Home

User Manual

Contents

1. nnne 48 2 Menus Eeer 49 3 Software Icons Description eusnnsnsnnsnenennnnnnnnnnnernnnnnnnnernnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn 50 4 Software Functionalities eee remar eere me rereree rare re rr seserananes 52 5 Worklist Keyboard Shortcuts e e eere eeee ese te tete tease sanata anas ranas 54 User Manual 47 Ref RAB271AEN Software Software Overview Pe ntra ES 60 1 Software Overview A software application is installed on the Workstation which is connected to the Pentra ES 60 Worklist Run QC and Calibration Logs Analyzer Seq H Sample ID Patient Number Patient Name Gender D 0 B Test Running Date 16 ftes DIF 11 07 2008 01 43 42 PM RBC 108 mm 4 68 SA WBC 109 mm 5 0 J Baso E HGB g dl 138 HCT II 411 337 1 67 0 38 MCV um MCH pg 23 7 7 6 ra e MCHC g dl 33 8 27 0 13 0 4 11 05 RDW 122 PLT 103 mm3 1249 0 06 MPV ums 53 i PCT 4 0232 2 Analyzer Alarms Suspected Pathology PDW Il 16 0 Morphology Flags 0 02 5 12 16 2008 04 07 26 PM The Pentra ES 60 application includes the following items 1 A Menu Bar which allows you to navigate in menus described in the Menus Description chapter 2 AToolbar with functions related to the displayed screen 3 The Content area depending on the selected menu
2. 1 Open the Archives window Access File gt Open Archive This one includes the list of all archived worklist and the total number of analyses Archives 03 23 2008 09 49 27 09 30 2008 10 21 16 10 13 2008 09 33 09 10 14 2008 14 46 47 10 14 2008 14 52 01 10 15 2008 15 19 44 10 30 2008 10 31 2008 08 14 45 11 06 2008 14 53 43 11 07 2008 09 19 59 0 0 0 a 0 5 0 0 0 0 6 2 Select the date and the worklist you want to display Click OK 3 Select File gt Close Archive to close the archived worklist and display the current one User Manual Ref RAB271AEN See also To Create a New Worklist p 88 To Print your Worklist p 92 Running Blood Specimen p 93 Worklist Overview p 86 Worklist Icons Description p 88 Worklist Keyboard Shortcuts p 54 91 Workflow Worklist 3 6 92 To Print your Worklist Pentra ES 60 D Print your list of orders to prepare your series of analyses Access Worklist gt Print Selected Area icon Your list of orders have been previously entered or received from the LIS You have selected orders to print see Worklist gt To Select the Order to Run chapter Open the Print window and click Worklist tab Print Run Results QC amp Calibration Logs EI Do You Want To Print The Worklist EE Selected B All X Cancel d LW MES EE Click Selected if you want to print only selected orders Cli
3. See also m Cycle Option p 135 User Manual 79 Ref RAB271AEN Workflow Running Quality Control Blood ES 2 1 80 2 Running Quality Control Blood To Identify a Control Blood with the Barcode Reader Access Main screen Worklist tab m The instrument has to be ready for analysis m The control specimen must be identified with a barcode label m Thelot number and target values have been previously defined Make sure your control lot has been checked in the Reserved Barcode Choice list of the Setting QC and Calibration menu To know more about control blood lot initialization see the Quality Assurance Quality Control chapter q ABX Difftrol this control material is specifically designed for use on Pentra ES 60 which 4 includes a complete blood count and a 5 part WBC differential CBC amp DIF 1 Click Add New Entry 2 Read the sample s barcode label with the barcode reader The lot number is displayed in the Sample ID field User Manual Ref RAB271AEN Workflow Pe ntra ES 60 Running Quality Control Blood D BE See dl P aa Worklist PX118N 3 Click the Run tab The control lot number is displayed The instrument is ready to run your control blood See also To Create Modify a Control Lot p 58 To Export Quality Control Data p 59 To Identify a Control Blood without Barcode Reader p 81 To Run a Control Blood p 82 To Check Control Blood Re
4. 2 Ifthe temperature still does not increase please contact your local HORIBA Medical representative Analysis Cycle Problems m Check if technical problems occur during analysis cycle m Control the sampling operations m Control the dilution operations 2 2 1 Sampling Operation Control D Follow this procedure if you detect a problem on sampling 1 Open the pneumatic access door 2 Check the motion of the needle go in Service gt Mechanical Systems gt Check Motors tab and click Sampling Needle The movements should be smooth and regular 3 Check that the needle is not bent If it appears to be bent replace it 4 Check the motion of the sampling syringe go in Service gt Mechanical Systems gt Check Motors tab and click Sampling Syringe The movements should be smooth and regular if not please contact your local HORIBA Medical representative 5 Shut the pneumatic access door Run an analysis and control the blood specimen aspiration See also m To Check Motors p 171 m To Replace the Sampling Needle p 181 User Manual Ref RAB271AEN Maintenance and Troubleshooting Pe n t r a ES 6 O Troubleshooting Procedures 2 2 2 To Replace the Sampling Needle D Follow this procedure to replace the sampling needle 1 Run a Maintenance Carriage Position cycle go in Service gt Mechanical Systems gt Maintenance Carriage Position tab and click Run 2 Switch off the instru
5. 56 1 MEINAero iiem 56 1 2 To Create Modify a Control Lot iren rtt ride de f SSES See 58 1 3 To Export Quality Control Data ri itti itio eter to ti ro End iet anre p eeu dada 59 2 Patient Quality Control XB LLLI LI eese eese maa aate ana mamamus 61 2 1 Patient Quality Control XB Overvlew nennen nennen nnne nennen nnns 61 2 2 TO Modify CH I c do 63 ME EU CE ccm 64 3 1 Repeatability e 64 3 2 TO Perform a Repeatability sis 21 itr n tret Est eeh copiada Ree d Lect Resp EES EARN RES 65 E AU mM 66 4 1 Calibration OvervIGW isisasssiasisgasasesgsingoddpesga faia daphado fusl can asd sent SERA SE deefe Ee ee eg 66 4 2 General Recommendati ris i ex bere iet P Ee EX Ea Etha EX ya resa iE PRA ERES 67 4 3 To Calibrate th Instrument oiii retinerent TAR 68 4 4 To Create Modify a Calibrator lot 70 DE EO TC a a 71 E ee ee s 71 DA NOVA a New EMtiyis ccs ege ee gees eege ee dE eege 72 User Manual 55 Ref RAB271AEN Quality Assurance Quality Control Pentra ES 60 1 1 56 1 Quality Control Quality Control Overview Access Main screen gt QC and Calibration tab gt Controls tab The Quality Control QC allows to monitor a set of analyses based on known sample values and ranges over a period of several months Statistical computations performed on the
6. Description and Technology Measurement Principles ES 204 Results From the Absorbance and Resistive measurement of the leukocytes 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 percentage of Basophils in comparison to the rest of the leukocytes they have a separate measurement and their own matrix Cells description m LYMPHOCYTES The lymphocyte is a very small round shaped cell with condensed cytoplasm and large nucleus This cell is normally positioned in the lower part of the Y axis as well as the lower part of the X axis because of its small size The far left side of the lymphocyte area LL should normally be empty Any detection of cells in the LL area indicates Small lymphocytes Platelet aggregates NRBCs Nucleated Red Blood Cells and or improperly adjusted flowcell alignment Background noise may also be detected in this area if the interference is important m MONOCYTES The monocyte is a very large irregular shaped cell with large convoluted nuclei The nucleus contains folds and sometimes vacuoles The cytoplasm is also large with non granular intra cellular material This cell does not scatter or absorbs a large amount of light when passing through the flowcell It is positioned in the lower part of the Y axis Because the monocyte is a large cell it is positionned o
7. NEU NEU MON and MONH are reported to Suspected abnormalities m Monocytes having granules in their cytoplasm or hyperbasophilic monocytes m Young neutrophils with non segmented nuclei bandcells Values for MN Standard type are 96100 and 120 These flag values can be defined for each blood type in Setting Type Parametering Alarms and Curve Thresholds tab User Manual 113 Ref RAB271AEN Workflow Results Interpretation nm db nam AM nra ES 60 6 2 3 11 NE flag Neutrophils Eosinophils Presence of a significantly large population of cells located in the separation area between neutrophils and eosinophils because of a superimposition of the two populations The neutro eosino flag appears when the number of counted particles in this area is higher than the limit set up in NE or when the number of counted particles regarding the total number of WBC is above the NE limit This flag is associated with an on LIC and LIC NEU NEU EOS and EOS are reported to Suspected abnormalities Young eosinophils Giant hypersegmented neutrophils Eosinophils with low intracytoplasmic material Immature cells Neutrophils with cytotoxic granulations Values for NE Standard type are 1 1 and 60 These flag values can be defined for each blood type in Setting gt Type Parametering gt Alarms and Curve Thresholds tab 6 2 3 12 NO flag Background Noise This flag occurs when the numbe
8. REFER SERVICING TO QUALIFIED SERVICE PERSONNEL DISCONNECT THE SYSTEM FROM SUPPLY BEFORE SERVICING USE ONLY WITH CORRECT POWER VOLTAGE REPLACE ONLY WITH SAME TYPE AND RATING OF FUSE Power Supply Connection ES The Power switch and Power supply connection should always be accessible When positioning the system for operational use leave the required amount of space for easy accessibility to these items User Manual Ref RAB271AEN Introduction Pe ntra ES 60 Labels and Connections 1 Power supply connector 2 ON OFF switch 3 3 Diluent and Waste Connections 1 ABX Diluent input 2 Waste output A Waste must be handled according to your local and or national regulations User Manual 19 Ref RAB271AEN Introduction Labels and Connections Pe ntra ES 60 3 4 Peripherals Connections 1 Barcode reader not used a 2 Printer not used 3 Serial port RS232 Printer and barcode reader have to be connected to the Workstation s USB ports See Computer Connections chapter All peripheral devices should comply with relevant standards 20 User Manual Ref RAB271AEN Introduction Pe ntra ES 60 Labels and Connections 3 5 Computer Connections 1 USB Keyboard Mouse Printer Barcode reader 2 Monitor 3 Serial port used used for instrument connection 4 Hi speakers not used 5 Serial port used for LIS connection 6 Power Supply
9. Type parametering Alarms and Curves Thresholds tab You have already defined a new type or you want to modify an existing one Each flag is adjustable according to a percentage and an absolute value Flags are triggered off according to these values see Workflow Results Interpretation chapter 1 Select the type you want to modify in the list 128 User Manual Ref RAB271AEN Settings Pentra ES 60 LE 1 3 Standard NL 29 NO 100 120 RMN 51 Standard LL 100 50 NE 82 2 Man L1 5 45 FLN 2 3iWomn NL 3 120 FNE 2 AlNewon MN 100 120 FMN 2 Santo RM 11 333 NOL 22 6Chid LN 25 999 NON 25 EINEN RN 11 999 LL 30 8 NE 14 60 LN 35 E u 4 600 NOE 48 10 LMN 70 11 iv AL 68 AN LMU 78 LMD 30 MN 30 50 3 RM 118 5 50 RN 118 45 D 2 Click Modify Enter the password and change the value in the Alarms levels or Curves And Matrix Thresholds table 4 Click Accept to validate Parameters D m Define differential order m Disable enable RUO parameters Results differential order can be set either to LMNEB or NLMEB RUO Parameters can be enabled or disabled when data is printed or transmitted Select RUO Warning option if you want to generate a warning on these parameters User Manual 129 Ref RAB271AEN Settings Setting Menu Pentra ES 60 United States for this instrument Their use should be re
10. User Manual 61 Ref RAB271AEN Quality Assurance Patient Quality Control XB Pe ntra ES 60 LI E gt Batch s Running Date 11 07 2008 10 43 28 AM Ze For each parameter a curve is displayed A point on a curve represents the mean value of the batch 20 runs It is possible to move the marker vertical line to switch from one batch to another This changes the batch number in the Batch field and the batch results on the right To move the marker you can either m click and drag m use the keyboard left and right arrows Each parameter has a normal value in black a high limit in red and a low limit in blue If a mean value of a batch is higher or lower than the limit set up by the user the points of the curve then turn to red or blue Batch Contents The Batch Contents window gives the 20 results of the selected batch Batch Contents RumingDate wec nec nos hcr mcv Ter mch mche 45 05 20 2008 15 25 05 20 2008 15 23 55 05 20 2008 15 31 54 05 20 2008 17 13 67 05 22 2008 14 35 76 05 22 2008 14 40 5 0 05 22 2008 14 41 83 05 22 2008 14 44 8 2 05 22 2008 14 46 51 05 22 2008 14 47 3 4 05 22 2008 14 48 68 05 22 2008 14 50 71 05 22 2008 14 51 66 05 22 2008 14 52 9 6 05 22 2008 14 53 75 05 22 2008 14 55 05 23 2008 03 46 49 05 23 2008 03 47 8 0 05 23 2008 09 48 3 3 05 23 2008 03 50 65 To open the Batch Contents window m Click Batch Contents in the XB Graph window or 62 User Manual Ref
11. et e EXE 03 50 470 138 422 309 295 328 123 2 03 15 2008 14 18 455 133 412 S 305 295 329 123 3 09 29 2008 11 23 62 um 134 mi a 34 307 333 123 4 10 23 200815 24 55 434 130 402 a 3 304 327 1724 5 10 30 2008 10 26 539 429 130 389 a 2 8 309 350 122 6 10 30 2008 1456 amp 5 450 130 399 e 24 287 324 124 710 301 2080958 75 469 145 424 a 272 299 335 124 8 10 31 20081403 71 486 150 439 90 28 307 34 121 9 11 07 2008 104364 457 139 412 9 269 307 340 124 Modify Limits sc Imc Jee uct Icy Jos Iw MCHC Upper Linits TEL E cR TON CNN 7730 Lower Linits A 400 ND 400 8 20 270 320 20 This quality control does not require any intervention from the operator nor the running of any specific controls The statistical calculation includes all patient results that does not contain analysis default When 20 results have been archived a batch is calculated A batch is the mean result for 20 analyses contained in that specific batch The XB alarm occurs when the calculation of the last batch shows a point located outside of the limits set by the operator displayed on the top right hand side of the XB main screen This alarm can be disabled in Setting gt QC and Calibration menu 60 batches can be recorded After 60 batches each new batch overwrites the oldest one XB Graph The XB Graph is a graphical representation of the XB batchs Click XB Graph to display it
12. 3 Click OK to validate The Pentra 60 Range Workstation window is displayed 120 User Manual Ref RAB271AEN Workflow Pentra ES 60 EDS 7 3 4 Log in with a new user account as described in Workflow gt Start of Day gt To Log in the Application chapter See also m To Log in the Application p 76 Stopping the Instrument 7 3 1 To Perform a Shutdown D Perform an instrument shutdown before ending your work session Access Main screen gt Shut Down icon The main screen has to be displayed 1 Click Shut Down 2 Wait during shutdown cycle Once the shutdown is completed the instrument can be switched off 7 3 2 To Switch Off the Instrument D Switch off the instrument and workstation at the end of the day A shutdown cycle must have been performed 1 Click Quit to quit the application 2 In the ABX Workstation Logout window choose the Quit Application option User Manual 121 Ref RAB271AEN Workflow End of Day Pentra ES 60 ABX Workstation Logout Change Operator Quit Application Click OK to validate Wait during application is closing The computer is restarting When the Log On to Windows window is displayed click Shut Down then click OK to validate o m io Switch off the instrument 7 3 3 To Switch Off the Printer D Switch off the printer at the end of the day 1 Check that no printout has been launched 2 Switch off the p
13. 7 Ifthe startup passed if instrument is clean blank cycles in conformity with the target values if repeatability is correct and the values are still out of the acceptable limits then carry out a calibration See also Precision Claims p 31 To Perform a Manual Startup p 78 To Perform a Concentrated Cleaning p 167 To Perform a Repeatability p 65 To Run a Control Blood p 82 Calibration Overview p 66 QC and Calibration p 124 To Calibrate the Instrument p 68 To Create Modify a Calibrator Lot p 70 4 3 To Calibrate the Instrument D Perform a calibration of your instrument Access Main screen gt QC and Calibration tab gt Calibration tab You must have performed the tasks described in Calibration gt General Recommendations chapter Q To calibrate the instrument use the ABX Minocal calibrator A 1 Select the calibrator from the Lot Number list If the calibrator is not listed see To Create Modify a Calibrator Lot chapter 2 Prepare the calibrator according to the specific instructions detailed in the calibrator package insert temperature mixing etc 3 Run the calibrator The instrument LED has to be green free tissue to prevent dried blood from re entering into the calibrator material Dried blood re entering into the vial may cause erroneous results such as flags and sample runs rejects Always wipe any excess blood from the cap and threads of the calibra
14. Access Setting gt QC and Calibration Reserved Barcode Choice Select the automatic checkboxes of the barcodes associated to the QC lots to automatically assign the results of these lots treatment and archiving in the QC or Calibration menu the row turns to green when selected If not selected the use of this barcode has no effect on the passage of the cycle The result then switches to the routine environment CV Max 96 Adjustment of the QC Repeatability and Calibration admissible Coefficients of variation expressed in 96 Q Variation coefficients calculation for each parameter is done with unrounded values 4 XB Options m XB Activates On or deactivates Off XB function m Mode three parameters Bull MCV MCH and MCHC or nine parameters WBC RBC HGB HCT MCV MCH MCHC RDW PLT User Manual Ref RAB271AEN Reserved Barcode Choic CONTROL 1 CONTROL 2 CONTROL 3 CONTROL 4 CONTROL 5 CONTROL 5 ONTROL 7 CONTROL 8 CONTROL 9 CONTROL 10 CONTROL 11 CONTROL 12 CALI 1 CALI 2 CALI 3 CALI 4 CALI 5 Vv Ive Iv Iv Vv r mi r Vv r Vv Vv Vv Vv P r r 1 2 Type Parametering QC29N QC23H QC33L QC33M QC33H Cx359 KRI CAL21H CAL45L CAL45M Settings Setting Menu XB Options XB C On Off Mod C Bul 9 Param D m Define Blood types m Assign a set of pathological limits alarms levels matrix thresholds to each type Assigning a typ
15. Active icon Deactivated icon Tooltips Dropdown lists Check boxes Radio buttons Data fields Scroll bars 52 Icons are not always effective depending on the screen currently displayed and instrument status An active icon is darker A deactivated icon is lighter A tooltip is a short piece of information about an icon or an area Place your mouse pointer over a key to display a tooltip A drop down list is a list of predefined items Select one item from the list to select it Only one item can be selected from the list Check boxes are options you can select Click the check box to select the option Several options can be selected in a list of check boxes Radio buttons are options you can select Click the radio button to select the option Only one option can be selected in a list of radio buttons Data fields can have a predefined format like a date field or can be empty Use the keyboard to enter data Scroll bars can be either vertical or horizontal Use it to display hidden parts of the screen or a list Lot Number Ex028 ly Range I Raw Values Iw Histogram and Matrix Calibration Users Lot Number CX118 IB Standard 2 Man 3 Woman 4 Newborn 5 Infant 6 Child User Manual Ref RAB271AEN Software Pe n t ra ES 6 O Software Functionalities Calendars User Manual Ref RAB271AEN ER December Mon Tue Wed Thu Calendars help you to select a da
16. Delete deletes selected result file s in the View patient results screen Zoom IList switches from list screen to View Patient Results tab mi Previous File displays previous results in the list gt Y Next File displays next results in the list U V Validate Sample validates a sample that does not need a rerun Rerun Sample programs rerun of a non validated results E User Manual Ref RAB271AEN 99 Workflow Results Management Pentra ES 60 5 3 To Search Patients Results D Search results for a known patient in current worklist or archived worklists Access Main screen gt Results tab gt View Patient Results tab You must know Patient Number or Patient Name or Sample ID ER 2 3 100 Enter in Results View Patient Results tab File Service Setting HE EI dM ee gl Worklist Run QC and Calibration Logs Analyzer Patient Sample ID zl C Patient Number Patient Number Birthdate Patient Name ha 05720 1977 KE y Sample ID Patient Name Gender fr bob z M Running Search Seat op sampeiD gt 1 cD 1 bob 123 CBC Homme 03 2 Mi tsm gt All The Results MT TEE Select one option Current Worklist or Archived Worklist In the Search criterion area a Select the item you want to search on Patient Number Patient Name or Sample ID b Type in data to search c Click Running Search If results match with the
17. Numeric Integration MCV MCH MCHC RDW PDW PCT MPV Calculation Units CBC Parameters Standard SI international 103 mm 109 L 109 L 102 mm RBC 10 mm 10 2 L 1012 L 104 mm HGB g dL g L mmol L g dL HCT L L L L 96 MCV um fL fL um MCH pg pg fmol pg MCHC g dL g L mmol L g dL RDW 96 96 96 96 PLT 103 mm 109 L 109 L 10 mm PDW 96 96 96 96 PCT 96 102 L 102 L MPV um fL fL um LYM 10 mm 109 L 109 L 102 uL LYM MON 103 mm 109 L 109 L 102 uL MON NEU 103 mm 109 L 109 L 102 uL NEU EOS 103 mm 109 L 109 L 102 uL EOS User Manual Ref RAB271AEN Specifications Pe n t ra ES 6 O Technical Specifications User Manual Ref RAB271AEN DIF Parameters Standard SI international BAS 10 mm 109 L 109 L 102 uL BAS 96 96 96 ALY 10 mm 109 L 109 L 102 uL ALY 96 96 96 96 LIC 103 mm 109 L 109 L 10 uL LIC 96 96 96 96 PDW PCT ALY ALY LIC LIC96 have not been established as indications for use in Q United States for this instrument Their use should be restricted to Research Use Only RUO 4 Not for use in diagnostic procedure See also m Units and Language p 136 27 Specifications Physical Specifications ES 2 1 2 2 2 3 2 4 28 2 Physical Specifications Power Requirements Power supply from 100 V to 240 V 10 50 Hz to 60 Hz Maximum power consumption 400 VA Instrument and workstation Ma
18. Ifit needs to be emptied refer to the Maintenance and Troubleshooting gt Maintenance gt To Replace the Waste Container chapter 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 m Atthe beginning of each day before startup check if the waste container needs to be emptied m During instrument operation do not remove the reagent tubes and the liquid waste tube under any condition A Waste must be handled according to your local and or national regulations See also m To Replace the Waste Container p 164 m Waste Handling Precautions p 40 1 2 To Switch On the Printer D Start the printer at the beginning of the day Check if the printer has enough paper for daily operations If not add some paper following the instructions of the printer s user guide 1 Press the ON OFF switch 2 Wait during printer s initialization 74 User Manual Ref RAB271AEN ES 3 Check that the control LEDs are on If the printer does not work properly refer to its user guide Workflow Start of Day See also m Printer Operation Problems p 178 m Printer p 22 1 3 Starting the Instrument 1 3 1 To Switch On the Instrument D Switch on the instrument and workstation at the beginning of your work session Before switching on the instrument and workstation ch
19. RAB271AEN Quality Assurance Pe nt ra ES 60 Patient Quality Control XB m Doucle click on a batch row in the XB main screen See also m QC and Calibration p 124 m XB Limits p 152 m To Modify XB Limits p 63 2 2 To Modify XB Limits D Modify the XB values and the permissible margin for each parameter Access Main screen gt QC and Calibration tab gt XB tab The XB main screen must be displayed 1 Click Modify Limits The XB Limits window is displayed XB Limits Modified On 0 tb 102 mm da 500 j 00 105 mm g di f po ho Em f fo um 4J 100 109 mm 20 pg J 20 od po x X Cancel 2 Change the values and the permissible margin of the parameters you want to modify 3 Click Accept to validate See also m Patient Quality Control XB Overview p 61 m QC and Calibration p 124 m XB Limits p 152 User Manual 63 Ref RAB271AEN Quality Assurance Repeatability 3 1 64 um d E P ntra ES 60 3 Repeatability Repeatability Overview Access Main screen QC and Calibration tab Repeatability tab The measurement of repeatability is based on a set of results obtained from consecutive analyses of the same human fresh normal blood sample At first the message Results Will Be Erased Please Confirm is displayed If you click OK the current list is deleted If you want to keep it click Cancel File Service S
20. Ref RAB271AEN Pentra ES 6o Specimen distribution in the chambers is carried out in a tangential flow of reagent which allows perfect mixing of the dilution and avoids any viscosity problems this multi distribution in a reagent flow is HORIBA Medical patent 2 2 Red Blood Cells and Platelets Detection 2 2 1 Detection Principles User Manual Measurement of impedance variation generated by the passage of cells through a calibrated micro aperture The specimen is diluted in an electrolytic diluent current conductor and pulled through the calibrated micro aperture Two electrodes are placed on either side of the aperture Electric current passes through the electrodes continuously When the cell passes through the aperture electric resistance between the two electrodes increases proportionately to the cell volume Ref RAB271AEN Description and Technology Measurement Principles 197 Description and Technology Measurement Principles 198 1 Voltage peaks for RBC and PLT m Thegenerated impulses have a very low voltage which the amplification circuit increases so that the electronic system can analyze them and eliminate the background noise m Results Number of cells counted per volume unit X calibration coefficient RBC histogram Distribution curves on 256 counting channels from 30 fL to 300 fL 2 Analogue conversion for RBC 3 Data integration and plotting of RBC distribution curve P
21. Select blood profile Standard Male Female Child default is standard using drop down list Choose a physician name from one dynamic list or add a new name 17 characters max Enter date and time of blood collection in MM DD YYYY HH mm Operator field is automatically updated by the name of the operator who starts the instrument Use this field to enter comments 50 characters max Color code of the worklist screen User Manual Ref RAB271AEN Blank This routine analysis is pending Red This analysis is currently running Green This routine analysis has been done Blue This Analysis such as QC Calibration Repeatability or blank is pending Pink This Analysis such as QC Calibration Repeatability or blank has been done already See also Worklist Icons Description p 88 Worklist Keyboard Shortcuts p 54 To Create a New Worklist p 88 To Open Archived Worklist p 91 To Print your Worklist p 92 Running Blood Specimen p 93 87 Workflow Worklist 3 2 Worklist Icons Description ES K E EN IO A Print Selected Area prints selected or all order files in a line mode Add New Entry creates a new order file Delete deletes order files that have not been run yet Display Search Screen Zoom IList switches from chart screen to Order Entry screen also accessible by double clicking the entry Previous File displays previous order in the list Next File displays
22. To Create Modify a Control Lot D m Create a new control lot m Modify an existing control lot Access Main screen gt QC and Calibration tab gt Controls tab The control lot you need is not in the Current Target list or the target values have to be modified 1 Select a control lot from the Current Target list 2 Click Modify Target The Target Values window is displayed Target Values Current Target r Cbe Values r Dif Values WBC rs f 10 103 mm LYM 23 0 60 VU A RBC jus 4p fats 108 rnm 15 h 15 Barcode HGB 42 05 g di 62 5 f 100 bat HCT faos 20 x 35 3 0 Expiration Date MCV fes ala um 35 st iteram PLT 242 30 103 mm3 218 f 0 70 MCH fess j 20 pg 0 12 f 0 12 mmm 48 f 30 g di 4 69 0 30 i26 j 40 Si 0 26 f 024 Jes 20 um 0 26 j 0 24 Threshold ES A Accept _ Floppy dick Q The DIF Values area and the Threshold button are displayed only if the control lot is a 4 DIF one The threshold values are protected with a password 58 Ref RAB271AEN Quality Assurance Pe nt ra ES 6 O Quality Control 3 Insert the floppy disk provided with the control specimen if you do not have a floppy disk enter manually the values for each parameter the lot number the barcode and the expiration date detailed in the control package insert The QC Target Level window is displayed QC Target Level C Medium C High wv OK X Cancel w If y
23. cannot be restored To have a report of your current settings before saving or restoring click Print Current Setting User Manual 137 Ref RAB271AEN Settings Setting Menu Pentra ES 60 1 4 8 Users D Create modify or delete a user account To make the User Details fields active click Create New User or Modify User for a selected one Delete User deletes the selected user entering its password m The maximum length is three characters for Login and seven characters for Password m ABX user account can be modified but cannot be deleted 1 5 Restricted These settings are restricted to HORIBA Medical technicians 138 User Manual Ref RAB271AEN Settings Pe nt ra ES 6 O Database 2 Database 2 1 To Save Database D Save the current instrument database on hard disk Access File gt Backup Database Q It is recommended to save your database regularly to secure data A 1 Open the Backup Database window 2 Type ina file name and click Save to start backup Backup Database Save in O Backup Eich EM S base0102 MDB B base1 101 MDB 7 201 MDB Save as type Database files mdb zl Cancel When the backup is over a message is displayed to confirm it In order not to exceed the hard drive capacity it is recommended to use the same file name for every backup previous backup is then overwritten Contact your Jj HORIBA Medical repr
24. gt lt HL ums ox e Du Limits m pas OI F Female M Male U Unknow 01 29 2009 15 18 09 1 Suspected Pathologies 2 Morphology flags 3 Analyzer alarms 4 Grayscale code for results Out of Panic limits Out of Normal limits or Rejected results More about alarms in Workflow Results interpretation chapter 102 User Manual Ref RAB271AEN Workflow Pe ntra ES 60 Results Management 5 4 2 Line Mode Printout HORIBA Medical Parc Euromedecine Montpellier Contact Tel 04 67 14 15 16 Fax 04 67 14 15 17 Patient Number Patient Name Gender Op ABX Seg Sample ID po HB HT VGM TGMH CCMH IDR PLA VMP THT LYM MON NEU EOS BAS LYM EOS BAS LYA GCI LYA GCI ate 06001 11 07 2008 10 36 53 189 88 5 335 129 287 87 0206 14 3 5 d K x 010 002 1 0 07 06001 11 07 2008 10 39 11 140 E 89 7 335 130 243 1 002 2 0 06 06001 19 07 2008 10 40 57 7 140 H 88 9 339 130 234 x x 7 E 3 002 2 0 03 06001 11 07 2008 10 43 28 13 9 88 335 129 234 X x 004 06001 18 07 2008 10 45 27 Y a X E 88 7 337 129 236 84 T T T T Y H 0 04 gt HI Limits gt lt hil Limits OXXX Reject XXX F Female M Male U Unknow Page 1 Printed 12 03 2008 11 39 50 5 5 To Send Results to the LIS D Send your results on request to the LIS Laboratory Information System Access Main screen gt Results tab gt Send Selected Area icon Q After each analysis cycle results are automatically sent to the LIS according
25. myelocytes and promyelocytes will all be classed as LIC and there given results will be included 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 monocyte populations ALY Platelet aggregates and debris from RBC cell fragments are found in the background noise area at the bottom 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 area where reactive lymphoid forms stimulated lymphocytes and plasmocytes are also found User Manual Ref RAB271AEN Pentra ES 60 Glossary 1 Glossary of TSlTIIS se ssa dd cate nicotene ented ce User Manual Ref RAB271AEN 205 Glossary Glossary of Terms ES 1 Glossary of Terms Accuracy Ability of the instrument to agree with a predetermined reference value at any point within the operating range closeness of a result to the true accepted value Analysis Field of Interval of concentrations or other quantitie
26. please contact your local HORIBA Medical representative 2 1 2 Workstation Login Problem D Follow this procedure if you have problems logging in the Workstation application 1 Log in with ABX account no password is needed If you cannot log in with ABX login please contact your local HORIBA Medical representative 2 Ifthe application starts verify that your account is in the Setting gt System Setting gt Users menu 3 If your account is not in the list create a new user account See also m Users p 138 2 1 3 Workstation Communication Problem D Follow this procedure if the Workstation cannot communicate with the instrument You cannot run any cycle from the Workstation application 1 Verify the connection to the instrument Instrument RS232 output to Workstation See Introduction gt Peripherals Connections chapter 2 Verify that the instrument is switched on 3 Try to run an Autocontrol cycle If you still cannot run any cycle please contact your local HORIBA Medical representative 2 1 4 Printer Operation Problems D Follow this procedure if the printer does not work 1 Check that the printer power cord is connected properly 2 Switch off and on the printer 178 User Manual Ref RAB271AEN Maintenance and Troubleshooting ES Troubleshooting Procedures 3 Check the paper feed Refer to your printer s user manual 5 Check the printer s configuration in Se
27. tab Unit Select the unit system you want to use More information about units in Specifications gt Technical Specifications gt Units chapter 103 mm3 108 mm g di Language Options Select the language you want to use Click Close to confirm The Workstation is shut down when configuration is changed Keyboard Properties reserved to HORIBA Medical technicians See also m Units p 26 136 User Manual Ref RAB271AEN Settings Pentra ES 60 seking venu 1 4 6 Analyzer ID m Enter the instrument Serial Number in the workstation software D m Choose maximum number of records in database m Choose number of records to delete in database Access Setting gt System Setting gt Analyzer ID tab S N is the Serial Number of the instrument In the Database setup area Max Number of TERRE Records is the maximum number of records that can be stored in the database from 5000 to 10000 Once this number is reached the number of records to delete can be set in the Number of Results to Delete field from 500 to 1000 1 4 7 Setting Save Restore D m Save analyzer or workstation settings on hard disk floppy drive m Restore saved settings on the analyzer and workstation Access Setting System Setting Setting Save Restore tab Restoring settings do not impact current users accounts users which have been deleted
28. 11 5 37 0 77 24 0 32 0 11 0 200 6 0 15 11 0 0 0 0 0 1 80 1 50 13 5 5 40 14 5 45 0 91 30 0 36 0 16 0 400 11 0 50 18 99 9 99 99 9 99 9 99 9 8 00 6 50 0 8 0 60 15 0 5 40 15 0 45 0 93 30 0 36 0 17 0 450 12 1 00 20 99 9 99 9 99 9 99 9 99 9 8 00 6 50 0 8 0 60 145 Settings Instrument Default Settings Pe nt ra ES 60 Parameter Panon Noman Norman Panon 0 BASS 0 0 20 0 30 ALY 0 0 2 5 2 5 LIC 0 0 3 0 3 0 ALY 0 0 0 25 0 25 LIC 0 0 0 30 0 30 3 2 Alarms Levels Standard DECHE NO 100 80 LL 100 80 LL1 5 55 NL 3 120 MN 15 120 RM 0 7 999 LN 2 5 999 RN 1 1 999 NE 1 1 30 L1 3 200 LMNE reject 50 MIC 5 MAC 45 HGB 3 60 Man arm evase leen RN NO 100 80 LL 100 80 LL1 5 55 NL 3 120 MN 15 120 RM 0 7 999 LN 2 5 999 RN 1 1 999 NE 1 1 30 L1 3 200 LMNE reject 50 MIC 5 MAC 45 146 User Manual Ref RAB271AEN Settings Pe ntra E amp 60 Instrument Default Settings am ee len HGB 3 60 Woman m e 2 OOOO NO 100 80 LL 100 80 LL1 5 55 NL 3 120 MN 15 120 RM 0 7 999 LN 2 5 999 RN 1 1 999 NE js 30 L1 3 200 LMNE reject 50 MIC MAC 45 HGB 3 60 Child 1 from 1 day to 1 month old DEEN NO 100 80 LL 100 80 LL1 5 55 NL 3 120 MN 15 120 RM 0 7 999 LN 2 5 999 RN 1 1 999 NE 1 1 30 L1 3 200 LMNE reject 50 MIC 5 MAC 45 HGB 3 60 Child 2 from 1 month to 2 years old am eee Te NO 100 80 LL 100 80 LL1 5 55 NL 3 120 MN 15 120 User Manual
29. 156 Repeatability 31 64 Reproducibility 30 Reserved barcode choice 124 Restoring settings 137 Results problems 183 Results Printing 101 Sending to LIS 103 Right monocytes 112 Right neutrophils 112 RM flag 112 RN flag 112 RS232 settings 131 Run menu 96 Sample carriage cleaning 169 Sampling needle replacement 181 Sampling syringe 193 Saving settings 137 SCL flag 108 119 Selecting Orders to run 93 Sending results 103 Serial number 137 Serial Number label 18 Settings Alarms and Thresholds 128 Pathological limits 127 Restoring 137 Saving 137 Shortcuts 54 Shutdown 121 166 Small cells 108 119 Small erythrocytes 44 Software Icons description 50 216 ES Overview 48 Specimen Volume 28 Stability 35 Startup 78 Storage Conditions 16 Switching off Instrument 121 Printer 122 Switching on Instrument 75 Printer 74 Symbols definition Caution 8 Danger 8 Nota 8 Target 8 Syringes Park position 173 Technical characteristics BASO 201 RBC PLT 198 WBC 201 202 Temperature conditions 15 28 Thresholds 128 142 Thrombocrit 200 Trademarks 7 Transmitting data 131 Transportation 16 Turbidity 42 Type parametering 125 Unlysed RBC 41 Variation coefficients Quality control 152 Volume of Specimen 28 Warranty 10 Waste Handling precautions 40 Output 19 WBC LMNE BAS balance 117 WBC Counting principles 201 Technical characteristics 201
30. 2009 by HORIBA ABX SAS All rights reserved No part of this publication 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 Medical HORIBA ABX SAS B P 7290 34184 MONTPELLIER Cedex 4 FRANCE Phone 33 0 4 67 14 15 16 Fax 33 0 4 67 14 15 17 User Manual Ref RAB271AEN ES Introduction 1 Warning and Precautions eis issees emen emen tttm ath tntn snae nnstnaa 10 af Be we Wanay EE 10 1 2 Safety Precautions sciet er HER ERE cada eee dad ede ase att e duda ed ET sacadas 11 NEG Eelere Run d I 12 2 e Ee Te E TE 14 25 ERVIFODETIe ET 14 2 2 LOGO eee ERE a deg e EEAUUFERERR RR RERRRRRRARA RR RENS ARR SR ERUED UK RO RERRYXRER Rada RR EE bos 14 puke PC ojU no p o ERE PR eege Eege eege gees 15 2 4 Humidity and Temperature Conditions Au 15 2 5 Electromagnetic Environment Check 15 2 6 Main Power Supply TEE 15 2 T Environmental ProtectiOD iue ieiuna pontis in e eee tR keea an n aai aaiae aiia 16 2 8 Storage Conditions and Transportator s AEN 16 2 9 Ee e TE 16 3 Labels and e Tu E Le metra ERRARE NER DLE RIA ME tU RHASA SURE Cep ARE oix E pesada 18 Skatepark ee t 18 3 2 Power Supply Connectlon tnnt tritt nex ER ER enu ERR enoa aa Ae DAS SERERE Cane ANEAN aad naii 18 3 3 Diluent and Waste Connections nennen nnn
31. H and LIC gt LIC H Large Immature Cell LIC gt LIC H or LIC gt LIC H Atypic Lymphocyte ALY gt ALY H or ALY gt ALY H Left Shift MN or NL and RN Monocytosis MON amp gt MON amp H or if MON 96 gt MON 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 0x103 mm or CO alarm Q m H means High panic limit 4 m L means Low panic limit 6 3 2 RBC Messages Anemia HGB HGBL Anisocytosis RDW gt RDW H Microcyte MIC Flag Macrocyte MAC Flag Hypochromia MCHC lt MCHC L Cold Agglutinin MCHC gt MCHC H and WBC lt 91 3x103 mm Microcytosis MCV MCVL Macrocytosis MCV gt MCV H Erythrocytosis RBC gt RBC H Interpretation Not possible RBC lt 0 01x10 mm or RBC reject or RBC gt 0 03 during Startup User Manual 115 Ref RAB271AEN Workflow Results Interpretation Pe n t ra ES 6 O Q m H means High panic limit 4 m L means Low panic limit 6 3 3 PLT Messages Thrombocytosis PLT gt PLT H Thrombocytopenia PLT lt PLTL Microcytosis MICP Flag Schizocytes No threshold between RBC and PLT on the curves Small Cell Small cells at the beginning of the platelet curve Platelets Aggregate Condition 1 PLT lt 150x10 mm WBC reject or NO PDW gt 20 or NO MPV gt 10 or NO PLT lt 150x103 mm or NO WEC reject or L1
32. LYM MON EOS BAS NEU LYM MON EOS BAS ALY LIC ALY LIC Woman 3 00 3 50 9 50 34 0 70 25 0 32 0 10 0 100 o e 4 00 3 80 11 5 37 0 80 27 0 32 0 11 0 150 6 0 15 11 2 00 1 00 0 20 OO OO oO 8 10 00 6 50 17 0 54 0 100 32 0 36 0 16 0 500 11 0 50 18 99 9 99 9 99 9 99 9 99 9 7 50 4 00 1 00 0 50 0 20 2 5 3 0 0 25 0 30 13 00 6 50 18 0 54 0 110 34 0 36 0 17 0 550 12 1 00 20 99 9 99 9 99 9 99 9 99 9 8 0 5 00 1 50 0 70 0 25 2 5 3 0 0 25 0 30 CETTE TN TNNT TON 7T NN RBC HGB HCT MCV MCH MCHC RDW PLT MPV PCT PDW NEU LYM MON EOS User Manual Ref RAB271AEN 3 00 3 50 9 50 34 0 70 25 0 32 0 10 0 100 6 o ooo o 4 00 3 80 11 5 37 0 80 27 0 32 0 11 0 150 6 0 15 11 on O ES 10 00 5 80 16 0 47 0 100 32 0 36 0 16 0 500 11 0 50 18 99 9 99 9 99 9 99 9 13 00 6 00 17 0 50 0 110 34 0 36 0 17 0 550 12 1 00 20 99 9 99 9 99 9 99 9 143 Settings Instrument Default Settings Pe nt ra ES 60 CE ST BAS 99 9 99 9 NEU 1 70 2 00 7 50 8 0 LYM 1 00 1 00 4 00 5 00 MON 0 0 20 1 00 1 50 EOS 0 0 0 50 0 70 BAS 0 0 0 20 0 25 ALY 0 0 2 5 2 5 LIC 0 0 3 0 3 0 ALY 0 0 0 25 0 25 LIC 0 0 0 30 0 30 Child 1 from 1 day to 6 month old TNI rr r T 10 0 10 0 26 0 30 0 RBC 4 00 4 00 6 00 6 00 HGB 13 5 13 5 19 5 19 5 HCT 44 0 44 0 64 0 64 0 MCV 98 100 112 114 MCH 30 0 30 0 38 0 3
33. Male cord 7 Power Supply Female cord 8 Network RJ 45 3 6 Warnings and Biological Risks Labels Definition Location Symbol General warning caution risk Back of the instrument of danger Warning biological hazard Right hand side of the instrument A User Manual 21 Ref RAB271AEN Introduction Printer Pentra ES o0 4 Printer Use the printer supplied or approved by HORIBA Medical Q The user must check the printer compatiblility with the Pentra ES 60 A list of compatible 4 printers is available on the documentation database Other gt printers at www horiba com See also m To Switch On the Printer p 74 m Printer Operation Problems p 178 22 User Manual Ref RAB271AEN ES Specifications 1 KH IEN eui S a 24 fa fly EA EE 24 1 2 Parameters ir e ee t E er EE cece epp deste eb ideae ee ERES 24 1 3 Throughput EI 25 1 4 TUBO dentita BEE 25 1 5 Computer Characteristics iisisti e RAN YRRRRRNPARSSKREEMNKRRETRIREERKARRRRRRRR ERRORS EE 25 1 6 Measurements and Computatton E 26 DES e AT RR aeeveuts 26 2 Physical Specificallolis asi rip ctn itin Upa 28 2 1 PowerRedgultemients eios o tiene retur en EAR AT SERIE EERNRR SEX RARE RMRERSE NNFERKEAXERARERARARSUEESK EaD 28 2 2 Humidity and Temperature Conditions Au 28 2 53 Dimension and RTL LEE 28 2 4 Minimum Specimen Volume 28 ZAMBIE 29 2 6 Counting Aperture Diarmleters er eee a
34. Park the instrument syringes for storage or transportation Access Service gt Mechanical Systems gt Park Syringes Position tab This function parks syringes when the instrument is not used for a long time or for transportation Click Run to park intrument syringes Q A progression bar is displayed Wait until it stops before doing any other action A User Manual 173 Ref RAB271AEN Maintenance and Troubleshooting Maintenance Pentra ES 60 1 7 Hydraulic Systems Menu Drain the instrument chambers Run rinsing cycles Run cleaning cycles Prime reagents 1 7 1 To Drain Chambers D Drain the 5 instrument chambers and or the diluent reservoir Access Service gt Hydraulic Systems gt Drain Chambers tab You can drain chambers if you detect a problem with the instrument s chambers 174 User Manual Ref RAB271AEN Maintenance and Troubleshooting Pentra ES 60 Maintenance b 3 Run an autocontrol to prime reagents in the chambers that have been drained 1 7 2 To Rinse Chambers and Cytometer D m Rinse the instrument chambers m Rinse the instrument cytometer Access Service gt Hydraulic Systems gt Rinse tab You can either m Rinse Chambers if you have excessive flagging on CBC parameters m Rinse Cytometer to remove bubbles from the flowcell if you have excessive flagging on 5DIFF parameters 1 7 8 Cleaning Cycles D Launch cycles to clean the i
35. RDW v BASO Histogram v BASO Threshold v LMNE Matrix v LMNE Matrix Threshold R5232 Settings 132 User Manual Ref RAB271AEN Settings Pentra ES 60 TRUM 1 4 3 Printer Create or delete a printer Set a default printer Define printout header Define printing options Access Setting gt System Setting gt Printer tab Header Each printout includes header in two lines that can be defined in the six Header fields Printing options Step by Step Printing Select to automatically print results after each analysis cycle Printing Blank Results Select to print results on blank cycles cycles on diluent during startup Unconditional Printing Select to print all the results Printing Normal Results Select to print only results within normal ranges with no alarm nor analysis reject Printing Abnormal Results Select to print abnormal results depending on options selected m with default analysis m with alarms m out of normal values m out of panic values of copies Select to have one or two printouts each time a result is printed out Enable m Select Range to print normality ranges on patient results m Select Raw Values to print them m Select Histogram and Matrix Thresholds to print thresholds in histograms and in the LMNE matrix m Select Messages to print pathological messages QC and Calibration Type Parametering l Parameters Restricted ale air Cmm E Loupe Unit Language Analyzer ID Se
36. Ranges Q Panic and normal ranges are defined for each blood type in Setting gt Type 4 Parametering menu h Indicates that the result is above the normal limit set by the user 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 See also m Type Parametering p 125 6 1 4 Results Exceeding Instrument Capacities Q Use the instrument s diluent to dilute the sample if a D flag occurs on WBC or HCT A Visible Range transmitted or gt Visible Range Parameter Linearity Limits Visible Range EE printed out WBC result result D DIL D RBC result result D DIL D HGB result result D DIL D HCT result result D DIL D PLT result result D DIL D Results displayed and printed out PLT C indicates the triggering of the PLT extended linearity mode for an HGB lt 2g dL amp PLT gt 15 x 103 mm between 1900 x 103 mm and 2800 x 103 mm Results transmitted C indicates the triggering of the PLT extended linearity mode for an HGB lt 29 dL amp PLT gt 15 x 103 mm between 1900 x 103 mm and 2800 x 10 mm See Workflow Results Interpretation chapter to know more about these flags These results require a dilution or PRP analysis for PLT of t
37. activity intensity reactivity used to calibrate graduate or adjust a measurement procedure or to compare the response obtained with the response of a test specimen sample NCCLS H38 P Carry over Amount of blood cells remaining in diluent following the cycling of a blood sample in percent 206 User Manual Ref RAB271AEN Glossary ES Glossary of Terms Cell control Preparation made of human blood with stabilized cells and surrogate material used for daily instrument quality control Certified reference material Reference material accompanied by a certificate of which one or several value s of the property ies is are certified by a procedure that establishes its association with an exact undertaking of the unit in which the property values are expressed and for which each certified value is accompanied by an uncertainty with a known level of confidence Chemical specificity specificity Property of an analytical method to selectively determine the concentration of the component s that it is designed to measure Coefficient of variation CV ISO 3534 1 For a non negative character ratio of the standard deviation to the mean Contaminant Effect Undesirable effect resulting from contamination Most commonly this is the effect exerted by a serum on that which follows or precedes it It may also arise from contaminating effects between reagents Control Substance used for monitoring the performance of a
38. chlorine Warning not to use bleach constitued with concentrated tablet User Manual 167 Ref RAB271AEN Maintenance and Troubleshooting Maintenance Pe ntra ES 60 1 In the Cleaning Cycles tab click Concentrated Cleaning 2 Click OK to confirm 3 Add comments in the Comment field to update the Reagents Logs 4 When this window is displayed open the instrument pneumatic door right side Do not click OK until you have poured the ABX Minoclair or diluted bleach in each chambers 5 Use the syringe to pour 3mL of ABX Minoclair or diluted bleach in each chamber mL amL mL mL amL A 6 A 6 Soak the bottle brush with ABX Minoclair and use it to clean only the upper part of the chambers if needed 7 Click OK 168 User Manual Ref RAB271AEN Maintenance and Troubleshooting Pentra ES 60 Maintenance 8 Close the instrument pneumatic door and wait for the instrument to complete the cleaning procedure about five minutes 9 When the progression bar is ended click OK to exit the concentrated cleaning cycle Run an analysis on a control blood See also m To Remove Instrument Covers p 156 1 5 5 To Clean the Sample Carriage D Clean the sample carriage and the chambers covers Access Service gt Mechanical Systems gt Maintenance Carriage Position tab Prepare bottle brush absorbant paper and ABX Minoclair Material Safety Data Sheet for handling
39. count Limitations to the leukocyte count also apply to the determination of the number absolute value and percentage of monocytes User Manual Ref RAB271AEN Specifications ES Limitations 6 3 13 Interferences on Neutrophils NEU The presence of excessive numbers of eosinophils metamyelocytes myelocytes promyelocytes blasts and plasma cells may cause an inaccurate neutrophil count Limitations to the leukocyte count also apply to the determination of the number absolute value and percentage of neutrophils 6 3 14 Interferences on Eosinophils EOS The presence of abnormal granulations degranulation of certain zones toxic granulations etc may interfere with the eosinophil count Limitations to the leukocyte count also apply to the determination of the number absolute value and percentage of eosinophils 6 3 15 Interferences on Basophils BAS The presence of significant numbers of white blood cells and or large immature cells as well as the contamination of the basophil counting channel may cause falsely high basophil counts Limitations to the leukocyte count also apply to the determination of the number absolute value and percentage of basophils Over evaluation in the Basophil count m Excessive number of leukocytes leukocytosis can cause artificial rise in the number of counted basophils due to the shifting of the leukocyte population in the zone of the basophil one m Monocytes and Blasts show large
40. 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 wave length of 550nm 2 3 2 Technical Characteristics Method Photometry Wavelength 550 nm Temperature of reaction 35 C Blood volume 10 uL Volume of ABX Diluent 1700 uL Volume of ABX Lysebio ABX Alphalyse 400 uL Complement of ABX Diluent 400 uL Final dilution rate 1 250 Final HGB result represents absorbance value obtained X coefficient of calibration 2 4 Hematocrit 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 percentage of this integration 2 5 RDW Calculation The RDW Red cell Distribution Width is used to determine erythrocyte abnormalities linked to Anisocytosis The RDW enables to follow the evolution of the width of the RBC histogram regarding 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 User Manual 199 Ref RAB271AEN Description and Technology Measurement Principles ES m K system constant m SD Standard Deviation according t
41. identified by abnormal MCH and MCHC values and the examination of a stained blood smear Cold agglutinins IgM which are elevated in Cold Agglutinin Disease may lower erythrocyte and platelet counts and increase the MCV The samples should be warmed to 37 C 99 F in a water bath for 30 minutes and then re run immediately afterwards using the analyzer or a manual method 6 3 3 Interferences on Hemoglobin HGB Turbidity of the blood sample several physiological and or therapeutic factors may produce falsely elevated hemoglobin results To obtain accurate results in blood samples with increased turbidity determine the cause of the turbidity and follow the appropriate method below m Anelevated leukocyte count a very high leukocyte count will cause excessive diffusion of the light In such cases the reference methods manual should be used The diluted sample should be centrifuged and the supernatant fluid measured with a spectrophotometer m Elevated lipemia elevated lipemia levels makes the plasma look milky This phenomenon can be seen with hyperlipidemia hyperproteinemia as in gammopathies and hyperbilirubinemia Accurate hemoglobin measurement can be achieved by using reference manual methods and a plasma blank Increased turbidity this phenomenon can be seen with red blood cells that are resistant to lysis It causes a falsely elevated HGB concentration but can be detected due to abnormal MCHC and MCH values and to an i
42. is a fully automated hematology analyzer used for the in vitro diagnostic testing of whole blood specimens The instrument can operate in m CBC mode Cell Blood Count m DIF mode CBC 5 population Differential count A control station Workstation is directly connected to the instrument and m drives the instrument orders and cycle requests are sent from the station to the instrument m collects and manages data received from the instrument m can be connected to a LIS system Parameters WBC White Blood Cells RBC Red Blood Cells HGB Hemoglobin concentration HCT Hematocrit MCV Mean Corpuscular Volume MCH Mean Corpuscular Hemoglobin MCHC Mean Corpuscular Hemoglobin Concentration RDW Red Distribution Width PLT Platelets PDW Platelets Distribution Width PCT Plateletcrit MPV Mean Platelet Volume LYM amp Lymphocytes absolute value LYM Lymphocytes percentage MON Monocytes absolute value MON Monocytes percentage NEU amp Neutrophils absolute value User Manual Ref RAB271AEN Specifications Pe ntra ES 60 Technical Specifications NEU 96 Neutrophils percentage EOS A Eosinophils absolute value EOS 96 Eosinophils percentage BAS Basophils absolute value BAS 96 Basophils percentage ALY st Atypical Lymphocytes absolute value ALY 96 Atypical Lymphocytes percentage LIC amp Large Immature Cells absolute value LIC 96 Large Immature Cells percentage United States for this instrument Their u
43. item 4 A Cycle Toolbar which allows you to launch cycles on the instrument and to quit the application 5 A Status Bar which gives you information about the software version and the date time See also m Software Functionalities p 52 m Software Icons Description p 50 m Menus Description p 49 48 User Manual Ref RAB271AEN 2 Menus Description Log in ES Worklist Run Main Screen Results QC and Calibration Logs Analyzer New Worklist Open Archive Close Archive File Backup Database Software Menus Description Restore Database Initialization Delete Database Check Motors Quit Check Valves Sampling Needle Adjustment Mechanical Systems Maintenance Carriage Position Hydraulic Systems Park Syringe Position Service Technician Adjustments jn Drain Chambers Technician Measurements Rinse Burn in Cycle Cleaning Cycles Miscellaneous Prime Cycles Date Time QC and Calibration Communication Type Parametering Printer Setting Parameters Cycle Option System Setting Unit Language E t E Restricted Analyzer ID Settin
44. not reliable User Manual 107 Ref RAB271AEN Workflow Results Interpretation t ES If the mobile threshold cannot position itself in the standard area between 18 fL to 25 fL a l PLT reject and a MICP flag is generated i The PLT results are not reliable Verify the 1 result using a Platelet Rich Plasma PRP or a manual platelet count 6 2 2 2 SCH Flag If the mobile threshold cannot be positioned no valley between the PLT and RBC histograms the SCH schistocytes flag is generated associated with a PLT reject then PLT results are not reliable Suspected abnormalities 2 10 20 30 m Schistocytes m Platelet aggregates Q If platelet aggregates or platelet clumping is suspected patient sample should be redrawn 4 in a sodium citrate tube Do not vortex the sample 6 2 2 8 SCL Flag The SCL Small Cell flag indicates the presence of small cells in the 2 fL and 3 fL zone A second analysis should be carried out and the results verified Q SCL flag belongs to the Analyzer Alarms flags category 4 108 User Manual Ref RAB271AEN Workflow E S Results Interpretation 6 2 3 Differential Leukocyte Flags 6 2 3 1 L1 Flag L1 Flag can be triggered out either on DIF or CBC mode L1 flag is established according to the ratio of the cells counted between the 0 channel and B BA1 It indicates a presence of abnormal number of cells in this area in relation to the total n
45. of the instrument engaging the user s responsibility In this case HORIBA Medical takes no A responsibility for the device nor for the results rendered Disposable gloves eyes protection and lab coat must be worn by the operator Local or national regulations must be applied in all the operations Mobile phones should not be used in proximity of the instrument All peripheral devices should comply with relevant standards Limited Warranty The duration of warranty is stipulated in the Sales conditions associated with the purchase of this instrument To validate the warranty ensure the following is adhered to m The system is operated under the instructions of this manual m Only software or hardware specified by HORIBA Medical is installed on the instrument This software must be the original copyrighted version m Services and repairs are provided by an HORIBA Medical authorized technician using only HORIBA Medical approved spare parts The electrical supply of the laboratory adheres to national or international regulations The system is operated according to HORIBA Medical recommendations Specimens are collected and stored in normal conditions Reagents used are those specified in this user manual Proper tools are used when maintenance or troubleshooting operations are performed authorized representative HORIBA Medical cannot guarantee this product in terms of specification latest revision and latest documentation Furth
46. 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 120x103 mm in CBC mode only a suspicion flag is triggered on PLT NRBCs Condition 2 LL or 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 0x103 mm or PLT reject or SCL alarm during Startup Q m H means High panic limit 4 m L means Low panic limit See also m Normal and Panic Ranges p 106 m SCL Flag p 119 m NO flag p 114 6 4 Analyzer Alarms 6 4 4 NO Flag More about NO Flags in Morphology Flags Differential Leukocyte Flags chapter 116 User Manual Ref RAB271AEN Workflow ES Results Interpretation See also m NO flag p 114 6 4 2 CO Flag Meaning Poor correlation The percentage of validated cells is abnormally low correlation between resistive Conditions and optical measurements is lt 50 m Stroma interfering with measurement m Strong pollution m Incorrect adjustment of the optical bench Suspected Abnormalities Consequences All the matrix parameters are reported to 6 4 3 Baso Flag Baso flag occurs on DIF mode only Conditions BAS 96 50 96 The Basophils are not taken away from the matrix populations and BAS 96 and Consequences BAS are repo
47. or The printer is out of order Check printer s connections switch it has not been selected on and add paper if needed If the Defect on printer make sure there is paper printer still does not work properly refer to your printer s user guide Printer being used action impossible The printer is already Wait for the current printout to operating complete and restart the request Transmission Message Possible cause Corrective action No ENQ character received on RS232 Defect on transmission Check the RS232 configuration No ACK character received on RS232 operations Please contact your local Internal error on RS232 HORIBA Medical representative Write error RS232 Timeout overflow on RS232 CRC error Instrument number error Message length error Receiving data error Calibration Access Denied Incorrect password entered Enter a valid password by the user Data not Saved Value Out of Range Incoherent value entered by Enter correct value the user XX XX XXXX This Date is no longer Valid Incoherent date entered by Enter a correct date the user Minimum of 3 Results Required for Selected results for calibration Select at least three results Calibration calculation not enough Max num done Start Cycle Refused 11 results are already See Quality Assurance Calibration recorded in the calibration chapter table Temperature Temperature out of range Thermic regulation problem Please contact your local HORIBA Medical represent
48. performed after a reagent replacement during the day 2 Check the expiration date of each reagent in the Expiration fields 1 3 4 Instrument Startup See also m To Replace a Reagent Bottle p 161 m To Replace the Diluent Container p 159 m To Replace the Waste Container p 164 m To Prime Reagents p 163 Startup is used to control the analyzer before running analysis It can be launched manually or automatically depending on the application settings User Manual Ref RAB271AEN 77 Workflow Start of Day Pentra ES 60 1 3 4 1 To Perform a Manual Startup Access Main screen gt Start Up icon m The Cycle Option that enables the automatic startup is not checked see Settings gt System Settings chapter m The System analyzer indicator see Analyzer tab has turned to green 1 Click Start Up O Q A progression bar is displayed Wait until it stops before doing any other action A 2 Wait during startup cycle Background counts analysis cycle on reagent without blood specimen are performed during startup cycle The startup is passed if background counts are within acceptable limits Background count limits WBC 0 3 x 10 mm RBC 0 03 x 10 mm HGB 0 3 g dL PLT 7 x 103 mm Once startup is done a Logs Comment window is displayed 3 Enter a comment in the Comment field and click OK to validate Results of the startup are saved and can be consulted in the logs To know more abou
49. precaution has been taken in the preparation of this manual HORIBA Medical 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 labelling Trademarks Microsoft and Windows are registered trademarks of Microsoft Corporation Other product names mentioned within this publication may be trademarks or registered trademarks of their respective owners 2 4 Graphics All graphics including screens and printouts photographs are for illustration purposes only and are not contractual User Manual 7 Ref RAB271AEN Foreword Legal Information ES 2 5 User Manual Symbols 2 6 To alert the operator of potentially hazardous conditions symbols described in this chapter are provided wherever necessary throughout the manual A Emphasizes information that must be followed to avoid hazard to either the operator or the environment or both Emphasizes information that must be followed to avoid possible damage to the instrument or erroneous test results Q Emphasizes information that can be helpful to the operator before during or after a specific 4 Operational function D Gives a summary of what can be achieved if the task is performed Copyright
50. precautions Sodium Hypochlorite concentration 1 3 of active chlorine Warning not to use bleach constitued with concentrated tablet It is highly recommended to use ABX Minoclair for these cleaning operations Refer to the 1 Click Run in the Maintenance Carriage Position tab 2 Open the instrument pneumatic door refer to Maintenance gt To Remove Instrument Covers chapter 3 Clean the upper surface of the chambers cover 1 with wet absorbant paper User Manual 169 Ref RAB271AEN Maintenance and Troubleshooting Maintenance Pentra ES 60 w While cleaning under the carriage small elements can drop into the chambers 4 Puta sheet of paper 2 on the chambers cover 1 5 Clean the protection 3 with wet absorbant paper 6 Use the bottle brush soaked with bleach to clean the white assembly 4 and below the carriage support panel 5 7 Remove and dispose of the sheet of paper 2 8 Close the instrument pneumatic door 9 Click OK to move the carriage back to its initial position See also m To Remove Instrument Covers p 156 170 User Manual Ref RAB271AEN Maintenance and Troubleshooting ES Maintenance 1 0 Mechanical Systems Menu Reset instrument Check motors Check valves Position carriage for maintenance Position syringes for storage 1 6 1 To Initialize Mechanical amp Hydraulical Assemblies D Run an initialization to reset mechanical and hydraul
51. reagents m Replace the waste container Verification after a reagent replacement make sure a blank cycle and a control run have been performed after a reagent replacement during the day 1 2 1 To Replace the Diluent Container D Replace the empty ABX Diluent container Access Main screen gt Analyzer tab At instrument startup the remaining quantity of ABX Diluent is compared to the daily workload set up by the user If a low level is expected during the working day a dialog box appears You can click OK and go on running specimen until the dialog box appears again Then the ABX Diluent must be changed 1 Unscrew the stopper assembly of the new container Risk of erroneous results if one reagent is poured to another container Never pour a reagent from one container to another Particles at the bottom of the old container can contaminate the new reagent and will cause unacceptable background results especially for Platelets 2 Remove the stopper assembly straw from the empty container and insert it into the new one A Properly dispose of the empty reagent container Follow your local regulations for reagent disposal 3 In the Analyzer tab double click the ABX Diluent icon User Manual 159 Ref RAB271AEN Maintenance and Troubleshooting Maintenance Pe ntra ES 60 gi E 20000 15464 qn 4 Inthe Reagent Replacement dialog box enter the new Diluent s Lot Number indicated on r
52. select a type in the list and click Apply Standard Values 4 To set a type as default select it in the list and click Set As Default Type Q Default Standard type setting is not modifiable Names of the five following types cannot 4 be modified neither You can now set the pathological limits alarms levels and or matrix thresholds of a type User Manual 126 Ref RAB271AEN Settings Setting Menu 1 2 2 To Set Pathological Limits D Define Normal and Panic limits of each blood type Access Setting gt Type parametering gt Pathological Limits and Thresholds tab You have already defined a new type or you want to modify an existing one 1 Select the type you want to modify in the list Default type Type Nami ical Limi Standard _ anic Low Normal Low IT WBC 20 40 1 0 15 0 Set As Default Type Age Ran i Standard 1 2 Man 3 Woman 4 Newbom 5 Infant B Child 7 8 o Modify Copy Paste Apply Standard Values Accept Cancel Mim x Pathological Limits and Thresholds Alarms and Curve Thresholds 2 Click Modify 3 Enter the password and change the value in the Pathological Limits table 4 Click Accept to validate Laboratory levels can be set by the operator according to its own specifications Results that exceed the Normal limits are identified with a flag m h for results above the upper limit m for results below the lower limit a Resul
53. stages and distribution and supports the sampling syringe and the blood distribution 2 Sampling syringe Distributes portions of the specimen into the dilution chambers and takes the sample from the first dilution and distributes it into the RBC PLT chamber 3 Counting assembly Receives the different rinsings and dilutions regulates the temperature of dilutions and provides the dilutions for RBC PLT HGB WBC BASO and LMNE 4 Draining syringe Drains the chambers bubbles the mixtures transfers by vacuum the LMNE specimen from the LMNE chamber to the injector of the optical flowcell 5 Diluent tank Contains diluent for an analysis cycle prevents diluent degassing as it is being aspirated by the syringes and is vacuum filled by the counting syringe 1 Optical bench Ensures the support and adjustment of the flowcell lamp and optical and electronic elements 2 Counting syringe Ensures the vacuum for the WBC and BAS counts ensures the vacuum for the RBC and the PLT counts and ensures the vacuum for filling the diluent tank with diluent 3 LMNE Syringe assembly Ensures the correct proportioning of the stop diluent in the LMNE chamber injects the specimen into the flowcell and injects the interior and exterior sheath into the flowcell 4 Reagent Syringe assembly Ensures the correct proportioning of the reagents Lysing reagent for hemoglobin ABX Lysebio ABX Alphalyse Cleaning reagent ABX Clean
54. that easily generates noise such as a centrifuge etc m Provide a space of at least 20 cm 8 in at the back of the instrument for a proper ventilation and an easy access to connections The Power switch and Power supply connection should always be accessible When positioning the system for operational use leave the required amount of space for easy accessibility to these items User Manual Ref RAB271AEN 2 3 2 4 2 5 2 6 Introduction ES Operational Conditions 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 grounding contact your facilities engineer to verify the proper outlet ground Humidity and Temperature Conditions Instrument operating temperature from 16 C 61 F to 34 C 93 F with a relative humidity of 8096 maximum without condensation If the instrument is stored at a temperature lower than 10 C 50 F it should stand for one hour at a normal room temperature before use Temperature gradient 2 C Electromagnetic Environment Check The instrument has been designed to produce less than the accepted level of electromagnetic interference in order to operate in conformity with its destination allowing the correct operation of other instruments also in conformity with their destination In case of suspected electromagnetic noise check th
55. the instrument is working accurately and precisely Quantification limit XP T 90 210 The smallest quantity of an analyte to be analyzed in a sample that can be determined quantitatively under the experimental conditions described in the method with a defined variability determined coefficient of variation Reagent blank Corresponds to the signal resulting from the reagent s used during an assay or a measurement of catalytic activity The sample is replaced by an equal volume of an appropriate solvent Reference material Calibrator reference values Material or substance of which one or several value s of the property ies is are sufficiently homogeneous and well defined to enable it to be used to calibrate a piece of equipment evaluate a measuring method or attribute values to materials Reference technique reference method Internationally recognized technique whose accuracy has been evaluated in comparison with a definitive technique or following a complete and detailed study The principle reagents apparatus operating procedure and the calculations are precisely defined User Manual 209 Ref RAB271AEN Glossary Glossary of Terms ES Reference values Results obtained for a given component in a reference population whose individuals are exempt from disease or treatments that may alter their values The reference values may vary notably according to the geographic origin sex and age of individuals They ar
56. to predefined 4 Criteria m You have entered the Results gt All the Results tab m You have selected results to send 1 Click Send Selected Area icon Send to L I S Select which result s you want to send to L I S C Last Result Ze Selected Results Ee Result C All The Results 2 Select one of the four options Last Result Current Result Selected Results or All the Results 3 Click OK to validate User Manual 103 Ref RAB271AEN Workflow Results Interpretation Pe n t ra ES 6 O 6 1 104 6 Results Interpretation General Flags 6 1 1 Parameter Reject A parameter reject is shown by and indicates that the result is not coherent The sample has to be checked counting problems poorly maintained instrument expired reagents clotted sample etc A rejected result cannot be validated Parameter Reject Triggers if WBC The difference between the two WBC counts is higher than on differential parameters the limit set for WBC Reject The difference between the two RBC counts is higher than the on MCV MCH MCHC RBC Ed gt limit set for RBC Reject HGB Three consecutive suspicion flags are triggered on HGB on MCH MCHC parameter The difference between the two HCT counts is higher than the on MCHC HCT GE E limit set for HCT Reject The difference between the two PLT counts is higher than the on PDW MPV PCT limit set for PLT Reject or SCL flag PLT or
57. values v CBC data Minotrol 3 parts for Low Normal and High levels results detailed by DIF data Difftrol 3 parts for Low Normal and High levels results detailed by parameters statistics results lot target values m Lot barcode identification must not be modified to allow QC export on the floppy disk m Statistical calculation results recorded in the file are based on the raw values determined by the instrument and not by the rounded values of control runs displayed in this file 60 See also To Create Modify a Control Lot p 58 To Identify a Control Blood with the Barcode Reader p 80 To Identify a Control Blood without Barcode Reader p 81 To Run a Control Blood p 82 To Check Control Blood Results p 84 Quality Control Overview p 56 Worklist Overview p 86 QC and Calibration p 124 User Manual Ref RAB271AEN 2 1 Quality Assurance ES A Patient Quality Control XB 2 Patient Quality Control XB Patient Quality Control XB Overview Access Main screen gt QC and Calibration tab gt XB tab The XB Patient Quality Control is used to detect any deviation in the quality of results using patient data only This data monitoring is based on a BULL method 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 File Service Setting EIL CO LL LI RH wolt Results QC and Calibration Analyzer
58. 111 Ref RAB271AEN Workflow Results Interpretation t ES 6 2 3 7 RN flag Right Neutrophils Presence of a significantly large population of cells located on the right side of the neutrophil area high LIC The right neutrophils flag appears when the number of counted particles in this area is higher than the limit set up in RN or when the number of counted particles regarding the total number of WBC is above the RN limit This flag is associated with an on m NEU NEU m LIC LICH Suspected abnormalities m Large neutrophils m Immature cells from granulocyte hemopoiesis metamyelocytes myelocytes promyelocytes Values for RN Standard type are 1 1 and 999 These flag values can be defined for each blood type in Setting gt Type Parametering gt Alarms and Curve Thresholds tab 6 2 3 8 RM flag Right Monocytes Presence of a significantly large population of cells located on the right hand side of the mococyte area low LIC The right monocytes flag appears when the number of counted particles in this area is higher than the limit set up in RM or when the number of counted particles regarding the total number of WBC is above the RM limit This flag is associated with an on m NEU NEU m MON MOND m LIC LICH Suspected abnormalities Large monocytes Hyperbasophilic monocytes Myelocytes or promyelocytes Large blasts Values for RM Standard type are 1 1 and 999 These flag values ca
59. 147 Ref RAB271AEN Settings Instrument Default Settings Pe nt ra ES 60 LIONE TT ON ea RM 0 7 999 LN 2 5 999 RN 1 1 999 NE 1 1 30 L1 3 200 LMNE reject 50 MIC 5 MAC 45 HGB 3 60 Child 3 from 2 years to 14 years old am e e NO 100 80 LL 100 80 LL1 5 55 NL 3 120 MN 118 120 RM 0 7 999 LN 2 5 999 RN 1 1 999 NE 1 1 30 L1 3 200 LMNE reject 50 MIC 5 MAC 45 HGB 3 60 3 3 Matrix Thresholds Standard Matrix thresholds Channel kee Proposed Current NOL 24 22 NON 27 25 LL 31 30 LN 35 35 NOE 50 48 LMN 69 70 AL 69 68 LMU 73 78 148 User Manual Ref RAB271AEN Pentra ES 60 Matrix thresholds Proposed LMD MN RM RN NL RMN NE FLN FNE FMN DA BA2 BAS Man Matrix thresholds Proposed NOL NON LL LN NOE LMN AL LMU LMD MN RM RN NL RMN NE FLN FNE FMN DA BA2 BAS Woman Matrix thresholds Proposed NOL NON LL User Manual Ref RAB271AEN 100 100 118 118 29 51 82 35 110 240 24 27 31 35 50 69 69 73 100 100 118 118 29 51 82 35 110 240 24 27 31 Settings Instrument Default Settings Channel Current 90 90 118 118 29 51 82 35 110 240 Channel Current 22 25 30 35 48 70 68 78 90 90 118 118 29 51 82 35 110 240 Channel Current 22 25 30 149 Settings Instrument Default Settings Pentra ES 60 Matrix thresholds Channel Proposed Current 150 LN 35 35 NOE 50 4
60. 2 Risk of erroneous results if the specimen is not continously mixed between each analysis Keep on mixing the specimen between each analysis See also m To Create Modify a Control Lot p 58 m To Export Quality Control Data p 59 m To Identify a Control Blood with the Barcode Reader p 80 m To Identify a Control Blood without Barcode Reader p 81 m To Check Control Blood Results p 84 m Quality Control Overview p 56 m Worklist Overview p 86 m QC and Calibration p 124 User Manual 83 Ref RAB271AEN Workflow Running Quality Control Blood 2 4 84 To Check Control Blood Results Pentra ES 60 qQ Check that control blood results are within the acceptable values Access Main screen gt QC and Calibration tab gt Controls tab A control blood specimen must have been run 1 Check your control blood results As runs are sorted by date your last run is the last line of table 2 2 Check that the results are within acceptable values given in the control blood leaflet File Service Setting e Mid B _ Worklist Run Results QC and Calibration Current T arg 5 Iv ABx 10 28 2008 16 04 CONTROL S DON DIF A 6 IV apx 10 29 2008 13 59 7 Iv ABx 10 29 2008 15 14 Barcode 1 pow 8 iv Agx 10 31 2008 09 23 3 Iv ABx 10 31 2008 14 32 Expiration Date 410 Iv ag 10 31 2008 14 38 11 05 2008 11 Iv
61. 202 Weight 28 Workflow O Worklist Archives 91 User Manual Ref RAB271AEN Pentra ES 650 Creating a new worklist 88 Icons 88 Overview 86 Printing 92 Shortcuts 54 Workstation communication problem 178 Workstation login problem 178 Workstation power problems 177 X XB Graph 61 Limits 152 Options 124 Overview 61 User Manual Ref RAB271AEN 217 218 Pentra ES oo User Manual Ref RAB271AEN
62. 3 RDW 10 PLT 10 MPV 10 NEU 10 LYM 10 MON 35 EOS 15 BAS 10 NEU 10 LYM 10 MON 35 EOS 15 BAS 10 3 5 XB Limits Parameter Value Tolerance WBC 7 3 RBC 5 1 HGB 14 3 HCT 45 5 PLT 320 100 MCV 90 10 MCH 29 MCHC 34 152 User Manual Ref RAB271AEN Settings Pentra ES 60 Instrument Default Settings RDW 14 2 User Manual T Ref RAB271AEN Settings Instrument Default Settings Pe nt ra ES 60 154 User Manual Ref RAB271AEN ES Maintenance and Troubleshooting 1 cupchr 156 1 1 To Remove Instrument Covers ek 156 1 2 Reagents Beplacernent irre e ciun p E e ER rp E d EORR RES 159 1 3 To Replace the Waste Container 164 1 4 To Decontaminate your Instrument uk 165 1 5 Hydraulic Maintenance iiri iini es tuor e auk Ern eege eg Fee CE t EE Rn ege deer ege 166 1 6 Mechanical Systems Meriu rrr t ER RE ERA RE ERE EENS 171 1 7 Hydraulic Systems Men 174 2 Troubleshooting Procedures ee rrerercerereransarnanenaaaaa 177 2 1 Operation Melen E 177 2 2 Analysis Cycle Problems 3 pc EE x Re RR ca REPE ERR Rx XE Mesa asda ERR ERR AEN COR 180 PASMSC Hil ce EEUU 183 3 Err r CSS ACS tee t M 188 User Manual 155 Ref RAB271AEN Maintenance and Troubleshooting Maintenance Pe ntra ES 60 1 Maintenance 1 1 To Remove Instrument Covers D O
63. 406 87 248 303 11 06 2008 Mean Target Diff 01 0 06 03 1 B 04 By Ly pen StendardDeviaion 007 oos ois e 06 516 ug SE eree 10 18 131 238 om 209 039 XB In the Current Target drop down list select your control lot If your control blood is not listed please refer to Quality Assurance Quality Control chapter The instrument is ready to run your control blood See also To Create Modify a Control Lot p 58 To Export Quality Control Data p 59 To Identify a Control Blood with the Barcode Reader p 80 To Run a Control Blood p 82 To Check Control Blood Results p 84 Quality Control Overview p 56 Worklist Overview p 86 QC and Calibration p 124 To Run a Control Blood D Prepare the control blood and run an analysis The control blood has previously been identified and the front panel LED has to be green User Manual Ref RAB271AEN Workflow Pentra ES 60 Running Quality Control Blood 1 Prepare your control blood according to the specific instructions detailed in the control blood package insert temperature mixing etc 2 Plunge the sampling needle into the control blood specimen and press the start bar fg 3 Remove the tube when the light indicator stops flashing The LED turns to red Recap the control blood specimen If you want to rerun once again your control blood you can a Proceed to your control blood tube identification b Rerun it as described in step
64. 7 30 Current time zone GMT Standard Time Adjust the date and time and click OK to validate 1 4 2 Communication D m Set RS232 and sending configuration ABX and ASTM formats m Define ABX Format transmitted data Access Setting System Setting Communication tab the technician in charge of the Laboratory Information System L I S Information about JJ Any modification of the instrument communication setup has to be done in agreement with communication setup of Pentra ES 60 is provided in the Output Format documentation User Manual 131 Ref RAB271AEN Settings Setting Menu Pentra ES 60 Q If any doubt please contact your local representative A RS232 Settings QC and Calibration Type Parametering Parameters Restricted Unit Language Analyzer ID Setting Save Restore Users R5232 Configuration Sending Configuration Bauds Stop Bit p Format Made Time Out 15 C 4800 Ze 18top C WORKS UNIDIR C 286 Waiting Time 8 C 9600 op C ARGOS SOH EOT 38400 ABX C BIDIR Works Separator C 57500 Length C ASTM Automatic disconnecti i 80 EE G Bbit Automatic disconnection Time LITT 7 bit E a pru Sending Options D Iv Step by Step Transmission e Unconditional Sending s A Conditionnal Sending B n iis Send Control Results Identified Results E None E KE H Without Default Analysis pen _Tesi
65. 70 User Manual Ref RAB271AEN 5 1 Quality Assurance ES 60 b Logs Logs Overview Access Main screen gt Logs tab The logs list events of your instrument for the following Reagent information about a reagent replacement Calibration information about the parameters coefficients Users comments after a maintenance for users Technicians comments after a maintenance for technicians Errors description of system errors Startup instrument startup results File Service Setting l Run Log Worklist Results QC and Calibration Analyzer Date Time Jeer nec Has eir Tut status Comment D 10 23 2008 10 22 53 AM 0 3 0 00 0 0 1 0 09 Done C Reagent C Calibration C Users Technicians C Enos c Si Add Entry W Ask Logs Comment To User Ask Logs Comment To User option if selected a comment dialog box is displayed after having performed the following Reagent replacement Calibration Cytometer rinse Concentrating cleaning Blank cycle System error User Manual Ref RAB271AEN Logs 71 Quality Assurance Logs 5 2 72 Pentra ES 60 To Add a New Entry D Add a new log entry after a maintenance Access Main screen gt Logs tab Adding a new entry can only be done in Users and Technicians logs this latter is protected by a password After any maintenance operation done by a user or a HORIBA Medical technician add a new log entry to keep the in
66. 8 Hydraulic maintenance 166 Hydraulic module 193 214 ES Icons description 50 Initialization 171 Installation 16 Instrument Startup 77 78 Switching off 121 Switching on 75 Interfering substances BAS 45 EOS 45 HCT 43 HGB 42 LYM 44 MCH 43 MCHC 43 MCV 43 MON 44 MPV 44 NEU 45 PLT 43 RBC 42 RDW 43 WBC 41 KSEDTA 35 Label Biological risk 21 Serial number 18 Warning 21 Large Immature Cells 110 204 Large platelets 43 Left lymphocytes 110 Left lymphocytes 1 111 Left neutrophils 111 Leukemia 41 LIC flag 110 Linearity limits 32 Lipids 42 LIS Laboratory Information System 103 LL flag 110 LL1 flag 111 LMNE Matrix count 202 LMNE syringe assembly 194 LN flag 111 Login 76 Logos Definition 8 Logout 120 Logs 71 Lymphocytes 204 User Manual Ref RAB271AEN ES Lyse Location 37 Priming 163 Replacing 161 Macrothrombocytes 41 Main board 195 Main screen 48 Maintenance carriage position 173 Maintenance procedure Dilution 182 Optical bench lamp replacement 185 Sampling needle replacement 181 Maintenance Hydraulic 166 Matrix thresholds 148 MCH calculation 200 MCHC calculation 200 MCV calculation 200 MDSS 196 Measurement Principles 26 Mechanical module 193 Menu description 49 Messages 188 Microcytes 107 Microsampling 36 Mixing 36 MN flag 113 Mono Neutro 113 Monocytes 204 MPV measurement 200 Multiple myelom
67. 8 LMN 69 70 AL 69 68 LMU 73 78 LMD 100 90 MN 100 90 RM 118 118 RN 118 118 NL 29 29 RMN 51 51 NE 82 82 FLN FNE FMN BA1 35 35 BA2 110 110 BA3 240 240 Child 1 from 1 day to 1 month old Matrix thresholds Channel Gees Proposed Current NOL 24 22 NON 27 25 LL 31 30 LN 35 35 NOE 50 48 LMN 69 70 AL 69 68 LMU 73 78 LMD 100 90 MN 100 90 RM 118 118 RN 118 118 NL 29 29 RMN 51 51 NE 82 82 FLN FNE FMN BA1 35 35 BA2 110 110 BA3 240 240 User Manual Ref RAB271AEN Pentra ES 60 Child 2 from 1 month to 2 years old Matrix thresholds Proposed NOL NON LL LN NOE LMN AL LMU LMD MN RM RN NL RMN NE FLN FNE FMN BA1 BA2 BA3 Child 3 from 2 years to 14 years old Matrix thresholds Proposed NOL NON LL LN NOE LMN AL LMU LMD MN RM RN NL RMN NE FLN FNE FMN BA1 User Manual Ref RAB271AEN 24 27 31 35 50 69 69 73 100 100 118 118 29 51 82 35 110 240 24 27 31 35 50 69 69 73 100 100 118 118 29 51 82 35 Channel Settings Instrument Default Settings Current 22 25 30 35 48 70 68 78 90 90 118 118 29 51 82 35 110 240 Channel Current 22 25 30 35 48 70 68 78 90 90 118 118 29 51 82 35 151 Settings Instrument Default Settings Pe nt ra ES 60 Matrix thresholds Channel Proposed Current BA2 110 110 BAS 240 240 3 4 QC Variation Coefficients WBC 5 RBC 5 HGB 3 HCT 5 MCV 3 MCH 3 MCHC
68. 8 0 MCHC 32 0 32 0 36 0 36 0 RDW 10 0 11 0 16 0 17 0 PLT 150 200 400 450 MPV 6 6 11 12 PCT 0 0 15 0 50 1 00 PDW D 11 18 20 NEU 0 0 99 9 99 9 LYM 0 0 99 99 9 MON 0 0 99 9 99 9 EOS 0 0 99 9 99 9 BAS 0 0 99 9 99 9 NEU 6 00 6 00 26 0 26 0 LYM 2 00 2 00 11 0 11 0 MON 0 40 0 40 3 10 3 10 EOS 0 0 0 85 0 85 BAS 0 0 0 65 0 65 ALY 0 0 2 5 2 5 LIC 0 0 3 0 3 0 ALY 0 0 0 35 0 35 LIC 0 0 0 35 0 35 Child 2 from 6 month to 2 years old CE ST E 10 0 10 0 26 0 30 0 RBC 4 00 4 00 6 00 6 00 HGB 13 5 13 5 19 5 19 5 HCT 44 0 44 0 64 0 64 0 144 User Manual Ref RAB271AEN Pentra ES 6o Settings Instrument Default Settings EE O e MCH MCHC RDW PLT MPV PCT PDW NEU LYM MON EOS BAS NEU LYM MON EOS BAS ALY LIC ALY LIC Child 3 from 2 years to 14 years old 30 0 32 0 10 0 150 6 Oo OO ON o 6 00 2 00 0 40 OO OO OO 100 30 0 32 0 11 0 200 6 0 15 11 0 0 0 0 0 6 00 2 00 0 40 EM O fon O e 112 38 0 36 0 16 0 400 11 0 50 18 99 9 99 9 99 9 99 9 99 9 26 0 11 0 3 10 0 85 0 65 2 5 3 0 0 35 0 35 114 38 0 36 0 17 0 450 12 1 00 20 99 9 99 9 99 9 99 9 99 9 26 0 11 0 3 10 0 85 0 65 2 5 3 0 0 35 0 35 TINI CNN 7 TN TIN 7 NN RBC HGB HCT MCV MCH MCHC RDW PLT MPV PCT PDW NEU LYM MON EOS BAS NEU LYM MON EOS User Manual Ref RAB271AEN 4 50 4 00 11 0 37 0 75 24 0 32 0 10 0 150 4 50 4 00
69. 96 WBC BAS count then LMNE flag is 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 except during technical intervention In any case it is the WBC BAS result that is reported The WBC balance flags LMNE and LMNE are activated only if m the test selected is DIF m the WBC LMNE BAS balance has been enabled by an HORIBA Medical technician These flags are associated with an on all differential parameters 96 and Jj CBC mode Limitations The WBC LMNE BAS balance flag indicates an instrument defect or highlights a known interference see Specifications Limitations chapter In case of pathology which treatments weaken the leucocytic membranes the agent of lysis of WBC channel can damage the cells and give a lower leukocytes counting The LMNE flag is then triggered off and a suspicion is associated to the WBC results It is recommended not to disable WBC balance flag and to work in DIF mode for all samples that can present this possible interference Selecting the CBC mode disables this control mode It is recommended to use this mode for patients not presenting this type of interference See also m Limitations p 41 6 4 6 PLT C Flag Meaning Platelet Concentrated Indicates the triggering of the PLT extended linearity mode for an HGB l
70. Check Valves cycle This controls the correct operation of valve 14 5 Perform a concentrated cleaning If these operations appear to be correct and RBC PLT and HCT parameters are still not repeatable please contact your local HORIBA Medical representative If the system appears to be operating properly fresh uncontaminated reagents are used and the precision is within the specifications the instrument may need to be calibrated as described in Quality Assurance Calibration chapter User Manual 183 Ref RAB271AEN Maintenance and Troubleshooting Troubleshooting Procedures Pe ntra E 60 2 3 3 Problems on HGB Follow this procedure if your instrument is not repeatable or if inconsistent flags occur on HGB parameter 1 Control the ABX Lysebio ABX Alphalyse bottle level and expiration date Replace it if necessary See Maintenance and Troubleshooting Reagents Replacement chapter 2 Open the pneumatic access door and check that the LED is lit when the system power is on If the HGB LED is not lit when the system power is on please contact your local HORIBA Medical representative 3 Perform a concentrated cleaning If HGB parameter is still not repeatable please contact your local HORIBA Medical representative 2 3 4 Problems on WBC and BAS Parameters Follow this procedure if your instrument is not repeatable or if inconsistent flags occur on WBC and or BAS parameters 1 Open the pneumatic acce
71. DR Ns do bl C and Calibration Logs Analyzer Test Running Date DOB J foir 10 13 2008 04 26 25 P WBC 109 mm 33 Lmz es rao wus 02 n ox neu 63 1 1521 eos 35 fo12 pes jos foo UMEN 04 RBC 105 mm ba l HGB g dl n 8 HCT GI g 6 MCV um 38 MCH pg 29 8 2 MCHC g dl ba RDW IER 97 PLT 102 mm2 151 MPV um as 3 ALY 0 03 LIC 0 01 Analyzer Alarms Suspected Pathology PCT boor PDW fis Morphology Flags 5 10 20 30 98 User Manual Ref RAB271AEN Pentra ES co 1 Patient file 2 DIF results and histograms Workflow Results Management 3 Results status indicator White not validated yet Red pending for rerun Green validated 4 Morphology Flags see Results Interpretation gt Morphology Flags chapter 5 Analyzer Alarms see Results Interpretation gt Analyzer Alarms chapter 6 Suspected Pathology see Results Interpretation gt Suspected Pathology chapter See also Morphology Flags p 107 Analyzer Alarms p 116 Suspected Pathologies p 114 To Search Patients Results p 100 5 2 Results Icons Description Display Search Screen searches on Patient Name field ES ES CE ES DI Print Selected Area prints results in a ticket mode or in a line mode selected or all Send Selected Area sends last current selected or all results to the LIS
72. EE Pere Ex Fas RR a ee 199 2 5 RDW Calculation nennen nnn nnnnnn nnns suni nnn ns isse enn sna asser sina snis 199 2 6 MCV MCH MCHC Calculation EE 200 2 7 MPV MG SUreMe nh cccccccessseeeeeeceeseceeeceaeeeeeeceeeenseeeeeceeusaeeesetsueaseceesensueaseeesteneasesessetsnanses 200 2 8 Plateletcrit Calculation rac e rta roe a ave brc dee i does Lev E vaa c EE ka Rena Ee 200 2 9 PDW Calculaton nennen nennen nnn rar eeaa nnns snna en aerea sa sensn assa a sensi naa snis 201 2 10 White Blood Cells Basophils Court 201 2 11 LMNE Matrix CGount eee nennnn nnn nnnnnnnnnannai nnn inna sn ssssa sins assa ses rss naa asta s annis 202 User Manual 191 Ref RAB271AEN Description and Technology Pentra ES 60 Description Pe ntra ES 60 1 Pentra ES 60 Description 1 1 Pentra ES 60 Front Side 1 Reagents compartment 2 Status LEDs red and green 3 Start bar 4 Sampling needle Pentra ESco 192 User Manual Ref RAB271AEN Description and Technology Pentra E amp 60 Pentra ES 60 Description 1 2 Pentra ES 60 Back Side 1 Diluent input Waste output 2 Peripherals connections 3 Instrument serial label 4 Switch On Off 5 Power supply connection 1 9 Mechanical and Hydraulic Modules User Manual 193 Ref RAB271AEN Description and Technology Pentra ES 60 Description Pe ntra ES 60 1 Sampling carriage Ensures needle positioning for the different sampling
73. HORIBA Medical Pentra ES o0 Hematology Analyzer User Manual Ref RAB271AEN Explore the future Automotive Test Systems Process amp Environmental Medical Semiconductor Scientific HORIBA Pentra ES 60 User Manual Pentra ES 69 C vo Be E es SAS 34184 MONTPELLIER Cedex 4 FRANCE User Manual Ref RAB271AEN ES Contents FOISWOFUL E 5 MILII 6 CERN e au EL Le me H aii goto te fe g BE 9 1 Warning and Pre Ca UbiOnS isictissasssisssencsscssssesanasessssanaanssseasnsadsantatvdnaansasstesuatntnestelvavnattanvavca 10 PES rirenrileispi t ne 14 3 Labels and A CENA asa a cal ERE untere pads tee 18 dur c 22 Elle Le Lu E 23 1 Kl TE MT eec gado isa aa dada ga 24 2 GE dE 28 3 Summary of Performance Data eee eese se ente tn sn stata sata tasa sa sn aaa 30 4 Sample Collection and Mixing eee eeeete entente tenente nnnens 35 5 Reagents SpecificalloHs einn tnn edi titur eie DER dna 37 O BICI M 41 EE 47 DEDUCI m 48 2 Menus DESCrpiOM e S 49 3 Software Icons Description eee eeremereremeeeerererer serasa rare serena rananes 50 4 Software Functi onialities tredium Eeg
74. If an error message is displayed during initialization or if the application does not start properly please contact your local HORIBA Medical representative Once logged in the main screen is displayed For more information see Software Software Overview chapter See also m Software Overview p 48 g Users p 138 m To Change Operator p 120 76 User Manual Ref RAB271AEN Pentra ES 60 1 3 3 To Control the Reagents Workflow Start of Day HD Check each reagent s level and expiration date before running a startup cycle Access Main screen gt Analyzer tab 1 Check the level of each reagent The percentage indicates the remaining level File Service Setting kd Fakalteisd ek Worklist System Analyzer Reagent Lot Number Capacity Level Change Expiration Operator Results ABXCLEANER EOSINOFIX 0605161 060606G1 1000 1000 825 912 J 08 26 2008 12 05 2007 09 08 2008 12 22 2007 ABX ABX QC and Calibration BASOLYSEN ABXLVSE emm eme 70 400 74 EEE 12052007 12705 2007 ounen 01 22 2008 ABX fall Logs ABXDLUENT wor m ee RA eme Fm If one reagent has to be changed refer to the Maintenance and Troubleshooting gt Maintenance gt Reagents Replacement chapter Verification after a reagent replacement make sure a blank cycle and a control run have been
75. LT histogram Distribution curves on 256 channels from 2 fL to a mobile threshold This threshold moves according to the microcyte population present in the analysis area 4 Analogue conversion for PLT 5 Data integration and plotting of PLT distribution curve 2 2 2 Technical Characteristics Method impedance Aperture diameter 50 um Temperature of reaction 35 C Count vacuum 200 mb Count period 2 x 5 s Initial blood volume 10 uL Volume of ABX Diluent 2500 uL Primary dilution for RBC and PLT m Blood 10 uL m Volume of ABX Diluent 1700 uL m Dilution 1 170 Secondary dilution for RBC and PLT m Dilution 42 5 uL from the primary dilution m Volume of ABX Diluent 2500 uL m Dilution 1 58 8 Final dilution 1 170 x 1 58 8 1 10000 Final dilution rate 1 10000 two successive dilutions are carried out ES 4 User Manual Ref RAB271AEN 2 3 Description and Technology ES Measurement Principles Hemoglobin Measurement 2 3 1 Measurement Principles m Alphalyse 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 spectrophotometry at a wavelength of 550nm m Lysebio Reagent for erythrocyte lysis and
76. MICP flag and not able to define the mobile threshold s position between 18 and 25 fL see Platelet flags chapter or SCH flag LMNE matrix Correlation between resistive and optical measurements si on all the differential 5096 adjustable parameters See also m Platelet Flags p 107 6 1 2 Suspicion A suspicion on a parameter is shown by The sample must be rerun HGB suspicion m Oneach analysis an HGB reference value is set mean of the last 3 HGB blank tests on diluent If difference between new HGB blank test on cycle and HGB reference value gt HGBB set by the user see Settings Setting Menu Type parametering chapter then a suspicion flag is triggered on HGB parameter User Manual Ref RAB271AEN Workflow Pentra ES 60 Results Interpretation m Other test is performed each analysis on HGB measures to evaluate their consistency Computation obtained on this test must be within acceptable ranges lt HGBMY limit set by the user if this test has failed is also associated with HGB result Platelet suspicion If PLT lt 120x10 mm in The result is presumed erroneous it CBC mode only on PLT applied on patients results only MUSI bs Checked with arerun sample or If PLT 120x103 mm PDW with a reference method if the second 20 in CBC and DIF mode result is still flagged WBC suspicion LMNE or LMNE or BASO on WBC applied on patients results flag
77. OS 0 9864 gt 0 95 See also m Glossary of Terms p 206 3 7 Results Exceeding Instrument Capacities Q Use the instrument s diluent to dilute the sample if a D flag occurs on WBC or HCT 4 Visible Range transmitted or gt Visible Range Parameter Linearity Limits Visible Range EECH printed out WBC result result D DIL D RBC result result D DIL D HGB result result D DIL D HCT result result D DIL D PLT result result D DIL D Results displayed and printed out PLT C indicates the triggering of the PLT extended linearity mode for an HGB lt 2g dL amp PLT gt 15 x 10 mm between 1900 x 10 mm and 2800 x 103 mm Results transmitted C indicates the triggering of the PLT extended linearity mode for an HGB lt 2g dL amp PLT gt 15 x 103 mm between 1900 x 103 mm and 2800 x 10 mm See Workflow Results Interpretation chapter to know more about these flags These results require a dilution or PRP analysis for PLT of the sample with the instrument s w Whole blood parameter results within visible range will still give a result value with a D flag diluent See also m PLT C Flag p 118 m Linearity Limits p 32 34 User Manual Ref RAB271AEN 4 1 4 2 Specifications ES Sample Collection and Mixing 4 Sample Collection and Mixing Q All blood samples should be co
78. X 1 2 48 Prime 42 9 X X X X 3 03 ABX Diluent Prime iai X 24 8 X X 1 22 ABX Cleaner Prime 1 6 X X 23 6 X 1 12 ABX Eosinofi x Prime 1 1 23 6 1 1 X X 1 20 ABX Basolys ell Prime 2 1 X X X 8 4 1 27 ABX Lysebio ABX Alphalys e Prime all 47 24 25 1 24 8 2 6 reagents Autoclean 14 2 1 1 1 0 3 1 38 cycle Autocontrol 23 4 X 1 4 X 1 1 04 cycle RBC 2 5 X X X X 7 chamber cleaning Unprime all X X X X X 6 25 Chambers 12 6 1 1 1 0 3 117 rinsing Cytometer 4 9 X X X X 111 rinsing Concentrated 25 X 1 4 X 0 9 4 10 cleaning Cleaning 12 6 1 d 1 0 3 1 19 5 4 Reagent Notices The CD ROM RAX055 delivered with your instrument provides Reagents Controls and Calibrators leaflets MSDS Latest versions of these documents are available online at 4 www horiba com User Manual 39 Ref RAB271AEN Specifications Reagents Specifications ES 5 5 Waste Handling Precautions 40 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 m Atthe beginning of each day before startup check if the waste container needs to be emptied m During instrument operation do not remove the reagent tubes and the liquid waste tube under any condition m If required waste can be neutralized before being discarded Follow your laboratory s protocol when neutralizing and disposing of waste m Dispose of the waste c
79. a 41 NE flag 114 Needle replacement 181 Neutro Eosino 114 Neutro Lympho 113 Neutrophils 204 NL flag 113 NO flag 116 Noise 116 Normal ranges 33 Notice of Liability 7 Nutritional deficiency 43 Optical bench 194 Optical bench lamp replacement 185 User Manual Ref RAB271AEN Orders Selecting 93 Package Content 16 Parameters CBC Parameters 24 DIF Parameters 24 Units 26 Park syringes position 173 Pathological limits Settings 127 Values 142 Pct calculation 200 PDW calculation 201 Peripherals 20 Pictograms Definition 8 Piercing carriage 193 Platelet agglutination 41 43 Platelet Alarms 107 Histograms 107 Plateletcrit 200 PLT Detection principles 197 Technical characteristics 198 Power Requirements 28 Supply 15 28 Precautions 10 Precision 30 31 Prime cycles 163 Printer 22 Switching off 122 Switching on 74 Printer connection 20 Printer operation problems 178 Printing Results 101 Worklist 92 Problems on results 183 QC export 59 Quality Control QC 56 Quality Control Variation coefficients 152 RBC Detection principles 197 215 Inclusions 43 Technical characteristics 198 RDW calculation 199 Reagent syringe assembly 194 Reagents 38 Bottle Replacement 161 Connection 37 Consumption 39 Controls 77 Location 37 Notices 37 Recommendations 37 Replacement 159 Red blood cells agglutination 43 Reject 104 Removing instrument covers
80. aex 10 2172008 14 41 12 Iv agx 10 31 2008 14 45 we 73 108 mm 13 Iv aex 10 31 2008 14 52 14 Iv Agx 10 31 2008 15 00 mc fico mes 15 Iv agx 10 31 2008 15 06 HGB g dl HCT foz x Nefi5 Intermediate Values Upper Limits PLT eso 103 mm QC Export Target Values Lower Limits Modified ER G Modify Target Mean Mean Target Diff Standard Deviation LJ G 4 Se Variation Coef Controls 142 138 138 140 13 9 13 9 142 144 142 138 141 417 407 416 413 407 403 418 427 414 40 6 413 89 88 89 89 89 89 89 89 89 89 89 Analyzer E E CE 243 242 237 241 230 235 243 237 232 238 223 MCH 145 140 135 140 0 0 0 2 1 43 42 2 40 2 38 2 41 4 1 2 0 63 1 53 0 38 0 44 270 240 210 237 3 7 84 331 Calibration 0 35 117 When control results are not within the acceptable values the parameter results are displayed m inred color if the values are too high m in blue color if the values are too low If any parameter results 2 and or any statistical data 3 are out of ranges perform the following 3 Verify that the analyzed control blood results correlates with control lot 1 If not perform a control identification procedure 4 Rerun the control blood 5 If results still do not match perform a concentrated cleaning and rerun the control blood again See Maintenance amp Troubleshooting To Perform a Concentrated Clea
81. as WBC balance alarm is disabled It is recommended to run these samples in DIF mode Cryoglobulins the increased levels of cryoglobulins that may be associated with various conditions myeloma carcinoma leukemia macroglobulinema lymphoproliferative disorders metastatic tumors autoimmune disorders infections aneurysms pregnancy thromboembolic phenomena diabetes etc may cause an increase in the leukocyte erythrocyte and platelets counts and the hemoglobin concentration The samples should be warmed to 37 C 99 F in a water bath for 30 minutes and then re run immediately afterwards using the analyzer or a manual method Macrothrombocytes in excessive numbers they may affect the leukocyte count by increasing the number of leukocytes counted Erythroblasts high concentrations of erythroblasts may increased the leukocyte count 6 3 2 Interferences on Red Blood Cells RBC The red blood cell dilution contains all of the elements found in the blood erythrocytes leukocytes and platelets During the erythrocyte count the platelets are not counted as they are smaller than the defined minimum threshold In very rare cases with an extremely high leukocyte count the erythrocyte count may be increased It should be corrected especially if the latter is very low in comparison with the leukocyte count Agglutinated red blood cells these may cause a falsely low RBC count Blood samples containing agglutinated red blood cells can be
82. at the instrument has not been placed in the proximity of electromagnetic fields or short wave emissions e g Radar X rays Scanners Cell phones etc Main Power Supply Grounding is required Check that earth wall plug is correctly connected to the laboratory grounding system If there is no such system a ground stake should be used Use only main supply cable delivered with the instrument Main power supply voltage fluctuations must not exceed 10 of the nominal voltage Connections to supply have to be done by your local representative See also m Grounding p 15 m Power Requirements p 28 User Manual 15 Ref RAB271AEN Introduction Operational Conditions ES 2 T 2 8 2 9 16 Environmental Protection Used Accessories and Consumables Disposal Disposable used accessories and consumables must be collected by a laboratory specialized in elimination and recycling of this kind of material according to the local legislation Instrument Disposal with European Directive 2002 96 EC on Waste Electrical and Electronic Equipment WEEE This product should be disposed of and recycled at the end of the useful life in accordance and or European Directive 2006 66 EC on batteries and accumulators Q If any doubt please contact your local representative 4 Storage Conditions and Transportation Instrument storage temperatures from 20 C 4 F to 50 C 122 F A Prior to the shipping of an i
83. ative Heating coil initialization Operating temperature not Wait for a few minutes reached User Manual Ref RAB271AEN Maintenance and Troubleshooting Pentra ES 60 Error Messages Reagents No diluent check level Diluent reservoir empty Replace the diluent container See Maintenance and Troubleshooting Reagents Replacement chapter Reagent low level Reagent name Replace the reagent bottle See Maintenance and Troubleshooting gt Reagents Replacement chapter Reagent low level Message triggered at the end Control the reagent levels and replace of the startup it if needed See Maintenance and Troubleshooting gt Reagents Replacement chapter Drain sensor time out Chamber and or syringe Please contact your local draining problems HORIBA Medical representative Transfer sensor time out Transfer problem with LMNE Please contact your local matrix sample HORIBA Medical representative Miscellaneous Message Possible cause Corrective action Emergency stop run an autocontrol Blocked motor Control the motor operations in Incorrect drains Mechanical Systems Check Thermal door opened Motors Service menu in not reaching home Blocked motor Please contact your local HORIBA Medical representative Thermal door opened Open during a cycle Close the door and rerun sample Illegal time Incoherent time entered by Enter correct time operator Data not saved value out of range Incorrect value entered by Enter correct value operator Use
84. ave selected in the list To Run the Specimen D Prepare the specimen and start the analysis on the instrument Access Main screen gt Run tab You have checked selected or printed your list of orders to prepare the specimen See Worklist chapter Recommendations on the analysis mode selection CBC or DIF When selecting CBC analysis there is no control mode on WBC erroneous countings that v may be caused by specific treatments on patients and WBC LMNE BAS balance is automatically disabled see Specifications gt Limitations chapter and Workflow gt Results Interpretation gt WBC LMNE BAS balance chapters 1 Enter Run tab File Service Setting BB oe b E E Worklist Results OC and Calibration Logs l Analyzer Zen H Sample ID Patient Number Patient Name Gender D D B Test Running Date g fren DIF 1172472008 04 11 18 PM RBC 108 mm3 0 00 L HGB g dl or HET DI MCV um MON MCH pg T NEU MCHC g d 7 EOS RDW X BAS WBC 103 mm3 LYM ALY MPV um LIC PCT GI Analyzer Alarms Suspected Pathology PDW Z User Manual Ref RAB271AEN Workflow Pe ntra ES 60 Running Blood Specimen The next specimen to run is shown in the Next field 2 If you need to run another specimen than the one shown in the Next field you can a Enter your new sample identification in the Sample ID field b Press Enter key to confirm If this identificati
85. bly to ensure an adequate seal 4 Install this new reagent bottle into the reagent compartment and close the door A Properly dispose of the empty reagent container Follow your local regulations for reagent disposal 5 In the Analyzer tab double click the reagent bottle icon to replace User Manual 161 Ref RAB271AEN Maintenance and Troubleshooting Maintenance Pe ntra ES 60 6 Inthe Reagent Replacement dialog box enter the new reagent s Lot Number indicated on reagent packaging 060329K2 7 Enter the new reagent s Expiration date and click OK in the Reagent Replacement dialog box to save your modifications 8 Inthe Logs Comment dialog box enter a comment to update the reagents log 9 Click OK to validate A prime cycle is automatically launched by the instrument 10 When the priming is finished the Analyzer tab is updated 162 User Manual Ref RAB271AEN Pentra ES 60 ABX CLEANER EOSINOFIX BASOLYSE II 0605161 O60606G1 0605161 060329K2 060505H1 mees E eia baal Fedre wel EI Pun Reus OC and Calibration Logs 12 05 2007 ERRO EE suene AS Maintenance and Troubleshooting Maintenance ABXLYSE ABX DILUENT 20000 12 05 2007 Viene b 3 The reagent log has been updated in the Logs tab 1 2 3 To Prime Reagents See also To Replace the Diluent Container p 159 To Prime Reagents p 163 To Replace the Wast
86. boratory workload and stored at 4 C Sample stability was assessed over a period of 72 hours The results mean of ten consecutive tests conclude with a relative sample stability claim of 48 hours for the CBC parameters and 24 hours for the DIF parameters User Manual 35 Ref RAB271AEN Specifications Sample Collection and Mixing ES 4 3 4 4 36 Sample stability at room temperature Ten normal and ten pathological specimens were collected from the routine laboratory workload and stored at room temperature 25 C Sample stability was assessed over a period of 72 hours The results mean of ten consecutive tests conclude with a relative sample stability claim of 48 hours for the CBC parameters and 24 hours for the DIF parameters Microsampling Instrument sampling mode enables the user to work with 100 uL microsamples for pediatrics and geriatrics On microsampling tubes the 100 uL volume can only be used in the following conditions m Thetube must always be held in vertical position m 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 minimum required level will be lost Mixing Blood samples must be gently and thoroughly mixed just before sampling This ensures a homogeneous mixture for measurement User Manual Ref RAB271AEN Specifications ES Reagents Specifications 5 Reagents Specifi
87. cation 37 Priming 163 Replacing 161 Cleaning cycles 167 Cleaning sample carriage 169 Cleaning Concentraded 167 CO flag 117 Coefficients of variation 124 Cold agglutinins 42 Communication 131 Computer 25 Connections 21 Connections 20 Computer 21 Diluent 19 Power supply 19 Waste 19 Control blood 56 Copyright 8 Correlation 117 Counting principles BASO 201 WBC 201 Counting Assembly 193 Syringe 194 Covers Removing 156 Creating control lot 58 Creating Account 138 Blood type 126 Worklist 88 Cryoglobulins 41 Database setup 137 Database Deleting 141 Restoring 140 Saving 139 Declaration of Conformity 7 Decontamination 165 Detection principles 213 RBC PLT 197 DHSS 202 Diluent tank 193 Diluent Input 19 Location 37 Priming 163 Replacing 159 Dilution 182 Dilution ratios 29 Dimensions 28 Disposal Accessories 16 Consumables 16 Instrument 16 Drain chambers 174 Draining syringe 193 Electromagnetic Environment Check 15 Electronic and Moving Parts 11 Environment 14 Environmental Protection 16 Eosinofix Location 37 Priming 163 Replacing 161 Eosinophils 204 Error messages 188 Erythroblasts 41 European Legislation 37 Exporting QC data 59 Flags 104 Flowcell 202 Giant platelets 43 44 Grounding 15 HCT measurement 199 Hematocrit 199 Hemoglobin 199 Hemolysis 41 43 HGB measurement 199 Humidity conditions 15 2
88. cations In order for the instrument to operate correctly high quality reagents must be used HORIBA Medical provides a full range of reagents These reagents are used for in vitro diagnostic All these reagents are manufactured by HORIBA ABX SAS B P 7290 34184 MONTPELLIER Cedex 4 FRANCE Phone 33 0 4 67 14 15 16 Fax 33 0 4 67 14 15 17 Refer to the reagent notices for Pentra ES 60 available online at www horiba com Q The reagents specified for this instrument have been approved in accordance with the 4 European Directive 98 79 EC Annex III for in vitro medical devices HORIBA Medical manufactures and markets reagents calibrators and control bloods A specially designed for use with this analyzer The use of products not recommended may give erroneous results or instrument operation problems For all information regarding the recommended products please contact your local representative 5 1 Reagents Location D Locate the instrument reagent bottles the diluent container and the waste container All the reagent bottles are installed into the instrument reagent compartment Diluent and waste containers are on the floor below the instrument User Manual 37 Ref RAB271AEN Specifications Reagents Specifications Pentra ES 60 5 2 38 1 ABX Cleaner 2 ABX Basolyse Il 3 ABX Eosinofix 4 ABX Lysebio ABX Alphalyse 80cm Max 5 ABX Diluent 6 Waste container Risk of
89. ce a day for a prolonged period on all parameters The results were used to quantify the Within Run precision and the Total Precision in accordance with the CLSI EP 5 A Guidelines Parameter ABX Minotrol SD of Run SD of Daily Total precision Control Means Means ID JX108 Low 0 001 0 001 WBC JX108 Normal 0 008 N A N A 0 013 JX108 High 0 031 N A N A 0 045 JX108 Low 0 000 N A N A 0 000 RBC JX108 Normal 0 001 N A N A 0 001 JX108 High 0 002 N A N A 0 003 JX108 Low 0 001 N A N A 0 001 HGB JX108 Normal 0 002 N A N A 0 007 JX108 High 0 005 N A N A 0 0012 JX108 Low 0 021 N A N A 0 025 HCT JX108 Normal 0 064 N A N A 0 122 JX108 High 0 104 N A N A 0 181 JX108 Low 6 271 N A N A 20 646 PLT JX108 Normal 40 229 N A N A 72 103 JX108 High 154 146 N A N A 381 388 Control pria Means CV JX108 Low 1 93 WBC JX108 Normal 0 9 N A N A 1 12 JX108 High 0 9 N A N A 1 05 JX108 Low 0 8 N A N A 0 86 RBC JX108 Normal 0 6 N A N A 0 79 JX108 High 0 7 N A N A 0 88 JX108 Low 0 4 N A N A 0 57 HGB JX108 Normal 0 3 N A N A 0 59 JX108 High 0 4 N A N A 0 60 User Manual Ref RAB271AEN Specifications Pe ntra ES 60 Summary of Performance Data Parameter ABX Minotrol Within Run CV CV of Run CV of Daily Total precision Control Means Means 470 JX108 Low 0 99 HCT JX108 Normal 0 7 N A N A 0 97 JX108 High 0 7 N A N A 0 89 JX108 Low 3 1 N A N A 5 69 PLT JX108 Normal 2 6 N A N A 3 46 JX108 High 2 5 N A N A 4 01 Expected Precision on control samples Paramete
90. cidal Fungicidal Active on Aspergillus fumigatus Active on Mycobacterium tuberculosis B K Antiviral VIH HBV and rotavirus Product Example validated by HORIBA Medical ANIOS detergent disinfectant WIP ANIOS ref 1316 424 Q See also the W H O World Health Organization guidelines Laboratory Biosafety 4 Manual 2nd edition for further information Instrument internal cleaning Counting chambers and hydraulics parts are decontaminated by using the Concentrated cleaning procedure See Hydraulic Maintenance gt To Perform a Concentrated Cleaning chapter Sampling probe Sampling probe must be decontaminated as follows User Manual 165 Ref RAB271AEN Maintenance and Troubleshooting Maintenance Pentra ES 60 1 5 166 1 Prepare a solution of Sodium Hypochlorite to 100ml l 2 Fill a 5ml tube with this solution 3 Run 5 analysis on bleach See also m To Perform a Concentrated Cleaning p 167 Hydraulic Maintenance DD Perform the required maintenance cleaning cycles 1 5 1 Cleaning Frequency One of the main factor contributing to accurate and reliable results is to have a well maintained instrument Several maintenance functions are available for the user to clean and check the instrument First follow the cycle frequencies indicated in the table below lt 100 analyzes per day gt 100 analyzes per day Startup 1 per day 1 per day Shutdown 1 per day 1 per day Cleani
91. ck All if you need to print the entire list See also To Create a New Worklist p 88 To Open Archived Worklist p 91 Running Blood Specimen p 93 Worklist Overview p 86 Worklist Icons Description p 88 Worklist Keyboard Shortcuts p 54 To Select the Order to Run p 93 User Manual Ref RAB271AEN Workflow ES Running Blood Specimen 4 Running Blood Specimen 4 1 To Select the Order to Run D Select the order you want to run in the worklist Access Main screen gt Worklist tab You have previously defined the orders The instrument runs priorly Q m The first selected order in the worklist 4 m fno order is selected the order following the last that has been run m f no order is selected and no analysis has been done yet the first order of the list 1 Click the Worklist tab 2 To select one order click the order holding Ctrl key Worklist The selection of the order to run is indicated as P Shownin the left column of the list 3 1611 horiba 212 assay horiba D 833 abx 3 To select several orders click the orders holding Ctrl key User Manual 93 Ref RAB271AEN Workflow Running Blood Specimen 4 2 94 Pentra ES 60 The selection of the orders to run is indicated as shown in the left column of the list Selected 3 1611 orders are the next to be run from the top to horiba 212 assay horiba the end of the list 899 abx You can now run the specimens that you h
92. d result in a falsely low count Manual methods may be necessary to obtain the platelet count Hemolysis hemolyzed samples contain a red blood cell stroma which may affect the platelet count Citrate blood Blood anti coagulated with citrate may contain platelet aggregates which could decrease the platelet count RBC Inclusions including Howell Jolly bodies Heinz bodies siderotic and basophilic granules etc may cause falsely elevated platelet counts Platelet agglutination the accumulation of platelets may cause a low platelet count The sample should be repeated and drawn into a sodium citrate anticoagulant tube to rule out the anticoagulant as a cause of aggregation and run again to determine the platelet count alone The final platelet count should be corrected making allowance for the dilution caused by the sodium citrate Platelet agglutination triggers the alarms L1 LL and LL1 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 DIF 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 Parenteral treatment Interference
93. e 2 In the Main screen gt QC and Calibration tab gt Controls tab select the lot to export from the Current Target list 1 Worklist Run Current Target CONTROLS PXT8N DIF Aa Gelz RuvingDae wec Rec Je mcr mc Jur 2 M ABX 11 06 2008 03 02 PM Results QC and Calibration Logs l Analyzer MCH 11 06 2008 02 46PM 7 3 455 141 40 3 87 252 30 3 73 4 63 140 388 86 243 30 3 Barcode 1 al Iv Agx 11 07 20080828AM 7 5 4 66 142 40 2 86 252 30 4 Px lt 118N 4 v ABX 11 07 2008 02 11 PM 7 3 4 80 145 420 88 244 301 Expiration Date 01 05 2009 3 Click QC Export 2 4 Click OK to confirm QC export WBC 75 103 mm RBC i75 108 mm3 HGB 42 gd Her faos dx dh Intermediate Values 8 5 4 30 147 42 9 30 272 31 9 er Limits prp 103 mm QC Export 2 ses 75 Am 142 409 86 242 233 wer Limits 65 460 137 389 82 202 279 Modified O oen Modify Target Mean 74 469 142 406 87 248 303 Mean Target Diff 0 1 0 06 03 1 5 04 UTE Standard Deviation 007 008 019 097 oe 516 012 be GEN Variation Coef 10 1852 131 238 om 209 039 m This function copies following information to floppy disk header Instrument name lab ID instrument serial number lot number file creation date time start period for lot use end period for lot use expiration date comment user lot comment unit used parameters statistics results lot target
94. e 52 5 Worklist Keyboard Shortcuts eee eerie ese se tenete tesa nan an asa sa sain ansa 54 Quality Aesurance EEN 55 User Manual i Ref RAB271AEN ES 1 Quality ng EE 56 2 Patient Quality Control XB eee Ite te eee se setate tease tasas tatus na nanas 61 EMis icniae 64 EU TT aa 66 CN LOS C E 71 ing s 73 1 Start of DAY 74 2 Running Quality Control Blood rrenan ra rerarara raras 80 she WMT IC 86 4 Running Blood Gpechmen een 93 5 Results Managem sesenta tnnt Prada HS RR EE XE RR RSS UR KR anna 98 6 Results Interpretatio uinea seco puniendi Raia 104 FEES as ia ud eee ice edna nea coma 120 ri le EE 123 1 Setting TN NN e si 124 Ho 139 3 Instrument Default Settings eei eereeeeeennete tenete tenent 142 Maintenance and Troubleshooting sess 155 1 cl cnr m 156 2 Troubleshooting Procedures ee e eseeseenenenn nennen nene 177 Dt E 188 Description and Technology 191 1 Pentra ES 60 DescripHol soie oio aiti Ee Ran 192 2 Measurement Principles rrnt
95. e Container p 164 Reagents Location p 37 Reagents Description p 38 Reagent Notices p 39 Instrument Reagent Consumption p 39 Waste Handling Precautions p 40 D m Prime reagents into the instrument m Unprime all reagents from the instrument Access Service Hydraulic Systems Prime Cycles tab Run these cycles to prime reagents into the instrument after service has been performed or after a reagent replacement for example User Manual Ref RAB271AEN 163 Maintenance and Troubleshooting Maintenance Da T ES AN 1 3 164 Mechanical Systems Hydraulic Systems Technician Adjustment Technician measurement Burn in cycle Miscellaneous Drain Chambers Rinse Cleaning Cycles Prime Cycles Diluent ABXLyse Cleaner All Reagents Eosinofix Basolyse Il Unprime All m Click the button corresponding to a reagent to prime it or click All Reagents to prime them all at a time m Click Unprime All to remove all reagents from the instrument See also To Replace the Diluent Container p 159 To Replace a Reagent Bottle p 161 To Replace the Waste Container p 164 Reagents Location p 37 Reagents Description p 38 Reagent Notices p 39 Instrument Reagent Consumption p 39 Waste Handling Precautions p 40 To Replace the Waste Container D Replace the waste container whenever this one is filled up When disposing of waste protective clothing must be worn lab c
96. e to a sample enhances the result rendering quality Internal parameters used in the result calculation are adjusted to the sample according to known hematological criteria Twenty different blood types can be created Type is defined by a set of Thresholds that trigger Suspected Pathologies Panic and normal ranges on parameters Alarms levels Matrix and histograms thresholds This access is protected by a password Enter 421 and click OK to validate 4 User Manual Ref RAB271AEN See also m Results Interpretation p 104 m Instrument Default Settings p 142 125 Settings Setting Menu em a ES AP 1 2 1 To Create a Blood Type m Define or modify a blood type m Apply standard values or copy values from another type m Set this type by default Access Setting gt Type Parametering 1 Select a field in the list and click Modify Default type Type Nam Standard Standard Set As Default Type JJ Standard 2 Man 3 Woman 4 Newbom 5 Infant B Child 2o Modify Copy Paste Apply Standard Values A Accept X Cancel 2 Enter the password and type in a new name 3 Click Accept to validate You can either apply standard values or values from another type a To copy paste types select the type you want to copy click Copy and place the cursor in an empty field of the list or on the type you want to apply values Then click Paste b To apply standard values
97. e usually expressed as a function of lower and upper limits that have been determined via statistical studies They may be established by the biologist according to the analytical techniques used or possibly verified when data from scientific publications is used The expression reference value is preferable to usual value or normal value Reliability Precision Aptitude of a measuring instrument to give very similar indications during the repeated application of the same measurand under the same measurement conditions Repeatability Closeness of the agreement between the results of successive measurements of the same measurand measurements undertaken entirely in the same conditions of measurement Reproducibilty Closeness of the agreement between the results of measurements of the same measurand measurements undertaken under a variety of measurement conditions Result of a measurement Value attributed to a measurand obtained by measurement Specimen To avoid any confusion with the term sample in the following context group of individuals from a population it is preferable to use the term specimen to designate a biological sample blood specimen urine specimen etc Specimen blank Signal resulting from certain properties of the environment in which the analyte is found Ideally it results from a signal measurement undertaken under the conditions of the reaction on the sample that does not contain the analy
98. eagent packaging 080509H1 mm cwm 05 08 2003 5 Enter the new Diluent s Expiration date and click OK in the Reagent Replacement dialog box to save your modifications 6 In the Logs Comment dialog box enter a comment to update the reagents log 7 Click OK to validate A prime cycle is automatically launched by the instrument 8 When the priming is finished the Analyzer tab is updated 160 User Manual Ref RAB271AEN Maintenance and Troubleshooting ES ei Maintenance Q The reagent log has been updated in the Logs tab A See also To Replace a Reagent Bottle p 161 To Prime Reagents p 163 To Replace the Waste Container p 164 Reagents Location p 37 Reagents Description p 38 Reagent Notices p 39 Instrument Reagent Consumption p 39 Waste Handling Precautions p 40 1 2 2 To Replace a Reagent Bottle D Replace an empty reagent bottle Access Main screen gt Analyzer tab At instrument startup the remaining quantity of each bottle is compared to the daily workload set up by the user If a low level is expected during the working day a dialog box appears You can click OK and go on running specimen until the dialog box appears again Then the bottle must be changed 1 Open the front door and remove the empty bottle from the reagent compartment Uncap a new reagent bottle Insert the stopper assembly tube into the new bottle and tighten the stopper assem
99. eck the following m Check operational conditions described in Introduction gt Operational Conditions chapter w m Check all instrument and workstation connections To know more about connections see Introduction Label and Connections chapter m Checkif the waste container needs to be emptied Follow instructions in Specifications Reagent Specifications Waste Handling Precautions chapter 1 Switch the workstation on 2 Switch the instrument on 3 Wait during initialization The Login window is displayed 4 Login as abx no password required Press Enter key to validate The Pentra 60 Range Workstation login window is displayed You can now log in the application See also Operational Conditions p 14 Waste Handling Precautions p 40 Computer Connections p 21 Diluent and Waste Connections p 19 Peripherals Connections p 20 User Manual Ref RAB271AEN 75 Workflow Start of Day Pentra ES 60 1 3 2 To Log in the Application SD Log in the application with your user name and password m The login window must be displayed m Your user profile must have been priorly created Q To enter the application each user must be logged in with its own username and an 4 associated password refer to Settings gt Users chapter HORIBA 1 Select a username from the Operator drop down list 2 Type in your password in the Password field 3 Click OK
100. er Lysing reagent for DIF count ABX Eosinofix Diluent used for the dilutions ABX Diluent Lysing reagent for WBC BAS ABX Basolyse Il 194 User Manual Ref RAB271AEN Description and Technology Pentra ES 60 Pentra ES 60 Description Main board Located on the left side of the instrument the board is fastened onto a door in order to allow access to the fluidic modules Main functions of the board m Amplifies processes and counts the following signals m Resistive signals and LMNE optical signals m RBC signal m PLT signal m WBC BAS signals m Measures hemoglobin m Pilots the motorised elements v Be careful not to disconnect the flat cables while opening the board support panel User Manual 195 Ref RAB271AEN Description and Technology Measurement Principles 2 1 196 2 Measurement Principles Multi Distribution Sampling System MDSS CBC mode In CBC mode 30yl of whole blood is aspirated then delivered with reagents into chambers as follows 1 Diluent 2 Air 3 7uL discarded 4 10uL for the BAS WBC count 5 10uL for RBC PLT dilution 6 3yL discarded DIF mode In DIF mode 53ul of whole blood is aspirated then delivered with reagents into chambers as follows 1 Diluent 2 Air 3 5yL discarded 4 25uL for the LMNE matrix 5 10uL for the WBC BASO count 6 10uL for the first RBC PLT dilution and the HGB measurement 7 3yL discarded ES User Manual
101. er information may be obtained from your authorized representative If this instrument has been supplied to you by anyone other than HORIBA Medical or an User Manual Ref RAB271AEN 1 2 Introduction ES Warning and Precautions Safety Precautions 1 2 1 Electronic and Moving Parts The following parts must not be handled or checked by the user m Electrical Power supply m Electronic circuit boards Operator injury may occur from an electric shock Electronic components can shock and injure the user Do not dismantle the instrument nor remove any components covers doors A panels and so on unless otherwise instructed within this document 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 Protection covers must not be opened during instrument operations Opening the doors and Y Moving parts It is strictly forbidden to disable sensors as it may cause operator injuries covers during instrument operations causes the instrument emergency stop 1 2 2 Biological Risk Consider all specimens reagents calibrators controls etc that contain human specimens extracts as potentially infectious Use established good laboratory Ad working practices when handling specimens Wear protective gear gloves lab coats saf
102. erroneous results if the diluent container is installed further than 80 cm 32 in below the instrument Diluent input tubing cristal 3x6 2 meters 80 in maximum Waste output tubing cristal 4x6 2 meters 80 in maximum Reagents Description Pentra ES 60 must be used exclusively with the following reagents ABX Diluent 10 Liters or 20 Liters for RBC PLT dilution sleeving and cleaning ABX Cleaner 1 Liter integrated for cleaning ABX Basolyse II 1 Liter integrated for WBC BAS differentiation WBC counting reference ABX Eosinofix 1 Liter integrated for LMNE and immatures differentiation ABX Lysebio ABX Alphalyse 1 Liter integrated for hemoglobin measurement ABX Minoclair 0 5 Liter non integrated for concentrated cleaning procedure See also Reagents Location p 37 Reagent Notices p 39 Instrument Reagent Consumption p 39 Waste Handling Precautions p 40 To Replace the Diluent Container p 159 To Replace a Reagent Bottle p 161 To Prime Reagents p 163 To Replace the Waste Container p 164 User Manual Ref RAB271AEN Specifications Pe n t Fa ES 6 O Reagents Specifications 5 3 Instrument Reagent Consumption Reagent consumption is given in mL per cycle Cycles ABX Diluent ABX Basolyse Il ABX Cleaner ABX Eosinofix ABX Lysebio ABX Alphalyse CBC 2 1 0 9 0 4 6 20 4 X 0 DIF 25 6 2 1 0 9 d 0 4 60 Startup 60 8 2 1 3 7 1 1 4 3 53 Shutdown 20 5 X 14
103. esentative service department if the hard drive capacity is exceeded Backup duration from 1 to 30 minutes depending on the database weight To get a quick saving a weekly backup is recommended User Manual 139 Ref RAB271AEN Settings Database Pentra ES 60 2 2 To Restore Database D Restore a previously saved database on the Workstation Access File gt Restore Database W Data that have not been saved since the last database backup is lost when a database is restored 1 Open the Restore Database menu The following message is displayed ABX WorkStation Information All New Results will be erased Are you sure you want to restore the database 2 Click Yes to confirm The Restore Database window is displayed Restore Database Look i C3 Backup EI rh E3 base1201 MDB Flenme oO Files of type Database files mdb Coma Q This access is protected by a password Enter 421 and click OK to validate A 3 Choose a database that has previously been saved and click Open to restore it When restoration is over a message appears and the workstation is restarted 140 User Manual Ref RAB271AEN Settings Pe ntra ES 60 Database 2 3 To Delete Database D Erase all the results and worklists of the current database Access File gt Delete Database Q This access is protected by a password Enter 421 and click OK to validate 4 1 Select the De
104. etting He ma Gore FE Bo Worklist Results QC and Calibration Logs Analyzer 10 16 2008 02 42 PM 8 10 16 2008 02 43 PM a 431 134 38 3 31 148 31 2 341 114 10 2 48 1 m iv 10 16 2008 02 44PM 5 4 4 30 134 384 ER 158 31 2 341 115 10 4 46 7 ER Iv ABX 10 16 2008 02 45 PM 5 4 434 134 38 6 31 150 30 9 33 9 11 5 10 4 471 87 Iv ABX 10 16 2008 02 47 PM 5 3 4 28 135 383 92 151 31 4 34 2 11 3 102 46 6 3 0 M 48x 10 16 2008 02 48PM 5 3 4 22 13 4 38 8 92 153 31 7 34 5 11 4 10 5 47 2 8 0 v ABX 10 16 2008 02 50PM 5 4 425 134 381 92 158 31 6 343 113 105 47 5 EN v ABX 10 16 2008 02 51PM 5 4 4 30 134 384 92 151 31 2 341 11 3 10 2 45 7 84 Iv ABX 10 16 2008 02 52PM 5 4 425 134 33 0 92 152 31 6 34 4 11 4 10 5 46 4 ER Iv ABX 10 16 2008 02 54 PM 5 5 427 134 38 0 31 153 31 3 34 3 11 6 10 5 45 7 34 Intermediate Values wec mec Wee Her mev ret meu enc now Mev Joo me z DIF Mean 54 428 134 392 92 1533 313 342 114 104 468 87 ME StanderdDevision 006 oos 003 027 02 339 024 02 on 012 079 04 ee 119 08 019 06 028 222 O76 059 095 114 17 52 Controls Repeatabilty CBC or DIF tests can be done combination is not supported with a limit of 35 results per test Beyond the 35th result data generated from a new analysis are disregarded Results are listed in the first table and statistical calculations are performed in the second one If a variation coefficient in 96 is out of the lim
105. ety glasses and or face shields and follow other biosafety practices as specified in OSHA Blood borne Pathogens Rule 29 CFR part 1910 1030 or equivalent biosafety procedures All accessible surfaces of the instrument can be potentially contaminated by human specimens Disposable gloves and lab coat must be worn by the operator Local and national regulations must be applied in all the operations The manufacturer uses disinfectant product for instrument decontamination and highly recommends it to decontaminate your instrument See Maintenance gt To Decontaminate your Instrument chapter to perform the instrument cleaning and decontamination procedure See also m To Decontaminate your Instrument p 165 User Manual 11 Ref RAB271AEN Introduction Warning and Precautions ES 1 3 Graphics and Symbols O Switch off position Switch on position Alternating current Manufacturer This product conforms to the EC Directives named in the Declaration of Conformity IVD in Vitro Diagnostic medical device Caution consult accompanying documents Biological risk gt Reagent Up gt Fragile handle with care Keep dry Kl Do not stack Temperature limitation B S L Batch code Catalogue number Use by BR Consult Instruction for Use CAL Calibrator Control 12 User Manual Ref RAB271AEN x B B User Manual Ref RAB271AEN ES Content Highly flammable This p
106. following question If there is a possible issue on this please check the user manual corresponding procedures Are there mechanical sampling or dilution problems while analysis cycle is running If obviously no doubt can be made on the analysis cycle operations step to following question If there is a possible issue on this please check the user manual corresponding procedures Are there incorrect results on all parameters or several only If obviously no doubt can be made on the results given by the instrument step to following question If there is a possible issue on this please check the user manual corresponding procedures Are there lots of flags pathology messages or technical alarms If there is a possible issue on the alarms given by the instrument please check the user manual corresponding procedures See also m Operation Problems p 177 m Analysis Cycle Problems p 180 m Results Problems p 183 Operation Problems m Verify peripherals and instrument operations m Control your reagents m Runa startup to check the correct operations 2 1 1 Workstation Power Problems D Follow this procedure if you have problems starting the Workstation 1 Make sure the power cord is connected properly See computer s user manual to connect it 2 Try to restart the Workstation User Manual Ref RAB271AEN 177 Maintenance and Troubleshooting Troubleshooting Procedures ES If nothing happens
107. formation archived 1 Click Add Entry in the Users Log The New Log Entry window is displayed New Log Entry Action I Duration Comment 2 If the fields are not empty click Clear to empty them 3 Enter the action performed its duration and a comment 4 Click OK to validate User Manual Ref RAB271AEN ES Workflow 1 Start of Davi aaa 74 1 1 To Check the Waste Container Level 74 1 2 To Switch On the Printer tete ceeessbede sdenasia casadengsvecs A ERERARS SMS KRERER Ra ER Sd aaa 74 1 3 Starting the Instr mierit iss iuo toco it eae rtt oo Erud sac eph drea Ee rk n edu a ERR VETE E ash cce A 75 2 Running Quality Control Blood errar entente tenute 80 2 1 To Identify a Control Blood with the Barcode Header 80 2 2 To Identify a Control Blood without Barcode Reader ea 81 2 3 To Runa Control BOO rm 82 2 4 To Check Control Blood Hesulte AAA 84 Bc MVORKIIS meer 86 3215 Led de EE 86 3 2 WOrklISE ICONS DescriptiOn sion ee iei prn ette eese e ers k Rx uReAmk A sey de pads Gs aaan ieai AR RR NN EA 88 3 3 To Create New WorkliSt eerie e Eee EERR Eae SERENATA aa ai DRM SREREEKKRATRKRERRRKR eege 88 3 4 TO Sort Re IM L 90 3 5 TO Open Archived Worklist 3 ttr nn E unu int REN RRRMSA SERERE NEAR E Rai RE AR ERR geg 91 3 6 1O Print your WorkiS T 92 4 Runni
108. g Save Restore Users Q Menus displayed in grey are reserved to technicians and are protected by a password 4 User Manual Ref RAB271AEN 49 Software Software Icons Description Pe n t ra ES 6 O 50 3 Software Icons Description RRE ES ES D E A cw if Print Selected Area opens a dialog box to choose printing options Send Selected Areas opens a dialog box to choose sending options Add New Entry creates a new order file Delete deletes selected data Display Search Screen opens the search functionality Zoom List allows to switch from list screen to Order Entry screen also accessible by double clicking the entry Previous File displays previous order in the list Next File displays next order in the list Validate validates result s Rerun Sample allows to program rerun of a non validated order Screen Help opens the instrument s user manual JM Start Cycle Startup runs a startup Start Cycle Shutdown runs a shutdown User Manual Ref RAB271AEN Software Pe ntra ES 60 Software Icons Description AA z X User Manual Ref RAB271AEN Start Cycle Autocontrol runs an autocontrol Start Cycle Cleaning runs a cleaning cycle Start Cycle Backflush runs a backflush cycle Quit Instrument Application closes the instrument application confirmation needed 51 Software Software Functionalities 4 Software Functionalities
109. ge population of cells located on RN RM channel 127 areas The large immature cells flag appears when the number of counted particles 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 limit Suspected abnormalities Promonocytes monoblasts hyper basophilic monocytes Metamyelocytes myelocytes promyelocytes Blasts large monocytes Large neutrophils Values for LIC Standard type are 3 and 0 3 ES These flag values can be defined for each blood type in Setting Type Parametering Alarms and Curve Thresholds tab 6 2 3 4 LL flag Left Lymphocytes Presence of a significantly large population of cells on the left hand side of the lymphocyte area The left lymphocytes flag appears when the number of counted particles is higher than the limit set up in LL or when the number of counted particles versus the number of WBC exceeds the LL limit This flag is associated with an on LYM LYM NEU NEU MON MON EOS EOS ALY ALY LIC LIC Suspected abnormalities Platelet aggregates Small lymphocytes Erythrocyte membrane resistant to lysis stroma Erythroblasts Values for LL Standard type are 100 and 50 These flag values can be defined for each blood type in Setting gt Type Parametering gt Alarms and Curve Thresholds tab User Manual Ref RAB271AEN Workflow ES Results Interpreta
110. granules and may shift on the basophil counting area This may interfere with an accurate count m Anabnormally 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 m 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 Under evaluation in the Basophil count m 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 m The basophils with very small sizes following treatments may interfere with leukocyte counts as cell sizes can not be distinguished m 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 User Manual 45 Ref RAB271AEN Specifications Limitations Pentra ES 60 46 User Manual Ref RAB271AEN ES Software 1 Software OVEIVICW
111. gt Hydraulic Systems gt Drain Chambers cycles Check the chambers are drained and rinsed properly If operations are faulty try to identify the source of the malfunction Q If any doubt please contact your local representative A User Manual Ref RAB271AEN Maintenance and Troubleshooting ES Troubleshooting Procedures 2 3 Results Problems Follow the following procedures if your instrument is no repeatable or if inconsistent flags occur 2 3 1 Problems on all Parameters D Follow this procedure if your instrument is not repeatable on all parameters Open the pneumatic access door Check the sampling operations Control the sampling syringe operations Control the counting syringe operations Ci eet en Perform a concentrated cleaning If these operations appear to be correct and that parameters are still not repeatable please contact your local HORIBA Medical representative If the system appears to be operating properly fresh uncontaminated reagents are used and the precision is within the specifications the instrument may need to be calibrated as described in Quality Assurance Calibration chapter 2 3 2 Problems on RBC PLT and HCT Follow this procedure if your instrument is not repeatable or if inconsistent flags occur on RBC PLT and HCT parameters Open the pneumatic access door Control the carriage motion operations Control the sampling syringe operations quu e Run a
112. he sample with the instrument s v Whole blood parameter results within visible range will still give a result value with a D flag diluent See also m PLT C Flag p 118 m Linearity Limits p 32 106 User Manual Ref RAB271AEN Workflow ES Results Interpretation 6 2 Morphology Flags 6 2 1 Erythrocyte Flags See also m Type Parametering p 125 6 2 1 1 MIC and MAC Flags MIC and MAC flags are triggered off when the percentage of cells counted respectively in the MIC area or MAC area versus the total number of RBC is higher than the limit set by the user m Value for Standard type is MIC 5 m Value for Standard type is MAC 45 MIC MAC 30 100 300 These flag values can be defined for each blood type in Setting Type Parametering Alarms and Curve Thresholds tab 6 2 2 Platelet Flags The PLT histogram contains 256 channels between 2 fL and 30 fL A mobile threshold at 25 fL by default moves according to the microcyte population present in the platelet analysis area See also m Parameter Reject p 104 6 2 2 1 MICP Flag An excessive number of particles on the right side of the threshold area after 25 fL generates the MICP Microcytes flag The mobile threshold looks for a valley between 18 fL and 25 fL standard area It indicates the presence of microcytes in the counting area of platelets If associated with a PLT reject then PLT results are
113. hils count m Inthe optical chamber during the acquisition of the LMNE matrix The reference count is the one obtained in the WBC and Basophils count chamber m Detection principle is the same as for RBC Differentiation betwen Basophils and other leukocytes is obtained by means of the ABX Basolyse Il specific lysing action m All the WBCs are counted between the electrical thresholds from 0 to BAS The basophils are located from threshold BA2 to threshold lt BA3 gt 0 BA1 BA2 BA3 Results WBC The number of cells counted within a specified amount of time per volume X WBC coefficient 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 Technical characteristics for WBC BAS counts Initial blood volume 10 ul CBC or CBC DIF Volume of ABX Basolyse Il 2000 ul Temperature of reaction 35 C Method Impedance User Manual 201 Ref RAB271AEN Description and Technology Measurement Principles Pe ntra ES 60 Technical characteristics for WBC BAS counts Aperture diameter 80 um Count vacuum 200 mb Count period 2 X 6 seconds Final dilution rate 1 200 2 11 LMNE Matrix Count Differential count in the flowcell is based on three essential principles m The Double Hydrodynamic Sleeving System DHSS which allows a linear flow of the cells through the light pa
114. ic assemblies Access Service gt Mechanical Systems gt Initialization tab After an initialization all the mechanical assemblies sampling needle carriages syringes etc return to their initial position which is the operating analysis position To initialize the instrument click Run Q A progression bar is displayed Wait until it stops before doing any other action A 1 6 2 To Check Motors D Control the correct operation of each motor Access Service gt Mechanical Systems gt Check Motors tab 1 Switch off the instrument 2 Open both the right cover and the left cover of the instrument 3 Loosen the two screws of the board support panel and open it w Be careful not to disconnect the flat cables while opening the board support panel 4 Switch on the instrument 5 In the Check Motors tab click the button corresponding to a motor User Manual 171 Ref RAB271AEN Maintenance and Troubleshooting Maintenance Pe ntra ES 60 Sampling Needle check the needle up and down operations The movements should be smooth and regular Carriage Syringe check the right and left movements of the carriage Sampling Syringe check the smooth and complete movement of the syringe Draining Syringe check the smooth and complete movement of the syringe Counting Syringe check the smooth and complete movement of the syringe Cytometer Syringes check the smooth and complete movement of the syringe
115. ical validation The first consists following a series of assays of verifying with appropriate controls that the principal errors have been maintained within acceptable limits The second involves ensuring the coherence of the result in its clinical context by comparing it with any previous results and with the results of other analyses requested for exploring the same function Validation Validation of methods Verification process that involves comparing the values of performance criteria as determined during the characterization study or experimentation phase test phase of the analytical method to those initially expected or assigned acceptable limits objectives to be attained and then to declare whether the method of analysis is valid or not see definition of the standard EN ISO CEI 17025 5 4 5 1 Validation technique A validation technique is a technique that following exhaustive study literary and experimental research is designated for use as a reference of exactitude for comparative assays or titrations of control sera It is chosen from amongst the reference techniques or selected by national or international companies or by consensus It has acceptable and recognized levels of precision and practicability It should be described in detail tested in several laboratories and include the definition of the equipment controls required on the apparatus the description of the various reagents and specifications the conditi
116. idated Rerun can not be required Red Rerun has been required An entry for the new run has been created in the worklist OR Jl aa cd RO Bes M fair oc osavase ra ron RBC s WBC I 30 100 300 Em E E E FEI The next specimen to run is shown in the Next field 2 See also m To Rerun Last Analysis from the Run Tab p 97 96 User Manual Ref RAB271AEN Workflow ES Running Blood Specimen 4 4 To Rerun a Specimen from the Worklist D Rerun a specimen when you need to verify results Access Main screen gt Worklist tab The specimen results must not be validated 1 Open your worklist 2 Select the order you want to rerun 3 Click the Rerun Sample icon see Worklist gt Worklist Icons Description chapter The entry is then duplicated at the end of the list and is part of entries to analyze You can now prepare the specimen to run the analysis See also m Worklist Icons Description p 88 4 5 To Rerun Last Analysis from the Run Tab D Rerun last analysis if you need to verify results Access Main screen gt Run tab The specimen results must not be validated 1 Click Run tab The last analysis is displayed The Rerun indicator is white See Running Blood Specimen gt Run Menu Overview chapter 2 Click the Rerun Sample icon See Worklist gt Worklist Icons Description chapter The entry is then duplicated at the end of the worklist and is part of entries
117. in PLT result may occur for samples from patients undergoing parenteral treatment with injection of lipid emulsion 6 3 10 Interferences on the Mean Platelet Volume MPV Giant platelets their volume exceeds the upper threshold defined for platelets and they are not therefore included in the calculation of the mean platelet volume by the analyzer The MPV value may be falsely lowered Very small erythrocytes microcytes the presence of red blood cell fragments schistocytes and white blood cell fragments may interfere with the accurate determination of the mean platelet volume Red blood cell agglutination may trap the platelets causing an incorrect MPV Red blood cell agglutination may be detected by observing abnormal MCH and MCHC values and by examining a stained blood smear Chemotherapy may also affect platelet volume Blood samples collected in EDTA will not maintain a stable Mean Platelet Volume Platelets collected in EDTA swell with time and temperature 6 3 11 Interferences on Lymphocytes LYM The presence of erythroblasts and erythrocytes that are resistant to lysis may cause an inaccurate lymphocyte count Limitations to the leukocyte count also apply to the determination of the number absolute value and percentage of lymphocytes 6 3 12 Interferences on Monocytes MON The presence of large lymphocytes atypical lymphocytes lymphoblasts and excessive numbers of basophils may cause an inaccurate monocyte
118. its set by the user in Setting gt QC and Calibration menu the value s background turns to red To get a proper CV calculation the results containing defaults generated directly from the analyses channels are rejected In that case the message Rejected result not recorded is displayed In the first table each line provides the following information User Manual Ref RAB271AEN Quality Assurance Yea 1 Mon ES Repeatability Sample number Name of operator Running date and time Value for each parameter These results can be printed and or deleted A See also m Precision Claims p 31 m To Perform a Repeatability p 65 3 2 To Perform a Repeatability D Check the repeatability of your instrument Access Main screen gt QC and Calibration tab gt Repeatability tab A fresh normal human blood is needed 1 Select the type of test on which you want to do a repeatability CBC or DIF Test 2 Run the blood sample The results are archived in the list 3 Wait until LED is green for next run 4 Repeat steps 2 and 3 between five and ten times with the same blood sample 5 Check the values calculated to know whether or not repeatability is good See also m Repeatability Overview p 64 m Precision Claims p 31 User Manual 65 Ref RAB271AEN Quality Assurance Calibration 4 1 66 4 Calibration Calibration Overview Pentra ES 6o Access Main scree
119. lete Database menu The ABX Workstation Information window is displayed ABX WorkStation Information Are You Sure You Want To Delete The Database All Results will be erased 2 Click Yes to confirm deletion When deletion is completed a message is displayed and the workstation is restarted User Manual 141 Ref RAB271AEN Settings Instrument Default Settings Pentra ES 60 3 Instrument Default Settings The following values are the software default values for pathological limits and thresholds alarm levels and LMNE matrix thresholds They are classified by types standard man woman child 1 child 2 and child 3 3 1 Pathological Limits and Thresholds Standard Parameter Panien Normani Norman Panis WBC 3 00 4 00 10 00 13 00 RBC 3 50 3 80 6 50 6 50 HGB 9 50 11 5 17 0 18 0 HCT 34 0 37 0 54 0 54 0 MCV 70 80 100 110 MCH 25 0 27 0 32 0 34 0 MCHC 32 0 32 0 36 0 36 0 RDW 10 0 11 0 16 0 17 0 PLT 100 150 500 550 MPV 6 6 11 i2 PCT 0 0 15 0 50 1 00 PDW 7 11 18 20 NEU 0 0 99 9 99 9 LYM 0 0 99 9 99 9 MON 0 0 99 9 99 9 EOS 0 0 99 9 99 9 BAS 0 0 99 9 99 9 NEU 1 70 2 00 7 50 8 0 LYM 1 00 1 00 4 00 5 00 MON 0 0 20 1 00 1 50 EOS 0 0 0 50 0 70 BAS 0 0 0 20 0 25 ALY 0 0 2 5 2 5 LIC 0 0 3 0 3 0 ALY 0 0 0 25 0 25 LIC 0 0 0 30 0 30 142 User Manual Ref RAB271AEN Pentra ES 6o Man Settings Instrument Default Settings EE CHE EC RBC HGB HCT MCV MCH MCHC RDW PLT MPV PCT PDW NEU
120. llected using proper technique A Consider all specimens reagents calibrators controls etc that contain human specimens extracts as potentially infectious Use established good laboratory A working practices when handling specimens Wear protective gear gloves lab W coats safety glasses and or face shields and follow other biosafety practices as specified in OSHA Blood borne Pathogens Rule 29 CFR part 1910 1030 or equivalent biosafety procedures When collecting blood specimens venous blood is recommended but arterial blood may also be used in extreme cases Blood collection must be placed in vacuum or atmospheric collection tubes For additional information on collecting venous and capillary blood samples refer to CLSI document H3 A6 dec 2007 and CLSI document H4 A5 june 2004 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 Recommended Anticoagulant The recommended anticoagulant is KSEDTA with the proper proportion of blood to anticoagulant as specified by the tube manufacturer K2EDTA is an acceptable alternative as long as the sample collection is made in normal conditions Otherwise blood clots may be possible Blood Sample Stability Sample stability at low temperature Ten normal and ten pathological specimens were collected from the routine la
121. losicencu aicut ina natan aC cuca fia den xag Eco Uu ne aCR MES 196 ii User Manual Ref RAB271AEN Pentra ES 60 EKOT Te E 1 Glossary of Ku euin ioo Ed S User Manual Ref RAB271AEN Pentra ES oo User Manual Ref RAB271AEN ES Foreword 1 Revisions 2 Legal a ue Le E 2 1 Declaration of Conformity 2 2 Notice of Liability 2 3 TradermarKs E zs APMC EET TETTE URL LLL LLLI 2 5 User Manual Symbols iret ether eege ERE Fees u exer ged HERR ERE e YEAR Dex YEAR RDea s 2 6 Copyright amp 2009 by HORIBA ABX SAS User Manual 5 Ref RAB271AEN Foreword Revisions Pentra ES 60 1 Revisions RAB271AEN 2 5 x July 2009 This document applies to the latest software version listed and higher versions When a subsequent software version changes the information in this document a new electronic issue CD ROM and or online help is released and supplied by HORIBA Medical To update a paper document please contact your local HORIBA Medical representative 6 User Manual Ref RAB271AEN 2 1 2 2 2 3 Foreword ES Legal Information 2 Legal Information Declaration of Conformity This instrument responds to the Standards and Directives named in the Declaration of Conformity Latest version of the CE Declaration of Conformity for this instrument is available on www horiba com Notice of Liability The information in this manual is distributed on an As Is basis without warranty While every
122. m Hag fiso m 10 mm gt I I XI XI 1 XI I 1 XI XI X1 E tu X HCT PLT 10 27 2008 ENS Standard Deviation 017 007 02 063 039 784 035 fox 4 LA Graph Variation Coef 237 154 143 153 04 331 117 Controls ep ili Calibration 1 Current target This area provides information about the control lot selected in the QC lot numbers list The lot number barcode expiration date and parameters values can be modified by clicking Modify Target If you replace or modify a lot all previous data concerning this lot will be lost User Manual Ref RAB271AEN Quality Assurance DAN i a ES Quality Control 2 Control s runs results The results displayed in this area are those of the control lot selected in the QC lot numbers list It is possible to select or unselect a result For example clear the first checkbox to discard the first result Results which are out of the limits defined in the Target Values window are blue too low or red too high 3 Parameters statistics This area provides statistics calculated from the selected results If you select unselect results the statistics are automatically recalculated If a variation coefficient in 96 is out of the limits set by the user in Setting QC and Calibration menu the value s background turns to red 4 z L J Graph Levey Jennings L J graph is a graphical representation of quality control data It is based o
123. ment and disconnect the power supply cable 3 Open the pneumatic access door right side of the instrument 4 Lift locker to free the needle 5 Disconnect the tube from the top of the needle carefully and replace the needle 6 Re assemble in reverse order User Manual 181 Ref RAB271AEN Maintenance and Troubleshooting Troubleshooting Procedures ES 182 7 Check the motion of the needle go in Service Mechanical Systems Check Motors tab and click Sampling Needle 8 Shut the pneumatic access door and run a startup cycle w When Startup is done make sure there is no leakage 2 2 3 Hydraulic Controls D Follow this procedure to check dilution sequences in the chambers Access Service gt Mechanical Systems gt Check Motors tab 1 Open the pneumatic access door 2 Carriage motion Run a Carriage Syringe check cycle The carriage should move over the chambers to the right and returns back to its left position If operations are faulty try to identify the source of the malfunction 3 Sample distribution Run a Sampling Syringe check cycle The movements of the syringe should be smooth and complete If operations are faulty try to identify the source of the malfunction 4 Drain Run a Draining syringe check cycle The movements of the syringe should be smooth and complete If operations are faulty try to identify the source of the malfunction 5 Drain and Rinse Run a Service
124. n QC and Calibration tab Calibration tab At first the message Results Will Be Erased Please Confirm is displayed If you click OK the current list is deleted If you want to keep it click Cancel 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 File Service Setting SE bel Gales ek Run QC and Calibration Results Logs Analyzer Sea Sel 0p _ Running Date Jr Rec nuce Hcr RT 1 Wax 11 07 2008 13 57 101 472 135 34 23 Lot Number 2 48x 11 07 2008 13 59 joi 466 135 369 253 cae Q 3 48x 11 07 2008 14 01 p9 4756 137 39 245 Bets 4 Iv aex 11 07 2008 14 03 101 4 66 136 371 246 5 Iv Aex 11 07 2008 14 04 hoo 4 70 135 372 234 6 Iv aex 11 07 2008 14 06 100 467 135 36 9 249 By fio 1 103 mm gt n 74 108 mm fi 38 g dl E 3 N 5 po 103 mm3 Target Values 101 474 138 383 240 wem Actual Coef 12651 20077 4518 2027 27172 Modified On New Coef 12651 20077 4518 2027 27172 ons 1 07 2008 Modify Target Mean 101 470 135 372 244 Variation Coef 092 087 06 097 289 Controls XB Calibration 3 Repeatability 1 Current target This area provides info
125. n analytical process or instrument Conventionally true value of a quantity Value attributed to a specific and recognized quantity sometimes by convention as the representative for an appropriate uncertainty for a given use Correction Value that is algebraically added to the raw result of a measurement to compensate for a systematic error m the correction is equal to the opposite of the estimated systematic error m Since the systematic error cannot be precisely known the compensation cannot be complete Correlation coefficient Quotient of the covariance of two characteristics by the product of their standard deviations It expresses the possible relationship between two variables that are known to be independent Its value must only be tested in comparison with zero according to a chosen risk It is usually of no interest in technical comparisons Default setting Original factory setting Deviation Value minus its reference value Error Result of a measurement minus a true value of the measurand Bias User Manual 207 Ref RAB271AEN Glossary Glossary of Terms ES Error of trueness of a measuring instrument Systematic indication error of a measuring instrument The trueness error is normally estimated by taking into account the mean of the indication error on an appropriate number of repeated observations Exactitude Precision Closeness of the agreement between the result of a measurement and the true
126. n be defined for each blood type in Setting gt Type Parametering gt Alarms and Curve Thresholds tab 112 User Manual Ref RAB271AEN Workflow ES GE Results Interpretation 6 2 3 9 NL flag Neutrophils Lymphocytes Presence of a significantly large population of cells located in the separation threshold area between lymphocytes and neutrophils The neutro lympho flag appears when the number of counted particles is higher than the limit set up in NL or when the number of counted particles regarding the total number of WBC exceeds the NL limit This flag is associated with an on m LYM LYM m NEU NEU Suspected abnormalities m Small neutrophils without granules and or slightly segmented m Lymphocytes with a segmented nucleus or Activated lymphocytes m Neutrophils with membrane weakness Values for NL Standard type are 963 and 120 These flag values can be defined for each blood type in Setting Type Parametering Alarms and Curve Thresholds tab 6 2 3 10 MN flag Monocytes Neutrophils Presence of a significantly large population of cells located in the separation threshold area between monocytes and neutrophils The mono neutro flag appears when the number of counted particles in this area is higher than the limit set up in MN or when the number of counted particles in MN versus the total number of WBC is above the MN limit This flag is associated with an on m ALY ALY m LIC LICH
127. n certain cases of membrane resistance partial lysis of red blood cells may be observed These unlysed red blood cells may cause an erroneously high white blood cell count These unlysed red cells can be detected on the WBC curve via an L1 alarm or in the form of an elevated base line of the lateral ascending section of the lymphocyte population Multiple myeloma the precipitation of immunoglobulins in patients with multiple myeloma may give elevated WBC counts User Manual 41 Ref RAB271AEN Specifications Limitations ES 42 Hemolysis hemolyzed specimens contain an erythrocyte stroma which may cause elevated white blood cell counts Platelet agglutination the accumulation of platelets may cause an elevated white blood cell count Platelet agglutination triggers the alarms L1 LL and LL 1 Leukemia leukemia can cause fragility of the leukocytes and subsequent destruction of these cells during the count thus resulting in an abnormally low white blood cell count These leukocytic fragments may also interfere with the various parameters of the differential white cell count An abnormally low leukocyte count may also be seen in patients with chronic lymphoblastic leukemia due to the presence of abnormally small lymphocytes which may not be counted by the analyzer Chemotherapy cytotoxins and immunosuppressants may weaken the leukocyte membranes and result in a low leukocyte count In these particular cases CBC mode must not be used
128. n the daily value for each control parameter its target value and range that are plotted on a graph for a periodic review 29 1 HONZ 1 0 6 NEUX 62 5 EOS 4 43 BASX 3 3 5 LYM amp 2 07 MON 0 0 04 NEUR 4 4 44 EOS 0 0 31 BASH 0 25 Next graph EST T H fi Operator Running Date 09 23 2008 10 07 46 For each parameter a curve is displayed A point on a curve represents a control blood analysis It is possible to move the marker black vertical line to switch from one analysis to another This changes the number in the Seq field and the results on the right To move the marker you can either m click and drag m use the horizontal scroll bar m use the keyboard left and right arrows Each parameter has a normal value in black a high limit in red and a low limit in blue If a mean value of a result is higher or lower than the limit set up by the user the points of the curve then turn to red or blue Click Next Graph to display more parameters User Manual 57 Ref RAB271AEN Quality Assurance Quality Control Pentra ES 60 See also m Worklist Overview p 86 m QC and Calibration p 124 m To Create Modify a Control Lot p 58 m To Export Quality Control Data p 59 m To Identify a Control Blood with the Barcode Reader p 80 m To Identify a Control Blood without Barcode Reader p 81 m To Run a Control Blood p 82 m To Check Control Blood Results p 84 1 2
129. n the right side of the X axis m NEUTROPHILS The neutrophil is larger in size than the lymphocyte It contains granular material in its cytoplasm along with a segmented nucleus Due to these cellular features more light will pass through neutrophils in the flowcell As a result neutrophils go higher on the Y axis and spread along the X axis according to their maturity Hyper segmentation and increased granules place this population higher along the Y axis m EOSINOPHILS The eosinophil is somewhat like the neutrophil It contains granular material and segmented nuclei within the cytoplasm The granular material is colorized with a reagent before passing through the light beam in the flowcell Due to the colorization action of the reagent the eosinophils are placed in the highest part of the Y axis Hyper segmentation and increased granules place this population in the top right area of the matrix Additional parameters LIC Large Immature Cells and ALY Atypical Lymphocytes complete the matrix spectrum of cellular placement Immature granulocytic cells are detected by their larger volumes and by the increased granules 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
130. ncrease in the base line of the ascending section of the WBC curve An erroneous hemoglobin concentration also causes erroneous MCH and MCHC values User Manual Ref RAB271AEN Specifications ES Limitations Fetal blood the mixing of fetal and maternal bloods may produce a falsely elevated hemoglobin value 6 3 4 Interferences on Hematocrit HCT Red blood cells agglutination can cause an inaccurate HCT value Red blood cell agglutination may be detected by observing abnormal MCV and MCH values and by examining a stained blood smear In such cases manual methods may be required to obtain an accurate hematocrit value 6 3 5 Interferences on the Mean Cell Volume MCV Red blood cell agglutination can cause an inaccurate MCV value Red blood cell agglutination may be detected by observing abnormal MCH and MCHC values and by examining a stained blood smear 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 careful examination of a stained blood smear may reveal the error 6 3 6 Interferences on the Mean Corpuscular Hemoglobin MCH The interferences cited for HGB and RBC affect the MCH and may cause inaccurate results 6 3 7 Interferences on the Mean Corpuscular Hemoglobin Concentration MCHC The interferences cited for HGB and the HCT affect the MCHC and may cause inaccurate results 6 3 8 Interference
131. nects AJ through a USB port or any other hot pluggable port such as IEEE 1394 infrared and so on you do not need to use this wizard Click Cancel to close the wizard and then plug the printer s cable into your computer or point the printer toward your computer s infrared port and turn the printer on Windows will automatically install the printer for you To continue click Next 2 Follow the instructions They will guide you through the new printer installation Pentra ES co User Manual Ref RAB271AEN Settings Pentra ES 60 seking venu 1 4 4 Cycle Option m Set approximate number of CBC and DIF runs per day m Seta frequency for autocleaning m Enable automatic startup Access Setting gt System Setting gt Cycle Option tab Daily workload approximate number of DIF and CBC runs per day used to warn the operator if reagent level is too short for the working day Autoclean Frequency number of analyses performed to trigger an autoclean cycle Select the Enable Automatic Startup option if you want the analyzer to automatically launch a Startup at the beginning of the day See also m To Schedule an Automatic Startup p 79 User Manual 135 Ref RAB271AEN Settings Setting Menu Pentra ES 60 1 4 5 Units and Language m Define the Units set D m Set the software language m Set the keyboard properties Access Setting gt System Setting gt Unit Language
132. next order in the list Rerun Sample programs rerun of a non validated order This entry is then duplicated at the end of the Worklist screen Sample ID Patient Name Patient Number Birthdate and Gender fields become non modifiable 3 3 To Create a New Worklist D Create a new list of orders everyday before starting analyses and save previous worklist Access File gt New Worklist 1 Enter the File menu and select New Worklist An empty worklist is opened 88 User Manual Ref RAB271AEN Workflow Pentra ES 60 Worklist 2 3 User Manual When a new worklist is created the previous worklist is automatically stored in archive file Click the Add New Entry icon The Order Entry screen is displayed U Standard Enter the order data a Sample ID or beep the tube label if you use barcode and press Tab key to move to the next field Select the On option and click Apply in the Sample ID Autonumbering area to increment the Sample ID field each new entry from a predefined value Choose DIF or CBC from the Test drop down list default test is DIF Enter Patient Name or select a suggested name of the drop down list Select the Department Enter the Birthdate Select Gender Male Female or Unknown Select the Type Standard by default Enter the Patient Number Physician Collect Date and Comment if necessary 2075920075 Double click the Order Entry screen or click the Zo
133. ng J Without Alarms cS NE mo Within the Normal Range Within Extreme Values R5232 Settings ABX Format m Reset sets to zero the communication between workstation and instrument The results waiting for transmission are erased and line can transmit or receive normally Q m Testing performs a serial port connection assay with LIS only for ABX and ASTM 4 protocols with current configuration takes and frees the line Messages indicate whether the communication is working correctly or not ABX Format Selected items are transmitted QC and Calibration Type Parametering Parameters Restricted Date Time Printer Cycle Option Unit Language Analyzer ID Setting Save Restore Users Numerical Results Flags And Pathologies Patient File Iv WBC Flags Lk Patient Number v Sample ID Iv WBC IV LMNE Flags v Patient Name v Collect Date Iv LYM amp H LYM LH RBC Flags Iv Birthdate Iv Date Of Analysis M MONS v MONZ Iv Plt Flags Iv Age Iv Test M NEU v NEU IV Gender v Analyzer Sequence Number M EOS v E0S d GE RE VV Physician 7 Number of Runs KE BASS v BAS a E Department V Operator D ALY ALY Iv WBC Pathology v Comment LCH T UC Iv RBC Pathology Iv Analyzer Number IV Plt Pathology Iv RBC Iv PLT V HGB Iv MPV 3 IV HCT Pet Histograms and Thresholds H MCV Pow IV WBC Histogram Iv WBC Threshold M MCH MV RBC Histogram v RBC Threshold M MCHC IV Plt Histogram Iv Plt Threshold Iv
134. ng Blood SPS cme nse Seege 93 4 1 To Select the Order to Run sssssssssssesesseseeeeeeee nennen nnne nennen nnn nnn nnne nennen nnns 93 4 2 TO Bun Ee VTT 94 AS ek dE e 96 4 4 To Rerun a Specimen from the Worklet nennen 97 4 5 To Rerun Last Analysis from the Run Tab 97 5 Results EIN ET E 98 5 1 Results Menu Cverniew ENEE 98 5 2 Results Icons Description ite pk e XR XRXRN RR Rar ERRSRA AA CRM MPERREFEKRRAREERREKRRRKRR eins 99 5 3 To Search Patients Results eerte teretes tun ernaia REISEN RRARRIARARRANRRNENNR SEE RRDARRRRREA 100 5 4 To Print your Besults n enirn n inerte iie pem Eb ecd 101 5 5 To Send Results to the LIS nnne nnne nnns nennen nnns 103 6 Results InherpretAtiOn icd das sta Saddi 104 SNNCICBar 104 6 2 Morphology Flags EE 107 6 9 Suspected Pathologles 2 2 e etie ert Lane ten era coti ens ud Lasse send aano ie dni ee nives Ranae en lobes 114 6 4 Analyzer ALAIN IS aii esser ete ce i nam SE iat fe e Ee endi akc ea 116 ric odo RY spas ida DS T 120 7 1 Instrument Inactivity and Automatic Cleaning ese 120 7 2 Re Ree Ce 120 7 3 STOPPING the Instr ment re Rune nr EXTERN Rana S CNEURERR SER EREERRERRKR ER RENE RR xA aaa 121 User Manual 73 Ref RAB271AEN Workflow Start of Day ES 1 Start of Day 1 1 To Check the Waste Container Level 1 Check the level of waste in the container 2
135. ng cycle automatic after 2 hours standby automatic after 2 hours standby Concentrated cleaning 1 per month 2 per month Sample carriage cleaning 1 per month 1 per month 1 5 2 To Perform a Shutdown SD Perform an instrument shutdown before ending your work session Access Main screen gt Shut Down icon The main screen has to be displayed 1 Click Shut Down 2 Wait during shutdown cycle Once the shutdown is completed the instrument can be switched off User Manual Ref RAB271AEN Maintenance and Troubleshooting Pentra ES 60 Maintenance 1 5 3 To Perform a Cleaning Cycle D Follow this procedure to run a Cleaning cycle Access Service gt Hydraulic Systems gt Cleaning Cycles tab After two hours off the system automatically asks the user to run this cycle 1 Inthe Cleaning Cycles tab click Cleaning This cycle performs a chamber rinsing and primes reagent that could remained into the heating coil 1 5 4 To Perform a Concentrated Cleaning Follow this procedure to give the counting chambers a thorough cleaning in case of a poor repeatabilty or failed startup Access Service gt Hydraulic Systems gt Cleaning Cycles tab Prepare a 5mL syringe a bottle brush and ABX Minoclair It is highly recommended to use ABX Minoclair for these cleaning operations Refer to the Material Safety Data Sheet for handling precautions Sodium Hypochlorite concentration 1 3 of active
136. ning chapter If results still do not match you may need to re calibrate your instrument See Quality Assurance gt Calibration chapter before attempting any calibration operation User Manual Ref RAB271AEN Pentra ES 60 User Manual Ref RAB271AEN Workflow Running Quality Control Blood See also m To Create Modify a Control Lot p 58 m To Export Quality Control Data p 59 m To Identify a Control Blood with the Barcode Reader p 80 m To Identify a Control Blood without Barcode Reader p 81 m ToRuna Control Blood p 82 m Quality Control Overview p 56 m Worklist Overview p 86 m OC and Calibration p 124 m To Perform a Concentrated Cleaning p 167 m Calibration Overview p 66 85 Workflow Worklist 3 1 86 3 Worklist Worklist Overview Access Main screen Worklist tab The worklist provides the list of orders to perform those currently in analysis and those already run New orders can be created from this menu These ones include all the patient data and the test to carry out Worklist screen description Two views are available m oneisa list with one analysis by line m oneisa detailed view of each field of the patient Order Entry refer to Worklist To create a new Worklist chapter 16 test 17 test2 18 tst3 19 CX118 20 CX118 21 0x118 22 CX118 23 CX118 24 CX118 25 PX118N 06001 tst3 465431 4656 8300 Cx118 OC and Calibration CALI 6 CALI am
137. nnn nrentn nnn nnne n nn 19 3 4 Peripherals Connectloris ieis rnit eu p yon a a EXER aaa a ak Ea E ERR asa Ran SEO dna inn REENEN 20 3 5 Computer CONNECTIONS E 21 3 6 Warnings and Biological Risks Labele 21 4 Printer udo b Od tM tn cdd MM a UEM Ra Ac ND IM d DUE 22 User Manual 9 Ref RAB271AEN Introduction Warning and Precautions ES 1 1 10 1 Warning and Precautions Work safety reliability and general characteristics are guaranteed by HORIBA Medical under the following conditions m User manual must be entirely read and personnel trained by HORIBA Medical before attempting to operate the instrument m The user always operates with full knowledge and appreciation of instrument warnings alarms and flags m Always refer to labelling and HORIBA Medical instructions in order to avoid to compromise system integrity This instrument must be operated as instructed in the user manual Any other use might compromise System integrity and might be hazardous for the operator This instrument complies with Standards and Directives named in the Declaration of Conformity The latest version of the Declaration of Conformity for this instrument is available online at www horiba com m Thereagents and accessories stipulated by HORIBA Medical have been validated in accordance with the European Directive for in vitro medical devices 98 79 EC m The use of any other reagents and accessories may place at risk the performance
138. nstrument Access Service gt Hydraulic Systems gt Cleaning Cycles tab Autocontrol cycle A series of mechanical hydraulic and electronic networks control is performed m General rinsing m Control of the correct draining of chambers m Initialization of mechanical assemblies User Manual 175 Ref RAB271AEN Maintenance and Troubleshooting Maintenance ES 176 Cleaning cycle This cycle performs a chamber rinsing and primes reagent that could remained into the heating coil Q After two hours off the system automatically asks the user to run this cycle A Concentrated Cleaning cycle This cycle has to be done to clean the chambers with bleach To perform a concentrated cleaning see Maintenance Hydraulic Maintenance chapter Backflush cycle This cycle delivers pressure through the rear of the apertures to remove blockages Do this procedure if you suspect the apertures are blocked See also m To Perform a Concentrated Cleaning p 167 User Manual Ref RAB271AEN 2 1 Maintenance and Troubleshooting ES Troubleshooting Procedures 2 Troubleshooting Procedures Whatever the issue occuring on your instrument a series of controls can be performed in the following logical order before attempting to carry out any intervention 1 2 3 4 Is there an instrument or peripheral operating issue If obviously no doubt can be made on the system operation step to
139. nstrument by transporter whatever the destination an external VW decontamination of the instrument must be carried out Before instrument removal from use transportation or disposal perform a general cleaning and a draining of your instrument See also m To Drain Chambers p 174 Installation A representative will install your instrument printer and software Package content Pentra ES 60 Power supply cable User Manual CD ROM Daily Guide Reagents Controls amp Calibrators CD ROM User Manual Ref RAB271AEN Pentra ES oo Installation kit Workstation Computer keyboard Computer mouse Printer Waste tank User Manual Ref RAB271AEN Introduction Operational Conditions 17 Introduction Labels and Connections 3 1 3 2 18 3 Labels and Connections Serial Number Label HORIBA ABX Rue du Caduc s Parc Euromedecino BP 7290 EN Ei ler Codex 4 T 33 46714 15 16 MADE IN FRANCE Fax 83 4 87 14 18 17 ane M NNI S A Seen FRESUENGY PUISSANCE POWER A 200 W ATTENTION AFIN D EVITER LES RISQUES DE CHOC ELECTRIQUE NE PAS OTER 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 TO REDUCE THE RISK OF ELECTRIC SHOCK DO NOT REMOVE COVER OR BACK
140. o statistical studies on cell distribution within the RBC histogram m MOV Mean Corpuscular Volume of erythrocytes 2 6 MCV MCH MCHC Calculation m 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 m Themean hemoglobin weight in each RBC is given by the formula MCH pg HGB RBC x 10 m 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 m MCHC g dL HGB HCT x 100 2 7 MPV Measurement The MPV Mean Platelet Volume is directly derived from the analysis of the platelet distribution curve 2 8 Plateletcrit Calculation Plateletcrit or thrombocrit is calculated according to the formula Pct PLT 103 mm x MPV um 10 000 200 User Manual Ref RAB271AEN Description and Technology Pe nt ra ES 6 O Measurement Principles 2 9 PDW Calculation 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 platelets starting from 2 fL S1 and 1596 of the number of platelets beginning with the variable top threshold S2 2 10 White Blood Cells Basophils Count Counting principle The WBC count is carried out twice by two different sensors m Inthe WBC BAS chamber at the same time as the Basop
141. oat gloves eye protection etc Follow your local and or national guidelines for biohazard waste disposal m At the beginning of each day before startup check if the waste container needs to be emptied m During instrument operation do not remove the reagent tubes and the liquid waste tube under any condition Make sure no cycle is in progress Unscrew the waste container cap Screw the cap on the full waste container and follow your local and or national guidelines for biohazard waste disposal 4 Close the empty container with the cap User Manual Ref RAB271AEN 1 4 Maintenance and Troubleshooting ES Maintenance See also m To Check the Waste Container Level p 74 m Waste Handling Precautions p 40 To Decontaminate your Instrument D Clean externally and internally the instrument considering the biological environment A m Never spill liquid on the instrument m Never use disinfectant product that contains alcohol All contaminated surfaces covers counting assembly area Slightly wet a sponge with disinfectant product and wipe the dirty surfaces Stainless steel parts Slightly wet a sponge with disinfectant product and wipe the dirty surfaces Dry with a soft cloth Computer screen Use a soft clot slightly wet with disinfectant product Wipe gently the screen and dry to remove any trace of moisture Products having the following microbiological properties Bacteri
142. om List icon to switch to Worklist screen A new entry is added at the end of the list 89 Ref RAB271AEN Workflow Worklist ES If you do not create a new order when you run the sample a new entry is automatically created at the end of the listwith default values KE Test DIF Gender Unknown Type Standard Sample ID Autonumbering n if option selected or empty When you have entered all your orders or received them from the LIS you may proceed to your sample analyses See also m To Open Archived Worklist p 91 m To Print your Worklist p 92 m Running Blood Specimen p 93 m Worklist Overview p 86 m Worklist Icons Description p 88 m Worklist Keyboard Shortcuts p 54 3 4 To Sort Orders D Sort the orders in the worklist according to your criterion Access Main screen gt Worklist tab Analyses already done are always displayed on top of the Worklist screen The default order is given by the Seq column 1 Click once the header of a column to get an increasing order The header turns blue 2 Click twice the header of a column to get a decreasing order The header turns green 3 Click three times to set back to default order Q Age and Comment columns can not be ordered A 90 User Manual Ref RAB271AEN Pentra ES 6o Workflow Worklist 3 5 To Open Archived Worklist D Open a prior worklist that has been saved on the Workstation
143. on human blood using a minimum of 5 dilution points The results of this study are as follows Linearity Range Linearity Limits Visible Range WBC 103 mm3 0 40 to 130 80 0 to 120 120 to 150 x 0 3 7 596 RBC 109 mm3 0 23 to 9 76 Diop 8 to 18 x 0 07 x 396 HGB g dL Oto 31 06 0 to 24 24 to 30 x 0 3 2 396 HCT 96 1 80 to 88 90 0 to 67 67 to 80 2 3 PLT 103 mm for 3 30 to 2007 O to 1900 1900 to 2800 10 12 596 HGB gt 2g dL PLT 10 mm for 7 to 2895 0 to 2800 2800 to 3200 x 10 12 596 HGB 2g dL amp PLT 15x103 mm See also m Glossary of Terms p 206 m Results Exceeding Instrument Capacities p 34 Carry over Source 510K submission K030144 The Pentra ES 60 carry over effects were evaluated by running a sample with high cell concentration three consecutive times H1 H3 then running a diluted sample consecutively 3 times L1 L3 Carry over L1 L3 H3 L3 x 100 FW 102mm RBC 109 mm HGB g dL PLT 103 mm Mean Low level 1 06 1 58 5 28 31 33 Mean High level 58 81 6 37 22 03 1106 67 Actual Carry over 0 26 0 0 179 0 186 Claimed Carry over lt 2 lt 2 lt 2 296 Method described in Guidelines for the Evaluation of Blood Cell Analyzers including those used for Differential Leukocyte and Reticulocyte Counting and Cell Marker Applications ISLH 14 January 1994 User Manual Ref RAB271AEN Specifications Pe nt r A ES 60 Summary of Performance Data See al
144. on is found in the current worklist the order is automatically associated to this new entry 3 Prepare your specimen according to the specific instructions detailed in Specifications Sample Collection and Mixing chapter Blood specimen must be thoroughly and gently mixed with a gentle up and down and rolling motion before any measurement 4 Plunge the sampling needle into the specimen tube and press the start bar fg 5 Remove the tube when the light indicator stops flashing The LED turns to red 6 Recap the specimen tube m Inthe worklist the order in progress is highlighted in red m When the LED turns to green again the instrument is ready for the next analysis You can now review the results of the analysis See also m Worklist p 86 m Sample Collection and Mixing p 35 m Known Interfering Substances p 41 m WBC LMNE BAS Balance p 117 User Manual 95 Ref RAB271AEN Workflow Running Blood Specimen Pe ntra ES 60 4 3 Run Menu Overview Access Main screen Run tab From this screen you can display the last analysis require a rerun validate results prepare next analysis Status of last analysis in the Run tab The status of the displayed analysis is shown by the Results status indicator square 1 Indicator color Status of the results White Specimen results have not been treated yet Validation and Rerun are possible Green Results have already been val
145. only The result is presumed erroneous it must be checked with a rerun sample or with L1 flag l on WBC and on absolute values of the 4 reference method if the second result differential parameters applied on patients jg still flagged results only LMNE suspicion EEE EE Action OO I flag on WBC I on BAS BAS LYM LYM96 MONK MON EOS EOS96 NEU NEU ALY ALY LIC LIC parameters applied on patients results only HGB gt 17 5 g dL or invalid is generated on BAS BAS LYM LYM MON MON NEU NEU EOS EOS parameters applied on patients results only LMNE or LMNE or MB or on BAS BAS LYM LYM96 MON LN flag MON EOS EOS96 NEU NEU ALY ALY LIC LIC parameters LL flag l on LYM LYM MON MON EOS EOS96 NEU NEU ALY ALY The result is presumed erroneous it must LIC LIC parameters be checked with a rerun sample or with a RN flag I on NEU NEU LIC LIC reference method if the second result is still flagged parameters RM flag l on MON MON NEU NEU LIC LIC parameters NL flag l on LYM LYM NEU NEU parameters MN flag l on ALY ALY LIC LIC parameters NEU NEU MON and MON are reported to NE flag I on LIC and LIC NEU NEU EOS and EOS are reported to User Manual 105 Ref RAB271AEN Workflow Results Interpretation Pe ntra ES 60 6 1 3 Normal and Panic
146. ons of storage and use of the reagents the operating procedure the calibration or standardization method the nature of the calibrators and the control method Verification EN ISO 10012 Confirmation by examination and establishment of proofs that the specified requirements have been met Whole blood Non diluted blood blood and anticoagulant only User Manual 211 Ref RAB271AEN Glossary Glossary of Terms Pentra ES 60 212 User Manual Ref RAB271AEN ES Index A Absorbance 203 Account Creating 138 Modifying 138 Accuracy 33 Adding log entry 72 Agglutinated red blood cells 42 43 44 Alarms Levels 146 Alarms Levels 128 Normality 104 Pathological 104 Qualitative 104 Reject 104 suspicion 104 Technical 104 Anticoagulant 35 Aperture diameters 29 Atypical lymphocytes 204 Automatic cleaning 120 Background Noise 15 Balance WBC LMNE BAS 117 Barcode 124 Barcode connection 20 Basolyse Il Location 37 Priming 163 Replacing 161 Basophils Counting principles 201 Technical characteristics 201 Thresholds 201 Blood Sample Stability 35 Blood transfusion 43 Blood types 125 Calibrating instrument 68 Calibration Prerequisites 67 Carriage Maintenance position 173 Carry over 32 Cell count 202 Cells description 204 Changing operator 120 User Manual Ref RAB271AEN Checking motors 171 Checking valves 172 Chemotherapy 41 43 44 Citrate blood 43 Cleaner Lo
147. ontainer according to your local and or national regulatory requirements See also m To Replace the Waste Container p 164 m To Check the Waste Container Level p 74 User Manual Ref RAB271AEN 6 1 6 2 6 3 Specifications ES Limitations 6 Limitations While every effort is taken by HORIBA Medical to investigate and indicate all known A interferences it is not possible to guarantee that all interferences 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 account Maintenance In Maintenance amp Troubleshooting section specific maintenance procedures are listed The maintenance procedures identified are mandatory for proper use and operation of the Pentra ES 60 e Failure to execute any of these recommended procedures may result in poor reliability of the system 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 procedures for conclusive verification of the results The chapter hereunder lists known limitations of automated blood cell counters which use the principles of impedance and light absorbance as principles of measurement Known Interfering Substances 6 3 1 Interferences on White Blood Cells WBC Unlysed red blood cells i
148. ou replace or modify a lot all previous data concerning this lot will be lost 4 Choose the control blood level and click OK to validate Q The last letter of the lot number barcode indicates the control level Choose Low if it 4 ends with an L Medium if it ends with an N or High if it ends with an H 5 Inthe Target Values window click Accept to validate The control lot is modified See also To Export Quality Control Data p 59 To Identify a Control Blood with the Barcode Reader p 80 To Identify a Control Blood without Barcode Reader p 81 To Run a Control Blood p 82 To Check Control Blood Results p 84 Quality Control Overview p 56 Worklist Overview p 86 QC and Calibration p 124 1 3 To Export Quality Control Data D Create a backup file with QC results and statistics on a floppy disk Access Main screen gt QC and Calibration tab gt Controls tab gt QC Export button At least one result must have been recorded User Manual 59 Ref RAB271AEN Quality Assurance Quality Control Pentra ES 60 The backup file created is a csv file readable with a spreadsheet program One file is generated per control lot The naming convention is the following xxx YYYYMMDD csv where xxx is the lot number and YYYYMMDD the file creation date Q RUO parameters PCT PDW ALY LIC are not exported in the backup file A Insert a formatted disk into the floppy driv
149. p CALI 6 CALI 6 CALI 6 CALI 6 CONTROL 8 DIF chirurgie HB2 55 DIF DIF 19020 v7 CBC edeme PREMIER DOSSIER NUMERO 165 0565 DIF echotomogr CALI amp CBC DIF DIF Iu iii i a 2 E em Worklist Fields Seq Sample ID E The sequence number is automatically incremented by the software and is unique When you enter the Sample ID it is compared to the list of reserved numbers corresponding to Control Calibration or Repeatability analyses If its ID already exists the entry is automatically completed If it has not been found it is searched among already run patients and pending ones When it already exists it is rejected to ensure this ID is unique 16 characters max User Manual Ref RAB271AEN ES Patient Name Patient Number Testing Department Birthdate Age Gender Type Physician Collect date Op Comment Workflow Worklist When you enter the Patient Name a search is done among already listed patients Names can be duplicated from a drop down list 30 characters max Provide a number to a patient 16 characters max Switch between DIF and CBC analysis mode Default type is DIF mode Choose from one dynamic list or add a new name 10 characters max of patient blood sampling location Enter patient date of birth MM DD YYYY Age is automatically updated with the patient date of birth Choose from one predetermined list Male Female or Blank
150. pen the right left and top covers of the instrument 1 In Service gt Mechanical Systems gt Maintenance Carriage Position tab click Run to place the carriage in a maintenance position 2 Switch off the instrument and disconnect the power supply cable 3 Unscrew the two screws 1 of the right door with a flat screwdriver 4 Open the pneumatic access door 156 User Manual Ref RAB271AEN Maintenance and Troubleshooting Pentra ES 60 Maintenance 5 Unscrew the four left cover screws 2 with a hexagonal key Remove the left cover Use the hexagonal keys supplied in the installation kit 6 Unscrew the main board tightening screws 3 to open the board support panel User Manual 157 Ref RAB271AEN Maintenance and Troubleshooting Maintenance Pentra ES 60 Nw Be careful not to disconnect the flat cables while opening the board support panel 7 Unscrew the seven hexagonal screws 4 of the top cover 8 Remove the top cover carefully Once you have completed the required maintenance or replacement procedure first place the top cover Then close the main board panel and place the left cover Then close the right door with a flat screwdriver See also m To Park the Syringes p 173 158 User Manual Ref RAB271AEN Maintenance and Troubleshooting ES Maintenance 1 2 Reagents Replacement m Replace empty diluent container or empty reagent bottles m Prime
151. pter 10 After about thirty analyses check values of MCV MCH and MCHC They have to be in conformity with the usual values of the laboratory See also m To Create Modify a Calibrator Lot p 70 m Calibration Overview p 66 m General Recommendations p 67 m OC and Calibration p 124 m Running Quality Control Blood p 80 User Manual 69 Ref RAB271AEN Quality Assurance Calibration Pentra ES 60 4 4 To Create Modify a Calibrator Lot D m Create a new calibrator lot m Modify an existing calibrator lot Access Main screen QC and Calibration tab Calibration tab The calibrator lot you need is not in the Lot Number list or the target values have to be modified 1 Select a calibrator from the Lot Number list 2 Click Modify Target The Target Values window is displayed Target Yalues Current Targe aus 103 mm Lot Number CX118 Barcode CX118 105 mm g di Expiration Date 12 05 2008 D i x Modified On 11 07 2008 109 mm A Accept 3 Enter the values for each parameter and the expiration date detailed in the calibrator package insert w If you replace or modify a lot all previous data concerning this lot will be lost 4 Click Accept to validate The calibrator lot is modified See also m To Calibrate the Instrument p 68 m Calibration Overview p 66 m General Recommendations p 67 m OC and Calibration p 124
152. r User Manual 185 Ref RAB271AEN Maintenance and Troubleshooting Troubleshooting Procedures Pe n t ra ES 6 O A Wait for the lamp to cool down before handling it 4 Unscrew the lamp fixation screws a few turns 186 User Manual Ref RAB271AEN Maintenance and Troubleshooting Pe ntra ES 60 Troubleshooting Procedures 5 Turn the lamp and remove it Replace the lamp by a new one w Do not touch the bulb with your fingers This will reduce significantly the shelf life of the lamp In case of contact clean the bulb with a solution of 90 alcohol and a soft paper 7 Put back the fixation system and block the screws Reconnect the lamp supply 9 Check that instrument operates normally a b c User Manual Ref RAB271AEN Close the right door Connect to power supply and switch on the instrument If the lamp is on wait until startup end switch off the instrument and disconnect power supply cable Then close the instrument covers connect to power supply and switch the instrument on If the lamp is off check the lamp connection remove the lamp and check its filament Try another lamp if possible If it still does not work please contact your local HORIBA Medical representative See also m To Remove Instrument Covers p 156 187 Maintenance and Troubleshooting Error Messages Pentra ES 60 188 3 Error Messages Printer The printer is disconnected switched OFF
153. r of counted particles in the background noise area is higher than the limit set up in NO or when the number of counted particles versus the total number of WBC is above the NO limit Suspected abnormalities Platelet aggregates Large number of platelets Erythrocyte membrane resistant to lysis stroma Erythroblasts Background noise Values for NO Standard type are 96100 and 120 These flag values can be defined for each blood type in Setting Type Parametering Alarms and Curve Thresholds tab 6 3 Suspected Pathologies Suspected Pathologies messages can be displayed and or printed out The triggering conditions are linked to the laboratory limits set by the user 114 User Manual Ref RAB271AEN Workflow Pentra ES 60 Results Interpretation quick and efficient screening of abnormal samples along with detection of certain conditions that lead to specific diagnosis It is recommended to use known reference methods to confirm diagnoses These messages indicate a possible pathological disorder and should be used to assist with 6 3 1 WBC Messages Leukocytosis WBC WBC H Leukopenia WBC WBCL Lymphocytosis LYM gt LYM H or if LYM 96 gt LYM H Lymphopenia LYM lt LYM EL or if LYM 96 lt LYM L Neutrophilia NEU gt NEU H or if NEU gt NEU H Neutropenia NEU lt NEU L or if NEU lt NEU L Eosinophilia EOS gt EOS H or if EOS gt EOS H Myelemia NEU gt NEU
154. r password Password required to carry Enter password out an operation Bad reference position Mechanical problem Please contact your local HORIBA Medical representative User password Password required to carry Enter a valid password out an operation Enter an identification To run an analysis in Enter the identification as described in alphanumerical mode the Workflow Worklist chapter identification is mandatory Language of Pentra changed please restart Language has changed Restart both instrument and the computer and instrument worstation User Manual 189 Ref RAB271AEN Maintenance and Troubleshooting Error Messages Pentra ES 60 190 User Manual Ref RAB271AEN ES Description and Technology 1 Pentra ES 60 DGS Critica acct Saga 192 1 1 Pentra ES 60 Front Gide ee ceeeeeerrecen een eerreeaee nan certeeaeanaenreren isnt r assa aa aser nns 192 1 2 Pentra ES 60 Back Sid ei cessive iii tic rx ee cr rr dm e OD e ER e XY XR DE SS REESEN E ER ARX DAR 193 1 3 Mechanical and Hydraulic Module 193 2 Measurement Principles 1 meses LLL LL ILL Lr ec rr sees na sma atra caes amas ma DE amarus 196 2 1 Multi Distribution Sampling System MIGG 196 2 2 Red Blood Cells and Platelets Detechon nennen nnns 197 2 3 Hemoglobin Measurerri rit iuuat inniti nra tact ein Een ebe EA gege Pago Ra Paco Esas ada dia aka ds 199 2 4 Hematocrit Measurerrient 5 iic n race cine a Fn ec rh En naa
155. rinter 122 User Manual Ref RAB271AEN ES Settings ERST ub c M 124 1 1 QC and Calibration ssseeeeesssseessseeseeeneeenene nennen nennen nnnnn nn nsn na nnns nain rss anser nnn 124 ka lype En Ee DEE 125 NS TEE TEE 129 1 4 System Settings re er ER e ERR eri iz Er oan ux ERE ane dl Saga diana EORR ER sa oul 130 NEO EE I ILU UD LUPIS 138 2 Da t a P iG H 139 2 1 To Save Database saisi renani a EXER RAN RR RARE RR RR ARREST EE RIRRRAPASXRRRANRAX RR RR FER LEE Fa ASNE 139 2 2 TO Restore DatabDa86 3 niri E ex endi ro ER Cost ra xa rera uu ve DR CR E CR VR ERR E EAR 140 2 3 To Delete Database nennen nennen nnnnnn nnns ss neas n nnns ssba nana nissan ases r nsns annuis 141 3 Instrument Default Setlinigs ine enero sndse tas S duni vn qum eqDa ues nde DRN ara dando ita 142 3 1 Pathological Limits and Thresholds AAA 142 3 2 Alarms Levels ensis cer n rr ERE Fade arx ROSE E eA EBERT Ex RUE EE ve a EORR ae REOR RR Apa P LSU YR wa cusses 146 3 3 Matrix Thresholde nennen nena nnns nna snnnssnai sinn ssa a isst snas senses anna 148 3 4 QC Variation ene EE 152 S DAB ETT OLTRE 152 User Manual 123 Ref RAB271AEN Settings Setting Menu ES 1 1 124 1 Setting Menu QC and Calibration m Select barcode identification for Control and Calibration sample m Choose XB mode m Set CV ranges for QC Calibration and Repeatability
156. rmation about the calibrator lot selected in the Lot Number list The lot number barcode expiration date and parameters values can be modified by clicking Modify Target If you replace or modify a lot all previous data concerning this lot will be lost User Manual Ref RAB271AEN Quality Assurance ES Calibration 2 Calibrator s runs results The results displayed in this area are those of the calibrator lot selected in the Lot Number list It is possible to select or unselect a result For example clear the first check box to discard the first result Results which are out of the limits defined in the Target Values window are blue too low or red too high 3 Parameters statistics This area provides statistics calculated from the selected results If you select unselect results the statistics are automatically recalculated If a variation coefficient in 96 is out of the limits set by the user in Setting QC and Calibration menu the value s background turns to red Q Make sure coefficients are within limits detailed in Settings gt Instrument Default Settings 4 Chapter If not please contact your local HORIBA Medical representative See also m General Recommendations p 67 QC and Calibration p 124 To Calibrate the Instrument p 68 To Create Modify a Calibrator Lot p 70 E E E m Calibration Coefficients p 4 2 General Recommendations D Perform these preliminar
157. roduct should be disposed of and recycled at the end of the useful life in accordance with European Directive 2002 96 EC on Waste Electrical and Electronic Equipment WEEE and or European Directive 2006 66 EC on batteries and accumulators Packaging recycling mark Electostatic Sensitive Device ESD DD A nm E Introduction Warning and Precautions Use no hooks Toxic Notice of environment friendly use period Ground 13 Introduction Operational Conditions ES 2 1 2 2 14 2 Operational Conditions Environment The operation of the Pentra ES 60 should be restricted to indoor location use only Instrument is operational at an altitude of maximum 3000 m 9840 ft The instrument is designed for safety from voltages surges according to INSTALLATION CATEGORY II and POLLUTION DEGREE 2 IEC 61010 1 Please contact your local representative for information regarding operation locations when it does not comply with the recommended specifications Location m Place your instrument on a clean and leveled table or workbench e Q Keep in mind that the instrument weighs approximately 35 Kgs 77 Ibs A 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
158. rs Low level Normal level Highlevel 596 496 396 RBC 396 2 596 2 596 HGB 2 596 296 1 896 HCT 596 496 396 MCV 396 2 596 296 RDW 596 596 596 PLT 1596 1096 7 LYM 8 8 8 MON 70 40 30 NEU 8 6 4 EOS 15 13 10 BAS 8 8 8 See also m Glossary of Terms p 206 3 2 Precision Claims Based on ten consecutive runs without alarm of the same fresh whole blood sample WBC 296 4 10 x 103 mm RBC 296 3 6 6 2 x 108 mm HGB 196 12 18 g dL HCT 296 36 54 96 PLT 596 150 500 x 103 mm See also m Repeatability Overview p 64 m To Perform a Repeatability p 65 User Manual 31 Ref RAB271AEN Specifications Summary of Performance Data Pe ntra ES 60 3 3 3 4 32 Linearity Limits Source 510K submission K030144 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 associated to a D flag This visible range is outside manufacturer range Linearity kits linearity was 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 Human Blood linearity was also obtained
159. rted to 6 4 4 MB Flag Meaning Mono BAS MB flag occurs on DIF mode only Conditions The percentage of basophils found in the BAS channel is above the percentage of Lympho Mono Neutro raw counts found on the matrix channel m Small basophils in the ALY area Blasts m Contamination of the basophil channel Possible triggers l on all the 96 and matrix parameters Consequences MONO and BAS in are reported to 6 4 5 WBC LMNE BAS Balance During the initial count of the WBC in the WBC BAS chamber a second WBC count is performed from the injected volume through the LMNE optical flowcell The two counts are compared User Manual 117 Ref RAB271AEN Workflow Results Interpretation ES If the difference between the LMNE and WBC BAS counts is higher than the defined threshold depending on the quantity of cells measured a LMNE or a LMNE flag is generated m The WBC count is within O and 2501 If the WBC LMNE count is 5096 WBC BAS count then LMNE flag is generated If the WBC LMNE count is 5096 WBC BAS count then LMNE flag is generated WBC count is within 2501 and 8000 If the WBC LMNE count is 20 gt WBC BAS count then LMNE flag is generated If the WBC LMNE count is 2096 WBC BAS count then LMNE flag is generated m WBC count is higher than 8000 If the WBC LMNE count is 1596 WBC BAS count then LMNE flag is generated If the WBC LMNE count is 15
160. s Dilution Syringes check the smooth and complete movement of the syringes Piercing Mechanism See also m To Remove Instrument Covers p 156 1 6 3 To Check Valves D Control the correct operation of each valve Access Service gt Mechanical To control the operation of a valve 1 Open both the right cover and the left cover of the instrument 2 In Check Valves tab click the button corresponding to a group of valves Parks 172 User Manual Ref RAB271AEN Maintenance and Troubleshooting ES Maintenance 3 Observe the valve operations carefully the movements have to be straight and regular See also m To Remove Instrument Covers p 156 1 6 4 To Move the Carriage to a Maintenance Position D Get an easy access to carriage assembly during a maintenance Access Service gt Mechanical Systems gt Maintenance Carriage Position This function allows the user to automatically move the sample carriage over the chamber area to simplify maintenance operations such as the replacement of a sampling needle or other maintenance procedures that may require the movement of the sample carriage 1 Click Run to move the carriage to its maintenance position Q A progression bar is displayed Wait until it stops before doing any other action 4 2 Once maintenance is done click OK to let the carriage return to its initial position 1 6 5 To Park the Syringes D
161. s of an analyte for which the technique is applicable without modification Its evaluation requires the establishment of linearity limits and possibly of the detection limit of the technique Synonym Field of measurement range of measurement Analyte Component substance material to be measured in a possibly complex environment Analytical sensitivity In compliance with the Common Technical Specifications CTS the analytical sensitivity refers to the limit of detection i e the small quantity of target marker that can be detected with precision Analytical specificity The capacity of the method to determine only the target marker Bias ISO 3534 1 Difference between the mathematical prediction of the results of the analysis and the accepted reference value Background count Measure of the amount of electrical or particle interference Calibration Set of operations to establish under specified conditions the relationship between the values of the quantity indicated by a measuring instrument or a measurement system or the values represented by a materialized measurement or by a reference material and the corresponding values of the quantity given by standards Calibration factors These are correction factors that the system uses to fine tune instrument accuracy Calibrator A reference material e g solution suspension or device of known quantitative qualitative characteristics e g concentration
162. s on the Red Distribution Width RDW The interferences cited for RBC and MCV affect the RDW and may cause inaccurate results Red blood cell agglutination this phenomenon may cause a falsely low erythrocyte count and an erroneous RDW In the blood samples red blood cell agglutination may be detected by observing abnormal MCH and MCHC values and by examining a stained blood smear Nutritional deficiency or blood transfusion these phenomena may cause elevated RDW results due to iron vitamin B12 or folate deficiencies It is also possible to observe an elevated RDW from the bimodal distribution of red blood cells from transfused blood 6 3 9 Interferences on Platelets PLT Very small erythrocytes microcytes the presence of erythrocyte fragments schistocytes and WBC fragments may interfere with the platelet count giving falsely elevated values Red blood cell agglutination may trap the platelets and cause a falsely low platelet count Red blood cell agglutination may be detected by observing abnormal MCH and MCHC values and by examining a stained blood smear Excessive numbers of giant platelets this phenomenon may cause a falsely low platelet count due to the fact that these giant platelets exceed the upper threshold defined for platelets and are therefore not counted as platelets User Manual 43 Ref RAB271AEN Specifications Limitations ES 44 Chemotherapy cytotoxins and immunosuppressants may weaken these cells an
163. se populations allow the extraction of qualitative information related to the stability of the instrument A maximum of twelve control lots can be created To create a new control blood lot you have to modify a control lot of the Current Target list For each control lot 400 results can be archived in the database Three control levels are available for each test Low Normal High The three controls can be simultaneously active allowing QC on three levels File Service Setting Hi SR eis ideni fal Worklist Results QC and Calibration Logs Analyzer Bare Leo maur PEIES Ee MCH ABX 10 28 2008 16 04 470 142 417 689 243 302 CONTROLS PX038N DIF Barcode 1 Expiration Date 2 10 11 05 2008 m WBC ABX 10 29 2008 13 59 e 4 60 138 40 7 88 242 30 0 ABX 10 29 2008 15 14 74 4 70 13 8 41 6 89 237 234 ABX 10 31 2008 08 23 74 472 140 41 9 89 241 29 7 ABx 10 31 2008 14 32 7 3 4 59 13 9 40 7 8g 230 30 2 10 31 2008 14 39 73 4 61 133 40 9 89 235 30 1 AB 10 31 2008 14 41 71 472 142 41 8 89 243 30 1 ABX 10 31 2008 14 45 AB 10 31 2008 14 52 ABX 10 31 2008 15 00 AB 10 31 2008 15 06 Intermediate Values Upper Limits 483 145 422 270 318 2 103 mm QC Export Target Values 468 140 402 E 240 283 Lower Limits 63 453 135 382 82 210 279 Modified 0 3 ELA Modify Target Mean 72 465 140 414 89 237 30 0 Mean T arget Diff 0 1 0 03 0 0 12 3 3 01 103 mm 13 RBC p m
164. se should be restricted to Research Use Only RUO Q PDW PCT ALY ALY LIC LIC have not been established as indications for use in 4 Not for use in diagnostic procedure 1 3 Throughput Analyses The rate of analysis for the Pentra ES 60 is of 60 samples per hour 1 4 Tube Identification Tube identification can be done either by using m Anexternal keyboard m An external barcode reader optional 1 5 Computer Characteristics Color Screen 15 in B00 x 600px Windows XP Prof Capacity 10 000 results graphics Hard drive 2 partitions CD ROM drive Floppy Disk 2 serial ports minimum USB Keyboard USB Mouse Communication protocols ABX ASTM User Manual 25 Ref RAB271AEN Specifications Technical Specifications Pe ntra ES 60 1 6 1 7 26 Pentra ES 60 workstation application has been validated by HORIBA Medical with Operating System MS Windows XP Prof only The use of any other Operating System might A compromise system integrity engaging the users reponsibility In this case HORIBA Medical takes no responsibility for the device nor for the results rendered The installation of Pentra ES 60 application on any personal computer requires specific settings that must be performed by an HORIBA Medical approved technician Measurements and Computation RBC PLT Impedance WBC BAS Impedance LYM MON NEU EOS ALY LIC Impedance and absorbance HGB Photometry HCT
165. search criterion defined they are displayed in a line mode You can double click a results line to open the results in a full screen mode User Manual Ref RAB271AEN Workflow ES Results Management 5 4 To Print your Results D Print your results on request Access Main screen gt Results tab gt Print Selected Area icon You have selected the results to print in the Results gt All the Results tab 1 Click the Print Selected Area icon and select Results tab 2 Select List to print in a line mode or Ticket to print in a full page with histograms and matrix 3 Click Selected if you want to print only selected results 4 Click All if you need to print the entire list User Manual 101 Ref RAB271AEN Workflow Results Management Pe n t ra ES 6 Q 5 4 1 Ticket Printout HORIBA Medical Parc Euromedecine Montpellier Contact Tel 04 67 14 15 16 Fax 04 67 14 15 17 Patient Name Operator ABX SampleiD tst3 H Bunning Date 11 07 2008 13 50 33 Blood Type Standard Suspected Pathology pg g dl 10 mm pm Morphology Flags Analyzer Alarms Microscopic Examination Anisocytosis L1 oO L1 Neutrophils Metamyelocytes Hypochromia oO LI LI Band Cells E Myelocytes Polychromasia oO LI oO Lymphocytes Promyelocytes Poikilocytosis L1 L1 L1 Monocytes Blasts Microcytosis L1 oO Eosinophils Atypical Macrocytosis LI oO Basophils NRBC s Pits Aggregates oO LI LI Comment
166. so m Glossary of Terms p 206 3 5 Normal Ranges Parameters Mal XN WBC 103 mm 4 10 4 10 RBC 108 mm 4 5 6 5 3 8 5 8 HGB g dL 13 0 17 0 11 5 16 0 HCT 96 40 54 37 47 MCV m3 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 96 11 0 16 0 11 0 16 0 PLT 103 mm3 150 500 150 500 MPV m3 6 11 6 11 PCT 96 0 15 0 5 0 15 0 5 PDW 96 11 18 11 18 LYM 25 50 25 50 MON 96 2 10 2 10 NEU 50 80 50 80 EOS 0 5 0 5 BAS 0 2 GER PDW PCT ALY ALY LIC LIC have not been established as indications for use in Q United States for this instrument Their use should be restricted to Research Use Only RUO 4 Not for use in diagnostic procedure Nw Expected values may vary with sample population and or geographical location It is highly recommended that each laboratory establishes its own normal ranges based upon the local population 3 6 Accuracy Source 510K submission K030144 The data shows a good correlation between the results obtained on Pentra ES 60 and the reference system User Manual 33 Ref RAB271AEN Specifications Summary of Performance Data P e nt r a ES 60 Parameter R comparison of means Accuracy Claims WBC 0 9956 gt 0 95 PLT 0 9978 gt 0 95 RBC 0 9965 gt 0 95 HGB 0 9985 gt 0 95 HCT 0 9992 gt 0 95 LYM 0 9937 gt 0 95 NEU 0 9946 gt 0 95 MON 0 9872 gt 0 95 E
167. spas hee pu ev Reo EXER XE il one du YA FERE RNE 29 3 Summary of Performance Data eee eee eres eee me ena a nan ana tata sna nan an anas 30 3 1 Precision Reproducibilily 5 nan kx eh tno kx hex nere Xue REAA KAREE EAEAP KERNE asa a RRR NE Rae 30 3 2 Precistob RE ET 31 3 9 Pinearity ARIES n c e or rte te Ee ae 32 Bis CANNY OV ERE EET EET EE 32 3 5 Normal Ranges EE 33 3 0 esce O nm 33 3 7 Results Exceeding Instrument Capachtles EEN 34 4 Sample Collection and Mixing eese estes entente tentent 35 4 1 Recommended Anticoagulant 5 2 cxt tendre ser uu ERE ee E NEESS SEENEN E SNR d Ry XR e 35 4 2 Blood Sample Stability E 35 2s Miercoles Y 36 A uen 36 5 Reagents SpecilicallOIIS i iiic cinancdn kann aur pra rb In Ca EREy edad irata aaa rk n Fe ORARE aaa tasca 37 mede EEUU 37 5 2 Reagents DescriptlOri E 38 5 3 Instrument Reagent Copneumption NEEN 39 5 4 Reagent NOUCeS S 39 525 Waste Handling PrecautlOris cta iicet arki Enan AAAA EANA EAER 40 SM Limitation RTT nce cena ates ecm weed ad 41 UNACUM 41 6 2 Blood SPECIMENS ivi sc sess inc roe rade ex ee ria Pe a Vx Sa ea TREE sa X EX Ve RR a VER VERS dO EINE 41 6 3 Known Interfering Gubetances AA 41 User Manual 23 Ref RAB271AEN Specifications Technical Specifications Pe ntra ES 60 1 1 1 2 24 1 Technical Specifications Intended Use This instrument
168. ss door 2 Run a Check Valves cycle to control the correct operation of valves 23 and 14 3 Perform a concentrated cleaning If these operations appear to be correct and WBC and BAS parameters are still not repeatable please contact your local HORIBA Medical representative 184 User Manual Ref RAB271AEN Maintenance and Troubleshooting ES Troubleshooting Procedures 2 3 5 Problems on Differential Follow this procedure if your instrument is not repeatable or if inconsistent flags occur on differential parameters 1 Control the ABX Eosinofix bottle level and expiration date Replace it if necessary See Maintenance and Troubleshooting Reagent Replacement chapter 2 Check that the optical bench lamp works properly when the instrument is on If not follow the user manual procedure to replace it 3 Run a cytometer rinse in Service Hydraulic Systems Rinse menu 4 Rerun the specimen 5 Perform a concentrated cleaning If these operations appear to be correct and Differential parameters are still not repeatable please contact your local HORIBA Medical representative 2 3 6 Optical Bench Lamp Replacement D Follow this procedure to replace the lamp of the optical bench 2mm and 3mm hexagonal keys are required to perform this maintenance 1 Switch off the instrument and disconnect the power supply cable 2 Remove the instrument covers See Maintenance gt To Remove Instrument Covers chapte
169. stricted to Research Use Only RUO 3 PDW PCT ALY ALY96 LIC LIC have not been established as indications for use in Not for use in diagnostic procedure 1 4 System Settings Set date and time Define RS232C output format and communication protocol Set printing options Define instrument s automatic cleaning frequency and daily workload Define unit set and language Define database maximum capacity Save or restore analyzer and workstation settings Manage user accounts m 1 4 1 Date and Time D Adjust date and time according to your country specifications Access Setting gt System Setting gt Date and Time tab 08 35 48 AM EL pen L 3 MMjddiyyyy 4 1 Current Time 2 Current Date 3 Four types of format can be defined for time m hh mm ss ampm from 00 to 12 130 User Manual Ref RAB271AEN Settings Pentra ES 60 iil m h mm ss ampm from O to 12 m H mm ss from O to 24 m HH mm ss from 00 to 24 Q H stands for Hour m for minute and s for second A 4 Three types of format can be defined for date m dd MM yyyy m MM dd yyyy m yyyy MM dd Q d stands for day M for Month and y for year A Click Change Date Time 5 to open the Date and Time Properties window Date and Time Properties Date amp Time Time Zone Internet Time Date Time September 2008 12 3 4 5 6 8 9 10 11 12 13 15 16 17 18 19 20 22 23 24 25 26 2
170. sults p 84 Quality Control Overview p 56 Worklist Overview p 86 QC and Calibration p 124 2 2 To Identify a Control Blood without Barcode Reader D Identify your control blood lot if there is no barcode label Access Main screen gt QC and Calibration tab gt Controls tab m The instrument has to be ready for analysis m The lot number and target values have been previously defined To know more about control blood lot initialization see Quality Assurance Quality Control chapter User Manual 81 Ref RAB271AEN Workflow Running Quality Control Blood Pe ntra ES 60 2 3 82 Q ABX Difftrol this control material is specifically designed for use on Pentra ES 60 which A includes a complete Blood Count and 5 part White blood cell differential CBC amp DIF 1 2 Open the Controls tab File Service Setting Ei steel sz Run SS Results s l Analyzer 11 05 2008 02 46 PM 141 403 2 W 88xX 11 06 20080302PM Ta 463 140 388 66 23 303 3 Iv agx t1 07 200808234M 715 466 142 402 85 252 304 4 IWw aex two7 20080231PM a 480 145 420 88 244 301 IBN CONTROL 10 PXO58L DIF CONTROL 11 PXOS8L DIF CONTROL12 PXD58H DIE 409 x N 4 Intermediate Values Upper Limits 8 5 4 90 147 423 30 272 31 9 242 109 mm QC Export Target Values 75 Am 142 409 86 242 283 Lower Limits 65 460 137 389 8 212 278 Moded Dn EE WE 74 469 142
171. t 29 dL Sondnions amp PLT gt 15x103 mm between 1900x103 mm and 2800x103 mm8 Display and PLT C printout Sending to LIS C See General Flags Results Exceeding Instrument Capacities chapter See also m Results Exceeding Instrument Capacities p 34 118 User Manual Ref RAB271AEN Pentra ES 60 6 4 7 SCL Flag More about Small Cells in Morphology Flags gt Platelet Flags chapter User Manual Ref RAB271AEN Workflow Results Interpretation See also m Platelet Flags p 107 119 Workflow End of Day apar ES RO 7 End of Day 7 1 Instrument Inactivity and Automatic Cleaning Cleaning cycles are automatically required when m Theinstrument has run xx analysis cycles from the date changing xx is defined by the user and set to 75 by default see Settings Setting menu chapter m The instrument has not been used for two hours m The instrument has not been used for four hours In this case a Startup cycle is required before running the cleaning cycle It is mandatory to power down the system if not used for more than a 36 hour period This eliminates the possibility of the dilution chambers evaporating and causing startup problems 7 2 To Change Operator D Switch from one operator to another 1 From the main screen click Quit 2 Choose the Change Operator option ABX Workstation Logout Change Operator C Quit Application X Cancel
172. t Blank log see Quality Assurance Logs chapter If the startup passes the instrument is ready for control blood analysis If the startup fails the instrument can run analyses but a Startup Failed message is displayed on next cycles See Maintenance and Troubleshooting gt Troubleshooting Procedures gt Operation Problems gt Startup Failed chapter It is mandatory to power down the system if not used for more than a 36 hour period This eliminates the possibility of the dilution chambers evaporating and causing startup problems See also m To Run the Specimen p 94 To Perform a Concentrated Cleaning p 167 Logs Overview p 71 Cycle Option p 135 Startup Failed p 179 78 User Manual Ref RAB271AEN Workflow ES Start of Day 1 3 4 2 To Schedule an Automatic Startup Access Setting System Settings Cycle Option tab If the Automatic Startup has been scheduled it is run as soon as connections with instrument have been checked as well as reagents levels 1 Select the Enable Automatic Startup option 2 Restart both instrument and workstation to get an automatic startup Once startup is done results are available in Logs Blank Log menu To know more about Blank Log menu see Quality Assurance Logs chapter If the startup passes the analyzer is ready for analysis If the startup fails the analyzer is ready for analysis but a Startup Failed message is displayed on next cycles
173. te To choose a month use the left and right arrows Then choose the day When done click randomly outside the calendar to close it c2 Today 11 27 2008 53 Worklist Keyboard Shortcuts ES 5 Worklist Keyboard Shortcuts Keys combination Up arrow Ctrl up arrow Down arrow Ctrl down arrow Previous page Next page Left arrow Ctrl left arrow Right arrow Ctrl 4 right arrow Shift down arrow Shift up arrow Tab Shift tab Ctrl delete Escape goes to previous line goes to first line goes to next line goes to last line goes to first line currently displayed cancels lines current selection goes to last line currently displayed cancels lines current selection moves to the left column moves to the first column on the left moves to the right column moves to the first column on the right selects several items downwards selects several items upwards moves to the next cell of the list moves to the previous cell of the list deletes the current selection cancels non saved modifications cancels lines current selection Key Mouse combination Ctrl click selects a line Ctrl shift click selects a block of lines only on entries already done Alt click Double click switch to Order entry screen 54 Switch to Results review only on patients already done User Manual Ref RAB271AEN ES Quality Assurance 1 Quality Control cR c
174. te or on the sample following elimination or inactivation of the analyte Standard Materialized measurement measuring apparatus reference material or measurement system designed to define undertake store or reproduce a unit or one or several values of a quantity to serve as a reference Standard deviation SD Measure of variation within a group samples or within a population Standard error of the mean S E M Statistical parameter indicating the dispersion of values at the level of the mean of a series of measurements Standard uncertainty Uncertainty of the result of a measurement expressed as a standard deviation Shutdown cycle Cleans the instrument s fluidic lines and apertures to help prevent residue build up 210 User Manual Ref RAB271AEN Glossary ES Glossary of Terms Startup cycle Ensures that the instrument is ready to run includes performing a background test Trueness Aptitude of a measuring instrument to give results that are exempt from systematic error Uncertainty Parameter associated with the result of a measurand that characterizes the dispersion of values that could reasonably by attributed to the measurand Validation analytical and biological This is the set of procedures used to ensure that a technique has the required reliability to meet the quality control requirements in the state of the art The validation generally comprises two stages a technical validation and a biolog
175. th HORIBA Medical patent m The cell volume which is measured by electrical current impedance changes 1 m The measurement of transmitted light at a 0 angle which allows a 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 2 m 25yL of whole blood is delivered to the LMNE chamber in a flow of ABX Eosinofix This reagent lyses the RBC stabilizes the WBC in their native forms and stains the eosinophil nuclei with a specific coloration m The solution is then stabilized with ABX Diluent and transferred to the flowcell Each cell is measured both in absorbance cytochemistry and resistivity volume Technical characteristics for WBC counts during acquisition of the matrix Initial Blood volume 25 uL Volume of ABX Eosinofix 1000 uL Volume of ABX Diluent 1000 uL Incubation duration 12s Temperature of reaction 35 C Method Impedance with hydrofocus Aperture diameter 60 um Flow diameter 42 um Injection duration 12s Injected volume 72 uL Final dilution rate 1 80 202 User Manual Ref RAB271AEN Description and Technology Pe ntra E amp 60 Measurement Principles No cell in the flowcell Baseline Poorly stained agranular High cell in the flowcell absorbance Hyper segmented with Low complex granularity and absorbance staining User Manual 203 Ref RAB271AEN
176. tion 6 2 3 5 LL1 flag Left Lymphocytes 1 Presence of a significantly large population of cells on the left hand side of the lymphocyte area The left lymphocytes 1 flag appears when the number of counted particles is higher than the limit set up in LL1 and when the number of counted particles in LL regarding the total number of lymphocytes exceeds the LL1 limit Suspected abnormalities Platelet aggregates Small abnormal lymphocytes Erythrocyte membrane resistant to lysis stroma Erythroblasts Values for LL1 Standard type are 965 and 45 These flag values can be defined for each blood type in Setting Type Parametering Alarms and Curve Thresholds tab 6 2 3 6 LN flag Left Neutrophils Presence of a significantly large population of cells located in the left hand side of the neutrophil area The left neutrophils flag appears when the number of counted particles in this area is higher than the limit set up in LNS or when the number of counted particles regarding the total number of WBC is above the LN limit This flag is associated with an on all WBC differencial parameters Suspected abnormalities m Neutrophil destruction due to incorrect storage of the sample or old sample m Contamination stroma or platelet aggregates Values for LN Standard type are 962 5 and 999 These flag values can be defined for each blood type in Setting Type Parametering Alarms and Curve Thresholds tab User Manual
177. to analyze You can now prepare the specimen to run the analysis See also m Worklist Icons Description p 88 m Run Menu Overview p 96 User Manual 97 Ref RAB271AEN Workflow Results Management Pe n t ra ES 6 Q 5 Results Management 5 1 Results Menu Overview Access Main screen gt Results tab This menu is used to review results from the current worklist to perform a search on patient file to print or to valid results to send or to rerun them Three modes are available View Patients Results tab See Results Management To Search Patients Results chapter All the Results tab DR m dd e Worklist Run Results QC and Calibration Logs Analyzer Seat Joe Sampeib fpaiemtName Patient Number 3 ABX nem DIF Standard 11 07 2 4 ABX net02 DIF Standard 11 07 2 5 ABX testa DIF Standard 11 07 2 6 ABX neta DIF Standard 11 07 2 8 ABX test DIF Standard 11 07 2 3 ABX 06001 DIF Standard 11 07 2 10 ABX 05009 DIF Standard 11 07 2 gt 11 ABX 06010 DIF Standard 11 07 2 17 ABX 06011 DIF Standard 11 07 2 13 ABX 06012 DIF Standard 11 07 2 14 ABX 05013 DIF Standard 11 07 2 15 ABX testl5 DIF Standard 11 07 2 16 ABX testlb DIF Standard 11 07 2 17 ABX test DIF Standard 11 07 2 18 ABX tst3 DIF Standard 11 07 2 3 EXIIT View Patient Results Double click a result line or click Zoom List to display the following window Review Results in full screen mode
178. tor vial with a lint 68 User Manual Ref RAB271AEN Quality Assurance DAN e ES A Calibration Risk of erroneous results if the specimen is not continously mixed between each analysis Keep on mixing the specimen between each analysis 4 Repeat step 3 at least four times In order to get a reliable calibration it is recommended to run at least four calibrator samplings and to discard the first one 3 to 11 samplings can be done for a calibration 5 Discard the first result from the list The instrument calculates the statistical calibration factors for each parameter 6 If the coefficient of variation is within the limits 20 calibration is possible click Calibrate to update calibration coefficients If the coefficient of variation is out of limits calibration is still possible but is Forced as indicated in the calibration log Worklist Run Results QC and Calibration Analyzer m Operator Lot Numer Forced Whe Geet Ribe Geert Hab Geet Het Geet PtCost Log b 10 15 2008 03 41 38 PM ABX CX 108 123 61 205 64 46 35 208 14 276 35 Reagent C Users Technicians C Emors C Startup 7 Click OK to confirm calibration Calibration log is updated Run three times the same calibrator to check the values Run a control blood and check that the values are within acceptable limits If not run a new control blood See Workflow Running Quality Control Blood cha
179. ts that exceed the Panic limits are identified with a flag m H for results above the upper limit m L for results below the lower limit You can now adjust the alarms levels and the thresholds of this type 1 2 3 Curves and Matrix Thresholds Each axis of the matrix X and Y is divided into 128 channels numbered from O to 127 The threshold adjustment is expressed in channels User Manual 127 Ref RAB271AEN Settings Setting Menu ES You can adjust the LMNE matrix thresholds to NON NOE m Improve the separation between different cell populations which can vary according to the anti coagulant in use or instrument internal adjustment m Modifythe flag areas in one way or another to improve their detection sensitivity In this case the numeric adjustment of the NE concerned flag must also be readjusted see Alarm levels m Modify one or several matrix areas in order to define more precisely a specific population for research purposes NL NOL LL AL LMD RM All the WBCs are counted between the electrical thresholds from 0 to BA3 The basophils are located from threshold BA2 to threshold lt BA3 gt 0 BA1 BA2 BA3 Q More information about alarms curves and thresholds in Workflow gt Results Interpretation 4 chapter 1 2 4 To Set Alarms Levels and Thresholds D m Define Alarms levels of a blood type m Adjust thresholds of the LMNE Matrix and histograms of a blood type Access Setting
180. tting gt System Setting gt Printer menu If all these operations appear to be correct and that the system still does not work properly please contact your local HORIBA Medical representative See also m To Switch On the Printer p 74 m Printer p 22 2 1 5 Reagents Controls D Follow this procedure to control reagents levels and expiration dates Access Main screen gt Analyzer tab 1 Check the level of each reagent 2 Check the expiration date of each reagent If needed replace the reagent See Maintenance and Troubleshooting gt Reagents Replacement chapter See also m Reagents Replacement p 159 2 1 6 Startup Failed D Follow this procedure if the instrument startup fails 1 Check the reagent expiration dates replace the reagent container if necessary 2 Re run a Startup 3 Ifthe Startup fails again perform a concentrated cleaning See also m To Perform a Concentrated Cleaning p 167 m To Perform a Manual Startup p 78 User Manual 179 Ref RAB271AEN Maintenance and Troubleshooting Troubleshooting Procedures ES 2 2 180 2 1 7 Temperature not reached D Follow this procedure when the operation temperature of the instrument is not reached Q Make sure the room temperature is within the temperature range as described in the 4 Introduction gt Operational Conditions chapter 1 Wait a few minutes to reach the operating temperature
181. tting Save Restore Users Header HORIBAMEDICAL aoo Pue du Caduc e Montpelier Printing Options of Copie E Step by Step Printing Unconditional Printing Si c2 IV Printing Blank Results Printing Normal Results Enabli Printing Abnormal Results E Range T Including Default Analysis I Raw Values T Including Alarms I Outside The Normal Values Ind rescue Outside The Panic Values LK Messages ora B4350 PCL Default Pins 1 Delete Printer 2 Pine Popes 3 Add Printer 4 Set as default printer 1 Select a printer from the list User Manual 133 Ref RAB271AEN Settings Setting Menu 134 2 Click Default Printer 1 Delete a printer 1 Select a printer from the list 2 Click Delete Printer 2 Display printer properties 1 Select a printer from the list 2 Click Printer Properties 3 to display the Print Setup dialog box Print Setup m Printer Name OKI B4350 PCL X Properties Status Ready Type OKI B4350 PCL Where LPTT Comment r Paper Orientation Size as 210 x 297 mm Portrait Source auto z C Landscape Network OK Cancel niic tees Add a printer 1 Click Add Printer 4 to display the Add Printer Wizard window Add Printer Wizard Welcome to the Add Printer Wizard This wizard helps you install a printer or make printer connections c If you have a Plug and Play printer that con
182. umber of leukocytes Suspected abnormalities A 1 i 1 1 i I m PLT aggregates m NRBCs Values for L1 Standard type are 3 and 200 These flag values can be defined for each blood type in Setting gt Type Parametering gt Alarms and Curve Thresholds tab DIF mode enhances detection of certain anomalies as it provides two additional flags LL and Q LL1 compared to CBC mode with only L1 flag large platelet aggregates and or erythroblasts 4 for example that are beyond electronic threshold HORIBA Medical highly recommends to use DIF mode that gives the best reliability in these anomalies detection 6 2 3 2 ALY flag Atypical LYmphocytes Presence of a significantly large population of cells located on the right hand side of the lymphocyte area The atypical lymphocytes flag appears when the number of counted particles in this area is higher than the limit set up in ALYst or when the number of counted particles regarding the total number of WBC is above the ALY limit Suspected abnormalities Large lymphocytes Reactive lymphoid forms Stimulated lymphocytes Plasmocytes Values for ALY Standard type are 962 5 and 0 25 These flag values can be defined for each blood type in Setting Type Parametering Alarms and Curve Thresholds tab User Manual 109 Ref RAB271AEN Workflow Results Interpretation 110 6 2 3 3 LIC flag Large Immature Cells Presence of a significantly lar
183. urer s code that identifies products such as reagents controls or calibrators Matrix Environment in which the analyte is found Mean m The sum of observations divided by their number Unless otherwise indicated the term mean designates the arithmetic value Measurement A series of operations whose aim is to determine a value of a quantity 208 User Manual Ref RAB271AEN Glossary ES Glossary of Terms Measurand Specific quantity subjected to measurement Noise Corresponds to random variations of the measurement signal for a given level It is measured by the standard deviation of a series of at least 30 measurements of the signal at the level in question Operating range Range of results over which the instrument displays prints and transmits data Parameter Component of blood that the instrument measures and reports Performance criteria Parameters characterizing the analytical procedure linearity repeatability trueness etc Platelet concentrate Labile blood product composed of platelets produced by blood bank centers and intended for transfusion PRP 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 Quality control QC Comprehensive set of procedures that a laboratory establishes to ensure that
184. value of the measurand Detection limit XP T 90 210 The smallest quantity of an analyte to be examined in a sample that can be detected and considered as being different from the value of the blank with a given probability but not necessarily quantified Two risks need to be taken into account m therisk of considering the substance present in the sample when in fact its quantity is nil m therisk of considering a substance absent when in fact its quantity is not nil Drift Slow variation over time of a metrological characteristic of a measuring instrument Femtoliter fL One quadrillionth 10715 of a liter Flag On printouts or screen letters or symbols that appear next to a parameter result to indicate specific conditions Grading Material positioning of each marker possibly of certain principal markers only of a measurement instrument according to the value of the measurand Linearity XP T 90 210 Capacity of a method of analysis within a certain interval to provide a value of information or results proportional to the quantity of analyte to be assayed in the laboratory sample This proportionality is expressed using a previously defined mathematical expression The limits of linearity are the experimental limits of quantities between which a linear standard model can be applied with a known level of confidence generally taken as being equal to 1 LIS Laboratory Information System Lot number Manufact
185. ximum heat output 1440 kJ h 1365 BTU h Printer refer to your printer s manual Workstation refer to your computer s manual See also m Grounding p 15 m Main Power Supply p 15 Humidity and Temperature Conditions Instrument operating temperature from 16 C 61 F to 34 C 93 F with a relative humidity of 8096 maximum without condensation If the instrument is stored at a temperature lower than 10 C 50 F it should stand for one hour at a normal room temperature before use Temperature gradient 2 C Dimension and Weight m Instrument dimensions 44 5 x 48 x 51 5 cm Width x Depth x Height m Instrument weight 35 Kgs 77 Ibs m Workstation dimensions and weight refer to your computer s manual Minimum Specimen Volume Quantity of whole blood aspirated User Manual Ref RAB271AEN Specifications Pe ntra E amp 60 Physical Specifications m CBC mode 30 uL m DIF mode 53 uL 2 5 Dilution Ratio RBC PLT 1 10000 WBC BAS 1 200 LMNE 1 80 HGB 1 250 2 6 Counting Aperture Diameters RBC PLT 50 um WBC BAS 80 um LMNE 60 um User Manual 29 Ref RAB271AEN Specifications Summary of Performance Data Pe nt r l ES 60 3 1 30 3 Summary of Performance Data Precision Reproducibility Source 510K submission K030144 The instrument was initially calibrated with the ABX Minocal calibrator Lot N CX322 Three levels of ABX Minotrol 16 material Lot N JX108 were run on
186. y actions before calibrating the instrument m The calibration is an exceptional procedure which must be carried out particularly after certain technical interventions installation maintenance service intervention m Thecalibration should not be carried out to compensate a drift on a result due for example to clogging of the instrument m If the frequency of re calibration is too important it may be the sign of the beginning of a problem technical reagents etc Make sure that the instrument is in perfect operating condition 1 Run a startup cycle The startup must be successful to start calibration See Workflow gt Start of Day chapter 2 Perform a concentrated cleaning procedure See Maintenance and Troubleshooting gt Maintenance chapter 3 Perform two blank cycles to check the cleanliness of the instrument 4 Check the repeatability of the instrument by running a fresh human normal blood sample 11 times with no alarm Discard the first result and calculate the CV on the remaining 10 runs See QC and Calibration Repeatability chapter User Manual 67 Ref RAB271AEN Quality Assurance Calibration ES f 5 Check that the CV calculated using the remaining 10 runs meets or exceeds the specifications See Specifications Summary of Performance Data chapter 6 Run a control blood and check that the values are within acceptable limits If not run a new control blood See Workflow Running Quality Control Blood chapter

Download Pdf Manuals

Related Search

Related Contents

CrossFire™ MX1B - maximatecc support  Manual as PDF  Audio CD DVD and Phono  電子音目覚まし時計 取扱説明書  Untitled  Installation Instructions Microwave Hood Combination  Emerson HD8197 Owner's Manual  SOLICITUD DE COTIZACIÓN (SDO/CUB/14/04) (BIENES) jueves    Technical Manual  

Copyright © All rights reserved. Failed to retrieve file