 sample ID 1 78 RES 90 REI 8 PLT Messages 88 Collect Date Time 20 Run Date Time Yes 118 i 35 Histograms and Thresholds Panel ve a WBC Histogram 88 WBC Threshold ve Diffplot EE se quence Number 240 RBC Histogram Yes RBC Threshold S Dittplt Threshold 88 Number of Runs ga PLT Histogram 8 PLT Threshold Yee Operatorr BASO Histogram 8 BASO Threshold 88 Default EPSON EPL 5700i AnalyzerNumber 8 Auto Clean 8 2 Startup Automatic 88 Unit Selection Us Defining the 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 set up in your system by a qualified technician using the information in the Host Transmission Specification document Consult a Beckman Coulter representative before editing the host communication settings A 42 624021CA A 4 PATIENT SETUP Working With Flagging Sets Ranges SETUP A PATIENT SETUP Note Flagging set modification name or limits will not be allowed if there are any previously analyzed sample result s with this flagging set in the database Selecting a Default Flagging Set Do this procedure to select a default flagging s
86. samples from Worklist 8 34 sample collection 8 2 INDEX sample ID autonumbering 8 3 8 22 entering A 2 manually entering 8 12 8 28 scanning with barcode reader 8 12 8 28 sample identification See sample ID sample report printout example 3 3 A 63 sample results delete 9 13 flagged or outside range what to do if 3 11 importance of verifying flagged results 9 14 irregular 9 32 reviewing 9 1 9 2 sorting 9 4 validating 9 11 samples entering IDs 3 3 number processed per hour 3 3 stability of 3 10 sampling probe malfunctioning 11 86 sampling syringe function 11 28 location 11 28 saving how to save software changes and selections 5 35 icons that save 5 35 schedule maintenance 11 1 Schistocyte triggering condition 9 30 SCL flag definition 9 28 scrolling how to scroll 5 34 view all information 5 31 SD standard deviation definition GLOSSARY 2 search for results 9 2 secondary window definition GLOSSARY 2 sensitivity A 48 A 80 serial number label location 1 3 INDEX 9 INDEX INDEX 10 Service password 5 26 Shutdown cycle definition GLOSSARY 2 procedure 6 5 SI 1 See reporting units SI 2 See reporting units SI 3 See reporting units SI 4 See reporting units Small cell triggering condition 9 31 sodium azide warning 1 11 software buttons 5 29 check boxes 5 30 do not install additional software 1 1 fields 5 30 icons 5 37 menu bar 5 28 menus 5 28
87. screen 14 Verify that the current sample results appear in the Run window 15 Verify the Sample ID and results before reporting the results 16 E to print a copy of the results Note A copy prints automatically if the Auto Print function is enabled 17 Verify that the Sample ID for the next sample is correct SampleiD_ Pane PatientiD_ 123 124 CBC DIFF 18 Repeat steps 3 through 17 until all samples are analyzed 8 33 8 SAMPLE ANALYSIS RUNNING STAT SAMPLES FROM WORKLIST ENTRIES 8 6 RUNNING STAT SAMPLES FROM WORKLIST ENTRIES Do this procedure to run a stat sample for asample ID that does not exist on the Worklist or asampleID 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 1 Ifthe sample is not on the Worklist enter the demographic information Ku r Sample Identification a the Worklist tab Spi ee Sample ID o o Panel cecrr FlaggingSet Standard Range Collect Date Time b Comment Patient Identification Patient ID c Enter the Sample ID required Enter the demographic information optional u 1 Enter
88. specimens were stored at room temperature and cold temperature For this study room temperature was 72 73 F 22 23 C and cold temperature was 37 39 F 3 4 C Each sample was analyzed in duplicate at the time interval indicated hours and the second run used to establish the mean The cold stored samples were removed from the refrigerator mixed and analyzed within five minutes Table 3 10 Sample Stability Room Temperature Parameter T1 TA T8 T24 T48 WBC Mean x102 uL 6 52 6 48 6 48 6 50 6 32 RBC Mean x106 uL 4 620 4 606 4 602 4 616 4 634 HGB Mean Hgb 13 70 13 62 13 60 13 62 13 66 HCT Mean 41 04 40 72 40 68 41 10 40 80 MCV Mean fL 88 60 88 20 88 40 89 00 88 00 RDW Mean 13 08 13 18 13 18 13 44 13 12 PLT Mean x109 uL 355 4 354 6 354 2 353 4 348 0 MPV Mean fL 8 18 8 62 8 60 9 02 9 52 NE Mean 54 10 53 40 53 84 53 12 56 24 LY Mean 31 96 32 84 32 32 33 22 33 86 MO Mean 7 60 7 60 7 44 7 44 4 42 E0 Mean 5 64 5 48 5 68 5 60 4 94 Mean 0 70 0 68 0 72 0 62 0 54 NE Mean 1 03 1 3 60 3 52 3 56 3 52 3 63 LY Mean x108 uL 2 02 2 06 2 02 2 09 5 70 MO Mean x103 UL 0 49 0 48 0 48 0 47 0 27 EO Mean x103 uL 0 38 0 37 0 39 0 38 0 32 BA Mean x103 uL 0 04 0 04 0 04 0 04 0 03 3 10 624021CA 3 4 Table 3 11 Sample Stability Cold Temperature SPECIFICATIONS CHARACTERISTICS LIMITATIONS
89. to possible instrument problems and or calibrator deterioration contact a Beckman Coulter representative All Forced calibrations are documented in the calibration log PN 624021CA CALIBRATION MANUAL CALIBRATION FACTOR ADJUSTMENT 10 4 MANUAL CALIBRATION FACTOR ADJUSTMENT Do this procedure if you know the calibration factors and want to change them to achieve calibration If you do not know the calibration factors do the procedure in Appendix C MANUAL CALIBRATION or calculate the new calibration factors from data using the following formula new factor required value actual value x current factor A o Nex 1 the Setup gt Quality Assurance 2 Typethe password and W D 3 the Calibration tab at the bottom of the Quality Assurance setup window PN 624021CA 10 11 10 CALIBRATION MANUAL CALIBRATION FACTOR ADJUSTMENT 4 Edit the calibration factors Highlight the number to edit b Editthe number c Repeat steps a and b for each parameter as needed 3 3 H 63 08 2001 141737 to save the changes 6 Yes to save the edited calibration EE factors Are You Sure You Want To Save The Calibration Factors The entry is placed in the Calibration log and indicated as Forced i 10 12 PN 624021CA CALIBRATION PRINTING CALIBRATION FACTORS 10 5 PRINTING CALIBRATION FACTORS Do this
90. to save the information and clear the box for additional entries 19 When the last entry is added D to save and exit 8 8 PN 624021CA SAMPLE ANALYSIS RUNNING PATIENT SAMPLES USING THE WORKLIST 20 the Run tab a RON SED cio al zd wd 21 22 its Qual Analyzer Logs ef Patient Name The Sample ID for the next sample to be processed is identified in the Sample ID Next field Gender Date of Bith Panel Unknown f cec mment Date T Cor 63 27 2001 11 1242 03 28 2001 14 00 06 21 Mix the specimen gently and thoroughly according to your laboratory protocol 22 Ifthe specimen tube does not have a pierceable stopper remove the stopper 23 Verify that the Sample ID in the Sample ID Next field matches the sample to be processed 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 PN 624021CA 8 9 SAMPLE ANALYSIS RUNNING PATIENT SAMPLES USING THE WORKLIST 24 Insert the tube into the correct position of the correct tube holder 25 Close the tube holder door to begin analysis IMPORTANT Do not log out of the Workstation while the Analyzer is running a cycle Logging out during an Analyzer cycle will cause problems with the Analyzer Workstation communication 26 Remove
91. used numbers by archiving them See Creating an Archive in Appendix E Creating a new archive resets the duplicate Sample ID process so that the IDs can be reused 2 22 How often you create a new archive depends on the frequency that your laboratory repeats sample IDs Table 2 9 shows some worklist examples for repeating Sample IDs Table 2 9 Worklist Examples and Archive Frequency How Often Sample IDs are Repeated Example When to Archive Daily Your laboratory starts the Sample ID At the beginning of each day the numbering at 001 each day and previous days data has to be archived continues the number sequence and a new archive created See through the day then restarts at 001 Creating an Archive the next day Monthly Your laboratory starts the Sample ID Atthe start of each month the previous numbering at 001 on the 1st day of month s data has to be archived and a each month and numbers sequentially new archive created See Creating an through the month and then restarts Archive at 001 the beginning of the next month Annually Your laboratory starts the Sample ID At the start of each year the previous numbering at 001 on January 1 every year and numbers sequentially through the year and then restarts at 001 the beginning of the next year year s data has to be archived and a new worklist created See Creating an Archive Beckman Coulter recommends that you
92. want to remove one or more calibration runs from the list of results Remember the instrument requires 3 runs to calculate the calibration statistics Ifyou want to remove one or more calibration runs go to step 10 e Ifyou do not want to remove any calibration runs go to step 11 Calibration passes when the CV96 is within the defined limits and the new calibration factors are within 2096 of the old calibration factors 10 Deselect the result s you want to exclude a the include field next to the result s you want to exclude b Theinstrument recalculates the calibration statistics based on the remaining calibration results For additional information see Interpreting Calibration Results N Mean 3 3 4 40 13 4 357 258 1 1 the appropriate Select parameter New Cal Factor 124 201 36 42 65 200 08 265 82 Old Cal Factor 122 81 201 7 42 73 200 38 267 83 box to select the parameters to be Rem vw am T 29 276 calibra ted Reference Values 100 4 39 13 4 35 6 256 Select Parameters MS Iv 10 8 PN 624021 CALIBRATION AUTO CALIBRATION 12 Print the calibration results b Select the Calibration information you want to print c Keepa copy of the calibration printout for your records 13 Update the calibrator factors or exit without updating To update the calibration factors U Save Calibration To exit without updating do not U S
93. you to search for information on specific system related topics through the Contents option and allows you to print this Operators Manual Instructions For Use in whole or in part through the Print Manual option The Help system is an electronic version of the Operators Manual and includes a table of contents an index for finding information quickly and a glossary of definitions When you access the Help menu there are three options available Contents Print Manual and About Figure 5 1 defines the screen that appears when you select Contents from Help menu Figure 5 1 Help Screen 444 4I Closes the topics pane when selected Displays the menu options for the onlilne Help Allows you to navigate through the Help Displays the contents of the selected Help topic Displays the topics contents illustrations or tables 9000000 Displays the Index letters when Index is selected PN 624021CA 5 13 GETTING STARTED USING THE ONLINE HELP SYSTEM Accessing Online Help Do this procedure to access the online Help system 0 EM Help gt gt Contents Note If you cannot access the online Help system contact your Beckman Coulter Representative Moving Resizing the Help Screen If the Help screen needs to be moved or resized do this procedure 1 Access online Help 2 move the Help window a the title bar and hold down the left mouse button b Move the mouse to drag the
94. you want to print a Press the key and 0 on each sample you want to print b Verify that a black dot p or P appears in the far left column of each selected sample and that the row is highlighted 3 0 EI to display the print menu PN 624021CA DATA REVIEW 0 AFTER LOCATING THE SAMPLE RESULTS 4 Select the desired print format To print only numeric results Print Summary List For Selected Rows To print the Run view of results and DiffPlots U Print Patient Report For Selected Rows Transmitting Sample Results You can transmit the last sample result or batch transmit a group of sample results to a host computer if applicable Sample results will automatically be transmitted to a host computer if the Autotransmission option is selected and the settings have been defined Transmitting the Last Sample Result i Ac T GE Ee Dices Diegosie Setup Heb Shel fil AM A sn WIS w c v 0 d forklist Results ality Assurance Analyze l Seq H Sample ID Patient IP Patient Name Panel Flagging Set Le a Standard Range 087 43 017 CBC DIFF Standard Range 08 42 0162 CBC DIFF Standard Range 08 ous IcBc DIFF Standard Range 08 ous CBC DIFF Standard Range 08 the Results tab at the top and then His os dme range 08 se ICBC DIFF Standard Range 08 z 37 0142 CBC DIFF Standard R
95. 0 0 00 0 1 Passed air co o 0 6 w pa 03 30 2001 08 13 30 00 000 0 Y Passed 03 30 2001 08 03 25 AM 00 000 0 0 Passed 03 29 2001 08 51 19 00 000 0 ji Passed b Cycles _ is Startup to initiate another Startup ANE routine Limits 0 03 03 F Y Pr User For Comment Comment c Ifthe Startup continues to fail ie i contact a Beckman Coulter oa representative Note the Run tab to view the Startup results 14 The Startup log automatically prints in tabular format if Auto Print is enabled If Auto Print is disabled e PN 624021CA 5 5 GETTING STARTED POWER UP POWER DOWN 15 Add comments to the Startup log if desired Add Comment a 1 the Add Comments box appeared 3 Type your comment here automatically type your Comment comments To access the Add Comments box ants x Startup Log tab gt gt Add Comments button then type your comments b 0 F to save your comments 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 Prime to prepare the Analyzer It is not necessary to do both 16 Ifthe system has remained idle for certain period of time you will be prompted to do a Startup or a Mini Prime 5 6 624021 GETTING STARTED POWER UP POWER DOWN 5 Power
96. 0 or higher As a backup or for instruments with software versions below 2 00 summary data can be transcribed onto Intelligent Character Recognition ICR forms The procedure for downloading to diskette is provided below Refer to the IQAP Hematology Procedure Manual PN 4206266 for the ICR forms procedure After enrolling in the IQAP you will receive the necessary supplies and instructions for submitting data Submit your IQAP data to Beckman Coulter each month immediately after completing your last set of controls For additional information see QAP Interlaboratory Quality Assurance Program in Chapter 1 Note The IQAP is unable to provide statistical comparison for parameters that do not have assay values assigned ATTENTION Until you receive an IQAP report from Beckman Coulter for a particular set of data do not delete that data There may be times when you need to provide additional information for the IQAP report and in those instances you need to refer to the control data PN 624021CA 7 11 QUALITY ASSURANCE SUBMITTING CONTROL RESULTS FOR IQAP INTERLABORATORY QUALITY ASSURANCE PROGRAM 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 the correct IQAP ID number is entered in the Workstation See Setting Up the IQAP ID for the proce
97. 1 Help Print Manual 2 Locate the information you want to print 3 File Print 4 Define what pages you want to print You can print all or part of the document 5 Dx PN 624021CA 5 21 GETTING STARTED USING YOUR AC T 5diff CP HEMATOLOGY ANALYZER OPERATOR MANUALS CD ROM 9 6 5 22 pone YOUR A eT 5diff CP HEMATOLOGY ANALYZER OPERATOR MANUALS ROM An Operator Manuals CD ROM was shipped with your instrument and contains the following components e COULTER AC T 5diff CP Hematology Analyzer Instructions For Use PDF and HTMI files e COULTER 5diff CP Hematology Analyzer Host Transmission Specification English PDF file e Adobe Acrobat Reader 4 0 or higher for reading the PDF files The purpose of the CD ROM is to allow you to access the same information from any compatible PC that you access through the Help menu on the 5diff CP Workstation PC You can use this CD ROM at any PC that meets the requirements listed in Minimum System Requirements for Using the CD ROM ATTENTION The Workstation PC that is part of your laboratorys AC T M 5diff CP system is configured to work only with the AC TTM 5diff CP system and is not intended for other PC operations such as running other software applications playing computer games or accessing the Internet This means that you cannot read the contents of this CD ROM on the 5diff CP system Workstation PC
98. 17 PDW calculation overview 2 17 INDEX 7 INDEX INDEX 8 performance characteristics accuracy 3 8 carryover 3 9 definition 3 8 GLOSSARY 2 reproducibility 3 8 performance specifications accuracy 3 6 carryover 3 7 definition 3 6 GLOSSARY 2 linearity 3 6 reproducibility 3 6 personal computer See also Workstation pg definition ABBREVIATIONS 2 Physician names delete A 6 pierce position of tube 5 11 Plt count determination 2 16 interfering substances 3 14 parameter overview 2 16 Plt aggregate triggering condition 9 31 power consumption 3 1 power supply 3 1 will not turn on what to do if 11 86 power button workstation 1 6 power supply cord connector location 1 3 powering down the system 5 7 powering up the system 5 1 precision definition GLOSSARY 2 previous archive how to print from E 2 primary window definition GLOSSARY 2 priming reagents procedure 11 72 when to do 11 72 print only select parameters A 65 printed reports 1 9 printer daily printer check 6 4 prints incorrectly what to do if 11 87 required model 1 14 PRINTER ERROR CHECK PAPER 11 84 printing empty logs 5 38 Help information 5 21 icons used for printing 5 38 operator manuals 5 21 overview 5 37 worklists from previous archive E 2 0 quality assurance QA definition 1 9 quality control QC definition GLOSSARY 2 quit application 5 25 R R flag description 9 19 range reportable 3 7 R
99. 2 Ll 10 Defaut Flagging Set 12 Standard Range fis E ie 17 hes hs E 2 9 H e X 7716 2004 04 21 49 PM 5 Setup PN 624021CA A 45 SETUP PATIENT SETUP 6 Edit the patient limit ranges Flags and Messages risss Sensitivity and Thresholds a Highlight the number to be Modified On Flagging Set Name Unis Pa o Parameter Action L Patient L Patient H Action H changed 40 11 0 150 lp RBC 350 450 650 750 Age Flange J HGB no 130 180 200 From To HCT 330 400 540 500 b the new number EN RE NE MCH 250 270 320 340 c Press to move between the MPV 50 60 10 0 120 1 0100 0150 0300 0 350 fields o m ES lu re wY 150 200 400 450 MO 10 30 100 120 00 10 50 60 BA 00 00 05 20 NER 170 200 750 900 075 150 400 450 MON 010 020 080 150 ER 000 004 040 060 BAR 000 002 010 030 21 x 7 U 7 to save and exit the window Creating Additional Flagging Sets You can create up to 14 additional flagging sets for a total of 20 flagging sets for your system Six are already pre defined and installed Do this procedure to create a new flagging set LN ANE 1 Verify that the flagging set you want to Copy To is created See Creating Additional F
100. 2 plastic K2 Greiner VACUETTE 454087 2 13x75 Yes 1 1 2 Greiner VACUETTE 454086 3 13x75 Yes 1 1 2 Greiner VACUETTE 454041 3 13x75 Yes 1 1 2 Greiner VACUETTE 454036 4 13x75 Yes 1 1 2 Kabe Kabevette 070132 3 11 5x65 No 3 6 Kabe Kabevette G 102325 3 5 12 5x76 Yes 1 4 1 5 6 Kabe Primavette V 0959 0510 2 6 11 5x66 Yes 3 1 6 LIP 133017 1 12x42 No 3 4 RAM Scientific 07 6011 125 uL No 3 Sarstedt Monovette 04 1901 200 2 6 13x65 Yes 4 1 5 6 Sarstedt Monovette 05 1167 100 2 7 11 5x66 Yes 3 1 5 6 SEIKSU INSE PACK SP 0402EM 2 12 6x75 Yes 1 1 2 Terumo Venoject VT 030STK 3 10 4x65 Yes 2 1 Notes The minimum sample volume in a collection device is 1 mL for collection devices that have a fill volume greater than 1 mL and three quarters the fill volume for collection devices that have a fill volume less than or equal to 1 mL 1 Ifthe tube is pierceable it is recommended that the tube not be pierced more than 3 times except for BD tubes which can be pierced a maximum of 7 times The tube may also be used in Tube Holder 2 position 4 if it has too many labels to fit in Tube Holder 1 Control material may be pierced until the open vial expiration dating and maximum number of events have been reached When used cannot be used with other tubes assigned to this position due to different probe depth adjustments Due to the aspiration plunger a different probe depth adjustm
101. 20 interfering substances 3 14 lymphocytes See LY Lymphocytosis triggering condition 9 29 Lymphopenia triggering condition 9 29 m definition ABBREVIATIONS 1 MACRO flag definition 9 26 Macrocyte triggering condition 9 30 Macrocytosis triggering condition 9 30 Macroplatelets triggering condition 9 30 Main card function 11 30 location 11 30 screws securing in place 11 30 maintenance schedule 11 1 material safety data sheet See MSDS MB flag definition 9 25 MCH calculation overview 2 15 interfering substances 3 13 MCHC calculation overview 2 15 interfering substances 3 13 MCV calculation overview 2 15 interfering substances 3 13 mean definition GLOSSARY 1 measurement of parameters 3 5 menu selecting menu items 5 33 menu items selecting 5 33 menus menu bar 5 28 pull down menus 5 28 messages See also interpretive messages messages See interpretive messages MIC flag definition 9 27 PN 624021CA PN 624021CA MICRO flag definition 9 26 Microcyte triggering condition 9 30 Microcytes triggering condition 9 30 Microcytic RBCs interference on Plt distribution curve 2 16 Microcytosis triggering condition 9 30 mixing specimen 8 2 mL definition ABBREVIATIONS 1 mm definition ABBREVIATIONS 1 MO description 2 20 interfering substances 3 14 mode definition GLOSSARY 1 monitor 1 6 monocyte See MO Monocytosis triggering condition 9 29 mouse how to use 5 32 movin
102. 2103 Low Commercial CBC WEC 5 2 2 F CONTROL2 JKIO3PN Nomal cec 25 2 2 FF CONTROLS JKTOGPH HGB 25 1 1 CONTROLI3 PXO3ILow Low CRC DIFF HCT 4 2 CONTROL14 PXO3INom Normal CBC DIFF 18 F CONTROL1S Commercial CBC DIFF MCH 25 15 CONTROLIS test Nomal CBC DIFF MEE 25 15 CALI T 308 CBC ROW 5 25 10 5 8 NE lY 10 5 MO 50 15 0 40 25 BA 150 E NER 50 3 a 4 Edit the CV Limits a At the CV Limits area highlight the number to edit b Edit the number c Repeat steps a and b as needed 9 Save the changes D to save and exit from the window OR to save and remain at this window to continue editing 71 SETUP QUALITY ASSURANCE SETUP Defining Shifts Do this procedure to define your laboratorys shifts to be either a 24 hour shift or multiple shifts A Ne 1 Setup gt gt Quality Assurance 2 Typethe password and 2 3 the Shifts tab 4 Atthe Shift Selection field select the desired option 24 Shift Modified On F e Multiple Shifts by If you selected 24 Hour Shift the system eem defaults applied which means no P ud sms few additional shift settings are required Go to step 6 If you selected Multiple Shifts go to step 5 3 3 H x 88 09 2001 142305
103. 24021CA DIAGNOSTICS 1 1 SYSTEM TROUBLESHOOTING PROCEDURES ISETCITS 3 the Reset Hardware tab ee a The instrument resets components to a home position Sampling Probe Test Do this procedure to test the sampling probe motor and reset the sampling probe to its home position A Dex 1 Diagnostics Operator Ac T 59 Operator 2 the Hardware Systems tab 624021CA 11 37 DIAGNOSTICS SYSTEM TROUBLESHOOTING PROCEDURES 11 38 3 the Motors tab 5diff Operator Hardware Systems Dituter Systems Cydes Reset Hardware Valves T 4 Sampling Probe The instrument exercises the sampling probe motor resets the sampling probe to its home position Traverse Test Sampling Probe Do this procedure to test the traverse assembly motor and reset the traverse assembly to its position A Nex Diagnostics gt gt Operator 5diff File D Ny Help 2 the Hardware Systems tab 5diff Operator Hardwarg Systems Dituter Systems Cycles Reset Hardware Motors Valves Th PN 624021CA PN 624021CA DIAGNOSTICS SYSTEM TROUBLESHOOTING PROCEDURES 3 the Motors tab 5diff Operator Hardware Systems Dituter Systems Cycles Reset Hardware Valves T 4 Traverse The instrument exercises the traverse moto
104. 3 FM Enter the target values and limits from the calibrators assay sheet a Press to move the cursor the value or limit you want to edit b Typethe number The Calibration screen is displayed to save the input If existing runs are present for this lot number they must be deleted before proceeding to continue PN 624021CA CALIBRATION AUTO CALIBRATION 10 verify that the lot number is correct for the calibrator to be used 11 Do Running Calibration Running Calibration Dee Verify that Setup Calibration was completed for the calibrator that you are using and that the Calibration screen is displayed on the Workstation monitor If the Calibration screen is not displayed a UJ the Quality Assurance tab b the Calibration tab at the bottom of the Quality Assurance window c Select the correct lot number d Verify that the calibration file is empty Delete any existing runs 2 Prime the instrument according to the instructions on the package insert PN 624021CA 10 5 CALIBRATION AUTO CALIBRATION 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 3 Prepare and mix the calibrator according to the instructions on the package insert 4 Insert the tube correctly into slot 1 of Tube Holder
105. 5 26 Worklists database and archive relationships 2 23 defined 2 22 examples 2 22 function 2 22 overview 2 22 printing from a previous archive E 2 workstation 1 6 definition GLOSSARY 2 do not install additional software 1 1 power button 1 6 X XB definition GLOSSARY 2 XM definition GLOSSARY 2 XXX NOT REACHING HOME 11 84 INDEX 11 INDEX INDEX 12 624021CA 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 following terms and conditions You May l 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 l Use copy or tra
106. 87 electrical problems 11 88 guide 11 86 mechanical problems 11 87 optical problems 11 88 pneumatic problems 11 87 power problems 11 86 printer problems 11 87 procedures 11 32 PN 624021CA PN 624021CA reagent problems 11 87 results problems 11 87 sampling problems 11 86 software could not connect to analyzer 11 86 Startup problems 11 86 tube holder 1 1 4 2 1 4 description 1 4 pierce position of tube 5 11 tube positions within 1 5 tubes inserting into tube holder 5 10 pierce position inside holder 5 11 placing in the piercing position 5 11 U U S See reporting units universal precautions 4 1 V Vac definition ABBREVIATIONS 2 validating sample results 9 11 Vds definition ABBREVIATIONS 2 verification definition GLOSSARY 2 volume in specimen tube 8 2 W warning definition 4 1 11 8 warning labels See labels waste neutralize before capping waste container 1 12 output connector location 1 3 waste container replacement 11 73 waste sensor 11 73 waste sensor function 11 73 location 11 73 INDEX waste syringe function 11 28 location 11 28 WBC definition ABBREVIATIONS 2 fragility 3 12 interfering substances 3 12 WBC count overview 2 18 WBC INTERPRETATION NOT POSSIBLE 9 29 9 31 WBC Lyse reagent description 1 11 replacement procedure 11 63 WBC BA diameter of aperture 3 5 whole blood definition GLOSSARY 2 window primary window after log on
107. A SETUP A QUALITY ASSURANCE SETUP A e 1 Setup gt gt Quality Assurance 2 the password and 0 2 3 W the General tab if necessary Reserved Name LotNumber Level_ Source Panel__ ac cv Repro cv Cali Cv 5 2 JE sg Ki Options Auto Pint 9 08 Repro Calibration IAP ID Con of CO CO Cot EN CN 2 5 3 H 07718 2004 11 43 17 AM 4 Atthe XM Options field 0 the button next to the desired option to enable disable as needed PN 624021CA A 69 SETUP QUALITY ASSURANCE SETUP 9 Save the changes to save and exit from the window OR to save and remain at this window to continue editing Defining Parameter CV Limits for QC Quality Control Do this procedure to define the CV coefficient of variation limits for QC These are the CV limits that the values in the control files are compared against A Ar 1 Setup gt gt Quality Assurance 2 Typethe password and 0 vj A 70 624021 PN 624021CA SETUP QUALITY ASSURANCE SETUP General alibratici if 3 the General tab if necessary stas Reserved Jf lumber sf nit memes i Name LotNumber Level Source Panel Parameter QC Repro CV cv WM CONTROLI
108. BC count determination 2 14 diameter of aperture 3 5 histogram determination 2 14 how it is determined 2 14 interfering substances 3 12 RBC INTERPRETATION NOT POSSIBLE 9 30 RDW calculation overview 2 15 interfering substances 3 13 reagent syringe function 11 29 location 11 29 Reagent s Low Insufficient Reagents To Complete Daily Workload 11 84 reagents consumption by cycle 3 5 expired how to handle 1 13 location 11 49 priming procedure 11 72 recommended 1 10 3 2 replacement procedures 11 49 when to replace 11 63 replacing the waste container 11 73 PN 624021CA PN 624021CA report printed reports 1 9 See also sample report reportable range 3 7 definition GLOSSARY 2 Hct 3 7 Hgb 3 7 Plt 3 7 RBC 3 7 WBC 3 7 reporting units formats available A 8 selection procedure 8 reproducibility definition GLOSSARY 2 performance characteristics 3 8 performance specifications 3 6 poor what to do if 11 87 rerunning samples in a Worklist 8 38 results exceeding instrument capacity 9 17 results search 9 2 review flag description 9 19 Rinse reagent description 1 11 replacement procedure 11 63 rinsing procedures baths 11 32 flow cell 11 32 flowcell 11 32 run controls procedure 7 2 RUO definition ABBREVIATIONS 2 S safety precautions biological 11 8 list of 4 1 while performing maintenance or service 11 8 sample analysis rerunning samples 8 38 running Stat
109. BC count and describes the average weight of hemoglobin in a red cell The calculation for MCH is _ Hgb MCH pg RBC 10 Note pg is the US unit format Other formats are available See Changing the Reporting Unit 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 MCH dL x1 g dL Het 00 Note g dL is the US unit format Other formats are available See Changing the Reporting Unit PN 624021CA 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 14 is an example of a Plt histogram with a normal Plt size distribution Figure 2 14 Typical Histogram Interference the Lower End of the Platelet Distribution Curve Particles that are approximately platelet size can interfere with the platelet histogram and count Small p
110. BILITY CHECK Do this procedure asrequired by your state or regulatory agencies or e for troubleshooting purposes Os Bex Select a fresh normal whole blood sample as defined by your laboratory guidelines 2 the Quality Assurance tab 3 the Reproducibility tab 4 the panel CBC or CBC DIFF IMPORTANT Risk of erroneous results if sample is not properly mixed before analysis Mix the blood specimen gently and thoroughly before analysis according to the tube manufacturer s recommendations and your laboratory protocol 9 Mixand analyze the sample IMPORTANT Do not log out of the Workstation while the Analyzer is running a cycle Logging out during an Analyzer cycle will cause problems with the Analyzer Workstation communication 624021CA 11 3 DIAGNOSTICS SHUTTING DOWN WINDOWS NT IMPORTANT Risk of erroneous results if sample is not properly mixed between analyses Mix the blood specimen gently and thoroughly before each analysis according to the tube manufacturer s recommendations and your laboratory protocol 6 Analyze samples until a minimum of an n of 10 is achieved 1 Compare the results to the CV limits Results that exceed the limits appear against a red background 8 Repeat the runs as required 9 Contact a Beckman Coulter representative if results exceed limits 11 5 SHUTTING DOWN WINDOWS NT When Windows NT shuts down it does an automated system
111. CATIONS CHARACTERISTICS 3 1 EX 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 Temperature Ambient Operating 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 2 Sample Volume Aspirated 3 3 Dilution Ratios 3 3 Throughput 3 3 Sample Identification 3 3 Database Storage 3 3 Flagging Sets 3 3 Output 3 3 Measurements and Computation 3 5 Counting Aperture Diameters 3 5 Reagent Consumption 3 5 Environmental Protection 3 5 vii CONTENTS 3 2 3 3 34 3 5 PERFORMANCE SPECIFICATIONS 3 6 Reproducibility 3 6 Linearity 3 6 Accuracy 3 6 Carryover 3 7 Reportable Range 3 7 PERFORMANCE CHARACTERISTICS 3 8 Reproducibility 3 8 Accuracy 3 8 Carryover 3 9 Sample Stability 3 10 LIMITATIONS 3 11 Maintenance 3 11 Blood Specimens 3 11 INTERFERING SUBSTANCES 3 12 4 PRECAUTIONS HAZARDS 4 1 l 42 43 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 5 GETTING STARTED 5 1 5 1 d 5 3 34 viii GENERAL 5 1 POWER UP POWER DOWN 5 1 Power Up the System 5 1 Power Down the System
112. COULTER 00 ACeT 5diff Cap Pierce Hematology Analyzer Instructions For Use CE PN 624021CA June 2010 Manufactured for B Beckman Coulter Inc 250 S Kraemer Blvd OULTER Brea CA 92821 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 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 nstrument alarms and error messages are not acknowledged and acted upon
113. CS SYSTEM LOGS 1 View your comment by scrolling right on the log report by 2 Adding Comments Before Log Entry Do this procedure to be prompted for your comments before the log entry is made For example after a Startup is run the system saves the Startup results to the Startup Log If you want to be prompted with the Add Comment window before the entry to the log is made you need to enable the Users Comments prompt for the Startup Log Otherwise to add a comment to the Startup Log entry you would have to do Adding Comments After Log Entry 1 the Analyzer Logs tab the desired log 5 1 21 td Llc gy zl v4 3 22 e Reagent Log EE Reagent Status Startup Log Reagent RINSE Fix HGB LYSE WBC LYSE DILUENT Lot Numbe e Calibration Log uncus Expiration Date Log Operator pct pc pa pa Error Log HE EN EE o NEG Change All Reagents Change Reagent Startup System lackgroun WBC RBC HGB PLT Wye WERE Passed Passed Passed Passed p Reagent Sevice 03 09 2001 155958 11 92 624021 DIAGNOSTICS OPENING THE TUBE HOLDER DOOR IF JAMMED 3 the box next to Prompt User for Comments as need to enable or disable the prompt mur 13 03 2001 152232 03 08 2001 14 47 55 checkmark in the box means that the E
114. Clinical Laboratory Standards NCCLS at 940 West Valley Road Wayne PA 19087 1898 USA For additional information on IQAP including how to enroll contact your Beckman Coulter representative Cell Controls A eT 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 use and for a list of measured parameters Calibrator 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 5diff Cal Calibrator to ensure accurate instrument measurements for WBC RBC Plt Hct and Hgb PN 624021CA 1 9 USE AND FUNCTION REAGENTS 1 8 REAGENTS Recommended Reagents Beckman Coulter recommends these reagents e ACeT 5diff Diluent e ACeT 5diff Fix e AC T 5diff WBC Lyse e ACeT 5diff Hgb Lyse and e AC T 5diff Rinse These reagents are manufactured by 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 reagent s bottle container label for detailed informatio
115. D Autonumbering Enabling A 2 Changing the Starting Number for Autonumbered Sample IDs A 4 Sample ID Autonumbering Disabling A 5 Deleting Physician or Location Names A 6 Changing the Reporting Unit A 8 Setting the Date Time A 11 Changing the Date A 11 Changing the Time A 13 Changing the Time Format A 15 Changing the Date Format A 16 Changing the Daily Workload A 18 Changing the Auto Clean Frequency Setting A 20 Enabling Disabling Automatic Startup A 22 Viewing Editing the Analyzers Serial Number SN A 23 Selecting a Language 24 Configuring the Printer A 26 Defining Printer Properties A 26 Adding a Printer A 28 Defining Results Autotransmission Settings 29 Analyzer and Workstation Configuration Settings A 31 Saving Analyzer Configuration Settings A 31 Restoring Analyzer Configuration Settings A 33 Printing Analyzer Configuration Settings A 34 Saving Workstation Configuration Settings A 36 Restoring Workstation Configuration Settings A 38 Printing Workstation Configuration Settings A 40 Defining the Host Communication Settings A 42 PATIENT SETUP A 43 Working With Flagging Sets Ranges A 43 Selecting a Default Flagging Set A 43 Editing Patient Limit Ranges in a Flagging Set A 45 Creating Additional Flagging Sets A 46 Flag Sensitivity and Thresholds A 48 Copying Action Limits and Patient Limits to Another Flagging Set A 49 Enabling Disabling RUO Research Use Only Parameters A 51 Enabling RUO
116. 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 coefficient of calibration BASO Count Differentiation between basophils and other leukocytes is obtained by means of the 5diff WBC Lyse specific lytic action In Figure 2 16 basophils are located in the area between the thresholds labeled and One hundred percent 10096 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 between the thresholds labeled and Figure 2 16 Figure 2 16 Areas Used to Determine WBC and BASO Parameter Results Q e WBC basophils BASO count Number of cells per volume x coefficient of calibration in percentage relative to the number of counted cells BASO plus WBC nuclei BASO BASO count WBC x WBC count 9 18 PN
117. DIAGNOSTICS COMPONENT LOCATIONS 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 Count syringe ensures the vacuum for the WBC and BASO counts ensures the vacuum for the RBC and Plt counts and ensures the vacuum for filling the diluent reservoir with diluent DIFF syringe assembly injects the diluted sample into the flow cell and e injects the interior and exterior sheath into the flow cell Reagent syringe assembly ensures correct reagent delivery gt Lysing reagent for Hgb AC T 5diff Hgb Lyse gt Rinsing reagent 5diff Rinse gt Lysing reagent for DIFF 5diff Fix gt Lysing reagent for WBC BASO 5diff WBC Lyse gt Diluent 5diff Diluent 11 29 DIAGNOSTICS COMPONENT LOCATIONS Figure 11 4 Main Card Main card amplifies processes and counts the resistive signals and DIFF optical signals the RBC signal the Pit signal and the WBC BASO signal measures hemoglobin controls the motorized components processes data and calculates results and communicates with the Workstation Screws that secure the Main card to the frame Cables that must not be pinched or damaged when the Main card door is opened ATTENTION When opening the Main card support panel use Latch that holds Main
118. ENT 20000000 12921530 Flagging Set Name Limits Standard Range Parameter ActionL NormalL NormalH Action H 2 0 4 0 11 0 15 0 RBC 3 50 3 80 6 50 7 50 Defaut HGB 9 0 120 18 0 20 0 HCT 30 0 36 0 540 60 0 NCV 70 76 96 120 Diff Balance Yes MCH 25 0 27 0 32 0 34 0 MCHC 30 0 31 0 35 0 360 RDW 9 0 11 0 16 0 250 From Age Range PLT 100 150 400 5 mow 50 6 0 10 0 120 Time hh mm ss Date MM dd yyyy f 0 150 0 300 0 350 0 45 0 70 0 750 0 200 40 0 45 0 0 io i a j 0 eneral Settings Formatting Auto Transmission Options ea Off Opti Baud Rate 38400 Format FIXED E I ike Data Bits 8 Comm Mode UNIDIR Bn oo Oi Enable s Parity none 88 Normals Only Stop 1 Time Out 15 WS Normals and selected Abnormals Flaggingal Protocol Waiting Time 8 No Parameter Value 88 Time 80 With Parameters Flags 88 Analyzer Number 1 XLS sma paten umns Yes Automatic disconnect 88 Outside Action Limits RE fhresholds 1 Channel Numerical Results Flags and Messages Patient File 29 WBC 88 RBC 8 8 WBC Flags yes Patient ID es Hi HGB 8 MCHC Yes Diff Flags Yes Patient Name yes 2 YS ES ict was Row yas Date of Birth ve 2 Ke ags 8 8 s Age Yes 2 8 8 Diff Flags YS Gender ves General
119. FF Analytical Alarm is reported Ifthe WBC count from the flow cell exceeds the WBC count from the WBC BASO bath by more than a predefined amount DIFF is displayed Ifthe 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 PN 624021CA DATA REVIEW REVIEWING FLAGGED RESULTS 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 DiffPlot Flags and Analytical Alarms 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 Alarms will occur and indicate the area within the DiffPlot that is affected If the R flag occurs on a DIFF parameter further investigate the result Twelve different flags may occur related to the position of the populations within the DiffPlot See Table 9 1 for additional information PN 624021CA CO Diff Reject DB debris 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
120. Help sr gy meo zd Worklist Results Quality Assuran f Analyzer Logs Reagent Status ES Rise rx vec LYSE puer LotNumber 00102001441 6640200005 60202400846 00402501284 60302000036 Opened Date 03 27 2001 Ewpiatin Date 03 30 2001 Operator 03 27 2001 03 27 2001 03 27 2001 03 27 2001 uso Beim jAaministrare joominisirero joaminisvato Fil Level J 03 27 2001 16 17 06 11 63 11 DIAGNOSTICS REPLACEMENT PROCEDURES Reagent Status 2 Change All Reagents Ree ANSE recuse LotNumber fomozcoraa1 004020005 00202400846 00402801284 00302600035 OpenedDate 0327201 Expiration Date 03 30 2001 04720 2001 08723 2001 foariyeoor aum min Admin Admin Admin Admin Fil Level 3x 0 2 2 2 Change All Reagents Change Reagent 3 the reagent compartment door 4 Remove the reagent bottles from the reagent compartment Fix is shown here 11 64 PN 624021CA DIAGNOSTICS REPLACEMENT PROCEDURES 9 Remove the bottle stopper assembly from the reagent you are replacing P m gt Gp 6 Uncapa new reagent bottle 1 Put the cap from the new container onto t
121. Histogram Flags Generated when the percentage of Mono CBC DIFF Panel basophils found in the BA channel is Baso 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 BASO If the BASO exceeds 50 a BASO flag is generated The basophils are not taken away from the DiffPlot LY MO NE populations 15 displayed and printed instead of the BA and BA and BASO is displayed and printed in the DiffPlot and Histogram section of the Flags and Messages area PN 624021CA 9 25 DATA REVIEW REVIEWING FLAGGED RESULTS RBC Histogram Flags See Figure 9 5 Table 9 3 RBC Histogram Flags Histogram Flag Illustrations of Histogram Flags Description RBC MICRO Figure 9 5 MICRO and MACRO Regions MICRO and MACRO flags are and or on RBC Histogram generated when the percentage of MACRO 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 5 Thresholds RBC1 and RBC2 define the MICRO and MACRO regions and are calculated based on the standard deviation of a normal RBC population MICRO and or MACRO are displayed and printed in the DiffPlot and Histogram section of the Flags and Messages area Default value 596 for MICRO and 7 5 for MACRO
122. ICATIONS 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 Carryover Table 3 5 Carryover Specifications Parameter Carryover WBC lt 2 0 RBC lt 2 0 Pit lt 2 0 Hgb lt 2 0 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 PN 624021CA Table 3 6 Reportable Range Low 1 Low 3 High 1 Low3 Parameter Units Reportable Range WBC 103 uL 0 0 100 0 RBC 106 uL 0 00 10 00 PIt 108 uL 0 0 1500 0 Hct 0 0 80 0 Hgb g dL 0 0 30 0 x 100 3 7 SPECIFICATIONS CHARACTERISTICS PERFORMANCE CHARACTERISTICS 3 3 3 8 PERFORMANCE CHARACTERISTICS Performance characteristics indicate actual performance 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 Standa
123. IMPORTANT Risk of sample mis identification if the entire barcode is not captured with the barcode reader especially with Interleaved 2 of 5 barcode format Position the barcode reader over the label to capture the entire barcoded sample ID Otherwise part of the sample ID may not be scanned resulting in mis identification Pass the barcode reader over the barcode label on the sample tube 9 Scan the Sample ID from the barcode label on the sample tube a Position the barcode reader over the barcode label b Squeeze the trigger button If the barcode is successfully read the barcode reader beeps the LED on top of the reader illuminates and the cursor advances to the next field c Verify the barcode reading to ensure that the Sample ID in the Sample ID Next field is correct 6 Select the panel CBC or CBC DIFF Add Edit Worklist Kil a b Select CBC or CBC DIFF Semple ID 2345 Flagging Set c Press to move the cursor to IE the Flagging Set field M p Patient Identification 8 14 PN 624021CA PN 624021CA SAMPLE ANALYSIS RUNNING PATIENT SAMPLES USING THE WORKLIST 7 Select another flagging set if appropriate 0 b Select desired flagging set c Press to move the cursor to the Collection Date and Time field If you manually select a flagging set that flagging set will be applied For information on the flagging set
124. ION FACTOR D NEW CALIBRATION FACTOR E C B A E B A xD 9 Repeat steps 3 and 4 ten more times for a total of 11 runs 6 Do Heading C 2 CALCULATIONS PROCEDURE PN 624021CA C 1 C 2 PN 624021CA CALCULATIONS PROCEDURE Calculate the mean for each parameter using samples 2 through 11 on the worksheet Write this number into row A on the worksheet Copy your calibrator material s assigned value to the worksheet Write this number into row B on the worksheet 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 Determine if calibration is necessary by comparing the absolute difference from row C to your material s calibration criteria table Ifthe absolute difference is less than the value in your material s calibration criteria table no calibration is required Ifthe absolute difference is between the values found in your material s calibration criteria table do Heading 3 CALCULATING NEW CALIBRATION FACTORS 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 2 MANUAL CALIBRATION C CALC
125. LES WITHOUT USING THE WORKLIST 12 Remove the tube when the tube holder door automatically opens after aspiration The red LED is still illuminated which means the Analyzer is busy processing the sample 13 Wait for the green LED to illuminate which indicates the system is ready for the next sample Information for the next sample to be processed is displayed in the Sample ID Next field 14 verify that the current sample results appear in the Run window 15 verify the Sample ID and results before reporting the results 16 8 to print a copy of the results Note A copy prints automatically if the Auto Print function is enabled 8 26 SAMPLE ANALYSIS 8 RUNNING PATIENT SAMPLES WITHOUT USING THE WORKLIST 17 verify that the Sample ID for the next sample is correct SampeiD Pane 123 124 CBC DIFF 18 Repeat steps 3 through 17 until all samples are analyzed PN 624021CA 8 27 SAMPLE ANALYSIS RUNNING PATIENT SAMPLES WITHOUT USING THE WORKLIST Running Samples Autonumbering Off If autonumbering is disabled on your system you must manually enter the Sample ID up to 16 alphanumeric characters by typing it at the keyboard or by scanning it using the barcode reader optional Barcode configuration is performed at installation ATTENTION Beckman Coulter recommends that you verify each barcode reading to ensure correct sample identification LN
126. N TUBE HOLDERS Some procedures in this manual require you to place a tube or vial into the tube holder and start analysis There are three factors to be aware of 1 The manufacturer and tube name of the cap pierceable tube vial that you are using See Appendix D TUBE LIST 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 Analyzerin this section 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 A e Nec 1 The tube holder door automatically opens when the system is ready PN 624021CA 5 9 GETTING STARTED POSITIONING TUBES IN TUBE HOLDERS 5 10 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 If the tube or vial can be cap pierced then ensure that the cap is secure before inserting the tube or vial into the tube holder 2 If you insert a tube or vial upside down into the tube holder Always insert the tube bottom first into the holder 2 Insert the tube vial into the appropriate position in the tube holder For information on the correct position of each tube within the tube hol
127. OGY 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 PIt 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 Parameter Results Obtained Using the RBC Histogram 2 15 MCH and MCHC Calculations 2 15 PN 624021CA PN 624021CA 2 8 CONTENTS 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 Determination 2 17 WBC Count BASO Count and DiffPlot Development 2 18 WBC Count 2 18 BASO Count 2 18 DiffPlot Development 2 19 WORKLISTS 2 22 Definition 2 22 Function 2 22 Duplicate Sample ID Check 2 22 Demographics Storage 2 23 Database Archive and Worklist Relationships 2 23 3 SPECIFI
128. PERATION PRINCIPLES SAMPLE ANALYSIS 2 6 SAMPLE ANALYSIS RBC and Platelet Analysis The RBC PIt 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 Initial volume of whole blood Volume AC T 5diff diluent Primary dilution ratio Secondary Dilution for RBC and 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 uL 1 700 uL 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 9in Hg 2x5 seconds 2 8 PN 624021CA OPERATION PRINCIPLES 2 SAMPLE ANALYSIS Parameter Results Obtained from the RBC PIt Dilution This final 1 10 000 RBC PIt dilution is used to e Determine the RBC count Develop the RBC h
129. PN 624021CA A 55 A SETUP PATIENT SETUP 11 the Parameters tab 12 Verify that parameters are disabled Setting Up the Patient Report This section contains information about Entering a Report Header e Enabling Disabling Autoprint for Patient Sample Reports Selecting the Number of Copies to Print e Selecting the Patient Sample Report Printout Option Selecting the Patient Sample Report Printout Features Selecting the Parameters to Print Entering a Report Header Do this procedure to enter your laboratory s information such as lab name address and so forth that you want printed on the top of each patient sample report LN File Cycles Diagnostics Setup gt gt Patients Ic System 2 Type the password and 56 624021 SETUP PATIENT SETUP 3 the Reports tab my Reports Headers Header 1 der2 Header 3 Header 4 Header 5 Header 6 Auto Print folCopy Report Format Printed Peremeters Option 1 z E a 1 c2 Optont s wc F NE NE uL Ly P MO MO Range 2 C Normals 2 EOF Messages d C Abnormals RBC p Detailed Fle l d Pep HGB Ww MHC F HT ROW DifplotThresholds ER v E Histogram Thresholds fv PLT MPV F Raw Values 2 your laboratory s information a you
130. Parameters A 51 Disabling RUO Parameters A 54 PN 624021CA PN 624021CA AJ CONTENTS Setting Up the Patient Report A 56 Entering a Report Header A 56 Enabling Disabling Autoprint for Patient Sample Reports A 58 Selecting the Number of Copies to Print A 60 Selecting the Patient Sample Report Printout Option A 61 Selecting the Patient Sample Report Printout Features A 64 Selecting the Parameters to Print A 65 QUALITY ASSURANCE SETUP A 67 Enabling Disabling Autoprint for Controls Reproducibility and Calibration A 67 Enabling Disabling XM Options A 68 Defining Parameter CV Limits for QC Quality Control A 70 Defining Shifts A 72 Setting Up a Control File Upload from Control Disk A 73 Setting Up a Control File Manual Method A 76 Sensitivity and Thresholds A 80 Reserving Control Lot Numbers A 80 Setting Up the IQAP ID A 81 Reproducibility Run Results A 83 BARCODE SPECIFICATIONS B 1 1 B 2 B 3 B 4 B 5 B 6 ET 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 BARCODE SCANNER CONFIGURATION B 4 CODE 39 AND CODABAR BARCODE SCANNER OPTIONS B 5 I 2 OF 5 PROGRAMMING OPTIONS AND TEST LABELS B 7 CONNECTING THE OPTIONAL BARCODE READER B 8 MANUAL CALIBRATION C 1 en C 2 C3 ANALYSIS PROCEDURE C 1 CALCULATIONS PROCEDURE C 2 CALCULATING NEW CALIBRATION FACTORS C 3 Calibration
131. R sl 03 28 2001 14 00 06 Open the appropriate control file 3 the Quality Assurance tab SESS aba 3 9010 ed Lodo wi zu v 2 9e Worklist Pun Results QueliyAssurence 4 the Control tab pugna me E E M M NR AM 28 2 s 193 76 em 21 5 Select the desired control file io A m 2 Low N 8 8 8 8 8 S Mean 25 2 65 18 0 75 Add Comment 25D n 005 009 042 065 a at Select m Ex som s mm 1 Delta Diff 01 003 00 04 1 Contro WBC 7 HGB MCV 7 MCH MCHC ROW 7 PLT MPV NE 7 LY 7 EO NER 7 Lyn 7 Eons gt b the desired control z IMPORTANT Risk of erroneous results if the control is not mixed according to the instructions in the control s package insert 2 Mix each control vial according to the instructions in the ACeT 5diff Control Plus cell control package insert 7 2 624021 PN 624021CA QUALITY ASSURANCE RUNNING CELL CONTROLS J Inspect the vial s 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 4 Insert the tube vial correc
132. Reservoir 2 w eJ v Note If you 0 All Baths or Diluent Reservoir a status bar appears to show progress For the other options the red LED illuminates when the function is in progress 9 Ifyou selected Diluent Reservoir OK to continue IMPORTANT Risk of erroneous results if you do not prime the Diluent after draining the Diluent reservoir Reprime the Diluent 6 After the Diluent Reservoir is drained prime the Diluent a J Diagnostics gt gt Operator b UU the Diluter Systems tab c UJ the Prime Reagents tab d UO Diluent PN 624021CA 11 35 DIAGNOSTICS SYSTEM TROUBLESHOOTING PROCEDURES 11 36 Hardware Systems The information in this section includes Hardware Reset Sampling Probe Test e Traverse Test Sampling Syringe Test Draining Syringe Test Counting Syringe Test Flow Cell Syringes Test e Dilution Syringe Test e Piercing Mechanism Test e Valves Test Traverse Service Position and e Parking the Syringes Hardware Reset Hardware Reset initializes the mechanical assemblies and resets instrument components such as motors and valves to a normal or home position A Aer Diagnostics gt gt Operator 5diff File Dia ECC Help 2 the Hardware Systems tab 59 Operator Hardware Systems Systems Cycles R Reset Hardware Motors Valves Tra PN 6
133. S 13 Press to move the cursor to the expiration date field 14 Select the reagents expiration date a ha at the Expiration Date field to open the calendar that shows the current date b Select the expiration date 1 as needed to advance to the correct month Note To return to a previous S d E 2 the correct day Expiration Date 05 17 2001 May 2001 Sun Mon Tue Wed Thu Fri 1 2 3 4 6 7 8 9 10 11 13 14 15 16 f 18 20 21 22 23 24 25 27 28 23 30 31 lt gt Today 03 28 2001 11 55 REPLACEMENT PROCEDURES DIAGNOSTICS 11 56 15 F to save the reagent s information 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 10096 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 Heading 11 7 SYSTEM RESET CYCLE c Do Priming the Reagents to manually prime the reagent s PN 624021CA PN 624021CA DIAGNOSTICS REPLACEMENT PROCEDURES Changing One Reagent 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 Changing the Diluent Reagent To replace all the reagents at the same time do Chang
134. SAMPLES 8 38 PN 624021CA CONTENTS 9 DATA REVIEW 9 1 9 1 LOCATING SAMPLE RESULTS 9 1 Searching for a Recent Result 9 1 Advanced Search 9 2 Sorting Sample Results 9 4 9 2 AFTER LOCATING THE SAMPLE RESULTS 9 6 Viewing Sample Results 9 6 Printing Sample Results 9 7 Printing a Single Sample Result 9 7 Printing a Batch of Sample Results 9 8 Transmitting Sample Results 9 9 Transmitting the Last Sample Result 9 9 Transmitting a Batch of Sample Results 9 10 Validating Sample Results 9 11 Deleting Sample Results 9 13 9 3 REVIEWING FLAGGED RESULTS 9 14 General 9 15 Types of Flagging Formats 9 16 Suspect Flag Format 9 16 Detailed Flag Format 9 16 Flags Interpretive Messages and Analytical Alarms 9 16 Flags 9 16 Definition 9 16 Types of Flags 9 16 Interpretive Messages 9 17 Definition 9 17 Analytical Alarms 9 17 Definition 9 17 Flags and Analytical Alarms Generated by the Instrument 9 17 Overview 9 17 Results Exceeding Instrument Capacity 9 17 Hemoglobin Flags 9 18 Hemoglobin Hematocrit Ratio Flag H amp H Flag 9 18 Hgb Blank Error 9 18 Hgb Read Error 9 18 Voteout Flag 9 18 WBC Count Flag and Analytical Alarms 9 18 DiffPlot Flags and Analytical Alarms 9 19 WBC Baso Histogram Flags and Analytical Alarms 9 25 RBC Histogram Flags 9 26 Plt Histogram Flags and Analytical Alarms 9 27 Patient Ranges and Action Ranges 9 28 Interpretive Messages 9 28 WBC Interpretive Messag
135. T 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 a Remove the tubing from of the rear port of valve 27 HUS BE b Grasp the upper half of the filter and twist it until it is completely loosened from the top fitting c Remove the tubing from the bottom of the filter 6 Properly dispose of the old rinse bath filter PN 624021CA 11 25 11 DIAGNOSTICS REPLACING THE RINSE BATH DRAIN FILTER 7 Install the new rinse bath filter a Connect the existing tubing to the WD bottom of the new filter SY Grasp the upper half of filter and insert the end into the fitting Secure the filter by turning as needed Connect the tubing on the bottom of the filter to the rear port of valve 2f Push the tubing down over the fitting till it is secure 8 Close the right side door 9 Reconnect the power cord to the rear of the analyzer 11 26 PN 624021CA DIAGNOSTICS REPLACING THE RINSE BATH DRAIN FILTER 10 Power up the system as instructed in Power Up the System in Chapter 5 11 Cycle a sample with known results to verify instrument performance 12 After the cycle is complete open the right side door to confirm there are no leaks and that the rinse
136. T SAMPLES WITHOUT USING THE WORKLIST 8 30 IMPORTANT Risk of sample mis identification if the entire barcode is not captured with the barcode reader especially with Interleaved 2 of 5 barcode format Position the barcode reader over the label to capture the entire barcoded sample ID Otherwise part of the sample ID may not be scanned resulting in mis identification Pass the barcode reader over the barcode label on the sample tube 4 Scan the Sample ID from the barcode label on the sample tube a Position the barcode reader over the barcode label Squeeze the trigger button If the barcode is successfully read the barcode reader beeps the LED on top of the reader illuminates and the cursor advances to the next field Verify the barcode reading to ensure that the Sample ID in tn the Sample ID Next field is correct Select the panel CBC or CBC DIFF a b C O a Select CBC or CBC DIFF Press to move the cursor to the Patient ID field CBC CBC DIFF CBC DIFF PN 624021CA PN 624021CA RUNNING PATIENT SAMPLES WITHOUT USING THE WORKLIST SAMPLE ANALYSIS 6 Enter the Patient ID optional up to 25 alphanumeric characters and no spaces manually enter the ID or scan the ID from the barcode if applicable or and select the ID from the existing list of Patient IDs if applicable 123 CBC DIFF 124 CBC IMPORTANT Risk of erroneou
137. THE ONLINE HELP SYSTEM Using the Tables Option The tables option displays a list of tables within the manual 1 Access online Help 2 Tables A list of tables appears 3 Scroll through the tables to locate the table you want to view 4 the table to display it on the screen Using the Illustrations Option The illustrations option displays a list of illustrations within the manual 1 Access online Help 2 Illustrations A list of illustrations appears PN 624021CA 5 19 GETTING STARTED USING THE ONLINE HELP SYSTEM 3 Scroll through the illustrations to locate the illustration you want to view 4 d the illustration to display it on the Screen Using the Search Option The search option allows you to locate help topics by searching for words or phrases the topics contain 1 Access online Help Search A search field is displayed Type the word s that you want to locate 5 20 Search If the word s you typed appears in the document each instance where it appears will be shown PN 624021CA GETTING STARTED 5 USING THE ONLINE HELP SYSTEM Printing Help Information Printing the Operator s Manual The Print Manual feature of the online Help system allows you to print all or part of the Operators Manual Instructions For Use This is the same information that is contained in the Help but in a printable book format
138. TUDES option is enabled otherwise the option is disabled Maintenance Log Sev 11 15 OPENING THE TUBE HOLDER DOOR IF JAMMED PN 624021CA IMPORTANT Risk 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 LN 2 Nel If the tube holder door fails to open go to step 2 2 Power down the System as instructed in Power Down the System in Chapter 5 11 93 DIAGNOSTICS OPENING THE TUBE HOLDER DOOR IF JAMMED 3 Unplug the analyzer from its power source wall outlet 4 Insert an allen wrench 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 5 Plug the analyzer into its power source 6 Power up the system as instructed in Power Up the System in Chapter 5 Verify system performance and resume normal operation 11 94 PN 624021CA A 1 INSTALLATION SETUP 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 defaul
139. TUP 4 Restore in Current Workstation Setup Je Optic A e Config Save Restore Language Current Analyzer Setup Current Workstation Setup 9 Indicate from where the settings should be restored e Ifyou want to restore the settings from the hard drive U Hard Drive e Ifyou want the settings to be restored from a floppy disk 1 Insert the disk into drive A 2 Floppy Disk o PN 624021CA A 39 SETUP SYSTEM SETUP Printing Workstation Configuration Settings Do this procedure to print the current Analyzer configuration settings LN 2 Ne File Cycles Diagnostics 9 Help amp 2 Patients 1 Setup gt gt System UJ 205 Quality Assurance 2 Type the password and 3 Config Save Restore tab 3 2 D H ela 07 16 2004 02 38 37 PM A 40 PN 624021CA SETUP A SYSTEM SETUP Genei 4 Print in Current Workstation Setup pum Mmmm s een I P detailed report on the Workstation s t aec pq settings is printed Figure A 1 Save Seve 9 Keep the printout for your records 624021 41 SETUP SYSTEM SETUP Figure A 1 Workstation Setup Report S N AD49004 Software Version V1 0 Param Version Operator Administrato 1000000 64 RIN FIX 100000 6361729 E HGBLYSE 400000 193668 WBC LYSE 1000000 769124 3 DILU
140. TY ASSURANCE SETUP A 80 Sensitivity and Thresholds The Threshold button on the Setup Control screen displays the Sensitivity and Thresholds for the control This screen is for Service use only If you accidentally access this screen select the Target button to return to the correct display 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 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 Based on that 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 LN ANE 1 Setup gt gt Quality Assurance 2 Typethe password and vj 3 the General tab if necessary Reserved Name LotNumber Level Source Panel ac cv Repro cv Cali Cv 5 2 2 Options Auto Pint 3Paam SPaam G Of Controls Calibration IAP ID Con of CO CO of P CN 3 amp 3 H x 7 18 2004 11 43 17 AM PN 624021CA SETUP A QUALITY ASSURANCE SETUP 4 Atthe Reserved Lot Number
141. Type Password 123 d Press Or OK 11 Wait for the Analyzer connection to be established 12 Setup gt gt Patients 13 14 Type the password and 2 U the Parameters tab 15 Verify that the RUO parameters are selected GATL GAILE v PLT r GPET QIMM GIMME HPV m GPDw A 53 A SETUP PATIENT SETUP Disabling RUO Parameters Do this procedure to disable the reporting of the RUO parameters LN Nx Ele Cycles Diagnostics SIZE Help FT ad System Setup gt gt Patients 2 the password and 3 the Parameters tab Disable RUO Parameters Changing Selected Parameter quires restarting the application 4 0 Disable RUO Parameters Disable EG Parameters Note If Disable RUO Parameters is not available then the RUO parameters are already disabled and you do not have to continue with this procedure A 54 624021CA SETUP PATIENT SETUP 5 0 to confirm that you will be automatically logged out 6 Wait while the systems logs out 1 Login again a When the Begin Logon box appears simultaneously press At Delete b Type User name and press rab c Type Password 123 d Press Or U OK 8 Wait for the Analyzer connection to be established 9 Setup Patients 10 Type the password and U Vv
142. ULATING NEW CALIBRATION FACTORS C 3 CALCULATING NEW CALIBRATION FACTORS 1 Do Heading 10 4 MANUAL CALIBRATION FACTOR ADJUSTMENT 2 Record these factors into row D on the worksheet PN 624021CA C 3 MANUAL CALIBRATION CALCULATING NEW CALIBRATION FACTORS Calibration Worksheet Bae Tw Jet ue iro LIMES TOTAL samples 2 through 11 C B A E B A xD C 4 PN 624021CA TUBE LIST DE D 1 TUBES APPROVED FOR USE WITH CP SYSTEM Table D 1 lists tubes shown to be compatible with the cap pierce mechanism of the AC T 5diff CP system Beckman Coulter does not recommend the use of one tube in preference to another nor guarantee the acceptability of the sample tube to produce quality results If you need information on a tube not listed in this appendix contact a Beckman Coulter representative Note Tube product numbers change frequently Verify the tube product numbers with the tube manufacturer Table D 1 Specimen Tubes for Use with the Tube Holders Volume mL unless Position in Position in Manufacturer Product otherwise Cap Tube Holder Tube Holder See and Tube Name Number stated Size mm Pierceable 1 2 Note ACT 5diff Cal 7547175 2 0 13X75 Yes 1 4 Calibrator 5diff Control 7547198 2 3 13 75 Yes 1 4 3 Plus Becton Dickinson 365974 0 25 to 0 50 4 BD Microtainer BD Microtainer 365973 0 25 to 0 50 No 1 BD Hemogar
143. Worksheet C 4 TUBE LIST D 1 D 1 TUBES APPROVED FOR USE WITH CP SYSTEM D 1 XV CONTENTS E WORKSTATION MANAGEMENT E 1 El ARCHIVE MANAGEMENT E 1 Creating an Archive E 1 Opening a Saved Archive E 2 Printing a Worklist from a Previous Archive E 2 E 2 DATABASE MANAGEMENT E 4 Backing Up the Database E 4 Restoring a Database E 5 Deleting a Database E 6 Database Compacting E 7 REFERENCES REFERENCES 1 GLOSSARY GLOSSARY 1 ABBREVIATIONS ABBREVIATIONS 1 INDEX INDEX 1 BECKMAN COULTER INC CUSTOMER END USER LICENSE AGREEMENT TRADEMARKS DOCUMENTATION PAGE xvi 624021 PN 624021CA ILLUSTRATIONS LA 1 2 1 3 1 1 5 1 6 Ley 1 8 1 9 2 1 2 2 2 3 2 23 2 6 yn 2 8 2 9 2 10 als 2 15 2l 215 2 16 aLr 2 18 3 1 ad 5 1 VN 3 3 34 3 3 5 6 Id 5 8 5 9 5 10 5 11 3 12 2 413 3 14 5 15 9 1 9 2 9 3 94 ACeT 5diff CP Analyzer 1 1 Overview of Analyzer 1 2 Analyzer Back Panel 1 3 Warning and Caution Labels Analyzer 1 3 Tube Holder 1 1 4 Tube Holder 2 1 4 Tube Positions in the Tube Holders 1 5 Workstation 1 6 Back of Workstation 1 6 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
144. You contact moving parts You mishandle broken parts Doors covers and panels are not opened closed removed and or replaced with care Improper tools are used for troubleshooting To avoid injury Keep doors covers and panels closed and secured in place while the instrument is in use Take full advantage of the safety features of the instrument Do not defeat safety interlocks and sensors Acknowledge and act upon instrument alarms and error messages 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 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 produ
145. a visual confirmation that a specific result has been reviewed and validated Before marking a sample result as validated remember e You cannot rerun a sample that has been marked as validated e You cannot validate the first run of a sample once a you request a rerun of that sample e You cannot unvalidate a validated sample Do this procedure if you want to mark the sample result as having been validated PN 624021CA 9 11 9 DATA REVIEW AFTER LOCATING THE SAMPLE RESULTS oo aS N S Nei XI vo Worklist Run Results ality Assurance AnalyzedLogs Sea ti Sample 1D Patient Name Panel Flagging Set 73 ilaa Standard Range 087 He 017 CBC DIFF Standard Range 08 42 0162 CBC DIFF Standard Range 08 ous IcBc DIFF Standard Range 08 ao orsz IcBC DIFF Standard Range 08 1 the Results tab at the top and then Hela semi Range 08 38 014 CBC DIFF Standard Range 08 24 37 0142 CBC DIFF Standard Range 08 the Results tab at the bottom if op Sa 7 35 0132 CBC DIFF Standard Range 08 necessary 34 013 CBC DIFF Standard Range 08 33 __ 0122 CBC DIFF Standard Range 08 a2 orz Standard Range 087 31 10112 CBC DIFF Standard Range 08 cec p1rF Standard Range 08 Ti 6092 cec p1FF Standard Range 007 m inj e 2 Highlight the sample result that you want to m
146. agent Log Startup Log Maintenance Log Enor Log Service Log Worklist Results Archive Summary List d the items you want to print For our example from above Reagent Log Norklist l Run l Result Quality Assurance Analyzer Logs Calibration Log Startup Log Maintenance Log Enor Log Service Log Worklist Results Archive Summary List 5 38 t PN 624021CA GETTING STARTED 5 ENTERING INFORMATION USING THE BARCODE SCANNER 9 11 ENTERING INFORMATION USING THE BARCODE SCANNER 1 0 the field where you want to enter information For example if you want to scan the Sample ID 0 the Sample ID field 2 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 illuminates on the reader and the cursor advances to the next field 3 Verify that the information was placed in the correct field PN 624021CA 5 39 GETTING STARTED UNDERSTANDING HOW FLAGGING SETS ARE APPLIED 5 12 UNDERSTANDING HOW FLAGGING SETS ARE APPLIED Your system includes 6 pre defined flagging sets Table 5 2 Table 5 2 Pre Defined Flagging Sets Flagging Set Number Name Age Range 1 Standard Range 2 Man 12 years 3 Woman 12 years 4 Newborn 0 to 30 days 5 Infant 1 month to 6 years 6 Child 6 years to 12 years No
147. ally conductive reagent is in the or WBC BASO 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 CP 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 o
148. alues 58 624021 SETUP PATIENT SETUP 4 the desired option nothing automatically prints normal and abnormal patient sample results automatically print e Normals only normal patient sample results automatically print e Abnormals only abnormal patient sample results automatically print Sdiff Patients Setup Reports Headers If you select Abnormals select one or more of the following options E Parameter Value Report Format Printed Parameters e With Parameter Flags orion 2 NE n ty Lye e Outside Patient Limits pde sow EO F EOF i H H BAt Outside Action Limits C ow fe oo mm d HGB 2 MCHC 2 D f mwesods F P E Row OF 4 liogram Thresholds PLT F 2 Raw Values 5 Savethe changes to save and exit from the window OR to save and remain at this window to continue setting up the Patient report 624021 59 SETUP PATIENT SETUP Selecting the Number of Copies to Print Do this procedure to define the number of copies 1 or 2 of the patient sample report that you want printed regardless of whether the reports autoprint LN amp Ne File Cycles Diagnostics Bl 4 System U Setup gt gt Patients 2 the password and 3 W
149. anel Patient ID 123 c Mix the specimen gently and thoroughly d Verify that the Sample ID is correct 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 e Place the sample tube in the correct tube holder position f Verify that the tube holder is positioned such that the sample tube is in the 12 00 o clock pierce position g Close the tube holder door IMPORTANT Do not log out of the Workstation while the Analyzer is running a cycle Logging out during an Analyzer cycle will cause problems with the Analyzer Workstation communication The sample is highlighted in red in the Worklist during analysis When analysis is complete the sample is removed from the Worklist and placed with the results in the Results list The system displays the Sample ID of the next sample to be processed based on the order of the Worklist before the Stat entry 8 36 624021CA SAMPLE ANALYSIS 8 RUNNING STAT SAMPLES FROM WORKLIST ENTRIES 4 Review the sample results 9 Verify the Sample ID and results before reporting the results 6 to print a copy of the results Note A copy prints automatically if the Auto Print function is enabled PN 624021CA 8 37 SAMPLE ANALYSIS RERUNNING SAMPLES 8 7 RERUNNING SAMPLES There may be instances when you will want to repeat a sample For example
150. ange 08 the Results tab at the bottom if e 35 0132 CBC DIFF Standard Range 08 necessary faa ous ICBC DIFF Standard Range 08 as 0122 cBC DIFF Standard Range 08 onz ICBC DIFF Standard Range 08 31 10112 CBC DIFF Standard Range 08 fon Standard Range 087 29 6102 Standard Range 087 28 010 CBC DIFF Standard Range 08 T1 6092 CBC DIFF Standard Range 18 a 0 8 624021 9 9 DATA REVIEW AFTER LOCATING THE SAMPLE RESULTS 3 The last result Ux The system transmits the last sample result to the host computer Transmitting a Batch of 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 autotransmit on and autoprint on Always allow sample analysis and or the host download to complete before batch printing and or batch transmitting IMPORTANT Risk of failure to print and or transmit all requested results Do not delete result s until printing and or transmitting are complete Allow all results to complete printing and or transmitting before using the delete function In addition to selecting specific results to batch transmit you can also select to transmit all results Once transmission begins it cannot be stopped oo s Diagnostics Setup N
151. ark as validated ATTENTION Remember that you cannot rerun a validated sample and you cannot validate the first run of a sample once you request a rerun of that sample Of 4 Verify that the sample has been validated Verify that the box in the upper right corner is now green 9 12 624021CA DATA REVIEW 0 AFTER LOCATING THE SAMPLE RESULTS Deleting Sample Results IMPORTANT Risk of failure to print and or transmit all requested results Do not delete result s until printing and or transmitting are complete Allow all results to complete printing and or transmitting before using the delete function N Nei ve Results ality Assurance Analyzet Logs Seq Wi Sample 1D Patient Name Panel Flagging Set 73 4 0172 Standard Range 08 Jas 017 CBC DIFF Standard Range 08 42 0162 ICBC DIFF Standard Range 08 Al 016 CBC DIFF Standard Range 08 40 0152 CBC DIFF Standard Range 08 1 the Results tab at the top and then s us PT 38 014 ICBC DIFF Standard Range 08 the Results or Search Results tab at the fee 35 0132 ICBC DIFF Standard Range 08 otto 0122 CBC DIFF Standard Range 087 Notes Cr Use the Result List View Results bur amatam e Iz tab at the bottom to delete sample EH results from the current archive Search Results
152. arms altitude range 3 2 INDEX mE analytical alarms definition 9 17 what triggers them 9 17 analyzer figures and description 1 2 Anemia triggering condition 9 30 Anisocytosis triggering condition 9 30 ANSI definition ABBREVIATIONS 1 anticoagulant recommended 3 2 8 2 aperture DIFF diameter 3 5 diameter 3 5 sensing system function 2 1 WBC BA diameter 3 5 See also blocked apertures archive frequency worklist requirements 2 22 printing from previous E 2 relationship with database and worklist 2 23 ASTM definition ABBREVIATIONS 1 ATL display print setup A 51 attention definition 4 1 Atypical Lymphocyte triggering condition 9 29 auto clean frequency 11 9 autonumbering sample IDs 8 3 8 22 autotransmit control results A 30 azide warning 1 11 BA interfering substances 3 15 backflush function 11 32 procedure 11 32 background count definition GLOSSARY 1 limits 6 1 backup database procedure E 4 band cells description 2 21 INDEX 1 INDEX INDEX 2 barcode labels default settings B 2 specifications B 1 symbologies list of B 1 barcode scanner optional entering information using the scanner 5 39 barcode definition B 1 BASO count calculation overview 2 18 overview 2 18 basophil overview 2 18 basophil percentage overview 2 18 basophil See BA Basophilia triggering condition 9 29 BATH ENCLOSURE DOOR OPENED 11 81 baths cleani
153. articles 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 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 Histogram 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 Plt count Number of cells counted per unit volume x Calibration coefficient Plt count is displayed and printed as Plt Nx10 cells nL Note cells pnL is the US unit format Other formats are available See Changing the Reporting Unit 2 16 PN 624021CA OPERATION PRINCIPLES PARAMETER DEVELOPMENT e MPV Measurement MPV Mean Platelet Volume is measured directly from analysis of the platelet distribution curve MPV is display
154. asurement Characteristics Method of analysis Spectrophotometry Wavelength 550nm PN 624021CA 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 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 Assemhly 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 AC 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 624021CA 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 Develop
155. ata Bits Comm Mode C Normals and Selected Abnormals Unidrec aal 115200 SDH EL Jo Parameter valle iu C Bidiectic With Parameter klages p Parity Protocol Outside Patentlimits Odd estes Time Qut 15 Gutside Acton Limits fo uns Waiting Ti 8 ime o None iis Time 80 Control Results XLS Delite Analyzer Number n Automatic Disconnect v LIS HIS Variable Format 3 e 3 H X 07 18 2004 12 04 33 PM Autotransmission of the results to the host computer occurs based on the settings defined in the Auto Transmission Option of system setup You can autotransmit patient and or control results Refer to the Host Transmission Specification manual for details on configuring the host communication protocol Do this procedure to define the auto transmission settings for transmitting results to a host computer if applicable A amp Nec 1 Setup gt gt System 2 the password and Vv A 29 A SETUP SYSTEM SETUP 3 the Communication tab 4 AtPatient Results select one of the following options e Off turns off autotransmission All autotransmits all patient results to the host computer e Normals Only autotransmits normal patient results only e Normals and Selected Abnormals autotransmits all normal patient results and the abnormal results that you define e No Parameter Value With Parame
156. ate Last Run Date 370502 09 06 2004 14 29 55 09 06 2004 16 11 49 Select the files to download for IQAP Calibration 07 18 2004 11 41 59 AM Allows you to include exclude the file Date of the first run in the control file Q Control file name o Date of the last run in the control file Control material lot number Note The only files that are displayed for inclusion in the IQAP download are those that have alot number in the same format as AC T 5diff Control Plus control material afirst run date within the last 3 months and atleast one selected result 7 13 7 QUALITY ASSURANCE SUBMITTING CONTROL RESULTS FOR IQAP INTERLABORATORY QUALITY ASSURANCE PROGRAM Download Procedure 1 the Quality Assurance tab 2 the IQAP tab 3 Toselect a control file to be downloaded a 0 until appears b Repeat step a until only the files you want to include in the download are selected 4 Insert a blank formatted diskette or a control diskette into the drive A of the Workstation s PC 7 14 PN 624021CA PN 624021CA QUALITY ASSURANCE SUBMITTING CONTROL RESULTS FOR IQAP INTERLABORATORY QUALITY ASSURANCE PROGRAM 6 following message appears Insert blank diskette Click OK to begin IGAP download Cancel mr Lo to begin the download If the IQAP ID is valid the system downloads the selected control data to the disket
157. ated by the Instrument PN 624021CA Overview The following sections define these instrument generated flags Results Exceeding Instrument Capacity e Hemoglobin Flags Voteout Flag e WBC Count Flag and Analytical Alarms e DiffPlot Flags and Analytical Alarms e RBC Histogram Flags e Plt Histogram Flags and Analytical Alarms and e Patient Ranges and Action Ranges Results Exceeding Instrument Capacity If a result exceeds instrument capacity the result will be indicated as follows If the result is below the lower limits of the instrument the result will be reported as 0 For example if the WBC is less than 0 1x10 pL WBC is reported as 0 0 If the result is outside the limits at which the parameter can be calculated the result is replaced by Ifthe result is above the instruments linear range Table 3 3 the result is flagged with or if the result is above the instruments reportable range Table 3 6 the result is replaced by For example if the WBC is greater than 100x10 uL the WBC result is replaced by Additionally related parameters may also be flagged or replaced 9 DATA REVIEW REVIEWING FLAGGED RESULTS 9 18 Hemoglobin Flags Hemoglobin Hematocrit Ratio Flag H amp H Flag If the Hgb g dL x 3 Hct96 is 0 8 or gt 1 2 the Hgb Hct MCH Pct and PDW will be flagged with The presence of this flag indic
158. ates that there may have been an error in the analytical process 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 flag If three consecutive samples produce a Hgb blank error the Hgb MCH and MCHC results are replaced by on the third sample 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 Ifthe WBC result is flagged with a V then the DIFF number results are also flagged with a V Ifthe RBC result is flagged with a V then the MCH MCHC RDW results are replaced by Ifthe Hct result is flagged with a V then the MCV and MCHC results are replaced by If the Plt counts votes out then the Plt result is flagged with a V WBC Count Flag and Analytical Alarms During the data collection for the DiffPlot the instrument also determines the WBC count from the flow cell The WBC flag DIFF or DI
159. atient Range and Action 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 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 Interpretive Messages ATTENTION Interpretive messages indicate a possible pathological disorder and should be used for assisting with quickly and efficiently screening abnormal samples and for diagnosis It is recommended that your laboratory use suitable reference methods to confirm diagnoses The interpretive messages print in the flag area on the patient report but only if they are enabled to print Tables 9 6 through 9 13 list interpretive messages and triggering conditions If you do not enable interpretive messages to print instrument flags must be used to identify potential abnormal sample results 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 LY96 lt LY LL and an absolute LYMPHOCYTOSIS LY gt LY HH occur only the LYMPHOCYTOSIS message
160. ave Calibration Note If differences exceed the defined limits you will have the option to calibrate which is called forced calibration 14 The system automatically records the calibration information to the Calibration Log You can add a comment to the log See Adding Comments to the Logs 15 Delete the calibration runs BJ b Select Erase all rows 624021CA 10 9 CALIBRATION AUTO CALIBRATION 16 Do Heading 7 1 RUNNING CELL CONTROLS to verify calibration Interpreting Calibration Results 10 10 The calibration screen shows N number of results included in the calibration statistics MEAN mean of the included results NEW CAL FACTOR what the calibration factor will be based on calculations from the new calibration data e OLD CAL FACTOR current calibration factor coefficient of variation of included results REFERENCE VALUES target values of the calibrator Calibration passes when The CV is within the limits defined in Setup Calibration The calibration factors are within the specified limits Forced Calibration ATTENTION Forced calibration should not be required A Forced calibration is indicated by e the CV is not within the defined limits and the new calibration factors are within 2096 of the old calibration factors The out of range CV and calibration factors are highlighted on the screen Prior to forced calibration which may be due
161. b Swingopen the door 11 10 PN 624021CA DIAGNOSTICS CLEANING PROCEDURES 4 Gently move the traverse assembly towards the rear of the instrument 9 Cover the baths with a lint free wipe This will protect them from falling contaminants PN 624021CA 11 11 DIAGNOSTICS CLEANING PROCEDURES 6 Locate the lower rinse block 1 Inspect the lower rinse block 11 12 PN 624021CA DIAGNOSTICS CLEANING PROCEDURES 8 the location of the white safety block Be careful not to move it from under the needle carriage as you do the rest of this procedure 9 Applya liberal amount of the cleaning solution to a fabric tipped applicator and clean the lower rinse block Repeat with additional applicators until the rinse block is clean CAUTION Be careful not to move the white safety block from under the needle carriage 10 Remove the lint free wipe from the baths PN 624021CA 11 13 CLEANING PROCEDURES DIAGNOSTICS 11 14 11 Apply a liberal amount of the cleaning solution to another fabric tipped applicator ATTENTION Do not wipe contaminants into the baths 12 Use the applicator to clean the top of a bath With an outward motion slowly and carefully wipe around the top of the bath 13 Using a new applicator for each bath repeat steps 11 and 12 until all baths are cleaned 14 verify that the white safe
162. bath is empty 13 Close the right side door secure the two screws using the door key and resume normal operation PN 624021CA 11 27 DIAGNOSTICS COMPONENT LOCATIONS 11 9 COMPONENT LOCATIONS See the following figures for component locations Figure 11 1 View of the Pneumatics Area Figure 11 2 Bath Assembly Figure 11 3 View Behind Main Card Left Side and Figure 11 4 Main Card Figure 11 5 Computer Workstation Front View Figure 11 6 Computer Workstation Back View Figure 11 1 View of the Pneumatics Area Traverse assembly 11 28 ensures probe positioning for the sample stages and distribution and supports the sampling syringe Sampling syringe aspirates sample e distributes portions of the specimen into the dilution baths and e takes the sample from the first dilution and distributes it into the RBC bath Waste syringe drains the baths bubbles the mixtures and transfers the DIFF specimen to the flow cell Diluent reservoir holds the necessary diluent for an analysis cycle prevents diluent degassing as it is being aspirated by the syringes and is vacuum filled by the count syringe Bath assembly receives the different rinsings and dilutions Tube holder holds the tubes vials PN 624021CA Figure 11 2 Bath Assemhly Figure 11 3 View Behind Main Card Left Side PN 624021CA 000000
163. bbreviations used in this manual INDEX Provides page numbers for indexed information xxii PN 624021CA INTRODUCTION CONVENTIONS CONVENTIONS This manual uses the following conventions e Primary Window refers to the initial window displayed after you log on to the system software When instructed to make a software selection the text appears in bold with two symbols to distinguish the menu path For example if instructed to choose Startup from the Cycles menu the text will appear as CYCLES STARTUP e Bold font indicates a software option such as CYCLES e Italics font indicates screen text displayed on the instrument such as Calibration Passed e Bold italics font indicates heading name within this document For example you may be instructed to do the Startup procedure which would appear as Do Startup Instrument refers to the ACeT 5diff cap pierce hematology analyzer e CP refers to cap pierce A Note contains supplemental information ATTENTION contains information that is important to remember or helpful when performing a procedure e Main card refers to the main circuit board card in the instrument e RBC bath is sometimes referred to as RBC PIt bath The terms screen and window are used interchangeably 5diff Rinse reagent is sometimes referred to as Rinse e ACeT 5diff Fix reagent is sometimes referred to as Fix e 5diff Hgb Lyse reagent is someti
164. bility Reproducibility Table 3 2 is based on 20 consecutive 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 0x103 uL MCV 1 096 90 fL Linearity Linearity is assessed using a commercially available low range and full range linearity test kit When analyzed and results computed according to the manufacturers 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 91 3 0 2 or 3 096 RBC 106 uL 0 30 to 8 00 0 07 or 5 096 Plt 103 uL 10 0 to 1 000 10 0 or 10 0 Hgb g dL 0 0 to 22 0 0 3 or 2 0 Het 1 8 10 55 9 2 0 or 3 096 56 0 to 63 8 5 0 or 25 096 Accuracy Accuracy Table 3 4 is assessed by duplicate analysis of normal and clinical specimens less than eight hours old when compared to an automated hematology analyzer that has been properly calibrated and maintained according to the manufacturers recommendation 3 6 624021CA Parameter Correlation WBC 20 95 RBC 20 95 Hgb 20 95 Het gt 0 95 Plt gt 0 95 Carryover Table 3 4 Accuracy Specifications SPECIFICATIONS CHARACTERISTICS PERFORMANCE SPECIF
165. bottle 9 Tighten the stopper assembly onto the bottle to ensure an adequate seal 624021CA 11 59 DIAGNOSTICS REPLACEMENT PROCEDURES 11 60 10 Put the new reagent bottle in the reagent compartment Fix is shown here 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 that the tubing is not pinched or twisted 11 verify that the tubing is not pinched or twisted 12 Change Reagent Reagent Statu Reagent RINSE Fix HGB LYSE WBC LYSE DILUENT Lot Number porozcoan 00402 00005 00202400846 100402801284 100302000036 OpenedDate 03 27 2007 03 27 2001 03 27 2001 03 27 2001 03 27 2001 Expiration Date 03 30 2001 04 20 2001 107052001 08 23 2001 08 11 2001 Operator FAdministreto FAdministreto Administrato Administrato Administrato Administrato Change All Reagent Change Reagent PN 624021CA DIAGNOSTICS 1 1 REPLACEMENT PROCEDURES 13 Select the reagent to be changed m b Select the reagent Replace a Heagent DILUENT 14 Enter the lot number from the new reagent container If the lot number entered has already been used the following message appears Invalid Reagent Lot Number Entered Please Enter Correct Reagent Lot Number Replace
166. bsorb 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 17 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 17 Debris Platelets and debris from erythrocyte lysis represent the background debris population located in the lower region of the DiffPlot 2 20 PN 624021CA 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 above the neutrophil population and are typically counted as IMM cells IMM cells are included in the reported neutrophil value See Figure 2 17 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 i
167. c 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 9 ror increased sample identification integrity 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 624021CA BARCODE SPECIFICATIONS B BARCODE LABEL TEST PAGES B 4 BARCODE LABEL TEST PAGES See Tables B 2 and B 3 Table B 2 Test Labels With the Check Digit Checksum lz345ABCDE 1234567 Code 128 8 Reads 12345670 11234567 890128 Code 39 EAN 13 If this label is read with Check Digit Reads 1234567890128 disabled the last character is also displayed lz34567859012 Interleaved 2 of 5 Reads 11 characters with Check Digit or reads 12 characters without Check Digit Table B 3 Test Labels Without the Check Digit Code 39 Label will not read if scanner is programmed to default condition 123123 Codabar PN 624021CA B 3 BARCODE SPECIFICATIONS BARCODE SCANNER CONFIGURATION B BARCODE SCANNER 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 are read Bar codes with
168. card open care not to disconnect or damage the electric cables Figure 11 5 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 11 30 PN 624021CA DIAGNOSTICS COMPONENT LOCATIONS Figure 11 6 Computer Workstation Back View Monitor power cord connection PC power cord connection Mouse connection Keyboard connection Analyzer connection Printer connection Monitor connection oo0coc0ocQ0ooQ0eP Host communications connector Note Your configuration may vary from that shown here PN 624021CA 11 31 DIAGNOSTICS SYSTEM TROUBLESHOOTING PROCEDURES 11 10 SYSTEM TROUBLESHOOTING PROCEDURES Diluter System Backflush The backflush feature pushes pressure through the rear of the apertures to remove blockages Do this procedure if you suspect blocked apertures LN AMEX 1 Cycles gt gt Backflush Note You can also access Backflush through the Operator Diagnostics options e LL Diagnostics Operator the Diluter Systems tab 0 the Cleaning Cycles tab 0 Backflush 2 Allow the backflush cycle to complete about 1 minute Rinse Baths and Flow Cell Do this to rinse the instruments baths and or flow cell with ACeT 5diff Diluent Rinse the baths if you have excessive f
169. ccompanied by little change or a decrease in WBC and or Plt OR decrease in RBC and Hgb accompanied by little change or an increase in WBC and or Plt 9 32 624021 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 calibration blood samples Manual calibration where known calibration factors can be directly entered Recommended Calibration Conditions Beckman Coulter recommends that you perform the calibration procedure e At ambient operating temperature of 16 C to 34 C 61 F to 93 F e Using AC T 5diff Cal Calibrator as an alternative to whole blood When to Calibrate Calibrate your instrument During installation before analyzing samples e After a Beckman Coulter service representative has replaced an analytical component instructed by a Beckman Coulter representative When to Verify Calibration Verify calibration of your instrument e required by your laboratory procedures and as required by local or national regulations e When cell controls such as AC T 5diff Control Plus exceed the manufacturers defined acceptable limits In the normal process of tracking data for an extended period of time your laboratory can decide to recalibrate the
170. cec oirr s 267 neuayonns 0947 24 237 55 180 76 Bl TZ manmanan R 238 R 183 c a tow N Li Li g Li 8 Mean 25 236 55 180 76 Add Comment 250 005 008 04 aes xw 25 088 068 118 046 to Target 25 233 55 184 7 NEN 04 012 04 15 4 Delta Diff 01 003 00 08 il WBC RBC HGB MCV MCH MCHC RDW PLT MPV NE LY MO 7E0 BA NER eona gt WBC Conr Data REC Corti Data Corti Data 7 9 7 QUALITY ASSURANCE RUNNING CELL CONTROLS 4 Add Comment ss 3j I L1 E 2481 21 Worst Pun Results Quality Assurance gt Include Date Time conTROL 15 cec oirr s 08022004 947 E 0730 2004 03542 m 07 29 2004 0646AM m 772 0216 PM E 0 29 2004 08564M 9 the comment 50 characters max Type your comment here Comment 7 10 624021CA QUALITY ASSURANCE SUBMITTING CONTROL RESULTS FOR IQAP INTERLABORATORY QUALITY ASSURANCE PROGRAM 7 2 SUBMITTING CONTROL RESULTS FOR IQAP INTERLABORATORY QUALITY ASSURANCE PROGRAM You can submit your control results to Beckman Coulter for inclusion in Beckman Coulter s IQAP program The primary method for submitting control data from the 5diff Cap Pierce instrument is a download to diskette software version 2 0
171. ch analysis according to the tube manufacturer s recommendations and your laboratory protocol 9 Repeatstep 4 until a minimum of an n of 10 is achieved 6 Review the data 7 Select the results to include in the calculation PN 624021CA SETUP A QUALITY ASSURANCE SETUP 8 8 to print the reproducibility results 9 Keep a copy of the printout for your records as required 624021 A 85 SETUP QUALITY ASSURANCE SETUP A 86 624021CA BARCODE SPECIFICATIONS B B 1 OVERVIEW Use the information in this appendix to test troubleshoot and reprogram your barcode scanner 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 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 5diff CP analyzer accepts six barcode symbologies e Code 128 e Code 39 e Codabar e Interleaved 2 of 5 EAN 8 and 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
172. container is no more than 80cm 31 5 in below the instrument 8 Putthe 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 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 that the tubing is not pinched or twisted 9 verify that the tubing is not pinched or twisted 624021CA 11 53 DIAGNOSTICS REPLACEMENT PROCEDURES 1 0 Change Reagent RINSE Fx HGB LYSE WBC LYSE DILUENT 100102 01441 10040200005 100202400846 100402801284 00302000035 03 27 2001 03 27 2001 03 27 2001 03 2 7 2001 03 27 2001 03 30 2001 04 20 2001 10 05 2001 08 23 2001 08 11 2001 imin min jAdmin Admin din 11 Select DILUENT from the list a Um b DILUENT Replace a Reagent DILUENT h 12 Enter the lot number from the new Replace Reagent reagent container If the lot number entered has already been used the following message appears Invalid Reagent Lot Number Entered Please Enter Correct Reagent Lot nnzzm2 Number 97300 F e x 11 54 PN 624021CA PN 624021CA DIAGNOSTICS REPLACEMENT PROCEDURE
173. ct a Beckman Coulter representative if the problem persists b Verify that the green LED is illuminated ready 10 startup automatically runs if the automatic Startup feature is enabled and the instrument is powered on If automatic Startup at power up is disabled U Ld 11 Allow Startup to finish 5 4 PN 624021CA GETTING STARTED 5 POWER UP POWER DOWN 12 Review the Startup results status Ele Cycles Diagnostics Setup Help al D 910 211 A 8 vd 9 Ds a Analyzer Logs if the screen is Reagent Status not already displayed Reagent RINSE HGB LYSE WECLYSE DILUENT Lot Number 0020202367 00802600117 00202401700 00402800176 00302000068 b Review the Startup results OpenedDate 09 04 2001 09 04 2001 08 04 2001 08 04 2001 09 04 2001 Exptatin Date 13 10 2001 06 08 2001 ps1 0 2001 23708 2001 1170872001 If Passed appears go to step c mm m 14 e If Failed appears go to step 13 11 04 2001 121341 13 1f Failed appears on Startup result L4 w cdm 69 9 ee a Startup Log tab and evaluate the numeric results ee F 04 17 2001 06 14 49 00 000 0 1 Passed 04 17 2001 06 09 47 PM O Fad 04 05 2001 08 43 37 00 000 0 3 Passed 04 04 2001 09 04 41 0
174. ct is fitted with 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 624021CA REVISION STATUS Issue A 6 03 Software Version 1 0 Issue B 10 04 Software Version 2 00 Added procedure to clean baths and rinse block Added information about the new features provided by software version 2 00 Updated illustrations Issue C 02 05 Software Version 2 01 Added IMPORTANT message in all appropriate places regarding the risk of failure to print and or transmit all requested results if the delete function is used before printing and or transmitting is complete Complies with the EU IVD Directive 98 79 EC 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 CA 06 10 Software Version 2 01 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 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
175. ct slot and tube holder 1 4 PN 624021CA USE AND FUNCTION DESCRIPTION Figure 1 7 Tube Positions in the Tube Holders ont m o hl Tube Holder 2 Tube Holder 1 7653099A The following list provides an overview of the tube holders and the tubes vials they accommodate For a detailed list see Appendix D TUBE LIST 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 ACeT 5diff Control Plus control tubes Position amp COULTER AC T 5diff Cal Calibrator vial Position Sarstedt Monovette 11 5 mm x 66 mm specimen tube collecting 2 7 mL of whole blood Bunt Becton Dickinson Microtainer for collection of 0 25 to 0 50 mL of whole blood Tube Holder 2 Position 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 Scientific microcollection device for collecting 125 pL of whole blood Position 19 mm x75 mm specimen tube with multiple labels PN 624021CA 1 5 USE AND FUNCTION DESCRIPTION Workstation Use the Workstation Figure 1 8 to set up and operate the instrument Figure 1 8 shows the Workstation Figure 1 9 shows the back of the Workstation Figure 1 8 Workstation
176. d If the waste container is not full and the alarm chirps beeps at regular intervals immediately replace the old battery with a new 9 V alkaline battery to ensure correct operation of the waste sensor alarm There is a waste sensor alarm unit mounted on Figure 11 8 Waste Sensor Alarm Unit Location back of the instrument Figure 11 8 As the waste container fills there is a float on the sensor that triggers the alarm which then emits a continuous intermittent beep until the waste container cap is removed If you need to move the waste sensor alarm closer to the waste container gently pull the alarm unit from the back of the instrument Do this procedure when the waste sensor alarm sounds or as needed AZAS 1 Tum the Analyzer off 2 Carefully remove the waste container cap with waste sensor attached PN 624021CA 11 73 DIAGNOSTICS REPLACEMENT PROCEDURES 3 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 disposal 4 Insert the waste sensor float into the new waste container and properly secure the cap 9 Turn the Analyzer on 6 Do Neutralizing the Waste and Tr
177. d 369651 2 13x75 Yes 1 1 2 glass K3 BD Hemogard 367661 3 13x75 Yes 1 1 2 glass K3 BD Hemogard 367650 3 13x75 Yes 1 1 2 glass K3 BD Hemogard 367652 3 13x75 Yes 1 1 2 glass K3 BD Hemogard 367653 5 13x75 Yes 1 1 2 glass K3 BD Hemogard 367658 5 13x75 Yes 1 1 2 glass K3 BD Hemogard 367662 5 13x75 Yes 1 1 2 glass K3 BD Hemogard 367841 2 13x75 Yes 1 1 2 plastic K2 BD Hemogard 367842 2 13x75 Yes 1 1 2 plastic K2 BD Hemogard 367856 3 13x75 Yes 1 1 2 plastic K2 BD Hemogard 367859 3 13x75 Yes 1 1 2 plastic K2 BD Hemogard 367861 4 13x75 Yes 1 1 2 plastic K2 BD Hemogard 367862 4 13x75 Yes 1 1 2 plastic K2 PN 624021CA D 1 TUBE LIST TUBES APPROVED FOR USE WITH CP SYSTEM Table D 1 Specimen Tubes for Use with the Tube Holders Volume mL unless Position in Position in Manufacturer Product otherwise Cap Tube Holder Tube Holder See and Tube Name Number stated Size mm Pierceable 1 2 Note BD Vacutainer 366385 3 10 25x64 Yes 2 1 glass K3 BD Vacutainer 366405 2 5 13x75 Yes 1 1 2 glass K3 BD Vacutainer 366564 2 5 13x75 Yes 1 1 2 glass K3 BD Vacutainer 366452 5 13x75 Yes 1 1 2 glass K3 BD Vacutainer 366536 5 13x75 Yes 1 1 2 glass K3 BD Vacutainer 367843 2 13 75 Yes 1 1 2 plastic K2 BD Vacutainer 367835 3 13x75 Yes 1 1 2 plastic K2 BD Vacutainer 367844 4 13x75 Yes 1 1
178. d select the physician from the list if applicable Patient Identification Patient ID 112760 Patient Date of Birth Physician Location Autonumbering roms aw 019 el H x 16 Press to move the cursor to the Location field 17 Enter the patients location up to 15 alphanumeric characters and spaces manually enter the location or and select the location from the existing list of locations if applicable Patient Identification Patient ID 112760 kl Patient Name Jane Doe Date of Birth p Age 35y Gender Female Physician Location Autonumbering 1 z Eu 2 8 H X 5 47 5 GETTING STARTED USING WORKLISTS 18 save the information e Ifyou have finished adding Worklist entries amp to save the information and exit the window e If you want to continue adding Worklist entries W 2 to save the infomration and remain at the window e If you want to exit the window without saving the information p 2x 19 When you finish adding entries amp to save and close the Worklist Downloading 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 Editing Worklist Entries ATTENTION Results cannot be edited and demographics downloaded from
179. dary window is displayed via a menu selection such as Setup and Diagnostics 5 28 624021 GETTING STARTED 5 SOFTWARE DETAILS Tabs Tabs appear at the top or bottom of a window and group information related to that window For example Worklist information is grouped in the window viewable by selecting the Worklist tab Figure 5 6 The tab text is gray when the tab is not selected and black when selected Figure 5 6 Worklist Tab Worklist Rur Result Quali Assurant e Analyzer Logs Name Date of Birth Age Gender essei Unknown Standard Range e Unknown Standard Range 24 89298836102 e Unknown Standard Range R 89298936112 FREZDIFF IInknawn Standard Ranne Buttons There are three types of buttons used within this software command text buttons bitmap buttons and radio buttons Command Buttons Command buttons contain text and appear within various windows of this software These buttons execute functions when selected See Figure 5 7 Figure 5 7 Text Button Setup Control Bitmap Buttons Bitmap buttons which function the same as command buttons appear in popup windows and for common functions appear across the bottom of Setup and Diagnostic screens See Figure 5 8 Figure 5 8 Bitmap Button Drop down Box E 624021 5 29 GETTING STARTED SOFTWARE
180. defined range 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 one day When the age is close to the limit of a flagging range the adjoining flagging range may be selected You can add up to 14 additional flagging sets numbers 7 through 20 and define the name and other parameters See Creating Additional Flagging Sets If a result is outside the selected range the result will be flagged You can choose any flagging set to be the default flagging set 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 needs See Selecting a Default Flagging Set 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 e for results above the upper limit and e for results below the lower limit See Editing Patient Limit Ranges in a Flagging Set for additional information If a result is outside the action limit range the result will be flagged HH for results above the upper limit and I for results below the lower limit Figure 5 15 shows the flagging set hierarchy that defines how flagging sets are applied to Sample IDs 5 40 PN 624021CA PN 624021CA UNDERSTANDING HOW
181. der as defined in Table D 1 Specimen Tubes for Use with the Tube Holders PN 624021CA GETTING STARTED 5 POSITIONING TUBES IN TUBE HOLDERS IMPORTANT Risk of erroneous results if the 1 sample tube is not placed in the holder correctly and if the tube holder is not positioned NN correctly in the instrument Ensure that the tube 4 is placed in the 12 00 o clock pierce position within the tube holder 3 Ensure that the tube is in the pierce position 12 00 o clock within the tube holder e If the tube is in the pierce position within the holder do step 4 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 4 Close the tube holder door The red and green LEDs flash during analysis 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 PN 624021CA 5 11 GETTING STARTED POSITIONING TUBES IN TUBE HOLDERS 5 When the LED is green 9 and the tube holder door opens remove the tube vial 5 12 624021 GETTING STARTED USING THE ONLINE HELP SYSTEM 5 5 5 USING THE ONLINE HELP SYSTEM Your COULTER 5diff CP system provides an online Help system that allows
182. download the most recent manual or system help for your instrument REVISION STATUS iv PN 624021CA PN 624021CA CONTENTS mE WARNINGS AND PRECAUTIONS ii REVISION STATUS iii INTRODUCTION xxi OVERVIEW xxi USING YOUR AC T 5diff CP HEMATOLOGY ANALYZER OPERATOR S GUIDE xxi ABOUT THIS MANUAL xxi CONVENTIONS xxiii GRAPHICS xxiii SYMBOLS xxiv Safety Symbols xxiv Tab Symbols xxiv 1 USE AND FUNCTION 1 1 1 1 INTENDED USE 1 1 General 1 1 Purpose 1 1 12 DESCRIPTION 1 1 ACeT 5diff CP Analyzer 1 2 Overview of Instrument 1 2 Back Panel 1 3 Warning and Caution Labels 1 3 Tube Holders 1 4 Workstation 1 6 1 3 PANELS 1 7 14 PARAMETERS 1 7 CBC Panel 1 7 CBC DIFF Panel 1 8 15 FEATURES 1 8 1 6 REPORTS 1 9 1 7 QUALITY ASSURANCE CONTROLS CALIBRATORS AND IQAP 1 9 IQAP Interlaboratory Quality Assurance Program 1 9 Cell Controls 1 9 Calibrator 1 9 18 REAGENTS 1 10 Recommended Reagents 1 10 Reagent Descriptions 1 11 Waste Handling Procedures 1 12 Neutralizing the Waste and Treating for Biohazards 1 12 Handling Expired Reagents 1 13 CONTENTS 1 9 PRINTER 1 14 1 10 ORDERING MATERIAL SAFETY DATA SHEETS MSDS 1 14 2 OPERATION PRINCIPLES 2 1 P 2 2 2 3 2L a3 2 6 an 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 TECHNOL
183. dure ATTENTION Incorrect runs will misrepresent the true mean and standard deviation SD of the summary data Therefore be sure that the runs you submit are correct 2 Review each control file to verify that the data you are going to submit is correct If necessary deselect any data runs that are not intended for IQAP submission such as acontrol that was analyzed in the wrong file control results with non numeric flags control results with non numeric parameter results 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 for that control file will be inaccurate Reminder To deselect a control run a 0 until appears b Repeat step a until you have deselected all the runs you want excluded from the statistics 3 Printa copy of the control file data for your records Downloading Results to Diskette for IQAP Submission After Preparing for 0 Download in this chapter do this procedure to download the results Supplies Needed Formatted blank diskette you provide or control diskette IQAP labels provided by Beckman Coulter in your IQAP packet Board stock return mailers also provided by Beckman Coulter IQAP 1 12 624021CA PN 624021CA QUALITY ASSURANCE SUBMITTING CONTROL RESULTS FOR IQAP INTERLABORATORY QUALITY ASSURANCE PROGRAM The IQAP Download Screen Lot No First Run D
184. e sample to be processed 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 Insert the tube into the correct position of the tube holder 8 39 RERUNNING SAMPLES SAMPLE ANALYSIS 8 40 9 Close the tube holder door to begin analysis IMPORTANT Do not log out of the Workstation while the Analyzer is running a cycle Logging out during an Analyzer cycle will cause problems with the Analyzer Workstation communication 10 Remove the tube when the tube holder door automatically opens Note The door opens after analysis is completed 11 Review the sample results The results from the first analysis and the re run appear on the Results List in the order they were processed 12 Verify the Sample ID and results before reporting the results 13 0 to print a copy of the results Note A copy prints automatically if the Auto Print function is enabled PN 624021CA DATA REVIEW 9 1 LOCATING SAMPLE RESULTS After a sample has been analyzed you can review the results Note 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 3 REVIEWING FLAGGED RESULTS for details Searching for a Recent Result
185. e background results especially for platelets PN 624021CA 11 49 DIAGNOSTICS REPLACEMENT PROCEDURES Viewing Reagent Levels Do this procedure to view a reagent level e N e ZN 7 Ae Worklist Run Results Quality Assuran Reagent Status EN RINSE Fix wec LYSE DILUENT 1 the Analyzer Logs tab to display the Lot Number 0010201441 0040200005 00202400846 00402801284 00302000035 Opened Date 03 27 2001 03 27 2001 03 27 2001 03 27 2001 03 27 2001 Reagent window ExpiationDate 03 30 2001 04 20 2001 10 05 2001 08 23 2001 0811 2001 Note If a reagent level indicates 0 DS nm Administreto ZZ Lm i you must replace that reagent Do m mm o NEM Changing One Reagent Fix WBC Lyse Hgb mee Lyse or Rinse Reagents or Changing the Da e e l es eer Diluent Reagent Semice Loa J tarup Loo ErorLog J Calibration Loa Maintenance Loc 03 27 2001 16 17 06 2 Exit this window by selecting another option 11 50 PN 624021CA DIAGNOSTICS REPLACEMENT PROCEDURES Changing the Diluent Reagent Do this procedure to replace the Diluent reagent To replace either Fix WBC Lyse Hgb Lyse or Rinse reagents do Changing Reagent Fix WBC Lyse Hgb Lyse or Rinse Reagents To replace all the reagents at the same time do Changing
186. e cursor to the Patient ID field 6 Enter the Patient ID optional up to SampeiD Pane Patient ID 25 alphanumeric characters and no 123 spaces 124 CBC E e Manually enter the Patient ID or Scan the Patient ID from the barcode if applicable or E x and select the ID from the existing list of Patient IDs if applicable IMPORTANT Risk of erroneous results if sample is not properly mixed before analysis Mix the blood specimen gently and thoroughly before analysis according to the tube manufacturer s recommendations and your laboratory protocol Mix the specimen gently and thoroughly 8 If the specimen tube does not have pierceable stopper remove the stopper 8 24 624021CA SAMPLE ANALYSIS 8 RUNNING PATIENT SAMPLES WITHOUT USING THE WORKLIST 9 verify that the Sample ID in the Sample ID Next field matches the sample to be processed 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 10 Insert the tube into the correct position of the correct tube holder 11 Close the tube holder door to begin analysis IMPORTANT Do not log out of the Workstation while the Analyzer is running a cycle Logging out during an Analyzer cycle will cause problems with the Analyzer Workstation communication PN 624021CA 8 25 SAMPLE ANALYSIS RUNNING PATIENT SAMP
187. e linked together in their operation and should be considered as a single component within the database This means that when you close an archive the worklist information and results for all processed samples are archived at the same time The date of the archive is the date it was created When an archive is opened all samples analyzed will be listed on the worklist including reproducibility blanks controls and calibrators Pending Worklist entries in an archive are displayed against a white background Worklist entries with results are displayed against a green background Sample analysis is not permitted in an archive other than the current active archive PN 624021CA 2 23 OPERATION PRINCIPLES WORKLISTS 2 24 624021 SPECIFICATIONS CHARACTERISTICS 3 1 INSTRUMENT SPECIFICATIONS Dimensions and Weight See Figure 3 1 WARNING Risk of operator injury if only one person lifts the instrument The instrument has no lifting handles and it weighs more than one person should lift Therefore to prevent injury at least two people following appropriate safety precautions should lift the instrument together Figure 3 1 Analyzer Dimensions and Weight 80 0 Ib 36 2 Kg 19 8 in 50 1 cm For the dimensions and weight of the Workstation refer to the PC printer and monitor documentation from the respective manufacturers Power Supply From 100 Vac to 240 Vac excluding the printer which is voltag
188. e or an incorrect data type Re enter the data Re analyze the sample n9 Database Could Not Be Backed Up Attempt to backup database failed Attempt was made to backup to a floppy Retry and save backup to drive D 2 fthe problem persists contact a Beckman Coulter representative Database Restore Attempt to restore a database Retry Unsuccessful failed 2 Ifthe problem persists contact a Beckman Coulter representative Date Entered Cannot Be A date later than today s was Enter a date no later than today s Later Than Today s Date entered Date Entered Cannot Be Prior To Today s Date A date prior to today s was entered Enter a date not prior to today s Drain Timeout Problems with draining Rinse bath filter may be clogged 1 Do Heading 11 7 SYSTEM RESET CYCLE 2 fthe problem persists contact a Beckman Coulter representative Host Communication There is a problem with the Verify that the protocol set up in the host Error Chars communication or handshaking to transmission screen matches the the host computer protocol expected by the host computer Host Communication There is a problem with the Verify that the protocol set up in the host Error ACK communication or handshaking to transmission screen matches the the host computer protocol expected by the host computer Host Communication There is a problem with the Verify t
189. e specific e g 100 to 120 Vac or 220 to 240 Vac 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 To protect against electrical shock the wall ground earth plug must be correctly connected to the laboratory grounding electricity installation PN 624021CA 3 1 SPECIFICATIONS CHARACTERISTICS INSTRUMENT SPECIFICATIONS Temperature Ambient Operating The ambient operating temperature is 16 C to 34 C 61 F to 93 F 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 workstation 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 for
190. e workstation has matched the results to the pre assigned data You can add demographic information e by manually entering the information see Adding Entries To Creating a Worklist ox e by downloading the information from a host computer see Downloading Worklists from 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 entry is removed The results are now available on the Results screen and the Run screen Note The duplicate sample ID check is a function of the Worklist This process occurs for all samples and is independent of the process of adding patient information PN 624021CA Adding Entries To Creating a Worklist Do this procedure if you want to add entries to a Worklist When entering information remember GETTING STARTED 5 USING WORKLISTS A Sample ID is required the remaining information is optional The Patient ID field accepts the ID from a list or an ID that is manually entered The Patient name field accepts alphanumeric characters If the date of birth is not known enter the patient s age 1 the Workli
191. eagent 2 Re enter the lot number Lot Number 11 83 DIAGNOSTICS SYSTEM ERRORS Table 11 2 Error Messages Continued Message Probable Cause Suggested Action No Diluent Check Level Diluent reservoir is unable to fill Diluent reagent is empty Check the diluent level If necessary do Changing the Diluent Reagent 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 XXX Not Reaching Home Note XXX name of motor Motor did not reach home sensor 1 Do Hardware Reset 2 Do Heading 11 7 SYSTEM RESET CYCLE 3 Ifthe problem persists contact a Beckman Coulter representative One or More Selected Calibration Factors Did Not Pass Criteria Calibration factors were not within the limits Contact a Beckman Coulter representative Patient Demographics Received From The Host Cannot Be Modified 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 Printer Error Check Paper An error indication has been sent from the Printer to the instrument usually a paper out message 1 Ensure there is paper in the Printer
192. eating for Biohazards 11 74 PN 624021CA DIAGNOSTICS REPLACEMENT PROCEDURES Replacing the Flow Cell Lamp Do this procedure when the flow cell lamp fails or when instructed by a Beckman Coulter representative Tools Supplies needed 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 ANE Power down the instrument as instructed in Power Down the System in Chapter 5 2 Unplug the Analyzer from its power source 3 Remove the left side panel of the instrument a Remove the four hex screws securing the left side panel to the instrument frame b Setthe screws aside for use later c Remove the hex screw from the upper front corner inside the left compartment PN 624021CA 11 75 DIAGNOSTICS REPLACEMENT PROCEDURES 4 Open the right side door a Use the door key to loosen the two screws on the right side door b Swing open the door 9 Remove the top cover a Remove the 5 hex screws that secure the top cover to the instrument frame b Carefully remove the top cover and set it aside 11 76 624021 DIAGNOSTICS REPLACEMENT PROCEDURES WARNING 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 proce
193. ecommended 1 9 results not acceptable 7 6 verifying calibration 7 1 cell control files deleting 7 16 submitting results for IQAP 7 11 upload values from control disk A 73 change operator ID 5 25 PN 624021CA PN 624021CA characteristics definition GLOSSARY 1 performance 3 8 cleaning procedures auto clean 11 9 baths 11 10 extended cleaning 11 6 for inside of instrument 11 6 for outside of instrument 11 5 rinse block 11 10 system cleaning 11 16 cm definition ABBREVIATIONS 1 coefficient of variation CV definition GLOSSARY 1 Cold agglutinin triggering condition 9 30 collecting specimens 8 2 comments add to control result 7 9 components resetting to home position 11 36 computation of parameters 3 5 connections Analyzer and Workstation fail to connect what to do if 5 4 workstation 1 6 consumption of reagents by cycle 3 5 contamination risk 11 8 control add result comment 7 9 definition GLOSSARY 1 graphs 7 7 procedure to run 7 2 recommended 3 2 transmitting results to host A 30 conventions definition GLOSSARY 1 used in this manual xxiii Coulter Principle how it is applied 2 2 count syringe function 11 28 11 29 location 11 28 11 29 cursor arrows 5 33 how to move 5 33 CV definition GLOSSARY 1 INDEX cycle count description 11 2 viewing 11 2 D DATA NOT SAVED VALUE OUT OF RANGE 11 82 database backup E 4 relationship with archive and worklist 2 23 storage
194. ect Date Time Comment Fatient Identification If you do not enter the patients birth date and gender the default flagging set is used For additional information on the flagging set hierarchy see Figure 5 15 7 Enter the date and time that the specimen was collected in a Enter the complete date Sample Identification Opr Admin Enter the time 29 co c Press to move the cursor to the Comments field Collect Date Time 04 19 2001 05 50 PM Comment r Patient Identification 5 44 PN 624021CA GETTING STARTED USING WORKLISTS Type your comments up to 50 alphanumeric characters and spaces and press to move to the Patient ID field Add Edit Worklist Sample Identification Opr Admin Sample ID 12345 Panel CBC DIFF Flagging Set 2 a Collect Dater fF 04 Comment h Patient Identificati 9 Enter the Patient ID up to 25 alphanumeric characters and no spaces manually type the Patient ID or scan the Patient ID from the barcode if applicable or 2 and select the Patient ID from the existing list of Patient IDs if applicable Patient Identific PatientID Patient Name Date of Birth Physician Location Autonumbering rofos 9 S el e x 10 Press to move to the Patient Name field 11 PN 624021CA Enter the patients name
195. ed and printed in femtoliters fL e Pct Calculation Pct plateletcrit is calculated according to the formula 3 petog Pit CIO uL x MPV fL 10 000 PDW Calculation PDW Platelet Distribution Width is calculated from the Plt histogram as the width of the curve between 51 and S2 As shown in Figure 2 15 SI and S2 are placed so that gt 15 of the platelets occur between 2fL and 51 gt 15 of the platelets occur between S2 and the variable upper threshold gt The PDW result is determined on the platelets between 51 and S2 Figure 2 15 Area of the Histogram Used to Determine the PDW Parameter Result A 15 gt 1 52 7615002 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 blank The system calculates the Hgb using both the blank and sample readings The final Hgb result represents absorbance value obtained x coefficient of calibration Hgb is displayed and printed as Hgb g dL Note g dL is the US unit format Other formats are available See Changing the Reporting Unit 624021CA 2 17 2 OPERATION PRINCIPLES PARAMETER
196. eding 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 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 Remove the lamp a PN 624021CA Use a 2 mm hex key to loosen the two screws a few turns Separate the metal bracket from the lamp and cable assembly Save the metal bracket and screws Turn the lamp counterclockwise to remove it from its housing 11 77 11 DIAGNOSTICS REPLACEMENT PROCEDURES 8 Discard the old lamp assembly IMPORTANT Risk of compromising output of the new lamp if the surface is smudged Fingerprints or A other smudges on the lamp can affect output Do not touch the surface of the lamp Using care not to touch the surface of the lamp a Insert the new lamp assembly inside the housing b Place the bracket with wings up on the housing c Turn the lamp assembly clockwise until secure d Reinstall the two screws removed in step 7 e 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 Pow
197. emented by 1 from the previously assigned number each time a sample is analyzed Sample ID Autonumbering Enabling Do this procedure to enable activate autonumbering for the Sample IDs A Der 1 the Worklist tab Add Edit Worklist En Sample Identification Opr Sample ID NEN Panel cec jorr Flagging Set Standard Rane Collect Date Time Comment Patient Identification Patient ID Patient Name Date of Birth Sa Age Gender Unknown Physician x Location Autonumbering A 2 624021CA SETUP A SYSTEM SETUP 3 Autonumbering ON bim LO Apply 4 Type the number where you want the autonumbering to begin For example if you want autonumbering to begin at 1 type 1 The first Sample ID will automatically be number 1 5 0 APPLY 026 624021 A 3 SETUP SYSTEM SETUP 4 1 Verify that the Sample IDs are correct a b the Run tab Confirm that the numbers are correct The Sample ID currently being processed appears in the In Progress field in the bottom left of the screen The Sample ID to be processed next appears in the Sample ID Next field For example if you started autonumbering at 1 and processed that sample the Next Sample ID will be 2 Changing the Starting Number for Autonumbered Sample IDs Do this procedure if you want to change the starting number where aut
198. en Selecting Deselecting Software Fields Some software screens allow you to select activate or de select deactivate certain software features 1 Move the cursor to the desired radio button or check box Auto Print C Normals PN 624021CA 5 35 GETTING STARTED WORKING WITH THE SOFTWARE 2 Forcheck boxes W the check box to select deselect the corresponding feature selected O not selected Include Date Time 12 19 00 8 47 12 19 00 8 48 12 19 00 8 49 AM 12 19 00 8 51 AM 12 19 00 8 52 AM A 3 Forradio buttons W a button to select deselect the corresponding feature selected not selected 4 Toselect from a list a Press the key and 0 on each row you want to select b Verify that a black dot P appears in the far left column and that the entire row is highlighted 5 36 Auto Print fee C Normals Worklist En Sample ID 12345 346 use Nix 0 has PN 624021CA GETTING STARTED 5 SYSTEM ICONS 9 9 SYSTEM ICONS Icons depict executable functions or status information Table 5 1 shows the icons used on this system Table 5 1 Software Icons x S Print Transmitto Delete Find Previous Next Restore Host Default P el S T bl Add Edit Validate Re run Load Help Results List Sample anon F Startup Shutdown Analyzer Analyzer Save Exit Save Remain Cancel
199. ent is required when used with other tubes in the same position Prior to cycling ensure that aspiration plunger is all the way at the bottom of the tube Qi Qu OS D 2 624021CA WORKSTATION MANAGEMENT B9 E 1 ARCHIVE MANAGEMENT Archiving is a process used to manage the information stored in the database The system will use the current active archive as a source for duplicate Sample ID checks This allows Sample IDs to be reused when a new archive is created When you close an archive it is stored within the database The filename assigned to the archive is the actual date and time that the archive was created Multiple archives can be stored in the database This section describes how to manage system archives including creating and opening It also provides a procedure to print Worklist orders from a previous archive Note There is no procedure for saving archives because an archive is automatically saved when a new one is created See Table 2 9 for additional information Creating an Archive IMPORTANT Risk of compromising system functionality if archives are not performed at the recommended intervals Beckman Coulter recommends that the archive function be performed a minimum of once a month Do this procedure to create a new archive When you create a new archive your current active archive is automatically saved To determine when to create a new archive see Table 2 9 1 If you were reviewing an old archive
200. er monitor keyboard mouse and software e barcode wand optional e printer and software kit IMPORTANT Risk of instrument damage and or erroneous results if you install additional software onto the personal computer or if you use the personal computer for anything other than stated within this documentation PN 624021CA 1 1 USE AND FUNCTION DESCRIPTION 5diff CP Analyzer Figure 1 2 shows an overview of the Analyzer Figure 1 3 shows the back panel of the Analyzer Figure 1 4 shows the warning and caution labels on the Analyzer Figure 1 5 shows Tube Holder 1 Figure 1 6 shows Tube Holder 2 Figure 1 7 shows the position of tubes in the tube holders Overview of Instrument WARNING Risk of operator injury when covers and doors are not closed and secured in place before you operate the instrument Ensure that all covers and doors are closed and secured before operating the instrument Figure 1 2 Overview of Analyzer Front Cover Tube Holder Reagent Access Door Top Cover Right Side Door Tube Holder Door manual release Green LED indicates instrument is ready Red LED indicates instrument is not ready Power ON OFF switch o 90000000 1 2 624021CA USE AND FUNCTION DESCRIPTION Back Panel Figure 1 3 shows the Analyzers back panel Figure 1 3 Analyzer Back Panel Serial number label Spare connector not used Spare connector not used
201. er Up the System in Chapter 5 The power on sequence should now perform a startup and background cycle if Auto Startup is selected 11 78 PN 624021CA PN 624021CA DIAGNOSTICS REPLACEMENT PROCEDURES 12 verify correct operation x ls a Gf Startup is not automatically done 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 turn the instrument off and unplug it from the power outlet Al 11 79 11 DIAGNOSTICS REPLACEMENT PROCEDURES 14 Replace the top cover a Place the top cover on the instrument b Fasten the 5 hex screws to secure the cover to the instrument frame c Re attach the left side panel and fasten the four hex screws to secure the door to the instrument frame d Close the right door 15 After closing all doors and replacing all covers plug the instrument into the power source 16 verify instrument performance by running a fresh whole blood sample 11 80 PN 624021CA 11 12 SYSTEM ERRORS What Error Messages Mean Table 11 2 lists errors messages that may appear on the instrument Table 11 2 Error Messages DIAGNOSTICS SYSTEM ERRORS 11 Probable Cause Suggested Action X Message Windows Have Been Displayed And Have Not Been Closed No More Message Windows Can Be Displayed More
202. er for details ATTENTION Use printers available in this field only These printers and their drivers have been validated for use with the AC T 5diff CP system 6 Select the desired printer settings 27 SETUP SYSTEM SETUP A 28 7 For additional property settings Properties Page setup options such as paper size paper source paper orientation copy count and other options are shown Print Setup x Printer Name EPSON EPL 5700 Properties J Staus Ready Type EPL 5700i Advanced Where LPT1 Comment Paper Orientation Size LT 8 5 11 d A C Portrait Source Auto Selection Landscape tees 8 OK to close the advanced properties screen 9 OK to close the print setup screen 10 W Vv to save and exit the window Adding a Printer ATTENTION If you want to add a Windows NT compatible printer to your system contact a Beckman Coulter representative PN 624021CA SYSTEM SETUP Defining Results Autotransmission Settings PN 624021CA Ac T 5diff System Setup General Units Analyzer Config Save SETUP Date Time Physician Location Comm Settings Formatting Auto Transmission Options Baud Rate Stop Bits promet Patient Results C 4800 9 e ot FIXED C 9600 C VARIABLE C All 38400 C Normals Only 57500 p D
203. erman C Italian C Spanish Note If you want to edit input locales such as language specific keyboards contact a Beckman Coulter representative 4 Change Input Locales and confirm settings 5 amp to save and exit the window Note message displays to remind you that changing the Language Options requires restarting the application A 25 A SETUP SYSTEM SETUP Configuring the Printer Defining Printer Properties Printer properties include paper size paper orientation portrait or landscape paper source print quality and so forth Do this procedure if you want to change any of the printer properties Actual printer setup information may vary depending on the printer used A Nec 1 Setup gt gt System 2 Typethe password and v 3 Printer tab Printer Properties Add Printer A 26 PN 624021CA PN 624021CA SETUP SYSTEM SETUP Print Setup BEI 4 Printer Properties Printer Name EPSON EPL 5700i Advanced Properties Status Ready Type EPSON EPL 5700i Advanced Where LPT1 Comment Paper Orientation Size 85x11in z C Portrait Source auto Selection Landscape Cancel 9 Select the printer from the Name list a ha at the Name field b Highlight the desired printer c Note Ifthe printer you want does not appear in the list you can add the printer See Adding a Print
204. erol May interfere with the proper counting of platelets ACD acid citrate dextrose blood Blood anticoagulated with ACD may contain clumped 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 an erroneously low or decreased platelet count Plt Agglutination Clumped platelets may cause a decreased 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 prevent platelet agglutination 2 Reanalyze the specimen for only the count 3 Correct the final Plt result for the effect of the sodium citrate dilution MPVt Giant platelets May exceed the upper threshold of the Plt 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 schizocytes 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 count is derived from the WBC c
205. es 9 29 Interpretive Messages 9 30 Plt Interpretive Messages 9 30 Combination WBC RBC PIt Interpretive Messages 9 31 624021CA Xi CONTENTS Xii 10 11 9 5 FLAG HIERARCHY 9 32 Replacement Flags Hierarchy 9 32 Parameter Flags 9 32 Patient Action Flags Hierarchy 9 32 IRREGULAR SAMPLE RESULTS 9 32 CALIBRATION 10 1 10 1 10 2 10 3 10 4 10 5 GENERAL 10 1 Recommended Calibration Conditions 10 1 When to Calibrate 10 1 When to Verify Calibration 10 1 PRE CALIBRATION CHECKS 10 1 AUTO CALIBRATION 10 3 Setup Calibration 10 3 Running Calibration 10 5 Interpreting Calibration Results 10 10 Forced Calibration 10 10 MANUAL CALIBRATION FACTOR ADJUSTMENT 10 11 PRINTING CALIBRATION FACTORS 10 13 DIAGNOSTICS 11 1 11 1 GENERAL MAINTENANCE 11 1 MAINTENANCE SCHEDULE 11 1 VIEWING THE CYCLE COUNT 11 2 REPRODUCIBILITY CHECK 11 3 SHUTTING DOWN WINDOWS NT 11 4 CLEANING PROCEDURES 11 5 Cleaning the Tube Holder 11 5 Cleaning the Outside of the Instrument 11 5 Cleaning the Inside of the Instrument 11 6 Extended Cleaning Procedure 11 6 Auto Clean 11 9 Shutdown 11 9 Cleaning the Baths and Lower Rinse Block 11 10 System Cleaning 11 16 SYSTEM RESET CYCLE 11 21 Mini Prime 11 22 PN 624021CA PN 624021CA CONTENTS 11 8 REPLACING THE RINSE BATH DRAIN FILTER 11 23 Purpose 11 23 Tools Supplies Needed 11 23 Procedure 11 23 11 9 COMPONENT
206. et A Ne Setup gt gt Patients F ty 2 Type the password and B Ac T 5diff File Cycles Diagnostics acl 2 System 3 the Flagging and Messaging tab 4 Highlight the flagging set that you want to be the default PN 624021CA No Flagging Set Name Age From Age AgeTo Standard Range Woman Newbom Days 30 Days Infant 1 Months 6 Years Child Years 12 Years 43 SETUP PATIENT SETUP 5 Set As Default 6 the change D to save and exit from the window OR il to save and remain at this window The flagging set name that you selected is now defined as the default flagging set A 44 PN 624021CA SETUP A PATIENT SETUP Editing Patient Limit Ranges in a Flagging Set Do this procedure to edit patient limit ranges within a flagging set ATTENTION The Standard flagging set cannot be edited The age range cannot be edited on any flagging set AN 1 Setup gt gt Patients 2 Typethe password and 0 vj 3 the Flagging and Messaging tab 4 Highlight the flagging set that you want DE lf Patients Setup di Flagging and Messaging Parameters Repo 1 to edit No Flagging Se Name Age From AgeTo 2 Man Modified Or 3 Women 16 21 4 Newbom Days 30 De By 5 Months 6 Yen Bo 6 eas
207. ets the draining syringe to its home position Counting Syringe Test Draining Syringe Do this procedure to test the counting syringe motor and reset the counting syringe to its home position A Nex Diagnostics gt gt Operator 5diff File Diag Ny Help 2 U the Hardware Systems tab 5diff Operator Hardwerp Systems Dituter Systems Cycles Reset Hardware Motors Valves Tre 11 41 DIAGNOSTICS SYSTEM TROUBLESHOOTING PROCEDURES 5diff Operator Hardware Systems Dituter Systems Cycles 3 the Motors tab Reset Hardware Valves T 4 Counting Syringe Counting Syringe The instrument exercises the counting syringe motor and returns the counting syringe to its home position Flow Cell Syringes Test Do this procedure to test the flow cell syringes motor and reset the flow cell syringes to their home position LN S Nel File D Ny Help Diagnostics gt gt Operator 59 Operator 2 the Hardware Systems tab Hardwerp Systems Dituter Systems Cycles Reset Hardware Motors Valves Tn 11 42 PN 624021CA DIAGNOSTICS SYSTEM TROUBLESHOOTING PROCEDURES 5diff Operator Hardware Systems Dituter Systems Cycles 3 the Motors tab Reset Hardware Valves T 4 Flowcell Syringes Flowcell Syringes The instrument exerc
208. evels Note If you run an expired control the system displays a message to alert you but accepts the results Be sure to remove these invalid results from the control file if not immediately then before IQAP download PN 624021CA PN 624021CA QUALITY ASSURANCE RUNNING CELL CONTROLS 9 Review the control results to ensure they are within the acceptable ranges before analyzing patient samples Verify that none of the controls were run past their expiration date If they were remove the invalid results from the control file and run a control that is not expired If the control results are within the acceptable ranges you are ready to analyze patient samples If a parameter value is out of range the result is backlit in yellow and flagged with H or L on the Run screen Review the control data according to your laboratory protocol or go to step 10 You can also 1 the Quality Assurance tab 2 Select the appropriate file from the Select Control drop down box 3 Review the control file summary data Scroll through the control runs as needed to view all data 4 Toreview the Levey Jennings graphs select the appropriate tab scroll to the right if necessary and double click the graph to expand the view To close the graph when finished U qe 1 9 7 QUALITY ASSURANCE RUNNING CELL CONTROLS 1 6 10 When control results are not within the acceptable ranges a Ensure proper mi
209. f white blood cells The differentiation between basophils and other white blood cells is also related to the AC T 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 2 2 624021CA OPERATION PRINCIPLES ACV TECHNOLOGY 2 3 ACV TECHNOLOGY Overview In the DIFF bath 25 pL of whole blood is mixed with 1 000 yL of AC T 5diff Fix reagent for 12 seconds then stabilized with 1 000 pL of AC T 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 DFF Figure 2 2 fluid dynamics uses a hydrodynamic focusing process to focus individual cells or particles a stream of di
210. g the Reagents 18 Inspect the reagent lines to ensure there are no air bubbles present If air bubbles are present repeat step 17 19 Power down the system as instructed in Power Down the System under Heading 5 2 POWER UP POWER DOWN 20 Power up the system as instructed in Power Up the System under Heading 5 2 POWER UP POWER DOWN PN 624021CA DIAGNOSTICS SYSTEM RESET CYCLE 11 7 SYSTEM RESET CYCLE The System Reset Cycle performs a general rinse draining and initialization of mechanical assemblies Do a System Reset Cycle if the instrument halts due to error e after an emergency stop of the instrument when the instrument reports a faulty operation or when prompted by the instrument LN e Net 1 Cycles gt System Reset Cycle Note You can also access System Reset Cycle through the Operator Diagnostics options Diagnostics gt gt Operator Deen ve Regens W the Diluter Systems tab IEEE Mini Prime W Extended Cleaning the Cleaning Cycles tab al System Reset Cycle 2 3 5 e t 2 Allow the system reset cycle to finish ai a ni ur kist mm is QualityAssurence Anaivs The progress bar shows the status of the operation 624021 11 21 DIAGNOSTICS SYSTEM RESET CYCLE Mini Prime Mini Prime primes all the reagent lines Do this
211. g the cursor 5 33 using to edit text 5 34 MPV interfering substances 3 14 measurement overview 2 17 MSDS definition ABBREVIATIONS 1 how to order 1 14 mW definition ABBREVIATIONS 1 Myelemia triggering condition 9 29 n definition ABBREVIATIONS 2 NCCLS 1 9 8 2 definition ABBREVIATIONS 2 NE description 2 20 interfering substances 3 14 Neutropenia triggering condition 9 29 neutrophil See NE Neutrophilia triggering condition 9 29 nm definition ABBREVIATIONS 2 INDEX NO DILUENT CHECK LEVEL 11 84 Nucleated RBC triggering condition 9 31 0 on off button workstation 1 6 online Help See Help system operating range definition GLOSSARY 1 operational hazards 4 2 Operator ID change 5 25 definition 5 24 logon 5 24 optical bench function 11 29 location 11 29 ordering parts record the part number 11 23 output 3 3 P Pancytopenia triggering condition 9 31 panel definition GLOSSARY 2 parameter results from Plt histogram 2 16 from RBC histogram 2 15 parameters analyzed CBC parameters 1 7 analyzed CBC DIFF parameters 1 8 definition GLOSSARY 2 how they are determined 2 14 measurement and computation 3 5 print only selected ones A 65 particles how they are detected 2 1 passwords for Administrator 5 26 for Service 5 26 for Admin user name 5 24 for BCI username 5 24 PC power button 1 6 PC See Workstation Pct plateletcrit calculation overview 2
212. ge the time Go to step 5 of Changing the Time for details Changing the Time LN 1 Setup gt gt System 2 Typethe password and 3 the Date Time tab 4 Change Date Time PN 624021CA A 13 SETUP SYSTEM SETUP W x Date Time Properties x 9 Set the current time by as Date amp Time Time Zone needed Date j Lime m z 200 of 4 12 3 d A 45 6 7 E 93 10 D i 11 12 13 14 15 16 17 s E 18 19 20 21 22 23 24 Sr NDS 25 26 27 28 29 30 31 1 05 20PM Current time zone Eastern Standard Time to save and exit the window OR APPLY then U OK to save and remain at this window to change the time Go to step 5 of Changing the Date for details 14 624021 SETUP SYSTEM SETUP Changing the 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 mm ss 5 30 12 HH mm ss 05 30 12 LN e Ner File Cycles Diagnostics Help amp e E Patients Quality Assurance 1 Setup gt gt System 2 the password and E eal 3 the Date Time tab Change Date Time PN 624021CA A 15 SETUP SYSTEM SETUP 4 Select the time format Current Date Time Format a
213. hat the protocol set up in the host Error ENQ communication or handshaking to transmission screen matches the the host computer protocol expected by the host computer Host Communication There is a problem with the Verify that the protocol set up in the host Error Internal communication or handshaking to transmission screen matches the the host computer protocol expected by the host computer PN 624021CA PN 624021CA Table 11 2 Error Messages Continued DIAGNOSTICS SYSTEM ERRORS 11 Probable Cause Suggested Action Host Communication There is a problem with the Verify that the protocol set up in the host Error Timeout communication or handshaking to transmission screen matches the the host computer protocol expected by the host computer Host Communication There is a problem with the Verify that the protocol set up in the host Error Write communication or handshaking to transmission screen matches the the host computer protocol expected by the host computer Host Communications Attempt was made to transmit Retransmit results that were not Error Queue Full Only The First d Results Will Be Sent more results than the system can spool transmitted Host Communications Attempt was made to transmit Retransmit results that were not Error Spooler Full more results than the system can transmitted Results Lost spool iore 4454 1 Patient ID is available the None
214. hat use impedance and light absorbance as measurement principles Table 3 12 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 elevated WBC counts Leukemia A very low WBC count may result in this disease state due to the 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 low WBC counts Cryoglobulins Increased levels of cryoglobulin that may be associated with myeloma carcinoma leukemia macroglobulinemia lymphoproliferative disorders metastic tumors autoimmune disorders infections aneurysm pregnancy thromboembolic phenomena diabetes and so forth which can elevate the WBC RBC or 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
215. he exterior of the sampling probe is rinsed ensuring sample integrity 10 pL of sample is delivered to the First Dilution Hgb bath for use in preparing the primary RBC PIt dilution and for measuring the Hgb value 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 The3 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 10 pL of sample is delivered to the First Dilution Hgb bath for use in preparing the primary RBC PIt dilution and for measuring the Hgb value 10 pL of sample is delivered to the WBC BASO bath for the WBC BASO count 25 of sample is delivered to the DIFF bath for development of the DiffPlot 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 A us Reagent input Tangential flow Bath 7616002A PN 624021CA 2 7 2 O
216. he Diluter Systems tab uj the Cleaning Cycles tab 0 Extended Cleaning ATAS 3 Open the right side door a Use the door key to loosen the two screws on the right side door b Swing open the door 4 Extended Cleaning You Have Requested to Run Extended Cleaning Cycle Continue appears PN 624021CA 11 DIAGNOSTICS CLEANING PROCEDURES 5 0 OK to initiate the cycle 6 After about 1 minute you will be prompted to pour the cleaning reagent BCI WorkStation Information M B 196 to 296 chlorine solution into the REAGENT INTO BATHS baths A CLICK OK TO CONTINUE Note Do not d OK until after you pour the cleaning reagent into the baths 3 2 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 1 Dispense 3 mL of the 196 to 2 chlorine solution into each bath 8 to continue 11 8 PN 624021CA DIAGNOSTICS CLEANING PROCEDURES 9 Close the right side door and secure the two screws with the door key S Allow the instrument to complete the cleaning procedure Note It takes about 5 minutes for the cycle to complete The system will automatically flush to
217. he empty container 8 Properly dispose of the empty bottle according to your laboratory guidelines PN 624021CA 11 65 DIAGNOSTICS REPLACEMENT PROCEDURES 9 Insert the stopper assembly tube into the new bottle 10 Tighten the stopper assembly onto the bottle to ensure an adequate seal 11 Put the new reagent bottle in the reagent compartment Fix is shown here 11 66 PN 624021CA PN 624021CA 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 that the tubing is not pinched or twisted 12 verify that the tubing is not pinched or twisted 13 Repeat steps 4 through 12 for each reagent 14 Close the reagent compartment door 15 Replace the Diluent reagent 11 67 11 DIAGNOSTICS REPLACEMENT PROCEDURES 16 Unscrew the stopper assembly from the Diluent container 17 Uncapa new Diluent container 18 Put the cap from the new container onto the empty container 19 Properly dispose of the empty container xi CENAN 11 68 PN 624021CA DIAGNOSTICS REPLACEMENT PROCEDURES 20 Insert the stopper assembly tube into the new container 21 Tighten the stopper assembly onto the container to ensure an adequate seal IMPORTANT Risk of
218. he sequence gt to display the next topic in the sequence to display the previous hyperlink 5 16 PN 624021CA GETTING STARTED 5 USING THE ONLINE HELP SYSTEM 4 View referenced or related topics the highlighted words in a topic body to link directly to the referenced topic a word in the highlighted hierarchy at the top of the topic to change topic levels The current topics position also appears in the hierarchy 9 Toview information not visible in the Help window scroll through the window by using the scroll bar Using the Contents Option The contents option displays is a list of subject headings within the manual 1 Access online Help 2 Contents to browse through topics by heading 3 to expand the headings PN 624021CA 5 17 GETTING STARTED USING THE ONLINE HELP SYSTEM 4 the topic you want to view Using the Index Option The index displays a list of entries sorted alphabetically It is probably the best way to find information about a specific concept or system feature 1 Access online Help 2 Index 3 the letter for which you want to see index entries list of entries that start with the letter you selected appears 4 Scroll through the topics as needed 5 a number after the index entry to display information about that topic 5 18 624021CA GETTING STARTED 5 USING
219. ic procedures 1 7 1 USE AND FUNCTION FEATURES CBC DIFF Panel 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 Neutrophil percentage NEZ Neutrophil number LY Lymphocyte percentage LY Lymphocyte number 0 Monocyte percentage MO Monocyte number E096 Eosinophil percentage EO Eosinophil number BA Basophil percentage BA Basophil number IMM t Immature cell percentage IMM t Immature cell number ATL t 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 1 5 FEATURES Features of the instrument include automated calibration automated quality control evaluation automated patient data storage closed vial sampling aspiration with probe wipe 12 or 26 parameter analysis with hi
220. icles and size volume of the particles passing through the aperture within a given time period Aperture Sensor System Overview The 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 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 PN 624021CA 2 1 OPERATION PRINCIPLES MEASUREMENT PRINCIPLES 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 Figure 2 1 Coulter Principle Solution to be analyzed Vacuum constant Current constant Y Analyzing electronic circuit Electrodes Time 7650331 When the count circuit is activated and an electronic
221. ient ID any entered demographic information will be deleted If the entry has a Patient ID already in the system prior to this Worklist entry then the demographic information for this Patient ID on the Worklist not in the database will be deleted when you delete the entry 1 the Worklist tab A TY Wb ed weg Jus poss Analyzer togs Patient ID Panel Date of Birth Age CBC DIFF i CBC DIFF CBC DIFF 2 Highlight the item you want to delete To select multiple entries for deletion 1 Press the key and Te ten te B each entry you want to delete 2 Verify that a black dot appears next to each selected entry ir 4 to delete the selected item s m Delete All Selected Items 5 50 624021CA DAILY ROUTINE 6 1 STARTUP PN 624021CA IMPORTANT Do not log out of the Workstation while the Analyzer is running a cycle Logging out during an Analyzer cycle will cause problems with the Analyzer Workstation communication Startup automatically runs when the instrument is powered on if the automatic Startup feature is enabled 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 Background limits are fi
222. imeter MO monocyte MPV mean platelet volume MSDS material safety data sheet mW milliwat PN 624021CA ABBREVIATIONS 1 ABBREVIATIONS 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 Vdc volts of direct current WBC white blood cell ABBREVIATIONS 2 PN 624021CA PN 624021CA Symbols definition 9 18 BASO definition 9 25 WBC definition 9 25 pL definition ABBREVIATIONS 1 A A Minimum Of 3 Results Must Be Included To Save The New Cal Factors 11 81 A Sample ID is Required Before Sample Will Be Analyzed 11 81 abbreviations list of ABBREVIATIONS 1 ACeT 5diff Cal Calibrator See calibrators 5diff Control Plus See cell controls AC T 5diff Diluent See diluent reagent See reagents AC T 5diff Fix See Fix reagent 1 10 See reagents AC T 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 ACeV technology overview 2 3 accuracy definition GLOSSARY 1 performance characteristics 3 8 performance specifications 3 6 ACD definition ABBREVIATIONS 1 Administrator password 5 26 agglutination definition GLOSSARY 1 alarms See analytical al
223. ing Reagents AN e Ner 1 the Analyzer Log tab 5diff Ele Cycles Diagnostics Setup Help SA yp si od 9 gt Worklist Run Results Quality Assuran Reagent Status Analyzer Logs RINSE Fx wectvse owuenT LotNumber 00102001441 Ewpitatin Date 03 20 2001 6040200005 Opened Date 03 27 2001 03 27 2001 04 20 2001 po202A00846 60302000035 03 27 2001 03 27 2001 03 27 2001 10 05 2001 08 23 2001 08 11 2001 0402501284 De Administrato Administrato Administrato Administrato MEN __ Change All Reagents Change Reagent Startup Sven Background RBC HGB PLT tel X p p rin Reagens Log J_EnorLog J Calibration Loa Maintenance Loa Log 03 27 2001 16 17 06 2 Open the reagent compartment door 11 57 11 DIAGNOSTICS REPLACEMENT PROCEDURES 3 Remove the appropriate reagent bottle from the reagent compartment Fix is shown here 4 Remove the bottle stopper assembly from the reagent you are replacing 9 Uncapa new reagent bottle 11 58 PN 624021CA DIAGNOSTICS REPLACEMENT PROCEDURES 6 Put the cap from the new container onto the empty container 1 Properly dispose of the empty bottle 8 Insert the stopper assembly tube into the new
224. ing normal hematology parameters Depending on sample mix and workflow conditions slightly higher or lower throughput might be observed Sample Identification You can manually enter a sample ID setup the instrument to 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 predefined 14 can be added 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 The instrument prints a report Figure 3 2 PN 624021CA 3 3 SPECIFICATIONS CHARACTERISTICS INSTRUMENT SPECIFICATIONS Figure 3 2 Sample Report Report Format Option 1 CITY STATE ZIP YOUR LABORATORY NAME YOUR LABORATORY ADDRESS 1 LAB PHONE NUMBER YOUR LABORATORY ADDRESS 2 LAB FAX NUMBER Sample ID 1 Patient Run Date Time 04 18 2001 04 30 55 PM Patient ID Collect Date Time Seq 391 Gender Unknown DOB Physician OPR Admin Age Location Flagging Set Standard Range Comments Startup status Range Range WBC 69 10e3jgL 40 11 0 LY 20 8 20 0 50 0 RBC 4 74 10e6 uL 3 80 6 50 MO 49 36 30 100 HGB 146 g dL 12 0 18 0 EO 19 10 50 HCT 432 96 360 54 0 BA 0 4 0 0 05 MCV 91 fL 76 196
225. 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 22 Put the new container no more than 80 cm 31 5 in below the instrument ee AP stn X Due PN 624021CA 11 69 DIAGNOSTICS REPLACEMENT PROCEDURES 23 Enter the lot number from each new container for every reagent If the lot number entered has already been used the following message appears Invalid Reagent Lot Number Entered Please Enter Correct Reagent Lot Number 24 Select each reagents expiration date metet Expiration Date 05 17 2001 EE May 2001 Sun Mon Tue Wed Thu Fri 1 2 3 4 5 6 8 9 10 11 12 13 14 15 16 9 15 19 20 21 22 23 24 25 26 27 28 29 30 31 at the Expiration Date field to open the calendar that shows the current date b Select the expiration date 1 Le as needed to advance to the correct month C jToday 03 28 2001 Note To return to a previous 1 mj 2 the correct day 11 70 PN 624021CA DIAGNOSTICS REPLACEMENT PROCEDURES 25 P to save the reagents information The system updates all of the reagents information primes the reagents and updates the level indicators Note Due to priming the reagent levels may not be displayed as 10096 ATTENTION If an instrument error occurs during the reagent replacement pr
226. ises the flow cell syringes motor and returns the flow cell syringes to their home position Dilution Syringe Test Do this procedure to test the dilution syringe motor and reset the dilution syringe to its home position LN Nex File Cycles Setup Help Diagnostics gt gt Operator AEE ad ENa 5diff Operator 2 the Hardware Systems tab Hardwarg Systems Diluter Systems Cycles Reset Hardware Motors Valves Tre PN 624021CA 11 43 DIAGNOSTICS SYSTEM TROUBLESHOOTING PROCEDURES 5diff Operator Hardware Systems Dituter Systems Cycles 3 the Motors tab Reset Hardware Valves T 4 Dilution Syringe Dilution Syringes The instrument exercises the dilution syringe motor and returns the dilution syringe to its home position Piercing Mechanism Test Do this procedure to test the piercing mechanism motor and reset the piercing mechanism to its home position LN Nel File L Ny Help Diagnostics gt gt Operator 59 Operator 2 the Hardware Systems tab Hardwerp Systems Dituter Systems Cycles Reset Hardware Motors Valves Tn 11 44 PN 624021CA PN 624021CA DIAGNOSTICS SYSTEM TROUBLESHOOTING PROCEDURES 3 the Motors tab 5diff Operator Hardware Systems Dituter Systems Cycles Reset Hardware Valves T 4 0 Piercing Mechan
227. ism The instrument exercises the piercing mechanism motor and returns the piercing mechanism to its home position Valves Test Piercing mechanism Do this procedure to test the valves motors and reset the valves to their home position A Nex Diagnostics gt gt Operator 5diff File ON 2 U the Hardware Systems tab 5diff Operator Hardwerp Systems Dituter Systems Cycles Reset Hardware Motors Valves Tre 11 45 DIAGNOSTICS SYSTEM TROUBLESHOOTING PROCEDURES 11 46 3 the Valves tab 5diff Operator Systems Systems Cycles ResetHardwere Motors uere 4 the option corresponding to the valves you want to test For example to test the valves 1 through 11 0 Valves 1 to 11 The instrument exercises the valves motors and resets the valves to their normal position Traverse Service Position Valves 1 to 11 Do this procedure to set the traverse assembly to its service position A 2 Nex Diagnostics gt gt Operator 5diff File Dia EEN Help 2 the Hardware Systems tab 59 Operator Hardwarp Systems Dituter Systems Cycles Reset Hardware Motors Valves Tre PN 624021CA DIAGNOSTICS SYSTEM TROUBLESHOOTING PROCEDURES 3 the Traverse Service Position tab Traverse Position Park Sy
228. istogram which is needed to obtain the Hct MCV and RDW results e Determine Plt count e Develop the Plt histogram which is needed to obtain MPV Pct 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 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 5diff Hgb Lyse 400 uL Additional volume of AC T 5diff Diluent 400 uL Final dilution for Hgb determination 1 250 Reaction temperature 35 C 95 F Me
229. ity is exceeded This means that when Reagent Log entry number 51 is ready to be stored entry number 1 will be deleted to make room for 51 And when entry number 52 is ready to be stored entry number 2 will be deleted and so forth Therefore only the most recent entries appear on the log up to the capacity of the log Logs cannot be deleted other than what is described above Viewing System Logs Do this procedure to review one of the following logs Reagents Log Startup Log Error Log Calibration Log Maintenance Log Ge i 73 File Cycles Diagnostics Setup Help 1 PN 624021CA az Sl wp 2474 noi the Analyzer Logs tab 11 89 DIAGNOSTICS SYSTEM LOGS 2 the tab for the log you want to E Cycles Diagnostics Setup Help view aA mp up s zio wi zb wv vi ve Notklist Pun Results GualityAssurance Analyzer Logs For example to view the Startup Log nm Le sene emnes Startup Log Note You can display the Error Log from any screen by double clicking on either of the System Status indicators at s 3 WBC RBC HGB PLT the top right corner of the screen MU og a ps i fV Prompt User For Comment Add Comments Reagents Reaoenti fa 518805199 0 korkoa J Calibration Loa Maintenance Loa Senwice Log 03 28 2001 152319 Adding Comments to the Logs You can enter comments into each of these logs
230. kground W File gt gt Close Archive If according to your laboratory protocol it is time to create a new see File New Archive Note You cannot create a new archive until any previously opened archive if any is closed PN 624021CA SAMPLE ANALYSIS RUNNING PATIENT SAMPLES WITHOUT USING THE WORKLIST a 3E lop wi zd wd 9j ve m Quality Assurance Analyzer Logs 0 Patient Name Gender Date of Bith Panel Unknown cec 2 the Run tab Run Date Time Comment 63 27 2001 111242 Sample 1D 123 In progres Next 124 B 03 28 2001 1400 06 3 Verify that the Sample ID is correct SampeiD Pane PatiemiD Since autonumbering is on the 123 Sample ID is automatically entered E To override the autonumber with another Sample ID 1 Highlight the autonumber in the Sample ID Next field 2 Type the desired Sample ID number 3 Press when the Sample ID is complete 4 Verify that the Sample ID number is correct Note Autonumbering automatically begins again with the autonumber that was overwritten 4 Press to move the cursor to the Panel field PN 624021CA 8 23 SAMPLE ANALYSIS RUNNING PATIENT SAMPLES WITHOUT USING THE WORKLIST 9 Select the panel CBC or CBC DIFF aJi CBC DIFF Patient ID CBC DIFF Og b Select CBC or CBC DIFF c Press to move th
231. l used for quality control parameters Usually EXPECTED reported on package 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 624021CA LIST OF ABBREVIATIONS uL 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 eosinophil fL femtoliter ft foot or feet 0 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 MCH mean corpuscular hemoglobin MCHC mean corpuscular hemoglobin concentration MCV mean corpuscular volume mL milliliter mm mill
232. lagging Sets for details 2 Setup gt Patients A 46 PN 624021CA PN 624021CA SETUP PATIENT SETUP Type the password and 0 v the Flagging and Messaging tab Select an empty available flagging set or select the next available empty row For example if there are only the 6 pre defined flagging sets on your system row 7 is the next available row Type the flagging set name For example if you want to create a flagging set for renal patients you may want to name the flagging set Renal Note Do not use an apostrophe or any other punctuation in the flagging set name Flagging and Messaging Flags and Messages Flags Modified On Flagging Set Name Limits pe Rar Parameter Action Patient L Patient H Action H ao T0 160 fome mic f 39 am 750 HGB 90 120 180 200 Fiom xo 0 50 my 7 76 NIS MCH 250 70 320 340 MON x0 mo 90 He ROW 90 no 160 250 PLT 100 150 400 500 Mese m MPV 50 60 10 0 120 bee rct 010 015 NE 400 so 70 750 lY 150 200 400 450 MO 10 30 100 120 fm 0 10 50 BA 00 00 05 20 MEC 10 20 Dm os 159 as Mo 00 oa 08 15 EO 000 004 040 060 em om om 3
233. lagging on CBC parameters e Rinse the flow cell to remove bubbles from the flow cell or if you have excessive flagging on DIFF parameters 11 32 624021 DIAGNOSTICS 1 1 SYSTEM TROUBLESHOOTING PROCEDURES LN e Ner 1 Diagnostics gt gt Operator 5diff Operator 2 the Diluter Systems tab 3 the Rinse tab 5diff Operator 4 Rinse Baths Flowcell The instrument rinses the selected component Note Rinse Baths finishes in about 2 minutes Rinse Flowcell finishes in about 1 minute 624021 11 33 DIAGNOSTICS SYSTEM TROUBLESHOOTING PROCEDURES Draining the Baths and or the Diluent Reservoir Do this procedure if you suspect a draining problem with the baths and or the diluent reservoir Aer Diagnostics Operator 5diff File Diagno EEN Help 2 the Diluter Systems tab 5diff Operator Hardware Systems Drain Baths Rinse Cleaning Cycles Prime Reagents 3 the Drain Baths tab 11 34 5diff Operator Hardware Systems Diluter Systems Cycles rise Rinse Cleaning Oycles Prime Reagents PN 624021CA DIAGNOSTICS SYSTEM TROUBLESHOOTING PROCEDURES 4 one of the following options e Rinse Bath e First Dilution Pea wem Dir eee e RBC PLT rec e WBC BASO All Baths e Diluent
234. lowing 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 624021CA 3 13 SPECIFICATIONS CHARACTERISTICS INTERFERING SUBSTANCES 3 14 Table 3 12 Interfering Substances Continued Parameter Interfering Substance PIt Very small RBCs microcytes RBC fragments schizocytes and WBC fragments May interfere with the proper counting of platelets and cause elevated 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 parameter are not counted Chemotherapy Cytotoxic and immunosuppressive drugs may increase the fragility of cells which may affect the proper counting of platelets Use the manual reference method to obtain an accurate Plt count Hemolysis Hemolysed specimens contain RBC stroma which may elevate Plt count Lipemic samples and or elevated triglycerides and or elevated cholest
235. luent The focused sample stream of the AC T 5diff CP 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 PN 624021CA 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 um 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 senso
236. lues 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 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 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 Hct will impact MCHC and may cause erroneous MCHC values RDW RDW is determined according to the RBC count and may be impacted by the fol
237. ly D or E 4 Double click Start HTM to launch the Operators Guide 9 Navigate through and or print the manual as noted Heading 5 5 USING THE ONLINE HELP SYSTEM PN 624021CA 5 23 GETTING STARTED SOFTWARE DETAILS 5 7 SOFTWARE DETAILS Overview The Workstation software is based on Windows NT Familiarity with Windows conventions and use would be beneficial but is not required Initial Windows NT Logon When the software initially loads a Windows NT logon window appears This is where you enter the user name and password information User Names and Passwords When you log on to the system you are required to type a user name Type one of the following e BCI for normal operation or e Admin for special procedures For normal operation which is the majority of the time logon using BCI as the User name 123 is the password for the BCI User name Once you enter the password for BCI the system automatically loads the Workstation application software For special procedures logon using the Admin User name Only do so when instructed by a Beckman Coulter representative who will provide you with the Admin password at that time Operator ID Logon After the initial Windows NT logon a splash screen appears This is where you enter your Operator ID AC T 5diff Your Operator ID is a 3 character alphanumeric code that identifies you as the operator Use your initials or any other 3 character combination
238. ly 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 PN 624021CA DATA REVIEW REVIEWING FLAGGED RESULTS 9 General Patient sample results are generated from sample analysis There may be instances when a patient sample result is flagged or a parameter number is replaced by a flag Carefully review all patient sample results especially results with flags and or messages For details see Flags and Analytical Alarms Generated by the Instrument and Interpretive Messages Flags and messages appear in on the Run screen in a special area Figure 9 1 and initially appear in a collapsed view Figure 9 2 shows the expanded view You may need to scroll to view all the messages Figure 9 1 Flags Messages Collapsed View Figure 9 2 Flags Messages Expanded View Flags and Messages Flags and Messages Diffplot and Histogram Flags Interpretive Messages Leukocytosis Neutrophilia Diffplot and Histogram Flags Interpretive Messages to expand the list Hl to collapse the list 624021 9 15 DATA REVIEW REVIEWING FLAGGED RESULTS Types of Flagging Formats The system provides two formats for reporting the information that is presented in
239. matic i Startup is enabled If automatic Startup is disabled Startup will run when you click on the icon Shutdown Daily Do Heading 6 4 SHUTDOWN to By clean the instrument Reproducibility check For troubleshooting or when required by your laboratory or regulatory agency Calibration verification As needed or when required by your laboratory or regulatory agency Replace reagents When empty or when there is not Reagent s Low Insufficient enough to complete your daily Reagents to Complete Daily workload Workload appears Extended cleaning As needed Poor instrument performance System Reset Cycle After an emergency stop of the instrument or when a faulty operation has been detected Replace Rinse Drain When instructed by a Beckman Coulter DRAIN SENSOR TIMEOUT may Filter representative indicate a possible filter restriction indicates Not Applicable DIAGNOSTICS VIEWING THE CYCLE COUNT 11 3 VIEWING THE CYCLE COUNT The instrument counts the number of cycles run after the software is installed for CBC DIFE CBC Startup Shutdown and System Reset Cycle Do this procedure to review the number of cycles analyzed by the instrument A amp Aer ET File Cycles Setup Help PE LI Diagnostics gt gt Operator e EXER 1 2 the Cycles tab 3 when finished PN 624021CA DIAGNOSTICS REPRODUCIBILITY CHECK 11 4 REPRODUCI
240. mends that you save the information to your hard drive e Ifyou want the settings to be saved to a floppy disk 1 Insert the disk into drive A 2 Floppy Disk PN 624021 PN 624021CA SETUP SYSTEM SETUP Restoring Analyzer Configuration Settings Do this procedure if you want to restore previously saved Analyzer settings to be the current settings 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 will 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 A amp Nec File Cycles Diagnostics Help amp ial Patients 1 Setup System 201 Quality Assurance 2 Type the password and 0 3 Config Save Restore tab Current Analyzer Setup t NentWorkstatid Setup Seve Seve Print Print 2 4 3 Hl 2 07 16 2004 02 38 37 PM A 33 SETUP SYSTEM SETUP A 34 4 Restore in Current Analyzer Setup Dee Time essa Cycle Option Units Analyeer Config Save Restore Language area CunentAnalyzerSetup Current W
241. mes referred to as Hgb Lyse e 5diff WBC Lyse reagent is sometimes referred to as WBC Lyse e ACeT 5diff Diluent reagent is sometimes referred to as Diluent U indicates select with or click the mouse GRAPHICS All graphics including screens and printouts are for illustration purposes only and must not be used for any other purpose 624021CA xxiii INTRODUCTION SYMBOLS SYMBOLS Safety Symbols 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 LN 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 Nex 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 5diff CP analyzer from the electrical outlet Tab Symbols Tabs divide this document into five sections reference operation special procedures and tro
242. mplete 4 Verify that the Sample ID is correct Collect Date Time rPatient Identification Note Autonumbering automatically begins again with the autonumber that was overwritten 8 4 PN 624021CA PN 624021CA RUNNING PATIENT SAMPLES USING THE WORKLIST SAMPLE ANALYSIS Select the panel CBC or CBC DIFF Og b Select CBC or CBC DIFF c Press to move the cursor to the Flagging Set field Add Edit Worklist r Sample Identification Opr Sample ID Flagging Set Comment Patient Identification Select another flagging set if appropriate Um b 0 the desired flagging set c Press to move the cursor to the Collection Date and Time field If you manually select a flagging set that flagging set will be applied For information on the flagging set hierarchy see Figure 5 15 Add Edit Worklist r Sample Identification Sample ID Flagging Set Collect Date Time Comment all Panel CBC DIFF Fatient Identification Enter the date and time that the specimen was collected a Enter the complete date Enter the time c Press to move the cursor to the Comments field Add Edit Worklist Sample Identification Opr Sample ID Flagging Set Collect Date Time 04 19 2001 05 50 PM Comment Xp Panel CBC DIFF andaid Range r Patient Identification 8 5
243. n 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 Waste Handling Procedures and Replacing the Waste Container 1 10 PN 624021CA 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 5diff Diluent is clear and odorless Composed of stabilized saline solution containing an organic buffer and less than 0 1 sodium azide AC T 5diff Diluent Dilutes whole blood samples e Stabilizes cell membranes for accurate counting and sizing Conducts aperture current and 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 bdiff Fix Le Used to lyse erythrocytes fix leukocytes and differentially s
244. n the packaging PN 624021CA 1 USE AND FUNCTION REAGENTS Waste Handling Procedures LN 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 disposal Consult 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 gas which can build up pressure in a capped container 50mL 250mL Neutralize waste contents after removing the waste container and before capping it for disposal 1 For20L of waste liquid add the following to the waste container Sodium Hydroxide Sodium Hypochlorite 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 the waste container and firmly tighten the cap to prevent waste contents from escaping lt 1 12 624021 USE AND FUNCTION REAGENTS 3 Dispo
245. n 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 624021CA 2 21 2 OPERATION PRINCIPLES WORKLISTS 2 8 WORKLISTS Definition A Worklist is a list of samples to be processed The Worklist also includes the patient information demographics that you enter such as name age date of birth gender location physician and comments for each Sample ID If you want to add demographic information for a patient you must do so before the sample is analyzed The information that you enter is printed on the final report and transmitted to a host computer if available Note You cannot modify demographics received from a host computer For Worklist setup information see Heading 5 13 USING WORKLISTS Function The Worklist has two functions choosing a flagging set and storing patient demographics Duplicate Sample ID Check The database maintains records of all Sample IDs processed If an operator enters a Sample ID that has already been used but not yet archived a Duplicate Sample ID warning message will appear If your laboratory Sample ID sequence repeats it is necessary to clear the current memory of
246. ng bleaching procedure 11 6 draining procedure 11 34 location illustration 11 29 rinsing procedure 11 32 baths draining procedures DIFE 11 35 First Dilution 11 35 Rinse Bath 11 35 blank cycle definition GLOSSARY 1 blast cells description 2 21 Blasts triggering condition 9 29 bleaching See cleaning procedures blocked apertures removing blockage 11 32 bps definition ABBREVIATIONS 1 buttons software 5 29 C calculation BASO count 2 18 carryover 3 7 MCH 2 15 2 15 2 15 plateletcrit Pct 2 17 RDW 2 15 calibration auto calibration 10 3 definition GLOSSARY 1 manual 10 11 C 1 passing requirements 10 10 pre calibration checks 10 1 printing calibration factors 10 13 requirements 10 1 running cell controls to verify 7 1 setup procedures 10 3 verification out of limit what to do it 11 86 calibration factors definition GLOSSARY 1 calibrator definition GLOSSARY 1 recommended 1 9 3 2 carryover definition GLOSSARY 1 performance characteristics 3 9 performance specifications 3 7 category installation 3 1 caution definition 4 1 caution labels See labels CBC definition ABBREVIATIONS 1 CBC parameters excessive flagging what to do if 11 32 CBC DIFF parameters excessive flagging what to do if 11 32 CD ROM contents 5 22 how to use 5 22 minimum system requirements 5 22 using at a PC 5 22 cell control definition GLOSSARY 1 no pre assigning in Worklist 7 1 r
247. nsfer 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 for 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
248. nt Name The sequence number is instrument generated It resets to 1 when a new archive is created The fields sort alphanumerically by character For example 10 will appear before 4 because it is being sorted by the 1 Numbers appear in a sorted list before letters For example Sample ID 482 will appear before Sample ID N482 unless sorted in descending order 9 4 PN 624021CA DATA REVIEW 0 LOCATING SAMPLE RESULTS Do this procedure to sort results XE Cycles Diagnostics Setup 1 Ss inl du 7 LEE w OH 2l os the Results tab at the top and the Results tab at the bottom if necessary par aa 0172 Standard Range 08 CBC DIFF Standard Range 08 zl sr I 2 the title of the column you want sorted For example to sort by the Sample ID the Sample ID column title The information is sorted and displayed in ascending low to high order next to the title indicates ascending order and indicated descending order 3 Tosortthatsame column in descending order the column title again 4 To return the results list to its original order Default Sort PN 624021CA 9 5 DATA REVIEW AFTER LOCATING THE SAMPLE RESULTS 9 2 AFTER LOCATING THE SAMPLE RESULTS After locating a sample result you can view print transmit valida
249. nt to see The 10 most recent control runs will be displayed To view all runs double click the graph The WBC RBC HGB tab is the default displayed You may need to scroll to the right to see the tab you want 5 0 Ld on the graph to close the graph view 1 8 624021CA PN 624021CA Adding QC Result Comments QUALITY ASSURANCE RUNNING CELL CONTROLS Do this procedure to add comments to control results LN Ne 1 the Quality Assurance tab 2 the Controls tab abd 3 x scd ci xb zip 9 ve Worklist Pun Results QueliyAssurence Analyzer Logs Include Date Time wec msc mcr mcv f courRoL15 7 24 237 65 180 07 30 2004 09 54 AM 26 239 55 183 76 2 17 23 2004 08 46 AM 25 237 54 180 76 07 28 2004 02 16 26 239 55 182 76 0970572004 07 28 2004 08 56 AM 25 232 55 177 76 m Limit 04 012 04 15 4 Deta Diff 01 003 00 04 1 WBC RBC 7 HGB MCH MCHC ROW 7 PLT MPV NE 7 LY MO 7 EO BA NEW 7 MoN Eons gt Conr Data REC Control Data HOB Conr Data Controls 3 Highlight the row of the control result that requires comments Ele Cycles Diagnostics Setup apa 3j 2 1 od zio E zii 9 ve Worklist Run Results Quality Assurance AnalyzerLogs Include Date Time wec msc ncr mev CONTROL 15
250. ntered eod Physician If you do not enter the year an invalid Location date message appears ror wo 2 o fall el x 13 Press to move to the patient s gender field 14 15 Select the patient s gender 0 b Select gender c Press to move the cursor to the physician s name field Enter the physician s name up to 30 alphanumeric characters and spaces e manually enter the physician s name or ig and select the physician from the list if applicable Patient Identification 112760 Jane Doe PatientID Patient Name Date of Birth 08 11 1965 Age 35y Female N zl Physician Location X e Kal e X Patient Identification Patient ID 112760 Patient Name Date of Birth Age 35y Gender Female Physician Location Autonumbering 8 7 SAMPLE ANALYSIS RUNNING PATIENT SAMPLES USING THE WORKLIST 16 Press to move the cursor to the Location field 17 Enter the patients location up to 15 alphanumeric characters and spaces Patient Identification mm manually enter the location or Paani E Patient Name Doe E Age 35y Gender Female X bd PE 5 E E and select the location Physician Location from the existing list of locations Autonumbering if applicable F On z6 Mem 2 amp H x 18 EET
251. ntrol reproducibility and or calibration reports upon completion of analysis For information on enabling disabling autoprint for patient sample reports see Enabling Disabling Autoprint for Patient Sample Reports A ex 1 Setup gt gt Quality Assurance 2 the password and 0 vj PN 624021CA A 67 SETUP QUALITY ASSURANCE SETUP 3 the General tab if necessary ac cv Repro cv Cali Cv 5 E 2 Options Auto Pint 9Paam 00 Controls Calbeation IAP ID Con of COo CO Con of EN CN 3 amp 3 H x 07718 2004 11 43 17 AM 4 Atthe Auto Print field the button next to the desired option to enable disable as needed 5 v to save and exit the window Enabling Disabling XM Options XM 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 XM analysis can be set to monitor either three parameters or nine parameters Your laboratory must establish its own mean values Do this procedure to enable activate or disable deactivate the XM options e 3 Param monitors MCH and MCHC OParam monitors WBC MCV MCH MCHC RDW and PLT Off default A 68 PN 624021C
252. ntrol Plus For information on setting up controls see Setting Up a Control File Upload from Control Disk When the system analyzes the 5diff Control Plus control it processes the control in the same manner as a patient sample The neutrophil lymphocyte monocyte and eosinophil populations are derived from the flow cell The basophil population is derived from the WBC BASO bath The Workstation allows you to set up files to store control results for CBC and or CBC DIFF analysis Before you can store controls 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 You cannot preassign controls into the Worklist PN 624021CA 7 1 QUALITY ASSURANCE RUNNING CELL CONTROLS A Nec IMPORTANT Risk of erroneous results Do not analyze an expired control Always verify the control s expiration date including open vial stability before analysis 1 Enter the control ID in the Sample ID field zb pi gt wd i oe Manually type the reserved lot JE pum Ee esse pee number for the control as the ENS eum Sample ID at the Run screen EN 1 0 the Run tab FEE 2 Type the reserved lot number Bs pea for the control in the DENM Sample ID Next field sos f e Patt ID Nes ER le EGE El O
253. number before each analysis A Ner 1 Prepare the Workstation for sample processing a the Results tab b Verify that the active archive is open white background on Worklist and Results list If an old archive is open green background W File gt gt Close Archive c If according to your laboratory protocol it is time to create a new Su File New Archive Note You cannot create a new archive until any previously opened archive if any is closed PN 624021CA 8 3 SAMPLE ANALYSIS RUNNING PATIENT SAMPLES USING THE WORKLIST 2 E De S TY Mii agg i 3 Note If the Worklist is downloaded wee d Je dose d ton Quality Assurance Anelyzer Logs Sample Patient ID Patient Name Panel Date of Birth Age from a host computer the Sample ID ZEE CBC DIFF and patient demographics are automatically downloaded and cannot be edited 3 ap to open the Add Edit Worklist window For information on changing the starting number see Changing the Starting Number for Autonumbered Sample IDs 4 Verify that the Sample ID is correct Since autonumbering is on the Sample ID is automatically entered Semple Identifica To override the number with another Sample ID Sample ID Flagging Set 1 Highlight the number in the Sample ID field Comment PO 2 the desired Sample ID number 3 Press when the Sample ID is co
254. o de select 5 35 how to select 5 35 selecting deselecting 5 35 software text boxes 5 30 Fix reagent description 1 11 replacement procedure 11 63 fL definition GLOSSARY 1 flag hierarchy 9 32 Flag Sensitivity and Thresholds A 48 flagged sample results importance of verifying 9 14 flagging sets 3 3 flags definition 9 18 WBC defined 9 25 action range 9 28 ATL definition 9 16 9 19 9 24 BASO definition 9 25 CO definition 9 19 9 20 DB definition 9 16 9 19 9 20 definition 9 16 GLOSSARY 1 DIFF definition 9 16 DiffPlot 9 19 H amp H 9 18 H definition 9 28 hemoglobin hematocrit ratio 9 18 HH definition 9 28 hierarchy 9 32 HISTO definition 9 16 IMM definition 9 16 9 19 9 24 L definition 9 28 LL definition 9 28 LN definition 9 19 9 22 MACRO definition 9 26 MB definition 9 25 MIC definition 9 27 MICRO definition 9 26 MN definition 9 19 9 21 NE definition 9 19 9 23 NL definition 9 19 9 21 patient range 9 28 SCL definition 9 28 SL definition 9 19 9 20 SLI definition 9 19 9 21 types of 9 16 UM definition 9 19 9 22 UN definition 9 19 9 22 WBC BA definition 9 16 what triggers them 9 16 flow cell rinsing procedure 11 32 flow cell lamp replacement 11 75 fragility of WBCs 3 12 PN 624021CA PN 624021CA G 5 definition ABBREVIATIONS 1 gal definition ABBREVIATIONS 1 GR definition ABBREVIATIONS 1 grounding requirements 3
255. o move to the Patient Name field 12 Enter the patients name up to 30 alphanumeric characters and spaces and press to move to the date of birth field Patient Identification Patient ID Patient Name Date of Birth Gender Female Physician Location po Autonumbering i E l 9 8 alil el X 13 8 16 Enter the patients date of birth and press Tab The system automatically calculates the patient s age and populates the age field based on the date of birth you entered If you do not enter the year an invalid date message appears r Patient Identification Patient ID Patient Name Date of Birth Physician Location 12345 Apply D amp sp 2 x PN 624021CA SAMPLE ANALYSIS RUNNING PATIENT SAMPLES USING THE WORKLIST 14 Press to move to the patient s gender field 15 Select the patient s gender b Select the gender c Press to move the cursor to the physician s name field Patient Identification 112760 Jane Doe PatientID Patient Name Date of Birth 08 11 1965 Age 35y Female N zl Physician Location X Pa 2 8 l El o x 16 Enter the physician s name up to 30 alphanumeric characters and spaces e manually enter the physician s name or U zi and select the physician from the list if applicable
256. ocedure the reagent s may not be fully primed If an error occurs a Acknowledge and resolve the error b Do Heading 11 7 SYSTEM RESET CYCLE c Do Priming the Reagents to manually prime the reagent s PN 624021CA 11 71 DIAGNOSTICS REPLACEMENT PROCEDURES Priming the Reagents The function primes reagents into the instrument Do this procedure 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 A Nex File Cycles 81 Setup Help EVZGN 1 Diagnostics Operator EZEN gt 5diff Operator 2 the Diluter Systems tab Hardware Systems Drain Baths Rinse Cleaning Cycles Prime Reagents Ac T 5diff Operator Systems Diluter Systems Cycles 3 Prime Reagents Hardware Drain Baths Rinse Cleaning Cycles Prime Reagents s 4 0 the desired option The instrument primes the selected reagent s 11 72 624021CA DIAGNOSTICS REPLACEMENT PROCEDURES Replacing the Waste Container WARNING Risk of biohazardous condition if the waste sensor alarm battery is not promptly replaced when needed The waste sensor alarm uses a 9 V alkaline battery for operation The waste sensor unit will alert you that the battery needs to be replace
257. on Back View 11 31 11 7 Reagent Bottle Location 11 49 11 8 Waste Sensor Alarm Unit Location 11 73 1 Workstation Setup Report A 42 2 Sample Results Report Areas Defined A 63 xviii PN 624021CA PN 624021CA TABLES LI 1 2 1 3 2 1 pA 2 3 24 a3 2 6 E 2 8 29 EMI 3 2 3 3 34 3 5 3 6 3 7 3 8 3 10 3 11 3 12 5 1 5 2 9 1 9 2 9 3 Bu 95 9 6 9 7 9 8 9 9 9 10 9 11 9 12 9 13 IL ll 11 3 1 AJ A 3 1 B 2 CBC Parameters 1 7 CBC DIFF Parameters 1 8 Reagent Descriptions 1 11 AC T 5diff CP 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 Worklist Examples and Archive Frequency 2 22 Reagent Consumption by Cycle in mL 3 5 Reproducibility Specifications 3 6 Linearity Specifications 3 6 Accuracy Specifications 3 7 Carryover Specifications 3 7 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 Sample Stability Room Temperature 3 10 Sample Stability Cold Temperature 3 11 Interfering Substances 3 12 Softwa
258. onumbering should begin If your laboratory reuses Sample IDs see Heading 2 8 WORKLISTS for details about preventing duplicate Sample ID messages LN 1 the Worklist tab PN 624021CA SETUP A SYSTEM SETUP J Type the starting number bim Lo Apply 4 0 APPLY 0 26 Sample ID Autonumbering Disabling Do this procedure to disable deactivate autonumbering for the Sample IDs A 1 the Worklist tab Autonumbering 3 Autonumbering ON box until the a Apply check mark disappears PN 624021CA A 5 SETUP SYSTEM SETUP 4 APPLY t 26 Autonumbering is now deactivated which means that you either have to manually enter the Sample ID or scan Sample ID off the barcode Deleting Physician or Location Names Do this procedure to delete Physician and Location names Once deleted they will no longer appear in the drop down lists of the Add Edit Worklist screen but they will remain with stored patient results AN 0 Nex 1 Setup gt gt System 2 Typethe password and 0 A 6 PN 624021CA SETUP A SYSTEM SETUP 3 the Physician Location tab 3 al a gel 2 4 Select the name you want to delete It appears in the field above the list Note the Physician and Location names appear in alphabetical order PN 624021CA A 7 SETUP SYSTEM SETUP A 8
259. options selecting deselecting 5 35 overview 5 24 scrollable lists 5 31 tabs 5 29 tool bar 5 28 software cursor See cursor software fields See fields software menu See menu sorting sample results 9 4 specifications performance 3 6 specimen limitations 3 11 specimen collection 8 2 specimen mixing 8 2 specimen tube volume 8 2 Startup description 6 1 failure 11 86 procedure 6 1 what to do if it failed 6 1 startup cycle definition GLOSSARY 2 stat defined GLOSSARY 2 stat samples procedure for running 8 34 Worklist entries 8 34 statim See stat symbols safety xxiv tab xxiv syringes parking procedure 11 47 system power down procedure 5 7 power up procedure 5 1 preparing it for analysis 8 1 system cleaning procedure 11 16 when to do 11 16 SYSTEM ERROR RUN SYSTEM RESET CYCLE 11 85 system reset cycle description 11 21 when required 11 21 T TABLE OF EXPECTED RESULTS definition GLOSSARY 2 tabs manual dividers xxiv used in the software 5 29 temperature ambient operating range 3 2 instrument not achieved 11 86 TEMPERATURE OUT OF RANGE 11 85 thresholds A 48 A 80 description 2 4 Thrombocytopenia triggering condition 9 30 Thrombocytosis triggering condition 9 30 throughput 3 3 TIMEOUT OVERFLOW ON RS232 11 85 tool bar 5 28 transmit control results to host A 30 traverse assembly function 11 28 location 11 28 troubleshooting dilution problems 11
260. or alarms are Do Hardware Reset mechanical motors triggered operation Current cycle stops Incorrect Leaks or Reagent alarms are 1 Do Heading 11 7 SYSTEM RESET pneumatic blockages triggered CYCLE operation 2 Do Rinse Baths and Flow Cell Current cycle stops 3 Do Priming the Reagents 11 87 DIAGNOSTICS TROUBLESHO 11 88 OTING GUIDES Table 11 3 Troubleshooting Guide Continued Problem Area Situation Probable Cause Suggested Action Incorrect optical operation Defective optical parts Dirty optical parts Specific flags Hgb blank cycle measurements are outside acceptable limit 1 Do Heading 11 7 SYSTEM RESET CYCLE Do Rinse Baths and Flow Cell Do Priming the Reagents c Incorrect electrical operation Incorrect main supply voltage Instrument would not initialize Ensure correct voltage from power source means not applicable PN 624021CA DIAGNOSTICS SYSTEM LOGS l l 11 14 SYSTEM LOGS The number of entries stored by each log varies The Reagents Log stores up to 50 entries The Startup Log stores up to 50 entries The Error Log stores up to 100 entries The Calibration Log stores up to 50 entries The Maintenance Log stores up to 100 entries The Service Log stores up to 100 entries The Service password is required for viewing Prior entries to the log are deleted based on first in first out as the capac
261. orkstation Setup 9 Indicate from where the settings should be restored Ifyou want the settings to be restored from the hard drive From C Hard Drive Row Disk xl Hard Drive then Ifyou want the settings to be restored from a floppy disk 1 Insert the disk into drive A Printing Analyzer Configuration Settings Do this procedure to print the current Analyzer configuration settings LN 2 Nes File Cycles Diagnostics 9 Help S m Patients 1 Setup gt gt System UUJ B Quality Assurance PN 624021CA SETUP A SYSTEM SETUP 2 Typethe password and 0 7 Config Seve Restor ent Workstatid Setup 3 Config Save Restore tab 3 2 D H ela 07 16 2004 02 38 37 PM 4 Print in Current Analyzer Setup area bete neta Oya Optic init Aaa Save Restore Language A detailed report on the Analyzer s settings is printed Seve Save je mil Restore Print 9 Keep the printout for your records At installation the Beckman Coulter representative gave you a copy of the printout based on the settings at the time of installation A 35 PN 624021CA SETUP SYSTEM SETUP Saving Workstation Configuration Settings This procedure allows you to save the Workstation s current configuration settings to the Workstation s hard drive or to a flopp
262. oubleshooting Guide Continued Problem Area Situation Probable Cause DIAGNOSTICS TROUBLESHOOTING GUIDES 11 Suggested Action Dilution Traverse motion Motor problem 1 Dothe appropriate motor test 2 fthe problem persists contact a Beckman Coulter representative Sample Pneumatic syringe Analyze a sample and check that specimen distribution problem is correctly distributed into the baths See Aspiration Drain and rinse Pneumatic syringe 1 Drain the baths See Draining the problem Baths and or the Diluent Reservoir 2 Rinse the baths See Rinse Baths and Flow Cell 3 Ifthe problem persists contact Beckman Coulter representative Results Poor Bent sampling probe Contact a Beckman Coulter representative reproducibility No parameter Bent sampling probe Contact a Beckman Coulter representative results No sample aspiration Reagent problem Excessive Collection and or Contact a Beckman Coulter representative flagging mixing problem with sample Reagent problem Printer Printer does not Printer may be turned Turn the printer on work off Printer may not be Refer to the printer user s manual setup or connected properly Reagents Level low Not enough reagent in Do Changing Reagents the bottle container Waste sensor Waste container is full Do Replacing the Waste Container alarm beeps Waste sensor battery Replace the battery is low Incorrect Defective stepper Mot
263. ount The presence of excessive eosinophils metamyelocytes myelocytes promyelocytes blasts and plasma cells may interfere with an accurate neutrophil count LY LY The lymphocyte 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 cell count absolute is derived from the WBC count The presence 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 PN 624021CA PN 624021CA SPECIFICATIONS CHARACTERISTICS INTERFERING SUBSTANCES Table 3 12 Interfering Substances Continued Parameter Interfering Substance E0 The eosinophil 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 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
264. pickup tube assemblies from their containers including Diluent 4 Place all reagent pickup tube assemblies in the chlorine solution 9 Prime all reagents as instructed in Priming the Reagents Chlorine solution will now be pulled into the instrument through the reagent pickup tubes PN 624021CA 11 17 11 DIAGNOSTICS CLEANING PROCEDURES 11 18 When priming is complete remove the reagent pickup tube assemblies from the chlorine solution and wrap the tubes in absorbent paper Prime all reagents as instructed in Priming the Reagents The chlorine solution will now be drained from the system Place the container with the distilled water in front of the reagent compartment Place all pickup tube assemblies into the container 0 10 Prime all reagents as instructed Priming the Reagents The distilled water will now be pulled in to rinse the system 11 Run a blank cycle PN 624021CA PN 624021CA DIAGNOSTICS CLEANING PROCEDURES 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 11 19 11 DIAGNOSTICS CLEANING PR 11 20 OCEDURES 16 Place the reagent containers in their respective locations 17 Prime all reagents as instructed in Primin
265. ple ID sample without a Sample ID 2 Analyze the sample System Error Run System Reset Cycle During a cycle a system error of the following type has caused the system to stop A motor has not returned to its home sensor when expected Adrain problem has been detected at one of the two drain sensors The right side door has been opened during a cycle losing temperature control at the baths A mechanical problem Do Heading 11 7 SYSTEM RESET CYCLE 2 fthe problem persists note the error message and contact a Beckman Coulter representative Temperature Out Of The temperature in the counting k Ensure the sure right side door is Range bath compartment is outside of closed the acceptable range 2 Wait a few minutes 3 Ifthe problem persists contact a Beckman Coulter representative Timeout Overflow On There is a problem with the Verify that the protocol set up in the host Rs232 communication or handshaking to transmission screen matches the the host computer protocol expected by the host computer Tube Holder Not Open Cap Pierce Door sticking e Check for obstructions or mis adjusted obstructed or defective interference with door Dothe OPENING THE TUBE HOLDER DOOR IF JAMMED procedure PN 624021CA 11 85 DIAGNOSTICS TROUBLESHOOTING GUIDES 11 13 TROUBLESHOOTING GUIDES Troubleshoot instrument problems by using Table 11 3 Table
266. porting unit format for each parameter For example if you selected SI 3 the SI 3 reporting units are displayed o0 107121 onc TTE oR amp to save and exit the window A 10 0 to confirm that you will be automatically logged out Parameter Selection PN 624021CA SETUP SYSTEM SETUP 7 Wait while the systems logs out 8 Login again a When the Begin Logon box appears simultaneously press ctrl at Delete b Type User name and press rab c Type Password 123 d Press Or OK 9 Wait for the Analyzer connection to be established 10 Resume normal operation Setting the Date Time Changing the Date A e Nec 1 Setup gt gt System PN 624021CA 11 SETUP SYSTEM SETUP A 12 N Type the password and 0 hi the Date Time tab Change Date Time Select the current date a b C Select the month Select the year Select the day Date Time Properties Date amp Time Time Zone l Date Time mew 3 P puc Po ve 12 3 4 456 7 E 3 10 7 11 12 13 14 15 16 17 m s 18 19 20 21 22 23 24 5 25 26 27 28 29 30 31 1 05 20PM Current time zone Eastern Standard Time PN 624021CA SETUP A SYSTEM SETUP 6 U v to save and exit the window OR APPLY then U OK to save and remain at this window to chan
267. pretive displayed and message Atypical printed as Lymphocyte are ATL and Absorbance triggered from the 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 127 regions section of the 5 flag is Flags and 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 9 24 PN 624021CA DATA REVIEW REVIEWING FLAGGED RESULTS 9 WBC Baso Histogram Flags and Analytical Alarms See Table 9 2 Table 9 2 WBC Histogram Flags Histogram Flag Illustrations of Histogram Flags Description WBC BASO WBC Figure 9 3 WBC BASO Histogram Flags Determined from the ratio of the cells CBC Panel counted between the 0 channel and Indicates the presence of an abnormal number of cells in comparison to leukocytes Plt aggregates 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 Figure 9 4 WBC BASO
268. procedure Ifthe system has been idle between 2 and 4 hours Ifthe Analyzer has been turned off then on again LN 2 Nex 1 U Cycles gt Mini Prime Note You can also access Mini Prime from within the Operator Diagnostics options W Diagnostics gt gt Operator ig the Diluter Systems tab J the Cleaning Cycles tab W Mini Prime 2 Allow the Mini Prime to finish about 2 minutes 3 Cycle a sample with known results to verify instrument performance 4 Resume normal operation 11 22 624021 DIAGNOSTICS REPLACING THE RINSE BATH DRAIN FILTER 11 8 REPLACING THE RINSE BATH DRAIN FILTER Purpose Do this procedure when instructed by a Beckman Coulter representative Tools Supplies Needed door key filter assembly Note For any part that you use from your spare parts kit be sure to record the part number for reordering Procedure AROS Power down the system as instructed in Power Down the System in Chapter 5 2 Disconnect the power cord from the back of the analyzer PN 624021CA 11 23 DIAGNOSTICS REPLACING THE RINSE BATH DRAIN FILTER 3 Open the right side door a Use the door key to loosen the two screws on the right side door b Swing open the door 4 Locate the filter between the rinse bath and valve 27 11 24 624021CA DIAGNOSTICS REPLACING THE RINSE BATH DRAIN FILTER IMPORTAN
269. procedures in e NCCLS publication H4 A3 for capillary e NCCLS publication H3 A3 for venipuncture Beckman Coulter recommends the use of tripotassium EDTA Dipotassium EDTA is a suitable alternative IMPORTANT Risk of erroneous results if the specimen tube is not filled to the quantity required When collecting samples venous and capillary always follow the manufacturer s recommended procedures and fill volumes IMPORTANT Risk of erroneous results if sample is not properly mixed before analysis Mix the blood specimen gently and thoroughly before analysis according to the tube manufacturer s recommendations and your laboratory protocol PN 624021CA SAMPLE ANALYSIS 8 RUNNING PATIENT SAMPLES USING THE WORKLIST 8 4 RUNNING PATIENT SAMPLES USING THE WORKLIST This procedure provides details on how to run samples using the Worklist Forrunning Worklist samples with autonumbering on see Running Worklist Samples Autonumbering On e For running Worklist samples with autonumbering off see Running Worklist Samples Autonumbering Off 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 Running Worklist Samples Autonumbering On If your instrument is configured to the Autonumbering ID mode the instrument automatically assigns a sample ID from 1 to 999999 and increments the
270. r Must Log Out 6 Login again to the Workstation and resume normal operation Database Compacting The database can store 10 000 results To optimize performance the system compacts the database each time you log in After 10 000 results have been stored at the next login the system automatically deletes the oldest results to reduce the database to 9 500 and allow additional results to be saved PN 624021CA E 7 WORKSTATION MANAGEMENT DATABASE MANAGEMENT E 8 PN 624021CA REFERENCES MEN LIST OF REFERENCES 1 PN 624021CA Coulter WH High speed automatic blood cell counter and cell size analyzer Paper presented at National Electronics Conference Chicago IL 1956 October 3 Webster s ninth new collegiate dictionary Merriam Webster Springfield MA 1989 Stedman medical dictionary 21st edition Williams amp Wilkins Baltimore MD 1966 NCCLS document H4 A3 Procedures for the collection of diagnostic blood specimens by skin puncture National Committee for Clinical Laboratory Standards Villanova PA 1991 NCCLS document H3 A3 Procedures for the collection of diagnostic blood specimens by venipuncture National Committee for Clinical Laboratory Standards Villanova PA 1991 REFERENCES 1 REFERENCES REFERENCES 2 624021CA 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
271. r detects only forward scattered light The optical measurement 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 Debris gt Absorbance 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 detec
272. r laboratory name in the Header 1 field Note You can type up to 25 alphanumeric characters and spaces in each header field b Type the remainder of your laboratory s information in the Header 2 through Header 6 fields 9 Save the changes D to save and exit from the window OR El to save and remain at this window to continue setting up the Patient report PN 624021CA A 57 SETUP PATIENT SETUP Enabling Disabling Autoprint for Patient Sample Reports Do this procedure to enable activate or disable deactivate the Autoprint feature that automatically prints patient sample reports upon completion of analysis The autoprint feature when selected allows the system to automatically print reports that you select For information on enabling disabling autoprint for controls reproducibility and calibration see Enabling Disabling Autoprint for Controls Reproducibility and Calibration LN Ne 1 Setup gt Patients 2 the password and 3 the Reports tab Header Header 3 Header 4 Header 6 folCopy ReportFormat Printed Parameters Option 1 of ids 3 wec 4 NE NER panis lY P 2 2 Range C Normals z E0 E EOF 2 emm 2 BA FEBR Abnomels ABC DECRE Detailed Fi F ae HGB E HCT RW F E DifploThresholds len E Histogram Thresholds Iv PLT y E Raw V
273. r resets the traverse assembly to its home position Sampling Syringe Test Traverse Do this procedure to test the sampling syringe motor and reset the sampling syringe to its home position A Nex Diagnostics gt gt Operator 5diff File D Ny Help 2 U the Hardware Systems tab 5diff Operator Hardwerp Systems Dituter Systems Cycles Reset Hardware Motors Valves Tre 11 39 DIAGNOSTICS SYSTEM TROUBLESHOOTING PROCEDURES 5diff Operator Hardware Systems Dituter Systems Cycles 3 the Motors tab Reset Hardware Valves T 4 Sampling Syringe Sampling Syringe The instrument exercises the sampling syringe motor and resets the syringe to its home position Draining Syringe Test Do this procedure to test the draining syringe motor and reset the draining syringe to its home position LN S Nel File D Ny Help Diagnostics gt gt Operator 59 Operator 2 the Hardware Systems tab Hardwerp Systems Dituter Systems Cycles Reset Hardware Motors Valves Tn 11 40 PN 624021CA PN 624021CA DIAGNOSTICS SYSTEM TROUBLESHOOTING PROCEDURES 11 3 the Motors tab 5diff Operator Hardware Systems Dituter Systems Cycles Reset Hardware Valves T 4 Draining Syringe The instrument exercises the draining syringe motor and res
274. rd Deviation SD CV WBC 10 5 0 14 1 32 RBC 4 74 0 04 0 88 Hgb 14 5 0 08 0 56 Hct 42 8 0 43 0 99 MCV 90 0 30 0 32 PIt 310 7 8 2 52 NE 50 2 0 46 0 90 LY 41 0 0 43 1 04 MO 3 9 0 18 4 60 E0 3 5 0 18 5 14 BA 1 3 0 09 6 96 Accuracy Accuracy Table 3 8 for the CBC and DIFF parameters was defined as agreement between the comparator instrument and the 5diff CP analyzer using normal and clinical specimens less than eight hours old covering the expected range of performance Table 3 8 Accuracy Characteristics Parameter Correlation WBC 0 99 RBC 0 99 Hgb 0 99 Hct 0 99 Plt 0 99 NE 0 99 LY 0 99 MO 0 96 E0 0 98 PN 624021CA Carryover SPECIFICATIONS CHARACTERISTICS PERFORMANCE CHARACTERISTICS 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 Low 3 Carryover High i Low3 x 100 Table 3 9 Carryover Characteristics Parameter Units High Level Low Level Carryover WBC 103 uL 73 4 0 90 0 09 106 uL 7 20 1 69 0 66 PIt 103 uL 822 35 0 0 04 Hgb g dL 20 7 4 83 0 21 PN 624021CA 3 9 SPECIFICATIONS CHARACTERISTICS PERFORMANCE CHARACTERISTICS Sample Stability The following tables show the average results for specimens from five normal donors collected in K3EDTA The
275. re Icons 5 37 Pre Defined Flagging Sets 5 40 Definition of DIFF Flags 9 20 WBC Histogram Flags 9 25 RBC Histogram Flags 9 26 Plt Histogram Flags and Analytical Alarms 9 27 Patient Range and Action Range Flags 9 28 WBC Interpretive Messages from Action Ranges 9 29 WEC Interpretive Messages from DiffPlot 9 29 RBC Interpretive Messages from Action Ranges 9 30 RBC Interpretive Messages from Flag Sensitivity 9 30 Plt Interpretive Messages from Action Ranges 9 30 Plt Interpretive Messages from the Plt Histogram 9 30 Interpretive Messages from a Combination of WBC RBC Plt Action Ranges 9 31 NRBCs and PLATELET AGGREGATES Interpretive Messages 9 31 Maintenance Schedule 11 1 Error Messages 11 81 Troubleshooting Guide 11 86 Instrument Default Settings A 1 Reporting Unit Format A 8 Daily Workload Runs per Panel A 18 Default Barcode Settings B 2 Test Labels With the Check Digit Checksum B 3 xix XX B 3 BA B 5 B 6 B 7 1 Test Labels Without the Check Digit B 3 Barcode Scanner Configuration Sheet B 4 Code 39 Barcode Scanner Options B 5 Codabar Barcode Scanner Options B 6 Interleaved 2 of 5 Options With Fixed Length Characters Test Labels B 7 Specimen Tubes for Use with the Tube Holders D 1 PN 624021CA INTRODUCTION mE OVERVIEW This introductory section contains the following topics e USING YOUR 5diff CP HEMATOLOGY ANALYZER OPERATOR S GUIDE e ABOUT THIS MANUAL
276. remove the chlorine solution that you dispensed in step 7 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 75 75 is the default See Changing the Auto Clean Frequency Setting Shutdown At the end of each day do Shutdown to cleanse the instrument shut down the computer and power off the analyzer and PC See Heading 6 4 SHUTDOWN for the procedure 624021 11 9 DIAGNOSTICS CLEANING PROCEDURES Cleaning the Baths and Lower Rinse Block Do this procedure as needed Tools Supplies Needed 25mL of a 196 to 2 chlorine solution produced from high quality fragrance free gel free bleach 5 to 696 solution of sodium hypochlorite available chlorine gt Ifusing 4 high quality fragrance free sodium hypochlorite dilute with an equal part of distilled water gt Ifusing 1096 to 1296 high quality fragrance free sodium hypochlorite dilute by adding 10 parts distilled water to 1 part of the sodium hypochlorite Lint free wipes Fabric tipped applicators Note The Extended Cleaning Procedure must be performed after this procedure AATAS 1 Power down the system as instructed in Power Down the System in Chapter 5 2 Disconnect the power cord from the back of the analyzer 3 Open the right side door a Use the door key to loosen the two screws on the right side door
277. ringes E 4 0 OK Run The traverse assembly is set to the service position Parking the Syringes Do this procedure to park the syringes LN amp Ne 1 Diagnostics Operator 5diff Operator 2 the Hardware Systems tab Hardwerp Systems Dituter Systems Cycles Reset Hardware Motors Valves Tr PN 624021CA 11 47 DIAGNOSTICS SYSTEM TROUBLESHOOTING PROCEDURES 3 the Park Syringes tab cR a Oan The syringes are parked 11 48 PN 624021CA DIAGNOSTICS REPLACEMENT PROCEDURES 11 11 REPLACEMENT PROCEDURES Changing Reagents If the instrument determines that there is insufficient reagent to complete the daily workload Reagent s Low Insufficient Reagents To Complete Daily Worhload appears after Startup Specific reagent low messages appear for each reagent when applicable For details about daily workload see Changing the Daily Workload Replace the reagent as instructed in e Changing One Reagent Fix WBC Lyse Hgb Lyse or Rinse Reagents Changing the Diluent Reagent or Changing Reagents Figure 11 7 shows the reagent bottles containers Figure 11 7 Reagent Bottle Location 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 unacceptabl
278. s defined for VRBCS or PLATELET AGGREGATES occur and WBC or SL1 or WBC Voteout occur PN 624021CA 9 31 9 DATA REVIEW FLAG HIERARCHY 9 4 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 If a V 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 second and third field Here are some examples 10 3 V 5 6 L 35 0 VHH 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 lt Patient Action Flags Hierarchy Patient Limits and Action Limits are ranked in the following descending order of importance HH LL H L 9 5 IRREGULAR SAMPLE RESULTS Erroneous results may occur if the sample is not adequately mixed before analysis Inadequate mixing may cause either of the following typical patterns of results when compared to the expected results increase RBC and Hgb a
279. s results if sample is not properly mixed before analysis Mix the blood specimen gently and thoroughly before analysis according to the tube manufacturer s recommendations and your laboratory protocol Mix the specimen gently and thoroughly 8 If the specimen tube does not have a pierceable stopper remove the stopper 9 verify that the Sample ID in the Sample ID Next field matches the sample to be processed 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 31 8 SAMPLE ANALYSIS RUNNING PATIENT SAMPLES WITHOUT USING THE WORKLIST 10 Insert the tube into the correct position of the correct tube holder 11 Close the tube holder door to begin analysis IMPORTANT Do not log out of the Workstation while the Analyzer is running a cycle Logging out during an Analyzer cycle will cause problems with the Analyzer Workstation communication 12 Remove the tube when the tube holder door automatically opens after aspiration The red LED is still illuminated which means the Analyzer is busy processing the sample 8 32 PN 624021CA PN 624021CA RUNNING PATIENT SAMPLES WITHOUT USING THE WORKLIST SAMPLE ANALYSIS 13 Wait for the green LED to illuminate which indicates the system is ready for the next sample Information for the next sample to be processed is displayed on the
280. se of the waste container according to your laboratory s guidelines Handling Expired Reagents Do this procedure to eliminate cyanides from expired 5diff Hgb Lyse 1 For of reagent add a 5O0mL of Sodium Hydroxide e solution 200g L soni b 100mL of freshly prepared Ammonium Persulfate solution 500g L or 50mL of Sodium Hydroxide solution 500g L o QM c 500mL of Sodium Hypochlorite m ies solution 3096 available chlorine 5 500mL Sodium Hypochlorite 1L 7650043A 2 Dispose of expired reagents according to your laboratory guidelines 624021 1 13 50mL Sodium Hydroxide 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 AC T 5diff CP analyzer 1 On the Internet go to www beckmancoulter com Select MSDS from the Customer Support drop down menu b Follow the instructions on the screen c Contact you Beckman Coulter representative if you have difficulty locating the information 2 Ifyou do not have Internet access 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 Outside the USA contact a Beckman Coulter representative 1 14 PN 624021CA OPERATION PRINCIPLES 2 1 OVERVIEW
281. se while the system is busy attempting to restore the database Restore Database Bath Enclosure Door Opened If a cycle is attempted while the right side door is open this 1 Close the door 2 Do Heading 11 7 SYSTEM RESET message is generated CYCLE Calibration Failed Cal Attempt was made to save Contact a Beckman Coulter Factor Out Of Range calibration factors but one or representative more of the factors are out of range PN 624021CA 11 81 DIAGNOSTICS SYSTEM ERRORS 11 82 Table 11 2 Error Messages Continued Message Probable Cause Suggested Action Cannot Add A Patient Attempt was made to add a patient None A patient name cannot be added to Name To Results With A name to a result with an existing a result with an existing Patient ID Patient ID Patient ID Cannot Add A Patient Attempt was made to add a patient None A patient name cannot be added to Name To Results With name to a result with an existing a result with an existing patient name An Existing Patient patient name Name Could Not Connect To Workstation software failed to 1 Verify proper cable connection Analyzer automatically connect to the between the Analyzer and Analyzer Workstation 2 Verify that the Analyzer is on 3 Verify that you followed the correct Power Up sequence Data Not Saved Value Out Of Range The results are unacceptable values They may be out of an expected rang
282. sits Pay particular attention to the sampling probe area Clean up spills promptly PN 624021CA 11 5 DIAGNOSTICS CLEANING PROCEDURES Cleaning the Inside of the Instrument AATAS If corrosive deposits are evident clean the inside of the instrument with a damp cloth and distilled water Be careful not to wipe contaminants into the baths Extended Cleaning Procedure Do this procedure to clean the baths with a 1 to 2 solution of sodium hypochlorite e Ifyou suspect a clog or fibrin e After doing the Cleaning the Baths and Lower Rinse Block procedure When directed by a Beckman Coulter representative Supplies needed One 5mL syringe 50mL ofa 1 to 2 chlorine solution produced from high quality fragrance free gel free bleach 5 to 696 solution of sodium hypochlorite available chlorine LN 1 Prepare a 196 to 296 chlorine solution using high quality fragrance free gel free bleach 5 to 696 solution of sodium hypochlorite available 500mL chlorine For example e Ifusing 4 bleach dilute with an equal part of distilled water Ifusing 10 to 12 bleach dilute by adding 10 parts distilled water to 1 part of the 10 to 12 high quality fragrance free sodium hypochlorite 11 6 PN 624021CA DIAGNOSTICS CLEANING PROCEDURES 2 Cycles gt Extended Cleaning Note You can also access Extended Cleaning through the Operator Diagnostics options W Diagnostics gt Operator t
283. st Poikilocytosis Eosinophils Atyp Lymph Microcytosis Basophils NRBC s Macrocytosis Comment Requested by Reviewed by For Research Use Only Not for use in diagnostic procedures RUO Out of Action Range Out of Patient Range XXX Printed 14 03 2001 11 08 10 AM Date of analysis PN 624021CA Range Area 1 of the report Time of analysis D Date time specimen was collected Area 2 of the report Patient information Physician Area 3 of the report p Flagging set p Location Q Header Parameter D Startup status Sample ID Result p Flags Messages area for other available flagging information Q Sequence number B Reporting unit Flags o 63 SETUP PATIENT SETUP Selecting the Patient Sample Report Printout Features Do this procedure to select the patient sample report printout features such as range messages e detailed flags e diffplot thresholds histogram thresholds and raw values typically used only for troubleshooting LN Ne File Cycles Diagnostics aa ii 1 System Setup gt gt Patients 2 the password and 3 the Reports tab t Reports Headers Header 1 Header 3 Header 6 _ of Copy Report Format p Printed Parameters Header 4 Auto Print a ot NE CAN Lv 2 2 Normals 0
284. st tab Ac T Sdiff jus Rene CualtyAssurancs Sample I Patient ID Palient Name Panel Date of Birth Age gt CBC DIFF CBC DIFF CBC DIFF Analyzer Logs t e Enter the Sample ID up to 16 alphanumeric characters and no spaces by manually entering the ID or by scanning the barcode if applicable Note If you try to enter more than 16 characters an audible alarm sounds ATTENTION Sample analysis will not occur without a valid Sample ID Add Edit Worklist r Sample Identificati Opr Sample ID Flagging Set Collect Date Time Comment Patient Identification PN 624021CA Press to move the cursor to the Panel field 5 43 GETTING STARTED USING WORKLISTS 9 Select the panel CBC or CBC DIFF Add Edit Worklist iL gt a r Sample Identification Opr Admin b Select CBC or CBC DIFF Sample ID 2345 Press to move the cursor to 2255 the Flagging Set field Collect Date Time Comment Patient Identification 6 Select the flagging set Sample Identification Kil gt Opr Panel CBC DIFF b Select the desired flagging set Sample ID Flagging Set Cc Press to move the cursor to the Collection Date and Time field If you manually select a flagging set that flagging set will be applied Coll
285. stograms and DiffPlots and manually entered autonumbered or barcoded patient sample identification 1 8 PN 624021CA USE AND FUNCTION REPORTS 1 6 REPORTS Sample result reports are printed based on your instrument setup See Setting Up the Patient Report for details For instructions on how to use the printer refer to the printers instruction manual In addition to sample reports the instrument also generates other reports such as e worklist reports results list reports control reports including Levey Jennings reproducibility reports calibration reports e reports including Levey Jennings and e log reports 1 7 QUALITY ASSURANCE CONTROLS CALIBRATORS AND IQAP 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 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 For information on determining laboratory procedures you can purchase the Physician s Office Laboratory Guideline POL2 T from the National Committee for
286. t configuration information Table A 1 Instrument Default Settings Feature Default Settings To Change the Setting Date format MM DD YYYY Do Changing the Date Format Time format AM PM Do Changing the Time Reporting unit US Do Changing the Reporting Unit Language ENGLISH Do Selecting a Language Sample ID mode Manual ID Do Sample ID Autonumbering Disabling Enable ATL IMM PCT and PDW NO Do Enabling Disabling RUO Research Use Only Parameters Autoclean frequency 75 Do Changing the Auto Clean Frequency Setting Automatic Startup Enabled Do Enabling Disabling Automatic Startup Daily workload CBC 10 Do Changing the Daily Workload CBC DIFF 40 Changes to Instrument Setup Any time you change the instrument setup print a setup report for your records See Analyzer and Workstation Configuration Settings for details PN 624021CA A 1 SETUP SYSTEM SETUP A 3 SYSTEM SETUP Activating Autonumbering and Setting The Starting Number Before you analyze a sample a sample ID is required You can manually enter the sample ID scan the barcode ID from the sample tube using the optional barcode reader or have the instrument automatically assign auto number the sample ID Ifyou do not enable the autonumbering feature you are required to manually type or scan a Sample ID before running the sample Ifyou enable the autonumbering feature the Sample ID number is automatically incr
287. t shifting populations PN 624021CA 2 4 2 5 PN 624021CA 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 um 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 BASO SAMPLE ANALYSIS OVERVIEW 0 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 A eT 5diff CP 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
288. t the Include box is checked for each result you want to transmit 0 98 Note To determine whether Auto Transmit is set to On or Off for control results see Defining Results Autotransmission Settings Displaying Levey Jennings Control Graphs Do this procedure to display the Levey Jennings Control Graphs AN Ne 1 the Quality Assurance tab 624021CA 7 7 QUALITY ASSURANCE Ele Cycles Diagnostics Setup Heb 2 the Controls tab 3 2910 221 RI ZI v ve Norklist Pun Resu s QualityAssurance AnaiyzerLogs Include Date Time mec mes mcr mcv rj CONTROL 15 CBC DIFF 2 08 02 2004 09 47 24 237 55 180 76 E 07 30 2004 0954 AM 26 238 55 183 76 07 29 2004 06 46 AM 26 23 54 180 76 2 07 28 2004 0216 26 23 65 182 76 LIML 3 07 28 2004 08 56 AM 25 232 65 177 x SET N 8 8 8 8 8 Mean 25 2 35 65 18 0 76 Add Comment 250 014 0 05 009 042 065 xcv 287 103 067 118 043 Target 26 238 65 184 7 ERN Limit 04 012 04 15 4 Deta Diff 01 003 00 04 1 WBC HGB MCV MCH MCHC RDW PLT MPV NE 7 LY MO 7 EO 7 BA NER 7 LY WOW Eons gt WBC Control Data Daa HOB Corer Data Conros 3 Select the control file to be reviewed a at Select Control b the desired control 4 the tab that represents the Levey Jennings control graph that you wa
289. t to delete If you want to erase all rows you do not have to select them there is an Erase all row option you can choose E D ATTENTION Control data cannot be recovered once it has been deleted Therefore be certain that Erase Selected TOW you want to delete erase the control data before Erase Unselected row you proceed Erase All row 5 the desired erase delete option The selected control data will be erased 7 16 PN 624021CA SAMPLE ANALYSIS ra 8 1 OVERVIEW This chapter provides information on running patient samples with and without using the Worklist Ifyou want to run sample using the Worklist do Heading 8 4 RUNNING PATIENT SAMPLES USING THE WORKLIST e Ifyou want to run samples without using the Worklist do Heading 8 5 RUNNING PATIENT SAMPLES WITHOUT USING THE WORKLIST 8 2 PREPARE THE SYSTEM FOR PROCESSING 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 Prime to prepare the Analyzer It is not necessary to do both LN If the system has remained idle for a certain period of time the system will prompt you to do a Startup or a Mini Prime PN 624021CA 8 1 SPECIMEN COLLECTION AND MIXING SAMPLE ANALYSIS 8 3 8 2 SPECIMEN COLLECTION AND MIXING A e Nec Collect whole blood in a salt of EDTA according to tube manufacturer s instructions and
290. tain granules of monocytes neutrophils and eosinophils ACT 5diff Fix is a deep blue aqueous solution that smells like alcohol ACT 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 to 25 C up to the expiration date indicated on the packaging ACT Sdiff WBC Lyse 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 bdiff Hgb Lyse Used to lyse blood cells and to determine hemoglobin concentration ACsT 5diff Hgb Lyse is a clear aqueous solution and is composed of potassium cyanide at 0 035 and a quarternary 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 bdiff Rinse UL Used as a rinsing agent AC T 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 o
291. te The progress indicator in the status bar indicates the progress Ifthe IQAP ID is not valid the following message appears Invalid IQAP number IQAP number must be entered before download can occur iJ 2 Verify that the correct IQAP ID was entered into the system See Setting Up the IQAP ID 3 Repeat steps 1 through 6 7 Allow the IQAP download to be completed Wait for a popup window that displays the message Download completed Remove diskette 8 then remove the diskette Download completed Remove diskette 9 Apply a label provided by Beckman Coulters IQAP department to the diskette The label identifies the owner of the submission in case the disk becomes corrupted 10 Insert the diskette into a return mailer and mail it to Beckman Coulter s IQAP department 1 15 7 QUALITY ASSURANCE DELETING CONTROL FILES 7 3 DELETING CONTROL FILES IMPORTANT Risk of failure to print and or transmit all requested results Do not delete result s until printing and or transmitting are complete Allow all results to complete printing and or transmitting before using the delete function Do this procedure to delete one or more control files 1 Ensure that you have control summary data to fulfill your regulatory requirements prior to deleting control files Once a control file is deleted the control information is gone and cannot be recovered 2 the Quality Assurance tab 3 Select or deselect the rows you wan
292. te or delete results Viewing Sample Results LN Nec 1 Select the sample you want to view 2 Toview numeric tabular sample results scroll right 3 Toview detailed results e Double click the desired result OR o to view the details The data is displayed as it was on the Run screen with results and DiffPlots 4 Toreview previous and next results lt for the previous result 0 2 for the next result 5 Toreturn to the results list o 9 6 624021 DATA REVIEW AFTER LOCATING THE SAMPLE RESULTS 9 Printing Sample Results You can print a single sample result or batch print a group of sample results Printing a Single Sample Result LN 1 Select the sample result you want to print 2 E 8 to display the print menu 3 Select the desired print format To print only numeric results Print Summary List Selected Rows To print the Run view of results and DiffPlots 0 Print Patient Report For Selected Rows PN 624021CA 9 7 DATA REVIEW AFTER LOCATING THE SAMPLE RESULTS Printing a Batch of 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 autotransmit on and autoprint on Always allow sample analysis and or the host download to complete before batch printing
293. ter Flags Outside Patient Limits Outside Action Limits 5 Control Results select On if you want to autotransmit control results to the host Only available for software version 2 00 and above 6 v to save and exit the window A 30 624021CA SETUP A SYSTEM SETUP Analyzer and Workstation Configuration Settings In addition to restoring Analyzer and Workstation configuration settings from a saved copy you can save and print current Analyzer and Workstation settings Saving Analyzer Configuration Settings This procedure allows you to save the Analyzer current configuration settings to the Workstation s hard drive or to a floppy disk You can restore saved settings if necessary The Beckman Coulter representative performs this procedure at installation Do this procedure if you change the Analyzers configuration File Cycles Diagnostics 7 Help im Patients Quality Assurance 1 Setup gt gt System 2 the password and 3 Config Save Restore tab 3 2 D H ela 07 16 2004 02 38 37 PM 624021 31 SETUP SYSTEM SETUP A 32 4 Save in Current Analyzer Setup area _ Config Seve Restore Current Workstation Setup 9 Indicate where the settings should be saved Ifyou want the settings to be saved to the hard drive Hard Drive then P Beckman Coulter recom
294. th Recommended Reagents Beckman Coulter recommends these reagents ACeT 5diff Diluent ACeT 5diff Fix 5diff WBC Lyse ACeT 5diff Hgb Lyse and ACeT 5diff Rinse See Heading 1 8 REAGENTS for additional information about these reagents Recommended Controls ACeT 5diff Control Plus is the recommended control See Heading 1 7 QUALITY ASSURANCE CONTROLS CALIBRATORS AND IQAP for additional information Recommended Calibrator ACeT 5diff Cal Calibrator is the recommended calibrator See Heading 1 7 QUALITY ASSURANCE CONTROLS CALIBRATORS AND IQAP for additional information Recommended Anticoagulant The recommended anticoagulant is K3EDTA with the proper proportion of blood to anticoagulant as specified by the tube manufacturer K EDTA is an acceptable alternative 3 2 PN 624021CA SPECIFICATIONS CHARACTERISTICS 3 INSTRUMENT SPECIFICATIONS 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 1 10 000 Hgb 1 250 Throughput The instrument can process up to 60 samples per hour in either mode CBC or CBC DIFE The instrument achieves nominal throughput when used in a routine laboratory environment with samples hav
295. than 10 information windows were opened by the system and have not been acknowledged Acknowledge all open information windows X value cannot be less than 1 The value entered is less than 1 Enter a value of at least 1 X value out of range The value entered is out of range Enter a value within the range A Minimum Of 3 Results Must Be Included To Save The New Cal Factors At least 3 results are required for calibration calculations and less than 3 have been run Run at least three results for calculation results to be generated A Minimum of 5 Results At least 5 calibration runs are Include at least 5 calibration runs before Must Be Included to required to save calibration saving the calibration factors Calibrate factors and less than 5 are included A Sample ID is Required A Sample ID is required to run Enter the sample ID Before Sample Will Be analysis Analyzed A Sample ID Must Be Attempt was made to create a Enter a Sample ID to create the Worklist Entered To Save Entry Worklist entry without a Sample ID entry Analyzer Communication The Analyzer and Workstation are 1 Verify that the cables are properly Error Unknown not communicating connected Message 2 Ifthe problem persists contact a Beckman Coulter representative Analyzer Must Be Idle Attempt was made to restore the Make sure Analyzer is idle before Before Attempting To databa
296. the Flags and Messages box Detailed and Suspect If the Detailed Flags option is selected samples are flagged using the Detailed format default Ifthe Detailed Flags option is not selected samples are flagged using the Suspect format Suspect Flag Format If the Detailed Flags option is not selected optional setting at the Reports setup screen the flags are reported displayed and printed in the Suspect format as follows DB prints as DB e The DIFF flag replaces the SL 511 NL MN UM LN UN and NE flags IMM prints as IMM e ATL prints as ATL The WBC BA flag replaces the DIFF DIFF WBC MB and BASO flags e The HISTO flag replaces the MICRO MACRO SCL MIC and SCH flags The flags will be printed on the patient report in the area labeled SUSPECT Detailed Flag Format If the Detailed option is selected default at the system s Reports setup screen the flags are reported displayed and printed in the detailed format Flags Interpretive Messages and Analytical Alarms Flags e Definition A flag is a symbol set of symbols or letters generated by the instrument to signal that a certain parameter requires additional attention Flags can appear in a number of ways Linked to a result when it exceeds the normal limits Linked to a problem in the morphology of the blood cell population Linked to instrument operation For details see Flags and Analytical Alarms Generated by the Instr
297. the Patient ID or if it Date of Birth Age Gender Unknown has already been entered Physician z select the ID from the io pull own list Buy Apply e E i x previously entered information will be displayed 2 Enter the information step 3 8 34 PN 624021CA SAMPLE ANALYSIS 8 RUNNING STAT SAMPLES FROM WORKLIST ENTRIES 2 Ifthe sample is on the Worklist locate the sample Sample ID 2345 a 0 the Worklist tab 12346 b Locate the sample that you want 12348 processed as a stat sample 12349 12350 c the far left column to mark the 12351 sample as next to be processed PN 624021CA 8 35 SAMPLE ANALYSIS RUNNING STAT SAMPLES FROM WORKLIST ENTRIES 3 Run the stat sample a the Run tab b Verify that the starting Sample ID appears for the sample you entered ET jJ and selected in step a 5 LL gt wj 9j Bs 0 Patient Name Gender Date of Bith Panel Unknown cec mment Date T Cor 63 27 2001 11 1242 Ifthe starting Sample ID is correct go to step c Ifthe starting Sample ID is not correct repeat step a IMPORTANT Risk of erroneous results if sample is not properly mixed before analysis Mix the blood specimen gently and thoroughly before analysis according to the tube manufacturer s recommendations and your laboratory protocol Sample ID P
298. the Reports tab ot Copy re xen F F Messages Detailed Flags aaaaqa a a aaa Histogram Thresholds Eo b d Diffplot Thresholds Vahine 4 0 1 or 2 for the number of copies to of Cop be printed each time 60 624021 SETUP PATIENT SETUP 9 Save the changes the window OR il to save and remain at this window to continue setting up the Patient report to save and exit from Selecting the Patient Sample Report Printout Option There are three report printing options The option you choose determines which areas will print on the report Figure A 2 Option 1 prints report areas 1 2 and 3 Option 2 prints report areas 1 and 2 Option 3 prints report area 1 Do this procedure to select the format for the patient sample report printout LN amp Ne File Cycles Diagnostics Help Setup gt gt Patients Pot iin c System 2 Typethe password and E v PN 624021CA A 61 SETUP PATIENT SETUP 3 the Reports tab m Header 3 Heeder 1 der 2 r LL Header 4 Header 6 Auto Print otCopy f ReportFormat Printed Parameters Option 1 Gu 1 p d wc r NE Enable iy 4 Lye i MO MO 2 C Normals LS 4 0 K Messages F BA F Abnormals REC MW MH F letailed Fi
299. the WBC BASO histogram which is needed to obtain the BASO count Differential 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 stabilizes the WBC in their native forms and 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 Figure 2 11 Flow Cell Operation 2 Second focused flow for optical detection Ju A 8S 1 Primary focused flow for impedance PN 624021CA 2 11 OPERATION PRINCIPLES SAMPLE ANALYSIS 2 12 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 AC T 5diff Fix Volume ACT 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 Dilu
300. the host computer cannot be edited Do this procedure to edit a Worklist entry 5 48 624021CA PN 624021CA GETTING STARTED USING WORKLISTS LN 2 1 Select the Sample ID or the Patient ID for the patient demographics you want to edit a the Worklist tab b Highlight the desired entry 0A 3 Edit the demographics ATTENTION The system selects the flagging set based on the age and gender of the patient If you do not enter an age and the gender and do not select a flagging set the default flagging set will be selected automatically You can manually enter the information or if the database has the information doctor location etc select it via drop down box Ele Cycles Diagnostics Setup alas Add Edit Worklist Sample Identification Opr Admin Sample ID 12345 Panel CBC DIFF Flagging Set Standard Range Collect Date Time 04 19 2001 05 50 PM Comment Po Patient Identification Patient ID 112760 fH Jane Doe Date of Birth 08 11 1965 Age 35y Gender Female Physician Location iti y 8 amp H x Patient Name Autonumbeting gt On 12345 Apply 4 to save and exit the screen 5 49 5 GETTING STARTED USING WORKLISTS Deleting Worklist Entries Do this procedure if you want to delete an entry from the Worklist ATTENTION If you delete a Worklist entry for a new Pat
301. the tube when the tube holder door automatically opens after aspiration The red LED is still illuminated which means the Analyzer is busy processing the sample 8 10 PN 624021CA RUNNING PATIENT SAMPLES USING THE WORKLIST SAMPLE ANALYSIS 21 Wait for the green LED to illuminate which indicates the system is ready for the next sample Information for the next sample to be processed is displayed in the Sample ID Next field on the Run screen SampeiD Pane PatientiD_ 123 124 CBC DIFF 28 Verify that the current sample results appear in the Run window 29 Verify the Sample ID and results before reporting the results 30 31 amp to print a copy of the results Note copy prints automatically if the Auto Print function is enabled Verify that the Sample ID for the next sample is correct 32 PN 624021CA Repeat steps 21 through 31 until all samples are analyzed 8 SAMPLE ANALYSIS RUNNING PATIENT SAMPLES USING THE WORKLIST 8 12 Running Worklist Samples Autonumbering Off If autonumbering is disabled on your system you must manually enter the Sample ID up to 16 alphanumeric characters by typing it at the keyboard or by scanning it using the barcode reader optional Barcode configuration is performed at installation ATTENTION Beckman Coulter recommends that you verify each barcode reading to ensure correct sample identifica
302. tient ID Patient Name Archive fase b choice of search criteria Sample ID Patient ID or Patient Name c Type the chosen identifier Note The search entry must match the database entry exactly to return a result Patient Name is not case sensitive PN 624021CA DATA REVIEW LOCATING SAMPLE RESULTS 9 3 the Search button If there are any DE ET matches they display ex E AT ais 8 il 21 ve Curent Archive Closed Archive Search criteria Sample ID Patient ID C Patient Name pasion Bess Search Results 07 18 2004 11 34 12 AM 4 Toview detailed results e Double click the desired result OR u to view the details The data is displayed as it was on the Run screen with results and DiffPlots 5 5 Toreturn to the list PN 624021CA 9 3 DATA REVIEW LOCATING SAMPLE RESULTS To print from the Search Results list a Press the key and 0 on each sample you want to print b Verify that a black dot p or appears in the far left column of each selected sample and that the row is highlighted 0 to display the print menu d Select your choice of print option Sorting Sample Results You can sort results in ascending or descending order at the Results window Information can be sorted by Seq sequence number Sample ID Patient ID or Patie
303. tion Os Be ONE Prepare the Workstation for sample processing a the Results tab b Verify that the active archive is open white background on Worklist and Results list If an old archive is open green background File gt gt Close Archive c If according to your laboratory protocol it is time to create a new 1 File New Archive Note You cannot create a new archive until any previously opened archive if any is closed 2 0 the Worklist tab Note If the Worklist is downloaded A from a host computer the Sample ID E L and patient demographics are automatically downloaded and cannot be edited PN 624021CA SAMPLE ANALYSIS 8 RUNNING PATIENT SAMPLES USING THE WORKLIST 3 P to open the Add Edit Worklist window 4 Enter the Sample ID by typing it or scanning it from the barcode label e Ifscanning the Sample ID go to step 5 e If typing the Sample ID 1 2 3 4 5 6 PN 624021CA 0 in the Sample ID field Type the Sample ID Press Verify that the Sample ID in the Sample ID field is correct Press to move the cursor to the Panel field Go to step 6 Add Edit Worklist r Sample Identificati Opr Sample ID Flagging Set Collect Date Time Comment Identification 8 13 SAMPLE ANALYSIS RUNNING PATIENT SAMPLES USING THE WORKLIST
304. tion From the measurements described above a DiffPlot is developed with optical transmission absorbance on the 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 12 DiffPlot Regions Absorbance PN 624021CA 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 BASO 10 pL 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 Diluent 1 000 uL 1 80 Count in the DIFF bath Hgb Measurement 10 uL ACeT Diluent 1700 uL Preliminary 35 C 95 F in the First After removin 1 170 e g dilution Final Sdiff Diluent 1 250 5diff Hgb Lyse 400 uL RBC and Plt Count 42 5 uL ofthe ACT 5diff Diluent 2 500 uL Secondary 35 C 95 F
305. tion then Open archive N press to select it Close archive OR Backup database e Press the underlined letter of the Restore database menu item Delete Database OR Logout the item PN 624021CA 5 33 GETTING STARTED WORKING WITH THE SOFTWARE 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 14 To scroll do one of the following W the cursor on one of the arrows to scroll the window in the direction of the arrow and hold the slider box and drag it along the scroll bar WU the slider instead of dragging the slider box Figure 5 14 Scroll Bars X e Editing Text There may be times when you need to edit text 1 Move the cursor to the line of text where you want to delete information 2 the left mouse button to anchor the CUrsor 5 34 624021CA GETTING STARTED 5 WORKING WITH THE SOFTWARE 3 Editthe text 4 Savethe changes See Saving Changes for details Saving Changes Throughout the procedures you will be instructed to save information There are two save icons on your system v Saves the information and exits the screen Zi Saves the information and remains at the current screen allowing you to continue working at that scre
306. tly into slot 1 of Tube Holder 1 or e slot 4 of Tube Holder 2 For information about the correct slot for each tube vial see Table D 1 IMPORTANT Risk of erroneous results if the desired sample tube vial is not positioned in the pierce position 12 o clock in the Analyzer 9 Ensure that the tube is in the pierce position within the tube holder If the tube is in the pierce position 12 00 o clock within the holder do step 6 If the tube is not in the pierce position within the holder rotate the holder until the tube is in the pierce position 7 3 RUNNING CELL CONTROLS QUALITY ASSURANCE 1 4 IMPORTANT Do not log out of the Workstation while the Analyzer is running a cycle Logging out during an Analyzer cycle will cause problems with the Analyzer Workstation communication 6 Close the tube holder door The red and green LEDs flash 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 7 When the LED is green 5 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 8 Repeat steps 1 through 7 for the remaining cell control l
307. ts 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 primary window The main window displayed when the application begins See secondary window 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 secondary window Any window displayed over the primary window when a secondary function is requested See primary window SD standard deviation A measure of variation within a group of samples or within a population 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 materia
308. ty block is in the correct position PN 624021CA PN 624021CA DIAGNOSTICS CLEANING PROCEDURES 15 Gently move the traverse assembly to the front of the instrument until it stops 16 17 Close the right side door and secure the two screws with the door key Reconnect the power cord to the rear of the analyzer 18 19 Power up the system as instructed in Power Up the System in Chapter 5 To remove any debris or contaminants from the baths do the Extended Cleaning Procedure 20 Cycle a sample with known results to verify instrument performance 11 15 11 DIAGNOSTICS CLEANING PROCEDURES System Cleaning This procedure may be performed prior to performing procedures that involve the handling of components that have contacted blood Tools Supplies Needed 500mL of a 196 to 2 chlorine solution produced from high quality fragrance free gel free bleach 5 to 696 solution of sodium hypochlorite available chlorine Deionized water Absorbent paper Distilled water D D D D 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 1 Do Extended Cleaning Procedure 2 Pour 500mL of distilled water into the other container 500mL 11 16 PN 624021CA DIAGNOSTICS CLEANING PROCEDURES 3 Remove all reagent
309. u 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 universal precautions when working with pathogenic materials Means must be available to decontaminate the instrument and to dispose of biohazardous waste 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 624021CA 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 A Biohazard Consider all materials Wear standard laboratory attire and follow safe AN specimens reagents controls 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 WA Electrical shock hazard Possibility Before continuing unplug the AC T 5diff CP N of electrical shock when analyzer
310. ubleshooting appendices and Workstation Each tab reflects a unique symbol Symbol Definition St Ww Y Identifies the reference section CM Identifies the operating instructions section a 9 Identifies the special procedures and troubleshooting section SEI Identifies the appendices section jo r Identifies the Workstation management section xxiv PN 624021CA USE AND FUNCTION 1 1 INTENDED USE General The COULTER 5diff Cap Pierce CP Figure 1 1 ACeT Sdiff CP Analyzer hematology analyzer Figure 1 1 isa 26 parameter fully automated hematology analyzer including a five part leukocyte differential counter capable of analyzing samples in a closed vial or open vial mode 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 diagnostic procedures Pct PDW IMM IMM ATL and ATL Purpose The purpose of the 5diff CP 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 1 2 DESCRIPTION The instrument consists of the e ACeT 5diff CP analyzer e Workstation comput
311. umber field PN 624021CA N S x A 77 SETUP QUALITY ASSURANCE SETUP 6 Press to move to the next field Select the controls expiration date a 0 E at the Expiration Date field to open the calendar that shows the current date b Select the expiration date 1 TA to advance to the correct month Expiration Date 09 05 2004 September 2004 Sun Tue Wed Thu 1 2 ape 7 9 13 14 15 16 19 20 21 22 23 26 27 28 29 30 c3 Today 07 18 2004 2 the correct day 8 Press to move to the next field 9 Select the source of the control material a zi at the Source field b Select Patient or Commercial as the source Be sure that the reference values are known for the material you select 10 Press to move to the next field A 78 624021CA SETUP A QUALITY ASSURANCE SETUP 11 Select the controls level low normal or high a 1 at the Level field b Select the level Low Normal or High 12 Press to move to the next field 13 Enter the assigned values and expected ranges from the 5diff Control Plus control assay sheet for each parameter Press Tab to move to the next field after each entry 14 to print a copy of the control setup information for your records 15 0 to save the control setup and exit the window PN 624021CA A 79 SETUP QUALI
312. ument Types of Flags This instrument uses two types of flags replacement and non replacement flags e Replacement flags also called codes replace a parameters numeric results e Non replacement flags appear next to the parameter results Up to two of these flags can be displayed for a parameter DiffPlot and Histogram flags appear in the Flags and Messages box in the lower right corner of the Results screen 9 16 624021CA DATA REVIEW REVIEWING FLAGGED RESULTS Interpretive Messages Definition Interpretive messages are triggered from the action limits established by your laboratory These messages which appear in the Flags and Messages box of the Results screen indicate possible pathological disorders For details see Interpretive Messages ATTENTION In rare instances samples with an unusually high number of flags may not have all interpretive messages printed in the Flags and Messages area of the patient sample report However all messages are displayed on the screen and the flag and or conditions triggering the interpretive message will appear on the printout and screen Analytical Alarms e Definition Analytical Alarms which also appear in the Flags and Messages box of the Run screen are messages generated by the Analyzer These messages indicate conditions that may be related to Analyzer operation and indicate if results will be influenced by these conditions Flags and Analytical Alarms Gener
313. ument as instructed in Power Down the System in Chapter 5 2 Disconnect the Workstation s power cord PN 624021CA BARCODE SPECIFICATIONS B CONNECTING THE OPTIONAL BARCODE READER 3 Disconnect the keyboard from the Workstation 4 Connect the barcode reader to where the keyboard was previously connected X lt 2 DM 9 Connect the keyboard to the other barcode reader connector 0 dm 6 Reconnect the power cord to the Workstation PN 624021CA B 9 BARCODE SPECIFICATIONS CONNECTING THE OPTIONAL BARCODE READER B 10 Power up the system as instructed in Power Up the System in Chapter 5 The power on sequence should now perform a startup and background cycle if Auto Startup is selected Program the barcode reader to the default configuration as instructed in Heading B 5 BARCODE SCANNER CONFIGURATION PN 624021CA MANUAL CALIBRATION C 1 ANALYSIS PROCEDURE Use a material with known reference values as your calibrator 1 Besure 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 4 Record the results on the calibration worksheet CALIBRATION WORKSHEET Sample Number WBC RBC Hgb Het Pit TOTAL MEAN A ASSIGNED VALUE B ABSOLUTE DIFFERENCE C CALIBRATION REQUIRED CURRENT CALIBRAT
314. unt 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 appears under the Diffplot and Histogram Flags heading Schistocytes appears under the Interpretive Messages heading and the count is flagged with Suspected abnormalities include the presence of schistocytes and or the presence of Plt aggregates See Figure 9 9 The result is not reliable Verify the result by an alternative method PN 624021CA 9 27 9 DATA REVIEW REVIEWING FLAGGED RESULTS Table 9 4 Histogram Flags and Analytical Alarms Continued Histogram Flag Illustrations of Histogram Flags Description PIt SCL Figure 9 10 Presence of Small Cells in SCL small cells indicates the continued the 2 fL and 3fL Regions presence of small cells in the 2fL and 3fL regions See Figure 9 10 SCL appears under the Analytical Alarms heading Small Cells appears under the Interpretive Messages heading and appears in place of PLT and MPV parameter values Rerun the sample and verify the results Patient Ranges and Action Ranges Table 9 5 shows the four flags that can be generated based on patient ranges and action ranges Sample results that appear on a red background indicate an HH or LL flag Results that appear on a yellow background indicate an H or L flag Table 9 5 P
315. 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 13 is an example of an RBC histogram with a normal RBC size distribution Figure 2 13 Typical RBC Histogram 30 300 7616036A PN 624021CA OPERATION PRINCIPLES 2 PARAMETER DEVELOPMENT Parameter Results Obtained Using the RBC Histogram e calculation MCV Mean Cell Volume is calculated using the Hct and the RBC count The is displayed and printed in femtoliters fL Note fL is the US unit format Other formats are available See Changing the Reporting Unit 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 where System constant SD Calculated standard deviation based on the red cell distribution Mean Cell Volume of the red cells MCH and MCHC Calculations e MCH calculation MCH Mean Cell Hemoglobin is calculated from the Hgb value and the R
316. utrophil 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 17 Lymphocyte Lymph Lymphocytes typically being small with regular shape are smaller in volume and lower in absorbance than the other cells and positioned in the lower region of the DiffPlot Figure 2 17 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 17 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 17 The presence of platelet aggregates is indicated by a distribution pattern that moves from the DiffPlot origin into the lymphocyte region Figure 2 17 NRBC cytoplasmic membranes lyse like those of mature erythrocytes The small nuclei that remain appear in the debris and small lymphocyte regions Figure 2 17 Monocyte Mono Monocytes are typically large cells with a kidney shaped nucleus and agranular cytoplasm These cells neither scatter nor a
317. viewing Results Calibration e Diagnostics Instrument Setup Log Sheets Manual Calibration References Glossary Abbreviations Index Defines requirements for interfacing the system with a host computer Provides training information for using the CP system Provides abbreviated procedures for the experienced operator Come visit us at www beckmancoulter com COULTER
318. will be displayed 9 28 624021CA DATA REVIEW REVIEWING FLAGGED RESULTS The following sections define e WBC Interpretive Messages e RBC Interpretive Messages e Plt Interpretive Messages and Combination WBC RBC Plt Interpretive Messages Note The DIFF and DIFF flags have hierarchy over any other interpretive message Other interpretive messages will not print WBC Interpretive Messages Table 9 6 lists WBC interpretive messages from Action Ranges Table 9 7 lists WBC interpretive messages from the DiffPlot Table 9 6 WBC Interpretive Messages from Action Ranges Printed Message Triggering Condition LEUKOCYTOSIS WBC WBC HH LEUKOPENIA WBC 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 NEZ lt NE LL or NE lt NE LL EOSINOPHILIA EO gt EO HH or E0 gt E0 HH MONOCYTOSIS MO gt MO HH or MO gt M0 HH BASOPHILIA BA gt BA HH or BA gt BA LARGE IMMATURE MM 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 WBC One or more analytical alarms occurred for WBC INTERPRETATION NOT POSSIBLE HH above the action range LL below the action range
319. window 30 Verify the Sample ID and results before reporting the results 31 8 to print a copy of the results Note A copy prints automatically if the Auto Print function is enabled PN 624021CA SAMPLE ANALYSIS 8 RUNNING PATIENT SAMPLES USING THE WORKLIST 32 Verify that the Sample ID for the next sample is correct 33 Repeat steps 21 through 31 until all samples are analyzed PN 624021CA 8 21 SAMPLE ANALYSIS RUNNING PATIENT SAMPLES WITHOUT USING THE WORKLIST 8 5 RUNNING PATIENT SAMPLES WITHOUT USING THE WORKLIST This procedure provides details on how to run samples without using the Worklist Forrunning Worklist samples with autonumbering on see Running Samples Autonumbering e For running Worklist samples with autonumbering off see Running Samples Autonumbering Off You will be required to enter a Sample ID Samples will be flagged using the selected default flagging set Panel selection and Patient ID are optional Running Samples Autonumbering On If your instrument is configured to the Autonumbering ID mode the instrument automatically assigns a sample ID from 1 to 999999 and increments the number before each analysis LN e Nec 1 Prepare the Workstation for sample processing a b 8 22 the Results tab Verify that the active archive is open white background on Worklist and Results list If an old archive is open green bac
320. xed and cannot be changed The acceptable background limits are WBC lt 0 3 x 103 pL3 lt 0 03 106 13 Hgb lt 0 3 g dL Plt lt 7 0 x 103 13 If the system determines that there is insufficient reagent to complete the day s work Reagent s Low Insufficient Reagent to Complete The Daily Workload appears Identify the low reagent and change it according to the Changing Reagents OR Continue and change the reagent when the specific reagent low message is displayed Do this procedure if you want to run Startup again The Startup cycle runs for approximately 3 minutes IMPORTANT Do not log out of the Workstation while the Analyzer is running a cycle Logging out during an Analyzer cycle will cause problems with the Analyzer Workstation communication LN e Nec 1 If automatic Startup at power up is ult disabled Or W Cycles gt Startup When Startup begins the Analyzer Logs screen automatically appears After about 3 minutes Startup will be completed The status will be displayed on the Analyzer Log screen and results will be stored in the Startup Log 6 1 DAILY ROUTINE STARTUP 6 2 2 Review the Startup results status a Analyzer Logs if the screen is not already displayed b Review the Startup results If Passed appears go to step 4 e If Failed appears go to step 3 Ac T File Cycles Diagnostics Setup Help SA p sudo x Ald zd wd 9i 23
321. xing 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 Diluter System 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 If results are within the acceptable ranges you are ready to analyze patient samples IMPORTANT Risk of failure to print and or transmit all requested results Do not delete result s until printing and or transmitting are complete Allow all results to complete printing and or transmitting before using the delete function 11 The control file results automatically print if Auto Print is enabled If Auto Print is disabled b Select the print option oo PN 624021CA QUALITY ASSURANCE RUNNING CELL CONTROLS IMPORTANT Risk of failure to print and or transmit all requested results Do not delete result s until printing and or transmitting are complete Allow all results to complete printing and or transmitting before using the delete function 12 The control file results automatically transmit if the Auto Transmission option for control results is set to On If Auto Transmit is set to Off a Verify tha
322. y available flagging set or select the next available empty row 9 Highlight the flagging set you want 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 PN 624021CA A 49 SETUP PATIENT SETUP 6 W Copy Copy From Copy To 7 Select the flagging set that you want to Copy To b Highlight the flagging set For example to copy to the Woman flagging set select Woman from the list 8 to copy 9 verify that the patient limit ranges have been copied correctly A 50 PN 624021CA SETUP A PATIENT SETUP Enabling Disabling RUO Research Use Only Parameters 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 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 Enabling RUO Parameters Do this procedure to enable the reporting of the RUO parameters A amp Ber File Cycles Diagnostics SIZE
323. y Workload You can specify the daily workload which is the approximate 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 3 shows the default values Table A 3 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 LN Nex 1 Setup gt gt System PN 624021CA SETUP A SYSTEM SETUP 2 Typethe password and 0 vj 3 Cycle Option 4 Type the number of daily runs for CBC and or for CBC DIFE 9 Savethe changes 0 7 to save and exit from the window OR 6 to save and remain at this window to continue editing PN 624021CA A 19 SETUP SYSTEM SETUP Changing the Auto Clean Frequency Setting The instrument automatically performs an autoclean after a specified number of analyses The default number of analyses is 75
324. y cycle Table 3 1 Reagent Consumption by Cycle in mL Approximate Cycle Reagent Duration Diluent WBC Lyse Rinse Fix Hgb Lyse CBC 22 6 2 1 0 9 0 4 60 sec CBC DIFF 28 5 2 1 0 9 1 0 0 4 60 sec Startupt 65 4 2 1 3 7 1 0 1 4 4 min 50 sec Shutdown 27 0 14 1 0 3 min Prime Diluent 44 9 10 Prime Rinse 24 8 1 min 20 sec Prime Fix 23 6 1 min 10 sec Prime WBC Lyse 23 6 1 1 E 2 min 20 sec Prime Hgb Lyse 2 1 8 4 1 min 30 sec Prime All Reagents 49 0 24 0 25 1 24 8 2 6 min Autoclean 13 4 1 0 1 0 1 0 0 3 1 min 35 sec System Reset Cycle 25 4 14 1 0 1 min 50 sec Clean Dil Cycle 6 5 10 sec one background count only The maximum is three Cycle runs automatically after 4 hr 30 min of non use indicates not applicable Environmental Protection Removal and recycling of this instrument must be done by a properly qualified laboratory in accordance with local legislation PN 624021CA 3 5 SPECIFICATIONS CHARACTERISTICS PERFORMANCE SPECIFICATIONS 3 2 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 Reproduci
325. y disk You can restore saved settings if necessary Do this procedure if you change the Workstation s configuration LN 2 Ner File Cycles Diagnostics Help amp m Patients 1 Setup gt gt System UUJ B Quality Assurance i 2 the password zu a 3 Config Save Restore tab 3 2 D H ela 07 16 2004 02 38 37 PM A 36 624021CA SETUP SYSTEM SETUP 4 Save in Current Workstation Setup TEE EE a TPE area Current Analyzer Setup Current Workstation Setup s Restore NS i Print Print 9 Indicate where the settings should be saved Ifyou want the settings to be saved to the hard drive Hard Drive then Ifyou want the settings to be saved to a floppy disk 1 Insert the disk into drive A 2 Floppy Disk PN 624021CA To HardDrive Floppy Disk el x A 37 SETUP SYSTEM SETUP Restoring Workstation Configuration Settings Do this procedure if you want to restore previously saved Workstation settings to be the current settings A File Cycles Diagnostics Help S ml Patients 1 Setup gt gt System UJ 205 Quality Assurance 2 the password and 3 Config Save Restore tab 3 2 D H ela I 07 16 2004 02 38 37 PM A 38 624021CA SETUP SYSTEM SE
326. y overview 2 1 weight 3 1 where to place it 3 2 interference electromagnetic 3 2 on the distribution curve 2 16 interfering substances 3 12 Interlaboratory Quality Assurance Program See IQAP interpretive messages definition 9 17 9 28 triggering conditions 9 29 what triggers them 9 17 IQAP defined 1 9 how to enroll 1 9 IQAP download 7 11 IQAP ID how to set up 81 irregular sample results 9 32 INDEX 5 INDEX INDEX 6 L L definition ABBREVIATIONS 1 L flag definition 9 28 labels serial number location 1 3 warning and caution location 1 3 laboratory limits description A 43 setup procedure A 43 lamp See flow cell lamp language selecting display language A 24 Large immature cell triggering condition 9 29 LCD definition ABBREVIATIONS 1 LED definition ABBREVIATIONS 1 Left Shift triggering condition 9 29 leukemia cause of WBC interference 3 12 leukocyte fragility 3 12 Leukocytosis triggering condition 9 29 Leukopenia triggering condition 9 29 Levey Jennings control graphs 7 7 limitations 3 11 limits background count 6 1 linearity definition GLOSSARY 1 performance specifications 3 6 LIS definition GLOSSARY 1 ABBREVIATIO NS 1 lists how to scroll 5 31 LL flag definition 9 28 Location names delete A 6 logon operator 5 24 passwords 5 24 User name 5 24 logout 5 25 lot number definition GLOSSARY 1 LY description 2

11 - Beckman Coulter

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