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ABX Pentra XL80

1. 13 8 7 4 480H 141 397 H 83 293 ZA 4 71 13 8 40 0H 85H 29 2 7 0 473 13 7 40 1H 85H 28 9 7 3 4 70 14 0 39 7H 84H 25 8 is ae G SSS Se Ri 7 5 4 61 13 9 38 8 84H 30 1 6 7 4 66 13 9 38 2 82 29 8 6 6 4 68 14 0 38 7 83 239 Vv Vv 2002 04 04 06 48 57 IV Admin 2002 04 04 07 10 58 IK Admin 2002 04 04 07 38 02 Iv Vv IV Admin 2002 04 04 09 02 09 Admin 2002 04 04 10 04 53 Admin 2002 04 04 10 07 47 Standard deviation Coef of variation 4i17H 121 085 165 142 141 Fig 3 4 QC grid screen Results are displayed in red when they are greater than the upper limits in blue when they are lower than the lower limits A Rejected analyses are not stored in QC A notification of rejection is entered in the logs v Statistics For selected results Mean values are displayed in red when they are greater than than the upper limits in blue when they are lower than the lower limits The coefficients of variation are displayed in red when they are greater than the coeffi cients set by the operator See Section 5 Settings 3 4 Coefficients of variation ranges page 5 13 When a Quality Control parameter is out of range a QC alarm is activated See Section 4 Workflow 5 3 13 Statistical function flags page 4 50 Pentra XL 80 User Manual RAB131GEN Quality control 3 7 ABX Pentra XL 830 boxes for selection or deselection of OC results Statistical calaculations are re com
2. D D printed and displayed 0 transmitted to the LIS PLT replaced with D D printed and displayed 0 transmitted to the LIS PLT replaced with D D printed and displayed O transmitted to the LIS Tab 4 6 Results exceeding Linear ranges of the instrument in the CDR Mode ABX format Pentra XL 80 User Manual RAB131GEN Worktlow Run results and associated Flags 5 3 3 Analysis reject A reject flag shown by occurs when two counts on a parameter differ more than the pre defined limits It indicates that the parameter result is inconclusive and should be investi gated for Manual rerun status and or instrument malfunction if consistent on every sample v RBC If the RBC parameter is rejected the MCV MCH MCHC and RDW parameter results are re placed by and or have the indicator v WBC If the WBC parameter is rejected the diff parameter results are replaced by and or have the indicator v PLT If the PLT parameter is rejected the PCT MPV and PDW parameter results shall be replaced by and or have the indicator v LMNE A reject on the LMNE channel indicates a poor correlation between the resistive and the optical measurements on the matrix It is shown by a on all the differential parameters in and The results are not reliable and specimen must be re analyzed NO flag
3. PDW Platelet Distribution Width is calculated from the PLT histogram The PDW is represented by the width of the curve between 15 of the number of plate lets starting from 2 fl S1 and 15 of the number of pla telets beginning with the variable top threshold S2 Fig 6 16 PDW calculation 6 16 Pentra XL 80 User Manual RAB131GEN Description amp Technology Measuring principles 3 3 WBC and differential count 3 3 1 General counting principles The WBC count is carried out twice by two different analysis methods which utilize the total WBC count in both areas Once in the BAS count chamber during the same time as the BAS count Once in the optical chamber during the same time as the LMNE count The WBC reference count is the count which is obtained from the WBC BAS count chamber 3 3 2 BAS WBC Count The measurement principle is exactly the same as the RBC PLT measurement The Differentiation between the BASO s and the other leukocytes is obtained by the use of the ABX BASOLYSE II reagent with it specific lysing action All the WBCs are counted between the electronic thresholds from lt BA1 gt to lt BA3 gt The basophils are counted between thresholds lt BA2 gt and lt BA3 gt a Mena pawn ig wh E Fig 6 17 WBC BAS histogram Technical characteristics of the WBC BAS counts Initial blood volume 10 ul CBC or CBC DIFF Method Impedance Vol ABX BASOLYSE II 2000
4. PLT 150 200 400 450 PCT owo 0 15 0 50 1 00 LYM 1 50 1 50 6 50 6 50 ALY Ce 0 25 0 25 Tab 5 29 Child 5 default settings Pentra XL 80 User Manual RAB131GEN 5 59 ABX Pentra XL 80 8 5 2 Alarms levels From the menu Settings Types Alarms and Curves Thresholds see Section 5 Settings 8 1 3 Modifying limit Alarm values page 5 44 Level Standard Level NO 100 80 LL1 O1 LD MN m 120 LN MN 1 A uo 999 NE MIC MACp m m Tab 5 30 Standard type alarm levels 5 00 Pentra XL 80 User Manual RAB131GEN Level Yo Level NO 100 80 LL1 O1 1 MN m 120 LN ine b Oo bb Sz m pes uw O1 w 999 NE MIC MACp Tab 5 31 Man alarm levels Woman Level Yo Level NO 100 80 Tab 5 32 Woman alarm levels Pentra XL 80 User Manual RAB131GEN Settings Sample Types 5 61 ABX Pentra XL 80 Child 1 Level Level NO LL1 MN LN NE MIC MACp 100 80 Sz Sz 1 m U M m U as m U w oO 120 999 Tab 5 33 Child 1 alarm levels Child 2 Level Level NO 100 80 ts Tab 5 34 Child 2 alarm levels 5 62 Pentra XL 80 User Manual RAB131GEN Child 3 Level Yo Level NO 100 80 LL1 O1 1 MN m 120 LN ine b Sz J bb Sz m pes Un O1 w 999 N
5. 5 3 2 Results exceeding Linear ranges of the instrument page 4 31 5 3 3 Analysis reject page 4 33 Flags linked to an abnormal morphology in the blood cell populations or to an anomaly during counts 5 3 4 Suspicion flags page 4 33 5 3 5 LMNE matrix flags page 4 35 5 3 6 Flags on WBC BAS histogram page 4 41 5 3 7 Flags on RBC histogram page 4 42 5 3 8 Flags on PLT histograms page 4 42 5 3 12 Pathology messages page 4 47 Analyzer alarms 5 3 11 Analyzer alarms page 4 46 5 3 9 WBC balance page 4 44 Flags linked to statistical function 5 3 13 Statistical function flags page 4 50 Flags linked to patient history 5 3 10 Delta Check page 4 45 The operator can adjust the Sensitivity of each flag See Section 5 Settings 8 Sample Types page 5 43 5 3 1 Normal and panic ranges h indicates that the result is above the normal limit set by the user l indicates that the result is below the normal limit set by the user H indicates that the result is above the panic limit set by the user L indicates that the result is below the panic limit set by the user These flags can also be criteria for the pathology messages 4 30 Pentra XL 80 User Manual RAB131GEN Worktlow Run results and associated Flags 5 3 2 Results exceeding Linear ranges of the instrument See Section 2 Specifications 3 3 Linearity page 2 9 Linearity limits
6. 9 Confirm the calibration while passing a control blood the values have to be returned within acceptable limits 10 After about thirty numerations analyses of the day check that values of MCV MCH and MCHC are in conformity with the usual values of the laboratory 4 2 Accessing the Calibration Main Menu From the Quality Assurance Menu see Fig 3 1 page 3 3 select the Calibration key be 136 5 2 BOL OGL OOL BOL OL cost ef veeintion g lAcivel coal 19402 16863 azaz asa zz07e N Meat aa belia MP Bia rk APA PERAN aa ma MR Mate HER Mina baba New cool Isan2 16863 aa 17864 006 IM Rare aan Fig 3 23 Calibration Access Key 3 26 Pentra XL 80 User Manual RAB131GEN Ouality Assurance v Calibration Key Function Runs an automatic calculation of the new coefficients see 4 4 1 Calibration Automatic Calculation passed page 3 29 This key is enabled only if a minimum of 5 runs on calibrator has been performed Access to the Target values window Target see 4 3 Target values page 3 27 Tab 3 5 Calibration Grid Keys If the Calibrator lot is different than the current calibrator material being used for calibra tion proceed with the following as described in 4 3 Target values page 3 27 4 3 Target values From the Calibration grid select the Target key see Tab 3 5 Calibratio
7. 3 2 CBC detection principles 3 21 RBC PLT The RBC s and PLT s are measured by an electronic impedance variation princi ple This means that an electronic field is generated around the micro aperture within the chamber in which the blood cells are pulled through The sample is diluted with an electroly tic Diluent electronic current conducting fluid mixed then pulled through a calibrated micro aperture Two electrodes are placed on either side of the aperture and electric current conti nuously passes between the two electrodes As the blood cells pass through the aper ture they create resistance Impedance in the electronic field between the two electrodes The voltage which measures the cells is proportional to the size of the cell Since the current is constant and remains unchanged the larger the cell is the more resistance it has The smaller the cell is the less resistance it has These electronic voltages vary in pulse size as the cells pass through the aper ture The pulses are amplified channeled according to size and thres hold grouped and then mathematically calculated along with the calibration coefficients to give a final numerical va lue for both RBC s and PLT s v Results Number of cells counted per volume unit x calibration coefficient v Histograms RBC Distribution curves on 256 coun ting channels from 30fl to 300fl PLT Distribution curves on 256 channels from 2fl to
8. 3 3 Running cycles The Within Run test must be done on a fresh normal whole blood sample 3 3 1 Manual mode Open the Within Run Data Grid screen see Fig 3 18 page 3 21 Select the test CBC or DIFF by pressing the CBC DIFF key of the grid see Tab 3 4 Within Run keys page 3 21 Select the STAT key of the generic toolbar Section1 Introduction 4 2 Generic toolbar description page 1 16 Once the STAT key has been selected the tube holder door opens Place the sample tube in the appropriate position of the tube holder Close the tube holder on the rear position the analysis cycle begins Rerun the sample several times The Within Run is complete once the operator exits the Within Run Data Grid screen 3 3 2 Rack mode Position the tube in any rack If there is more than one sample tube placed in the rack each tube will be analyzed the number of times specified by the Sampling Number Open the Within Run Data Grid screen see Fig 3 18 page 3 21 Select the test CBC or DIFF by pressing the CBC DIFF key of the grid see Tab 3 4 Within Run keys page 3 21 Place the rack in the Rack Loader Select the Start Rack key Section1 Introduction 4 2 Generic toolbar description 3 22 Pentra XL 80 User Manual RAB131GEN Ouality Assurance Within run page 1 16 The rack is loaded and the results will automatically appear in the grid 3 3 3 Results PENTRA
9. DIFF Fig 4 60 Daily result grid The Daily Report grid contains all the Reports Validated Rejected Unmatched Unvali dated from a single day of work which include the Status see Report Status page 4 71 the time the Sample ID the Patient ID and name first name the Test CBC DIFF and the sam ple type given to the sample Select a date that you want to review by using the scrolling icon to move through the list v Report Status Each Report shown in the Archives function includes an indicator which provides its status as indicated V Validated Report U Unvalidated Report R Rejected Report Unmatched Report W Report Waiting for Examination T Validated and Transmitted Report Pentra XL 80 User Manual RAB131GEN 4 71 ABX Pentra XL 80 v Daily results function keys Heading Key Name Patient Report Daily Report E Media om 7 Date Im Delete Select all Unselect all Print Send Click a line Click a line Click Sample ID Patient ID or Time headings Sorting out Tab 4 15 Daily Report function Keys v Printing options Function Displays the search by patient screen see 7 3 Patient Report page 4 73 Displays the search by date screen see 7 2 Daily Report Description page 4 71 Opens Exported Report Media selection window Floppy disk or network see 7 5 Reviewing expor
10. Fig 1 15 Radio button The Edit key must be selected to modify the Radio button v 4 4 6 Data Fields These fields are rectangular areas within a specific menu that are used to display input or edit specific information within each field For example Name Date Time etc Some fields have predefined formats Date Number Text etc These data fields may be modified when they appear in WHITE Use the Tab key to move the cursor from one field to the next 1 20 Pentra XL 80 User Manual RAB131GEN Rack Sample ID _ 02544545 Fos Fig 1 16 data Fields The Edit key must be selected to modify a data field Ld 4 4 7 Sliders When data can not be displayed within the same window a horizontal or vertical slider will appear Drag it or click the arrows to move through all the data PENTRA8O Within Run Close tube setting Sampling Number 5 Selected Analysis 4 i sel op TestDate Admin 2002 03 27 13 20 49 Admin Admin Admin 2002 03 27 13 21 41 2002 03 27 13 22 34 2002 03 27 13 23 27 Standard deviation 0 45 0 2 011 0 08 2 Standard deviation 0 33 0 11 0 11 0 89 0 39 0 22 0 15 Coef of variation 1 28 1 04 0 61 0 88 0 2 0 63 0 43 Fig 1 17 Sliders Pentra XL 80 User Manual RAB131GEN Introduction Software overview 1 21 ABX Pentra XL 80 1 22 5 Workflow overview Pentra XL 80 introduces the Biotechnical validation which purpose
11. Fig 3 29 Logs main screen Press the Logs key of the main screen 3 32 Pentra XL 80 User Manual RAB131GEN Ouality Assurance v Logs access keys Function Launches Quality control log screen see 5 3 Quality control logs page 3 34 Ouality Control Launches settings log screen see 5 5 Settings logs page 3 Settings 35 Error Launches error log screen see 5 7 Error logs page 3 35 Launches Blank cycle log screen see 5 9 Blank cycle logs Blank cycle Tema 3 25 Launches Logs by Date screen see 5 10 Patient logs Logs by Date Tana D Tab 3 6 Log access keys Pentra XL 80 User Manual RAB131GEN Logs 3 33 ABX Pentra XL 30 v Logs function key Function Opens a comment window The user can enter a com Add Comments Add comments ment to associate to the Logs entry on which he is positioned 5 permits to the user to print the current logs as a list P alae between two dates Tab 3 7 Logs function keys 5 2 Calibration logs o v D eo Fig 3 30 Calibration logs For every calibration a notification is done in this log new coefficients display For a LMNE channel calibration a notification is done For every target change a notification is done For every rejected analysis in calibration a notification is done When an analysis is launched with an expirated calibrator
12. L L J Graphs Chap 3 6 9 4 Pentra XL 80 User Manual RAB131GEN Languages Chap 5 24 Limitations Chap 2 16 Linearity Chap 2 9 Logs Chap 1 17 Chap 3 32 Chap 5 7 M Main functions Chap 1 17 Maintenance Chap 7 3 chart table Chap 7 3 Manual match on Exception Chap 5 8 Manual Rerun Chap 4 64 MCV MCH MCHC calculation Chap 6 16 MDSS Chap 6 11 Measuring principles Chap 6 11 CBC detection principles Chap 6 13 LMNE Matrix Chap 6 18 WBC and differential Chap 6 17 Mixing Chap 4 25 MPV Measurement Chap 6 16 N Normal and panic ranges Chap 4 30 Normal Ranges Chap 2 11 O Optical bench lamp replacement Chap 7 15 Order overview Chap 1 22 Order amp runs association Chap 4 51 P Panels amp cover dismantling Chap 7 19 Pathological limits Chap 5 46 Pathology messages Chap 4 47 Pct Calculation Chap 6 16 PDW calculation Chap 6 16 Performance data Chap 2 7 Precision Chap 2 7 Precision Repeatability Chap 2 8 Prime cycles Chap 7 32 Print conditions Chap 5 21 Printer Chap 1 26 Chap 5 31 Glossary amp Index Index Printout Chap 5 33 properties Chap 5 31 Printout Chap 4 27 Q Quality Assurance Chap 1 17 access Chap 3 3 Coefficients of variation ranges Chap 5 13 Number of calibration runs Chap 5 13 settings Chap 5 12 XB options Chap 5 12 Quality control Chap 3 4 access Chap 3 4 Delete results Chap 3 9 Graphics Chap 3 8 keys Chap 3 5 L J Graphs Chap 3 6 Print results Chap 3 9 Run Chap 3 13 screen
13. 0 5 0 33 0 5 STARTUP cycle estimated duration and consumptions are given for one blank cycle Specifications Summary of performance data 3 Summary of performance data 3 1 Precision Reproducibility The Pentra XL 80 was initially calibrated with ABX MINOCAL lot Number MCAL321 Three levels of PENTRA 5D Hematology Control ABX Difftrol material Lot No PX52 were run in duplicate twice daily for 20 days The results were used to quantify within run preci sion SD of the run means SD of the daily means and Total Imprecision in accordance with the NCCLS EP 5 A Guidelines Parameter Mn Within Run SD Sen sana eae lated Means Means SD PX052 High 0 67 0 53 0 53 0 81 WBC PX052 Normal 0 11 0 1 0 12 0 16 PX052 Low 0 06 0 04 0 04 0 07 PX052 High 0 06 0 04 0 05 0 07 RBC PX052 Normal 0 06 0 04 0 04 0 06 PX052 Low 0 03 0 02 0 03 0 04 PX052 High 0 12 0 07 0 09 0 13 HGB PX052 Normal 0 08 8 0 07 0 11 PX052 Low 0 05 0 05 0 04 0 06 PX052 High 0 76 0 61 0 65 0 95 HCT PX052 Normal 0 62 0 62 0 62 0 88 PX052 Low 0 28 0 34 0 37 0 48 PX052 High 16 29 8 32 10 6 16 72 PLT PX052 Normal 9 01 5 2 8 64 11 35 PX052 Low 3 61 3 87 4 69 6 PX052 High 1 73 1 2 1 34 2 Neutro PX052 Normal 0 76 0 53 0 41 0 77 PX052 Low 0 97 0 8 0 72 1 14 PX052 High 1 79 1 27 1 54 2 19 Lympho PX052 Normal 0 86 0 67 0 55 0 94 PX052 Low 1 24 0 72 0 78 1 28 PX052 High 0 32 0 25 0 14 0 32 Mono PX052 Normal 0 18 0 09 0 12 0 18 PX052 Low 0 21 0 13 0 08 0 19 PX
14. Manual entry grid Suspected pathologies Curves and matrix Ouality control Within Run analysis Calibration Startup Hematology parameters Tab 5 11 Printer settings A Six fields of 20 characters maximum each see Fig 5 25 page 5 33 List of installed printers Printer used by the software Calls Windows NT window for adding a local printer Calls the printers properties screen see 5 4 2 Printer properties page 5 34 The printer displayed into the printer list is the default printer The printer displayed into the printer list is removed Normal limits are printed out when checked see Fig 5 25 page 5 33 Raw counts are printed out when checked see Fig 5 25 page 5 33 Manual formula are printed out when checked see Fig 5 25 page 5 33 Pathologies are printed out if checked see Fig 5 25 page 5 33 Printed out when checked Quality control Within Run Calibrator Startup Unmatched results are automatically printed out when checked Selected parameters are not printed out Printing the raw counts will be possible only if System Printer Raw option See Fig 5 24 System Printer tab page 31 has been checked in this screen Print the run raw counts in full page for selected rows option is selected See Section 4 Workflow 6 4 1 Printout or Transmit Report list page 4 65 5 32 Pentra XL 80 User Manual RAB131GEN Settings System 5 4 1
15. Meaning Left Lymphocytes Presence of a significantly large population on the left hand side of the lymphocyte area This flag appears when the number of particles counted is higher than the limit set up in LL or when the number of coun ted particles versus the total number of WBC exceeds the LL limit Suspected abnormalities e Small lymphocytes e Platelets aggregates e NRBCs e Erythrocyte membrane resistant to lysis stroma This flag is associated with an on LYM LYM NEU NEU MON MON EOS EOS ALY ALY LIC LIC Meaning Left Lymphocytes 1 Presence of a significantly large population of cells on the left hand side of the lym phocytes area This flag occurs when the number of particles counted is higher than the limit set up in LL1 and when the number of particles counted in LL regar ding the total number of lymphocytes is above the LL1 limit Suspected abnormalities e Platelet aggregates e NRBCs e Erythrocyte membrane resistant to lysis stroma e Stroma e Small abnormal lymphocytes vy NL flag Absorbance NoN NoE Channel 127 LMD RM Resistivity Fig 424 NL flag Standard value for NL 3 120 See Section 5 Settings 8 3 Alarms amp Cur ve thresholds page 5 47 v MN flag Absorbance NoN NoE MN Channel 127 LMD RM Resistivity Fig 4 25 MN flag Standard value for MN 100 120 See Section 5 Settings 8 3 Alarm
16. Menu headings are displayed at the top of the screen when a menu is selected Hints can be displayed by moving and holding the cursor on menus keys see Fig 1 11 page 1 18 PENTRA XL 80 Quality Assurance A TFP F TG T 5 pma Ri A p 7 3 eo be alams ea a AE Fig 1 11 Software arborescence and Hints 4 4 2 Tabs description Tabs are used to group similar functions that pertain to a specific menu Press a Tab or click once with the mouse to access that specific function Menu 1 18 Pentra XL 80 User Manual RAB131GEN Introduction Software overview ir Fig 1 12 Menu tabs 4 4 3 Scrolling list These small menus include a list of options and sometimes include a Free Field to enter or edit data within the menu The Edit key must be selected to access a Scrolling list y K hh mm ss arom himrnss ampm tH mm ss HHmmss I O al mSS xl Fig 1 13 Scrolling list 4 4 4 Checked box A Checked Box will enable or disable an option in a specific menu Placing a Check Mark within the box will enable the option Removing a Check Mark from the box will disable the option The Edit key must be selected to modify the Checked Box Pentra XL 80 User Manual RAB131GEN 1 19 ABX Pentra XL 830 Fig 1 14 Checked box 4 4 5 Radio button Selection between options excluding each other
17. OK key to confirm your entries Your profile will now be added to one of the profile lists A user can edit insert delete a login of the same level or a lower level but not at a higher level Entering the name of the user is done in the login windows See Daily Guide RAB156C v User login while Pentra XL 80 software running A new user can login whitut reinitializing the instrument Double click the second box A of the Footer see Fig 5 32 User list page 5 41 f PENTRA AL 80 Fig 5 32 User list When the Login window appears select the user in the list Pentra XL 80 User Manual RAB131GEN 5 41 ABX Pentra XL 80 Enter the password then press the Validate button see Fig 5 33 User password page 5 42 ka Bc ey Ss AL AI O Ai Tr sk oe Fig 5 33 User password A This functionality is not available in the Settings and Calibration menus and also while a cycle is running on the instrument 5 42 Pentra XL 80 User Manual RAB131GEN Settings Sample Types 8 Sample Types 20 different blood sample types are available 8 of theses sample types have already been incremented Standard Man Woman Child1 Child2 Child3 Child4 and Child5 The Types screen will allow the operator to create the following changes A new type see 8 1 Accessing the Types parameters menu page 5 43 Pathological limits see 8 2 Pathological limits page 5 46
18. RAB131GEN Intro Operational conditions 3 Operational conditions 3 1 Environment page 1 9 3 2 Location page 1 9 3 3 Grounding page 1 10 3 4 Humidity Temperature conditions page 1 10 3 5 Electromagnetic environment check page 1 10 3 6 Environmental protection page 1 10 3 7 Transportation and storage conditions page 1 11 3 8 Installation page 1 11 3 9 Interconnections page 1 12 3 10 Racks page 1 13 3 1 Environment The operation of the Pentra XL 80 should be restricted to indoor location use only Operation of the instrument at altitudes of over 3000 Meters 9800 feet is not recommended The in strument is designed for safety from voltages surges according to INSTALLATION CATEGORY II and POLLUTION DEGREE 2 IEC 61010 1 Please contact your local HORIBA ABX representative for information regarding operation lo cations when it does not comply with the recommended specifications 3 2 Location The Pentra XL 80 should be placed on a clean and leveled table or workbench Please note that the Pentra XL 80 and printer weigh approximately 55 kilograms 121 lbs Avoid exposure to sunlight Place your instrument where it is not exposed to water or vapor Place your instrument where it is free from vibration or shock Place your instrument where an independent power receptacle can be used Use a receptacle different from the one used by a device that easily generate noise such as a centrifuge etc Pro
19. Troubleshooting v Procedure 10 Differential LMNE Repeatability If Differential results are non repeatable a Perform a concentrated cleaning see 4 3 4 Clean Cycles page 7 34 b If this does not correct the Differential count call your HORIBA ABX representative department 5 3 Flags v Procedure 11 Default analysis WBC a Perform a concentrated cleaning see 4 3 4 Clean Cycles page 7 34 b Re run the specimen c Check the operation of liquid valve lt 23 gt and lt 14 gt Opening and closing during cycle If defective replace the valve d If this does not correct the WBC results call your HORIBA ABX representative depart ment RBC PLT a Perform a concentrated cleaning see 4 3 4 Clean Cycles page 7 34 b Re run the specimen c Check the operation of liquid valve lt 14 gt Opening and closing during cycle If defec tive replace the valve d If this does not correct the RBC PLT results call your HORIBA ABX representative de partment HGB a Check the HGB LED is illuminated when system is on Fig 7 45 HGB LED b Perform a concentrated cleaning see 4 3 4 Clean Cycles page 7 34 c Re run the specimen d Check the operation of liquid valve lt 14 gt Opening and closing during cycle If defec Pentra XL 80 User Manual RAB131GEN 7 41 ABX Pentra XL 30 tive replace the valve e If this does not correct the HGB resu
20. User Manual RAB131GEN 4 9 ABX Pentra XL 80 Worklist sample identification i an lang am UF 5 Pal w Sample detected on position 3 0068 0068 0069 0089 0070 P 0070 i 567415 1 1 5675415 i 1 025646 1 2 025646 1 2 0060 0067 AUTO SIDS 1 3 Auto Numbering Auto SIDxx Order and sample matched Result Identification Matched with an order Rack x Position y Fig 45 Rack position Manual match ON 4 10 Pentra XL 80 User Manual RAB131GEN Worktlow Workflow 1 7 Exception management The usual sample identification management is the automatic and secure matching of orders with the corresponding sample tubes Exceptions will occur when automatic matching is impossible For instances when a sample tube is found in a non defined position in the worklist or when a barcode label cannot be read T NN peta re aS j a F ao ee Em lg p i ri F p HN TSART ET CE 5 i jenang Hi pee Gl Nia Tn 1 on pa i i L p 3 iai aj A hed ai Mi i he Fig 4 6 Order result workflow Setting the exceptions criteria must be performed in the configuration of the Setting func tion Manual match on Exception See Section 5 Settings 2 2 5 Identification option page 5 7 defines a specific treatment of expectations Run Results obtained for each speci
21. 0102 z A 12 0112 2 0113 0103 Z A 03 A 13 0104 A nA 4A 0114 Fig 1 9 Rack Identification Number Back side Pentra XL 80 User Manual RAB131GEN 1 13 ABX Pentra XL 80 4 Software overview The Pentra XL 80 includes a control station which software designed by HORIBA ABX is in stalled on a loading PC with a twelve inch 800 x 600 operated touch screen The Main Menu of the system includes two menu selection bars located on the lower horizon tal and right vertical portions of the touch screen 1 The Contextual toolbar see 4 1 Contextual toolbar description page 1 15 is located on the bottom of the screen 2 The Generic toolbar see 4 2 Generic toolbar description page 1 16 on the right 3 The Main menu access keys see 4 3 Main Menu description page 1 17 are featured in the center portion of the touch screen 4 Startup and Shutdown operation keys are also featured in the center portion of the touch screen PENTRA XL 80 Fig 1 10 Main Menu A Status Bar is also located at the bottom of the screen which indicates the Date ald Time Software version Operator Code and the Cycle Bar Graph Startup Shut down and Calibration Either pressing on the screen with a finger or making the selection with the Mouse activates all Toolbar and Menu keys To modify edit or review data in screens and tabs refer to 4 4 Miscellaneous page 1 18 1 14 Pentra XL 80 User Manual RAB131GEN Int
22. Instrument Rinse procedure o ooWo W1 WWoWoWoWoW mna Lyse instead of Alphalyse in the Prime Cycles MENU ooooo o Wo WWW oo WWW Pentra XL 80 User Manual RAB131GEN Chap 3 19 Chap 4 21 Chap 4 56 Chap 4 60 Chap 4 66 Chap 4 72 Chap 5 14 Chap 5 18 Chap 5 31 Chap 5 34 Chap 5 39 2 2 V1 4 0 Software improvements and user manual updates CDR mode validation RAM189 ban ab na Chap 2 13 COR Mode RAW GG cerren E E ces Chap 4 31 Automatic validation on Plt suspicion RAM174 esssssssssssssssesessssssososososososesosos Chap 5 16 CDR mode validated dilution RAM189 Kocok Chap 5 18 network settings modification RAM174 sssesssesessssssssssosesosesosescsescscsesosesese Chap 5 30 Begin of day screen with new logo ooooo W W0 momo mma Chap 5 39 CDR mode validation RAM189A aomsnskata anus alan Chap 8 2 Pentra XL 80 User Manual RAB131GEN 0 5 0 6 XL 2 3 V1 5 0 Software improvements and user manual updates input output labels modification oooooWoWoWo WWW mma Chap 1 5 reagent and waste label addition wacana Chap 1 6 biological risk label warning addition o oom WWW maan Chap 1 7 Correction error contextual toolbar instead of generic oooooo Wo Woo Chap 1 14 Reagent consumption modification o oom mma Chap 2 6 Standardisation Linearity and Error limit oooWoW Woo oom maan Chap 2 10 Modifying control lot ACTION nenas 50 Hen aman Rama RN U an NAN EEANN C
23. LEDS When the Green LED is lit the instrument is ready to sample When both LEDs are blinking alternatly instrument is busy sampling When the Red LED is lit instrument is in operation Refer to Section 8 Annex 3 Compatible tube list page 8 6 DP Pentra XL 80 User Manual RAB131GEN 6 5 ABX Pentra XL 80 1 5 Rear view Fig 6 5 Rear View 1 Serial number label 2 Main power supply inlet 3 Diluent and waste connections 4 Host computer connection 5 Printer connection 6 6 Pentra XL 80 User Manual RAB131GEN Description amp Technology Automatic mode principles 2 Automatic mode principles v Rack loading The Pentra XL 80 will allow continuous loading of sample tube racks during all phases of op eration Racks are placed and then drawn onto a mechanism which allows the mixing and sampling of each tube within the rack Micro switches allow detection of the racks when placed in the loading tray Fig 6 6 Tube height detection and correction The Sample tube is detected and the tube height is adjusted by the presence of 2 rolling de tectors within the mechanism see Fig 6 6 page 6 7 Sensors are also present within the mechanism to index the rack position at any time during its presence through the loader Pentra XL 80 User Manual RAB131GEN 6 7 ABX Pentra XL 80 v Sample mixing Fig 6 7 Sample mixing 360 end over end rotations for approximat
24. RAB131GEN 8 9 ABX Pentra XL 830 8 10 Pentra XL 80 User Manual RAB131GEN ABX Pentra XL 80 Glossary amp Index Contents EE oir Ya ngan ea eee ee re 9 2 2 T O vee eececcescccetscsensccensccessecesccesecesecssecetsesenseseate 9 4 Pentra XL 80 User Manual RAB131GEN 9 1 ABX Pentra XL 80 This section includes the following 1 Glossary page 9 2 2 Index page 9 4 1 Glossary accuracy agglutination background count blank cycle calibration calibration factors calibrator carryover cell control characteristics coefficient of variation control CV default expiration date fL femtoliter field flags linearity 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 Clump Measure of the amount of electrical or particle interference Runs an analysis on diluent in order to verify the counting aperture clean liness A procedure to standardize the instrument by determining its deviation from calibration references and applying any necessary correction factors These are correction factors that the system uses to fine tune instrument accuracy A substance traceable to a reference method for preparation or material used to calibrate graduate or adjust measurement The amount in percent of blood cells remaining in diluent following the cycling of
25. This reagent breaks down the RBC cell membrane and releases the Hemoglobin within the cell The hemoglobin released by the lysing reagent combines with the Potassium cyanide from the lysing reagent to form a chromogenous cyanmethemoglobin compound This compound is then measured through the optical part of the first dilution chamber by way of spectro photometry at a wavelength of 550nm v Lysebio Reagent for erythrocyte lysis and cyanide free determination of hemoglobin By addition of agent of lysis hemoglobin is released All the heme iron is oxidized and stabilized Oxidation resulting complexes are quantified by spectrophotometry at a wavelength of 550nm 6 14 Pentra XL 80 User Manual RAB131GEN Description amp Technology Technical characteristics for the HGB MEASUREMENT Blood volume 10 ul Method Photometry Vol ABX DILUENT 1700 ul Wavelength 550 nm Vol LYSE 400 ul complement ABX DILUENT 400 ul Final dilution rate 1 250 Temperature of reaction 35 C Tab 6 2 HGB measurement v Results Hemoglobin results are given as such Absorbance value obtained from the sample x coeffi cient of calibration 3 2 3 HCT Measurement All the RBC pulses are grouped into various sizes Each group pulse height is then averaged All the pulse height averages are then averaged one final time for a mean average of all the RBC pulse heights This function is a numeric integration of the MCV The HCT results are given as a per
26. a notification is done 5 3 Quality control logs Every time that the QC targets are changed a notification is done 3 34 Pentra XL 80 User Manual RAB131GEN Ouality Assurance Logs Every time that an analysis made on a QC is rejected a notification is done 5 4 Reagent logs For every reagent change a notification is done 5 5 Settings logs At every modification in the settings a notification is done 5 6 Maintenance logs For every maintenance a notification shall be done by the user or technician in this screen After any maintenance operation open the Maintenance logs screen Press the Insert key in order to enter an action the duration and a comment about this action Press ok key to save the new entry 5 7 Error logs A notification shall be done when an alarm is displayed 5 8 Host logs Each time a file from the Host is rejected a notification is done This rejection is generated in the software rather than the raster when for example An order is pending a ReRun The rack on which the tube is found is in progress of an analysis 5 9 Blank cycle logs For every Startup analysis performed a notification is done A Startup has passed if the cycle is launched and the WBC RBC HGB and PLT parameters are within acceptable limits the notification line is displayed in green A Startup has failed if the cycle is launched and if the three consecutive analyses done
27. checked box Selection list or cap ture enabled 20 characters max Selection list or cap ture enabled 20 characters max Date time 50 characters 25 characters 20 characters 5 characters edit box 5 characters drop down list 4 19 ABX Pentra XL 80 2 3 5 Searching by sample ID The operator has the ability to select a specific sample record from the Sample ID field Just select the Search Sample key see Tab 4 3 Order fields page 4 19 The Search Sample key is accessible if the Edit or Insert mode has been selected Once the Search Sample key has been selected the following screen will be displayed PENTRA 80 Search Sample 02 Sample ID Collecting Date Type Department Physician 025646 Man LABORATORY UNIT 1 RICHARD 025987 Standard 02598745 Standard 02659874 Woman LABORATORY UNIT 1 EDMOND Fig 4 10 Search by sample ID screen Only the samples recorded in the Worklist are displayed in the Search Sample window Samples in progress will not be dis played The Sample ID field enables the user to type in the first characters of the sample ID desired As each letter is typed the grid is refreshed to display the Sample list corresponding to the characters entered The Sample ID field enables the operator to view the Alpha or Numeric character sequenc ing as it is being typed As each character is being typed the Grid refreshes and displays the Sa
28. or Reject key If the Report includes defects the following window is open Warning Please confirm the report validation AN F Incomplete KM With reject suspicion invalidity or linearity overflow Fig 4 51 Report validation warning This window can not be modified by the operator and means Incomplete all parameter groups have not been included in the Report With reject suspicion invalidity or linearity overflow Some of the parameter groups of the Report includes reject and or suspicions and or invalidities and or are outside linearity limits of the instrument Select OK to confirm the Report Validation or Rejection A notification is done in the Remarks heading of the alarm Tree view to identify the parameter groups of the Report 6 4 Rerunning sample manually The user has the ability to manually select a Rerun from the Report being reviewed in the 4 64 Pentra XL 80 User Manual RAB131GEN Workflow Report Full Screen Mode From the Report display screen see Fig 4 40 page 4 55 select the Rerun key PENTRA 80 Fig 4 52 Rerun request When the Rerun key has been selected a message will be displayed asking for confirmation on the Sample ID Patient ID Patient Name and the Patient First name A new entry is then generated into the Worklist Proceed as described in Daily Guide RAB156C to run the analysis on this new order The Reru
29. value HCT Hematocrit Red blood cells agglutination May produce an inaccurate HCT and MCV values Red blood cell agglutination may be detected by observing abnormal MCH and MCHC values as well as by examination of the stained blood film In such cases manual methods may be required to obtain an accurate HCT value Pentra XL 80 User Manual RAB131GEN Limitations 2 17 2 18 XL MCV Mean Corpuscular Volume Red blood cell agglutination May produce an inaccurate MCV value Red blood cell ag glutination may be detected by observing abnormal MCH and MCHC values as well as by examination of the stained blood film In such cases manual methods may be required to obtain an accurate MCV value Excessive numbers of large platelets and or the presence of an excessively high WBC count may interfere with the accurate determination of the MCV value In such cases care ful examination of the stained blood film may reveal the error MCH Mean Corpuscular Hemoglobin The MCH is determined according to HGB value and the RBC count The limitations listed for the HGB and RBC will have an effect on the MCH and may cause inaccurate values MCHC Mean Corpuscular Hemoglobin Concentration The MCHC is determined according to the HGB and HCT values The limitations listed for the HGB and HCT will have an effect on the MCHC and may cause inaccurate values RDW Red blood cell Distribution Width The red blood cell distrib
30. 0 15 0 50 1 00 LYM 2 00 2 00 11 0 11 0 ALY goo 0 35 0 35 Tab 5 25 Child 1 default settings Pentra XL 80 User Manual RAB131GEN 5 55 ABX Pentra XL 80 Child 2 Panic L Normal lL Normal h Panic H WBC 10 0 10 0 26 0 30 0 HGB 13 5 15 5 19 5 19 5 MCV C 100 112 114 MCHC 32 0 32 0 36 0 36 0 PLT 150 200 400 450 PCT oo 0 15 0 50 1 00 LYM 2 00 2 00 11 0 11 0 ALY es Ka 0 35 0 35 Tab 5 26 Child 2 default settings 5 56 Pentra XL 80 User Manual RAB131GEN Settings Sample Types Child 3 Panic L Normal l Normal h Panic H WBC 5 00 5 00 15 0 17 0 HGB 11 5 12 0 14 0 14 5 MCHC 32 0 32 0 36 0 36 0 PLT 150 200 400 450 PCT owo 0 15 0 50 1 00 LYM 2 00 2 00 8 00 8 00 ALY goo 0 35 0 35 Tab 5 27 Child 3 default settings Pentra XL 80 User Manual RAB131GEN 5 57 ABX Pentra XL 80 Child 4 Panic L Normal lL Normal h Panic H WBC 4 50 4 50 13 5 15 0 HGB 11 0 Ales 14 5 15 0 MCHC 32 0 32 0 36 0 36 0 PLT 150 200 400 450 PCT oo 0 15 0 50 1 00 LYM 1 50 1 50 6 50 6 50 ALY ee 0 25 0 25 Tab 5 28 Child 4 default settings 5 58 Pentra XL 80 User Manual RAB131GEN Settings Sample Types Child 5 Panic L Normal l Normal h Panic H WBC 4 50 4 50 13 5 15 0 HGB 11 0 likes 14 5 15 0 MCHC 32 0 32 0 36 0 36 0
31. 06 03 2003 16 43 57 70777 aoooooo a qaaa Fig 3 31 Logs per Day Select one line of the grid to display events of the day see Fig 3 31 page 3 36 All the events of the current date selected line can be printed out by selecting Print Send key The grid can be sorted by decreasing date if the date displayed in the From field is anterior to the date displayed in the To field LMNE channel calibrations are not visible in this screen 3 36 Pentra XL 80 User Manual RAB131GEN ABX Pentra XL Workflow Contents AV KOW oat E EEES 4 3 1 1 Sample tube management i oooooooWoo 4 3 Tn N O ONN e E E EA EEEE E A 4 3 DV OVI E E E E E E one eter 4 4 1 4 Sample identification me bonita aneka aga 4 5 1 5 Barcode Identification knee mana 4 5 1 6 Sample identification on Rack position 4 8 Ia Exception nana Ce MCI Leni 4 11 1 8 Sample runs and order associatiOn 4 13 1 9 Keran Con One na 4 13 1 10 Patient file management oooooo 4 14 1 11 Loading Worklist from the LIS 4 14 2 VV ORK CSC MOU OWN AN Pt 4 15 De Nig MEN ane on ananda area ab aman Hb E 4 15 2 2 Accessing the Worklist funCtiOn 4 15 DAs MW ON ET Oleg ee oa bi btr bder 4 16 DA Ro Me sn R 4 22 3 Sample collection amp MIXING eee cece eeeeeeees 4 25 3 1 Recommended anticoagulant o ooo 4 25 3 2 Blood sampl
32. 06 10e6 mm3 13 6 0 2 g dl 36 5 10 261 10 ANALYSES M Admin 2002 04 02 15 04 16 9 6 4 56 13 6 36 4 263 V Admin 2002 04 02 15 05 12 9 7 4 59 13 5 36 7 269 IK Admin 2002 04 02 15 06 08 9 7 4 58 13 5 36 8 269 7 1 1 7 New coef 136 26 171 39 43 42 181 65 252 76 Fig 3 27 Calibration printout v Deleting calibration results For deleting results from the Calibration Results Grid select the Check Boxes to select or de select results and parameters then select the Delete key from the Contextual Toolbar and select Selected Unselected or ALL for deletion see Fig 3 28 page 3 31 Now confirm your selection Delete options Fig 3 28 Delete options Pentra XL 80 User Manual RAB131GEN 3 31 ABX Pentra XL 80 5 Logs These are the event logs for the Pentra XL 80 They contain all of the notifications made au tomatically by the software while the Pentra XL 80 is in operation Logs functions are described in 5 1 Accessing the Logs function page 3 32 5 2 Calibration logs page 3 34 5 3 Quality control logs page 3 34 5 4 Reagent logs page 3 35 5 5 Settings logs page 3 35 5 6 Maintenance logs page 3 35 5 7 Error logs page 3 35 5 8 Host logs page 3 35 5 9 Blank cycle logs page 3 35 5 10 Patient logs page 3 36 5 11 Logs by Date page 3 36 5 1 Accessing the Logs function J
33. 1 Ouerty or Azerty keyboard 1 Printer 7001020 1 Empty waste container cap er SN DATO leB 1 Power supply cable HAN524A 1 Mouse pad RAB156 1 Daily guide RAX055 1 Reagents Controls amp Calibrators CD ROM RAX040 1 User manual and Help on screen CD ROM Tab 1 1 Package list table Pentra XL 80 User Manual RAB131GEN 1 11 ABX Pentra XL 80 3 9 Interconnections 3 9 1 Electrical amp Computer connections see 2 2 PC connection label page 1 8 Fig 1 7 Computer connections E ae 5 2 X USB 8 COM2 Labo Link 3 an 6 Printer 9 COM1 To Mother Board i Fa 7 COM3 External Bar Code Reader 10 Power 3 9 2 Printer connection see 2 1 4 Output label page 1 7 3 9 3 Reagent connections ment on the bench when the ABX Pentra XL 80 is operated at altitudes over f It is mandatory to install the diluent container at the same level than the instru 1000 Meters 3280 feet See Section 7 Maintenance amp Troubleshooting 2 1 1 Reagent locations and connec tions page 7 9 1 12 Pentra XL 80 User Manual RAB131GEN Introduction Operational conditions 3 10 Racks The Pentra XL 80 racks are identified on the system by means of Barcode labeling These labels must be placed on the racks in the following manner Gan AE 0201 _ _ 03 Ta Fig 1 8 Rack barcode Identification and Rack type Front side TI kes TI 0202 TNI N mN 0203 AWIN o TT co
34. 17 b hematological results are beyond their parameter limits which are defined by the user or samples that are rejected These criteria are specific to each sample Type see 4 3 2 Rerun by parameters page 5 18 c hematological results are beyond the linearity limits see 4 3 3 Rerun on Dilu tion page 5 18 d hematological results trigger Delta check alarms See Section 4 Workflow 5 3 10 Delta Check page 4 45 e Sample have been correctly identified in the Worklist and Runs have been matched with orders See Section 4 Workflow 1 9 Rerun conditions page 4 13 4 3 1 Rerun on alarms Refer to Section 4 Workflow 5 3 Flags page 4 30 for Hematological alarms interpre tation prior to selection in this screen For modification of the Rerun conditions in Alarms From the Rerun screen select the Gene ral tab Scroll the Types list and select a type to configure Select the Edit key Select the alarm box that you want to trig ger the re sampling if you want to apply these modifications on MRE all sample types select the Apply on all Ty pes check box Fig 5 12 R 1g an en Select the OK key to confirm your choice of re sampling conditions Pentra XL 80 User Manual RAB131GEN 5 17 ABX Pentra XL 80 4 3 2 Rerun by parameters PENTRA XL 80 Rules Sa e M m m M 7 Ly n E E m m M m n a C a M CE E E U E
35. 2 L J Graphs page 3 6 1 3 QC data screen grid page 3 7 1 4 Graphics screen page 3 8 1 5 Print send or delete results page 3 9 1 6 New blood control setup page 3 10 1 7 Running control blood page 3 13 1 1 Access to the Quality Control Menu Press the Quality Control key Fig 3 2 Quality Control access key 3 4 Pentra XL 80 User Manual RAB131GEN Ouality Assurance y Quality Control Key Key Name Function Access to the Target values window see 1 6 New blood control setup page 3 10 Selection of a new control lot omoare oo BI Control Name see Selection of a control page 3 10 24 controls can be saved 12 in CBC 12 in DIF Target In Data screen Grid Selected or all results or statistics only see Print send or delete results page 3 9 Send to the host selected or all results In L J graphs Printing with 100 full points Print Transmit Tab 3 1 Quality Control Keys Pentra XL 80 User Manual RAB131GEN Quality control 3 5 ABX Pentra XL 30 1 2 L J Graphs This is the graphical representation of Quality control data based on the daily value for each Control parameter its target value and range that are plotted on a graph for periodic review A total of 100 points per parameter can be displayed on the screen and on the printout The hematology parameters are displayed in groups of 5 Two or four views can be accessed d
36. 3 Within run The Within Run is based on results that are obtained by consecutive analyses of the same blood sample v Sections detailed in Within Run 3 1 Accessing the Within Run Data Grid page 3 21 3 2 Closed tube sample setting page 3 22 3 3 Running cycles page 3 22 3 1 Accessing the Within Run Data Grid From the Quality Assurance Menu see Fig 3 1 page 3 3 select the Within Run key i 070 087 056 TE Fig 3 18 Within Run Data Grid v Within Run Keys Function Deletes Unselected Selected or All results see 3 3 4 Print Delete Transmit or delete Results page 3 23 Prints selected or all results or Statistics only Print Transmit Sends selected or all results see 3 3 4 Print Transmit or delete Results page 3 23 Switches from CBC to DIFF test CBC DIFF see 3 3 Running cycles page 3 22 Tab 3 4 Within Run keys Pentra XL 80 User Manual RAB131GEN 3 21 ABX Pentra XL 80 3 2 Closed tube sample setting The operator is allowed to run within run samples in both Manual Mode and Rack Mode Close tube setting Sampling Number h Enter the number of sample takes to be per formed on the sample tube for Rack mode Fig 3 19 Closed tube mode setting A The Within Run Data Grid must be opened when performing a sample repeat ability cycle Each tube of the rack is analysed the number of times specified by the sampling number
37. 3 2 5DIFF Matrix thresholds Each axis of the matrix X and Y is divided into 128 channels numbered from 0 to 127 13 Y vertical indices and 13 X horizontal indices will allow the user to locate these chan nels by multiples of 10 The first index channel of the 5 Diff matrix is the origin at the bottom left corner This is the 0 channel The second channel will be 10 the third channel will be 20 the fourth channel will be 30 and so on The threshold adjustments are expressed in channels RMN Fig 5 39 Matrix thresholds There are only 3 basic reasons to adjust the matrix thresholds see 8 1 3 Modifying limit Alarm values page 5 44 a To improve the separation between different cell populations which may vary according to the selection of anti coagulant for blood sample collection or minor internal instru ment adjustments b To modify the alarm areas of these cell populations for improvement in detection sen sitivity c To modify one or more matrix areas in order to define a more precise measurement of a specific cell population for research purposes see 8 5 3 Matrix thresholds page 5 64 5 48 Pentra XL 80 User Manual RAB131GEN Settings Sample Types Thresh Purpose Low limit High limit NOL Separation between Noise amp Left Lympho 0 LL NON Separation between Noise amp Left Neutro NOL NOE LL Separation between Left Lympho amp Lympho NOL AL LN Separation between Neutro amp
38. 34 Super User Hydraulical Drain Chambers 1 Rinse Drains the rinse chamber 2 HGB Drains the HGB chamber 3 LMNE Drains the LMNE chamber 4 RBC PLT Drains the RBC PLT chamber 5 WBC BASO Drains the WBC BASO chamber 6 All Drains all the chambers Pentra XL 80 User Manual RAB131GEN 7 31 ABX Pentra XL 80 4 3 2 Prime cycles This menu will allow the user to prime reagents into the instrument Run this procedure after service has been performed on the instrument mmm This function allows only the priming of reagents into the instrument It does not PJ set the reagent quantities to 100 PENTRA XL 80 Hyd Fig 7 35 Super User Hydraulical Prime Cycles 1 ABX Diluent Primes ABX Diluent reagent 2 ABX Cleaner Primes ABX Cleaner reagent 3 ABX Eosinofix Primes ABX Eosinofix reagent 4 ABX Basolyse 2 Primes ABX Basolyse 2 reagent 5 ABX Lyse Primes ABX Lyse reagent 6 All reagents Primes all reagents at the same time 7 32 Pentra XL 80 User Manual RAB131GEN Maintenance amp Troubleshooting Service menu description 4 3 3 Unprime cycle PENTRA XL 80 Hydraulic System maa ae Me Mus PA Mere MEA CO Vesamvitg To OTST Fig 7 36 Super User Hydraulical Unprime Cycle 1 Diluent reservoir Drains the diluent reservoir 2 All Unprimes all the reagents from the instrument Pentra XL 80 User Manual RAB131GEN 7 33 ABX Pentra XL 80 4 3 4 Clean Cycles PENTRA
39. 44 Selection of parameter group When a parameter group including alarms is selected these alarms will be associated with the report see Fig 4 45 page 4 59 04 26 2003 11 40 05 Fig 4 45 Run results panel When a Manual entry has been performed a M is displayed next to the parameters see Fig 4 46 page 4 59 Fig 4 46 Manual entry indicator Pentra XL 80 User Manual RAB131GEN 4 59 ABX Pentra XL 30 v history panel history is the most recent Validated Report which is used for the Delta Check survey See Section 5 Settings 4 5 Setting Delta check page 5 22 The older reports historic can be reviewed in the history panel but will not interfere in the Delta Check calculation history Historic l al At B i a b 4 Current day Current day 1 Current day 30 Delta Check validity period Fig 4 47 history scheme When there is no history the history panel remains blank If a Report is DIFF and the history is CBC missing parameters are ignored and replaced by ddla 989 gaano 383 sanno ddla Fig 4 48 Review of the history Reviewing the previous validated reports can be done using Left Right arrows see Fig 4 48 page 4 60 6 2 2 Report Edit v Accessing the Report Edit screen see 6 1 2 Report Function sequence page 4 51 1 From the Report Display or Report Details screen selecting the Expanded
40. 7 S Physician T Collecting date Patient comment 25 Patient ID Patient name First name Date of birth Age Gender Patient data Tab 4 3 Order fields Patient Information Number of rack in which the tube is placed Tube position in the rack Button displayed if the Rack position has been received from the host Entry of Sample ID Search sample key see 2 3 5 Searching by sample ID page 4 20 Type associated to the blood characteristics See Section 5 Settings 8 Sample Types page 5 43 Selection of CBC or DIFF mode Enabled if the software is in EDIT or INSERT mode Opens a Sample comments window Indicates that order is a Rerun Department reguesting the order See Section 5 Settings 2 3 Department Physicians tab page 5 8 Physician reguesting the order See Section 5 Settings 2 3 Department Physicians tab page 5 8 Date and time of the specimen collection Opens a Patient comments window Entry of Patient ID Search Patient key see 2 3 6 Searching by patient name page 4 20 Entry of patient name Entry of patient first name Entry of patient date of birth Patient age Male Female or Unknown If displayed indicates that patient data has been received from the Host Pentra XL 80 User Manual RAB131GEN 2 characters from 1 to 10 16 characters Selection list 20 characters max Default test is dis played 50 characters
41. AS na Desain 6 11 3 1 Multi distribution sampling sytem MDSS 6 11 3 2 CBC detection principles aan Naa Nan 6 13 3 3 WBC and differential count ooooooWoWo 6 17 Pentra XL 80 User Manual RAB131GEN 6 1 ABX Pentra XL 80 The following section is the Pentra XL 80 technology description including 1 Pentra XL 80 description page 6 2 2 Automatic mode principles page 6 7 3 Measuring principles page 6 11 1 Pentra XL 80 description 1 1 Front View Fig 6 1 Pentra XL 80 front view 1 Reagent cover Access to bottles 2 Rack loading tray Capacity of 10 racks of 10 tubes 3 Rack ejection tray Capacity of 10 racks 4 Left front cover Access to the rack mechanical loading system 5 Tube holder door opens when performing manual analysis 6 Right Front cover Access to the rack ejection mechanical system 6 2 Pentra XL 80 User Manual RAB131GEN Description amp Technology Pentra XL 80 description 1 2 Left side view Fig 6 2 Pentra XL 80 left side view 1 Reagent Access Open this cover to replace empty bottles 2 Optical bench Ensures the support and adjustment of the flowcell lamp and optical and electronic elements 3 LMNE Syringe assembly Ensures the correct proportioning of the stop diluent in the LMNE chamber Injects the specimen into the flowcell Injects the interior and exterior sheath flow into the flowcell 4 Reagent Syringe assemb
42. Alarm levels amp curve thresholds see 8 3 Alarms amp Curve thresholds page 5 47 8 1 Accessing the Types parameters menu From the Settings window select the Type key E m ai A 4 is a TE j Ki a JE ie kar Yuli Sa em Bun hi mgar a dE 5 ae Varn k A FERT Fp I oran i byo a deal i a E an BR ee EE Be mo ina p u Ea e EREE ee Em gt i hrl Fig 5 34 Type parameters Alarms amp curves thresholdsTab From this menu the operator will have the ability to Create a new blood type see 8 1 2 Creating a new blood sample type page 5 44 Modify Pathological limits see 8 1 3 Modifying limit Alarm values page 5 44 Modify Alarms amp Curve thresholds see 8 1 3 Modifying limit Alarm values page 5 44 When one of the Child types is selected a third tab will appear indicating Age v Range see 8 4 Age range page 5 51 Pentra XL 80 User Manual RAB131GEN 5 43 ABX Pentra XL 30 8 1 1 Functions keys Key Heading Function Allows to define a new blood type see 8 1 2 Creating meet a new blood sample type page 5 44 Allows to modify the selected type except the Stan Edit dard type which is always in read only see 8 1 3 Modifying limit Alarm values page 5 44 Copies values from one type to another see 8 1 4 Sample Type copying page 5 45 In Edit mode the selected type takes v
43. Atypical Lymphocytes LIC Large Immature Cells but also if a Manual entry has been performed Bands Metamyelo cytes Myelocytes Promyelocytes Blasts Others percentages and absolute values And CBC parameters RBC HGB HCT MCV MCH MCHC RDW PLT MPV PDW PCT NRBC When a Manual entry has been performed a My is displayed next to parameters Bands Metamyelocytes Myelocytes Promyelocytes Blasts Others NRBC are re ported to when the Report differential has been determined from an instru ment analysis run Rejected reports show crossed parameters see Fig 4 43 page 4 58 Pentra XL 80 User Manual RAB131GEN 4 73 ABX Pentra XL 80 7 3 1 Patient Archives function keys Heading Key Function Displays the search by date screen Danh pan see 7 2 Daily Report Description page 4 71 When a patient is selected Reports are displayed on the right Patient ID Naga Search patient Launches the search patient Screen see 7 3 2 Search Button patient page 4 74 Aan Printing of the last 4 files with patient data Running data matrix and histograms Displays the Report in full screen mode Section 4 Workflow 7 4 Reviewing a Report in full screen mode page 4 75 Click a report Click a Report band Tab 4 16 Patient Archives function Keys 7 3 2 Search patient In order to review the reports associated to a known patient select the Search patient key see Tab 4 1
44. BEFORE SERVICING USE ONLY WITH CORRECT POWER VOLTAGE REPLACE ONLY WITH SAME TYPE AND RATING OF FUSE HAS 0204 Fig 1 2 Serial number label 2 1 2 Reagent and waste connection labels Waste output Connection used for Waste output tubing on Waste position Waste level detection Connection used for Waste level detection on Waste Alarm posi tion Diluent input Connection used for Diluent input tubing on Diluent position DILUENT WASTE ALARM amp Fig 1 3 Reagent and waste label Pentra XL 80 User Manual RAB131GEN 2 1 3 Biological risk label see Fig 1 3 page 1 6 Consider all instrument accessible surfaces as potentially contaminated with blood Use protective gloves to operate instrument 2 1 4 Output label Fig 1 4 Ouput Label 1 RS 232 output LIS Laboratory Information System connection 2 Printer connection Do not connect any printer which has not been recommended by an HORIBA ABX gualified engineer 3 Ethernet connection This network output is classified as Safety extra low voltage SELV 4 USB connection Pentra XL 80 User Manual RAB131GEN Introduction Labels 1 7 ABX Pentra XL 80 2 2 PC connection label Fig 1 5 Internal PC connections Caution label It is strictly forbidden to remove protection covers during instrument operations Refer to 3 9 Interconnections page 1 12 for other peripheral connections Pentra XL 80 User Manual
45. Daily Report screen see Fig 4 60 page 4 71 select the line of the result that you want to display in full screen From the Report display the Report Details and Report Edit screens can be displayed Read only as described in 6 1 Reviewing Report page 4 51 Other Reports that are associated with the same patient can be displayed by using the right and left arrows To return to the Daily Reports screen select the Return key in the full screen mode Printing out and or transmitting this result to a host computer is enabled from this screen by selecting the Print Send key 7 5 Reviewing exported reports The Media key allows to review Exported Reports that have been deleted from the Ar chives Function Selecting the Media key will open a choice box to define the exported data location Floppy disk or Network refer to Section 5 Settings 6 4 Report exportation page 5 38 Whatever the Media this one is read if data are accessible a browser ie5 is launched to dis play data in a chart Sorting out is available in the following fields Sample ID Patient ID Patient Name Validation Date Pentra XL 80 User Manual RAB131GEN 4 75 ABX Pentra XL 80 PENTRA XL 80 Archives Media Fig 4 64 Exported Reports table 4 76 Pentra XL 80 User Manual RAB131GEN Worktlow Status 8 Status This function screen provides instrument real time information about t
46. Diff key will open the Report Edit screen view in a read Only mode in order to consult the Manual entry 2 From the Report Details screen selecting the Edit key will open the Report Edit screen view in an edition mode 4 60 Pentra XL 80 User Manual RAB131GEN Workflow Report Manual entry can only be performed on Unvalidated reports by using the Re port Edit function screen PENTRA XL 80 Report Edit ole BREL _ i yl uc ie i e ie L 30 E NG 20 EE O 0 01 22 1990 J13Y BE Fig 4 49 Report Edit screen v Manual entry procedure Select the Edit key to make the following fields editable e RBC HGB HCT PLT WBC Differential Yo NRBC s see 1 Fig 4 49 Report Edit screen page 4 61 Comments see 2 Fig 4 49 Report Edit screen page 4 61 Enter values in the standard units in the editable fields Select the Recalculation key Select the OK key The Report now includes the new values of the manual entry A My flag is displayed next to the parameters on Report screens Analyzer Alarms Pathology messages histograms and curves remain the same e Hematology flags are recalculated Pentra XL 80 User Manual RAB131GEN 4 61 ABX Pentra XL 80 v Report Edit function keys Heading Key Name Action Function H Aoo Calculation of the parameters of the different Recalcul
47. E Ea E G E a G G G E E E a m mnam eenn nnn unnu an mm CE E E E E E m m m eeen eee mennun CS E E E E eee E E E E E E E E Fig 5 13 Rerun by parameters default settings From the Rerun screen select the General tab Scroll the Types list and select a type to configure Select the EDIT key Choose the limits Panic Normal set by the user or rejected parameters that will trigger a rerun Select or De select the boxes to trigger or not trigger a rerun on parameter limits If you want a rerun for any parameter that is out of the normal low limits select the Normal l key and select any of the parameters that you would like to have a rerun on low limits If you want to apply these modifications on all sample types select the Apply on all Types check box Now select the OK key to confirm your selections 4 3 3 Rerun on Dilution HORIBA ABX Validated dilution ratios are A 1 3 for WBC LMNE 1 2 for RBC HGB PLT Other dilutions ratio may not allow any results to be shown value replaced by D according to local registrations 5 18 Pentra XL 80 User Manual RAB131GEN Settings Rules Dilution tab settings are applied on all Sample types Please refer to Section 8 Annex 1 CDR mode page 8 2 for details about CDR mode When hematological results trigger dilution flag See Section 4 Workflow 5 3 2 Results exceeding Linear ranges of the instrume
48. Edit Creation or review of a manual entry The sequence from one screen to the other is the following Pentra XL 80 User Manual RAB131GEN 4 51 ABX Pentra XL 80 4 52 Report List w i BIM IMN g wa ia Td Wo W 72 Wo og N ara OR IE 4 Ona W Report Edit TA Report Details Fig 4 38 Report function sequence Pentra XL 80 User Manual RAB131GEN Workflow Report 6 1 3 Report list 3 States are possible for report Validated The report succeeds to operator defined criteria and has been automatically val idated See Section 5 Settings 4 2 Biological validation conditions page 5 15 or manually see 6 1 2 Report Function sequence page 4 51 Unvalidated Default state of the report Rejected The Report failed to be validated It has been manually rejected A Validated or rejected Reports are non modifiable v function keys Heading Key Name Action Function Launches the Run results Association View see 6 5 Run order association page 4 68 Disabled if a cycle is in progress or if there is no Association key unmatched result This key is associated with a counter which indicates the number of Run Results saved in the Matching chart Checks all the Run lines in the list Select all column Selected A counter displays the number of selected Runs Unchecks all the Run lines in the list Unselect all column Selected A counter displays the
49. Floppy access key Now select the level of control you want to load Fig 3 9 Load control window A If you use a control blood with a Barcode label make sure that the reserved box has been checked see Fig 3 11 page 3 12 Confirm by selecting the OK key v Manual target value entry Select the Target key see Tab 3 1 Quality Control Keys page 3 5 to open the Target modify window select the Edit key Select the barcode field twice to keep the previous lot Fig 3 10 Control Lot Read the label with the external Barcode reader or manually type in the lot Use the Tab key to move to the next field or entry Confirm your entry by selecting the OK key If you use the control blood with a barcode label make sure that the reserved box has been checked see Fig 3 11 page 3 12 Pentra XL 80 User Manual RAB131GEN 3 11 ABX Pentra XL 830 2002 0478 Gl KERON Use the scrolling box key to open a calendar and Es April 2002 Tg select the expiration date Mon Tue Wed Thu Fri Sat Sunf Modify or enter target values by selecting the area Bae ee T in which you want to replace the value Fig 3 11 Control expiration date ee PENTRA xL 80 Modify Target le nE 05 05 2002 x na ee S E ir Fig 3 12 Manual entry of target value By selecting the tab Threshold you can also modify threshold and Alarm levels 3 12 Pentra XL 80 U
50. LYMPHOCYTES MONOCYTES Ly ATYPICAL LYMPHOCYTES ALY LARGE IMMATURE n 2 CELLS LIC a Fig 6 20 LMNE matrix results LYMPHOCYTES The Lymphocytes are a very small round shaped cell with condensed cyto plasm and large nucleus These cells are normally positioned in the lower part of the optical Y axis as well as the lower part of the volume X axis because of their small size The far left side of the lymphocyte zone LL should normally be empty Any detection of cells in the LL zone will indicate Small lymphocytes Platelet aggregates NRBC s Nucleated Red Blood Cells and improperly adjusted flowcell alignment Background noise may also be detected in this zone if the interference is great MONOCYTES The Monocytes are a very large irregular shaped cell with large convoluted nu clei The nucleus contains folds and sometimes vacuoles The cytoplasm is also large with non granular intra cellular material These cells will not scatter or absorb a large amount of light when passing through the flowcell They will therefore be positioned in the lower part of the optical Y axis Because the monocytes are a large cell they will be placed to the right of the volume X axis 6 20 Pentra XL 80 User Manual RAB131GEN Description amp Technology NEUTROPHILS The Neutrophils are larger in size than the lymphocytes The neutrophils con tain granular material in their cytoplasm along with a segmented nucleus Due to these cellul
51. Manual RAB131GEN 4 23 ABX Pentra XL 80 2 4 3 Rack view functions The operator is able to select an Empty tube to directly enter a new order specifically to this position If a rack is currently being processed order entry is not allowed If the tube position is not empty sample and patient information are displayed 2 4 4 Printing the rack view From the rack view screen Select the Print send key Worklist Man LABORATORY UNIT 1 Unknown ABX e e AUTO SID13 Standard Unknown Technician e e AUTO SID14 Technician e Fig 4 18 Rack view print out The rack view printout ticket shows the patient informations the sample informations the clinical informations 4 24 Pentra XL 80 User Manual RAB131GEN Worktlow Sample collection amp mixing 3 Sample collection amp mixing All blood samples should be collected using proper technique AA Consider all Specimens Reagents Calibrators Controls etc that contain human C2 blood or serum as potentially infectious Use established good laboratory working practices when handling specimens Wear protective gear Gloves Lab coats Safety glasses and or Face shields and follow other bio safety practices as specified in OSHA Blood borne Pathogens Rule 29 CFR part 1910 1030 or equivalent bio safety procedures When collecting blood specimens Venous blood is recommended but Arterial blood may also
52. Methods and technologies Multi Distribution Sampling System MDSS Customised Dilution Ratio CDR v Measurements and computations Impedance for WBC PLT RBC BAS Photometry for HGB Impedance and light scattering for LYM MON NEU EOS ALY and LIC Computation from stored data that was directly measured for HCT MCV MCH MCHC RDW MPV PCT and PDW Pentra XL 80 User Manual RAB131GEN e a S P e mes y ge we F r a na co 1 EIL TIinrnra C III E CA KL LO L 1 AaS 2 Physical specifications 2 1 Power requirements Power supply from 100 Vac to 240 Vac 10 AN AE SE A E IT TN 50 Hz to 60 Hz Power consumption ooo oo Maximum 230 VA Heat output Max 670 Kjoules h 635 BTU h PONE sana osni nenen Depends on printer model P an teat Ann NN See printers manual 2 2 Operating temperature and humidity 6 16 34 C 61 93 F room temperature Maximum relative humidity 80 for temperature up to 31 C 88 F decreasing linearly to 50 relative humidity at 40 C 104 F 2 3 Dimension and weight DIMENSIONS oooooooooc Wc Woo 82 x 57 x 54cm Pa Na naa 32 3 x 22 4 x 21 5 in We WEI na Naa an Na Na 55 Kg PN aa ciate ea cia TOEA T SA 122 lbs 2 4 Minimum specimen volume CBC Mode CBC senat ennsn 30uL CBC 5DIFF Mode DIFF ooco oo 53ul 2 5 dilution ratios MWC PAS peta sant non ate aan ana 1 200 SUN nm st
53. Print all the results Print statistics only Fig 3 6 QC print options v L J graphs L J graphs can also be printed from the L J Graphs screen When in this screen select the data to be printed then select the Print Send key 1 5 2 Sending results to the LIS Enter into the Data Grid screen see Fig 3 4 page 3 7 Select the Print Send key and choose an option Selected or All results Now select the Send key Selected results will now be sent to the host computer 1 5 3 Deleting results v Graphics screen You can only delete the last QC result from the Graphics screen Select the Delete key see Fig 3 5 page 3 8 using the Delete key Pentra XL 80 User Manual RAB131GEN Ouality control ABX Pentra XL 80 v QC Data Grid Multiple results can be selected and deleted from the QC Data Grid Once the grid has been opened the Delete window becomes available see Fig 3 7 page 3 10 Delete options Selected C Unselected ls CAI Fig 3 7 QC delete options 1 6 New blood control setup It is most necessary to enter all required information related to a new lot of control blood before any QC analysis can take place on such a lot Target values Parameter ranges Alarm levels 5DIFF Matrix thresholds and other control blood characteristics should be entered pri or to the analysis of the new lot v Selection of a control Select the Target key
54. Printout example Report Printout Unvalidated Final report date DAD 2008 15 16 18 Type Standard Haku Analyzer Alanna b20 pnn Microscopic Examination Arisocytoss CI Io Neutropnis Hypochromia T Bands Poyohromasda Lymphocytas Polkilocytosii 1 Monocytes Micronytiosis Eodnophis Mocrooytoss Bosophils PLT Clumps Total MRE a Outat Panie Range Our of Normal Range Fig 5 25 Result printout Pentra XL 80 User Manual RAB131GEN 5 33 ABX Pentra XL 80 5 4 2 Printer properties lt EPSON EPL 5800 Advanced Default Toner Save Off Fig 5 26 Printer properties example 5 34 Pentra XL 80 User Manual RAB131GEN Settings System 5 5 Cycle option To modify one of the cycle option select the Edit key and use the following functions PENTRA XL 80 System 17 00 00 Fig 5 27 System Cycle option tab Heading key Function Default value Number of analyses performed to trigger the autoclean Autoclean Freguency yes 100 Startup Startup cycle is automatic at begin of day if checked Checked o Shutdown cycle is automatic at the programmed time Checked if checked Workflow notion approximate number of DIF amp CBC Daily workload analyses per day Used to warn the operator if reagent level is too short for the working day Options described in Daily Guide RAB156C when the Begin of Day occurs are available if 1 the instrument i
55. Restore setting from hard disk Opens a dialogue window in order to select one of the save settings Opens a dialogue window in order to select the save path of the current Save setting on floppy configuration on a disk If the floppy is unformatted the software then invites the user to format it Opens a dialogue window in order to select one of the save settings on Restore settings from floppy edk Tab 5 14 Workstation save restore 6 2 3 Update of the online help The User Manual CDROM includes the user manuals in all languages English Italian Spanish Portuguese German Danish Swedish Greek and French This one contains the User manuals in a PDF format for printing and reviewing operations It also includes last update of the online help file This one can be easily installed on your Pentra XL 80 using the Help Update key as follows Insert the CDROM into the instrument CD drive Open the Settings Save and Restore settings screen Press the Update help key to access to User manual screen The contents of this CDROM can be reviewed on all PC having an Acrobat reader software installed version 5 0 or high er Choose your language The Print pdf key opens the user manual in Acrobat reader software in order to be read or printed The View HTML key opens the online help recorded on the CDROM The Install Help key will install the new online help from the CDROM on your instrument
56. The XB Patient Ouality Control is used to detect any change in the guality of results by use of patient data only This data monitoring is performed without any user intervention and can be applied to a set of 9 parameters WBC RBC HGB HCT RDW PLT MCV MCH MCHC or 3 parameters MCV MCH and MCHC The operator makes the selection of parameters based on their own population studies See Section 5 Settings 3 2 XB options page 5 12 The XB data can be processed as follows All the analyses associated to a patient analysis that is not associated with a Calibrator or a Quality Control blood and in the Standard Male Female or Child types which have neither Reject nor null value on a parameter nor DIL flags on WBC or HCT nor Invalidities nor SCL MIC or SCH flags and PLT result When a total of 20 results are archived an XB batch is computed The batch data commutated is the mean result for all 20 analyses contained in that specific batch The date of computation of the batch values is noted as the batch date An XB alarm occurs when the calculation of the last batch shows a point located outside of the limits set by the operator see 2 5 XB limits page 3 19 The operator can disable this alarm A maximum of 60 batches can be stored within the software v XB section includes 2 1 Access to the XB menu page 3 15 2 2 XB Graphs page 3 16 2 3 XB Data Grid screen page 3 17 2 4 Batc
57. Troubleshooting Maintenance amp Iroubleshooting procedures The following section provides Pentra XL 80 maintenance and troubleshooting information including Maintenance amp Troubleshooting procedures page 7 3 Replacement procedures page 7 9 Instrument panels amp cover Removals page 7 19 Service menu description page 7 22 Troubleshooting page 7 37 Hydraulic diagram page 7 43 Ad Go Ut A W PO FF Error messages page 7 44 1 Maintenance amp Troubleshooting procedures 1 1 Hydraulic cycles maintenance chart table One of the main contributing factors to accurate and reliable results is an instrument that is maintained on a constant basis and correctly performed by the operator Several maintenance functions are available on the system for the user to clean and check the instrument The frequency of maintenance cycles depends upon the number of analysis cycles per day Perform the instrument maintenance according to the chart table Maintenance Sample output Analyses per Day Cycles Startup 1 per day 1 per day Shut down 1 per day 1 per day Concentrated cleaning 1 per month 2 per month 1 2 Maintenance procedures Operations Frequency Each time a low level reagent ioccurs keagent replacement see 2 1 Reagent replacement page 7 9 On request see 2 2 Optical bench lamp replace Optical bench lamp replacement ment page 7 15 On request see 2 3 Sampling probe replacement
58. VOC ana an na ON AE 3 34 5 3 Quality COMI OF 1085 maa 3 34 SAR open Op 9 T ant 3 35 oes re ci 1019 ea an ee ree EE eee ree EN 3 35 5 6 Maintenance NOS Os gene cteetizcceneanunsoged noten dane On AR Nabati 3 35 Dig MUON E e en ea A sana 3 35 Pentra XL 80 User Manual RAB131GEN 3 1 ABX Pentra XL 80 O E e E 3 35 5 9 Blank Cycle Ogs anestesi ma anisa on iei 3 35 OPa MOP E E 3 36 511e Logs Diona memanas 3 36 Pentra XL 80 User Manual RAB131GEN Ouality Assurance The Quality Assurance menu is accessible by selecting the Quality Assurance key from the Main Menu screen Fig 3 1 Quality Assurance access key Four functions are available in this menu Quality Control see 1 Quality control page 3 4 XB see 2 Patient Quality Control XB page 3 14 Within Run see 3 Within run page 3 21 Calibration see 4 Calibration page 3 25 Logs are described in 5 Logs page 3 32 Pentra XL 80 User Manual RAB131GEN ABX Pentra XL 830 1 Ouality control The Quality Control allows the monitoring of a set of analyses based on known samples over a period of several months Statistical computations performed on these populations allow the extraction of qualitative information related to the stability of the instrument A total of 24 Control lots can be saved in Quality control All QC functions are described in the following sections 1 1 Access to the Quality Control Menu page 3 4 1
59. WBC result D displayed and printed D displayed and printed sees WBC result 0 transmitted to the LIS 0 transmitted to the LIS Parameter Visible range gt Visible range LYM MON NEU EOS BASO ALY LIC reported to RBC result D displayed and printed D displayed and printed RBC rell RBC result O transmitted to the LIS O transmitted to the LIS MCV MCH MCHC and RDW reported to RT HGB result D displayed and printed D displayed and printed ecules HGB result 0 transmitted to the LIS O transmitted to the LIS MCH and MCHC reported to HCT result D displayed and printed D displayed and printed sie HCT result 0 transmitted to the LIS O transmitted to the LIS MCH and MCHC reported to PLT result D displayed and printed D displayed and printed ecules PLT result O transmitted to the LIS O transmitted to the LIS for HGB gt 2g dL MPV PCT and PDW reported to PIT PLT result D displayed and printed D displayed and printed for HGB lt 2g dL result PLT result 0 transmitted to the LIS O transmitted to the LIS Bye PLT gt 15X10 mm MPV PCT and PDW reported to Tab 4 5 Results exceeding Linear ranges of the instrument ABX format A Platelet Concentrat
60. XL 80 Hydraulic System fess leat Io iS al aan on all sa Sa ALA cdl IS Ii Fig 7 37 Super User Hydraulical Clean Cycle 1 Concentrated Cleaning Allows to clean chambers with a bleach solution 2 BackFlush This cycle allows the user to clear the counting chambers with counter pressure in case of aperture blockage 3 Rinse Cytometer This cycle allows the user to backflush the LMNE flowcell with ABX Diluent to rid the counting area of air bubbles and or blockage 4 3 5 Concentrated cleaning remove the right hand side panel see 3 Instrument panels amp cover Removals page 7 19 to access to the chambers Select Concentrated Cleaning key then press Validate key in the following window to con firm the cycle see Fig 7 38 page 7 34 Warning cd x4 Fig 7 38 Concentrated cleaning confirmation The cycle starts when the following window is displayed see Fig 7 39 page 7 35 and be 7 34 Pentra XL 80 User Manual RAB131GEN Maintenance amp Troubleshooting Service menu description fore pressing Validate key pour into each chamber 3ml of Minoclair or bleach diluted to 4 chloride see Fig 7 40 page 7 35 PENTRA 80 AN Pour 3 ml of ABX MINOCLAIR into chambers Press Enter To Continue Fig 7 39 Concentrated cleaning pour Minoclair Fig 7 40 Pour Minoclair Select Validate key once Minoclair has been distributed into all the chambe
61. a blood sample A preparation made of human blood with stabilized cells and surrogate material used for dailyinstrument quality control See performance characteristics An expression in percent of data SD spread related to the mean CV SD mean x100 A substance used for monitoring the performance of an analitycal process or instrument See Coefficient of variation An original factory setting The last day that you can use that specific lot number of reagent control or calibrator Abbreviation for femtoliter One quadrillionth 1015 of a liter An area on a screen for entering data on printouts or screens letters or symbols that appear next to parameter results to indicate specific conditions The ability of an instrument to recover expected results reference values or calculated values for such parameters as WBC RBC Hgb and Plt at varying levels of concentration of these parameters within specified limits Pentra XL 80 User Manual RAB131GEN LIS lot number mean order operating range parameter performance Platelet concentrate PRP Quality control QC reproductibility SD Shutdown cycle Specifications Startup cycle Verification Whole blood Glossary amp Index Abbreviation for Laboratory Information System A manufacturer s code that identifies products such as reagents controls or calibrators Arithmetic average of a group of data Set of data used for the request of the an
62. aa adat 1 80 RBC PLT csccceseccessccccsscccesscccesecceesceeeees 1 10000 TAGS E E E E E 1 250 2 6 HGB measurement HGB chamber LED 555 nm Modified Drabkin method cyanmethemoglobin Light source co Electroluminescent diode Wavelength ooooo oo 550nm 10nm Pentra XL 80 User Manual RAB131GEN Physical specifications 2 5 ABX Pentra XL 80 2 7 Counting aperture diameters WBC BAS ccccccceceseececececcecsceseecacececeeraceceees 80um We AINE taon aa 60um RBC PLT c ccccsccececececcecececcscsceccesscececcaceceees 50um 2 8 Reagent consumption ml Gules Estimated Diluent Eosinofix Basolysell Cleaner duration ml ml ml ml CBC DIFF 0 45 27 6 1 0 2i Ti CBC 045 21 6 2 0 1 1 Prime Diluent 300 47 6 Prime Eosinofix 134 1 6 23 7 Prime Basolyse 2 ier 17 23 7 1 0 Prime Cleaner 124 17 24 7 Prime Lyse 131 2 7 Prime all 7i 47 6 24 0 24 0 25 0 att aes 3 35 61 2 0 5 1 21 Shut Down 4 00 33 5 1 0 1 0 19 1 Rinse Cytometer 130 5 0 Autoclean 133 28 2 1 0 1 0 1 0 Miniclean 038 10 9 1 0 2 0 1 0 ros Tee 39 1 1 0 1 0 1 0 Backflush 035 Tab 2 3 Reagent consumption software version v1 6 1 A OY control It could be a maximum of three cycles 2 9 Compatible tube list See Section 8 Annex 3 Compatible tube list page 8 6 Pentra XL 80 User Manual RAB131GEN 0 41 0 41 8 4 8 4 1 0 0 5
63. abnormal granules degranulated areas toxic granules may interfere with the eosinophil count ing BAS Basophil cell count absolute BAS Basophil percentage The Basophil cell count is derived from the WBC cell count v Over evaluation in the Basophil count Excessive number of leukocytes leukocytosis can cause artificial rise in the number of counted basophils due to the shifting of the leukocytes population in the zone of the basophil ones Monocytes and Blasts show large granules and may shift on the basophil counting area This may interfere with an accurate count An abnormally low number of leukocytes leukopenia may increase too the basophil results The elements present in the zone of basophil are brought back on a small total quantity of leukocytes which increases the statistical error and may cause variabilities in the percentage The weakness of leukocyte cells shown in certain diseases Chronic Lymphocytic Leukemia or during anti cancer treatment chemotherapy can be translated on the basophilic channel by under evaluation of the leukocytes because of their destruction and thus cause a statistical increase in the basophil ones v Under evaluation in the Basophil count During leukemia basophils may lose their cytochemical characters and react abnormally with the reagent The destruction of the basophil cytoplasms prevents their differentiation with the other leukocytes The basophils with very small siz
64. and PDW should be restricted to research and Investiga tional measurements only Pentra XL 80 User Manual RAB131GEN Specifications Technical specifications LYM Lymphocytes and NEU Neutrophils and BAS Basophils and ALY Atypical Lymphocytes and HGB Hemoglobin Concentration MCV Mean Corpuscular Volume MCHC Mean Corpuscular Hemoglobin Concentration PLT Platelets MPV Mean Platelet Volume Tab 2 2 DIFF parameters PCT PDW ALY and LIC have not been established as indications for this product in the United States The use of PCT PDW ALY and LIC should be restricted to re search and Investigational measurements only 1 3 Throughput Analyses 80 samples per hour Pentra XL 80 User Manual RAB131GEN 2 3 XL 1 4 Tube identification By means of Keyboard internal and external Barcode 1 5 Reagents ABX Diluent 20 or 10 Litres ABX Cleaner 1 Litre Integrated ABX Eosinofix 1 Litre Integrated ABX Basolyse II 1 Litre Integrated ABX Alphalyse or ABX Lysebio 0 4 Litre Integrated 1 6 Internal Computer Capacity 10 000 results graphics Color LCD touch screen 12 inches Industrial PC board Windows XP Processor frequency ooo Celeron 566 MHz Me RAN ea ea ree eee 256 Mb Hard Ori VE emo naa semuaa 10 Gb mini Floppy disk e CD ROM drive RS 232C Ethernet USB Keyboard Mouse 1 7
65. and erase the previous one Pentra XL 80 User Manual RAB131GEN 5 37 ABX Pentra XL 80 6 3 Dump database PENTRA XL 80 Save And Restore Settings u pa Mon Tue Wed Thu Fri Sat Sum NE 17 NO AG DA 2 1 1 D j 20 a 3U 9 10 11 13 14 15 16 17 18 19 20 21 22 30 1 2 3 4 5 6 CD Today 06 12 2003 2 3 4 5 6 7 8 06 12 2003 09 27 51 Tale iS 04 08 2003 17 29 59 eo Fig 5 29 Database maintenance tab Heading key Function Upon confirmation deletes all orders runs and results and associated patients prior to the selected date A notification is made in the logs Delete data before this date Tab 5 15 Database maintenance key 6 4 Report exportation 6 4 1 Monthly exportation Once a month it is possible to save the reports that have been deleted by the operator on an external media floppy disks or network hard disk in another format than the one used by the Pentra XL 80 The format used to export the reports is compressed XML This one can be easily exploited by a standard browser Internet Explorer 5 for example but can not be re imported on the Pentra XL 80 All the reports that are deleted in the current month are stored to be exported at the begin ing of each month if required by the operator This exportation is performed during the Begin of day sequence of the new month See Daily Guide RAB156C To configure Report exportation a
66. be used in extreme cases Blood collection must be placed in a Vacuum or atmospheric col lection tubes For additional information on collecting venous and capillary blood samples refer to NCCLS document H3 A4 and NCCLS document H4 A4 sept 1999 The sample collection tube has to be filled to the exact quantity of blood indicated on the tube itself Any incorrectly measured blood sample collections will show a possible variation in the results 3 1 Recommended anticoagulant The recommended anticoagulant is K3EDTA with the proper proportion of blood to anticoag ulant as specified by the tube manufacturer K2EDTA is an acceptable alternative as long as the sample collection is made in normal con ditions Otherwise blood clots may be possible 3 2 Blood sample stability Specimens may be used between 15 20 minutes after collection The results on all parameters depend on the mode of conservation of the sample Depending on the parameter to be measured the sample stability may be upto 48 hours Refer to Section 2 Specifications 3 Summary of performance data page 2 7 3 3 Microsampling The Open tube sampling mode enables the user to work with 100ul microsamples for pe diatrics and geriatrics 3 4 Mixing The cap piercing mode performs an automatic pre mixing cycle by rotation which lasts ap proximately 1 minute For the open tube mode blood samples must be gently and thoroughly mixed just before plac ing
67. count of the WBC s in the WBC BASO chamber a second WBC count is per formed from the injected volume through the LMNE optical flowcell The two counts are compared If the difference between the LMNE and WBC BASO counts are higher than the defined threshold depending on the quantity of cells measured a LMNE or a LMNE flag will be generated based upon the following conditions The WBC count is within 0 and 2501 If the WBC LMNE count is 50 higher than the WBC BAS count a LMNE flag will be generated If the WBC LMNE count is 50 lower than the WBC BAS count a LMNE flag will be generated e WBC count is within 2501 and 8000 If the WBC LMNE count is 20 higher than the WBC BASO count a LMNE flag will be generated If the WBC LMNE count is 20 lower than the WBC BASO count a LMNE flag will be generated WBC count is higher than 8000 If the WBC LMNE count is 15 higher than the WBC BASO count a LMNE flag will be generated If the WBC LMNE count is 15 lower than the WBC BASO count a LMNE flag will be generated The WBC BAS channel is considered as a reference and is used to calibrate the WBC LMNE channel The calculated ratio between the two channel calibration coefficients is stable ex cept during technical intervention In any case it is the WBC BAS result that is reported The WBC balance flags will appear in the Analyzer alarm area A The WBC balance flags LMNE and LMNE are activated only if t
68. flow call sheath Ter sheath 2 Change the RBC sampling circuit add 2 valves 36 amp 37 04709706 2087 3 J YY LV4 Flow cell sample supply Opens pathway from the DIFF bath to the flow cell The tubing TG2 06 was 1 52 between Valve 12 2 to Reagent Heater 10 and Reagent Heater 12 to 1 6 fitting 26 06 06 2087 14 1 er 4 A Ys LV5 Fl LL le inject 0 t th f le LMNE i Flow cell sample injector Upens waste path for sample syringe The tubing TG2 06 60 was 1 52 between Reagent Heater 9 and 11 24 03 06 1208714 H LV6 R tput trol Select e to probe rinse block or WBC BASO bath Design amp Symbol ea Change the TYGON 2075 by TYGON Tubing from WBC BASO 3 fo RBC_3 chamber 01 09 05 2087 9 G_ Designation PENTRA 80 ae oe Al ee eee nen flow cell and aN Minato aan aing AN Change the TYGON by TYGON 2075 tubing on Basolyse Il circuit from bottle to WBC BASO chamber 2 and WBC BASO 3 RBC 3 chamber 15 07 05 2087 9 F HYDROPNEUMATIC DIAGRAM Elena Manutaetaring and RI count valve Opens vacuum count line for an a The tubing 1 52 50 was 40 between E3 ground connector and M2 photocell ADC 08 06 05 2087 1 E Standard tol R h 5 LV17 Waste syringe 2 vent Opens waste vent through the rinse chamber andar oterance ouqnness efer to LV19 Diluent reservoir fill Opens reservoir vent and fill it with drain syringe 2 Rotate and move the T11 connector from M2 cell to LV33 28 02 05 2087 11D Matari LV24 Waste syringe 1 vent Opens waste vent through t
69. of whole blood is aspirated then delivered into the following chambers as indicated kasa m Diluent One segment of sample for the Dilution Ai chamber which is used for the RBC PLT it dilution and the Hemoglobin 7ul discarded measurement 10ul WBC BASO The other segment of sample is used for o 10ul RBC PLT HGB the WBC BASO count 8 3ul discarded Fig 6 10 Segment distribution in CBC mode 3 1 2 Diff Mode While in the DIFF Mode 53ul of whole blood is aspirated then delivered with into the following chambers as Diluent indicated Air One segment of sample for the Dilution Sul discarded chamber which is used for the RBC PLT Bean Differential dilution and the Hemoglobin E 10W WBC BASO Diaa a 10W RBC PLT HGB The second segment of sample is used for the WBC BASO count 8 Syl discarded The last segment of sample is used for the LMNE chamber from which the sam ple is taken into the flowcell for the Fig 6 11 Segment distribution in DIFF mode LMNE count Pentra XL 80 User Manual RAB131GEN 6 11 ABX Pentra XL 30 3 1 3 Sample distribution Each segment of sample is distributed into the chambers by means of a Tan gential flow of reagent This flow allows for perfect mixing of each dilution and avoids any viscosity problems This tan gential flow process is patented by HORIBA ABX Fig 6 12 Sample distribution in a tangential flow 6 12 Pentra XL 80 User Manual RAB131GEN
70. see NO flag page 4 35 5 3 4 Suspicion flags v Plt A suspicion flag on PLT parameter indicates the detection of a possible anomaly during platelet count Conditions Triggered flag Consequences If PLT message Platelets Aggregates occurs and if PLT lt PLT l PLT low Normal limit defined by the user as described in 5 3 1 Normal and panic ranges page 4 30 os ly on PLT and Plt result needs to be If MCHC or MCH parameters are outside Panic limits defined by confirmed according the user as described in 5 3 1 Normal and panic ranges a AME to boost page 4 30 Working Practices If PLT lt 120x10 mm in CBC mode only If PLT lt 120x10 mm PDW gt 20 in DIFF mode only A No automatic validation can occur when PLT parameter has been suspected Pentra XL 80 User Manual RAB131GEN 4 33 ABX Pentra XL 80 4 34 v Hemoglobin A suspect flag is generated if two consecutive Hemoglobin blank measurements are dif ferent from the pre defined value in Settings Type Parametering Alarms and Curves Threshold Tab Alarm Level Gnd HGB parameter absolute value See Section 5 Settings 8 3 1 Alarm levels page 5 47 A suspect flag is generated if the three Hemoglobin measurements are different from the pre defined value in Settings Type Parameterising Alarms and Curves Threshold Tab Alarm Level Grid HGB parameter percent value See Section
71. see Tab 3 1 Quality Control Keys page 3 5 in order to open the Target modify window Scroll through the Control name list and select the control you would like to modify From 1 to 12 reserved to CBC control from 13 to 24 reserved to DIFF If you need to modify the target values or lot proceed as described in Target initialization by floppy page 3 10 or in Manual target value entry page 3 11 v Target initialization by floppy Each order of Blood controls ABX DIFFTROL comes with a floppy disk so that the operator can insert the disk and update the new control lots without any manual entry of data Lot Target values and Ranges Alarms and Thresholds and Expiration Date are included on the floppy disk for each level of control Select the Target key see Tab 3 1 Quality Control Keys page 3 5 in order to open the Target modify window Now select the Edit key When modifying a control lot analyses from the previous lot must be either erased or saved A Warning message will be displayed Selecting the Yes key will delete all previous control lot information Selecting the No key will recalculate previous Control quality statistics accord ing to the new lot targets 3 10 Pentra XL 80 User Manual RAB131GEN Ouality Assurance Ouality control Insert the floppy disk into the drive Select the Edit key then the Floppy disk key see Fig 3 8 page 3 11 Fig 3 8
72. stabilized with Diluent and transferred into the LMNE flowcell Each cell is mea sured in absorbance Fig 6 18 DHSS principles cytochemistry and resistive vol ume impedance changes Technical characteristics of the WBC counts during the acguisition of the matrix Initial blood volume 25 ul Method Impedance with hydrofocus Vol ABX Eosinofix 1000 ul Aperture diameter 60 um Diluent Volume 1000 ul Flow diameter 42 ym Final dilution rate 1 80 Injection duration 12 s Temperature of reaction 352 Volume injected 72ul Incubation duration 12s Tab 6 4 WBC counts 6 18 Pentra XL 80 User Manual RAB131GEN Description amp Technology Measuring principles No cell in the flowcell Baseline Poorly stained agranular cell in the flowcell Low absorbance Hyper segmented with complex gra nularity and staining High absorbance Fig 6 19 Absorbance measurement Pentra XL 80 User Manual RAB131GEN 6 19 ABX Pentra XL 80 v Results From the Absorbance and Resistive measurement of the leukopcytes a matrix is developed with cell volumes on the X axis and optical transmission on the Y axis Study of the matrix image allows a clear differentiation of 4 of the 5 leukocyte populations Due to the low per centage of Basophils in comparison to the rest of the leukocytes they have a separate measurement of their own instead of being present in the matrix absorbance NEUTROPHILS FOSINOPHILS
73. temperature b If temperature is not reached call your HORIBA ABX representative service department Calibration verification out of acceptable limits a Clean the system see 4 3 4 Clean Cycles page 7 34 and re run the control b Run a new vial c Calibrate the instrument Section 3 4 Calibration page 3 25 v Procedure 4 Sampling probe Sampling probe a Check probe motion see 4 2 2 Check motors page 7 24 b Open the righthand side panel to access to the chambers Section 7 3 3 Right hand side panel removal page 7 20 c Run an analysis cycle on blood d Control the specimen aspiration Blood delivering in the chambers e Check the probe is not bent v Procedure 5 Dilution Carriage motion a Check that hydraulic operations appear to work properly Reagent level in each cham ber and carriage motion 7 38 Pentra XL 80 User Manual RAB131GEN Maintenance amp Troubleshooting Troubleshooting Sample distribution a Run an analysis cycle and check that specimen distribution is performed correctly into chambers b A probe rinse is previously carried out in the rinse chamber 1 Blood appears in this chamber c The first specimen is delivered to the first dilution chamber 2 Brown colour the second to the WBC Baso chamber 5 Clearer and the third one to the LMNE chamber 3 The darkest d Check that bubbling is provided to these chambers once the speci
74. tested using available Low Range and Full Range Linearity Test kits The Test kits were analyzed and data was computed according to the Manufacturer s instructions w Human Blood Linearity was also obtained on human blood using a minimum of 5 dilution points The re sults of this study are as followed Pentra XL 80 User Manual RAB131GEN ABX Pentra XL 80 Y Error Limit Linearity Linearity Visible Parameters ere which ever is Range Limits Range greater WBC 10 mm 0 45 124 0 120 120 150 0 3 7 5 RBC 10 mm 0 22 8 9 0 8 0 8 0 18 0 0 07 t3 Yo HGB g dl 1326 0 24 24 30 0 3 3 HCT 1972 Oo 67 80 ze 210 3 PLT 10 mm3 7 2087 0 1900 1900 2800 10 12 5 for HGB gt 2 g dL PLT 102 mm3 5 2792 0 2800 2800 3200 10 12 5 for HGB lt 2 g dL PLT gt 15X10 mm Tab 2 8 Linearity source 510K submission K024002 3 4 Carryover Carry over effects were evaluated by assaying a sample with high cell concentrations three consecutive times 11 3 followed immediately by testing a diluted sample consecutively 3 times j1 3 Carry over is then ji 33 Carryover x100 13 j3 The overall results gave the following Mean low levels 0 78 1 047 4 09 28 67 Mean high levels 43 64 8 56 25 94 739 00 Carry over 0 070 0 268 0 046 0 286 Tab 2 9 Cary over table This is the method as described in Guidelines for the Evaluati
75. tion Pentra XL 80 User Manual RAB131GEN 7 47 ABX Pentra XL 30 7 48 Alarm Loader Left Sensor Error Loader Right Sensor Error Lower Piercing Sensor in Wrong Position Mismatch Between the First and Second Barcode Tube Read on Rack d Pos d No diluent in analyzer reservoir Printer alarm Printer module closed QC Failed Rack Moving Left Sensor Error Rack Moving Right Sensor Error Rack not identified Reagent level too low for daily workload Reagent level too low to run a analasys Reagent level too low to run a rack Result not stored RS232 alarm Sample ID d already in progress LIS communication module closed Tube Detection Sensor in Wrong Position Tube Level Detection Sensor in Wrong Position Two racks with same ID d in transfer rail Unable to launch print module Unable to launch SIL communi cation module Unloader Sensor in Wrong Posi tion Upper Piercing Sensor in Wrong Position Error Type Sensor state Sensor state Sensor state Barcode Incorrect level of diluent into reservoir Printer problem Software QC Failed Sensor state Sensor state No read of Rack Barcode Label Out of Reagent Out of Reagent Out of Reagent Software RS232 external problem Software Software Sensor state Sensor state Barcode Software Software Sensor state Sensor state Pentra XL 80 User Manual RAB131GEN Help Message Run an i
76. tomatic biological validation One among three criteria must be chosen Manual validation This is to disable the automatic validation The reports remain unval idated and can be manually validated or rejected Unconditional validation All the reports are automatically validated apart from un matched reports Validation criteria the operator must choose the criteria that if triggered will unvalid the report Only one criteria present in a report is enough to unvalid it When these cri teria are selected a report will be unvalidated if hematological results trigger alarm L1 LL1 MB or Pentra XL 80 User Manual RAB131GEN 5 15 ABX Pentra XL 80 hematological results are beyond their parameter limits which are defined by the user see 8 2 Pathological limits page 5 46 or trigger Delta check alarms or samples that are rejected PENTRA XL 80 Rul CE U E G E U U E U H E CE S E E U E E E E E EI CE G E G U U E E U U EI RESES III ea ea ea a lka ka M M M M M M M M M M M M M M M M M M M Vd90900009 0900000000009 CE E E U E H Be E E E E CE E E E E H K K KI KI KI KI KI RESI lt I lt I lt I lt I CE E D E E ECI E E E E E E Fig 5 11 Biological validation tab For modification of the Biological Validation Conditions proceed as followed Select the Edit key Select the Criteria If Validation criteria has bee
77. valve Tab 8 2 Compatible tube position 2 Because of the cap thickness and the lack of space between the holder and the top of the tube the holder may not open correctly Requires an additional adjustment procedure in the Menu Service Super User Menu Wechanical Sys tem Holder Adjustment adjust The Level on Position 2 to 8 0 instead of 3 0 See Section 7 Maintenance amp Troubleshooting 4 2 6 Sample tube Holder adjustment page 7 28 Pentra XL 80 User Manual RAB131GEN 8 7 ABX Pentra XL 80 3 1 3 Tube holder position 3 Comar R amp D system TX2B 185331F 2 2ml Without cap with thread Tab 8 3 Compatible tube position 3 3 1 4 Tube holder position 4 Sarstedt 901091 0 5ml Ba J Without cap Unlostable ormat Out of Kabe ABX3001001 0777008RED 0 5ml Aan Without cap Unlostable Tab 8 4 Compatible tube position 4 The tube accepts a small sticker not supplied by the manufacturer 3 1 5 Tube holder position 5 condition Out of Becton D Microtainer 365975 0 5ml f Without cap Microgard orma Tab 8 5 Compatible tube position 5 The tube accepts a small sticker not supplied by the manufacturer Cap fitted with an adaptator Requires an additional adjustment procedure in the Menu Service Super User Menu Mechanical System Holder Adjustment adjust the Level on Position 5 to 10 0 instead of 3 0 See Section 7 Maintenance amp Troubleshooting
78. when the number of particles coun ted in this area is higher than the limit setup in RN or when the number of parti cles counted regarding the total number of WBC is above the RN limit Suspected abnormalities e Large neutrophils e Immature cells from granulocyte hemo poiesis metamyelocytes myelocytes promyelocytes This flag is associated with an on NEU NEU LIC LIC Pentra XL 80 User Manual RAB131GEN 4 39 ABX Pentra XL 30 v LIC flag Absorbance NoN LMD RM Resistivity Fig 4 30 LIC flag Standard value for LIC 3 0 3 See Section 5 Settings 8 5 Defaults settings of the Pentra XL 80 types page 5 51 v ALY flag Absorbance NoN NoE Channel 127 LMD RM Resistivity Fig 4 31 ALY flag Standard value for ALY 2 5 0 25 See Section 5 Settings 8 5 Defaults settings of the Pentra XL 80 types page 5 51 4 40 Pentra XL 80 User Manual RAB131GEN Meaning Large Immature Cells Presence of a significantly large population of cells located on RN RM channel 127 areas This flag occurs when the number of particles counted in this area is higher than the limit set up in LIC or when the number of counted particles regarding the total number of WBC is above the LIC li mit See Section 5 Settings 8 2 Pathological limits page 5 46 Suspected abnormalities e Large monocytes e Hyper basophilic monocytes e Myelocytes Metamyelocytes Promye
79. window scroll the list to choose the type where the values must be pasted Now select the OK key 8 1 5 Type automatic association v Sample with known types except Standard If the type is known when the order is created or captured in the worklist this one is used to provide results v Sample with no type The default type see Tab 5 17 Types function Keys page 5 44 is automatically as sociated to provide results When the Standard type is captured in the order or defined as default type an auto matic search on Department Date of birth or Gender field is performed 1 if a type name has been entered in the department field this one is used to provide results 2 if the date of birth corresponds to one of the child age ranges see 8 4 Age range page 5 51 this one is used to provide results 3 if the Gender is known the Male or Female type is used to provide results Pentra XL 80 User Manual RAB131GEN 5 45 ABX Pentra XL 80 8 2 Pathological limits PENTRA XL 80 Types IDAE iS eco a alee lle ata Fig 5 37 Pathological limits tab A set of limits is available for each sample type The operator according to the laboratory specifications can modify these limits The limits that have been entered into the 8 different types Standard Man Woman Child1
80. your Horiba ABX representative WBC lt 0 3 10 mm RBC lt 0 03 10 mm HGB lt 0 3 g dl PLT lt 7 102 mm LMNE lt 0 30 3 Check the repeatability of the instrument by running 6 times a normal human blood without taking account of the first result See Section 3 Quality Assurance and Logs 3 Within run page 3 21 4 Deselect the first result from the results table and check that the CV obtained out on the other 5 results are lower than WBC 2 RBC 2 HGB 1 HCT 1 PLA 5 5 Run a control blood and check that the values are within the acceptable limits If not run a new control blood If the values are still out of the acceptable limits and instrument is clean blank cycles in Pentra XL 80 User Manual RAB131GEN 3 25 ABX Pentra XL 80 conformity with the values given in the manual and repeatability is correct Acceptable CV values carry out the calibration as described in Section 3 Ouality Assurance and Logs 4 1 2 Calibration procedure page 3 26 4 1 2 Calibration procedure 6 Run at least 4 times Calibrator without taking the values of the first result into account See Section 3 Quality Assurance and Logs 4 4 Running calibration page 3 28 7 Calibrate the instrument on the average of the last three results according to indications of the manual See Section 3 Quality Assurance and Logs 4 4 1 Calibration passed page 3 29 8 Run 3 times again Calibrator to check the values
81. your analysis as described in Daily Guide RAB156C mm An automatic dilution can be programmed on Pentra XL 80 when hematological re sults trigger dilution flag as described in Section 5 Settings 4 3 3 Rerun on Di lution page 5 18 When the CDR mode is used dilution not equal to 1 the dilution ratio selected will be indicated in the Run Results Tree view as shown Report Number 3 Date Runs Number Ag m Flags and Alarms 06 11 2003 13 40 09 RBC 108 mm2 502 M Morphology Flags Rack Pos Testing X 150 M MIC imr HGB g dL 5 Suspected Pathology DIFF z z 450 M HCT Pa Sie WBC Interpretation Not Pos Sample ID MCV um 90 M RBC Interpretation Not Possi 234 MCH pg 299 M Thrombocytopenia Collection Date HP 333 M C D R MCHC g dl eae RBC 1 2 Type ED o O o BM PLT 1 2 Standard Remarks Department PLT 10 mm RBC of Manual Entry SSE lle 7 WBC of the Run 06 11 2002 a Ta PLT of the Run 06 11 2003 72 eel DIFF of the Run 06 11 2003 PDW e Lomments 2a WBC 10 mm Patient ID JA Be o Patient N atient Name LYM First Name MON BJ Date of Birth Age BAS GEE 7 IT Soe ee Unknown LIC 4 gt a x 2 Version V1 Obeta6 Technician 06 18 2003 8 54 23 gt n al Fig 3 2 CDR Tree View Pentra XL 80 User Manual RAB131GEN Annex CDR mode ABX Pentra XL 30 The results issued of the CDR mode are shown within bracke
82. 0 1 4 Instrument Rinse Run this procedure before the transport of the instrument after a demonstration or before a long period without functioning 1 4 1 Instrument rinse 1 Run an Instrument general cleaning See Instrument general cleaning page 7 4 2 Remove straws from Reagent bottles and plunge them into an empty bottle 3 Remove straw from Diluent cubitainer and plunge it into the empty bottle 4 Enter Service Super User Menu Hydraulic Unprime Cycle then click the All button See Unprime cycle screen page 7 6 PENTRA XL 80 Hydraulic System Fig 7 3 Unprime cycle screen 5 Press the Validate button then repeat this cycle a second time 6 Dry the straws using absorbant paper 7 Plunge the straws in a bottle full of distilled water 8 Enter Service Super User Menu Hydraulic Prime Cycles then click the ALL REAGENTS button See Prime cycles screen page 7 7 7 6 Pentra XL 80 User Manual RAB131GEN Maintenance amp Troubleshooting Maintenance amp Troubleshooting procedures PENTRA AL 80 Fig 7 4 Prime cycles screen 9 Press the Validate button then repeat this cycle a second time 10 Run several manual cycles 11 Remove the straws from the distilled water bottle then plunge them into an empty bottle 12 Run several ALL Unprime cycles See Unprime cycle screen page 7 6 to drain the instrument 1 4 2 Syringes and carriage park Move
83. 0 connexion mode 5 3 1 General tab page 5 25 5 3 2 ABX format tab page 5 27 5 3 3 RS232 settings tab page 5 28 5 3 4 ASTM format page 5 28 5 3 5 Network settings page 5 28 The System Communication menu settings affects what information is sent to and received from the LIS This information has been configured in your system by a qualified technician using the LIS Output Format documentation P N RAAO24B 5 3 1 General tab The format the mode and the link of the LIS connexion are defined in this tab According to the format ABX or ASTM and mode chosen several options are possible Pentra XL 80 User Manual RAB131GEN 5 25 ABX Pentra XL 30 Format UNIDIR mode Communication from the PXL80 to the LIS editable disabled SOH EOT editable if UNIDIR disabled BIDIR mode Communication in both directions editable checked Read Only RS232 settings Baud rate Parity Stop Bit Flow control and Data bits see 5 3 3 RS232 settings checked Read Only editable tab page 5 28 Network settings Configuration of the Ethernet link disabled editable Soh Soh conflict Time Out before new Soh when there is a Soh Soh conflict paltan rapeh Response time Time Out in seconds for the recep edabe TRIE tion Max time Time Out in seconds before automatic eni PERAN TANI disconnection Automatical disconnect Automatic disconnection editable checked Read Only Ouery mode The guery connection mode allows th
84. 00 BA3 RM 118 Tab 5 41 Matrix Threshold values of the Child 1 type Child 2 Channel Child 2 NOL 24 RN NON 27 NL LIL 31 RMN LN 35 NE NOE 50 FLN LMN 69 FNE AL 69 FMN LMU 73 BA1 LMD 100 BA2 MN 100 BA3 RM 118 Tab 5 42 Matrix Threshold values of the Child 2 type Pentra XL 80 User Manual RAB131GEN Channel 240 Channel 118 29 51 240 Settings Sample Iypes Child 3 Channel Child 3 Channel NOL 24 RN 118 NON 27 NL 29 LL 31 RMN 51 LN 35 NE 82 NOE 50 FLN 2 LMN 69 FNE 2 AL 69 FMN 2 LMU 73 BA1 35 LMD 100 BA2 110 MN 100 BA3 240 RM 118 Tab 5 43 Matrix Threshold values of the Child 3 type Child 4 Channel Child 4 Channel NOL 24 RN 118 NON 27 NL 29 LL 31 RMN 51 LN 35 NE 82 NOE 50 FLN 2 LMN 69 FNE 2 AL 69 FMN 2 LMU 73 BA1 35 LMD 100 BA2 110 MN 100 BA3 240 RM 118 Tab 5 44 Matrix Threshold values of the Child 4 type Pentra XL 80 User Manual RAB131GEN 5 67 ABX Pentra XL 80 Child 5 Channel Child 5 Channel RM 118 Tab 5 45 Matrix Threshold values of the Child 5 type 5 68 Pentra XL 80 User Manual RAB131GEN ABX Pentra XL 0 Description amp Technology Contents 1 Pentra XL 80 description ooooooo 6 2 Tl on ata 6 2 1 2 Left side NI 6 3 loe MN ee ia N E 6 4 1 4 Stat tube holder csc vervecescnsorcdcatenecsdbivetsesdietbexevesserawieness 6 5 Ta ROI WAC WV e EAE 6 6 2 Automatic mode principles 6 7 De IEA SUI ne DINI Pes betina
85. 052 High 0 24 0 14 0 17 0 26 Eosino PX052 Normal 0 32 0 29 0 21 0 37 PX052 Low 1105 0 83 0 48 1 06 PX052 High 0 1 0 08 0 09 0 13 Baso PX052 Normal 0 05 0 05 0 03 0 06 PX052 Low 0 1 0 07 0 07 0 11 Tab 2 4 Reproducibility Standard deviation Pentra XL 80 User Manual RAB131GEN ABX Pentra XL 80 EA Ra pe a Within Run CV of run CV of Daily Aa Gaara CV Means Means CV PX052 High 4 04 3 16 3 18 4 83 WBC PX052 Normal 1 54 1 44 1 61 2 19 PX052 Low PDA 1 64 1 78 2 78 PX052 High 1 27 0 79 1 02 1 47 RBC PX052 Normal 1 2 0 93 0 87 1 38 PX052 Low 1 38 0 88 1 16 1 64 PX052 High 0 76 0 42 0 56 0 83 HGB PX052 Normal 0 59 0 57 0 55 0 8 PX052 Low 0 81 0 73 0 61 0 99 PX052 High 1 67 1 35 1 44 2 09 HCT PX052 Normal 1 58 1 57 1 58 2 23 PX052 Low 1 54 1 83 2 02 2 63 PX052 High 3 29 1 68 2 14 3 38 PLT PX052 Normal 3 34 1 93 32 4 2 PX052 Low 4 94 5 3 6 42 8 22 PX052 High 3 2 07 2 32 3 47 Neutro PX052 Normal 1 06 0 74 0 57 1 08 PX052 Low 1 58 ls 1 17 1 86 PX052 High 4 96 3 51 4 27 6 05 Lympho PX052 Normal 3 67 2 87 2 35 4 05 PX052 Low 4 52 2 61 2 83 4 65 PX052 High 7 95 6 28 3 52 7 98 Mono PX052 Normal 7 34 3 95 4 92 7 67 PX052 Low 13 82 8 88 5 25 12 75 PX052 High 11 38 6 51 8 13 12 33 Eosino PX052 Normal 10 65 9 65 7 1 12 4 PX052 Low 10 73 8 51 4 86 10 84 PX052 High 3 27 2 54 3 03 4 21 Baso PX052 Normal T 32 1 21 0 89 1 55 PX052 Low 3 29 2 18 2 34 3 64 Tab 2 5 Reproducibility CV Evaluation of Precision Performance o
86. 1 17 Super User menu Chap 7 22 Check motors Chap 7 24 Check Sensors Chap 7 26 Check valves Chap 7 26 Holder adjustment Chap 7 28 Hydraulical Chap 7 31 Mechanical Chap 7 24 Rack adjustment Chap 7 30 Sampler test Chap 7 27 System Local settings Chap 5 23 Printer Chap 5 28 Chap 5 31 RS232 settings Chap 5 28 T Temperature conditions Chap 1 10 Thresholds Chap 5 48 Troubleshooting Chap 7 37 Tube List for rack Chap 8 9 List for tube holder Chap 8 6 Tube holder door Chap 6 2 Types Chap 5 43 Defaults settings Chap 5 51 U Units Chap 5 10 User profiles Chap 5 40 W Warning and precautions Chap 1 2 Waste container Chap 7 15 Waste handling Chap 2 15 Within Run Chap 3 21 access Chap 3 21 Key Chap 3 21 Run Chap 3 22 Workflow Chap 4 3 association Chap 4 13 Barcode Identification Chap 4 5 Exception management Chap 4 11 Rack position Chap 4 8 Sample ID Chap 4 3 Chap 4 5 9 6 Pentra XL 80 User Manual RAB131GEN Glossary amp Index Index Worklist Chap 4 4 Worklist Chap 4 15 access key Chap 4 15 Auto Numbering Chap 4 23 grid Chap 4 16 order Chap 4 17 Rack view Chap 4 22 search patient Chap 4 20 search sample Chap 4 20 X XB Chap 3 14 access Chap 3 15 Batch Chap 3 18 Graphs Chap 3 16 Grid screen Chap 3 17 Key Chap 3 15 limits Chap 3 19 Z Zoom Chap 4 28 Pentra XL 80 User Manual RAB131GEN 9 7 ABX Pentra XL 80 9 8 Pentra XL 80 User Manual RAB131GEN
87. 2 2 Lamp test Once the lamp replacement is complete verify that the instrument operates correctly Power on the instrument and verify that the Optical Bench lamp is lit If the lamp is illuminated wait until the instrument startup is complete then power off the instrument and re install the covers and panels 1 If the lamp is not illuminated 2 Verify that the lamp connection is connected properly 3 Remove the lamp and verify that the lamp filament is not damaged 4 Try another lamp if available 5 If all these simple remedies do not work contact your local HORIBA ABX representative 2 3 Sampling probe replacement Power off the instrument Remove the right hand side panel from the instrument see 3 Instrument panels amp cover Removals page 7 19 Run a Maintenance syringe position sequence Super user Others menu 4 4 Others page 7 36 Pentra XL 80 User Manual RAB131GEN 7 17 ABX Pentra XL 80 Lift the locker top retaining bracket to free the sample probe see Fig 7 19 page 7 18 Fig 7 19 Probe locker Gently disconnect the tubing connected to the top of the sample probe and remove the probe see Fig 7 20 page 7 18 Fig 7 20 Probe replacement Place the sample tubing back onto the top of the sample probe Re insert the top retaining part of the sample probe back into its retaining slot Lower the locking arm to secure the probe Tighten the Rinse block retaining screws
88. 33 D w Ta 2 N gt Mu Fig 5 17 Delta Check tab The Absolute variation gives the Maximum difference in absolute value between the cur rent parameter and its history See Section 4 Workflow 6 2 1 Report Details page 4 57 This value is used for the Delta check flag triggering The Relative variation gives the Maximum difference in percentage between the current pa rameter and its history This value is used for the Delta check flag triggering The History validity period gives the maximum period in days taken into account in the Delta Check survey The factory adjustment value is 30 min 0 max 999 Delta check on off if off no Delta Check alarm will occur In order to modify the Absolute or Relative Variation values Select the EDIT key Choose Delta check On Highlight the figure you want to modify and type in the new value Confirm by selecting the OK key 5 22 Pentra XL 80 User Manual RAB131GEN Settings System 5 System 5 1 Accessing the System screen From the Settings window select the System key Fig 5 18 System screen The System screen includes four tabs for the configuration of Local settings see 5 2 Local settings page 5 23 e Communication see 5 3 Communication page 5 25 Printer see 5 4 Printer page 5 31 Cycle option see 5 5 Cycle option page 5 35 5 2 Local settings This tab allows the date ti
89. 4 i iv iv lw Vv Iv lw Iv iv M Iv lv iv M M v v M iv iv Vv iv M Fig 5 15 Delta Check Invalidity tab Pentra XL 80 User Manual RAB131GEN Settings Rules 4 4 Print and transmit conditions From the Rules screen select the Print and Transmit conditions tab PENTRA XL 80 Rules Vv na Ia A 4 D amp M Eu i Fig 5 16 Print Transmit conditions v Conditions for printing The operator can define the Reports that need to be automatically printed All conditions can be selected simultaneously Default adjustment is Unvalidated report and Rejected report selected Validated report unselected v Transmit Conditions The operator can define the Reports that are automatically transmitted to the LIS This con dition is exclusive Default ajdustment is Validated Report Only selected Manual only option will disable any automatic transmission Whatever the Transmit conditions that have been set manual transmissions are always possible Pentra XL 80 User Manual RAB131GEN 5 21 ABX Pentra XL 80 4 5 Setting Delta check This function enables the operator to configure the Delta Check flag sensitivity See Section 4 Workflow 5 3 10 Delta Check page 4 45 From the Rules screen select the Delta check tab see Fig 5 17 page 5 22 PENTRA XL 80 Rules feuelsseesss E 33
90. 4 2 6 Sample tube Holder adjustment page 7 28 3 1 6 Tube holder position 6 Manufact Model Part number Additive Vol Vacuum Stickers eine Type of cap condition Out of Becton D Microtainer 365973 0 5ml format Without cap Tab 8 6 Compatible tube position 6 The tube accepts a small sticker not supplied by the manufacturer 8 8 Pentra XL 80 User Manual RAB131GEN Annex Compatible tube list 3 1 7 Tube holder position 7 Manufact Model Part number Additive Vol Vacuum Stickers sisal Type of cap condition Locking mechanism Sarstedt Monovette 05 1167 100 2 7ml Tab 8 7 Compatible tube position 7 3 2 Compatible tube list for rack 3 2 1 Rack GBLO280 type A or B Becton D Vacutainer 367651 K3 EDTA With cap Hemogard Becton D Vacutainer 367652 K3 EDTA 5ml 3ml With cap Hemogard Becton D Vacutainer 367654 K3 EDTA 5ml 4 5ml With cap Hemogard Becton D Vacutainer 368452 K3 EDTA 5ml With cap Hemogard Sarstedt 04 1901 2 6ml Locking mechanism Terumo Venoject VT 050STK K3 EDTA 5ml 5ml With cap Rubber with groove Terumo Venoject VT 053STK K3 EDTA 5ml 3ml With cap Rubber with groove Greiner Vacuette 454036 K3 EDTA 5ml 4ml With cap Hemogard Greiner Vacuette 454223 K3 EDTA 5ml 4 5ml With cap Hemogard Tab 8 8 compatible tube list Rack A or B 3 2 2 Rack GBLO327 Type C Sarstedt Monovette 05 1167 100 2 7ml Locking mechanism Tab 8 9 compatible tube list Rack C Pentra XL 80 User Manual
91. 4 53 Printing options screen in a full screen mode Print Run Results and Raw counts of the selected Reports in a full screen mode Print Send eee oa 68 PET PDW ALY IUC ane for Reasearch Usa Only Fig 4 54 Selected rows printout 4 EOS BAS 21 21 81 2 Printed on DOSZ 17 56 39 Operator Technician Page 1 Fig 4 55 Compact report list 4 66 Pentra XL 80 User Manual RAB131GEN Workflow Report A Printing the raw counts will be possible only if Print the run raw counts in full page for selected rows option is selected as shown in Fig 4 53 Printing options screen page 4 66 and System Printer raw option See Section 5 Settings 5 4 Printer page 5 31 has been checked too v Sending options Print Send Send the most recent Report to the LIS Send the selected Reports to the LIS Send all the Reports to the LIS Fig 4 56 Sending options screen Pentra XL 80 User Manual RAB131GEN 4 67 ABX Pentra XL 30 6 5 Run order association An Unmatched Report see 1 7 Exception management page 4 11 needs to be manually associated with an order to be validated printed or transmitted A notification of the Manual match will be systematically attached to this Report 6 5 1 Association grid description From the Report list screen see 6 1 1 Accessing the Report list page 4 51 select the Association key This function wi
92. 4 Pentra XL 80 User Manual RAB131GEN Ouality Assurance Calibration 4 Calibration The Calibration function is used to determine the Precision and Accuracy of the analyzer with use Of a specifically formulated product to recover each parameter within close tolerances of known target values and limits Coefficients of variation and percent difference recovery must be within their specified limits v Sections detailed in Calibration 4 1 General recommendations page 3 25 4 2 Accessing the Calibration Main Menu page 3 26 4 3 Target values page 3 27 4 4 Running calibration page 3 28 4 1 General recommendations The calibration on HORIBA ABX instruments is an exceptional procedure which must be car ried out particularly in case of certain technical interventions installation maintenance service intervention The calibration should not be carried out to compensate a drift on a result due for example to a clogging of the instrument 4 1 1 Preliminaries Before carrying out a calibration it is essential to make sure that the instrument is in perfect condition of operation and to follow the following steps 1 Carry out a Concentrated cleaning procedure See Section 7 Maintenance amp Troubleshooting 4 3 5 Concentrated cleaning page 7 34 2 Perform two blank cycles to check the cleanliness of the instrument other cycles Blank cycle and check the results are within the following values If not contact
93. 5 Settings 8 3 1 Alarm lev els page 5 47 If 3 consecutive suspect flags are noted on Hemoglobin during Sample Analysis the Hemoglobin value will be rejected and replaced with During instrument STARTUP the HGB Blank measurement value is pre defined from fresh Diluent If the Blank value is not within the measured limits the message Startup Failed HGB Blank will be displayed v LMNE When WBC populations are detected in abnormal quantities in one or more areas of the LMNE matrix a suspect flag will be displayed next to the parameter s in question If one result appears with one or several parameters that display a suspect flag the result should be further investigated Pathology suspicion clotted sample plasma cells etc A suspicion flag is generated on the BAS BAS LYM LYM MON MON NEU and NEU parameter results if Hgb gt 17 5 g dl or invalid If a suspicion flag on WBC occurs then is also generated on BASH BAS LYM LYM MON MON NEU NEU ALY ALY LIC LIC parameter results If a flag LMNE or LMNE or BASO see 5 3 9 WBC balance page 4 44 is triggered then a suspicion flag on WBC parameter is generated too v RBC Conditions Triggered flag Consequences If MCHC or MCH parameters are outside Panic limits defined by the user as described in 5 3 1 Normal and panic ranges on RBC on HCT MCV pag
94. 5 22 following flags should appear Delta Check D Delta Check D v Delta Check triggering conditions 1 Absolute Delta check D Current value history value If Absolute value D gt absolute value set by the operator See Section 5 Settings 4 5 Setting Delta check page 5 22 Then Dabs is generated if D 0 or Dabs is generated if D lt 0 2 Relative Delta Check D is calculated with the below formula current value history D x 100 current value history 2 If absolute value D gt relative value set by the operator See Section 5 Settings 4 5 Setting Delta check page 5 22 Then D is generated if D gt 0 or D is generated if D lt 0 3 Delta check status A Delta check is triggering off if Dabs and D have been generated y Delta check is triggering off if Dabs and D have been generated This alarm can be reviewed in the Report Details screen see 6 Report page 4 51 to ac cess to this screen Pentra XL 80 User Manual RAB131GEN 4 45 ABX Pentra XL 80 PENTRA XL 80 Report Details Ej K oO m Fig 4 36 Delta check in the Report Details screen 5 3 11 Analyzer alarms v CO flag Meaning poor correlation Correlation is noted as the percentage of validated cells measured between the Resistive mea surement and the Optical measurement as they pass through the LMNE flowcell If the cell measurements be
95. 5 7 ABX Format settings Pentra XL 80 User Manual RAB131GEN 5 27 ABX Pentra XL 80 5 3 3 RS232 settings tab According to the format chosen ABX or ASTM 5 3 1 General tab page 5 25 the RS232 Settings tab will be available to set the following Heading key Function Default value Baud Rate speed selection 9600 Parity parity selection None Flow control protocol selection Xon Xoff Stop bits Stop bit selection 1or2 Data bits length selection 8 bits Read Only Tab 5 8 RS 232 settings 5 3 4 ASTM format According to the configuration of the General tab see 5 3 1 General tab page 5 25 the ASTM format tab is available This format has been configured in your system by a qualified technician using the LIS Output Format documentation Call your HORIBA ABX representative for any modification of this information Heading key Function Numerical results Selected hematology paramaters sent to the LIS Flags and Pathologies See Section 4 Workflow 5 3 Flags page 4 Flags and Pathologies 30 associated to the selected parameters sent to the LIS Selected fields sent to the LIS See Section 4 Workflow 2 Worklist Patient File description page 4 15 Tab 5 9 ASTM Format settings 5 3 5 Network settings This tab is available only if your instrument has been configured to have a Network Link See Section 5 Settings 5 3 1 General tab page 5 25 5 28 Pentra XL 80 User Manua
96. 6 Patient Archives function Keys page 4 74 PENTRA XL 80 Search Patient Ma PatientID PatientName FirstName Date of Birth Age Gender 789 MARTINET i O1j 12f 1965 38 Y Female 0004 MARTINEZ 12 01 1945 57 Y Female La ha PA A A D 4 j 7 1 A gt 1 We y y C4 UI AN l f 4 d i Fig 4 63 Search patient screen Type the Patient name or the First characters into the Patient Name field located in the upper left hand portion of the screen If this patient exists in the Archives function it will be displayed on a single line along with the rest of patient information Patient ID First name Birthday Gender etc Now select the OK key to display the patient Reports 4 74 Pentra XL 80 User Manual RAB131GEN Workflow Archives 7 4 Reviewing a Report in full screen mode 7 4 1 Patient Archives screen From the Patient Archives screen see Fig 4 62 page 4 73 select the Report that you want to display in full screen From the Report display the Report Details and Report Edit screens can be displayed Read only as described in 6 1 Reviewing Report page 4 51 Other Reports that are associated with the same patient can be displayed by using the right and left arrows To return to the Patient Reports screen select the Return key in the full screen mode 7 4 2 Daily Reports screen From the
97. 80 Modify Target _ v iil Fig 3 17 XB limits screen Select the Edit key to modify the limit values then select the value that you want to edit Use the Tab key to move to the following field Press the OK key to confirm the new values entries If any XB parameter within the last batch is out of its limits an XB Alarm will occur Section 4 Workflow 5 3 13 Statistical function flags page 4 50 If the printer is selected a message XB is printed out This flag can also be transmitted via the data output if it has been activated from the RS output format If a printer is configured with the system a message stating XB will be noted on the print out The XB flag can also be transmitted to a host computer if it has been selected in the RS232 Output Format This alarm occurs when the last batch statistical calculations are complete no matter which operational screen the operator is in The values that are presently displayed in the XB limits screen are factory Default values These values can be edited for a specific group or patient population to detect any possible drift in calculations Pentra XL 80 User Manual RAB131GEN 3 19 ABX Pentra XL 830 Parameters Tolerance Tab 3 3 XB limits ranges v Printing XB Limits Use the Print Transmit key to print out the XB limits 3 20 Pentra XL 80 User Manual RAB131GEN Ouality Assurance Within run
98. A XL 80 Run in Progress 06 04 2003 14 53 23 g Analyzer Alarms Suspected Pathology NRBCs Anisocytosis Macroplatelets 61 6 3 42 278 1 54 0 39 28 016 Fig 4 19 Reports display screen Runs of current analysis are automatically displayed as shown Flags appear on a tree view mode based on five categories Morphology Flags Analyzer Alarms Suspected Pathologies Quality Assurance Flags Remarks These flags are listed in 5 3 Flags page 4 30 v Zoom in feature A zoom feature is available for each parameter graphic RBC PLT BAS LMNE by selecting the histogram or matrix representation see Fig 4 20 page 4 29 4 28 Pentra XL 80 User Manual RAB131GEN Worktlow Run results and associated Flags PENTRA XL 80 STAT Mode k gio OF __ AUTO SID25 g ao PAR Ne a ES Se 45 as P ta oS H H oO M ui Fig 4 20 Result display zoom Select the Return key to return the display to normal Pentra XL 80 User Manual RAB131GEN om y pmu z 4 29 ABX Pentra XL 80 5 3 Flags Flags are divided up into 5 different groups Flags linked to Run results that exceed the normal parameter limits 5 3 1 Normal and panic ranges page 4 30 Flags linked to Run results that exceed the linear range of the instrument that leads to Rejected Analysis
99. ABX Pentra XL 30 2 Index A Age range Chap 5 51 Alarm level Chap 5 47 Archives Chap 4 70 Access Chap 4 70 Daily Report Chap 4 71 Patient Report Chap 4 73 Search patient Chap 4 74 Association grid Chap 4 68 Automatic numbering Chap 4 23 Chap 5 6 B BASO WBC Count Chap 6 17 Batch Chap 3 18 C Calibration General recommendations Chap 3 25 Carryover Chap 2 10 CDR mode Chap 8 2 Specifications Chap 2 13 Clean Cycles Chap 7 34 Consumption power consumption Chap 2 5 Reagent Chap 2 6 Contextual toolbar Chap 1 14 Cycle option Chap 5 35 D Date and time Chap 5 23 Default settings of instrument types Chap 5 51 Delta check Setting Chap 5 22 Drain chambers Chap 7 31 Dump database Chap 5 38 E Environmental protection Chap 1 10 Error messages Chap 7 44 F Flags Chap 4 27 Alarm levels Chap 5 47 ALY flag Chap 4 37 BASO Chap 4 41 CO flag Chap 4 46 L1 flag Chap 4 41 LIC flag Chap 4 40 LL flag Chap 4 36 LL1 flag Chap 4 36 LMNE Chap 4 44 LMNE Chap 4 44 LN flag Chap 4 38 MAC Chap 4 42 MIC Chap 4 42 MN flag Chap 4 37 NE flag Chap 4 40 NL flag Chap 4 37 NO flag Chap 4 35 Normal and panic ranges Chap 4 30 Pathology messages Chap 4 47 QC failed Chap 4 50 reject Chap 4 33 Results exceeding Linear ranges of the instrument Chap 4 31 RM flag Chap 4 39 RN flag Chap 4 39 SCH Chap 4 43 SCL Chap 4 43 Suspiscion Chap 4 34 XB flag Chap 4 50 Front View Chap 6 2 H History Chap 4 60 Identification option Chap 5 7
100. ABX Pentra XLso User Manual P n RAB131GEN CE HORIBA ABX mal B P 7290 HORIBAABX fee 34184 MONTPELLIER Cedex 4 FRANCE Diagnostics ABX Pentra XL 80 This section includes the following 1 Revisions 2 List of modifications 1 Revisions Index Tea Software revision Section Date note RAB131AA RAH981AA V 1 0 0 All 17 06 03 V1 0 0 CE Ivd labelling RAB131BA RAH986AA corrections All 15 09 03 See V1 1 0 Software RAB131C RANOO2 V1 1 0 Software version improvements and 15 03 04 corrections page 4 v4 N Software Version amp See V1 4 0 Software DS ii w improvements and user 27 01 05 Company name change manual updates page 5 See V1 5 0 Software RAB131EEN RAN165a v1 5 0 Software version improvements and user 08 06 05 manual updates page 6 RAB131FEN RAN229A v1 6 0 Software version Cancelled 28 08 06 See v1 6 1 Software RAB131GEN RAN229B v1 6 1 Software version improvements and user 15 03 07 manual updates page 7 This document applies to the latest higher software version When a subsequent software version is released only electronic version CD ROM and or online help of this user manual is updated and supplied by HORIBA ABX To update a paper document please contact your local HORIBA ABX representative v Declaration of conformity Latest version of the CE declaration of conformity for this instrument is available on www horiba abx com v Notice of liability The Inf
101. ANN M IMBERT Service Central d Hematologie de l Hopital Henri Mondor Facult de m decine de Cr teil Paris XII Pentra XL 80 User Manual RAB131GEN 2 11 ABX Pentra XL 80 2 12 R2 Comparison of means Accuracy Claims WBC 0 99 20 95 PLT 0 99 20 95 RBC 0 95 20 95 HGB 0 99 20 95 HCT 0 96 20 95 Lympho 0 94 Neutro 0 97 Mono 0 81 Eosino 0 96 Baso 0 4 Tab 2 12 Accuracy table source 510K submission K024002 3 7 Leukocyte differential count Data from 200 samples for Leukocyte Differentiation was collected in accordance with the recommended NCCLS guidance documents AGREEMENT 92 5 85 5 74 97 FALSE POSITIVE RATIO 2 3 2 2 20 6 1 6 FALSE NEGATIVE RATIO 44 41 9 47 5 33 3 Tab 2 13 Leukocyte differentiation table Laboratory Standards NCCLS documents Reference Leukocyte Differential Proportional and Evaluation of Instrumental Methods Approved Standard NCCLS document H20 A ISBN 1 56238 131 8 1992 source 510K submission K024002 3 8 Sample stability study In accordance with the ICSH guidance 10 samples were collected from the routine laboratory workload 5 normal samples and 5 abnormal samples The samples were divided into 2 ali quots one of which was stored at room temperature and one at 4 degrees centigrade Sample stability was assessed over a 72 hour period The following results were obtained Pentra XL 80 User Manual RAB131GEN Specifications
102. B graphs 60 total points 3 16 Pentra XL 80 User Manual RAB131GEN Ouality Assurance Patient Ouality Control XB 2 3 XB Data Grid screen From the XB graphs menu see Fig 3 14 page 3 16 select the Details key to open the XB Data Grid screen see Fig 3 15 page 3 17 PENTRA XL 80 XB 9 parameters XB Operator Admin Running date 2002 05 28 14 29 34 2002 04 05 11 51 32 Admin 2002 04 08 11 09 22 Admin 2002 05 27 17 16 23 Admin 2002 05 28 11 22 34 Admin 2002 05 28 14 29 34 Admin 2002 05 28 15 22 31 Admin 2002 05 29 12 18 14 Admin 2002 05 30 11 42 15 Admin 2002 05 30 16 03 53 Standard deviation Coef of variation Bal 32 E A A 2002 06 05 11 53 34 Fig 3 15 XB Data grid screen The XB data grid contains the individual hematology data as well as the batch number The running date and limit values are also included The Statistical data includes the mean of all the batches Standard deviation and Coefficients of variation When the Batch values and or Means are not within their specific limits see 2 5 XB limits page 3 19 they will be displayed in Red if they are greater than their upper limit in Blue if they are lower than their lower limit Select the XB key to display the contents within a specific batch v Printing XB Data grid Select the Print Transmit key to print a list of the batches Pentra XL 80 User Manual RAB131GEN 3 17 ABX Pen
103. BC reject or L1 or LL1 PDW gt 20 or L1 or LL1 MPV gt 10 or L1 or LL1 PLT lt 150x10 mm or PDW gt 20 PLT lt 120x10 mm in CBC mode only a suspicion flag is triggered on PLT Condition 2 LL or URBES WBC reject L1 or WBC reject LL1 Platelets Aggregate If conditions 1 and 2 are not satisfied Erythroblasts and if L1 or LL1 or WBC reject Macroplatelets MPV gt 11 Interpretation Not possible PLT lt 5 0x10 mm or PLT reject or PEC alarm during Startup Tab 4 9 PLT pathology messages H extreme high limit L extreme low limit v Miscellaneous Message Condition Pancytopenia RBC lt Land WBC lt Land PLT lt L Tab 4 10 Miscellaneous pathology messages H extreme high limit L extreme low limit Pentra XL 80 User Manual RAB131GEN 4 49 ABX Pentra XL 80 5 3 13 Statistical function flags v XB flag This alarm is a specific alarm that is associated with patient guality control This particular flag is noted when batch results are outside the XB limits established by the user If one of the mean values from 1 batch of 20 samples is outside of the established limits an XB alarm will be activated See Section 3 Quality Assurance and Logs 2 5 XB limits page 3 19 Selecting and Deselecting an analysis can activate the XB alarm The user has the option of enabling or disabling the XB alarm in the Instrument Settings functions See Sec
104. Child2 Child3 Child4 and Child5 are Factory Default values see 8 5 1 Pathological limits and thresholds page 5 51 The Standard Type values are set values and cannot be modified by the user Man Woman Child1 Child2 Child3 Child4 and Child5 Factory Default values can be modi fied by the user Results exceeding the Normal Ranges limits are marked with the following flags h for results above the normal upper limit l for results below the normal lower limit Results exceeding the Panic Ranges limits are marked with the following flags H for results above the extreme upper limit L for results below the extreme lower limit 5 46 Pentra XL 80 User Manual RAB131GEN Settings Sample Types 8 3 Alarms amp Curve thresholds 8 3 1 Alarm levels Each flag is adjustable according to the numbers entered in the percentage and or an abso lute value field of the parameter The flags are triggered by values exceeding these set numbers 100 100 5 3 15 p25 LA 3 50 pS EA 3 Fig 5 38 Standard alarm levels See Section 4 Workflow 5 3 Flags page 4 30 Default values have been incremented for the 8 types Standard man woman child1 child2 child3 child4 and child5 see 8 1 3 Modifying limit Alarm values page 5 44 see 8 5 2 Alarms levels page 5 60 Pentra XL 80 User Manual RAB131GEN 5 47 ABX Pentra XL 80 8
105. Copyright 2007 by HORIBA ABX All rights reserved No part of this book may be reproduced or transmitted in any form or by any means electronic mechanical photocopying recording or otherwise without the prior written permission of HORIBA ABX HORIBA ABX Parc Eurom decine Rue du caduc e B P 7290 34184 MONTPELLIER Cedex 4 FRANCE Tel 33 0 4 67 14 15 16 Fax 33 0 4 67 14 15 17 Pentra XL 80 User Manual RAB131GEN 0 3 0 4 XL 2 List of modifications 2 1 V1 1 0 Software improvements and corrections XB Limits defaults valles se taman sneakers Worklist printing option Light mode o Woo mn Button Expanded DIFF instead of Extended oooooWoWoWooWoWoWoWooWoo WWW Translation History instead of Anteriority oooo Woo Wc Report printing options Light mode ooooWoWooWooWoWW mma Archive Panting options Light mode sisa hn ema Max CV Ge fatilt Vale eos BA teen a Rerun conditions default settings endah nemenin ea hn an buana aa Defaults settings for Printer Properties ooooWo Woo W WWW Update of the Printer properties xcccaeceieccesacoisnscsseenscessvensennisnswereaddesiwarasecoiewevs Day by day exportation of the deleted files oooooWcoWoWoooo User login while PXL80 software running ooooW WWW maan Defaults settings associated to the V1 1 0 version release oooo Woooo Correction of the WBC counting thresholds oo WWW WWW
106. E MIC MACp Tab 5 35 Child 3 alarm levels Child 4 Level Yo Level NO 100 80 Tab 5 36 Child 4 alarm levels Pentra XL 80 User Manual RAB131GEN Settings Sample Iypes 5 63 ABX Pentra XL 80 Child 5 Level Level NO 100 80 LL1 O1 LD MN m 120 LN MN UD UI r U U UO ms S ta 999 NE MIC m m MACp Tab 5 37 child 5 alarm levels 8 5 3 Matrix thresholds From the menu Settings Types Alarms and Curves Thresholds Standard Channel Standard Channel LMD 100 BA2 110 RM 118 Tab 5 38 Matrix Threshold values of the Standard type 5 04 Pentra XL 80 User Manual RAB131GEN NOL NON LL LN NOE LMN AL LMU LMD MN RM Channel 24 21 31 35 50 69 69 73 100 100 118 Channel RN 118 NL 29 RMN 51 NE 82 FLN 2 FNE 2 FMN 2 BA1 35 BA2 110 BA3 240 Tab 5 39 Matrix Threshold values of the Man type NOL NON LL LN NOE LMN AL LMU LMD MN RM Channel 24 27 31 35 50 69 69 73 100 100 118 Channel RN 118 NL 29 RMN 51 NE 82 FLN 2 FNE 2 FMN 2 BA1 35 BA2 110 BA3 240 Tab 5 40 Matrix Threshold values of the Woman type Pentra XL 80 User Manual RAB131GEN Settings Sample Types 5 65 ABX Pentra XL 80 5 60 Child 1 Channel Child 1 NOL 24 RN NON 27 NL LL 31 RMN LN 35 NE NOE 50 FLN LMN 69 FNE AL 69 FMN LMU 73 BA1 LMD 100 BA2 MN 1
107. E VENT 111 02 150 NOTCHED TUBING 2 06 140 2120 P5 152300 SC I I I I I l I I I l I I I l I l E PO Ng 2 06 160 206h60 2 06 160 152 170 TG 2 06 160 I Wa AA pn oe R TN l 3 5 ies y j 152 160 JL A nc 4 4 A amp Lt a na 1 LA 7 1m 1 Y Yj 2 pan p AURP SYRINGE t 16 fs 2 sal 206120 s 5 1 02 175 N u Z Z gt CH ae s eee NOTCHED L Hb Se ja lor TUBING N l rf 4 fal aa lt lt O lt l E 4 l _ 1 m mm p ICG es Ca Ca OO CD l 132 480 REAGENT SYRINGE 2 54 190 i 206210 Pa La na LMNE SYRINGE M4 P37 1 l M3 215 s 1 30 320 1P A2 130 20 YA 1 52 230 Ne 29 X 206550 152 15 TB 254 180 HENNA ME FILTER 1 ama m2 UNO ae a Li Kal orl iki Ni Bo Ps 4 rr tot PVC 3x6 L 2000 MAXI po WU WASTE ABX DILUENT4 5 ENTE G 71 Na Die ferential diluent Selecta
108. LL see LL flag page 4 36 and LL1 see LL1 flag page 4 36 are available in DIFF mode and provide more reliability in anomaly detection This mode should be rec ommended v MB flag DIFF mode only Meaning Mono BAS This flag occurs when the percentage of basophils found in the BAS channel is above the per centage of Lympho Mono Neutro raw counts found in the LMNE matrix channel v BASO DIFF mode only If the BAS exceeds 50 a BASO flag is generated The Basophils will not be removed from the LMNE Matrix populations and a will be dis played instead of the BAS and BAS This alarm appears in the Analyzer Alarms area on the screen and on the print out Pentra XL 80 User Manual RAB131GEN 4 41 ABX Pentra XL 80 5 3 7 Flags on RBC histogram RBC1 RBC2 Fig 4 33 RBC histogram Standard values for MIC 5 Standard values for MAC 45 See Section 5 Settings 8 3 Alarms amp Curve thresholds page 5 47 5 3 8 Flags on PLT histograms Fig 4 34 PLT histogram 4 42 Pentra XL 80 User Manual RAB131GEN MIC and MAC flags are generated when the percentage of cells count ed in the microcytic area MIC and macrocytic area MAC compared to the total number of RBCs are above the set limits for both MIC and MAC percentages set up by the user RBC1 and RBC2 thresholds define the microcytic and macrocytic areas and are calculated according to the MCV and the RDW from
109. Laboratory Td Biosafety Manual 2nd edition for further information 1 3 2 Instrument internal cleaning v Concentrated cleaning Counting chambers and hydraulics parts are decontaminated by using the Concentrated cleaning function as described in 4 3 5 Concentrated cleaning page 7 34 7 4 Pentra XL 80 User Manual RAB131GEN Maintenance amp Troubleshooting Maintenance amp Iroubleshooting procedures v Sampling probe Sampling probe must be decontaminated as follows 1 Prepare a solution of Sodium Hypochlorite to 100ml I 2 Fill a 5ml tube with this solution 3 Run 5 analysis on bleach using the Stat mode as described in Daily Guide RAB156C Please also refer to the W H O World Health Organization guidelines Laboratory Td Biosafety Manual 2nd edition for further information 1 3 3 Rinse chamber filter cleaning 1 This filter has to be cleaned once a month as follows 2 Dismantle the Right hand side panel as described in 3 Instrument panels amp cover Removals page 7 19 in order to access to dilution chambers Fig 7 1 Rinse chamber filter location 3 Locate the filter below the rinse chamber 4 Remove the filter disconnecting tubings and open it unscrewing both parts Fig 7 2 Dismantling the filter 5 Rinse both parts of the filter under tap water 6 Leave the filter dry and re install reverse order Pentra XL 80 User Manual RAB131GEN 7 5 ABX Pentra XL 8
110. Left Neutro NON LMN NOE Separation between Noise amp Eosino NON Cha 127 LMN Intersec dot between Lympho Mono Neutro area LN LMU AL Separation between Lympho amp Left Lympho LL LMU LMU Upper dot of the separation slope ALY Mono AL LMD LMD Lower dot of the separation slope ALY Mono LMU RM MN Upper dot of the separation slope Mono Neutro LMN RM RM Separation between Mono amp Right Mono LMD Cha 127 RN Separation between Neutro amp Right Neutro MN Cha 127 Tab 5 18 Matrix DC thresholds resistive Threshold Purpose Low limit High limit NL Separation between Lympho amp Neutro 0 RMN RMN Separation between Right Mono amp Right Neutro NL NE NE Separation between Neutro amp Eosino RMN Channel 127 Tab 5 19 AC Thresholds Absorbance Threshold Purpose FLN Channel number for the NL alarm area FNE Channel number for the NE alarm area FMN Channel number for the MN alarm area Tab 5 20 Channel Width Pentra XL 80 User Manual RAB131GEN 5 49 ABX Pentra XL 80 8 3 3 BAS curve threshold All of the leukocytes are shown between 0 and BA3 thresholds See Section 6 Description amp Technology 3 3 WBC and differential count page 6 17 L1 absolute value is calculated between the channel 0 and the BA1 threshold The percentage of basophils is calculated according to the number of particles from the BA2 threshold to the BA3 threshold These thresholds are factory adjusted to the following values Thr
111. PAN Yo Yo Yo o EOS BAS BAS ALY ALY LIC LIC STD Yo Yo Yo SI Yo Yo Yo mmol L Yo Yo Yo JAPAN Yo Yo Yo Tab 5 4 Units Open the Units tab Now select the Edit key and scroll through the Unit Selection list see Fig 5 6 page 5 11 Select the units of choice and then select the OK key to confirm your selection 5 10 Pentra XL 80 User Manual RAB131GEN Settings Soft parameters PENTRA XL 80 Soft Parameters Ca a STANDARD v STANDARC INTERNATIONAL SYSTEM MMOL Japan Fig 5 6 Units tab Pentra XL 80 User Manual RAB131GEN 5 11 ABX Pentra XL 80 3 Quality assurance settings 3 1 Accessing the QA settings From the Settings window select the Quality Assurance key ANN 2 kem p Ac Msh SEN NS uer W e r H 1 _ H i 1 L k les le MF A Ja ai i E RE BE FER ma Le TREE ELJ EL JL L EA hy Ia Ta Fig 5 7 Quality Assurance settings There are three configurations available in this menu XB options see 3 2 XB options page 5 12 Number of calibration runs see 3 3 Number of calibration runs page 5 13 Calibration QC and XB coefficient values see 3 4 Coefficients of variation ranges page 5 13 3 2 XB options The XB function See Section 3 Quality Assurance and Logs 2 Patient Quality Control XB page 3 14 is based on a BULL method and includes a calculation on 3 or
112. Parameters menu oo 5 5 PMA ana an aan NN 5 6 2 3 Department Physicians tab oooooooWoW 5 8 IE E E o TETE ea 5 10 3 Quality assurance settings J 5 12 3 1 Accessing the QA settings 5 12 BP A O O eE E E EEEE 5 12 3 3 Number of calibration runs oooooocoWoW 5 13 3 4 Coefficients of variation ranges o 5 13 Dh TINGS eoa T 5 15 4 1 Accessing the Rules screen ioooooWo 5 15 4 2 Biological validation Conditions o 5 15 4 3 Rerun conditios escroissir endi a 5 17 4 4 Print and transmit conditions oooooooWoW 5 21 A De etun Dela CNC Ce asiaan eT aa 5 22 Die OY e i ne TEET 5 23 5 1 Accessing the System screen oooWoW 5 23 E E N o E O E A nari 5 23 D3 COMMUNICA ON Maan 5 25 O T sea E AAA E AE EE E S 5 31 EE Op On E E na 5 35 A E E ment E ART 5 36 6 1 Access to Save Restore Screen oooo 5 36 G5 St SUI OM oo aa ea aa 5 36 Gaos Dn oat DS naa aa ani 5 38 GA REPOT EXP OAUON naat aman sesak 5 38 Pentra XL 80 User Manual RAB131GEN 5 1 ABX Pentra XL 830 AO OVO ee 5 40 7 1 Accessing the User screen ooooooooWo 5 40 7 2 User menu function KEYS soo 5 40 7 3 Creating a new User profile ooooooo 5 41 Oam en ee na ara 5 43 8 1 Accessing the Types parameters MENU iiiii i 5 43 8 2 Pathological limits enam ea naa mas aur 5 46 8 3 Alarms
113. Sampling probe replacement page 7 17 Once a month see 1 3 3 Rinse chamber filter clean Rinse chamber filter cleaning ing page 7 5 before any intervention on your instrument See De Cie We decontamination Instrument general cleaning page 7 4 Instrument Rinse See Instrument Rinse page 7 6 Pentra XL 80 User Manual RAB131GEN 7 3 ABX Pentra XL 30 1 3 Instrument general cleaning 1 3 1 Instrument external cleaning The external surfaces of the instrument must be decontaminated considering the biological environment A 1 Never spill liquid on the instrument 2 Never use Disinfectant product that contains alcohol v Touch screen Use a soft clot slightly wet with disinfectant product Wipe gently the screen and dry to remove any trace of moisture v All contaminated surfaces covers counting assembly area Slightly wet a sponge with disinfectant product and wipe the dirty surfaces v Stainless steel parts Slightly wet a sponge with disinfectant product and wipe the dirty surfaces Dry with a soft cloth Products having the following microbiological properties Bactericidal Fungicidal Active on Aspergillus fumigatus Active on Mycobacterium tuberculosis B K Antiviral VIH HBV and rotavirus Product Example validated by HORIBA ABX ANIOS detergent disinfectant WIP ANIOS ref 1316 424 Please also refer to the W H O World Health Organization guidelines
114. Summary of performance data Room Temperature 4 Celsius Yo Deviation WBC 0 1 44 1 85 7 19 0 0 41 0 1 9 87 Deviation RBC Deviation HGB Deviation HCT Deviation PLT Deviation Lympho 1 42 1 4 3 06 1 42 0 71 3 3 0 0 55 0 7 6 41 0 0 87 0 69 2 83 0 93 0 53 0 03 0 0 42 0 37 1 11 5 73 5 81 4 95 0 8 87 11 58 12 23 9 49 22 36 29 95 0 8 61 0 15 19 53 Deviation Neutro Yo 4 38 6 79 6 10 0 1 18 9 85 23 78 1 71 18 75 39 52 0 10 28 25 40 19 86 5 38 12 11 24 22 0 22 83 11 66 8 52 0 6 52 0 00 18 48 9 78 7 61 210 87 Deviation Mono Deviation Eosino ome Oke Oka Fo Deviation Baso Tab 2 14 Sample stability study Guidelines for the evaluation of blood cell analysers including those used for differential leuko cyte and reticulocyte counting and cell marker applications International Council for Standardization in Hematology Clin Lab Haemat 1994 16 157 174 v Sample Stability Conclusion The results conclude with a relative sample stability claim of 48 hour period at 4 C and at room temperature source 510K submission K024002 3 9 CDR Mode specifications The CDR mode technique of dilution has been specifically validated through tests using com mercially available Full range Linearity test kits The test kits were analyzed and data computed according to the manufacturer instruction Each kit includes 6 levels and 1 level was used as the reference value Each level was ana
115. The barcode Sample ID Pentra XL 80 User Manual RAB131GEN 4 3 ABX Pentra XL 30 The order searching mode is generated based on specific settings that were select ed by the operator See Section 5 Settings 2 2 General tab page 5 6 When the associated order is found the instrument will automatically perform the required analysis that was generated from the information in the worklist such as defined blood type and the patient demographics that are associated with each sample 1 3 Worklist Worklist orders allow the following criteria A single identification of a sample tube Selection of the test to be performed CBC or DIFF Selection parameter ranges according to the specific blood types i e Male Female Child etc The creation of a patient file and patient demographics Matching orders to specific patient files When creating orders there are only 2 modes available 1 A graphics screen see 2 4 Rack view page 4 22 that simulates a rack view with sample tube positions This mode must be used with the following Setting Rack Position See Section 5 Settings 2 2 5 Identification option page 5 7 2 A grid that is intended to identify the sample tube by means of Barcode labeling Entering the sample tube position in the rack is not available while in this mode This mode must only be used with the following setting Barcode See Section 5 Settings 2 2 5 Identification option pag
116. Types and Help Messages page 7 49 7 6 Expiration Date Error Types and Help Messages page 7 49 7 7 Analyzer Internal Error Types and Help Messages page 7 49 7 44 Pentra XL 80 User Manual RAB131GEN 7 1 Analyzer error types and help messages Alarm Carriage motor failure Carriage mechanism not reach ing home Counting syringe motor failure Counting syringe mechanism not reaching home Diluter syringe motor failure Diluter syringe mechanism not reaching home DRAIN 1 syringe motor failure DRAIN 1 syringe mechanism not reaching home DRAIN 2 syringe motor failure DRAIN 2 syringe mechanism not reaching home Drain sensor sensor number 1 2 or 3 time out Injection syringe motor failure Injection syringe mechanism not reaching home LMNE transfer sensor time out Needle motor failure Needle mechanism not reach ing home Piercing UP or DOWN bad posi tion Reagent temperature out of range Value Min amp Max Reagent Temperature sensor not connected Reagent Temperature sensor failure Sampling syringe motor failure Maintenance amp Troubleshooting Error type Carriage Motor home switch always detected Carriage Motor Mechanism initial ization failed Counting Syringe Motor home switch always detected Counting Syringe Motor Mecha nism initialization failed Diluter Syringe Motor home switch always detected Diluter Syringe Motor Mechanism initialization faile
117. XL 80 Within Run Close tube setting Sampling Number 2002 04 03 14 28 20 2002 04 03 14 29 06 2002 04 03 14 23 51 2002 04 03 14 30 37 2002 04 03 15 15 41 2002 04 03 15 16 50 2002 04 03 15 17 44 2002 04 03 15 18 34 2002 04 03 15 13 21 2002 04 03 15 20 22 Maximum Mean Standard deviation 2 Standard deviation Coef of variation Fig 3 20 Within run results This grid includes statistical data for each parameter maximum minimum mean standard deviation The coefficient of variation will be displayed in red if it is greater than the upper limit established by the operator Section 5 Settings 3 4 Coefficients of variation ranges page 5 13 Results can be excluded from the statistical data by using the check boxes to de select the analyses 3 3 4 Print Transmit or delete Results v Print or Transmit Open the Within Run Data Grid screen Using the Print Transmit key see Tab 3 4 Within Run keys page 3 21 Select either Print or Send depending which action you would like to create Pentra XL 80 User Manual RAB131GEN 3 23 ABX Pentra XL 30 Print Send Print Send Fig 3 21 Print Send Within run results v Delete results Open the Within Run Data Grid screen Using the Delete key see Tab 3 4 Within Run keys page 3 21 discard the unselected selected or all results from the grid Delete options Fig 3 22 Delete Within Run Results 3 2
118. a mobile threshold This threshold moves according to the micro cyte population present in the analysis area Description amp Technology Measuring principles Fig 6 13 Impedance Principles Pulse height ae sa lt f wel t Pulse BC pulse Number of cells Analogue conversion Cell size Data integration and plotting of RBC distribution curve Number of cells l i Cell size Fig 6 14 RBC distribution curve umber of cells Analogue conversion Cell size Data integration and plotting Numbered of PLT distribution curve Fig 6 15 PLT Distribution curve Pentra XL 80 User Manual RAB131GEN 6 13 ABX Pentra XL 80 v dilutions Technical characteristics of the RED BLOOD CELL and PLATELET counts Initial blood volume 10 ul Method Impedance Vol ABX DILUENT 2500 ul Aperture diameter 50 um Final dilution rate 1 10000 Count vacuum 200 mb Temperature of reaction SAN Count period 2 X 6 seconds Two successive dilutions are carried out Primary Dilution for RBC and PLT Blood ul 10 pl Vol ABX DILUENT 1700 dilution 1 170 Secondary Dilution RBC and PLT from the primary dilution Dilution ul 42 5 ul Vol ABX DILUENT 2500 dilution 1 58 8 Final dilution 1 170 x 1 58 8 1 10000 Tab 6 1 RBC PLT dilutions 3 2 2 HGB Measurement During the analysis cycle lysing reagent is released into the Dilution chamber v Alphalyse
119. ad position Barcode internal connection Internal Barcode Error problem System stop due to synchroniza Internal synchronization failed tion problem Motor d is busy Run a new cycle while analyzer ibn Analyzer already in cycle Valve already activated Pentra XL 80 User Manual RAB131GEN Help Message Run an Initialization Run an Initialization Run an Initialization Run an Initialization Run an Initialization Run an Initialization Run an Initialization Run an Initialization Run an Initialization Run an Autoclean Run an Initialization Run an Autoclean Run an Initialization ABX Pentra XL Annex Contents In OR MOC eee E EE 8 2 Do OAC CTI LEIO eree EE E E EEE 8 5 Da COMP AGI LOC WISE srie ai erase 8 6 3 1 Compatible tube list for Tube holder 8 6 3 2 Compatible tube list for TACK soe on aman 8 8 Pentra XL 80 User Manual RAB131GEN 8 1 ABX Pentra XL 30 This section includes the following 1 CDR mode page 8 2 2 Reagent Leaflets page 8 5 3 Compatible tube list page 8 6 1 CDR mode The CDR Customized Dilution Ratio mode allows the user to obtain a result from samples with a very high cell concentration The instrument may performs automatic dilution to 1 2 1 3 or 1 5 based upon operator dilution ratio selection If the dilution ratio selected is one that has been validated by HORIBA ABX refer to Section 2 Specifications 3 9 CDR Mode specific
120. al RAB131GEN 4 57 ABX Pentra XL 80 v Current Report panel The displayed Report is composed of selected parameter groups from the Run Results and or Manual entry 1 If a parameter group has been unselected see Fig 4 42 page 4 58 parameters are unvalidated and replaced by 2 When a manual entry has been performed a M is displayed next to the parameters see Fig 4 42 page 4 58 The Expanded DIFF key is displayed when a manual entry has been performed 3 The Waiting for examination checked box can be modified only if the report is Unvalidated Fig 4 42 Manual entry indicator and unvalid pararameters 4 When a report is rejected parameters are crossed out see Fig 4 43 page 4 58 BESS ERE SEES Fig 4 43 Rejected report 4 58 Pentra XL 80 User Manual RAB131GEN Worktlow Report v Run Results panel Selection of parameter groups is possible only if the report is Unvalidated Use the Runs arrows left and right to review all runs and select the parameter groups to construct the report see Fig 4 44 page 4 59 Selecting one parameter group of a Run will unchecked the same parameter groups of all the other Runs The Report panel is automatically refreshed when a selection is performed WBC 103mm 81 g oe I SN NeW 616 BE GH Z8 2 OMON 7 Ba Ow a a ES EE eee As 07 0 06 lay 1 f oos po E 2 010 E FE Fig 4
121. alues of the standard type Set as default type The type selected in the list becomes the default type Type management Copy Apply standard values Tab 5 17 Types function Keys 8 1 2 Creating a new blood sample type Select the Insert key Type Management Type Management Fig 5 35 Creating a new type Type in the name of the type 20 characters maximum From here you may Select the OK key to confirm the new type created Select the Apply standard values to paste the values from the standard type to the new created type and then select the OK key to confirm the pasted values Copy values from one type to the new created type see 8 1 4 Sample Type copying page 5 45 Modify limits or modify alarms levels amp curves thresholds see 8 1 3 Modifying limit Alarm values page 5 44 8 1 3 Modifying limit Alarm values From the Pathological limits tab or Alarms amp curves Thresholds tab select the Edit key Click the figure you want to modify and enter a new value Once all entries have been made select the OK key to confirm your modifications 5 44 Pentra XL 80 User Manual RAB131GEN Settings Sample Iypes 8 1 4 Sample Type copying From the Type management field select a sample type that you would like to copy from in the below example Woman Then select the Copy key Copy Frown Woman Fig 5 36 Type copying In the Copy
122. alytical process Range of results over which the instrument displays prints and transmits data A component of blood that the instrument measures and reports targeted performance of the instrument based on established ranges and parameters specifications Labile blood product composed of platelets produced by blood bank centers and intended for transfusion Cellular suspension in the plasma high platelet concentration obtained by sedimentation from a whole blood sample to determine on the hematology analyzer the platelet count in the presence of a contaminating microcytic RBC population A comprehensive set of of procedures a laboratory establishes to ensure that the instrument is working accurately and precisly This procedure checks that the system gives similar results within estab lished limits every time it measures the same sample A measure of variation within a group samples or within a population standard deviation Cleans the instrument s fluidic lines and apertures to help prevent residue buildup See performance specifications Section 2 Specifications 3 Summary of performance data page 2 7 Ensures that the instrument is ready to run includes performing a back ground test Procedure to analyze cell controls or whole blood with known values to determine if your results are within the acceptable range Non diluted blood blood and anticoagulant only Pentra XL 80 User Manual RAB131GEN Glossary
123. amp Curve thresholds 5 47 ited CCNA e E E E ae ot 5 51 8 5 Defaults settings of the Pentra XL 80 types 5 51 5 2 Pentra XL 80 User Manual RAB131GEN Settings Menu Settings overview The following section is the Pentra XL 80 Settings menu description including 1 Menu Settings overview page 5 3 2 Soft parameters page 5 5 3 Quality assurance settings page 5 12 4 Rules page 5 15 5 System page 5 23 6 Save and restore page 5 36 7 User profiles page 5 40 8 Sample Types page 5 43 1 Menu Settings overview 1 1 Accessing the Settings menu Select the SETTINGS key on the Main screen Cl Q E F Toiy tis 3 a i R T k Fig 5 1 Settings menu access key Pentra XL 80 User Manual RAB131GEN 5 3 ABX Pentra XL 80 5 4 1 2 Menu Settings functions Key Name Function Allows to define CV for calibration QC and Within Run see 3 Quality assurance settings page 5 12 The XB mode must also be set here Quality Assurance Opens management screens for specific system options date and aaa time RS 232 printer see 5 System page 5 23 Opens management screen to define operator profiles see 7 User Ee profiles page 5 40 Tab 5 1 Menu settings function Keys Pentra XL 80 User Manual RAB131GEN Settings Soft parameters 2 Soft parameters 2 1 Accessing the Soft Parameters menu From the S
124. ance NoN NoE Channel 127 Neutro a N a emer a a EAN Lym n L AL 1 4 2 NL NoL LMD RM Resistivity Fig 4 26 LN flag Standard values for LN 2 5 999 Section 5 Settings 8 3 Alarms amp Curve thresholds page 5 47 v NE flag Absorbance NoN NoE Channel 127 LMD RM Resistivity Fig 4 27 NE flag Standard value for NE 1 1 60 See Section 5 Settings 8 3 Alarms amp Cur ve thresholds page 5 47 4 38 Pentra XL 80 User Manual RAB131GEN Meaning Left Neutro Presence of a significantly large population of cells located on the left hand side of the neutrophil area This flag occurs when the number of particles counted in this area is higher than the limit setup in LN or when the number of particles counted regarding the total number of WBC is above LN limit Suspected abnormalities e Neutrophil destruction due to incorrect storage of the sample or an old sample e Contamination stroma or platelet aggregates This flag is associated with an on all WBC differencial parameters Meaning Neutro Eosino Presence of a significantly large population of cells located in the separation area between neutrophils and eosinophils be cause of a superimposition of the 2 populations This flag occurs when the number of particles counted in this area is higher than the limit setup in NE or when the number of particules counted regar ding the total number of WBC i
125. and thresholds From the menu Settings Types Pathological limits and Thresholds Section 5 Settings 8 1 3 Modifying limit Alarm values page 5 44 Pentra XL 80 User Manual RAB131GEN 5 51 ABX Pentra XL 80 Standard type Panic L Normal l Normal h Panic H WBC 3 00 4 00 10 00 13 00 HGB 9 50 115 17 0 18 0 MCHC 32 0 32 0 36 0 36 0 PLT 100 150 500 550 PCT 0 000 0 15 0 50 1 00 LYM 1 00 1 00 4 00 5 00 Tab 5 22 Standard default settings 5 52 Pentra XL 80 User Manual RAB131GEN Settings Sample Types Panic L Normal l Normal h Panic H WBC 3 00 4 00 10 00 13 00 HGB 11 0 13 0 17 0 18 0 MCHC 32 0 32 0 36 0 36 0 PLT 100 150 500 550 PCT 0 000 0 15 0 50 1 00 LYM 1 00 1 00 4 00 5 00 Tab 5 23 Man default settings Pentra XL 80 User Manual RAB131GEN 5 53 ABX Pentra XL 80 Panic L Normal lL Normal h Panic H WBC 3 00 4 00 10 00 13 00 HGB 9 50 11 5 16 0 17 0 MCHC 32 0 32 0 36 0 36 0 PLT 100 150 500 550 PCT oo 0 15 0 50 1 00 LYM 1 00 1 00 4 00 5 00 Tab 5 24 Woman default settings 5 54 Pentra XL 80 User Manual RAB131GEN Settings Sample Types Child 1 Panic L Normal l Normal h Panic H WBC 10 0 10 0 26 0 30 0 HGB 13 5 13 5 19 5 19 5 MCV Cae 100 112 114 MCHC 32 0 32 0 36 0 36 0 PLT 150 200 400 450 PCT owo
126. ansmitted to the instrument by a LIS When a patient file is modified by the LIS or manually by the user all previous reports attached to that file are flagged 1 11 Loading Worklist from the LIS The Pentra XL 80 contains communication connections for Bi directional transmission to and from a Host computer A single Patient ID always identifies Worklist orders generated from the Host computer When loading from the Host if identification number of the tube already exists in the worklist previous order will be updated to include the last modifications of the new order Remember it is impossible to update the order on the instrument when it has been transmit ted to the instrument from the Host computer 4 14 Pentra XL 80 User Manual RAB131GEN Worktlow Worklist description 2 Worklist description 2 1 Overview A worklist is a list of orders generated on a daily basis These orders can include Orders for samples that have not been analyzed Orders for samples that have been analyzed but a Rerun status has been requested Re runs can be automatic according to the settings in System Rules See Section 5 Set tings 4 3 Rerun conditions page 5 17 or Manual reruns from the Report screen see 6 4 Rerunning sample manually page 4 64 Once the sample order has been analyzed and automatically matched to an order the orders are removed from the worklist The orders are also removed from the worklist w
127. ar features more light will show through these cells as they pass through the flowcell This affect will place the neutrophils higher on the optical Y axis and spread them along the volume X axis according to their maturity Hyper segmentation and increased granules will place these cells even higher on the optical Y axis EOSINOPHILS The Eosinophils are somewhat like the neutrophils They contain granular ma terial and segmented nuclei within the cytoplasm The granular material is colorized with the ABX EOSINOFIX before they are passed through the light path in the flowcell Due to the col orization action of the reagent the eosinophils will be place in the highest part of the optical Y axis Hyper segmentation and increased granules will spread this population across the right top of the matrix Additional parameters LIC Large Immature Cells and ALY Atypical Lymphocytes com plete the matrix spectrum of cellular placement Immature granulocytic cells are detected by their larger volumes and by the increased gran ules which allow more light to pass through the cells and increase the intensity of scattered light Therefore cells such as metamyelocytes will be found to the right of the neutrophils and almost at the same level Myelocytes and promyelocytes will be found on the far right of the matrix in the saturation position The metamyelocytes myelocytes and promyelocytes will all be classed as LIC and there given results will be incl
128. ation groups RBC PLT WBC DIFF according to the manual entries Carel Does not modify the Report Displays the previous values Ee Percentage of NRBC s on the slide NE Range 0 to 100 Tab 4 13 Report list Function Keys 462 Pentra XL 80 User Manual RAB131GEN Workflow Report 6 3 Validation or rejection of a Report Validated or rejected reports are non modifiable A The Report list provides the status of a report Validated The report succeeds to operator defined criteria and has been automat ically validated See Section 5 Settings 4 2 Biological validation conditions page 5 15 or manually Unvalidated Default state of the report Rejected The Report failed to be validated It has been manually rejected The Unvalidated Reports can be Manually rejected or validated from the Report List see 6 1 3 Report list page 4 53 or the Report Display see 6 1 4 Report display page 4 55 screens 6 3 1 Validation of several Reports 1 Open the Report List screen by selecting the Report key see 6 1 1 Accessing the Report list page 4 51 PENTRA 80 Report List We e C Rejected j C Validated and Transmitted 6 Validated but not Transmitted i C Waiting for examination Testi Date MARTIN I Male E 1308 DIFF 04 10 2003 12 26 49 Junillon Female 06 22 1926 CBC 04 10 2003 14 43 30 a 2003 16 42 25 2003 15 00 17 2003 14 55 40 AN Please confirm the select
129. ations page 2 13 these results are reportable All other dilution ratios maybe considered for information use only Non validated dilution ratio may not allow any results to be shown value replaced by D according to local regulations PENTRA XL 80 STAT Mode RBC E Morphology Flags Sample ID fo544 Collection Date 10 mrm MPV um 10 1 h PCT 0 327 PDW as Physician 10 mrm Next Sample ID 1567489 NEU 587 288 Patient Name Lym 335 1 64 Collection Date Yy SCENCIO MON 52 025 i 0 Fos 23 O11 Date of Birth Age Bas 03 sa 02 02 1945 58 Y Aa i3 0 06 pe uc 08 0 04 y Version V1 0beta6 Technician 05 27 2003 17202 Fig 8 1 CDR access key From the Stat mode screen select the CDR key see Fig 8 1 page 8 2 in order to open the Dilution screen Pentra XL 80 User Manual RAB131GEN 1 1 2 13 1 5 WBC LMNE G is c RBC PLT HGB G c c Two parameter groups WBC LMNE or RBC PLT HGB can be independently diluted with 3 predefined dilution ratios 1 1 2 1 3 1 5 The dilution ratios validated by HORIBA ABX are the WBC and LMNE of 1 3 and the RBC HGB and PLT of 1 2 If the test is DIFF the dilution ratio for WBC is applied on the LMNE values Select a dilution ratio and confirm with the OK key This ratio will be applied to the next order only Run
130. automatic Rerun The Setting is Rack Position and Manual match on Exception OFF The order has been created by Rack position The order is identified by an AutoSID or a SID The run has been matched with the order v Scenario 2 allowing automatic Rerun The Setting is Barcode and Manual match on Exception OFF A barcode has been read The order has not been created v Scenario 3 allowing automatic Rerun The Setting is Barcode and Manual match on Exception ON The order has been created Pentra XL 80 User Manual RAB131GEN 4 13 ABX Pentra XL 80 The order is identified by a SID The run has been matched with the order 1 10 Patient file management The Pentra XL 80 Patient file management enables the filling of orders if the patient demo graphic data is known If no data is placed into the Patient ID field an automatic identification number is created as followed AUTO PID xxx This mode will create limitations for sample pro cessing It is highly recommended that you use the Patient ID field to create a single Patient ID for each patient sample This field is highly necessary to create patient files that can be archived and easily associated with searching on Patient ID criteria in order Patient demographical data can only be modified when it is Manually created on the instrument The Host computer can only modify patient demographical data that has been tr
131. cally archived into the system memory if Begin of day screen has been configured as described in Daily Guide RAB156C Reviewing the Archives is accessible by three modes 1 By date Daily Reports see 7 2 Daily Report Description page 4 71 2 By patient Patient Reports see 7 3 Patient Report page 4 73 3 Reviewing Reports exported to an external media see 7 5 Reviewing exported reports page 4 75 7 1 Accessing the Archives Select the Archives key from the generic toolbar e5 r r ro Ci m i La 1 in a Fig 4 59 Archives access When the Archives function is opened the Daily Reports screen is displayed 4 70 Pentra XL 80 User Manual RAB131GEN Workflow Archives 7 2 Daily Report Description PENTRA XL 80 Reports by Date 14 08 55 13 59 54 14 09 07 14 00 04 14 09 19 0002 0003 0003 0004 0004 UPUIS MARTIN MARTIN MARTIN DUPUIS MARTIN Claude Claude Claude Ren e Claude DIFF DIFF _ DIFF DIFF DIFF DIFF 14 09 31 14 00 15 14 01 56 14 00 24 14 10 00 0005 0005 0006 0006 0006 MARTIN MARTIN MARTIN DUPUIS Claude Claude Claude Renee DIFF DIFF DIFF DIFF DIFF 0007 IP _ DIFF 0007 DIFF AUTO_SID1 DIFF AUTO SID2 DIFF AUTO SID3 DIFF AUTO_SID4 DIFF AUTO SIDS 1 _ DIFF AUTO SID6 _ DIFF AUTO SID7
132. ce O NA Caution consult accompanying documents Reagent gt Fragile handle with care i Do not stack LOT Batch code Use by L Calibrator gt CONT Content 1 4 Pentra XL 80 User Manual RAB131GEN Switch on position Manufacturer This product conforms to the EEC Standards and Directives named in the Declaration of Conformity Biological risk Keep dry Temperature limitation Catalogue number Consult Instructions for Use Control This product should be disposed of and recycled at the end of the useful life in accordance with the WEEE Directive 2002 96 CE Introduction Labels 2 Labels 2 1 Input Output Labels Fig 1 1 Rear panel labels Pentra XL 80 User Manual RAB131GEN 1 5 XL 21 1 Identification label 4 HORIBA ABX 15 18 E T7 207 14 t5 MADE IN FRANCE went PENTRAXL BO NUMERO DE SERIE SERIAL NUMBER TENSION SECTEUR VOLTAGE INPUT 100 240 V ih FIN f y FREQUENCE rA SA Uel D Faeoveney 20 60 Hz A us Pns PUISSANCE ATTENTION AFIN DEVITER LES RISQUES DE CHOC ELECTRIQUE NE PAS OTERA LES CAPOTS ET LES TRAPPES D ACCES APPELER UN REPARATEUR QUALIFIE DEBRANCHER LE CABLE DALIMENTATION SECTEUR AVANT TOUTE INTERVENTION VERIFIER QUE LA TENSION EST CORRECTE N UTILISER EN REMPLACEMENT QUE DES FUSIBLES DE MEME TYPE ET DE MEME CALIBRE CAUTION E THE RISK OF ELECTRIC SHOCK DO ER OR BACK QUALIFIED SERVICE PERSONNEL SYSTEM FROM SUPPLY
133. centage of this integration 3 2 4 RDW calculation The RDW Red cell Distribution Width is used to determine erythrocyte abnormalities linked to Anisocytosis The RDW will enable the user to follow the evolution of the width of the RBC histogram in relation to the number of cells and their average volume The RDW is also a calculation from the RBC histogram Calculations are as followed RDW K X SD MCV With K system constant SD Standard Deviation according to statistical studies on cell distribution within the RBC histogram MCV Mean Corpuscular Volume of erythrocytes Pentra XL 80 User Manual RAB131GEN Measuring principles 6 15 ABX Pentra XL 80 3 2 5 MCV MCH MCHC calculation MCV Mean Cell Volume is calculated directly from the entire RBC histogram MCH Mean Cell Hemoglobin is calculated from the HGB value and the RBC count The mean hemoglobin weight in each RBC is given by the formula MCH pg HGB RBC x 10 MCHC Mean Corpuscular Hemoglobin Contained is calculated according to the HGB and HCT values Mean HGB concentration in the total volume of RBC is given by the formula MCHC g dL HGB HCT x 100 3 2 6 MPV Measurement The MPV Mean Platelet Volume is directly derived from the analysis of the platelet distribu tion curve 3 2 7 Pct Calculation Thrombocrit is calculated according to the formula Pct PLT 10 mm x MPV um 10 000 3 2 8 PDW calculation
134. container according to your laboratory s protocol Close the empty container with the cap and dispose of waste liquids according to your lo cal national organizations 2 2 Optical bench lamp replacement 2 2 1 Lamp replacement A Wait for the lamp to cool down before handling it Power off the instrument Open the instrument left hand and right hand side panels lift the top cover of the instrument as well see 3 Instrument panels amp cover Removals page 7 19 Locate the Optical bench at the top left of the instrument see Fig 7 15 page 7 16 Pentra XL 80 User Manual RAB131GEN 7 15 ABX Pentra XL 80 Fig 7 15 Optical bench location Disconnect the lamp connector see Fig 7 16 page 7 16 Fig 7 16 Optical bench lamp disconnection Loosen the lamp holding bracket screws a few turns see Fig 7 17 page 7 16 Fig 7 17 Lamp fixation screws Turn the lamp bracket from the loosened screws and remove the lamp see Fig 7 18 page 7 17 7 16 Pentra XL 80 User Manual RAB131GEN Maintenance amp Troubleshooting Replacement procedures Fig 7 18 Lamp dismantling Once the old lamp has been removed replace it with a new lamp Use a lint free wipe to clean any residue or fingerprints from the new lamp before placing it into the optical bench This will ensure that the new lamp will perform at its optimum peak Tighten the lamp fixation screws Connect the lamp to its power supply 2
135. d DRAIN 1 Syringe Motor home switch always detected DRAIN 1 Syringe Motor Mecha nism initialization failed DRAIN 2 Syringe Motor home switch always detected DRAIN 2 Syringe Motor Mecha nism initialization failed Drain Sensor Injection Syringe Motor home switch always detected Injection Syringe Motor Mecha nism initialization failed LMNE transfer sensor Needle Motor home switch always detected Needle Motor Mechanism initial ization failed Piercing Syringe Motor Reagent Temperature Reagent Temperature sensor Reagent Temperature sensor Sampling Syringe Motor home switch always detected Help Message Run an Auto Clean Check Motor in Service Menu Run an Auto Clean Check Motor in Service Menu Run an Auto Clean Check Motor in Service Menu Run an Auto Clean Check Motor in Service Menu Run an Auto Clean Check Motor in Service Menu Run an Auto Clean Check Motor in Service Menu Run an Auto Clean Check Motor in Service Menu Run an Auto Clean Check Motor in Service Menu Run an Auto Clean Check Motor in Service Menu Run an Auto Clean Check Motor in Service Menu Run an Auto Clean Run an Auto Clean Check Motor in Service Menu Run an Auto Clean Check Motor in Service Menu Run an Auto Clean Run an Auto Clean Check Motor in Service Menu Run an Auto Clean Check Motor in Service Menu Run an Auto Clean Check Motor in Service Menu Run an initialization Run an initial
136. d associated Flags page 4 27 6 Report page 4 51 7 Archives page 4 70 1 Workflow This chapter describes the overall operation of Patient sample management through the sys tem which include creating orders matching orders automatic and manual patient file management sample exceptions and many other features which identify the sample all the way to final reports The chapter section description is as indicated in the following order 1 1 Sample tube management page 4 3 1 2 Workflow page 4 3 1 3 Worklist page 4 4 1 4 Sample identification page 4 5 1 5 Barcode Identification page 4 5 1 6 Sample identification on Rack position page 4 8 1 7 Exception management page 4 11 1 8 Sample runs and order association page 4 13 1 10 Patient file management page 4 14 1 11 Loading Worklist from the LIS page 4 14 1 1 Sample tube management Pentra XL 80 can automatically load racks once the sample tubes have been positioned The STAT mode can be utilized to analyze one to several specimens manually while in the rack mode The rack will stop at the introduction of the STAT mode and continue with the remain ing samples on the rack once the STAT mode is complete 1 2 Workflow Once the Pentra XL 80 has started the analysis process on a sample tube an order is generated to search the worklist for 2 of the following criteria The Rack position number where the tube has been placed
137. de to the Depth and Level fields Run key This key allows the acceptance of the number of steps from the Sample probe Home position to the top flat surface of the tube holder The obtained value is returned into Position id field Holder Open Time key This key allows the instrument to calculate the amount of time it takes for the tube holder to completely open This value will be entered into the Time field Pentra XL 80 User Manual RAB131GEN 7 29 ABX Pentra XL 830 4 2 7 Rack adjustment The Rack Adjustment menu allows to define for each type of rack the depth and level of sam pling inside the tube Depth This measurement is the actual depth of the rack in millimeters corresponding to the rack Type Level This measurement is subtracted from the depth of sampling in millimeters in rela tionship to the rack Type Accept Values key This key is used to accept any changes made to the Depth and Level fields PENTRA XL 80 Mechanical System Se ee wow wu eile E 3 3 3 3 3 3 3 3 2 P 3 A 3 3 3 7 3 St ce Px Bt IK Fig 7 33 Super User Mechanical Rack Adjustment 7 30 Pentra XL 80 User Manual RAB131GEN Maintenance amp Troubleshooting Service menu description 4 3 Hydraulical menu 4 3 1 Drain chambers Hydraulic System Fig 7
138. e 4 30 Pentra XL 80 User Manual RAB131GEN 5 3 5 LMNE matrix flags v NO flag Absorbance NoN NoE Left Neu Left Lympho Lym NoL LL AL LMD RM Channel 127 N NL Resistivity Fig 4 21 No flag Standard value for NO 100 120 See Section 5 Settings 8 3 Alarms amp Cur ve thresholds page 5 47 Worktlow Run results and associated Flags Meaning Background NOise This flag occurs when the number of parti cles counted in the background noise area is higher than the limit set up in NO or when the number of counted particles ver sus the total number of WBC is above the NO limit Suspected abnormalities e Platelet aggregates e Large number of platelets e Erythrocyte membrane resistant to lysis stroma e NRBCs e Pollution This alarm appears in the Analyzer Alarms area on the screen and the printout y Pentra XL 80 User Manual RAB131GEN 4 35 ABX Pentra XL 30 v LL flag Absorbance NoN NoE Channel 127 2 7 L LMD RM Resistivity Fig 4 22 LL flag Standard value for LL 100 50 See Section 5 Settings 8 3 Alarms amp Cur ve thresholds page 5 47 v LL1 flag Absorbance NoN NoE Channel 127 LMD RM Resistivity Fig 4 23 LL1 flag Standard value for LL1 5 45 See Section 5 Settings 8 3 Alarms amp Cur ve thresholds page 5 47 436 Pentra XL 80 User Manual RAB131GEN
139. e 5 7 The worklist sample management depends on laboratory organization This must be defined when the instrument is installed barcode or rack position 4 4 Pentra XL 80 User Manual RAB131GEN Worktlow Workflow 1 4 Sample identification A Single sample number identifies orders that are generated from the worklist If the operator does not enter a number the instrument will automatically assign a number as followed AUTO SID xxxxx sample ID Rack Fas PatientID Oo 123658 36597 AUTO SID AUTO SIUS AUTO SID AUTO SIOF AUTO SIDE be ek be kek Ow 0 om wo Nk Re Fig 4 1 Automatic sample numbering If the operator enters an order with a Sample ID that already exist in worklist the previous order will be updated Modifications cannot be performed during the sample analysis process Orders are deleted once the sample analysis is complete 3 modes of sample identification are available Barcode identification see 1 5 Barcode Identification page 4 5 Rack Position identification see 1 6 Sample identification on Rack position page 4 8 Automatic numbering by the instrument 1 5 Barcode Identification The Barcode Identification mode is the most recommended mode on the Pentra XL 80 because it ensures the best security and flexibility Easy association between Sample orders and the sample tube can be identified by the barcode The Sample ID field must match that of the barcode label Ent
140. e Mode message will be displayed and printed for an HGB lt 2g dL and PLT gt 15x10 mm Pentra XL 80 User Manual RAB131GEN 4 31 ABX Pentra XL 80 4 32 v CDR Mode See Section 2 Specifications 3 9 CDR Mode specifications page 2 13 Parameters WBC CDR mode RBC CDR mode HGB CDR mode HCT CDR mode PLT CDR mode for HGB 2g dL PLT CDR mode for HGBx2g dL PLT gt 15X10 mm gt Dilution ratio value RBC Value between brackets D value D printed and displayed value O transmitted to the LIS RBC Value between brackets D value D printed and displayed value 0 transmitted to the LIS HGB Value between brackets D value D printed and displayed value 0 transmitted to the LIS HCT Value between brackets D value D printed and displayed value 0 transmitted to the LIS PLT Value between brackets D value D printed and displayed value O transmitted to the LIS PLT value between brackets D value D printed and displayed value 0 transmitted to the LIS gt Dilution ratio value visible ranges WBC replaced with D D printed and displayed 0 transmitted to the LIS RBC replaced with D D printed and displayed 0 transmitted to the LIS HGB replaced with D D printed and displayed 0 transmitted to the LIS HCT replaced with
141. e Ree sasa P80XL to require the order to the LIS Tab 5 5 Communication General tab Sending options Function Default value Send Quality Control Reports Do the Qc analysis send to the LIS Unchecked Send Within Run Reports Do the Within Run results send to the LIS Unchecked Send Startup Reports Do the Startup results send to the LIS Unchecked Send Unmatched Reports Do the Unmatched Reports send to the LIS Unchecked Tab 5 6 Sending options 5 26 Pentra XL 80 User Manual RAB131GEN Settings System Fig 5 22 System Communication tab 5 3 2 ABX format tab According to the Format chosen on the General tab see 5 3 1 General tab page 5 25 an ABX format tab is available The ABX Format allows the transmitted data batches to be variable in size This variable size allows the transmission of Histograms Thresholds and 5 DIFF matrixes as shown on the system The RS232 settings tab can be modified according to the selections chosen by the operator see 5 3 3 RS232 settings tab page 5 28 Heading key Function Numerical results Selected hematology paramaters sent to the LIS Flags and Pathologies See Section 4 Workflow 5 3 Flags page 4 Flags and Pathologies 30 associated to the selected parameters sent to the LIS Selected fields sent to the LIS See Section 4 Workflow 2 Worklist Patient File description page 4 15 Histograms and thresholds Selected data sent to the LIS Tab
142. e stability soon 4 25 SA eno an WINE mao ba E 4 25 Ma MN aces aaepenannareadaneneysade 4 25 4 KUN SU Oa ee eat 4 26 5 Run results and associated Flags 4 27 Sk Peru Ra occu 4 27 5 2 RUU Sole anna ot 4 28 To e om on E 4 30 is IN SOO ea ee anna ae an no 4 51 Os REVICW 110 ROPO enneo beken iren EE penat mita 4 51 6 2 Construction OF a Repot tangan 4 57 Pentra XL 80 User Manual RAB131GEN 4 1 ABX Pentra XL 830 6 3 Validation or rejection of a Report ooo 4 63 6 4 Rerunning sample manually ooooooo 4 64 6 5 Run order ASSOCIATION ssicnce lt dstenedanomaraqacoenenewndenieacretons 4 68 Ae ANGIN ES ae ee po ema ana aa pena AR an 4 70 Tol Accessing the ATOM CS ani eonveni ane nee eh an em ear 4 70 7 2 Daily Report Description ooo 4 71 Fm ee IN KEPO teen Na aan aa 4 73 7 4 Reviewing a Report in full screen mode 4 75 7 5 Reviewing exported repOFts oooo o ooooo 4 75 pS sega caterers nan E 4 77 8 1 Accessing the Status screen oooooooo 4 77 8 2 Status screen description aired csxestordectadorameocertanenevatier 4 78 oe SEA WIS E E aries ML 4 79 4 2 Pentra XL 80 User Manual RAB131GEN Worktlow Workflow Workflow chapter includes the following Workflow page 4 3 Worklist description page 4 15 Sample collection amp mixing page 4 25 1 2 3 4 Running specimen page 4 26 5 Run results an
143. e trig gers of each alarm These are selected by default They can be disabled Tab 5 2 General tab function Keys 2 2 2 Automatic numbering When the instrument has not received an order the instrument then associates an automatic Sample ID number that is incremented for each new cycle This automatic Sample ID number is identified in the ID field as AUTO SIDn where n is the incremented number that is entered in this box Select the Edit key and then select the AUTO SID box figure see Fig 5 2 page 5 5 Now type in a beginning number to start the daily sequencing then select the OK key to confirm your entry In order to enter the initial daily auto numbering start sequence the Worklist from the previous day must be erased See Daily Guide RAB156C 2 2 3 RUO parameters The RUO parameters Research Use Only are as indicated PCT PDW ALY LIC If the Visible box on the soft parameter screen has a Check mark see Fig 5 2 page 5 5 the instrument software will trigger the following message when results are displayed on the screen PCT PDW ALY and LIC are for research use only This message will also be printed out and or transmitted to the LIS Select the Edit key and then place a Check mark in the Visible or Invisible box Now select the OK key to confirm your choice 5 6 Pentra XL 80 User Manual RAB131GEN Settings Soft parameters 2 2 4 Instrument L
144. echanism initialization failed Sampler Transfer Motor home sen sor always detected Sampler Transfer Motor End trans fer rack switch not detected Sampler Transfer Motor End trans fer rack switch always detected Mixer Motor Mechanism initializa tion failed Mixer Motor home sensor always detected Mixer Motor Grabers sensor posi tion not detected Rack in the wrong side in loading area Pentra XL 80 User Manual RAB13 1GEN Help Message Run an Auto Clean Check Motor in Service Menu Run an initialization Run an initialization Run an initialization Run an Auto Clean Replace the lamp see 2 2 Optical bench lamp replacement page 7 15 Help Message Run an initialization Check motor in Service Menu Run an initialization Check motor in Service Menu Run an initialization Check motor in Service Menu Run an initialization Check motor in Service Menu Run an initialization Check motor in Service Menu Run an initialization Check motor in Service Menu Run an initialization Check switch in Service Menu Run an initialization Check switch in Service Menu Run an initialization Check motor in Service Menu Run an initialization Check motor in Service Menu Run an initialization Check motor in Service Menu Set rack in the right side posi tion and restart automatic cycle Maintenance amp Troubleshooting Error messages Alarm Error Type Help Message No rack No Rack in loadi
145. ector Syringes Lefthand side of the instrument check for smooth and complete movement of the syringe 3 Counting Syringe Lefthand side of the instrument check for smooth and complete movement of the syringe 4 Drain 2 Syringe Motor Lefthand side of the instrument check for smooth and complete movement of the syringe 5 Piercing Mechanism Close the Tube Holder Door and verify smooth and complete piercing movement 6 Loading Mechanism Check for smooth and complete movement of Rack Loader 7 Transfer Mechanism Check for smooth and complete movement of the rack transfer mechanism 8 Mixer Mechanism Check for smooth and complete rotational movement of the sample tube mixer 9 Sampling Needle Check for smooth and complete movement of the sample probe 10 Carriage Motor Right hand side of the instrument Check for smooth and complete movement of the sampling carriage 11 Sampling Syringe Right hand side of the instrument on the carriage check for smooth and complete movement of the Sampling syringe 12 Drain 1 Syringe Motor Right hand side of the instrument check for smooth and complete movement of the Waste Drain syringe Pentra XL 80 User Manual RAB131GEN 7 25 ABX Pentra XL 830 4 2 3 Check valves This menu will allow the user to check the operation of all electrical valves on the instrument Power off the instrument Open the instrument right and left front doors and remove the right hand and lef
146. ed reports validation 2003 14 56 12 16 53 21 2003 16 53 37 2003 09 28 46 a PEAN a x23 BEA KO o Mehin E o aa Fig 4 50 Report validation 2 Select the Unvalidated view of the screen 3 Then select the Reports to validate 4 select the Validate Report key Pentra XL 80 User Manual RAB131GEN 4 63 ABX Pentra XL 30 5 A confirmation message is displayed Select the OK key Reports are automatically transferred to the Validated view of the Report List ferred either to Validated and transmitted or Validated but not transmitted view See Section 5 Settings 4 4 Print and transmit conditions page 5 21 According to the settings of the Transmit conditions these Reports are trans y 6 3 2 Rejection of several Reports Proceed the same than described in 6 3 1 Validation of several Reports page 4 63 but Select the Reject Report key instead of Validate Report A confirmation of the Rejection is displayed Select the OK key Reports are automatically transferred to the Rejected view of the Report List 6 3 3 Validation or Rejection of a single Report Open the Report List screen by selecting the Report Key see 6 1 1 Accessing the Re port list page 4 51 Select the Unvalidated view of the screen Click the Report to validate to open it in the Report Display screen see 6 1 4 Report dis play page 4 55 Select Validate
147. ely 1 minute ensures optimum mixing of the samples The Tube Grabber contains 2 grabbers which work in conjunction with the tube sampling The first tube grabber grabs the number 1 tube and mixes it for 30 seconds The tube is then placed back into the rack The same process applies for the second tube in the rack Then both tubes numbered 1 and 3 are grabbed and mixed at the same time for another 30 seconds more The tubes are placed back into the rack and then tubes numbered 2 and 4 are taken and mixed and so on 6 8 Pentra XL 80 User Manual RAB131GEN Description amp Technology Automatic mode principles v Sample tube identification An internal Barcode reader identifies both racks and sample tubes to ensure true identifica tion and security of results v Fig 6 8 Sample tube identification Pentra XL 80 User Manual RAB131GEN 6 9 ABX Pentra XL 80 v Sample Cap Piercing In order to keep the sample volume at a very small amount approximately 60ml HORIBA ABX utilizes a Double needle sample probe This probe consists of an external piercing nee dle with narrow internal sampling probe that aspirates the sample while the cap is being pierced Fig 6 9 Sample Cap piercing 6 10 Pentra XL 80 User Manual RAB131GEN Description amp Technology Measuring principles 3 Measuring principles 3 1 Multi distribution sampling sytem MDSS 3 1 1 CBC mode While in the CBC Mode 30ul
148. epending on the analysis mode CBC or DIFF Changing the parameter view can be made by selecting the parameter tabs WBC RBC HGB HCT PLT MPV MCV MCHC HCT MCH and NEU EOS BAS LYM MON see Fig 3 3 page 3 6 1 Indicates the target value shown by the centerline in the parameter field 2 Indicates the Maximum Target value shown by the upper line in the parameter field 3 Indicates the Minimum Target value shown by the lower line in the parameter field 4 Individual parameter value points as indicated by the cursor Blue indicates a value that is lower than the low limit Fig 3 3 L J graphs Red indicates a value that is higher than the upper limit The date displayed is the date of the control run which is indicated by the cursor 3 6 Pentra XL 80 User Manual RAB131GEN Ouality Assurance 1 3 OC data screen grid From the L J graphs screen use the Details key to display the OC data screen grid v Analyses results 1 Check boxes select deselect QC data 2 Operator that processed the control runs 3 Date and time that the QC run was processed 4 Filter DIFF CBC or All parameters 5 Use sliders to view all parameters 6 This field will display all comments associated with the specific QC run Click on the individual results line so that it will display it in Grey 7 This field shows the number of QC runs selected from the Check boxes
149. ering the sample tube posi tion in the rack is not available while in this mode Pentra XL 80 User Manual RAB131GEN 4 5 ABX Pentra XL 80 1 5 1 Setting Barcode Manual match OFF The Sample ID field corresponds to the barcode of the label In this mode it is impossible to allocate a position for the tube in the worklist The Pentra XL 80 tab Settings Soft parameters General tab barcode option is set as shown See Section 5 Settings 2 2 5 Identification option page 5 7 Barcode Id 123 Barcode reading Problem on reading as NX ilk Ty a ET cm aE NEn OK 2 Sa Ah ae AA n E ae iw i t AP SF I 7 Identification re done Result 1d 123 Fig 4 2 Barcode Manual match OFF 4 6 Pentra XL 80 User Manual RAB131GEN Worktlow Workflow 1 5 2 Setting Barcode Manual match ON The Pentra XL 80 tab Settings Soft parameters General tab barcode option is set as shown See Section 5 Settings 2 2 5 Identification option page 5 7 OK OK Problem on reading Worklist check Worklist check Worklist matched Identification re done Y Y Result 1d 123 Fig 4 3 Barcode Manual match ON Pentra XL 80 User Manual RAB131GEN 4 7 ABX Pentra XL 80 1 6 Sample identification on Rack position Setting Rack Position See Section 5 Settings 2 2 5 Identification opt
150. es following treatments may interfere with leukocyte counts as cell sizes can not be distinguished The abnormal basophils degranulation following allergies may interfere with leukocyte counts because cell sizes can not be distinguished and because they may lose their characteristic intracytoplasmic material Pentra XL 80 User Manual RAB131GEN ABX Pentra XL 80 Quality Assurance Contents je Doain A ere 3 4 1 1 Access to the Quality Control Menu 3 4 Pa Ga aa 3 6 MOG data See Ori esrin AA 3 7 1 4 Graphics SO eat ee aa 3 8 1 5 Print send or delete results oooooooooooo 3 9 1 6 New blood control setup 3 10 1 7 Running CoOntioOOOOk ons ne aan 3 13 2 Patient Quality Control XB oooooooo 3 14 2 1 Access to the XB Menu os sccccsedersrersseseorcrenenressentstdeassee 3 15 De A GS E A E tea NE 3 16 2 3 AB Data OGG SC es asn 3 17 2A BCA COM Na 3 18 PE P E A Sa aa Gaara 3 19 Sa MEN MI E E E 3 21 3 1 Accessing the Within Run Data Grid 3 21 3 2 Closed tube sample setting ooo 3 22 3e RUNNIN CYC lE Sor ee re ee 3 22 EE TA ET E A A ey eet serv err ese 3 25 4 1 General recommendations oooooWoW 3 25 4 2 Accessing the Calibration Main Menu 3 26 Ay Bre Wan CU ae en ba terse 3 27 4 4 Running Oa na 3 28 Ia BOP sn om et asa eren shee E E E A E 3 32 5 1 Accessing the Logs function eeeeeeeeeeeeneteeeeeeees 3 32 SAN NO RAO 9
151. escription Sal aa Aa al IK Fig 7 26 Super User menu 7 23 Pentra XL 80 User Manual RAB131GEN ABX Pentra XL 80 4 2 Mechanical menu 4 2 1 Instrument Initialization PENTRA XL 80 Mechanical System Fig 7 27 Super User Mechanical Initialization Select the Initialization key and then select the Run key to start the initialization cycle This cycle will place all mechanical assemblies in a ready for analysis position This will be a starting state for the Auto sampler Sampling probe sample Carriage Syringes etc This is also termed as a mechanical homing for all assemblies to their ready position 4 2 2 Check motors This menu will allow the user to check the operation of all the motor driven assemblies independently Power off the instrument Open the instrument right and left front doors and remove the right hand and left hand side panels see 3 Instrument panels amp cover Removals page 7 19 Once the side panels have been removed power on the instrument From the Main screen select the Super User Menu and then Mechanical Check Motors 7 24 Pentra XL 80 User Manual RAB131GEN Maintenance amp Troubleshooting Service menu description PENTRA XL 80 echanical System Fig 7 28 Super User Mechanical Check Motors 1 Diluter Syringes Left hand side of the instrument check for smooth and complete movement of the syringe 2 Inj
152. eshold Purpose BA1 Separation between L1 counting area and WBC BA2 Separation between WBC amp BAS BA3 End of the BAS Counting area Tab 5 21 BAS thresholds 5 50 Pentra XL 80 User Manual RAB131GEN Settings Sample Types 8 4 Age range This tab is accessible if and only if one of the child types has been selected from the Type management list see Fig 5 35 page 5 44 PENTRA AL 80 Types IDAE 6 YOMOD E e 10 YOMOD MERE eo l 12 YOMOD Fig 5 40 Types Age Range This tab will allow the user to define limits between pediatric areas The child type range is displayed in purple The low range of a child n 1 begins at the high range of child n 1 day The date format of the range is as followed xx year xx month xx day To modify the range of one child select the Edit key Move left right the cursor of the child type to display the wished high range Select the OK key to confirm your range selection 8 5 Defaults settings of the Pentra XL 80 types The following values are the software default values for pathological limits amp thresholds Sec tion 5 Settings 8 5 1 Pathological limits and thresholds page 5 51 Alarm levels Section 5 Settings 8 5 2 Alarms levels page 5 60 Matrix thresholds classified by types standard man woman Child 1 2 3 4 and 5 8 5 1 Pathological limits
153. ettings window select the Soft parameters key This will bring up the Soft parameters general menu Fig 5 2 Soft parameters General menu There are three tabs available from this menu General see 2 2 General tab page 5 6 Department Physicians see 2 3 Department Physicians tab page 5 8 Units see 2 4 Units tab page 5 10 Pentra XL 80 User Manual RAB131GEN 5 5 ABX Pentra XL 80 2 2 General tab 2 2 1 General tab functionalities Key Heading Function Defines the initial value of the autonumbered Sample Auto Nompeung mabe NUMSENNY ID see 2 2 2 Automatic numbering page 5 6 Enables disables RUO parameters for printing and RUO parameters RUO parameters sending operations see 2 2 3 RUO parameters page 5 6 Enables disables automatic prompts for logs Logs Logs see 2 2 4 Instrument Logs page 5 7 Dau rece Tee Test performed when no order is associated to a sample tube Depends on laboratory operation mode Barcode Option Barcode Option all sample identified with barcode or not see 2 2 5 Identification option page 5 7 QC or XB alarms options Section 4 Workflow Alarms Alarms 5 3 13 Statistical function flags page 4 50 Are the QC failed and XB blocking alarms Defines the number of consecutive instrument mishaps or alarms for stopping analysis operations from 1 to 5 Number of consecu Shoneting OGO times tive analyses with Operator can choose the number of consecutiv
154. f Clinical Chemistry Devices Approved Guideline NCCLS document EP5 A ISBN 1 56238 145 8 1999 source 510K submission K024002 3 2 Precision Repeatability Three normal blood are tested 10 times running one in CBC mode one in diff mode and one in open tube The average the variation ratio together with the standard deviation of the measure for each sample will be calculated Pentra XL 80 User Manual RAB131GEN Specifications Summary of performance data Manual CV Yo P 7 WBC 1 24 1 16 1 22 RBC 0 51 0 86 1 00 HGB 0 34 0 38 0 54 HCT 0 53 0 78 1 03 PLT T51 2 25 1 66 LYM 2 20 2 21 MONO 4 69 6 18 NEU 137 0 77 EOS 6 28 9 41 BASO 11 11 16 62 Tab 2 6 Repeatability table N 10 v Precision claims WBC lt 2 0 4 10x 10 ne RBC lt 2 0 3 6 6 2 x 10 uL HGB lt 1 0 12 18 g dl HCT lt 2 0 36 54 PLT lt 5 0 150 500 x 10 yL Tab 2 7 Precision claims source 510K submission K024002 3 3 Linearity Linearity range The Manufacturer s tested linearity zone of the instrument using linearity kits and or human blood Linearity limits Maximum and minimum values within instrument returns no dilution alarm Visible range Range values given by the instrument These values above linearity limits are given as an indication They are given associated with a D flag This Visible range is outside Manufacturer s range v Linearity kits Linearity was
155. fic expectation condition are saved in a specific screen which allows the matching of identified orders to non identified runs see 6 5 1 Association grid description page 4 68 Pentra XL 80 User Manual RAB131GEN 4 11 ABX Pentra XL 80 1 7 1 Sample identification on both barcode and Rack Position If a sample tube is identified by a barcode although the setting is Rack Position See Section 5 Settings 2 2 5 Identification option page 5 7 the instrument checks that the worklist Sample ID corresponds to the tube barcode identification and that the rack position of the tube corresponds to the one entered in the Worklist If not the instru ment generates an exception Example RACK WORKLIST Rack 1 Rack 1 Position 1 Position 1 Barcode 123 Sample ID 124 sample ID Rack Fos Patient ID 0068 0069 0070 The tube identified 123 position 1 1 does not correspond to the order position 1 1 which is identified 124 This tube is analyzed in the instrument default test The result and the order must be manually matched 1 7 2 Identification with barcode without order However Pentra XL 80 does not generate an exception in this case provided that the rack position of this tube has not been reserved for an order in the worklist Example RACK WORKLIST Rack 1 Rack Position 1 Position Barcode 123 Sample ID Rack Pos IL do Paciente Nome d This tube is analyzed in the instru
156. for a good seal on the sample probe Power on the instrument and verify that there are no fluid leaks during startup Re install the right hand side panel 7 18 Pentra XL 80 User Manual RAB131GEN Maintenance amp Troubleshooting Instrument panels amp cover Removals 3 Instrument panels amp cover Removals Chapters in this section 3 1 Left front door removal page 7 19 3 2 Right front door removal page 7 20 3 3 Right hand side panel removal page 7 20 3 4 Left hand side panel removal page 7 21 Power off the instrument Disconnect the power supply cable 3 1 Left front door removal Pull the Left Front cover down as indicated in 1 and then pull out to remove it as indi cated in 2 see Fig 7 21 page 7 19 Fig 7 21 Left Front cover Pentra XL 80 User Manual RAB131GEN 7 19 ABX Pentra XL 30 3 2 Right front door removal Pull the Right Front cover down as indicated in 1 and then pull out to remove it as indi cated in 2 see Fig 7 22 page 7 20 Fig 7 22 Right front cover 3 3 Right hand side panel removal Locate the 2 locking screws at the top of the right side panel Place a flat tipped screwdriver into the screw slots and turn counter clockwise to unlock the screws see Fig 7 23 page 7 20 Fig 7 23 Righthand side panel Lift the panel up and out of its placement slot 7 20 Pentra XL 80 User Manual RAB131GEN Maintenance amp Troub
157. g the Details key 2 PENTRA XL 80 Rack View Rack Pos m an Collection Date par 10 2001 09 10 00 Type woman Department maternite Physician FRICH Philippe Comments eS RSS Rerun T Patient ID po 0002 Patient Name pms S3 First Name gan Philippe Date of Birth e fpa 14 1955 47 Y Gender Femelle X QD 05 1 3 2003 14 20 20 Ane Version V1 Obetad FTechrician Fig 4 66 Selection of a tube 4 80 Pentra XL 80 User Manual RAB131GEN Worktlow Status v Search sample screen When a sample ID or Patient name has been searched by using Sample ID search key or Patient Name search key the positions of the found results are shown in red see Fig 4 67 page 4 81 PENTRA XL 80 Rack View Rack Pos Bian ID RS Collection Date Type Standard Department Physician Comments s 5 i Patient ID Patient Name First Name Date of Birth E3 Gender Inconnu Version Y1 0beta4 Technician 05 1 3 2003 14 10 20 Fig 4 67 Search sample screen Pentra XL 80 User Manual RAB131GEN 4 81 ABX Pentra XL 80 4 82 Pentra XL 80 User Manual RAB131GEN ABX Pentra XL Settings Contents 1 Menu Settings Overview 5 3 1 1 Accessing the Settings MENU oooooooo 5 3 1 2 Menu Settings functiOns ooo 5 4 2 DOM Para tek kaset pap abon am eS Tana 5 5 2 1 Accessing the Soft
158. gave wrong results on the WBC or RBC or HGB or PLT parameters the notification line is red A Startup has failed if HGB blank value is not within acceptable limits The notification line is red The default limit values are WBC lt 0 3 10 mm RBC lt 0 03 10 mm HGB lt 0 3 g dl PLT lt 7 10 mm LMNE lt 0 30 Pentra XL 80 User Manual RAB131GEN 3 35 ABX Pentra XL 30 5 10 Patient logs For every modification to a patient file by the WorkList or by the HOST a notification is done When exception is generated because of the mismatch of the rack position of the sample and the order Section 4 Workflow 1 7 Exception management page 4 11 a notifica tion is done e When the user matches an order and a result in the association screen a notification is done If a recomputing of the result is done the notification shall contain this information 5 11 Logs by Date This function groups the Calibration logs Maintenance logs and Reagents logs together on the same screen and displayed by date Two scrolling lists From and To allow the user to display log events in a chosen interval These events when they exist are displayed in a grid mode and detailed in the right part of the screen PENTRA XL 80 Logs 03 03 2003 06 03 2003 IA 04 10 2003 17 38 18 _ 04 10 2003 17 40 12 g 04 10 2003 17 41 53 04 10 2003 17 44 44 Ki 04 10 2003 17 45 12 iz 06 03 2003 16 36 51 E
159. grid Chap 3 7 Send results Chap 3 9 Targets Chap 3 10 R Rack Chap 1 13 Identification Number Chap 1 13 RDW calculation Chap 6 15 Reagent Chap 2 4 Chap 6 2 consumption Chap 2 6 cover Chap 6 2 Diluent and waste connections Chap 6 6 replacement Chap 7 9 Repeatability Chap 2 7 Report Chap 4 51 Access Chap 4 51 Anteriority Chap 4 60 Construction Chap 4 57 Details Chap 4 57 Display Chap 4 55 Edit Chap 4 60 List Chap 4 53 Manual entry Chap 4 58 Chap 4 61 Pentra XL 80 User Manual RAB131GEN 9 5 ABX Pentra XL 30 Rejected Chap 4 58 Chap 4 63 Validation Chap 4 63 Rerun Conditions Chap 5 17 Delta Check Chap 5 19 On Dilution Chap 5 18 On alarms Chap 5 17 Run in Progress Chap 1 17 Run Result screen Chap 4 28 Runs amp Report overview Chap 1 23 Runs orders matching Chap 4 69 RUO parameters Chap 5 6 S Sample Compatible tube list Chap 2 6 Chap 8 6 Sampling probe replacement Chap 7 17 Save Restore Chap 5 36 Search patient Chap 4 20 Services Chap 1 17 Settings Chap 1 17 Chap 5 3 Access Chap 5 3 General tab Chap 5 6 Identification option Chap 5 7 Save Restore Chap 5 36 Soft parameters Chap 5 5 system Chap 5 23 thresholds Chap 5 48 User profiles Chap 5 40 Shutdown Chap 1 17 Soft parameters Chap 5 5 Software Chap 1 14 arborescence and Hints Chap 1 18 overview Chap 1 14 Specifications Chap 2 2 Parameters Chap 2 2 Physical Chap 2 5 Reagent Chap 2 15 Stability study Chap 2 12 Startup Chap 1 17 Status Chap
160. h content page 3 18 2 5 XB limits page 3 19 3 14 Pentra XL 80 User Manual RAB131GEN Ouality Assurance Patient Ouality Control XB 2 1 Access to the XB menu From the Quality Assurance Menu see Fig 3 1 page 3 3 select the XB key Fig 3 13 XB Graphic screen v XB Keys Function Access to XB limit modifying screen see 2 5 XB limits page 3 19 In XB Data grid prints a list of Batch see Printing XB Data grid page 3 17 In XB graphs mode prints graphs with 60 full points Print Transmit Tab 3 2 XB keys Pentra XL 80 User Manual RAB131GEN 3 15 ABX Pentra XL 30 2 2 XB Graphs The XB Graphs see Fig 3 14 page 3 16 are a representation of each batch parameter and their limits plotted on a graph up to 60 batches All 60 batches will be displayed on the screen and on the printout see 2 5 XB limits page 3 19 Use the Parameter Tab keys to select between parameter groups For the XB limit values the Red line indicates the Maximum limit the Green line indicates the Target value and the Blue line indicates the Minimum limit The Yellow cursor can be positioned by the opera tor to select a specific batch Parameter values of a se lected batch are displayed in Red if grea ter than the upper limit in Blue if lower than the lower limit Fig 3 14 XB Graphs v Print XB graphs Use the Print Transmit key to print out X
161. h slave Run an Initialization Error management failed Unknown cycle Run an Initialization Error on cycle d Run an Initialization Error on start internal chrono Run an Initialization HGB Blank Error Management HGB blank cycle incorrect Run an Autoclean Home Motor d error Run an Initialization Incorrect pos motor carriage od Min Yd Max d Carriage motor bad position Run an Initialization Incorrect pos motor counting Yod Min d Max d Incor ve Pen naa rect pos motor PRESSURE 2d Pressure motor bad position Run an Initialization Min d Max Yod 1 0 Lre ea ea ee Diluter motor bad position Run an Initialization Min Yod Max Yod Pentra XL 80 User Manual RAB131GEN 7 49 ABX Pentra XL 80 7 50 Alarm Error Type Incorrect pos motor drain 1 Yod Min Yod Max Yod Incorrect pos motor FLUSH Yod Min Yod Max Yod Flush motor bad position Incorrect pos motor drain 2 DRAINING 2 motor bad posi od Min d Max d tion Incorrect pos motor injector hd Min d Max d Injector motor bad position Incorrect pos motor loading d Min d Max d Loader motor bad position Incorrect pos motor mixer d cae ANU TON AT Mixer motor bad position Incorrect pos motor needle d Min d Max Yd Needle motor bad position Incorrect pos motor sampling hd Min d Max d Sampling motor bad position Incorrect pos motor tranfer d Min d Max d Translation motor b
162. hap 3 10 Automatic printout and deletion of the results after calibration Chap 3 29 Pit suspicion flags AUCILION in ae ea Dio an tea enak Chap 4 33 Differential suspicion flag addition if HGB 17 5 g dL ooooW W W5W oom XX Chap 4 34 LIC and GCL Standard valles eeonvondsen nenen kene riss sine NAN EN UNP NAN AAN NN Anna an Chap 4 40 Modification of concentrated cleaning pour minoclair into WBC Baso chamber Chap 7 35 LMNE lamp error message addition oooo W Woo oom manah Chap 7 46 Addition error message on rack movement oooo WoooWoWoWoWoWoWoW Chap 7 47 Pentra XL 80 User Manual RAB131GEN 2 4 V1 6 1 Software improvements and user manual updates Update of the revision table oooWoc o W Woo mana Chap 0 Page 2 Declaration of Conformity is removed o Woo oWoWoWmoWoWoWoWoW Wah Chap 0 Page 2 WEEE directive addiliON ses nnan estetis sanam PEN ER REEE EEE AR a Chap 1 Page 4 PC connection label Update woco o woooowoowene mama nama nan ban Chap 1 Page 8 Correction in the safety requirements standard oo oo Chap 1 Page 9 Installation Kit update sinden on aon danbo anna an SALA ena an OaN Tp San ana SA Taka Dua ana abs Chap 1 Page 11 diluent installation at altitude over 1000 meters oooWo Wo Wooooo Chap 1 Page 12 Main ment neW OESI goes an aa RN NN Chap 1 Page 14 Internet link to printer Information ooooo Woo Waah Chap 1 Page 26 TOL ABX dil
163. he following 1 All Reagent levels with CBC and DIFF analyses capacity 2 Counters for racks waiting for analysis racks running and racks that have been analyzed for the current day 3 Statistics on the current day analyses maintenance cycles 4 Statistics since the installation of the Pentra XL 80 8 1 Accessing the Status screen Select the Status key of the main menu Tn E ail 3 k Tun li k s r ng i i K 1 Ta t EEL w Fi D e o A5 aema a e s T z e NAN na Tea Lai Fig 4 65 Status screen Pentra XL 80 User Manual RAB131GEN 4 77 ABX Pentra XL 80 v Status screen selection keys Heading Key Function Print send In Loader 2 In loader Complete 4 Complete Tm gt lt 94 Reagent Tab 4 17 Status selection keys Prints the Status screen with additional information for reagents Can not be transmitted Click the In loader view to open the Worklist Click the Complete view to open the Rack view screen Click the Reagent bottle to perform a reagent replace ment procedure See Section 7 Maintenance amp Trouble shooting 2 1 Reagent replacement page 7 9 8 2 Status screen description 8 2 1 Reagent level view Each reagent bottle has its graphic representation with the reagent level left in percentage of the total volume of the bottle container for diluent When a reagent level is too low an alarm is d
164. he rinse chamber M1 cell on syringe 1 and M2 cell on syringe 2 ECR1730 Add sleevings on LV10 amp LV11 ECR1716 2 06 300 was 1 52 LV23 2 Probe rinse block 2 11 05 04 11232 2 ee e eo ae The Tubing 102 250 was 240 T2 3 LMNE syringe SI and tubing 114 65 was 1021T4 I LMNE syringe 3 GC JADC 1702704 988 B lreatment HORIBAABX LV28 Flow cell drain Opens path from flow cell calgui to DIFF bath for drain Creation according prototype and NMLOXXAS q diagram ADC 08 07 02 1861 A ICoating Montpellier FRANCE Description KE By Date ECR Ne NML012A Sheet S Dim in millimeters This drawing is the property of HORIBA ABX and may not be reproduced or distributed without authorization ABX Pentra XL 30 7 Error messages When an error or an alarm is detected by the instrument it is reported into the Alarm screen The Alarm key is activated and blinks see Fig 7 46 Alarm key page 7 44 press Alarm key to access to the Alarm screen see Fig 7 47 Alarm screen page 7 44 Check the type of error and follow the instruction from the Alarm screen Fig 7 46 Alarm key 05 28 2002 11 56 27 Front Cover Open Front Cover Open Fig 7 47 Alarm screen Error messages in this section 7 1 Analyzer error types and help messages page 7 45 7 2 Transfer error types and help messages page 7 46 7 3 STAT mode error type and help message page 7 47 7 4 Environment Error Types and Help Messages page 7 47 7 5 User Error
165. he test selected is DIFF and if this flag has been activated The WBC Balance can be enabled or disabled by an approved ABX Service Technician Contact your local ABX Technical Service Representative for selection of this option These flags are associated with an on all differential parameters and CBC mode Limitations The WBC balance flag will indicate an instrument defect or it can also highlight a known interference See Section 2 Specifications 5 Limitations page 2 16 In the case of pathology whose treatments weaken the leucocytic membranes the agent of lysis of WBC channel can damaged the cells and give a lower leukocytes counting The LMNE flag will then be triggered off and a suspicion will be integrated to the WBC results We thus recommend not to disable WBC balance flag and to work in DIFF mode for all the samples which can present this possible interference Selecting the CBC mode will disable this control mode It is thus recommended to use this mode for patient not presenting this type of interference 4 44 Pentra XL 80 User Manual RAB131GEN Worktlow Run results and associated Flags 5 3 10 Delta Check Current analysis is compared to history when it does exists parameter by parameter This comparison is applied on hematologic parameters and when the difference between his tory and current results are not within operator defined limits See Section 5 Settings 4 5 Setting Delta check page
166. hemotherapy May also affect the sizing of PLIs Blood samples collected in EDTA will not maintain a stable Mean Platelet Volume 4 Platelets collected in EDTA swell depending on the time post collection and storage temperature LYM Lymphocyte count absolute value LYM Lymphocyte percentage The Lymphocyte count is derived from the WBC count The presence of erythroblasts cer tain parasites and erythrocytes that are resistant to lysis may interfere with an accurate LYM count Limitations listed for the WBC count pertain to the LYM and counts as well MON mononuclear cell count absolute MON Mononuclear percentage 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 in terfere with an accurate monocyte count Limitations listed for the WBC count pertain to the MON and counts as well NEU neutrophil count absolute NEU Neutrophil percentage The neutrophils cell count is derived from the WBC cell count The excessive presence of eosinophils metamyelocytes myelocytes promyelocytes blasts and plasma cells may in terfere with an accurate neutrophils count Pentra XL 80 User Manual RAB131GEN Limitations 2 19 2 20 XL EOS Eosinophil cell count absolute EOS Eosinophil percentage The eosinophil cell count is derived from the WBC cell count The presence of
167. hen the operator manually matches them to a result see 6 5 3 Runs orders matching page 4 69 Orders can be entered into the Worklist as followed Manually from the Worklist see 2 3 1 Creating an order page 4 17 or from the Re ports screen if you are requesting a Rerun see 6 4 Rerunning sample manually page 4 64 Automatically from a host computer non modifiable Worklist functions are described in the following chapter sections 2 2 Accessing the Worklist function page 4 15 2 3 Worklist grid page 4 16 2 4 Rack view page 4 22 2 2 Accessing the Worklist function Select the Worklist key on the generic toolbar PENTRA XL 80 WORKLIST Rack Pos pample ID S llectin Ss 22 1990 15 05 00 DIFF Type Man hd ician OUILLARD J P Comments BREZ c ient ID Date of Birth a 2 27 1925 77A Gender Fig 4 7 Worklist access The worklist is available in two screens with use of the following buttons Pentra XL 80 User Manual RAB131GEN 4 15 ABX Pentra XL 80 v Worklist view selection keys Heading Key Function Displays the worklist grid view see 2 3 Worklist grid page 4 16 Grid view key Displays the Rack view see 2 4 Rack view page 4 22 Enabled if the barcode option is on Rack Position see 1 3 Worklist page 4 4 Rack view key Tab 4 1 Worklist selection keys The order Capture Modification is available on
168. ic reruns and manual entries reguired for an order Here following the Pentra XL 80 report production schemes v One report for each run Each run is automatically or manually validated because all parameters are within operator defined criteria The report includes the copy of the Run results 5DIFF wm wt y Fig 1 18 One report for each run v One report Run or Rerun An automatic Rerun has been performed The operator validates either Run or Rerun This val idation can also be automatic The report includes either Run or Rerun results 3 amp Fig 1 19 One report Run or Rerun Pentra XL 80 User Manual RAB131GEN 1 23 ABX Pentra XL 80 v One report Run Manual entry On request the report can be determined by modifying run results microscopic examina tion the operator performs a Manual entry 1 A Fig 1 20 One report Run Manual entry v One report Run Rerun Report can be created from the selection of different groups of parameters RBC PLT WBC differential issued of several run results of the same sample Fig 1 21 One report Run Rerun 1 24 Pentra XL 80 User Manual RAB131GEN Introduction Workflow overview v One report Run Rerun Manual entry In that case the report has been created from the selection of different groups of parameters RBC PLT WBC differential issued of several run results of the same sample A manual entry ha
169. ick twice for descending order Click three times to return to the original order 6 1 4 Report display From the Report list screen click a line of the grid to display the Report in a full screen mode as indicated below PENTRA XL 80 Report view Fig 4 40 Report display The Date field remains blank as long as the Report is Unvalidated If not the displayed date is the date of the Report validation or rejection Pentra XL 80 User Manual RAB131GEN 4 55 ABX Pentra XL 80 v Report display keys Heading Key Name Function El Right arrow Displays the next report in a full screen mode Report comment Allows the operator to add a comment to Report This key will reject the current Report A confirmation message is displayed to perform the rejection see 6 3 Validation or rejection of a Report page 4 63 Reject report Opens the Report Details screen view in order to Detail access to all Runs and histories see 6 2 1 Report Details page 4 57 This key allows the operator to modify the Report Report Comment Comment The comment can not be modified if the Report is already rejected or validated Tab 4 12 Report display Function Keys 4 56 Pentra XL 80 User Manual RAB131GEN Worktlow Report 6 2 Construction of a Report Run results includes 4 hematological parameter grou
170. immunoglobulins which are high in cold agglutinin disease may cause lower RBC and PLT counts and increase MCV HGB Hemoglobin Turbidity of the blood sample Any number of physiological and or therapeutic factors may produce high incorrect HGB results To obtain accurate hemoglobin results when in creased turbidity of the blood sample occurs determine the cause of the turbidity and fol low the appropriate method below High WBC An extremely high WBC will cause excessive light scatter In these cases use reference manual methods The diluted sample should be centrifuged and the superna tant fluid measured with a spectrophotometer High lipid concentration A high concentration of lipids in the blood sample will give the plasma a milky appearance This condition can occur with hyperlipidemia hyperpro teinemia as in gammapathies and hyperbilirubinemia Accurate hemoglobin determina tions can be achieved by using reference manual methods and a plasma blank Increased turbidity may also be seen in cases where the red blood cells are resistant to lysing This condition will cause an incorrect high HGB result but may be detected by ob serving the abnormal MCH MCHC values and the increased baseline on the leading edge of the WBC histogram Erroneous hemoglobin results will cause the results of the MCH and MCHC to be incorrect as well Fetal bloods The mixing of fetal and maternal bloods may produce a high inaccurate HGB
171. ion page 5 7 i e that the identifier is given by the sample position on the rack When a Barcode label is not used on a sample tube the order must contain the sample tube position in the rack The Sample ID field is now available for manual entry but it is not mandatory to do so If the sample tube position in the rack was indicated the Run results will contain sample identification If not the instrument assigns an auto numbering AUTO SID xxx to ensure that the final Run results for this sample contains a single identification 1 6 1 Setting Rack position Manual match OFF The Pentra XL 80 tab Settings Soft parameters General tab barcode option is set as shown See Section 5 Settings 2 2 5 Identification option page 5 7 4 8 Pentra XL 80 User Manual RAB131GEN Workflow Workflow Worklist sample identification i z J a Sample detected on position 3 SampleID SampleID Rack Pos PatientiD 0068 0068 0069 0069 sos P i 1 as 1 1 0060 0067 oe F 31 Result identification Auto Numbering Rack x Position y Auto SIDxx Fig 4 4 Rack position Manual match OFF 1 6 2 Setting Rack position Manual match ON The Pentra XL 80 tab Settings Soft parameters General tab barcode option is set as shown See Section 5 Settings 2 2 5 Identification option page 5 7 Pentra XL 80
172. is to provide one unique Report for each analysis reguest Order see 5 1 Order and Worklist overview page 1 22 even when Rerun of the sample has been performed Validated Report Data man ement an gt gt order Run results gt a DANA E ES E A N LIS Analysis T 5 1 Order and Worklist overview Clinical An order is the set of data which is used for requesting an analytical process The order includes 3 data areas of intervention as followed v The patient information Patient ID Patient name Birthdate Sex v The sample information Sample Id barcode or other Sample type Child Male female Sample test Complete Blood Count or Differential v The clinical information Sample collection date Department requesting the Order Physician requesting the Order Orders can be received from the LIS or manually entered by the operator in the Pentra XL 80 The Worklist is the list of orders generated on a daily basis See Section 4 Workflow 2 Worklist description page 4 15 Orders are removed from the Worklist after Report validation Pentra XL 80 User Manual RAB131GEN Introduction Workflow overview 5 2 Runs amp Report overview 5 2 1 Runs Analytical processes and obtained results are defined as Runs Runs are constitued of 4 he matological parameter groups RBC PLT WBC Differential 5 2 2 Reports Sample Reports are determined from runs automat
173. isplayed to warn the operator Proceed as de scribed in Section 7 Maintenance amp Troubleshooting 2 1 Reagent replacement page 7 9 Analysis capacity provides the number of CBC and DIFF analyses that can be carried out with the current reagent left in all bottles 8 2 2 Statistics of the day The Pie chart displays statistics on patient runs only 1 in blue run results within normal ranges 2 in black run results out of Normal limits see 5 3 1 Normal and panic ranges page 4 30 3 in red run results out of Panic limits see 5 3 1 Normal and panic ranges page 4 30 A bar graph with the DIFF and CBC analyses in percentage of the total analyses of the day A bar graph with the percentage of Rerun performed in the day 4 78 Pentra XL 80 User Manual RAB131GEN Worktlow Status Counters for Maintenance cycles performed in the day Startup ShutDown Autoclean 8 2 3 Statistic summary Statistics since the first startup of the instrument are the same than for Daily Statistics see 8 2 2 Statistics of the day page 4 78 8 3 Rack status 8 3 1 In loader Selecting the In loader view will open the Worklist function see 2 4 Rack view page 4 22 To return to Status screen select the Return key 8 3 2 Complete Selecting the Complete view will open the Rack view function see Fig 4 66 page 4 80 This is a graphic view of the rack ejection tray It show
174. ition 1 position 5 position 6 position 7 8 6 Pentra XL 80 User Manual RAB131GEN Annex Compatible tube list 3 1 1 Tube holder position 1 TG Piercin Manufact Model Part number Additive Vacuum Stickers a Type of cap condition Becton D Vacutainer 368452 K3 EDTA 5ml MAN BC With cap menta se Becton D Vacutainer 367651 K3 EDTA 5ml 2ml MAN BC With cap Hemogard Becton D Vacutainer 367856 K3 EDTA 5ml 3ml MAN BC With cap Hemogard Becton D Vacutainer 367652 K3 EDTA 5ml 3ml MAN BC With cap Hemogard Becton D Vacutainer 367654 K3 EDTA 5ml 4 5ml MAN BC With cap Hemogard Terumo Venoject II VP 053SDK K3 EDTA 5ml 3ml MAN With cap Ultraseal Terumo Venoject VT 050STK K3 EDTA 5ml 5ml MAN With cap i aui Terumo Venoject VT 053STK K3 EDTA 5ml 3ml MAN With cap mA wi ABX Rubber CML TH5COC K3 EDTA 5ml 4ml MAN BC With cap strongly not 3004002 3 advisable Greiner Vacuette 454087 K3 EDTA 5ml 2ml MAN BC With cap Hemogard Greiner Vacuette 454086 K3 EDTA 5ml 3ml MAN BC With cap Hemogard Greiner Vacuette 454036 K3 EDTA 5ml 4ml MAN BC With cap Hemogard Greiner Vacuette 454223 K3 EDTA 5ml 4 5ml MAN BC With cap Hemogard Locking Sarstedt 04 1901 2 6ml i mechanism Tab 8 1 compatible tube position 1 3 1 2 Tube holder position 2 Rubber strongly Becton D Vacutainer 6385 K3 EDTA Without cap not advisable Rubber strongly Terumo Venoject VT 030STK K3 EDTA 3ml 3ml MAN With cap A not advisable Greiner Minicollect 450403 K3 EDTA 1ml With cap with
175. ive display of the Reports that are Rejected A counter indicates their current number in the list 5 Validated but not Transmitted exclusive display of the Reports that are Validated but not Transmitted A counter indicates their current number in the list The current report line is displayed in grey The selected report lines are displayed in green v Sorting out Sorting Reports is available in the following columns Date time Sample ID Patient ID Patient Name FirstName Gender Date of Birth 000024 Junillon Female 06 22 1926 CE 000024 Junillon Female 06 22 1926 CB 000024 Junillon Female 06 22 1926 CB 0002 SANTOS Jean Philippe Female 08 14 1955 DIF p002 SANTOS Jean Philippe Female 08 14 1955 DIF 123 MARTIN Claude Male 02 06 1965 CE 123 MARTIN Claude Male 02 06 1965 DIF i Patient Name FirstName Gender Date of Birth 000024 Junillon Female 06 22 1926 CBC U 720 456 DUPUIS Renee Male 02 06 1926 DIFF 04 10 2003 17 16 lt 0002 SANTOS Jean Philippe Female 08 14 1955 DIFF 04 10 2003 16 53 000024 Junillon Female 06 22 1926 CBC 04 10 2003 16 53 2 0007 LESBROS Marcel Male 05 08 1956 DIFF 04 10 2003 15 00 0010 LACAHUTE Laurence Female 12 16 1978 CBC 04 10 2003 14 56 1 Fig 4 39 Report grid information Click a column title for sorting the Report data see Fig 4 39 page 4 54 Pentra XL 80 User Manual RAB131GEN Workflow Report Click once for ascending order Cl
176. ization Run an initialization Run an Auto Clean Check Motor in Service Menu Pentra XL 80 User Manual RAB131GEN Error messages 7 45 ABX Pentra XL 30 7 46 Alarm Sampling syringe mechanism not reaching home Thermostated Compartment Temperature sensor not con nected Thermostated Compartment Temperature sensor failure Thermostated Compartment temperature out of range Value Min amp Max Thermostated Compartment Panel open Lamp voltage is out of order Alarm Loading motor mechanism not reaching home Loading motor failure Stop rack loading switch not detected Stop rack loading switch detected Sampler Transfer mechanism not reaching home Sampler Transfer motor failure Stop rack Transfer switch not detected Stop rack Transfer switch detected Mixer mechanism not reaching home Mixer motor failure Mixer Bad grabber position Rack in wrong side position Error type Sampling Syringe Motor Mecha nism initialization failed Thermostated Compartment Tem perature Thermostated Compartment Tem perature Thermostated Compartment Tem perature Thermostatic Compartment Door The LMNE optical bench lamp is out of order 7 2 Transfer error types and help messages Error Type Sampler Loading Motor Mechanism initialization failed Sampler Loading Motor home switch always detected Sampler Loading Motor Sampler Loading Motor Sampler Transfer Motor M
177. kflow 2 Worklist description page 4 15 See Daily Guide RAB156C See Daily Guide RAB156C Displays the number of reports See Section 4 Workflow 6 Report page 4 51 See Section 4 Workflow 7 Archives page 4 70 4 3 Main Menu description Access to the main functions of the system Introduction Software overview Startup Shutdown Logs e Quality Assurance Run in Progress Status Services Settings Tab 1 4 Main menu function keys Runs the startup cycle Runs the shutdown cycle Launch the Logs menu Launches the Quality Assurance menu Launches the Run in Progress menu Launches the reagent Status menu Launches the Services menu Launches the Settings menu Pentra XL 80 User Manual RAB131GEN The gauge on the bottom status bar progresses at the same time as the cycle Flashes when the Startup cycle has to be performed The gauge on the bottom status bar progresses at the same time as the cycle Section 3 5 Logs page 3 32 Section 3 5 Logs page 3 32 See Daily Guide RAB156C See Daily Guide RAB156C Section 7 4 Service menu description page 7 22 Section 5 Settings page 5 3 1 17 ABX Pentra XL 80 4 4 Miscellaneous 4 4 1 Software arborescence and Hints keys Tabs Function keys can be enabled or disabled according to the instrument or soft ware status Enabled Disabled
178. l RAB131GEN Settings System PENTRA Xi 90 System Fig 5 23 System Network settings Two methods are available for the Pentra XL 80 Ethernet connexion By using Sockets process By using a FTP file transfert protocol Pentra XL 80 User Manual RAB131GEN 5 29 ABX Pentra XL 80 Heading key Function Default value Analyser IP address Instrument IP address empty Default Gateway Default Gateway empty Port Number Port Number used by TCP IP sockets 4148 FTP directory Directory name of the FTP server empty password password for the FTP login empty Test Runs a short network Test Tab 5 10 Network settings 5 30 Pentra XL 80 User Manual RAB131GEN Settings System 5 4 Printer PENTRA XL 80 System lose wil EEN Mee am INE Vv D MP vw m m m eo Oo a M M iv v Iv M v iv M M aa M M M v M M M Mv v Fig 5 24 System Printer tab Default settings for the checked boxes are as shown Fig 5 24 page 5 31 To modify printer properties select the Edit key and use one the following functions Pentra XL 80 User Manual RAB131GEN 5 31 ABX Pentra XL 80 Heading key List Function Report header Printer Enable Auto Print Hematology param eters Report header Printer Name Default printer Add printer Printer properties Set Default Printer Delete Printer Range Raw
179. leshooting Instrument panels amp cover Removals 3 4 Left hand side panel removal Lift the reagent compartment cover to expose the 2 retaining screws on the rear of the left side panel Remove Left Panel by unscrewing 2x CHC M4X6 at the front and loosening 2x CHC M4X6 at the rear see Fig 7 24 page 7 21 Fig 7 24 Lefthand side panel Now slide the left side panel forward and lift it out of the instrument Pentra XL 80 User Manual RAB131GEN 7 21 ABX Pentra XL 80 4 Service menu description When the user enters the Service Menu screen the following menus will be available to the user PENTRA XL 80 Menu Fig 7 25 Service Menu screen 3 Maintenance Hydraulical cycles are available on this menu Miniclean short rinsing sequence of the counting chambers Concentrated Cleaning Thorough cleaning of the chambers with a bleach solution see Concentrated cleaning page 7 34 Autoclean Automatic Cleaning cycle This can be automatically run every n analysis cy cles See Section 5 5 5 Cycle option page 5 35 as well as a Super User sub menu see 4 1 Super User menu page 7 22 4 1 Super User menu 3 menus are available to the user for maintenance intervention on the instrument 4 2 Mechanical menu page 7 24 4 3 Hydraulical menu page 7 31 4 4 Others page 7 36 7 22 Pentra XL 80 User Manual RAB131GEN Maintenance amp Troubleshooting Service menu d
180. liters if necessary Select the Level field and edit if necessary see Fig 7 12 page 7 14 Pentra XL 80 User Manual RAB131GEN 7 13 PENTRA XL 80 Reagent Reagent ABX LSE O Lot Nb o21018K1 Capacity ml 400 Level ml 400 Change Date o6 12 2003 Expiration fio 18 2003 Operator Technician Use barcode reader Replace reagent bottle before pressing this button Version 1 0 0 Technician 06 12 2003 15 48 46 Fig 7 12 Reagent Level Select the OK key to accept the changes see Fig 7 13 page 7 14 PENTRA 80 Reagent Reagent ABX LSE m px L Lot Nb oz 1018K1 Capacity ml 400 lt Level ml 400 7 Change Date o6 12 2003 Expiration fio 18 2003 Operator Technician Use barcode reader Replace reagent bottle before pressing this button Version 1 0 0 Technician 06 12 2003 15 48 46 Fig 7 13 Reagent replacement validation 7 14 Pentra XL 80 User Manual RAB131GEN Maintenance amp Troubleshooting Replacement procedures Once the OK key has been selected the instrument automatically primes the reagent see Fig 7 14 page 7 15 PENTRA 80 Reagent ABX LYSE 021018K1 10 18 2003 SEFC kd i ra x i gt Fig 7 14 Reagent priming 2 1 3 Waste container replacement Unscrew the waste container cap Replace waste
181. ll be disabled if all the results are already matched with orders IPENTRA XL 80 Match View W E Select An Order 0011 MILLAU 0012 CANDELA 0002 SANTOS 0002 SANTOS 0003 0004 0005 AUTO PID4 1 8 8 8 8 8 9 9 9 Fig 4 57 Association grid This screen will show 2 lists Worklist orders not matched to runs as it has been defined in the Worklist sample ID patient ID etc Runs with Rack Position of the tubes or and Barcode Identification of the sample as the instrument has read it On the right hand side of the screen Running date Rack Position fields associated to the selected Runs Other fields of the order in grey defined in the Worklist A Orders in progress are not displayed in this screen 4 68 Pentra XL 80 User Manual RAB131GEN Worktlow Report 6 5 2 Association grid keys Heading Key Function Deletes selected order of the Worklist a confirmation Delete message is displayed Do you want to delete the order which sample ID is XXX Associates the selected order with the selected runs OK see 6 5 3 Runs orders matching page 4 69 A notification is done in the logs On the run list Displays the Rack and position of the tube displays Click a line Click a line the running date too Allows to match the tube with its default order if no order is selected Tab 4 14 Associati
182. locytes e Large Blasts e Large Neutrophils Meaning Atypical Lymphocytes Presence of a significantly large population of cells located on the right hand side of the Lymphocytes area This flag occurs when the number of particles counted in this area is higher than the limit setup in ALY or when the number of particles counted regarding the total number of WBC is above the ALY limit See Section 5 Settings 8 2 Pathological limits page 5 46 Suspected abnormalities e Large Lymphocytes e Reactive Lymphoid forms e Stimulated lymphocytes e Plasmocytes 5 3 6 Flags on WBC BAS histogram v L1 flag CBC and DIFF mode OU ho BAZ Fig 4 32 WBC histogram Standard value for L1 3 200 See Section 5 Settings 8 3 Alarms amp Curve Worktlow Run results and associated Flags L1 flag is established according to the ratio of the cells counted be tween the 0 channel and BA1 L1 indicates the presence of an ab normal number of cells in comparison with leukocytes Suspected abnormalities e PLT aggregates e NRBCs L1 flag is associated with an on WBC value and on absolute values of the differential parameters thresholds page 5 47 ia In certain cases the L1 flag will not be triggered off because of the poor sensitivity of this flag large platelet aggregates and or erythroblasts that are beyond the electronic threshold This happens in CBC mode only Two additional flags
183. low level alarm When a Reagent Low Level alarm appears on the screen select the Check key see Fig 7 8 page 7 11 to display the Reagent Status window see Fig 7 9 page 7 11 PENTRA XL 80 Status E Normal DIFF 80 J E hj e0 fi A mn H L Shut Down 20 8 AutoClean MERE Normal DIFF 60 Rerun Start Up Shut Down ee it T ao AutoClean Ih Version V1 0 ak echnician 05 23 2003 15 02 54 Fig 7 9 Reagent status window Pentra XL 80 User Manual RAB131GEN 7 11 ABX Pentra XL 80 From the reagent status window select the reagent you want to replace Once you select the reagent the following screen will be displayed see Fig 7 9 page 7 11 Now select the Edit key to modify any reagent specifications see Fig 7 10 page 7 12 PENTRA AL 80 Reagent 021018K1 Fig 7 10 Reagent edit 7 12 Pentra XL 80 User Manual RAB131GEN Maintenance amp Troubleshooting Replacement procedures PENTRA XL 80 Reagent ABX LYSE 021019K1 Derijama SSS amp fit y i aan on aml a Ae Mu AI amp Kd Fig 7 11 Reagent replacement Select the Lot Nb field and then use the Barcode reader to update some of the reagent specifications Lot number Expiration date see Fig 7 11 page 7 13 The reagent level is set to an automatic default level Verify this level and or change it to the correct level in milli
184. lts call your HORIBA ABX representative depart ment Differential LMNE a Check optical bench lamp is lit when instrument is on If not replace the lamp see 2 2 Optical bench lamp replacement page 7 15 b Run a Cytometer rinse see 4 3 4 Clean Cycles page 7 34 c Re run the specimen d If this does not correct the WBC results call your HORIBA ABX representative depart ment 7 42 Pentra XL 80 User Manual RAB131GEN Maintenance amp Troubleshooting Hydraulic diagram 6 Hydraulic diagram see on next page Pentra XL 80 User Manual RAB131GEN 7 43 B 7 06 800 152 760 TRANSLATION Inch to mm Inf diam JI In 102 208 VENT 020 050 mml Oost 1 l CIC IK 152 200 gt ver ane 025 0 oeo 4 megu Ge 16206800 Tr i f 1m WN SSS 2 PVC CRISTAL PolyVinileChlorure TYGONe TG TYGON 2075 S SILICON mA g Ge ISOLATOR ISOLATOR Wn 1 30 15 SAMPLE SYRINGE N a DRAIN 1 52 100 BUBBLING ISOLATOR 2 06 300 R EOSINOFIX E2 Im 152 335 1 52 90 d i DRAIN SYRINGE 7 8 9 SAN Geel At ALIA N N N i 21 2 2 sp PA o a 1 52 70 i 2 06 610 O 33 i ENN T NI 352500 LMNE TRANSFERT 2 06 VW ________ 1 52 120 BUBBLING 2 DRAIN COUNT WBC RBC 133 PROBE WIPE WBC BUBBLING DILUENT FILL DRAIN 152 440 RESERVOIR FILLING LMNE RINS
185. ly Ensures the correct proportioning of the reagents Lysing reagent for hemoglobin ABX Lyse Cleaning reagent ABX Cleaner Lysing reagent for DIFF count ABX Eosinofix Diluent used for the dilutions ABX Diluent except the LMNE stop diluent Lysing reagent for WBC BAS ABX Basolyse II 5 Floppy and CD drivers Pentra XL 80 User Manual RAB131GEN 6 3 ABX Pentra XL 80 1 3 Right side view Fig 6 3 Pentra XL 80 right side view 1 Sampling syringe Whole blood sample take and distribution of portions of the specimen into the dilution chambers 2 Count Assembly Receives the different rinsings and dilutions Regulates the temperature of dilutions Provides the dilutions for WBC BAS RBC PLT and HGB 3 Mother board Amplifies processes and counts the following signals Resistive signals and LMNE optical signals RBC Signal PLT signal WBC BAS signals Measures hemoglobin 6 4 Pentra XL 80 User Manual RAB131GEN Description amp Technology Pentra XL 80 description 1 4 Stat tube holder There are 3 Positions for the Stat tube holder door Open as shown e Rack mode intermediate position Sampling position rear Fig 6 4 Stat tube holder 1 Sampling position 1 For 5ml tubes 2 Sampling position 2 For 3ml tubes 3 Sampling position 3 For Controls Calibrators amp Latex material 4 Sampling position 4 For microtainer 5
186. lyzed 4 times Dilution Ratio Visible Range This range is a range that is beyond the Dilution Ratio Value of the instrument These ranges are indications Parameters values within will have a D flag associated with the value Pentra XL 80 User Manual RAB131GEN 2 13 ABX Pentra XL 80 Kana Dilution Ratio Dilution Ratio Error Limit Parameters Dilution E l Value Visible Range which ever is greater Ratio WBC 10 mm 1 3 120 360 360 550 40 3 15 RBC 10 mm 1 2 0 8 0 8 0 18 0 0 07 3 HGB g dl 1 2 0 24 24 30 0 3 3 HCT 1 2 0 67 67 80 2 3 PLT 10 mm3 1 2 1 900 3 800 3800 5500 10 25 for HGB gt 2 g dl amid PLT 10 mm3 for HGB lt 2 g dl 1 2 2 800 5 600 5600 7500 10 25 PLT gt 15x10 mm Tab 2 15 Results Obtained on CDR mode with validated dilution ratio to be validated according to local Good Laboratory Practices requirements See Section 8 Annex 1 CDR mode page 8 2 2 14 Pentra XL 80 User Manual RAB131GEN Specifications Reagent specifications 4 Reagent specifications The HORIBA ABX reagents specified for this instrument have been approved in ac cordance with the European Directive 98 79 CE Annex III for in vitro medical de vices The CD ROM RAX055 delivered with your instrument provides Reagents Controls and Calibrators leaflets msds Latest versions of these documents are available on www horiba abx com docu me
187. me format modification see 5 2 1 Date and time format page 5 23 and language modification see 5 2 2 Languages options page 5 24 5 2 1 Date and time format HH mm ss 3 adi 0 Fig 5 19 date time format Select the Edit key then scroll through the Date or Time lists The date formats are as followed MM dd yyyy dd MM yyyy yyyy MM dd Pentra XL 80 User Manual RAB131GEN 5 23 ABX Pentra XL 80 The time format options in the drop down list are as followed hh mm ss am or pm HH mm ss 5 2 2 Languages options The software language options are English French German Italian Spanish Portuguese From the Local Settings screen select the Edit key then select language that is appro priate for your operations Now select the OK key to confirm your selection Fig 5 20 Language format 5 2 3 Change date and time From the Local settings tab see Fig 5 18 page 5 23 select the Edit key Then select Change Date Time key Change the date and time so that the computer can become updated with the current date and time 5 24 Pentra XL 80 User Manual RAB131GEN Settings System Date Time Properties 128 5 amp F 8 9 10 11 12 13 14 1516 F IG 3 220 5a 22 23 25 26 27 28 23 30 Fig 5 21 Date and time window 5 3 Communication This function allows to configure the Pentra XL 8
188. men have been di luted Fig 7 44 Chambers Drain and rinse a Check chambers are drained and rinsed b If operations are faulty identify the source of the malfunction when possible and call your HORIBA ABX representative department 5 2 Results v Procedure 6 All parameters Repeatability According to the CV specifications See Section 2 3 Summary of perfor mance data page 2 7 Is the instrument non repeatable on all parameters If not perform directly the procedure corresponding to the non repeatable parameter If all parameters are not repeatable continue this procedure c Visually check that the sampling operation appears to be correct d Control the sampling syringe operations see 4 2 2 Check motors page 7 24 e Control the counting syringe operations see 4 2 2 Check motors page 7 24 f Perform a concentrated cleaning see 4 3 4 Clean Cycles page 7 34 Pentra XL 80 User Manual RAB131GEN 7 39 ABX Pentra XL 30 g If all these operations appear to be correct call your HORIBA ABX representative de partment Calibration a If the system appears to be operating properly if fresh uncontaminated reagents are being used and the precision is within the specifications Pentra XL 80 may need a cal ibration Section 3 4 Calibration page 3 25 v Procedure 7 RBC PLT HCT Repeatability If RBC PLT amp HCT are non repeatable a Check the second dilution i
189. ment default test e If the setting is Manual match on Exception ON See Section 5 Settings 2 2 5 Identification option page 5 7 the Sample ID provided with the result is the barcode 4 12 Pentra XL 80 User Manual RAB131GEN Worktlow Workflow It is important to define the specific working method for sample identification in your laboratory Systematic use of barcodes must be defined as Barcode If barcode are not used select Rack Position If both Barcode and Rack position are used select the Rack Position 1 8 Sample runs and order association This screen allows manual matching between sample runs and worklist orders that have been classified as exceptions This screen will show 2 lists Sample Runs found by the instrument and defined as Non matched Sample Runs that are Non matched to Orders To match the Runs of non identified tubes with orders see 6 5 Run order association page 4 68 Matching non identified Runs with order never modifies orders y 1 9 Rerun conditions Automatic Rerun is performed according to the rules defined in the Settings function See Section 5 Settings 4 3 Rerun conditions page 5 17 if an order has been created in the Worklist and if the sample run is matched with the order If none order has been created in the Worklist the run is identified with an auto numbering then no Rerun will occur v Scenario 1 allowing
190. mooi sman 7 6 2 Replacement procedures oooooo 7 9 2 Reagent FED AC Cie Maratea Gt 7 9 2 2 Optical bench lamp replacement ou 7 15 2 3 Sampling probe replacement oooooooWoWoW 7 17 3 Instrument panels amp cover Removals 7 19 3 1 Left front door TreMOvaLico o cooo o ocooo oo Ko oo iW oo 7 19 3 2 Right front door removal ooooooWoWooW 7 20 3 3 Right hand side panel removal oooooWo 7 20 3 4 Left hand side panel removal ooooocoWo 7 21 A Service menu description oocccoaa 7 22 Ale Sup ee Ii ke na 7 22 4 2 Mechanical menu 7 24 AD Hydraulical eno ia 7 31 A Ai Oa Re nenas it 7 36 Dz Trouble OOM eta Bee Neta nasa 7 37 5 1 Instrument operation MOde o 7 38 Die I COUN US EE O SA NA NA 7 39 Bere ana aan na 7 41 Gaya Oni ane Ser 7 43 Fo HPO ne ea 7 44 7 1 Analyzer error types and help messages 7 45 7 2 Transfer error types and help messages 7 46 7 3 STAT mode error type and help message 7 47 7 4 Environment Error Types and Help Messages 7 47 Pentra XL 80 User Manual RAB131GEN 7 1 ABX Pentra XL 30 7 5 User Error Types and Help Messages 7 6 Expiration Date Error Types and Help Messages 7 7 Analyzer Internal Error Types and Help Messages 7 2 Pentra XL 80 User Manual RAB131GEN Maintenance amp
191. mple list that corresponds to the characters entered When a specific Sample ID is located select the OK key to exit the screen and return to the Worklist 2 3 6 Searching by patient name The operator has the ability to select a specific Patient file from the Patient Name field Just select the Search Patient key see Tab 4 3 Order fields page 4 19 Once the Search Patient key has been selected the following screen will be displayed PENTRA 80 Search Patient Patient ID Patient Name First Name Date of Birth Age Gender JONES Marleen 03 05 1970 32 A Female ELEONOR MIKA 10 06 1984 174 Male Fig 4 11 Search patient window The Patient Name field enables the operator to view the Alpha or Numeric character se quencing as it is being typed As each character is being typed the Grid refreshes and displays the Patient list that corresponds to the characters entered When a specific Patient Name is located select the OK key to exit the screen and return to the Worklist 4 20 Pentra XL 80 User Manual RAB131GEN Workflow Worklist description 2 3 7 Printing out the worklist Selecting the Print key from the Contextual toolbar will print out the Worklist Grid The following window appears see Fig 4 12 page 4 21 Fig 4 12 Worklist printout window A Full printing and Light printing mode are available v Full printing Order informations are printed out in the grid m
192. n key is disabled if the Run Results are unmatched see 6 5 Run order association page 4 68 orif a Rerun for this order is already in the Worklist An automatic Rerun is triggered on a sample IF a mishap occurs during Rerun analysis for instance Emergency stop of the instrument the first Run results are stored in the Unvalidated list of the Report list function Validation or Rejection operations on these Run results might be impossible If this happens proceed as follows to unblock these Run Results Open the Worklist selecting the Worklist key Locate the order that has been automatically generated for the Rerun analysis Select this order and use the Delete key to erase it Now the Results of the first run should be accessible for Validation or Rejection 6 4 1 Printout or Transmit Report list Several printing and report transmission options are available from the Report List Press the Print Send key then choose one of the following options Pentra XL 80 User Manual RAB131GEN 4 65 ABX Pentra XL 80 v Printing options Print selected Reports in a grid mode see Fig 4 54 page 4 66 Print selected Reports in a li ght grid mode see Fig 4 55 page 4 66 Print all Reports in a grid mode Print all Reports in a light grid mode Print selected Reports in a full screen mode Print all Reports in a full screen mode Print the most recent Report Fig
193. n Grid Keys page 3 27 to open the Calibration Target screen for editing PENTRA XI 80 Calibration Target a Tag ee PPN Ke Mud Fig 3 24 Editing the target values Select the Edit key to edit the target fields Read the barcode label on the calibrator with the external Barcode Reader or type in all the calibrator information using the calibrator Assay sheet that comes with the calibrator kit Once all entries have been made select the OK key to save the information Pentra XL 80 User Manual RAB131GEN Calibration 3 27 ABX Pentra XL 80 Exit the Target values menu by selecting the Return key 4 4 Running calibration If Ouality control check procedure has failed see 1 7 Running control blood page 3 13 1 Verify that the reagents are sufficient fresh and uncontaminated 2 Run a system Startup and verify that the Backgrounds are at their lowest possible limits 3 Run Within Run and verify that the Coefficients of variation are within their limits Use a Minocal calibrator to calibrate Pentra XL 80 Follow the calibrator package insert for proper instructions on mixing and handling of the product Ifa new lot needs to be entered into the system follow the procedure as described in 4 3 Target values page 3 27 Open the Calibration Grid as described in Accessing the Calibration Main Menu page 3 26 Select the Stat Mode key Gently mix the calib
194. n all the operations Portable mobile telephones should not be used in proximity of the instrument All peripheral devices should be IEC compatible 1 1 Limited guarantee The duration of guarantee is stipulated in the Sales conditions associated with the purchase of this instrument To validate the guarantee ensure the following is adhered to 1 The system is operated under the instructions of this manual 2 Only software or hardware specified by HORIBA ABX is installed on the instrument This software must be the original copyrighted version 3 Services and repairs are provided by an HORIBA ABX authorized technician using only HORIBA ABX approved spare parts 4 The electrical supply of the laboratory follows the national regulations 5 Specimens are collected and stored in normal conditions Pentra XL 80 User Manual RAB131GEN Introduction Warning and precautions 6 Reagents used are those specified in this user manual 7 Proper tools are used when maintenance or troubleshooting operations are performed See Section 7 Maintenance amp Troubleshooting 1 2 Maintenance procedures page 7 3 If this instrument has been supplied to you by anyone other than HORIBA ABX or A an authorised representative HORIBA ABX cannot guarantee this product in terms of specification latest revision and latest documentation Further information may be obtained from your authorised representative 1 2 Safety Preca
195. n is called Forced and a warning message shall request confirmation to continue When running calibration a warning message appears on the screen stating a Forced cal ibration has been detected another message will appear asking you if you wish to continue the calibration You have the option of continuing or rejecting the calibration at this time 4 4 3 Coefficients of calibration ranges Check that the coefficients of calibration are within the following acceptable limits Or else please contact your HORIBA ABX representative department Coefficients of calibration Minimum Standard Maximum WBC 90 137 200 RBC 100 225 300 HCT 100 220 300 HGB 25 40 55 PLT 130 290 400 RDW 0 1 0 35 1 MPV 0 1 1 0 LMNE 0 5 0 86 1 5 4 4 4 Printing sending or deleting calibration results v Printing and sending calibration results Calibration results can be printed out and or sent to a host computer by selecting the Print Send key Specific results and parameters may be included or excluded from statistical cal culations by selection of the Check Boxes in the Calibration Results Grid see Fig 3 26 page 3 31 Press the Print key of the Contextual Toolbar to open it Pentra XL 80 User Manual RAB131GEN Ouality Assurance Calibration f Print Send Print Send Fig 3 26 Print and send windows Calibration List View cx318 2002 04 05 2002 03 29 Admin RBC HGB HCT PLT 9 7 0 2 4 57 0
196. n selected 1 then check the criteria parameter by param eter or row by row selecting the corresponding key 2 one click will check all parameters of the row a second click will uncheck all Select the OK key to confirm your choice Only one set of criteria is available for all sample types A Automatic biological validation will work when Delta check has not been computed for the following reasons history is missing or delta check is disabled see 4 5 Setting Delta check page 5 22 or one parameter of the history has been unvalidated or was outside linearity limits Automatic biological validation will not work Reports remain unvalidated when Delta check has not been computed for the following reasons one param eter of the report was unvalidated or outside the linearity limits Factory adjustment is all criteria selected No automatic validation can occur when PLT parameter has been suspected See Section 4 Workflow 5 3 4 Suspicion flags page 4 33 5 16 Pentra XL 80 User Manual RAB131GEN Settings Rules 4 3 Rerun conditions In these 3 tabs the user has the option of establishing the criteria for sample rerun condi tions The re sampling of sample tubes will be based on these criteria Re sampling will be reguired if a hematological results trigger alarm conditions L1 LL1 MB These criteria are de fined for all types of blood see 4 3 1 Rerun on alarms page 5
197. nd destination proceed as followed From the Save and restore menu screen select the Export Report Configuration tab 5 38 Pentra XL 80 User Manual RAB131GEN Settings Save and restore Select the EDIT key Select the check box to authorize the exportation of deleted results at the beginning of each new month Now choose the media floppy disk or network by FTP In case Network by FTP has been chosen now enter Host name or IP address of the FTP server The share folder of the FTP server The login and password of your FTP account Select the OK key to confirm 6 4 2 Day by day exportation It is also possible to require the exportation of the deleted files of the last working day at the startup of the instrument PENTRA XL 80 Fig 5 30 Begin of day exportation option Export deleted reports now when checked the instrument will proceed to an immediate exportation of the last day deleted files If unchecked the deleted files will be exported at the beginning of each new month if the instrument is configured as described in 6 4 1 Monthly exportation page 5 38 Pentra XL 80 User Manual RAB131GEN 5 39 ABX Pentra XL 80 7 User profiles In the Pentra XL 80 software there are 3 groups of user profiles The ABX technicians profile which gives access to specific technical functions which is accessed only by an HORIBA ABX certified technician The Trai
198. nedUsers software profile which allows access to Service menus useful for instru ment maintenance operations It also allows access to Instrument settings and Calibration functions The Users profile wich allows access to daily working operations v User profiles sections 7 1 Accessing the User screen page 5 40 7 2 User menu function keys page 5 40 7 3 Creating a new User profile page 5 41 7 1 Accessing the User screen From the Settings window select the User key Fig 5 31 Setting User profiles 7 2 User menu function keys Function Insert Allows a new user to be added Edit Modifies a user profile Deletes a user profile A confirmation profile is dis Delete played Tab 5 16 User menu function keys 5 40 Pentra XL 80 User Manual RAB131GEN Settings User profiles 7 3 Creating a new User profile To create a New Profile follow the steps as indicated From the Settings window select the User key Select the Insert key In the Name login operator field type in your operator name 10 characters maxi Enter your password 10 characters maximum Default password is ABX Select the Group field and scroll through the list to select a User or Trained User profile Now select the Operator Code field and enter your code Once all information requested has been completely filled in on the User screen select the
199. ng area No message Unload racks and restart auto Unloading area full Unloading area full matic cycle Run an initialization Open left front cover and remove rack from loading area Close left front cover and restart automatic cycle Tube too high tube may not be TUDE tog anemia correctly inserted in rack Bad rack transfer movement Movement control Run an initialization left B EEE ON eu Pele MEN Moana Movement control Run an initialization right Undesirable Rack Movement Movement control Run an initialization Detected Close front covers Front cover open Front cover open Run an initialization 7 3 STAT mode error type and help message Alarm Error Type Help Message Tube holder mechanism failure Door not open No message 7 4 Environment Error Types and Help Messages Alarm Error Type Help Message d Incoh t s Result s f ee Seer ts pone rene eeu te 12 Incoherent Results Run an initialization o An i Wip anay System Run an initialization icati ith A NN ee Pm bo UG System Run an initialization Failed Hel Sejalan Tiens el Senso Sensor state Run an initialization Error Error on raw results sending Result failed Run an initialization volley SETS TN LUCID OS Sensor state Run an initialization tion Folate SADC TE AIHA BO Sensor state Run an initialization tion rone Saman Sin Luang a Sensor state Run an initialization tion H 1 Posi E Olda Semo Ca ang Pe Sensor state Run an initialization
200. nitialization Run an initialization Run an initialization Run an initialization Check diluent level and run a prime diluent cycle Check printer No message Ckeck Quality Control data in QC screen Run an initialization Run an initialization Check barcode label Check reagent Check reagent and restart auto matic cycle Check reagent and restart auto matic cycle Run an autoclean Check host connection No message No message Run an initialization Run an initialization No message No message No message Run an initialization Run an initialization Maintenance amp Troubleshooting Error messages Alarm Error Type Help Message Empty waste container and Waste container full Waste Container Full restart automatic cycle XB failed XB failed Check XB in XB screen 7 5 User Error Types and Help Messages Alarm Error Type Help Message Instrument stopped by user Run an AutoClean Instrument stopped by user at Initializati the end of analysis Run an Initialization Instrument stopped by user at the end of rack 7 6 Expiration Date Error Types and Help Messages Alarm Error Type Help Message Change reagent and restart Reagent s Yos expired automatic cycle Check OC epiration date and use p QC Lot Nb Barcode s expirated another QC Lot 7 7 Analyzer Internal Error Types and Help Messages Alarm Error Type Help Message Com error on slave d Communication error wit
201. nt page 4 31 an automatic re sampling can be required by configuring this menu From the Rerun screen select the Dilution tab Select the EDIT key Choose the parameter that will trigger a rerun in case of a D flag Now select the Dilution ratio 1 1 2 1 3 1 5 in comparison with the initial dilution The instrument will perform automatically this new dilution into both dilution chambers WBC LMNE chamber See Section 6 Description amp Technology 3 3 WBC and differential count page 6 17 and RBC PLT HGB chamber See Section 6 Description amp Technology 3 2 CBC detection principles page 6 13 Now select the OK key to confirm your selections Fig 5 14 Dilution tab 4 3 4 Rerun on Delta Check and invalidity These tab settings are applied on all Sample types 54 Pentra XL 80 User Manual RAB131GEN 5 19 ABX Pentra XL 80 5 20 When hematological results trigger Delta check flag See Section 4 Workflow 5 3 10 Delta Check page 4 45 or if parameters are invalid results are replaced with refer to Sec tion 4 Workflow 5 3 Flags page 4 30 an automatic re sampling can be required From the Rerun screen select the Delta Check Invalidity tab Select the EDIT key Choose the parameter that will trigger a rerun on a Delta check flag or invalidity Now select the OK key to confirm your selections PENTRA XL 80 Rules
202. ntation v Waste handling precautions When disposing of waste protective clothing must be worn lab coat gloves eye protection etc Follow your local and or national guidelines for biohazard waste disposal If required waste can be neutralized before being discarded Follow your laboratory s protocol when neutralizing and disposing of waste Dispose of the waste container according to the local or national regulatory requirements Pentra XL 80 User Manual RAB131GEN 2 15 2 16 XL 5 Limitations A While every effort is taken by HORIBA ABX to investigate and indicate all known interference s it is by no means possible to guarantee that all interference s have been identified At all times results should be validated and communicated only once all information relating to the patient has been assessed and taken into ac count 5 1 Maintenance In Section 7 Maintenance amp Troubleshooting 1 Maintenance amp Troubleshooting proce dures page 7 3 specific maintenance procedures are listed The maintenance procedures identified are mandatory for proper use and operation of the Pentra XL 80 Failure to execute any of these recommended procedures may result in poor reliabil ity of the system 5 2 Blood specimens Verification of any abnormal test result including flagged results or results outside of the normal range should be performed using reference methods or other standard laboratory pro cedu
203. nts Reference manual methods may be necessary to obtain an accurate platelet count Pentra XL 80 User Manual RAB131GEN Speci Hemolysis Hemolysed specimens contain red cell stroma which may increase platelet counts A C D blood Blood anticoagulated with acid citrate dextrose may contain clumped platelet which could decrease the platelet count Platelet agglutination Clumped platelets may cause a decreased platelet count and or a high WBC count The specimen should be recollected in sodium citrate anticoagulant to ensure the anticoagulated character depending on agglutination and reanalyzed only for the platelet count The final PLT result must be corrected for the sodium citrate dilution effect However these platelet clumps do trigger flags L1 LL and LL1 MPV Mean Platelet Volume Giant platelets that exceed the upper threshold of the Platelet parameter may not be counted as platelets Consequently these larger platelets will not be included in the in strument s calculation of Mean Platelet Volume Very small erythrocytes microcytes erythrocytic fragments schistocytes and white blood cell fragments may interfere with the proper counting and sizing of Platelets Agglutinated erythrocytes May trap Platelets causing an incorrect MPV result The pres ence of agglutinated erythrocytes may be detected by observation of abnormal MCH and MCHC values and by careful examination of the stained blood film C
204. number of unselected Runs Print or send options see 6 4 1 Printout or Transmit Report list page 4 65 Print Send This key will reject the Selected Reports of the Report Reject reports List screen see 6 3 Validation or rejection of a Report page 4 63 This key will validate the Selected Reports of the al AA Validate reports Report List screen see 6 3 Validation or rejection of a Report page 4 63 Click a line Click a line Displays the corresponding Report in full page see 6 1 4 Report display page 4 55 Tab 4 11 Report list Function Keys Pentra XL 80 User Manual RAB131GEN 4 53 ABX Pentra XL 30 4 54 v Report list information Use the slider see Fig 4 37 page 4 51 to display all the items in the Report list as indi cated below Sample ID Number Patient information Patient ID Patient name First Name Gender Date of birth Test performed Analysis date Following filters 1 Unvalidated when checked the Report list shows the Unvalidated Reports only A counter indicates their current number in the list 2 Validated and transmitted exclusive display of the Reports that have been transmitted and validated A counter indicates their current number in the list 3 Waiting for examination exclusive display of the Reports that are Waiting for examination A counter indicates their current number in the list 4 Rejected exclus
205. ode Patient clinical sample see Fig 4 13 page 4 21 Worklist AUTO_SID13 Standard Unknown a AUTO SID14 Standard Unknown e Fig 4 13 Worklist grid printout v Light printing A light printout of the Worklist one order by line is also available Select the Light printing option and press the OK button see Fig 4 14 page 4 21 Worklist Ooo o ss aopa ft Man o L Ii test Standard IN Ooo S A oo o 0 loihjkjdsogkbi auto Pos Je oS d Man S d Fig 4 14 Worklist light printout Pentra XL 80 User Manual RAB131GEN 4 21 ABX Pentra XL 80 2 4 Rack view When no barcode are used the order must contain the sample tube position in the rack see 1 6 Sample identification on Rack position page 4 8 From the Worklist grid select the Rack view key PENTRA 80 WORKLIST Ka Fig 4 15 Capture of the rack number Read the Rack Number with the External Barcode reader to display the Rack graphics screen This Rack View will display the order information and test type reguested for each position on the rack PENTRA XL 80 IWORKLISTIJ ii i z N 025646 MPTY Fig 4 16 Rack view screen Select one empty position to enter a new sample tube Fill in the order field information see Tab 4 3 Order fields page 4 19 Sample Informa
206. oducibility icenevahsheiaessarsaiadesoxenkoncheckoxes 2 7 3 2 Precision Repeatability 4 ooooWoWoW 2 8 2 MOA E E E O E A 2 9 N O GI e orumtaios oacustamncanectenees 2 10 329 Nona RINGS orien a eE Aan 2 11 E ee bi 2 11 3 7 Leukocyte differential count 2 12 3 8 Sample stability study kaan Bantan aa 2 12 3 9 CDR Mode specifications 2 13 A Reagent specifications 2 15 Ds Ea ON nore E E ss 2 16 Bale OY ECU ENS MCC aren Wamena una ana au 2 16 5 2 BIOOd SPECIMENS enade msssaeunegase aideorsdbanddeaseccpantnnnee eee 2 16 5 3 Known interfering substances oooooo 2 16 Pentra XL 80 User Manual RAB131GEN 2 1 ABX Pentra XL 80 2 2 Pentra XL 80 specifications includes the following 1 Technical specifications page 2 2 2 Physical specifications page 2 5 3 Summary of performance data page 2 7 4 Reagent specifications page 2 15 5 Limitations page 2 16 1 Technical specifications 1 1 Intended Used Pentra XL 80 system is a fully automated hematology analyzer used for the in vitro diagnostic testing of whole blood specimens 1 2 Parameters RBC Red Blood Cell HCT Hematocrit MCH Mean Corpuscular Hemoglobin RDW Red Distribution Width PDW Platelets Distribution Width PCT Plateletcrit Tab 2 1 CBC Parameters PCT and PDW have not been established as indications for this product in the Unit ed States The use of PCT
207. ogs When a reagent is replaced an instrument calibration is performed and or a maintenance operation is carried out a report of these interventions is automatically created in the ap propriate instrument log Reagents Calibration or Maintenance When these boxes are checked see Fig 5 2 page 5 5 a prompt reguiring comments is au tomatically displayed see Fig 5 3 page 5 7 ABX CLEANER ys N 4 Y v PENTRA XL 80 cleaner replacement by ABX Ji ill Pa a E km 8 Fig 5 3 Comments dialog box From the Soft parameters screen select the Edit key then select the appropriate boxes for your applications Once your selections have been made select the OK key to confirm your selections 2 2 5 Identification option Fig 5 4 Identification option This option must be setup according to the specific working order of the laboratory opera tions See Section 4 Workflow 1 Workflow page 4 3 Pentra XL 80 User Manual RAB131GEN 5 7 ABX Pentra XL 80 v Identification Option Barcode check this option if all tubes are going to be identified by barcode labels Rack position Check this option if samples With and Without barcode labels are going to be analyzed on the instrument v Manual match on Exception Must be ON to allow a manual match between orders and results See Section 4 Workflow 1 7 Exception management page 4 11 2 3 Department Phy
208. on 9 ex tended parameters The 3 parameters include MCV MCH MCHC The 9 parameters include WBC RBC HGB HCT MCV MCH MCHC RDW PLT This function allows the operator to select the XB mode 3 9 parameters or XB calculation disabled Menu XB inaccessible Select the EDIT key and check the chosen radio key Select the OK key to confirm your selection 5 12 Pentra XL 80 User Manual RAB131GEN Settings Ouality assurance settings C XB 3 Parameters XB 9 Parameters Fig 5 8 XB options 3 3 Number of calibration runs The number of calibration runs that can be entered by the user is from 1 to 99 runs if re quested The Minimum number of runs for good statistical calculations during calibration is 5 From the Quality Assurance window select the Edit key see Fig 5 7 page 5 12 Now select the titled field Minimum required sampling number for automatic calibration and highlight the number in the field Modify the number to the number of runs requested for calibration Remember the Minimum is 5 Now select the OK key to confirm your entry 3 4 Coefficients of variation ranges Coefficients of variation CV applied on statistical calculations as calibration See Section 3 Quality Assurance and Logs 4 4 1 Calibration passed page 3 29 QC See Section 3 Quality Assurance and Logs 1 3 QC data screen grid page 3 7 and within run grids See Section 3 Qualit
209. on function Keys 6 5 3 Runs orders matching This screen will allow the user to manually match Sample tubes and Worklist Orders that have been classified as Exceptions see 1 7 Exception management page 4 11 Select a run in the lower half of the association grid that you want to associate an order with Now select the order in the upper half of the association grid to associate to the selected run Then select the OK key A confirmation message will be displayed see Fig 4 58 page 4 69 Fig 458 Matching confirmation Once the matching has been performed the selected lines will disappear The matched run will be added to the Report list screen see Report list information page 4 54 A notification is added to the instrument logs A If the order type is different from the Run one the Run results will be recomput ed with the new type settings thresholds limits The recomputed Run re sults will be flagged in the Remarks flags see 5 2 Run Result screen page 4 28 If the order test differs from the Run test then the test of the matched Run CBC When the user validates the association and no order is selected the following message will be displayed Do you still want to match the tube with its default order Pentra XL 80 User Manual RAB131GEN 4 69 ABX Pentra XL 80 7 Archives At the end of the day on the 24 00 clock all Reports from the previous day are automati
210. on of blood cell analyzers includ ing those used for differential leukocyte and reticulocyte counting and cell marker applications ISLH 14 January 1994 v Carry over Claims SS Be Be E Claims lt 2 0 lt 2 0 lt 2 0 lt 2 0 Tab 2 10 Carry over claims source 510K submission K024002 2 10 Pentra XL 80 User Manual RAB131GEN 3 5 Normal Ranges Parameters Male Female WBC 10 mm 4 10 4 10 RBC 106 mm3 4 50 6 50 3 80 5 80 HGB g dl 13 0 17 0 11 5 16 0 HCT 40 0 54 0 37 0 47 0 MCV um 80 100 80 100 MCH pg 27 0 32 0 27 0 32 0 MCHC g dl 32 0 36 0 32 0 36 0 RDW 11 0 16 0 11 0 16 0 PLT 103 mm3 150 500 150 500 MPV um 6 11 6 11 PCT 0 15 0 50 0 15 0 50 PDW 11 18 11 18 NEU 50 80 50 80 LYM 25 50 25 50 MON 2 10 2 10 EOS 0 5 0 5 BAS 0 2 0 2 Specifications Summary of performance data Tab 2 11 Normal ranges table Important Expected values will vary with sample population and or geographical location It is highly recommended that each Laboratory establish its own Normal ranges based upon the local population 3 6 Accuracy The Accuracy performance was proven by comparing the Pentra XL 80 with a recognised com parison instrument using 200 patient whole blood specimens operating within the instrument normal functioning range 1 Bibliography AIDE MEMOIRE D HEMATOLOGIE Prof C SULTAN M GOUAULT HELM
211. ooo 7 19 A Service menu description excascacinssverstacwosevnereascnesartiaaserecisvansanvoceeveseeses 7 22 Se POU DISS OON Naaah nan ee aan enam mbah Ba RaR b AA NS 7 37 6 TAY CRAIC CAG TAIN oem 7 43 fe Por Mes PE ea bat ne bana 7 44 Section 8 Annex EEE Mn 8 2 2s Reagent Eede hasnt rcs oa en SA Pa Aa 8 5 3 Compatible t pe aa tenan Kanak 8 6 Section 9 Index amp Glossary anna aa NN NN ANN ARA 9 2 2 IN Sa na 9 4 XL Intro Contents 1 Warning and precautions oooWoW 1 2 1 1 Limited an Sen Nan 1 2 1 2 Safety ON oa 1 3 1 3 graphics ANG symbols La aan asn GR 1 4 Do Cage nenen min E 1 5 2 mp dani Labe Sae esa 1 5 22x PF COMME CON label mma 1 8 3 Operational COMO Se iein 1 9 APE ON E S E sane 1 9 De kota On E A E E E T 1 9 Jes UU ta ara nba ara 1 10 3 4 Humidity Temperature conditions o 1 10 3 5 Electromagnetic environment check o 1 10 3 6 Environmental protection ooWoWWW 1 10 3 7 Transportation and storage Conditions 1 11 JO WYSE ANG VO Ml cee conyers E 1 11 Senter one Oa 1 12 Te Ra lt enere eer ene E ee 1 13 2 SOM OVENI CW ea aa 1 14 4 1 Contextual toolbar descriptiOn ooc 1 15 4 2 Generic toolbar description Joa 1 16 4 3 Main Menu description oeeoa 1 17 AA NMS CCMAMCOUS waskerunsesobar bean aant etos mma en aan Op ata 1 18 5 Workflow Overview Wana 1 22 5 1 Order and Worklist overvie
212. ormation in this manual is distributed on an As Is basis without warranty While every precaution has been taken in the preparation of this manual HORIBA ABX will not assume any liability to any persons or entities with respect to loss or damage caused or alleged to be caused directly or indirectly by not following the instructions contained in this manual or by using the computer software and hardware products described herein in a manner inconsistent with our product labeling Pentra XL 80 User Manual RAB131GEN v Trademarks Microsoft and Windows are registered trademarks of Microsoft Corporation Other product names mentioned within this publication may be trademarks or registered trademarks of other companies v Graphics All graphics including screens and printouts photographs are for illustrations purposes only and are not contractual v Potentials hazards To alert the operator of potentially hazardous conditions one of the bold captioned headings which are described below is provided wherever necessary throughout this text Flags a procedure that if not followed properly can prove to be extremely hazardous to either the operator or the environment or both A Emphasizes an operating procedure that must be followed to avoid possible damage to the instrument or erroneous test results Emphasizes the important information especially helpful to the operator before during or after a specific operational function v
213. osuppressive drugs may increase the fragility of the leukocyte membranes which may cause low WBC counts In these particular cases CBC mode must not be used as WBC balance alarm see Section 4 Workflow 5 3 9 WBC bal ance page 4 44 is disabled It is recommended to run these samples in DIFF mode Pentra XL 80 User Manual RAB131GEN Speci Cryoglobulins Increased levels of cryoglobulin that may be associated with myeloma carcinoma leukemia macroglobulinemia lymphoproliferative disorders metastic tumors autoimmune disorders infections aneurism pregnancy thromboembolic phenomena dia betes etc which can increase the WBC RBC or PLT counts and the HGB concentration The Specimen must be warmed up to 37 C 99 F in a bain marie for 30 minutes and analyzed again immediately after analyzer or manual method Macrothrombocytes in excessive numbers may affect and increase Leukocyte numera tion RBC Red Blood Cells Erythrocytes The red blood cell dilution contains all the formed ele ments in the blood erythrocytes leukocytes and platelets During erythrocytes counting red blood cells platelets are not counted as their size falls below the minimum threshold Agglutinated erythrocytes May cause a low incorrect RBC count Blood samples contain ing the agglutinated red blood cells may be suspected by elevated MCH and MCHC values and shown by examination of the stained blood film Cold agglutinins IgM
214. ps RBC PLT WBC Differential Sample Reports are determined from runs automatic reruns and manual entries required for an order See Section1 Introduction 5 Workflow overview page 1 22 See 6 2 1 Report Details page 4 57 to construct the report with Run results and to re view histories See 6 2 2 Report Edit page 4 60 to create or review a manual entry 6 2 1 Report Details From the Report Display view see 6 1 4 Report display page 4 55 select Details PENTRA XL 80 Report Details lt 05 28 2003 16 43 32 272 88 I v ra 05 28 2003 16 35 08 lt I 8 GP 2 1 HdA eae S 61 0 331 26 6 1 44 225m oi fen ami Ass jom J2 orn nias ai TEA AA Fig 441 Report Details screen E m an y R E er Am ECRM ieee ae AN ECE pa EEEN ag es oo Eel ee aa ae i i 1 Current Report see Current Report panel page 4 58 2 Run results associated to this report see Run Results panel page 4 59 3 histories of the Patient see history panel page 4 60 4 Four tabs to review parameters curves and alarms CBC DIFF parameters values CBC values PLT RBC WBC histograms DIFF values LMNE matrix BAS histogram Flags Pathology messages 5 Selection deselection of the Parameter blocks 6 Waiting for examination indicator Pentra XL 80 User Manu
215. puted after each selection deselection of results There is not limit on the number of results to be saved for a specific blood con trol lot One or more results may be excluded from the CV calculations by using the check 1 4 Graphics screen From the L J Graphs or Data screen grid select the Matrix key to display the last QC result PENTRA XL 80 Graphics Screen or Ja w sd Fig 3 5 QC graphics screen Flag and alarm definitions are described in detail in Section 4 Workflow 5 3 Flags page 4 30 v Entering a comment Comments can be entered into the Comment field when in the QC Graphics screen A Max imum of 50 characters may be entered Select the Comment field and enter your comments Press the OK key once your have finished your entry These comments can be displayed in the QC data grid see Fig 3 4 page 3 7 3 8 Pentra XL 80 User Manual RAB131GEN Ouality Assurance 1 5 Print send or delete results 1 5 1 Printing results v Graphics screen Results are printable from the Graphics screen see Fig 3 5 page 3 8 in a full screen mode Select the Print Send key Then select the OK key v QC Data Grid From the Data Grid screen Selected Unselected and ALL results can be printed by selec tion choice as indicated in Fig 3 6 page 3 9 Print Send Print selected results
216. r NL and RN Monocytosis MON gt MON H or if MON gt MON Yo H Basophilia BAS gt BAS H or if BAS gt BAS H Blasts BAS gt BAS H and LIC gt LIC H and RM Interpretation Not possible WBC lt 0 1x103 mm or WBC gt 85 0x10 mm or CO alarm Tab 4 7 WBC pathology messages H extreme high limit L extreme low limit indicates that the pathology is detected on the high and low absolute values of the pa rameter in question Pentra XL 80 User Manual RAB131GEN 4 47 ABX Pentra XL 80 4 48 v RBC messages Message Condition Anisocytosis RDW gt RDW H Microcyte MIC gt 10 Macrocyte on Mac Flag Cold Agglutinin MCHC gt MCHC H and WBC lt 91 3x10 mm Macrocytosis MCV gt MCV H Interpretation Not possible RBC lt 0 01x10 mm or RBC reject or RBC gt 0 03 during Startup Tab 4 8 RBC pathology messages H extreme high limit L extreme low limit Pentra XL 80 User Manual RAB131GEN Workflow Run results and associated Flags v PLT messages Message Condition Thrombocytosis PLT gt PLT H Thrombocytopenia PLT lt PLT L Microcytosis MIC schistocytes No threshold between RBC and PLT on the curves Small Cell Small cells at the beginning of the Platelet curve condition 1 PLT lt 150x10 mm WBC reject or NO PDW gt 20 or NO MPV gt 10 or NO PLT lt 150x10 mm or Platelets Aggregate NO W
217. rator and place it into the appropriate position in the tube holder Now close the tube holder door to run the analysis When the tube holder door opens remove and recap the vial for pre mixing of the next cycle Calibration results may be erroneous if the calibrator is not mixed properly between each analysis cycle Once the analysis is complete the first result is displayed in the Results Grid Run the calibrator 4 more times The Minimum number of sampling is 5 for good statistical calculations The calibrator may be run from 1 to 99 times if needed Section 5 Settings 3 3 Number of calibration runs page 5 13 3 28 Pentra XL 80 User Manual RAB131GEN Ouality Assurance Calibration PENTRA AL 80 Calibration 2002 04 02 15 03 20 Admin 2002 04 02 15 04 16 3 6 4 56 13 6 36 4 Admin 2002 04 02 15 05 12 9 7 4 59 13 5 36 7 M Admin 2002 04 02 15 06 08 9 7 4 58 13 5 36 8 M Admin 2002 04 02 15 08 57 9 7 4 64 H 13 7 371 M Admin 2002 04 02 15 09 50 3 8 4 62 13 8 37 1 TE Bs va Res x 261 10e3 mm3 Modified on 2002703729 fanin 3 aE amp vd apa I Pn an K Fig 3 25 Calibration result grid When calibration results are received on the display they are saved as calibration data and not received as sample results Calibration results are not transmitted to a host computer they are kept in the calibration Results Grid Ifa calibration cycle is
218. rejected it will not be displayed or stored An error mes sage will be displayed on the screen indicating that the calibration sample was rejected To remove results from the statistical calculation select the check box see Fig 3 25 page 3 29 to remove the mark To remove Parameters from the Coefficient calculations select the check box see Fig 3 25 page 3 29 to remove the mark When a Coefficient of variation is displayed in Red it is above its limit and that parameter will fail calibration 4 4 1 Calibration passed There are only 2 passing criteria for calibration 1 The Coefficients of variation must be within their limits Section 5 Settings 3 4 Coefficients of variation ranges page 5 13 2 The percent differences between the Target value and the Mean values must be less than 20 Instrument allows you to select an automatic calibration Press the Automatic calculation key Pentra XL 80 User Manual RAB131GEN 3 29 ABX Pentra XL 80 3 30 A message is displayed to confirm the Autocalibration Selecting the ok key will automat ically print the results and then erase them from the Result grid 4 4 2 Forced calibration This is an indication that the current calibration analysis is not within the acceptable limits 1 The Coefficients of variation are greater than their limits 2 The percent difference between the Target value and the Mean values is greater that 20 The calibratio
219. res for conclusive verification of the results The sections below list known limitations of automated blood cell counters which use the principles of impedance and light absorbance as principles of measurement 5 3 Known interfering substances WBC White Blood Cells Leukocytes WBC results that exceed the linearity limits of the sys tem will require dilution of the blood sample Leukemia sample followed by a leukopenia Re assaying the diluted sample will help to obtain the correct assay value Unlysed Red Cells In some rare instances the erythrocytes in the blood sample may not be completely lysed These non lysed red blood cells may be detected on the WBC histo gram with an L1 alarm or as an elevated baseline on the side leading edge of the lym phocytes population Non lysed erythrocytes will cause a falsely elevated WBC count Multiple myeloma The precipitation of proteins in multiple myeloma patients may give high WBC counts Leukemia A very low WBC count may result from this disease because of possible in creased fragility of the leukocytes leading to destruction of some of these cells during counting These white cell fragments will also interfere with the white cell differential pa rameters A suspiciously low WBC count may also be seen in patients with lymphocytic leu kemias due to the presence of abnormally small lymphocytes which may not be counted by the instrument Chemotherapy Cytotoxic and immun
220. roduction Software overview 4 1 Contextual toolbar description This toolbar that located at the bottom of the screen contains the same selections regardless of what initial menu is open Help Details Insert Edit OK Cancel Delete Print Return Ouit Help Details Insertion Modification Validation Cancel Delete Print Return Ouit Tab 1 2 Contextual toolbar Keys Brings up the help file Details displays supplementary information Inserts new data Edits Modifies data Validates an action Cancels an action Deletes data Prints data Ouits the current menu Ouits the ASPO2 software Pentra XL 80 User Manual RAB131GEN 1 15 ABX Pentra XL 80 1 16 4 2 Generic toolbar description The Generic toolbar function keys are accessed from the toolbar located on the right side of the screen These function keys are the most frequently used besides the Main Cycle Launch keys Stop Alarm a Worklist Fi Start Rack f Stat Reports Archives Stops the analyzer Launches Alarm menu Opens Worklist Runs the automatic mode Runs the manual mode Opens reports menu Opens Archives menu Tab 1 3 Generic toolbar keys Pentra XL 80 User Manual RAB131GEN Flashes when an alarm is triggered See Section 7 Maintenance amp Trouble shooting 7 Error messages page 7 44 Displays the number of orders See Section 4 Wor
221. rol XB cooooW Jaana 3 Within run 1 E E A T E TE E E T E E 3 2 4 Calibration ACAD HOM EEEE AEE T E E T 3 25 SPN Ee PENEI O E O O O A eee eto A 3 32 Section 4 Workflow CN EON a E E E E 4 3 2s Workist ae Chp IN ccasncccranaaseninataassnosceacadeaoetsacniansimesanianeddecnnnsesdsiaeee 4 15 3 Sample collection amp MIXING oooombbbkklklnnnnnnnn 4 25 A Kuna Spon ssi r EET TA 4 26 5 Run results and associated Flags oollllllnnaan 4 27 Ge Kepo ee ana 4 51 PA ONE an Mean 4 70 On Man Ne ea 3 4 77 Section 5 Settings 1 Menu Seftingss OVENI urenset daeina iEn Ona Bean 5 3 2 Sot paramet S ceanii a Rae niksa 5 5 3 Quality assurance settings sssssssssssessseserrrerersssssssssssessrereerreeeesesse 5 12 Pentra XL 80 User Manual RAB131GEN 0 10 XL AN Pa EA E N E E 5 15 Ee A E E cin aps A S ET E E e S 5 23 0 Save and TESTON east aan an nan Rona aa 5 36 7 User OVO MCS an Aoa Aa aras RASA 5 40 e CS oo coerce 5 43 Section 6 Description amp Technology Pentra XL 80 User Manual RAB131GEN 1 Pentra XL 80 CS Poor 6 2 2 Automatic mode principles sssissssissiiierssicieriressssssnessissririrerissdinssssinss 6 7 da PACE orason EEEE e 6 11 Section 7 Maintenance amp Troubleshooting 1 Maintenance amp Troubleshooting procedures eo oo 7 3 2 Replacement procedUeS senen ben muammar BN ASIN 7 9 3 Instrument panels amp cover Removals e oooW
222. rs Then the fol lowing message is displayed PENTRA 80 AN Pour 3 ml of ABX MINOCLAIR into WBC Baso chamber Press Enter To Continue Fig 7 41 Concentrated cleaning pour Minoclair into WBC Baso chamber Pour 3ml of Minoclair or bleach diluted to 4 chloride into WBC BASO chamber last chamber on the right side Fig 7 40 page 7 35 Select Validate key Wait for the instrument to complete the cleaning Pentra XL 80 User Manual RAB131GEN 7 35 ABX Pentra XL 80 4 4 Others PENTRA XL 80 Others Fig 7 42 Super User Others 1 Cycles Counter shows the number of specified cycles performed by the instrument 2 Run Park Syringe Position This key allows the user to place the syringe pistons in a safe position for long term non usage or storage and when the instrument will be in transport from one location to another 3 Run Maintenance Carriage Pos This key allows the user to automatically move the Sample Carriage over the chamber area for sample probe replacement and or other maintenance procedures that may require the movement of the sample carriage 4 Each calibration coefficient can be forced to a value Enter the value you want to modify in the Calibration coefficients grid Confirm the modifications by pressing the Accept values A notification is automatically done in the calibration logs see Fig 7 11 page 7 13 Any modification of the coefficients will affect the res
223. s amp Cur ve thresholds page 5 47 Worktlow Run results and associated Flags Meaning Neutro Lympho Presence of a significantly large population of cells located in the separation threshold area between lymphocytes and neutro phils This flag occurs when the number of particles counted in this area is higher than the limit set up in NL or when the number of counted particles regarding the total number of WBC is above NL limit Suspected abnormalities e Small neutrophils without granules and or slightly segmented e Lymphocytes with a segmented nucleus or Activated Lymphocytes e Neutrophils with membrane weakness This flag is associated with an on LYM LYM NEU NEU Meaning Mono Neutro Presence of a significantly large population of cells located in the separation threshold area between monocytes and neutrophils This flag occurs when the number of parti cles counted in this area is higher than the limit set up in MN or the number of particles counted in MN versus the total number of WBC is above the MN limit Suspected abnormalities e Monocytes having granules in their cyto plasm or hyperbasophilic monocytes e Young neutrophils with non segmented nuclei bandcells This flag is associated with an on AY AL LIC LIC and replaces NEU NEUK MON MON by Pentra XL 80 User Manual RAB131GEN 4 37 ABX Pentra XL 30 v LN flag Absorb
224. s above the NE limit Suspected abnormalities e Young eosinophils e Giant hypersegmented neutrophils e Eosinophils with low intracytoplasmic material e Immature cells This flag is associated with an on LIC LIC and replaces NEU Yo NEU EOS Yo EOS by v RM flag Absorbance NoN NoE Channel 127 Resistivity Fig 4 28 RM flag Standard value for RM 1 1 999 See Section 5 Settings 8 3 Alarms amp Cur ve thresholds page 5 47 v RN flag Absorbance NoN NoE RN Channel 127 LMD RM Resistivity Fig 4 29 RN flag Standard value for RN 1 1 999 See Section 5 Settings 8 3 Alarms amp Cur ve thresholds page 5 47 Workflow Run results and associated Flags Meaning Right Mono Presence of a significantly large population of cells located on the right hand side of the monocyte area low LIC This flag oc curs when the number of particles counted in this area is higher than the limit setup in RM or when the counted particles re garding the total of WBC is above RM limit Suspected abnormalities e Large monocytes e Hyperbasophilic monocytes e Myelocytes or promyelocytes e Large blasts This flag is associated with an on NEU NEU MON MON LIC LIC Meaning Right Neutro Presence of a significantly large population of cells located on the right hand side of the neutrophil area high LIC This flag occurs
225. s also been done for at least one of the parameter group Fig 1 22 One report Run Rerun Manual entry w Unconditional validation All the runs are automatically validated Several reports can be produced for the same order Pentra XL 80 User Manual RAB131GEN 1 25 ABX Pentra XL 80 6 Printer Use the printer supplied or approved by HORIBA ABX Latest printer information as well as consumable part numbers are available on www horiba abx com documentation 1 26 Pentra XL 80 User Manual RAB131GEN XL Speci Contents 1 Technical specifications cooW 2 2 Tek Intond ed SC ccc ccoscetonmpnaeceoeiedsasosaacedecanoncasaweeteesaticars 2 2 1 2 Parame meee MeN T eer ee er eee ro a rn ere Tt ere ee 2 2 1 3 Throughput Analyses ooooooWoo 2 3 TAs Tube identica on same E 2 4 E e EE E E in oa 2 4 fh GUC Tet COM pe aN 2 4 1 7 Methods and technologies n 2 4 2 Physical specificationS eeeeeseeesssssssssesseereeresereesees 2 5 ZN POW Cl rege Mebel on 2 5 2 2 Operating temperature and humidity 2 5 23 Dimension and Weight ne en Sana 2 5 2 4 Minimum specimen voluMe e boaaan 2 5 Does ON AO en ar 2 5 2 0 HGB meas remEent anna ssnt alan an maba 2 5 2 7 Counting aperture OA LES as hit na 2 6 2 8 Reagent CONSUMPTION MI 2 6 2 Compatible WDE list bee n e 2 6 3 Summary of performance data eene 2 7 3 1 Precision Repr
226. s carried out correctly 42 5ul of this dilution are aspirated from chamber 2 into hydraulical circuit and injected with diluent into chamber 4 b Check bubbling in the RBC PLT chamber 4 once the dilution is carried out Dilution remains transparent c Perform a concentrated cleaning see 4 3 4 Clean Cycles page 7 34 d If all these operations appear to be correct call your HORIBA ABX representative de partment Calibration a Perform a calibration of the instrument see Calibration page 7 40 v Procedure 8 HGB Repeatability If HGB is non repeatable a Run an analysis cycle b Check dilution colour in the chamber 2 Milky when sample is first delivered to the chamber then brown transparent when lyse is injected c Perform a concentrated cleaning see 4 3 4 Clean Cycles page 7 34 d If this does not correct the HGB count call your HORIBA ABX representative depart ment Calibration a Perform a calibration of the instrument see Calibration page 7 40 v Procedure 9 WBC Baso Repeatability If WBC Baso are non repeatable a Perform a concentrated cleaning see 4 3 4 Clean Cycles page 7 34 b If this does not correct the WBC Baso count call your HORIBA ABX representative de partment Calibration a Perform a calibration of the instrument see Calibration page 7 40 7 40 Pentra XL 80 User Manual RAB131GEN Maintenance amp Troubleshooting
227. s started on a new working day date changed 2 the Begin of day time is over see Fig 5 27 page 5 35 Begin the Day Tab 5 12 Cycle option Pentra XL 80 User Manual RAB131GEN 5 35 ABX Pentra XL 80 6 Save and restore 6 1 Access to Save Restore screen From the Settings window press the System key m PA No 2 mg ai i i Aing zt al wa i Ne r y ba 2 et Fig 5 28 Save and restore configuration The Save and restore screen provides the operator with three tab choices as indicated 6 2 Configuration page 5 36 6 3 Dump database page 5 38 6 4 Report exportation page 5 38 6 2 Configuration 6 2 1 Analyzer setting functions Heading key Function Save settings on hard disk Opens a dialogue window in order to save the current configuration aa e Opens a dialogue window in order to select one of the save settings Opens a dialogue window in order to save the current configuration on Save setting on floppy a dick Opens a dialogue window in order to select one of the save settings on Restore settings from floppy hedik Tab 5 13 Analyzer save restore 5 36 Pentra XL 80 User Manual RAB131GEN Settings Save and restore 6 2 2 Workstation setting functions Heading key Function Opens a dialogue window in order to select the save path of the current Save settings on hard disk configuration
228. s the racks that have been run since the Begin of Day the most recent one is the bottom one Rack numbers are displayed on the left side of each rack view DIFF tubes are shown in green CBC tubes in yellow The position of the tube in the rack is given at the bottom of the Rack view screen v Rack view screen selection keys Heading Key Function i When a tube have been previoulsy selected the Detail Details key will open the Report Details screen see Fig 4 41 page 4 57 One click on a tube is shown by a red circle see Fig 4 66 page 4 80 This will display the demographics of this tube in the right part of the screen Sample and Patient data Opens the Search by Sample ID screen see 2 3 5 Searching by sample ID page 4 20 Sample TUrseatcn oe result of the search is ae by red tubes a Fig 4 67 page 4 81 Opens the Search by Patient ID screen see 2 3 6 Searching by patient name page 4 20 anen opardi result of the search is shown by red tubes see 4 67 page 4 81 Tube selection Tab 4 18 Rack view selection keys Pentra XL 80 User Manual RAB131GEN 4 79 ABX Pentra XL 80 v Selection of a tube in the Rack view screen The selection of a tube is shown by a red circle 1 around the tube position see Fig 4 66 page 4 80 The Demographics of the tube is displayed on the right part of the screen From this selection the Report details view is accessible by selectin
229. se check that the instrument has not been placed in the proximity of electromagnetic fields or short wave emissions i e Radar X rays Scanners Cell phones etc 3 6 Environmental protection v Disposal Used accessories and consumables Must be collected by a laboratory specialized in elimination and recycling of this kind of ma terial according to the local legislation v Disposal Pentra XL 80 instrument It should be disposed of in accordance with local legislation and should be treated as being 1 10 Pentra XL 80 User Manual RAB131GEN Introduction Operational conditions contaminated with blood The appropriate biological precautions should be taken If any doubt please contact your HORIBA ABX representative service department v 3 7 Transportation and storage conditions Storage temperature 20 C 50 C AA Prior to the shipping of an instrument by transporter whatever the destination an YY external decontamination of the instrument must be carried out 3 8 Installation An HORIBA ABX representative will install your instrument software and printer v Package contents Verify that all of the parts from the package list are present Part Number Ouantity Designation XEA785B 1 Installation kit Pentra XL 80 XBA453B 1 Barcode reader GBDO72A 4 Lifting handles GBL0280 10 Rack 10 vials 13x82 XBA322B 1 Waste sensor CBKO48A 1 Computer Mouse GBLO250 1 Keyboard drawer CBKO43A or CBKO45A
230. ser Manual RAB131GEN Ouality Assurance Ouality control 1 7 Running control blood 1 7 1 Running in STAT mode Verify that the lot of control blood has been entered as described in 1 6 New blood control setup page 3 10 Prepare the Blood control according to the specific instructions detailed in the blood control package insert temperature mixing Select the Stat key the tube holder door will open Read the lot with the external barcode reader or manually type the Lot Select the OK key Place the vial into the appropriate possition and close the door to the backwards position When the analysis is complete the QC results will automatically be saved in the QC menu for that specific lot 1 7 2 Running in Rack mode With barcode label identification Verify that the lot of control blood has been entered as described in 1 6 New blood control setup page 3 10 Prepare the Blood control according to the specific instructions detailed in the blood control package insert temperature mixing Position the blood control in any rack verify that the Barcode label will be readable by the internal barcode reader Place the rack in the rack loader and select the Start Rack key When the analysis is complete the QC results will automatically be saved in the QC menu for that specific lot Pentra XL 80 User Manual RAB131GEN 3 13 ABX Pentra XL 80 2 Patient Ouality Control XB
231. sicians tab To prevent manual entering of clinical information for each order this tab provides fields to enter Department names and Physician names that are requesting the analysis of the samples See Section 4 Workflow 2 Worklist description page 4 15 From the Soft Parameters menu select the Department Physicians tab PENTRA AL SIS 04 10 2003 16 53 00 04 10 2003 09 05 42 Vv eke eo aa TI Fig 5 5 Department Physicians tab Use the following function keys to insert delete or modify a department Physician 5 8 Pentra XL 80 User Manual RAB131GEN Settings Soft parameters v Functions keys Function Addition of new department Physician if the focus is on the department list the software allows the addition of a department 20 charac ters maximum Tab 5 3 Function Keys Pentra XL 80 User Manual RAB131GEN 5 9 ABX Pentra XL 80 2 4 Units tab Selection of a set of units among the following UNITS WBC RBC HGB HCT PLT MCV STD 10 mm 10 mm g dl Yo 10 mm um SI 10 l 1012 1 g l Vl 10 l fl mmol L 10 1 101271 mmol L VA 10 l fl JAPAN 10 mm 1 10 mm g dl Yo 104 mm ym MCH MCHC RDW MPV PCT PDW STD pg g dl um Yo Yo SI pg g l Yo fl 102 1 Yo mmol l fmol mmol L fl w JAPAN pg g dl um LYC LYC MON MON NEU NEU EOS STD Yo Yo Yo Yo SI Yo Yo Yo Yo mmol l o Yo Yo Yo JA
232. t Obtain a Sample tube rack and place some tubes in position and leave 2 or 3 empty spaces rom the Main screen select the Super User Menu and then Mechanical Sampler Test Now select the Start Rack key and verify that the rack identification and all the tubes in the rack have been detected Rack number Type of rack CBC or DIFF e Barcode numbers Pentra XL 80 User Manual RAB131GEN 7 27 ABX Pentra XL 80 PENTRA XL 80 Mechanical System Q il Fig 7 31 Super User Mechanical Sampler Test 4 2 6 Sample tube Holder adjustment The Sample tube holder and sampling needle positions has been factory adjusted Do not at tempt to modify them unless instructed to do so by an HORIBA ABX Representative 7 28 Pentra XL 80 User Manual RAB131GEN Maintenance amp Troubleshooting Service menu description PENTRA XL 80 Mechanical System Fig 7 32 Super UserNMechanical Holder Adjustment Depth For each hole position Id the depth is measured in millimeters Level This measurement is subtracted from the total depth of each hole position Id so that the sample probe will not touch the bottom of any sample tube placed in these posi tions Position id This measurement is taken from the Sample probe Home position to the top flat surface of the tube holder Accept Values key This key is used to accept any changes ma
233. t hand side panels see 3 Instrument panels amp cover Removals page 7 19 Once the side panels have been removed power on the instrument From the Main screen select the Super User Menu and then Mechanical Check Valves Closely observe the valve operations movements have to be straight and regular PENTRA XL 80 Mechanical System Fig 7 29 Super UserNMechanical Check Valves 1 Valves 1 to 12 Verify the correct operation of these valves 2 Valves 13 to 19 Verify the correct operation of these valves 3 Valves 20 to 23 Verify the correct operation of these valves 4 Valves 24 to 30 Verify the correct operation of these valves 5 Valves 31 to 35 Verify the correct operation of these valves 4 2 4 Check Sensors Verify the activity of all of the mechanical sensors mainly switches on the instrument If all switches are working properly they will be indicated in Green From the Main screen select the Super User Menu and then Mechanical Check Sensors 7 26 Pentra XL 80 User Manual RAB131GEN Maintenance amp Troubleshooting Service menu description PENTRA XL 80 Mechanical System ll aa em iS D Fig 7 30 Super User Mechanical Check Sensors Verify that all sensors are indicated in Green If any sensor s are indicated in Red con tact your local HORIBA ABX Technical Support Representative for further instructions 4 2 5 Sampler tes
234. ted reports page 4 75 Opens a calendar in order to select the Report validation date The date can also be manually typed in Enables the deletion of all unselected or selected analyses Checks all the Report lines of the list column Selected Unchecks all the Report lines in the list column Selected Printing or sending options all the lines or selected lines only see Fig 4 61 page 4 72 Displays the Report in full screen mode see 7 4 Reviewing a Report in full screen mode page 4 75 One click for ascending order beside heading Another click for descending order beside heading A third click restores initial order see Fig 4 60 page 4 71 Fig 4 61 Printing options 4 72 Pentra XL 80 User Manual RAB131GEN Workflow Archives 7 3 Patient Report The Archives function allows the user to review demographics of the patient If the Patient ID is known follow the steps as indicated From the Daily Report grid select the Patient Report key see Tab 4 16 Patient Archives function Keys page 4 74 PENTRA XL 80 Reports by Patient SEE EE Fig 4 62 Patient Archives screen The Slider icon 1 can be used to display all the Reports that are associated with this patient The Slider icon 2 can be used to display all the parameters that are associated with this pa tient the differential including NEU LYM MON EOS BAS ALY
235. the depth limit is exceeded erroneous results will occur Diluent and Waste tubing lengths are critical upon installation Follow the recom mended lengths for best results DILUENT input tubing Cristal 3x6 2 meters 80 in maximum WASTE output tubing Cristal 4x6 2 meters 80 in maximum A Make sure that a blank cycle and Control run will be carried out after the change of a reagent in the course of day Bottles and container locations see Fig 7 7 page 7 10 1 ABX lyse 2 ABX Basolyse II 3 ABX Eosinofix 4 ABX Cleaner 5 ABX Diluent 6 Waste container Pentra XL 80 User Manual RAB131GEN 7 9 ABX Pentra XL 30 Fig 7 7 Reagent location 2 1 2 Integrated reagents amp Diluent container replacement During instrument startup the instrument software compares the remaining quantity of each reagent to the daily workload setup If one or more reagents reach a Low Level during the working day an alarm occurs and the following alarm window will appear indicating the fol lowing message see Fig 7 8 page 7 11 7 10 Pentra XL 80 User Manual RAB131GEN Maintenance amp Troubleshooting Replacement procedures ISecion Date Alarm Error D Environment and software 05 13 2002 11 34 58 Reagent Reagent Level too low to run an analysis Environment and software Reagent Reagent Level too low to run an analysis Change reagent and restart automatic cycle amp Y Fig 7 8 Reagent
236. the RBC histogram The PLT histogram contains 256 channels between 2fL and 30fL A mobile threshold at 25 fL by de fault moves according to the microcytic RBC s that are present in the platelet analysis area The PLT flags are generated under the following conditions Worktlow Run results and associated Flags An excessive presence of particles on the right side of the threshold area after 25 fL will generate the MIC Microcytes flag shown in the plate let alarm area In this case the mobile threshold looks for a valley between 18fL and 25fL standard area If the mobile threshold can not posi tion itself in the standard area between 18fL to 25fL a PLT reject and a MIC flag will be generated The PLT results are not reliable Verify the result using a Platelet Rich Plasma PRP or a manual platelet count If the mobile threshold cannot be po sitioned no valley between the PLT and RBC histograms the SCH schis tocytes flag will be generated Suspected abnormalities e Presence of schistocytes e Presence of PLT aggregates Verify this abnormality by viewing the peripheral blood smear to confirm your results Fig 4 35 PLT Flags The SCL Small Cell flag will indicate the presence of small cells in the 2fL and 3fL zone A second analysis should be carried out and the results verified Pentra XL 80 User Manual RAB131GEN 4 43 ABX Pentra XL 80 5 3 9 WBC balance During the initial
237. the right hand side of these screens from both worklist views 2 3 Worklist grid 2 3 1 Creating an order page 4 17 2 3 2 Contextual toolbar keys page 4 18 2 3 3 Grid functions page 4 18 2 3 4 Order information fields page 4 19 2 3 5 Searching by sample ID page 4 20 2 3 6 Searching by patient name page 4 20 2 3 7 Printing out the worklist page 4 21 The left part of the screen shows the list of orders the left right slider allows the display of hidden information on the orders The right part aloows the creation modification of the orders in the Edit mode The Worklist patient file management depends on the specific working method for sample identification in your laboratory see 1 Workflow page 4 3 4 16 Pentra XL 80 User Manual RAB131GEN Worktlow Worklist description PENTRA XL 80 WORKLIST E Mss Fig 4 8 Worklist grid 2 3 1 Creating an order From the Worklist grid select the Insert key see Tab 4 2 Function Keys page 4 18 to create a new order Fill in the order information using the right part of grid screen see Tab 4 3 Order fields page 4 19 Select the test to be performed by clicking the CBC DIFF key Refer to 1 4 Sample identification page 4 5 Then select the OK once all entries have been made Pentra XL 80 User Manual RAB131GEN 4 17 ABX Pen
238. the syringes and the carriage in a safe position 1 Enter Service Super User Menu Others and press the Run park syringe position button See Park screen page 7 8 Pentra XL 80 User Manual RAB131GEN 7 7 ABX Pentra XL 80 PENTRA XL 80 Others Cycles Counter Calibration Coefficients CBC fo WBC 139 92 RBC 165 20 CBC DIFF fo HGB 42 52 StartUp fo HCT 177 27 PLT 242 68 ShutDown fo ROW 0 35 AutoClean MPV 1 00 LMNE 0 88 Accept Values z OS KD Version V1 1 0 01 12 2004 10 38 07 Fig 7 5 Park screen 2 Before the transport of the instrument press the Run maintenance carriage position button 3 Block the carriage using the Plastic rails See Plastic rails page 7 8 Fig 7 6 Plastic rails 4 Close the door and turn off the instrument 7 8 Pentra XL 80 User Manual RAB131GEN Maintenance amp Troubleshooting Replacement procedures 2 Replacement procedures This section describes how to replace a low level reagent see 2 1 Reagent replacement page 7 9 an optical bench lamp see 2 2 Optical bench lamp replacement page 7 15 the sampling probe see 2 3 Sampling probe replacement page 7 17 2 1 Reagent replacement 2 1 1 Reagent locations and connections A When installing the Diluent on the system it is most important to maintain the depth of the container no lower than 80 cm 31 5 in below the instrument If
239. them into the tube holder and closing the tube holder door This will ensure a homogeneous mixture for measurement Pentra XL 80 User Manual RAB131GEN 4 25 ABX Pentra XL 80 4 Running specimen See Daily Guide RAB156 v Recommendations on the analysis mode selection CBC or DIFF When selecting CBC analysis there is no control mode on WBC erroneous countings that may be caused by specific treatments on patients See Section 2 Specifications 5 Limitations page 2 16 and WBC balance description See Section 4 Workflow 5 3 9 WBC balance page 4 44 4 26 Pentra XL 80 User Manual RAB131GEN Worktlow Run results and associated Flags 5 Run results and associated Flags Runs results and associated flags chapter includes 5 1 Printer output format page 4 27 5 2 Run Result screen page 4 28 5 3 Flags page 4 30 A Report function allows the operator to review the Run Results of the day see 6 Report page 4 51 A Run In Progress function displays Run results of the current analysis 5 1 Printer output format Report Printout Unvalidated AN 3541 YO Th 4 01 0 5 151 0 6 Out of Panic Ronge Dut of Namal Range The operator can modify the Printer output format by selecting the Settings function key See Section 5 Settings 5 4 Printer page 5 31 Pentra XL 80 User Manual RAB131GEN 4 27 ABX Pentra XL 80 5 2 Run Result screen PENTR
240. tion Clinical information Patient Information 4 22 Pentra XL 80 User Manual RAB131GEN Worktlow Worklist description Select the test type to be performed on the sample Note the color of the indicators DIFF in Green CBC in yellow If a test type is not selected an instrument Default test is performed DIFF The cursor automatically moves to the next rack position If no positions are available the cursor then moves to the next rack number 2 4 1 Auto Numbering If a Sample ID is not entered into a sample tube position an Auto number is given to the order as indicated EDWARDS AUTO_SID1 3 I REDDING Fig 4 17 Rack auto_numbering Select the Worklist Grid view key see Tab 4 1 Worklist selection keys page 4 16 to display orders associated with the captured rack For more details about sample identification refer to 1 Workflow page 4 3 v 2 4 2 Rack view contextual toolbar keys Heading Key Function Modification of an order for a position already filled except Edit if the rack is in the process of being analyzed Rack and position fields Sample ID are not modifiable Deletes orders for a position already filled except if the rack is in the process of being analyzed Delete Two choices Emptying the rack and position fields Deleting the order Print see 2 4 4 Printing the rack view page 4 24 Tab 4 4 Function Keys Pentra XL 80 User
241. tion 5 Settings 3 2 XB options page 5 12 The XB alarm can stop the instrument operations if the user has selected the XB alarm con ditions in the Instrument Settings functions See Section 5 Settings 2 2 General tab page 5 6 v QC failed This flag will appear when the quality control does not meet the criteria that were selected in the Instrument Settings functions The user has the option of selecting or de selecting these criteria See Section 5 Settings 2 2 General tab page 5 6 4 50 Pentra XL 80 User Manual RAB131GEN Workflow Report 6 Report This section describes how to 1 Review Reports of the day see 6 1 Reviewing Report page 4 51 2 Construct a Report see 6 2 Construction of a Report page 4 57 3 Validate or reject Reports see 6 3 Validation or rejection of a Report page 4 63 4 Request Manual Reruns see 6 4 Rerunning sample manually page 4 64 5 Associate unmatched Run results with Worklist orders see 6 5 Run order association page 4 68 6 1 Reviewing Report 6 1 1 Accessing the Report list Select the Reports key on the generic toolbar Fig 4 37 Report list 6 1 2 Report Function sequence 4 screens allows the operator to manually validate the reports Report List List of all the reports of the day Report View Review of reports in a full page mode Report Details Construction of the report with Run results Review of history Report
242. tra XL 30 2 4 Batch content When selecting the XB Batch content this will display all 20 results within that specific batch From the XB Data Grid screen see Fig 3 15 page 3 17 or from the XB Graphs see Fig 3 14 page 3 16 select the XB key to open specifically selected batch contents PENTRA XL 80 Batch Contains EH D Hi 6 l l d l i l i KIK K KI KI KI KI I lt I lt I D q TE Ji Admin 2002 05 28 14 1222 79 568 167 498 88 293 35 17 27 vy eo LS Oo 8 TITITTTTTIX te PI a Fig 3 16 XB Batch content A Maximum of 5 results may be de selected from the last batch only Select the Check Box es to de select results to be excluded from the statistical calculations The number of analyses included in the batch values is shown in the square located to the right of Selected Analysis When results are de selected from the batch the statistical val ues are automatically re calculated v Printing XB batch content Use the Print Transmit key to print out the displayed contents of the selected batch 3 18 Pentra XL 80 User Manual RAB131GEN Ouality Assurance Patient Ouality Control XB 2 5 XB limits From the XB Data Grid screen see Fig 3 15 page 3 17 or from the XB Graphs see Fig 3 14 page 3 16 select the Target key to open the XB Limits screen see Fig 3 17 page 3 19 PENTRA XL
243. tra XL 80 2 3 2 Contextual toolbar keys Heading Key Name Function Edit Insert Delete Print Tab 4 2 Function Keys 2 3 3 Grid functions Modification of an order Rack and position fields Sample ID are not modifiable Orders transmitted from the host can not be modified too Entry of a new order Rack and Position fields are not available for data entry Deletes orders except if the rack is in the process of being ana lyzed Prints worklist see 2 3 7 Printing out the worklist page 4 21 When the user selects a line of information the order details are displayed on the right hand side of the screen 025987 N 02598745 565465 3 AUTO SID1 JONES REDDING ELEONOR REDDING AUTO_SID4 ELEONOR Fig 4 9 Sorting out by title clicked Select a column description or title to sort out the items within One click for ascending order Two clicks for descending order Three clicks to restore the initial order Multiple selections are not allow at this time Only one selection at a time 4 18 Pentra XL 80 User Manual RAB131GEN 2 3 4 Order information fields Heading Button Function Worktlow Worklist description Format Rack Pos Io Ic Sample ID Type Test Button 2 WY Sample comment S MOSI wo amp Rerun Department 2 2
244. ts xx xx into the Run display screen When these Run Results are selected in the Report the CDR parameters are also indicated with brackets xx xx RDW parameter is reported to A Refer to Section 2 Specifications 3 9 CDR Mode specifications page 2 13 8 4 Pentra XL 80 User Manual RAB131GEN Annex Reagent Leaflets 2 Reagent Leaflets The CD ROM RAX055 delivered with your instrument provides Reagents Controls v and Calibrators leaflets msds Latest versions of these documents are available on www horiba abx com documentation Pentra XL 80 User Manual RAB131GEN 8 5 ABX Pentra XL 830 3 Compatible tube list 3 1 Compatible tube list for Tube holder A Tube lists given in the tables below are not exhaustive If the tubes in use in your laboratory does not match with these lists please contact your Horiba ABX service representative Warning on microsampling tubes On microsampling tubes the 100yl volume can only be used in the following conditions The tube must be held always in vertical position Blood mixing must be obtained by slight tapping on the tube Do not rotate the tube for mixing otherwise the blood will be spread on the tube side and the mini mum reguired level will be lost v Legend MAN Manufacturer BC Barcode v Tube holder position GBLO183S Standard tube holder Position 1 position 2 position 3 position 4 GBLO372S Optional tube holder Pos
245. tween the resistive and optical are less than 50 a CO flag will be indicated Suspected abnormalities e Stroma interfering with the measurement e Strong pollution e Incorrect adjustment of the optical bench v Others e From LMNE Matrix NO flag e From WBC Balance LMNE LMNE e From WBC BAS Histogram BASO 446 Pentra XL 80 User Manual RAB131GEN Worktlow Run results and associated Flags 5 3 12 Pathology messages Pathological suspicion messages will be displayed and or printed out The triggering condi tions are linked to the laboratory limits that were entered by the user These messages will indicate a possible pathological condition and should be used A to assist with quick and efficient screening of abnormal samples along with detec tion of certain conditions that lead to specific diagnosis It is recommended to use known reference methods to confirm diagnoses v WEC Messages Leukocytosis WBC gt WBC H Leukopenia WBC lt WBC L Lymphocytosis LYM gt LYM H or if LYM gt LYM H Lymphopenia LYM lt LYM Lor if LYM Yo lt LYM L Neutrophilia NEU gt NEU H or if NEU gt NEU H Neutropenia NEU lt NEU L or if NEU Yo lt NEU L Eosinophilia EOS gt EOS H or if EOS gt EOS H Myelemia NEU Yo gt NEU H and LIC gt LIC H Large Immature Cell LIC gt LIC H or LIC Yo gt LIC H Atypic Lymhocyte ALY gt ALY H or ALY gt ALY H Left Shift MN o
246. uded in the neutrophil value The Blast cells will be generally located to the right of the monocyte population and as such will increase the LIC count Small blast cells will be found between the normal lymphocyte and mococyte populations ALY Platelet aggregates and debris from RBC cell fragments are found in the background noise area at the lower left corner of the matrix Most of the cell population thresholds are fixed and give the normal limits for the normal leukocyte morphologies Changes in the morphology of a specific population will be indicated on the matrix by a shift in the corresponding population A Blast alarm is generated from increased counts within the LIC area this is correlated with the Blast detection on the Basophil histogram Large lymphocytes are usually detected in the ALY Atypical Lymphocytes zone where re active lymphoid forms stimulated lymphocytes and plasmocytes are also found as well Pentra XL 80 User Manual RAB131GEN Measuring principles 6 21 ABX Pentra XL 80 6 22 Pentra XL 80 User Manual RAB131GEN ABX Pentra XL 0 Maintenance amp Troubleshooting Contents 1 Maintenance amp Troubleshooting procedures 7 3 1 1 Hydraulic cycles maintenance chart table 7 3 1 2 Maintenance procedures sssssssesesseeetnenntananaes 7 3 1 3 Instrument general cleaning ooooooo 7 4 1 4 Instrument RIOS6 o o o oooo ooooo
247. uent availa bi Yao laba aa AR an ata aan Chap 2 Page 4 MESC OUDOT Na Na NN AP SI AS Chap 2 Page 5 Reagent consumption modification ooooWoo WWW Chap 2 Page 6 CD ROM RAX055 instead of reagent leaflets oooo ooWoWooo Chap 2 Page 15 Known interferences due to chemotherapy ooW oo WoWoW oo Chap 2 Page 16 Interferences in the platelet counting Elevated lipids and bilirubine Chap 2 Page 18 Interferences in the basophil count csscecsececsccececscescsecececsseececeeees Chap 2 Page 20 Calibration general recommendations oooo oo Chap 3 Page 25 Recommendations on the analysis mode selection ooooo oo Chap 4 Page 26 Addition of transmitted flag according to linearity limits Chap 4 Page 31 Message platelet Concentrate MOdC csscscsccecscececsscecsceecscesceceeees Chap 4 Page 31 Plt suspicion flags modification oWoooWoWoWooooWW maan Chap 4 Page 33 LMNE and WBC suspicion flag modification ooWooWooWo Chap 4 Page 34 Modification on RBC suspicion flag o oo oo WWW XX Chap 4 Page 34 Recommendations on CBC mode L1 flag o Wcom WWW Chap 4 Page 41 CBC mode limitations WBC Balance ooooo WWoroooWoWooWoW WWW Chap 4 Page 44 Platelet aggregate message conditions oooo oo Wc Woo Chap 4 Page 49 Raw COUNTS printing conditions oooooWoWoW WWW maan Chap 4 Page 67 Ra
248. ul Aperture diameter 80 um Final dilution rate 1 200 Count vacuum 200 mb Temperature of reaction 35 C Count period 2 X 6 seconds Tab 6 3 WBC BAS count v Results WBC The number of cells counted within a specified amount of time per volume x WBC co efficient of calibration BAS The number of cells counted within a specified amount of time per volume x the WBC calibration coefficient in a percentage as to the total number of leukocytes Basophils and WBC nuclei Pentra XL 80 User Manual RAB131GEN 6 17 ABX Pentra XL 80 3 3 3 LMNE Matrix count The WBC and 5 part Differential count in the flowcell are based on 3 essential principles e The double hydrodynamic slee ving DHSS which allows a linear flow of the cells through the light path HORIBA ABX patent e The cell volume which is measu rement by electrical current impedance changes e The measurement of Transmitted mun ano bancii light at a Ox angle which allows a EEEE measured response according to the internal structure of each cell and its absorbance as unabsorbed light passes through the spaces in the nuclear material of each cell This is known as diffused light 25ul of whole blood is delivered into the LMNE chamber in a tan gential flow of EOSINOFIX This reagent lyses the RBCs stabilizes WBCs in their native forms and stains the Eosinophil nuclei with a specific coloration for there measu rement in the matrix The solution is then
249. ults and shall be the respon sability of the user 7 30 Pentra XL 80 User Manual RAB131GEN Maintenance amp Troubleshooting Troubleshooting 5 Troubleshooting Y check check check D ka OK Vox OK O On Off switch Failed Proc 3 p Bottle ere Proc 3 one Replacement PY y Section 3 check check check D gt ED Vox Yo Technical operations Proc 5 See error messages check check check check check j All Parameters RBC Plt Hct WBC BASO Differential A Vox Repeatability check check PORE IN GEA MUAK NN i Flags OK OK Yo check U OK Differential Proc 11 section 4 section 4 Differential Fig 7 43 Troubleshooting guide Pentra XL 80 User Manual RAB131GEN 7 37 ABX Pentra XL 30 5 1 Instrument operation mode v Procedure 1 Printer See printer s user manual to connect to switch on off or to feed paper v Procedure 2 Reagents Bottle replacement see 2 1 2 Integrated reagents amp Diluent container replacement page 7 10 Waste container see 2 1 3 Waste container replacement page 7 15 v Procedure 3 Instrument startup Startup failed a Check all reagent s expiration dates Replace bottle if necessary b Re run a Startup cycle c Perform a concentrated cleaning see 4 3 4 Clean Cycles page 7 34 Temperature not reached a Wait for five minutes to reach the operating
250. ution width is determined according to the RBC count Nutritional deficiency or blood transfusion May cause high RDW results due to iron and or cobalamin and or folate deficiency PLT Platelets Elevated lipids and or cholesterol may interfere with correct platelet counting From patients undergoing parenteral treatment with intralipids brought it is noted an over estimate of the platelet counting which can mask a thrombopenia in DIFF mode In this case sample re run should be done in CBC mode Elevated bilirubine may interfere with correct platelet counting From patients with severe hepatic disorder liver transplant it is noted an over estimate of the platelet counting which can mask a thrombopenia Very small erythrocytes microcytes erythrocyte fragments schistocytes and WBC frag ments may interfere with the proper counting of platelets and cause elevated PLT counts Agglutinated erythrocytes May trap platelets causing an erroneously low platelet count The presence of agglutinated erythrocytes may be detected by observation of abnormal MCH and MCHC values and by careful examination of the stained blood film Giant platelets in excessive numbers may cause a low inaccurate platelet count as these large platelets may exceed the upper threshold for the platelet parameter and are not counted Chemotherapy Cytotoxic and immunosuppressive drugs may increase the fragility of these cells which may cause low PLT cou
251. utions 1 2 1 Electronic and moving parts The following parts must not be handled or checked by the user electrical Power supply electronic circuit boards Danger of explosion if battery is not replaced correctly When replacing the battery always use the same and or equivalent type recommended by the manufacturer Dispose of used batteries according to the manufacturer s specific instructions Moving parts It is strictly forbidden to disable sensors as it may cause operator injuries Protection covers must not be opened during instrument operations 1 2 2 Biological risks Consider all Specimens Reagents Calibrators Controls etc that contain human 2 blood or serum as potentially infectious Use established good laboratory work Wy ing practices when handling specimens Wear protective gear Gloves Lab coats Safety glasses and or Face shields and follow other bio safety practices as spec ified in OSHA Blood borne Pathogens Rule 29 CFR part 1910 1030 or eguivalent bio safety procedures HORIBA ABX uses disinfectant product for instrument decontamination including touch screen and highly recommends it to decontaminate your instrument refer to Section 7 1 3 Instrument general cleaning page 7 4 to perform the instrument decontamination procedure Pentra XL 80 User Manual RAB131GEN 1 3 XL 1 3 graphics and symbols Switch off position Alternating current In Vitro Diagnostic Medical Devi
252. vide a space of at least 20 cm 8 inches at the back of the instrument for arranging the power cable and tubings The Power switch and Input voltage supply connection should always be accessi ble When positioning the system for operational use leave the reguired amount of space for easy accessibility to these items Pentra XL 80 User Manual RAB131GEN 1 9 ABX Pentra XL 80 Fig 1 6 Power ON OFF switch 3 3 Grounding Proper grounding is required when installing the system Check the wall outlet ground Earth for proper grounding to the facilities electrical ground If you are unsure of the outlet ground ing contact your facilities engineer to verify the proper outlet ground 3 4 Humidity Temperature conditions The Pentra XL 80 must operate between temperatures of 16 to 34 C 61 to 93 F Maximum relative humidity should be 80 for temperatures up to 31 C 88 F and decreasing linearly to 50 relative humidity at 40 C 104 F If the system is kept at a temperature of 10 C 50 F or less it must be allowed to sit at room temperature for 1 hour before it can be used for operation 3 5 Electromagnetic environment check The Pentra XL 80 has been designed to produce less than the accepted level of electromag netic interference in order to operate in conformity with its destination allowing the cor rect operation of other instruments also in conformity with their destination Incase of suspected electromagnetic noi
253. w ooooo 1 22 5 2 RUNS amp REDON OVErVIOM memanaskan 1 23 Gene ene ee eee eer een eee et eer 1 26 Pentra XL 80 User Manual RAB131GEN 1 1 1 2 ntra XL 80 This section provides important information to get you started with Pentra XL 80 Warning and precautions page 1 2 Labels page 1 5 Operational conditions page 1 9 1 2 3 4 Software overview page 1 14 5 Workflow overview page 1 22 6 Printer page 1 26 1 Warning and precautions User manual must be enterely read and personnel trained by HORIBA ABX before attempting to operate instrument The user always operates with full knowledge and appreciation of in strument warnings alarms and flags Always refer to labeling and HORIBA ABX instructions in order to avoid to compromise system integrity The Pentra XL 80 responds to the Standards and directives named in the Declaration of Con formity added at the beginning of this manual A The reagents and accessoiries stipulated by HORIBA ABX have been validated in accordance with the European Directive for in vitro medical devices 98 79 CED The use of any other reagents and accessoiries may place at risk the perfor mance of the instrument engaging the Users reponsability In this case HOR IBA ABX takes no responsability for the device nor for the results rendered Disposal gloves eyes protection and lab coat must be worn by the operator Local or national regulations must be applied i
254. w COUNTS printing conditions oom mm maan Chap 5 Page 32 Secondary dilution principle modification o oo Chap 6 Page 4 Blank cycle and control run after reagent change ooooo oo Chap 7 Page 9 Sampling probe replacement procedure modified ooWWo W0 W Woo Chap 7 Page 17 Secondary dilution principle modification o oo Chap 7 Page 40 New Hydra lic aa ea Ng en entar aa Dnoiaira Chap 7 Page 43 Companie TUDE USL lt cencshanseeeseacccanaceseesnceeceana E T Chap 8 Page 6 Greiner Minicollect sample tube homologation o Woo oo Chap 8 Page 7 Pentra XL 80 User Manual RAB131GEN ABX Pentra XL 80 0 8 Pentra XL 80 User Manual RAB131GEN User manual content User manual content and revisions 1 Ka an inna asa ca 0 2 2 Leto no AN ee an Gan na nba 0 4 Section1 Introduction 1 Warning and precautions nenen anon 1 2 Ze We MOG an I A NN an Pan 1 5 3 Operational CONGIU One 1 9 4 one nk 1 14 De W rklow ONE Ore eng ne NN UN TIA Sit 1 22 Os PUIG ae mona ana 2 1 26 Section 2 Specifications 1 Technical socei Alona BEN an Gani ana 2 2 Aa spec ae aa en bi aa 2 5 3 Summary of performance data 2 7 4 Reagent Specifications oooo Wo Woomoc o mo 2 12 Aa esol E E E A Opp peenareeee mee napeteas 2 16 Section 3 Quality Assurance and Logs l te OUa CONTO AA ERE NA aE 3 4 Patien lity Control XB 14 2 Patient Quality Cont
255. y Assurance and Logs 3 1 Accessing the Within Run Data Grid page 3 21 are modifiable within this window Pentra XL 80 User Manual RAB131GEN 5 13 ABX Pentra XL 80 Fig 5 9 CV default values Select the EDIT key and highlight the figure you want to modify Enter the new value and select the OK key 5 14 Pentra XL 80 User Manual RAB131GEN Settings Rules 4 Rules 4 1 Accessing the Rules screen From the Settings window select the Rules key C Manual Validation Unconditional Validation AeA eae ees maces K K A KK K Ky A A A K K K A KI KI KI KI XA Q K K KI 4 dy mumm m m M m a a a a U CE G U N S E E IKI KI KI 0 KI Kl mm m m m a a m m m m m a a ooo oe eee S Fig 5 10 Accessing the Rules screen The Rules screen includes four tabs which will enable the operator to configure the follow ing conditions Biological validation conditions see 4 2 Biological validation conditions page 5 15 Rerun conditions see 4 3 Rerun conditions page 5 17 Print conditions see 4 4 Print and transmit conditions page 5 21 Transmit conditions see 4 4 Print and transmit conditions page 5 21 and to adjust the sensitivity of the Delta Check flags see 4 5 Setting Delta check page 5 22 4 2 Biological validation conditions In this tab see Fig 5 11 page 5 16 the user has the option to enable or disable the au

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