Home

ABX Pentra 60

1. 1 11 3 5 Normal FANGS a RTT m UI mm 1 12 e 1 13 3 7 Leukocyte differential 1 13 3 8 Sample stability study 1 13 3 9 Results exceeding instrument capacities 1 14 4 REAGENTS SPECIFICATIONS 1 15 4 1 Reagent specifications 1 15 4 2 Waste handling precautions 1 15 1 16 5 1 Maintenance MEET EEUU 1 16 5 2 5 1 16 5 3 Known interfering substances 1 17 page XIII Introduction RABOSOGEN DESCRIPTION amp TECHNOLOGY 1 PENTIRA S0DESGHBIPTIOIL capi vaa uad End NUUS Neira Ica Ear 2 2 1 1 Pentra GO general description eee ene 2 2 12 Penra 60 lt 2 3 1 3 Mechanical and hydraulic modules esse 2 4 2 MEASURING PRINCIPLES 2 7 2 1 Multi Distribution Sampling System MDSS
2. 3 32 6 CFT RATING ER 3 33 ME eeclesie fees saints 3 33 6 1 1 Operator selection 3 33 6 1 2 Change lot 3 33 6 1 3 Change expiration date 3 34 6 1 4 Change target values 3 34 EIN LU Er leguepMe X 3 34 6 2 Change coefficients lees eene 3 38 6 9 Print coefficients 3 39 6 4 S 3 39 7 REAGENTS LEVEL CMAN GE 2 3 40 Tale Reagents COMMS CUOUS 3 40 422 Daly WOFRKIOA G nai uU PR te ME MM I MAN PN MM MUS 3 41 7 3 Peagentreplacerrierib u sever coss eio 3 42 7 3 1 Bottle 1 3 42 7 3 2 Diluent container replacement 3 42 7 3 3 Level update sper ess 3 43 TE A 3 43 3 Specimen Run amp Results RABOSOGEN 1 INSTRUMENT START UP 1 1 Waste levels e At the beginning of each day check if the waste container needs to be emptied Be careful Wastes must be handled according to your local national regulations e See Chapter 5 Maintenance amp Troubleshooti
3. 1 6 2 2 Operating temperature and humidity 1 6 2 3 Dimensions and Weight 1 6 2 4 Minimum specimen volume eese eee 1 6 2 95 OS 1 7 2 6 Hgb measurement 1 7 2 7 Counting aperture diameters 1 7 2 8 Reagent CONSUMPTION mtl eere seres 1 8 SUMMARY OF PERFORMANCE DATA 1 9 3 1 Precision Reproducibility 1 9 3 2 Precision Repeatability 1 10 ee WIE SS se c ces cece 1 11 3 4 1 11 5 Normal ranges Q 1 12 a te T 1 13 3 7 Leukocyte differential count 1 13 3 8 Sample stability study 1 13 3 9 Results exceeding instrument capacities 1 14 REAGENTS SPECIFICATIONS 1 15 4 Reagent specifications ice uus Saee ewes 1 15 4 2 Waste handling precautions 1 15 INS c 1 16 cx NI 1 16 SPECIMENS sansa saan
4. 1 3 4 Concentrated cleaning e Cleans the chambers with bleach Procedure e Press a rinse cycle is run Wait for the following message to be displayed e Open the instrument pneumatic door into each chamber and press eA e Close the instrument door and wait for the instrument to complete the cleaning procedure Concentrated cleaning duration around 5 mn 1 4 Mechanical systems 1 4 1 Initialization e All the mechanical assemblies Sampling probe carriages syringes return to their initial positions i e the operating analysis positions 1 4 2 Check motors To control the correct operation of each motor e Switch off the instrument e Open the door see on previous page and the left cover of the instrument Be careful to the flat cables while opening the door e Loosen the 2 screws of the board support panel and open it e Once both sides of the instrument are open switch on the instrument Enter the check motors menu and control each motor pressing the corresponding number Right side of the instrument 1 Sampling needle Check the needle up and down operations The movements should be smooth and regular 3 Sampling syringe Check that the syringe up and down movements are smooth and regular 4 Draining syringe Check the correct up and down movements of the syringe Left side of the instrument 5 Counting syringe Same operation check 6 Cytom
5. 3 4 CALIBRATION VERIFICATION CONTROL BLOOD SAMPLING 3 5 RUNNING SPECIMENS 3 6 4 1 Alphanumerical mode eene nnn nnn 3 6 4 2 Sequence 3 6 4 3 Analysis mode selection 3 6 LX M 3 7 4 5 Automatic cleaning ais coat o t i o 3 8 4 6 End of the day 5 3 8 c oe ee ee eee 3 9 MOOG mm 3 9 D2 DIF IO oa ress reac geese a ea te eit ee ees 3 10 ctos lie ee nr ner ee ee ee eer ee eee ere ee er 3 10 5 3 1 Normal and panic ranges 3 11 ooo LMNE Matix AS 3 14 5 3 3 Flags on WBC BASO histogram 3 26 5 3 4 Flags on RBC histogram 3 27 5 3 5 Flags on PIE DISIOgESTTE Drs PIA RP eds 3 27 WBC Dalai Sane cece 3 29 5 4 Pathology 3 30 5 4 1 WBC messages 3 30 5 4 2 RBC messages 3 31 9s PIC MESSAGES 1 xx eu 3 31 5 4 4 Miscellaneous 3 32 5 5 Analyzer
6. a ee eee ee 7 em isi Sa WASTE YW Designation HYDROPNEUMATIC DIAGRAM PENTRA 60 OT q Rectify the length of the tubing between LV23 1 and bath 3 1 52 220 was 200 CTH ADC 04 23 01 86 slandarg Roughness 251 110 and 2 54 140 was 2 05 Add 3 sleeves 152 350 was 290 ECO 4868 185 10 was 11 ECO 4582 2 05 15 was 20 and 2 05 50 was 40 Tube 1 52 260 was 250 Reagent heater 1 Valve 22 2 EC04583 Add waste and diluent external tubes ADC 07 12 1999 5633 Treatment Add sleevings on external sheath circuit Creation according be diagram PNEU D Update 04310 and ECO4411 suite ADC 05 11 1999 4399 Coating Description Chk Date ECO NMLOO1A Sheet S This drawing is the property of ABX and may not be reproduced or distributed without authorization lt DIAGNOSTICS
7. c H 5 2 1 2 Cleaning CYyCIE P 5 2 1 3 Hydraulics systems EE 5 3 We BAG MSI C ace 5 3 Gente A E es 5 3 1 3 3 Drain chambers 5 4 1 3 4 Concentrated cleaning 5 5 1 4 Mechanical E beue zur MERE MOS 5 6 po IOV m S T T 5 6 1 4 2 Check motors 5 6 1 4 3 Check valves 5 8 1 4 4 Maintenance carriage position 5 9 T E TII TUI 5 9 1 6 Sampling probe 5 10 2 TROUBLESHOOTING qM 5 11 2 1 Instrument operation mode 5 12 ers c Neue ee ee eee 5 13 PACSUN RR e T T Mm 5 16 II S eee 5 18 1 MAINTENANCE e One of the principle factors contributing to accurate and reliable results is a well maintained instrument Several maintenance functions are available for the user to clean and check the instrument On the chart table below the maintenance cycle frequencies are indicated CYCLES lt 100 ANALYSES PER DAY gt 100 ANALYSES PER DAY Shut down 1 per day 1 per day Autoconcentrated cleaning 1 per month 2 per month 1 1 Autocontrol cycle e This cycle is required
8. 1 16 5 3 Known interfering substances 1 17 1 Specifications RABO80GEN 1 TECHNICAL SPECIFICATIONS e The ABX PENTRA 60 is a fully automated hematology analyzer used for in vitro diagnostic testing of whole blood specimens e The ABX PENTRA 60 is able to operate either in CBC mode Cell Blood Count 12 parameters or in CBC 5DIFF mode 5 population Differential count 26 parameters 1 1 Parameters 1 1 1 CBC Mode WBC White Blood Cell RBC Red Blood Cell Hgb Hemoglobin concentration Het Hematocrit MCV Mean Corpuscular Volume MCH Mean Corpuscular Hemoglobin MCHC Mean Corpuscular Hemoglobin Concentration RDW Red Distribution Width Platelets PDW Platelet Distribution Width MPV Mean Platelet Volume Pct Plateletcrit PDW and PCT have not been established as indications for this product in the United States The use of PCT and PDW should be restricted to research and Investigational measurements only page 1 2 1 Specifications 1 1 2 CBC 5DIFF Mode WBC LYM MON NEU EOS BAS LIC ALY Hgb Hct MCV MCH MCHC RDW Pit PDW MPV Pct RABO80GEN White Blood Cell Lymphocytes and Monocytes and Neutrophils and Eosinophils and Basophils and Large Immature Cell and Atypical Lymphocyte and Red Blood Cell Hemoglobin concentration Hematocrit Mean Corpuscular Volume Mean Corp
9. 4 19 V T C Uu TU 4 19 re ga E eee ere r 4 19 7 1 2 Define Operator E t T T 4 20 gid E UE 4 20 7 3 frequency 4 20 TAs CONGO Da Say Ol T E cee T 4 21 7 5 Change 4 21 126 Reagent capace 4 22 4 22 4 22 TP T T T TE 4 23 page XVI Introduction RABO80GEN MAINTENANCE amp TROUBLESHOOTING pag el E E 5 2 eM eeeausere us M 5 2 jpeMer sisete Pe 5 2 TOS uus n NNI NUMERI MUS NUS 5 9 1 BACKUS T H 5 3 ee re a ee ne een ee ee ee ee ee 5 3 198 9 Drain chamber S nie toss dos tain es ween rasan nied eee sesame aie ns ERE da inet 5 4 1 3 4 Concentrated cleaning xeu cc caedaeacnacadascdereuesaueseeencesseneat 5 5 Vie Can Call SY Ste ilo Kem ETT 5 6 P 5 6 NC ONS 5 6 1 4 3 Check valves ees 5 8 1 4 4 Maintenance carriage position cece eee eee eee eee eee ene eee eee 5 9 PMC IO e
10. 2 7 2 2 RBC 7 PIt detection principles Eat 2 8 2 9 FIGDTHeSSUrerrerit E EF Rake E A 2 9 2d ASU Celi severe 2 10 2 5 ROW CIC UNION 2 10 2 6 MCV MCH MCHC CalculatlOli uerit patre E E EE EIER 2 10 2 7 MPV 2 11 CC UO 2 11 2 9 PDW dE REN ne eee eee 2 11 2 10 WBC and C FCU Ir EP EF EXER RUE 2 12 2 10 1 General principles 2 12 2 10 2 BASO WBC 2 12 2 10 3 LMNE MANIX 2 13 XIV Introduction RABO80GEN SPECIMEN RUN amp RESULTS Ts INSTRUMENT START UP wet 3 2 3 2 e ed EE E E EEE N E E A E EEE 3 2 LEG Pentra 0 Start UD een nee 3 2 2 SPECIMEN COLLECTION AND MIXING 3 4 2 1 Recommended anticoagulant 3 4 222 BIOOG Sample Sle 3 4 2 9 MICFOSSPEIDIFIC MERE NEMESIS 3 4 Zo rem 3 4 3 CALIBRATION VERIFICATION CONTROL BLOOD SAMPLING
11. CoL 29 02 99 18 05 39 CALIBRATION DATE 25 02 99 OPERATOR 0 1 LOT Z IX94N EXP DATE 05 05 99 TARGET VALUES 10 1 10 mm REC 105 mm HGE Fan HET RBC 209 211 4 591 1 07 e The calibration is completed press p to quit the calibration chart table B Calibration forced If the statistic figures are not within the acceptable limits e Coefficient of variation is not within the limits or e The percentage difference between the target and the mean value is greater than 20 e The out of range coefficient is shown in reverse video and a flag H higher or L lower is displayed next to it 3 Specimen Run amp Results RABO80GEN e Press to save the new coefficients the calibration is forced ESC or eu to quit and save the previous coefficients e Press lt gt to print the new coefficients a message Forced calibration is printed out on the calibration print form e Press m to quit the calibration chart table The results involved in the statistical calculations are shown wih a x in the first column CALIBRATION DATE 25 02 99 FORCED CALIBRATION LOT JX94N TARGET VALUES WBC RBC HGE HCT COEFF MEAN EXP a OPERATOR DATE 05 05 99 page 3 37 3 Specimen Run amp Results RABOSOGEN 6 2 Change coefficients e Calibration can be achieved directly by changing the calibration coefficients
12. page 1 13 1 Specifications Use the instrument diluent to dilute the sample if a D flag occurs on WBC or Hct page 1 14 RESULTS DISPLAYED 3 9 Results exceeding instrument capacities RABO80GEN PARAMETER Linearity Limits VisiBLE RANGE gt VISIBLE RANGE WBC result result D DIL RBC result result D DIL HGB result result D DIL HCT result result D DIL PLT for Hgb22g dl result result D DIL PLT for Hgb 2g dl amp result result D DIL PIt 15x105 mm RESULTS TRANSMITTED OR PRINTOUT PARAMETER Linearity Limits VisiBLE RANGE gt VisiBLE RANGE WBC result result D 0 RBC result result D 0 HGB result result D 0 result result D 0 PLT for Hgb22g dl result result D 0 PLT for Hgb 2g dl amp result result D 0 PIt gt 15x10 mm e Results displayed and printed out PLT C message indicates the triggering of the PLT extended linearity mode for an Hgb 2g dl amp Pit gt 15x10 mm between 1900x10 ul and 2800x10 ul e Results transmitted message indicates the triggering of the PLT extended linearity mode for Hgb 2g dl Plt gt 15x10 mm between 1900x10 ul and 2800x10 ul 1 Specifications RABO80GEN 4 REAGENTS SPECIFICATIONS 4 1 Reagent specifications e In order for the instrument to operate correctly high quality reagents must
13. 2 SPECIMEN COLLECTION AND MIXING e All blood samples should be collected using proper technique Consider all Soecimens Reagents Calibrators Controls etc that contain 2 human blood or serum as potentially infectious Use established good laboratory working practices when handling specimens Wear protective gear Gloves Lab coats Safety glasses and or Face shields and follow other bio safety practices as specified in OSHA Blood borne Pathogens Rule 29 CFR part 1910 1030 or equivalent biosafety procedures e e When collecting blood specimens Venous blood is recommended but Arterial blood may also be used in extreme cases Blood collection must be placed in a Vacuum or atmospheric collection tubes For additional information on collecting venous and capillary blood samples refer to NCCLS document H3 A4 and NCCLS document H4 A4 sept 1999 e he 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 2 1 Recommended anticoagulant e The recommended anticoagulant is 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 2 2 Blood sample stability e Specimens may be used between 15 20
14. PLT 10 pl for Hgb22g dl PLT 107 pl for Hgb 2g dl amp Plt215x10 mm LiNEARITY LiNEARITY VISIBLE Limits 0 3 7 5 0 23 to 9 76 0 to 8 8 to 18 0 07 3 0 to 31 06 0 to 24 24 to 30 0 3 3 1 80 to 88 90 0 to 67 67 to 80 2 3 3 30 to 2007 0 to 1900 1900 to 2800 10 12 5 7 to 2895 0 to 2800 2800 to 3200 10 12 5 Source 510K submission K030144 3 4 Carry over e The ABX PENTRA 60 carry over effects were evaluated by assaying a sample with high cell concentrations three consecutive times i1 3 followed immediately by testing a diluted sample consecutively 3 times j1 3 1 3 i3 j3 Carry over X 100 Carry over 96 is then WBC RBC HGB PLT Mean low levels 1 06 1 58 5 28 31 33 Mean high levels 58 81 6 37 22 03 1106 67 Carry over 0 260 0 000 0 179 0 186 This is the method as 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 page 1 11 1 Specifications page 1 12 RABOSOGEN e Carry over Conclusion Hesults provided are extremely satisfactory In order to provide for eventual possibilities within the laboratory environment the following claims shall be made RBC HGB PLT Claims 2 0 2 0 2 0 2 0 Source 510K submission K030144 3 5 Normal ranges PARAMETERS MIALE FEMALE WBC 10 pL 4 10 4
15. Unit setup UNITS Possible flags LAB LIMITS 5 1 CBC Mode e IDENTIFICATION MODE Sequence DATE 14 04 99 TIME 16 17 06 SEG Normal ranges Pathology messages page 3 9 3 Specimen Run amp Results RABOSOGEN 5 2 DIF Mode e IDENTIFICATION MODE Alphanumerical mode BATE L4 7 04 99 TIME 16 11 07 SEQ 10 i mm g di pg a d 1 1095 mm Te A I eM x tac A As lt gt con 3 3 i 4 1 0 1 P ry lt gt lt gt gt soos a OSS MMC lt gt faa xm m q gt pP 5 0 45 lt lt 5 3 Flags These flags can be divided up into 5 different groups e Flags linked to a result when it exceeds the normality limits e Flags linked to a problem in the morphology of blood cell population e Flags linked to a result or to instrument operation leading to a default analysis e Flags linked to instrument in use Each flag sensitivity can be adjusted by the operator see Chapter 4 Instrument configuration page 3 10 3 Specimen Run amp Results RABO80GEN 5 3 1 Normal and panic ranges 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 resu
16. e Immature cells from granulocyte hemopoiesis metamyelocytes myelocytes promyelocytes This flag is associated with an on e NEU NEU e LIC 96 LIC T Standard values for RN Absorbance NoN NoE Channel 127 1 1 999 Adjustment see Chapter 4 instrument configuration RMN NoL LE AL LMD RM Resistivity page 3 24 3 Soecimen Run amp Results RABO80GEN LIC flag Meaning Large Immature Cells Presence of a significantly large population of cells located on RN RM channel 127 areas This flag occurs when the number of particles counted in this area is higher than the limit set up in LIC or when the number of counted particles regarding to the total number of WBC is above the LIC limit Suspected abnormalities e Large monocytes e Hyper basophilic monocytes e Myelocytes Metamyelocytes Promyelocytes e Large blasts e Large neutrophils T Standard values for LIC Absorbance NoN NoE Channel 127 2 0 2 Adjustment see Chapter 4 Instrument configuration NE RMN No AL LMD RM Resistivity page 3 25 3 Specimen Run amp Results RABOSOGEN 5 3 3 Flags on WBC BASO histogram T Standard values for L1 see Chapter 4 Instrument page 3 26 3 200 Adjustment configuration CBC and DIFF Mode L1 flag is established according to the ratio of the cells counted between the 0 channel and L1 indicates the presence of an abnormal number of ce
17. 5 1 Numerical valts dE cu eM ERE ERES UP MEME 4 14 5 3 2 Flags and pathologies SP RE ErSEC UI UE 4 15 5 3 3 Histograms and thresholds 4 15 DEOR ded 4 15 4 15 5 4 Send latest result 4 16 SM 4 17 Oc TTDCIelesETOSHILEcadiscd uat p DUM TER MERI 4 17 6 2 Printer emm 4 17 WN VU o 4 19 ege T t t T 4 19 FAN GL Maas NT 4 19 7 1 2 Define Operator 4 20 7 2 Identification MOqdE Pr re eee eee 4 20 7 3 Autoclean frequency 4 20 7 4 Change password 4 21 7 5 Pu ae Q ao e t Mtm er 4 21 7 0 Reagent 4 22 Tels 4 22 4 22 WBO NIC Occ ea 4 23 4 Instrument Configuration RABO80GEN 1 DATE AND TIME e Date and time can be setup according to the country specifications 1 1 Date format e 3 different date formats can be used DD MM YY MM YY DD YY MM DD Move the cursor in front of the required selection and press e The new date format is r
18. 5 4 2 RBC messages high extreme limit MESSAGE L low extreme limit ANEMIA ANISOCYTOSIS MICROCYTE MICROCYTE MICROCYTE MACROCYTE HYPOCHROMIA COLD AGGLUTININ MICROCYTOSIS MACROCYTOSIS ERYTROCYTOSIS 5 4 3 Plt messages H high extreme limit MESSAGE L low extreme limit THROMBOCYTOSIS THROMBOCYTOPENIA MICROCYTOSIS SCHIZOCYTE SMALL CELL Pit AGGREGATE 1 ERYTHROBLASTS 2 ERYTHROBLASTS Pit AGGREGATE MACROPLATELETS RABOSOGEN TRIGGERING CONDITIONS lt L RDW gt RDWH on MIC flag MIC gt 10 gt 15 on MAC flag MCHC lt MCHC L MCHC gt and WBC lt 91 3x10 mm MCV lt MCVL MCV gt MCV H RBC gt RBC H TRIGGERING CONDITIONS Pit Pit lt See Triggering conditions for these flags in paragraph Flags on RBC curve Pit lt 150x10 mm WBC Reject or NO PDW gt 20 or NO MPV gt 10 or NO lt 150x10 mm or WBC Reject or L1 or LL1 PDW gt 20 L1 or LL1 MPV gt 10 or L1 or LL1 lt 250 103 LL or WBC reject L1 or WBC reject LL1 1 and 2 are false L1 or LL1 or WBC reject MPV gt 11 page 3 31 3 Specimen Run amp Results RABOSOGEN H high extreme limit L low extreme limit page 3 32 5 4 4 Miscellaneous MESSAGE TRIGGERING CONDITIONS WBC lt WBC L and RBC lt RBC L and Pit lt PIt L PANCYTOPE
19. ABX Pentra User Manual P n HAN 618A Explore the future HORIBA GROUP HORIBAAB X Diagnostics Instrument User Manual Update RAM207AEN ABX Pentra 60 User Manual Update Please take note of the modifications on next pages Please cross out the appropriate sections in the user manual prior to inserting this addendum at the beginning of the user manual Date 25 09 06 gt il O Explore the future HORIBA GROUP User Manual Update RAM207AEN 2 3 User Manual Update Tab 1 1 Concerned sections of the ABX Pentra 60 user manual RABO80G Known interferences due to chemotherapy Specifications 1 17 5 3 Known interfering substances in the basophil count 3 6 4 Running specimens Recommendations on the analysis mode Specimen Run amp Results 3 26 5 3 3 Flags on WBC BASO histogram L1 Flag 3 29 5 3 6 WBC balance CBC mode limitations WBC Balance 1 WBC Balance The WBC balance flags LMNE and LMNE are activated only if the test selected is DIFF A and if this flag has been activated The WBC Balance can be enabled or disabled by an ap proved HORIBA ABX Service Technician Contact your local HORIBA ABX Technical Service Representative for selection of this option These flags are associated with an on all differential parameters and The WBC balance flag will indicate an instrument defect or it can
20. 2 3 Grounding e 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 2 4 Humidity and temperature conditions e ABX PENTRA 60 must operate between temperatures of 16 to 34 C 61 to 93 F Maximum relative humidity should be 80 for temperatures up to 31 C 88 F and decreasing linearly to 50 relative humidity at 40 C 104 F If the system is kept at a temperature of 10 C 50 F or less it must be allowed to sit at room temperature for 1 hour before it can be used for operation page IX Introduction RABOSOGEN 2 5 Electromagnetic environment check e he ABX PENTRA 60 has been designed to produce less than the accepted level of electromagnetic interferences 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 that the instrument has not been placed in the proximity of electromagnetic fields or short wave emissions i e Radars X rays Scanners Cell phones etc 2 6 Environmental protection e Disposal Used accessories and consumables must be collected by a laboratory specialized in elimination and recycling of this kind of material according to the local legi
21. ccr Sans Serif o Drafte EE Draft Condensed 2 Park 49 W Micro Adjust 1 Pressing the FONT key will change the states of both LEDs 1 and 2 swiched off or lit To configure the Draft mode press the FONT key until the LED 2 is lit and the LED 1 is switched off 4 Instrument Configuration RABO80GEN 7 OTHERS 7 1 Calibration 7 1 1 CV limits e This menu gives the variation coefficients upper limits for each parameter used in the calculations of the variation coefficients e When calibration CV results are not within these ranges a flag H is triggered next to the CV value see Chapter 3 Specimen Run amp Results Calibration e Move the cursor to the value to modify and enter the new value Press nter to validate e The factory values are shown on the below chart table CV Limits Standard WBC RBC HGB HCT PLT PO N page 4 19 4 Instrument Configuration RABO80GEN 7 1 2 Define Operator An operator identification is associated to calibration operations see Chapter 3 Specimen Run amp Results Calibration This one is modifiable from the menu Operator 4 of them can be entered moving the cursor to the OP2 OP4 fields Press e to validate e The selection of the operator is performed directly in the Calibration menu 2 Identification mode To sele
22. e QC samples identification can be entered into QC window Next ID field e Open the vial and start sampling 4 Instrument Configuration RABO80GEN During control mode Results are printed with the title CONTROL Pathological limits MIC amp MAC alarms are disabled BASO curve is not printed e In order to use ABX DIFFTROL control blood it is necessary to adjust matrix thresholds and coefficients according to the values delivered with the control blood lot you are going to use e Parametering is done through menus CONTROL MODE CHANGE COEFFI CIENT and CONTROL MODE FLAGS SENSITIVITY Using key to se lect and modify value press e key to validate page 4 11 4 Instrument Configuration RABO80GEN 5 DATA OUTPUT page 4 12 e Several formats are available ARGOS The ARGOS format allows the numerical result transmission only and the batch size is set to 406 characters for one result ABX The ABX format allows the size of the transmitted data batches to be varied Histograms thresholds and matrix are available from the connection WORKS The WORKS format enables the user to received data on a spreadsheet program from the RS232 port e This function allows the user to set up the RS232 Connection mode Two modes are available on ABX PENTRA 60 e An unidirectional mode that performs the data transmission towards the main laboratory computer e A bidirectional mode which is performed
23. 10 RBC 10 uL 4 50 6 50 3 80 5 80 HGB g dL 13 0 17 0 11 5 16 0 HCT 40 0 54 0 37 0 47 0 MCV um 80 100 80 100 MCH pg 27 0 32 0 27 0 32 0 MCHC g dL 32 0 36 0 32 0 36 0 RDW 11 0 16 0 11 0 16 0 PLT 10 uL 150 500 150 500 MPV um 6 11 6 11 PCT 0 15 0 50 0 15 0 50 _ 11 18 11 18 NEU 50 80 50 80 25 50 25 50 MON 2 0 2 10 EOS 0 5 0 5 BAS 0 2 0 2 Expected values will vary with sample population and or geographical location It is highly recommended that each Laboratory establish its own Normal ranges based upon the local population Bibliography AIDE MEMOIRE D HEMATOLOGIE Prof C SULTAN M GOUAULT HELMANN M IMBERT Service Central d H matologie de l Hopital Henri Mondor Facult de m decine de Cr teil Paris XII 1 Specifications RABO80GEN 3 6 e The data shows good correlation between results achieved on the ABX PENTRA 60 versus the reference system which can be resumed as follows Accuracy CLAIMS PARAMETER R CoMPARISON OF MEANS WBC 0 997 20 95 PLT 0 998 20 95 RBC N A N A HGB N A N A HCT N A N A LYM N A N A NEU N A N A MON N A N A EOS N A N A BAS N A N A Source 510K submission 144 3 7 Leukocyte differential count Not available at the time of publication 3 8 Sample stability study e Not available at the time of publication
24. BASO 5 RBC PLT 6 ALL CHAMBERS 7 DILUENT RESERVOIR GLOSSARY LIST OF ABBREVIATIONS PNEUMATIC DIAGRAM Annex GLOSSARY page Annex 2 DEFINITION accuracy agglutination background count blank cycle Calibration calibration factors calibrator carryover cell control characteristics coefficient of variation control CV default expiration date fL femtoliter field flags linearity lot number RABOSOGEN Ability of the instrument to agree with a predetermined reference value at any point within the operating range closeness of a result to the true accepted value Clump Measure of the amount of electrical or particle interference Runs diluent through the system to clean it out A procedure to standardize the instrument by determining its deviation from calibration references and applying any necessary correction factors These are correction factors that the system uses to fine tune instrument accuracy A substance traceable to a reference method for preparation or material used to calibrate graduate or adjust measurement The amount in percent of blood cells remaining in diluent following the cycling of a blood sample A preparation made of human blood with stabilized cells and surrogate material used for daily instrument quality control See performance characteristics An expression in percent of data SD spread related to the mean CV SD mean x100 A substance use
25. Mode DIF 53yl page 1 6 1 Specifications RABO80GEN 2 5 Dilution ratios WBC BASO 1 200 1 80 1 10 000 1 250 2 6 Hgb measurement Hgb chamber LED 555 nm e Modified Drabkin method cyanmethemoglobin e Light source Electroluminescent diode e Wavelength 550nm 10nm 2 7 Counting aperture diameters WBC BASO 80 um e LMNE 60 um e 50 um page 1 7 1 Specifications RABO80GEN 2 8 Reagent consumption ml REAGENT APPROXIMATE DILUENT BasoLyse ll CLEANER EOSINOFIX ALPHALYSE RATION CBC Cycle 20 4 2 1 0 9 X 0 4 60 Diff Cycle 25 6 2 1 0 9 1 0 4 60 Startup 60 8 2 1 3 7 1 1 4 353 Prime Diluent 42 9 X X X X 303 Prime Cleaner 1 1 X 24 8 X X 122 Prime all reagents 47 24 25 1 24 8 2 6 Autoclean cycle 14 2 1 1 1 0 3 138 Autocontrol cycle 23 4 X 1 4 X 1 14 RBC chamber cleaning 2 5 X X X X 7 Unprime all X X X X X 625 Chambers rinsing 12 6 1 1 1 0 3 1717 Cytometer rinsing 4 9 X X X X 111 Concentrated cleaning 25 X 1 4 X 0 9 410 Cleaning 12 6 1 1 1 0 3 119 for one background count only maxi 3 page 1 8 1 Specifications RABO80GEN 3 SUMMARY OF PERFORMANCE DATA 3 1 Precision Reproducibility e The instrument was initially calibr
26. RBC RDW SD VA Vac WBC RABOSOGEN monocyte mean platelet volume material safety data sheet number neutrophil nanometer Plateletcrit Platelet Distribution Width platelet red blood cell red distribution width standard deviation voltampere volt alternatif current white blood cell page Annex 5 152 200 1 52 70 LV1 Differential diluent Selects flow cell sheath 2 LMNE chamber 152 640 TRANSLATION Inch mm int diam LV2 Differential diluent Selects flow cell sheath 1 or sheath 2 E1 LV4 Flow cell sample supply Opens pathway from the LMNE chamber fo the flow cell LV5 Flow cell sample injector Opens waste path for sample injector syringe 1 02 205 152 820 J LV10 Diluent output control Routes diluent to probe rinse block or heating coil 1 i LV12 Rinse output control Selects rinse to probe rinse block or WBC BASO chamber 18 3 LV14 RBC PLT count valve Opens vacuum count line for RBC chamber m LV20 Waste syringe vent Opens waste vent through the rinse chamber cc cc LV21 Sweep flow diluent Routes diluent Fo heating coil or sweep flow z Y C CRISTAL TUBE 2 e LV22 Diluent bath select Routes diluent via heating coil to Hgb or RBC chamber a 2 TYGON TUBE lt lt LV23 WBC BASO count vacuum Routes vacuum direct through RBC PLT counting head ai 5 o LV24 Flow cell drain Opens path from flow cell
27. e Replace the container by a new one and install the straw deep in the new container e Proceed as described in 7 3 3 Level update page 3 42 3 Soecimen Run amp Results RABO80GEN 7 3 3 Level update Use the 9 and f to display the reagent CHANGE key in reverse video e Press a prime cycle is automatically run The reagent level is updated to 100 7 4 Prime e This function runs priming cycles useful at the instrument first installation or in case of a technician intervention Remove the straws from the reagent bottles and containers before running 7 Unprime all cycle page 3 43 INSTRUMENT CONFIGURATION T DATE AND TIME 4 2 Ti Date MEC dE 4 2 1 2 Change 4 2 4 3 3 LABORATORY LIMITS EE MC 4 4 3 1 Normal ranges E TE 4 4 3 1 1 CBC s Normal ranges 4 4 3 2 DIF S Normal ranges 4 5 TANGO Genesee s 4 5 3 3 Hag Sensitivity CE adus 4 6 34 mresrioldS 4 7 cs umi 4 7 4 8 3 3 LIVINE MAIK user potat 4 8 ZO ONTBOL MODE uta esos UM UM MESS 4 10 B OLTP sr E ee 4 12 5 1 R8232 Configuration Dr 4 13 5 2 96NdNG COMMUN ATOM EN 4 13 DO EA CEA HM 4 14
28. may cause a decreased platelet count and or a high WBC count The specimen should be recollected in sodium citrate anticoagulant to ensure the anticoagulated character depending on ag glutination and reanalyzed only for the platelet count The final PLT result must be corrected for the sodium citrate dilution effect However these platelet clumps do trigger flags L1 LL and LL1 A C D blood Blood anticoagulated with acid citrate dextrose may contain clumped platelet which could decrease the platelet count Chemotherapy Cytotoxic and immunosuppressive drugs may increase the fragility of these cells which may cause low PLT counts Reference manual methods may be necessary to obtain an accurate platelet count Elevated lipids and or cholesterol May interfere with correct platelet counting MPV Mean Platelet Volume Giant platelets that exceed the upper threshold of the Platelet parameter may not be counted as platelets Consequently these larger platelets will not be included in the instrument s calculation of Mean Platelet Volume Very small erythrocytes microcytes erythrocytic fragments Schizocytes and white blood cell fragments may interfere with the proper counting and sizing of Platelets Agglutinated erythrocytes May trap Platelets causing an incorrect MPV result The presence of agglutinated erythrocytes may be detected by obser vation of abnormal MCH and MCHC values and by careful examination of the stained blood
29. output fo LMNE chamber for drain uJ a 1 02 110 5 QD 2 1 52 100 DRAIN BUBBLING LMNE TRANSFERT PROBE WIPE m 1222152300 0 19 4 1 85 10 E2 1 52 80 1 52 335 15290 1 02 240 DRAINING SYRINGE 7 2 05 580 Nu L de 1 41 ae __ 152 400 eH d 1 52 500 2 05 300 4 1 52 120 sus RI m im E 1 b _ 1 52 350 i a o d __ iin pamm 1 02 205 COUNT DILUENT FILL TANKER FILLING mE d os SSS See Se BE eae cc ud 2 RICE lt e T m MEE ce a ae 3 VENT T m TUBING rn co 20515 V 1 2 05 100 DGA 2 0550 _ di REA E gu 5 2 5 170 152 22 UT 205520 25 d EU E ee eee E 5 1 52 310 2 54 14 0 1 T6 2 ee 2 54 150 ee 9 M 2 0560 20555 28 29 21 31 2 2 05 400 2 05 4 00 152 350 J i 1 1 11 2 05 E 2 05 E 2 05 20 2 05 d DILUENT 20530 20520 29244 pere pere 7 T1 17 T8 T9 T10 2 05 30 L2 2 34 20 wr di md Se UNE
30. population of cells on the left hand side of the lymphocytes area This flag occurs when the number of particles counted is higher than the limit set up in LL1 and when the number of particles counted in LL regarding to the total number of lymphocytes is above the LL1 limit Suspected abnormalities e Platelet aggregates e NRBCs e Erythrocyte membrane resistant to lysis stroma e Stroma e Small abnormal lymphocytes Absorbance Channel 127 NL LMD RM Resistivity page 3 17 3 Specimen Run amp Results RABOSOGEN Meaning Neutro Lympho Presence of a significantly large population of cells located in the separation threshold area between lymphocytes and neutrophils This flag occurs when the number of particles counted in this area is higher than the limit set up in NL or when the number of counted particles regarding to the total number of WBC is above NL limit Suspected abnormalities e Small neutrophils without granules and or slightly segmented e Lymphocytes with a segmented nucleus or Activated Lymphocytes e Neutrophils with membrane weakness This flag occurs associated with an on e LYM 90 e NEU T Standard values for NL Absorbance Yes 120 Channel 127 Adjustment see Chapter 4 instrument configuration NoL LE AL LMD RM Resistivity page 3 18 3 Soecimen Run amp Results RABO80GEN T Standard values for MN 96 100 120 Adjustment see Chapt
31. results if the calibrator is not continuously mixed between each analysis Continue mixing the calibrator between each analysis In order to obtain the best possible calibration it is recommended to run at least 5 calibrator samplings page 3 34 3 Soecimen Run amp Results RABO80GEN Interpretation e Currently each result is selected i e that this one is involved in the statiscal calculation e To discard a result from the statiscal calculation move the cursor to the result line and press to obtain a single square e Use the qu and qu to scroll up and down on the results chart table e The instrument calculates the statistical calibration factors for each parameter Recall of the previous coefficient of calibration Calculation of the new coefficient of calibration Mean of the results Coefficient of variation ESC e Press e A Calibration passed e f the statistic figures are within the acceptable limits Coefficient of variation is within the limits setup as described Chapter 4 Instru ment configuration and The percentage difference between the target and the mean value is less than 20 The calibration passed e Press e to save the new coefficients nter e Press to print the new coefficients page 3 35 3 Specimen Run amp Results RABOSOGEN The results involved in the statistical calculations are shown wih a x in page 3 36 the first column
32. similar results within established limits every time it measures the same sample A measure of variation within a group samples or within a population standard deviation Cleans the instrument s fluidic lines and apertures to help prevent residue buildup See performance specifications Ensures that the instrument is ready to run includes performing a background test Procedure to analyze cell controls or whole blood with known values to determine if your results are within the acceptable range Non diluted blood blood and anticoagulant only page Annex 3 Annex RABOSOGEN LIST OF ABBREVIATIONS page Annex 4 uL um ACD ALY microliter micrometer acid citrate dextrose Atypical Lymphocyte BAS or BASO basophil bps CBC Cl cm CV DHSS diff dL EDTA EOS fL ft Gb Het Hgb Hz LED LIC LYM mb Mb MCH MCHC MCV MDSS MHz mL mm bit per second cell blood count chlorine centimeter coefficient of variation double hydrodynamic sleeving differential deciliter ethylenediaminetetraacetic acid eosinophil femtoliter foot or feet gram gigabyte hematocrit hemoglobin hertz liter pound light emitting diode Large Immature Cell lymphocyte meter millibar megabyte mean corpuscular hemoglobin mean corpuscular hemoglobin concentration mean corpuscular volume multi distribution sampling system megahertz milliliter millimeter Annex MON MPV MSDS NEU nm Pct PDW Plt
33. some of them are not needed delete the corresponding dot by means of The RUO parameters are PCT PDW LIC and ALY In US mode setup by an approved HORIBA technician at the instrument installation the RUO parameters are automatically erased In this mode if the user has enabled these parameters from the menu SETUP OTHERS IDENTIFICA TION a warning message will be systematically printed out and sent to the host 4 Instrument Configuration RABO80GEN 5 3 2 Flags and pathologies e As for 5 3 1 Numerical values select the alarms and the pathology mes sages to be sent out by means of the window Flags and pathologies pressing 5 3 3 Histograms and thresholds e As for 5 3 1 Numerical values select the histograms and the thresholds to be sent out by means of the window Histograms and Thresholds pressing 5 3 4 Patient file e As for 5 3 1 Numerical values select the patient file data to be sent out by means of the window Patient File pressing 4 Instrument serial number CBC or CBC 5DIFF 5 3 5 Raw values e As for 5 3 1 Numerical values select the Raw values to be sent out by means of the window Raw values pressing 5 page 4 15 4 Instrument Configuration RABO80GEN 5 4 Send latest result e Once the RS232 has been configured as described above press QUPD to send out the latest result to the main laboratory computer via the RS
34. when they are known e Move the cursor to function CHANGE COEFFICIENTS and press A specific password is requested to enter the function e Enter the User password defined as described Chapter 4 Instrument configu ration and press Enter e Move the cursor down to the WBC RBC HGB HCT PLT and RDW positions and enter the required new coefficients As the WBC LMNE parameter is automatically calibrated by the WBC ba lance see section 4 WBC balance only an HORIBA ABX certified technician is allowed to change it e When the required coefficients have been changed press the setup CALIBRATION COEFFICIENT STD VALUE MINIMUM MAXIMUM WBC 137 90 200 RBC 25 10 20 HGB 40 20 550 220 6 20 PIT 2 40 RW 0350 09 MV 1 00 e RDW can be calibrated by means of calibration coefficients These coeffi cients are incremented to 0 35 by default The RDW is calculated according to the below formula RDW result RDW coeff x RDW calculated page 3 38 3 Specimen Run amp Results RABO80GEN 6 3 Print coefficients e Move to PRINT COEFF and press print out the coefficients 6 4 Repeatability e The repeatability check is done by doing fresh blood CBC runs from 3 to 11 maximum Means and CV for each parameter are displayed into menu CALIBRATION REPEATABILITY e Open REPEATABILITY menu e To run specimens and to select
35. 232 ouput page 4 16 4 Instrument Configuration RABO80GEN 6 PRINTER 6 1 Print latest result e Press 2 to print out the latest result configured as described below 6 2 Printer configuration Selection of the paper length e Move the cursor by means of gt and 8 to the correct length e The selection is performed when a dot appears in the square pressing Factory adjusted to 12 inches Normal range pathology printout raw values see result printout below Pathologies and normal ranges are printed out when a dot appears in both squares Raw values of the counts can also be printed out Zoomed printed screen Print If enabled the screen printed out by means of the c key will be zoomed Disable printer When selected the results are not printed out and no print alarm is triggered page 4 17 4 Instrument Configuration RABO80GEN page 4 18 Normal ranges Pathologies RESULT DATE 14 04 99 TIME 16 17 06 SEQ 129 LO5 mm gt 4 1o mm5 4 lt a m g dl a Ene c lt gt Am 2 xm dee QE Rud ete gt Mee M Mc M S m em Character selection for the use on the ABX PENTRA 60 see printer user manual for details The printer must be configured in Draft mode Roman Font I
36. 3 32 3 32 se Mii eM 3 33 2 9155 T 3 33 6 1 1 Operator selection 3 33 6 1 2 Change lot NUMDET 3 33 6 1 3 Change expiration date iius jective deen aU eek sean EEPNSR 3 34 6 1 4 Change target values x2 SEEN Md rM 3 34 Bis om R n T een nee 3 34 6 2 Change coefficients 3 38 6 3 Print coefficients MEM DRE 3 39 6 4 Repeatability 3 39 7 REAGENTS LEVEL CHANG EE 3 40 7 1 REAGENTS connections 3 40 3 41 7 3 Reagent replacement 3 42 3 1 3 42 7 3 2 Diluent container replacement 3 42 UT 3 43 acne ses ses reper ye crore sie ME 3 43 page XV Introduction RABOSOGEN INSTRUMENT CONFIGURATION 1e DATE ANGI TIME sain T EN EEEE 4 2 seme E EE E E E ET 4 2 TOMA E ER R EE 4 2 CINE o
37. 3 5 d RUNNING SPECIMENS 3 6 4 1 Alphanumerical mode TT oo 3 6 2 5 x P EN 3 6 4 3 Analysis mode selection 3 6 EO E DET 3 7 4 5 genere TR 3 8 AGENG Of Nhe day NSIN RR OE 3 8 o RE UEP 9 3 9 IEOR MOI 3 9 sw e EEEE ee E E E E E EE 3 10 RUN 3 10 5 3 1 Normal panic ranges RUE EFE RUF ERE 3 11 5 3 2 LMNE MaX MAGS eternum nien iuc woe ass Ind os sU PRONUM EDU EI EE UE 3 14 5 9 3 Flags on VBO BASCO hISEOgl GTI ive esedsuuuetU prt R OE 3 26 5 9 4 Flags RBC histogram SuSE esM 3 27 5 3 5 Flags FIL nistogr al Ti 3 27 WBO E aidai 3 29 93 Pathology TING S 3 30 5 4 1 WBC messages 3 30 RBC ISS 40 5 MH 3 31 SA IE Ie SS Ae 3 91 5 4 4 Miscellaneous NACE EH Va ROLE pU S
38. 6 424 Please also refer to the W H O World Health Organization guidelines Laboratory Biosafety Manual 2nd edition for further information page VI Introduction RABO80GEN Instrument internal cleaning e Concentrated cleaning Counting chambers and hydraulics parts are decontaminated by using the Concentrated cleaning function as described further in this manual Sampling probe e Sampling probe must be decontaminated as follows 1 Prepare a solution of Sodium Hypochlorite to 100ml l 2 Fill a 5ml tube with this solution 3 Run 5 analysis on bleach Please also refer to the W H O World Health Organization guidelines Laboratory Biosafety Manual 2nd edition for further information page VII Introduction 1 6 Graphics and symbols O pd J a gt J C O Z page VIII Switch off position Alternating current In Vitro Diagnostic medical device Caution consult accompanying documents Reagent Fragile handle with care Do not stack Batch code Use by Calibrator Content p tt RABOSOGEN Switch on position Manufacturer This product conforms to the EEC Standards and Directives named in the declaration of conformity Biological risk Keep dry Temperature limitation Catalogue number Consult Instructions for Use Control This product should be disposed of and recycled at the end of the useful life in accordance w
39. ASO count LMNE flag is generated e WBC count is within 2501 and 8000 If the WBC LMNE count is higher than 20 of the WBC BASO count a LMNE flag is generated If the WBC LMNE count is lower than 20 of the WBC BASO count LMNE flag is generated e WBC count is higher than 8000 If the WBC LMNE count is higher than 15 of the WBC BASO count a LMNE flag is generated If the WBC LMNE count is lower than 15 of the WBC BASO count LMNE flag is generated The WBC BASO channel is considered as a reference and is used to calibrate the WBC LMNE channel The ratio calculated between the two channel calibration coefficients is except technical intervention stable In any case it is the WBC BASO result that is reported The WBC balance flags LMNE and LMNE shall not be triggered if and only if The test selected is CBC e The WBC Balance option is not activated These flags are associated with an on all differential parameters and L1 flag is associated with an on WBC value and on absolute values of the differential parameters page 3 29 3 Specimen Run amp Results RABOSOGEN 5 4 Pathology messages e Pathology suspicion messages may be displayed and printed out Triggering conditions are linked to the laboratory limits entered by the user These messages indicate a possible pathological disorder and should be used to assist with quick and efficient screening of abnormal samples an
40. ED MESSAGE CAUSES USER ACTIONS No ENQ character received on RS232 No ACK character received on RS232 Internal error on RS232 Write error RS232 Defect on Timeout overflow on RS232 transmission CRC error operations Instrument number error Message lenght error Receiving data error Calibration DISPLAYED MESSAGE Causes USER ACTIONS Access denied Incorrect pasword entered by the operator Incoherent value entered by the operator Illegal date Incoherent date entered by the operator Minimum tagged CBC incorrect Selected results for calibration at least 3 calculation lt 3 Max num done start cycle refused 11 results are already recorded in the calibration table Data not saved value out of range Switch on or Press ON LINE or See the printer s user s manual Feed paper or See the printer s user s manual Wait for the current printout to complete and restart the request Check the RS232 configuration Menu SETUP RS 232 RS232 CONFIGURATION Call HORIBA ABX representative service department Re type the password Re type in the item Re type in the date Select at least 3 results Perform the procedure described section 3 to change coefficients or to exit the calibration menu Miscellaneous DISPLAYED MESSAGE Causes USER ACTIONS Emergency stop Run an autocontrol Blocked motor umi not reaching home Thermal door opened Illegal time Data not saved value out of range U
41. HORIBA ABX instructions in order to avoid to compromise system integrity e The ABX PENTRA 60 responds to the Standards and Directives named in the declaration of conformity e The reagents and accessories stipulated by ABX have been validated in accordance with the European Directive for in vitro medical devices 98 79 CE e The use of any other reagents and accessories may place at risk the perfor mance of the instrument engaging the Users reponsability In this case HORIBA ABX takes no responsability for the device nor for the results rendered e Disposal gloves eyes protection and lab coat must be worn by the operator Local or national regulations must be applied in all the operations Portable mobile should not be used in proximity of the instrument e All peripheral devices should be IEC compatible Introduction RABOSOGEN 1 2 Limited garantee e The duration of guarantee is stipulated in the Sales conditions associated with the purchase of this instrument To validate the guarantee ensure the following is adhered to 1 The system is operated under the instructions of this manual 2 Only software or hardware specified by HORIBA ABX is installed on the instrument This software must be the original copyrighted version 3 Services and repairs are provided by an HORIBA ABX authorized technician using only HORIBA ABX approved spare parts 4 The electrical supply of the laboratory follows the natio
42. INOFIX ilitre Integrated e ABX BASOLYSE 1 litre Integrated e ABX ALPHALYSE or LYSEBIO 0 4 litre Integrated 1 5 Keyboard amp Display e HORIBA ABX specific keyboard silicone made e LCD 128 x 240 pixels LED Backlighted 1 6 Data processing e 68331 type microprocessor e RS232C output 1 7 Measurements and computation Impedance for WBC RBC BASO e Photometry for Hgb e Impedance and light scattering for LYM MON NEU EOS ALY and LIC Computation from stored data that was directly measured for Hct MCV MCH MCHC RDW MPV Pct PDW page 1 5 1 Specifications RABO80GEN 2 PHYSICAL SPECIFICATIONS 2 1 Power requirements Power supplies from 100Vac to 240Vac 10 50 Hz to 60 Hz e Power Consumption Analyzer 200 VA t Printer Depends on the printer see Printer s manual 2 2 Operating temperature and humidity e 16 34 C 61 93 F room temperature e Maximum relative humidity 80 for temperatures up to 31 C 88 F decreasing linearly to 50 relative humidity at 40 C 104 2 3 Dimensions and Weight e Analyzer dimensions Height approximately 516 mm 20 3 in H Width approximately 444 mm 17 5 in Depth approximately 481 mm 19 in e Analyzer weight approximately 35Kgs 77lbs 2 4 Minimum specimen volume CBC Mode CBC 30ul e CBC 5DIFF
43. LOW FOR IMPEDANCE MEASUREMENT TECHNICAL CHARACTERISTICS THE COUNT DURING THE ACQUISITION THE MATRIX Blood volume 25 ul Method Impedance with hydrofocus Eosinofix volume 1000 ul Ruby diameter 60 Diluent volume 1000 ul Flow diameter 42 um Final dilution rate 1 80 Injection duration 12 seconds Reaction temperature 35 C Volume injected 72 yl Incubation duration 12S Results e From these measurements a matrix is drawn up with volumes on the X axis and optical transmission on the Y axis The study of the matrix image permits the clear differentiation of 4 out of 5 leukocyte populations As a matter of fact the basophil population is very small compared to the other 5 in a small blood sample page 2 13 2 Description amp Technology RABO80GEN page 2 14 2 Description amp Technology RABO80GEN MONOCYTES The monocytes being cells with large kidney shaped nuclei and a large non granular cytoplasm will neither be scattered nor absorb a large amount of light They will therefore be positioned in the lower part of the optical axis but clearly to the right of the volume axis Certain large monocytes can be found on the right side of the matrix in the lower LIC Large Immature Cells zone The immature granulocytic cells are detected by their larger volumes and by the presence of granules which increase the intensity of the scattered light Therefore cells such as metamyelocytes will be fo
44. NIA 5 5 Analyzer alarms Total rejection of the matrix Meaning poor correlation The percentage of validated cells is abnormally low appears when the correlation between the resistivity measurement of particles and their optical measurement is less than 50 Suspected abnormalities e Stroma interfering with measurement e Strong pollution e Incorrect adjustment of the optical bench e From LMNE Matrix NO flag e From WBC Balance LMNE LMNE e From WBC BASO Histogram BASO 3 Specimen Run amp Results RABO80GEN 6 CALIBRATION e Two modes are available 1 AUTOCALIBRATION using calibration blood samples 2 CHANGE COEFFICIENT calibration coefficients are known and can be entered directly 6 1 Autocalibration e When the 3 Calibration verification has failed calibrate the instrument as follows 6 1 1 Operator selection e Enter the AUTOCALIBRATION Menu e Move the cursor to one of the 4 required operator identifications e Press to validate the selection See Chapter 4 Instrument configuration to change the operator identification 6 1 2 Change lot number e Move the cursor to LOT field if this one has to be changed If not perform the 6 1 3 Change expiration date e Press the cursor turns to a flashing _ below the figures or letters to replace Use and to display the letters and numerical keyboard to display the figures e Press to val
45. ON REVISIONS Hl 1 WARNINGS AND PRECAUTIONS IV aM usse IV 1 2 Limited garantee V 1 3 Safety precautions electronic and MOVING parts V 1 4 Biological qe VI 1 5 Instrument cleaning icut rena Ra En ER rrr Rr DIR DERE VI 1 6 Graphics and symbols nnn VIII 2 WORKING CONDITIONS sn hne hn nnne nsns nnne nnn nnns IX 21 T EET E IX BOG T T IX Mr c P IX 2 4 Humidity and temperature conditions IX 2 5 Electromagnetic environment X 2 6 Environmental protection X 2 7 Transport and storage conditions X 2 8 Installation M MPH c XI 2 9 Package Dr XI page XII Introduction RABO80GEN SPECIFICATIONS 1 TECHNICAL SPECIFICATIONS 1 2 11 Parameters he ee eee re nth ALS eS eee eee ee
46. Primary DILUTION FOR RBC anp PLT Blood ul 10 ABX DILUENT uL 1700 dilution SECONDARY DILUTION RBC AND PLT FROM THE PRIMARY DILUTION Dilution pl 42 5 ABX DILUENT pL 2500 dilution FINAL DILUTION 1 170 X 1 58 8 1 10000 page 2 8 2 Description amp Technology RABO80GEN Results e Number of cells counted per volume unit x Calibration coefficient Histograms RBC Distribution curves 256 counting channels from to 300fl Distribution Curves on 256 channels from 2fl to a mobile threshold This threshold moves according to the microcyte population present in the analysis area 2 3 Hgb measurement During the analysis cycle lysing reagent is released into the Dilution chamber e 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 wavelenght of 550 nm e Lysebio Reagent for erythrocyte lysis and cyanide free determination of hemoglobin All the heme iron is oxidized and stabilized producing chromogenic species for quantitation by spectrophotometry at a wavelength of 550 nm TECHNICAL CHARACTERISTICS FOR THE MEASUREMENT OF THE HEMOGLOBIN Volum
47. Source 510K submission 144 page 1 9 1 Specifications RABO80GEN Precision claims PARAMETER CV NoMiNAL VALUES WBC 2 0 10 0 x 107 mn RBC 2 0 4 67 x 10 mm HGB 1 0 13 6 g dl HCT 2 0 36 0 PLT 5 0 243 x 10 mm Source 510K submission K030144 3 2 Precision Repeatability e Based on 10 consecutive samples of the same fresh whole blood sample without alarm PARAMETERS CV TEST LEVEL WBC lt 2 at 10x10 mm RBC lt 2 at 5x109 mm lt 5 at 300 10 Hgb lt 1 at 15 g dL Hct lt 2 at 45 page 1 10 1 Specifications RABO80GEN 3 3 Linearity limits e Linearity range The Manufacturer s tested linearity zone of the instrument using linearity kits and or human blood e Linearity limits Maximum and minimum values within instrument returns no dilution alarm e Visible range Range values given by the instrument These values above linearity limits are given as an indication They are given associated with a D flag This Visible range is outside Manufacturer s range e 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 e Human Blood Linearity was also obtained on human blood using a mini mum of 5 dilution points The results of this study are as follows 105 ul HGB g dl HCT 96
48. The basophils are located from threshold lt BA2 gt to threshold BAS TECHNICAL CHARACTERISTICS THE WBC BASO COUNT Blood volume 10 pl Method Impedance BASOLYSE Il volume 2000 ul Ruby diameter 80 um Dilution rate 1 200 Depression of count 200 mb Reaction temperature 35 C Duration of the count 2 X 6 seconds Results WBC Number of cells per volume x coefficient of calibration BASO Number of cells per volume x coefficient of calibration in percentage regarding the total number of leukocytes BASO WBC nuclei 2 Description amp Technology 2 10 3 LMNE matrix e The WBC and Differential count are based on 3 essential principles 1 The double hydrodynamic sleeving DHSS HORIBA ABX patent 2 The volume measurement impedance changes 3 The measurement of transmitted light with O angle which permits a response according to the internal structure of each element and its absorbance by means of incident light diffusion e 25ul of whole blood is delivered to the LMNE chamber in a flow of EOSINOFIX This reagent lyses the RBC stabilizes the WBC in their native forms and stains the eosinophil nuclei with a specific coloration e The solution is then stabilized with diluent and transferred to the measuring chamber Each cell is measured both in absorbance cytochemistry and resistivity volume RABOSOGEN 2 SECOND FOCUSED FLOW FOR OPTICAL DETECTION mil 1 PRIMARY FOCUSED F
49. a normal human blood without taking account of the first result if the repeatability is not correct please contact your HORIBA ABX Representative 4 Calculate the CV obtained out on the 5 results the values of CV must be lower than those given in the manual 5 Run a control blood and check that the values are within the acceptable limits If not run a new control e f the instrument is clean blank cycles in conformity with the values given in the manual that repeatability is correct values of CV acceptable and that the values of control are not within the acceptable limits then it is possible to carry out a calibration 6 Run at least 4 times Calibrator without taking the values of the first result into account 7 Calibrate the instrument on the average of the last three results according to indications of the manual Take care to respect the minimum and maximum calibration coefficient values given in the manual Run 3 times again Calibrator to check the values 8 Confirm the calibration while passing a blood of control the values have to be returned within acceptable limits 9 After about thirty analyses of the day check that values of MCV MCH and MCHC are in conformity with the usual values of the laboratory page 3 5 3 Specimen Run amp Results RABO80GEN 4 RUNNING SPECIMENS Two Identification modes are available see Chapter 4 5 configuration to configure the ID mode 1 alphanumerica
50. acccording three different steps Communication initialization Results transmission End of communication Protocol XON XOFF protocol controls data flow between ABX PENTRA 60 and main laboratory computer Any modification of the instrument s DATA OUTPUT setup has to be done in agreement with the technician in charge of the main computer system the password is required to access to the RS232 menu 4 Instrument Configuration RABO80GEN 5 1 RS232 Configuration e Choose the baud rate the parity the character length the stop bit and the protocol as follows Move the cursor to the parameter to be selected and press 8 the selection is shown by a dot inside the square e Press lt gt to validate nter 5 2 Sending configuration e This function allows the user to configure the format and the mode The ABX format can be selected if the data transmission length is done on 8 bits page 4 13 4 Instrument Configuration RABO80GEN page 4 14 5 3 ABX format e A selection of transmitted parameters among numeric values alarms and pathologies curves and thresholds and patient files can be carried out this selection only concerns ABX format 5 3 1 Numerical values To select the hematologic parameters to be transmitted press 1 The Numerical values menu is opened e The dot inside the square displayed in front of the parameters indicates that these ones will be sent out e If
51. after an emergency stop of the instrument or when a faulty operation has been detected A series of mechanical hydraulic and electronic networks control is performed General rinse Control of the correct drains of the chambers Initialization of the mechanical assemblies 1 2 Cleaning cycle e This cycle performs a chamber rinsing as the Rinse Chambers cycle and it also primes reagent that could remained into the heating coil e After one hour off the system automatically asks the user to run this cycle e User can run this cycle after a stop shorter than an hour by means of the beside menu 1 3 Hydraulics systems 1 3 1 Backflush 1 3 2 Rinse e Delivers pressure through the apertures of the counting chambers to clean them in case of blockages e ABX Diluent is sent to either chambers pressing 1 or cytometer pres sing 2 to rinse out these parts separately The cytometer rinse includes a sequence that removes bubbles that could remain inside the flowcell 1 3 3 Drain chambers Runs chamber draining cycle for the following parts e Rinse Sampling probe rinsing chamber 7 drain e First dilution First dilution chamber 2 drain LMNE chamber 3 drain RBC PLT RBC PLT chamber 4 drain e WBC BASO WBC BASO chamber 5 drain e All chambers General drain e Diluent reservoir Diluent reservoir 6 drain Ja 2 7 NN
52. ag must also be readjusted too see S 3 Flag Sensitivity 3 To modify one or several matrix areas in order to define more precisely a specific population for research purposes Absorbance NoN NoE Channel 127 Resistivity page 4 8 4 Instrument Configuration RABO80GEN DC thresholds resistive vertically shown on the matrix are adjustable by the user THRESHOLD PURPOSE STANDARD Low HIGH LIMIT Separation between Noise and Left Lymphocytes 0 NoN Separation between noise and Left Neutro 25 NoL NoE LL Separation between Left Lymphocytes and Lymphocytes 30 NoL AL LN Separation between Neutro and Left Neutro 135 NoE Separation between the noise and Eosino 48 NoN Channel 127 LMN Intersection dot between Lympho Mono amp Neutro thresholds 70 IN AL Separation between the Lympho and the Atypical Lympho 68 LMU LMU Upper dot of the separation slope between Atypical Lympho amp Mono 78 AL LMD LMD Lower dot of the separation slope between Atypical Lympho 8 Mono 90 1 0 RM MN Upper dot of the separation slope between Mono 8 Neutro 90 LMN RM RM Separation between Monocytes and Right Monocytes 118 1 0 17 RN Separation between Neutro and Right Neutrophils 118 127 AC thresholds Absorbance horizontally shown on the matrix are adjustable by the user THRESHOLD PURPOSE STANDARD Low LIMIT NL Separation be
53. also highlight a known A interference see User manual In the case of pathology whose treatments weaken the leucocytic membranes the agent of lysis of WBC channel can damaged the cells and give a lower leukocytes counting The LMNE flag will then be triggered off and a suspicion will be integrated to the WBC results We thus recommend not to disable WBC balance flag and to work in DIFF mode for all the samples which can present this possible interference Selecting the CBC mode will disable this control mode It is thus recommended to use this mode for patient not pre senting this type of interference 2 L1 LL1 Flag mm In certain cases the L1 flag will not be triggered off because of the poor sensitivity of this flag large platelet aggregates and or erythroblasts that are beyond the electronic thresh old This happens in CBC mode only Two additional flags LL see User manual and LL1 see User manual are available in DIFF mode and provide more reliability in anomaly de tection This mode should be recommended 3 Recommendations on the analysis mode selection CBC or DIFF When selecting CBC analysis there is no control mode on WBC erroneous countings that may be caused by spe cific treatments on patients see User manual and WBC balance description see User manual User Manual Update RAM207AEN 4 Known interfering substances 4 1 WBC Chemotherapy Cytotoxic and immunosuppressive drugs may increase the fragility of th
54. ampling syringe e Distributes portions of the specimen into the dilution chambers e Jakes the sample from the first dilution and distributes it into the RBC PLT chamber Count assembly e Receives the different rinsings and dilutions e Regulates the temperature of dilutions e Provides the dilutions for WBC BASOS RBC PIt Hgb 4 m Draining syringe Diluent tank e Drains the chambers e Contains the necessary diluent for an analysis cycle e Bubbles the mixtures e Prevents Diluent degassing as it is being aspirated Transfers by vacuum the LMNE specimen from the by the syringes mixing chamber towards to the injector of the optical e Is vacuum filled by the counting syringe flowcell page 2 4 2 Description amp Technology RABO80GEN T Optical bench e Ensures the support and adjustment of the flowcell lamp and optical and electronic elements Counting syringe e Ensures the vacuum for the WBC and BASOS counts e Ensures the vacuum for the RBC and the Pits counts e Ensures the vacuum for filling the diluent tank with diluent LMNE Syringe assembly e Ensures the correct proportioning of the stop diluent in the LMNE chamber e Injects the specimen into the flowcell e Injects the interior and exterior sheath into the flowcell 7 Reagent Syringe assembly e Ensures the correct proportioning of the reagen
55. at contain human blood or serum as potentially infectious Use established good laboratory working practices when handling specimens Wear protective gear Gloves Lab coats Safety glasses and or Face shields and follow other bio safety practices as specified in OSHA Blood borne Pathogens Rule 29 CFR part 1910 1030 or equivalent bio safety procedures e HORIBA ABX uses disinfectant product for instrument decontamination and highly recommends to decontaminate regularly your instrument 1 5 Instrument cleaning Instrument external cleaning e The external surfaces of the instrument must be decontaminated considering the biological environment Never spill liquid on the instrument Never use Disinfectant product that contains alcohol e Screen Use a soft clot slightly wet with disinfectant product Wipe gently the screen and dry to remove any trace of moisture e All contaminated surfaces covers counting assembly area Slightly wet a sponge with disinfectant product and wipe the dirty surfaces e Stainless steel parts Slightly wet a sponge with disinfectant product and wipe the dirty surfaces Dry with a soft cloth Products having the following microbiological properties e Bactericidal e Fungicidal e Active on Aspergillus fumigatus e Active on Mycobacterium tuberculosis e Antiviral VIH HBV and rotavirus Product Example validated by HORIBA ABX ANIOS detergent disinfectant WIP ANIOS ref 131
56. ated with Minocal Calibrator Lot No CX322 e Three levels of ABX MINOTROL material Lot No JX108 were run in duplicate once daily for a prolonged period on all parameters The results were used to quantify within run precision and Total Precision in accordance with the NCCLS EP 5 A Guidelines PARAMETER ABX MINoTROL WITHIN RUN SD or RUN SD or DAILY TorAL CONTROL MEANS MEANS Precision SD JX108 Low 0 001 N A N A 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 0 012 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 PARAMETER ABX MiNorROL CV OF RUN CV OF DAILY TOTAL MEANS MEANS PRECISION CV JX108 Low 1 8 N A N A 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 JX108 Low 0 9 N A N A 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
57. be used HORIBA ABX provides all the necessary reagents The HORIBA ABX reagents specified for this instrument have been approved in accordance with the European Directive 98 79 CE Annex for in vitro medical devices e The CD Rom RAX055 delivered with your instrument provides Reagents Controls and Calibrators leaflets msds Latest versions of these documents are available on www horiba abx com documentation 4 2 Waste handling precautions When disposing of waste protective clothing must be worn lab coat gloves eye protection etc Follow your local and or national guidelines for biohazard waste disposal e If required waste can be neutralized before being discarded Follow your laboratory s protocol when neutralizing and disposing of waste e Dispose of the waste container according to the local or national regulatory requirements page 1 15 1 Specifications RABO80GEN 5 LIMITATIONS Whilst every effort is taken by HORIBA ABxX to investigate and indicate all known interference s it is by no means possible to guarantee that all interference s have been identified At all times results should be validated and communicated only once all information relating to the patient has been assessed and taken into account 5 1 Maintenance In Chapter 5 Maintenance amp Troubleshooting specific maintenance procedures are listed The maintenance procedures identified are mandatory for proper use an
58. bove the upper limit L for results below the lower limit CBC s and differential panic ranges are separated between two screens See 7 2 1 Normal ranges to adjust them page 4 5 4 Instrument Configuration page 4 6 3 3 Flag Sensitivity RABOSOGEN e Each flag is adjustable according to a percentage and or an absolute value Beyond these values the corresponding flag is triggered off e The standard values are factory installed on the instrument and shown in the screen below Move the cursor to the value to modify and enter the new value Password is required to enter this function e Press to validate LI NI Mn Rm Ln Rn Ne L1 Mic Mac FLAGS e The following chart table gives the standards FLAG SENSITIVITY STANDARDS 100 120 100 50 5 45 3 120 100 120 1 1 999 2 9 999 1 1 999 1 1 60 3 200 5 45 3 0 60 The meaning of each flag is described Chapter 3 Specimen Run amp Results MHGB indicates the reject level between the three HGB measures BHGBi allows to reject an HGB reference value that is faulty see Chapter 3 Specimen Run amp Results 4 Instrument Configuration RABO80GEN 3 4 Thresholds 3 4 1 WBC BASO All of the leukocytes are shown between the and thresholds L1 absolute value is calculated between the channel 0 and the threshold see Chapte
59. c sees 5 9 1 6 Sampling probe replacement 5 10 5 11 2 1 Instrument operation mode sesesencidandedicuesenicswersenecsweveveceedontiaendieneseaseoes 5 12 2 2 Analysis 6 e 5 13 DU NNNM 5 16 gt 5 18 MENG OVE RVIE YV 5 20 page XVII Introduction RABOSOGEN Cue coul e ANNEX 2 LIST OP ABBREVIATIONS aa EESE ANNEX 4 FINI DIAGRAM ce ee ANNEX 6 page XVIII SPECIFICATIONS 1 TECHNICAL SPECIFICATIONS sncessteacactesdocssvetequriderementeneseicedees 1 2 tih te OA MS RIO ETE 1 2 MOQO eee oe ne ee eee eee eee 1 2 12 2 CBO ODIFF MOGGE 1 3 UN P 1 4 1 2 Throughput Analyses 1 5 1 3 Tube ldentification veces 1 5 A sane ce cen 1 5 1 9 Keyboard DISDIAY uuditvesscierutusetdigederbeivteretidrexecke tabes to lads 1 5 1 0 Data 1 5 1 7 Measurements and computation 1 5 2 PHYSICAL SPECIFICATIONS tutu or Iu a SEU EU PRESSE S 1 6 2 1 Power requirements
60. cator stops flashing the LED turns to red remove the tube e When the LED turns to green again the instrument is ready for the next analysis page 3 7 3 Specimen Run amp Results RABOSOGEN 4 5 Automatic cleaning e When the instrument has run 75 specimens from the date changing an automatic cleaning procedure is carried out e The automatic cleaning frequency can be adjusted by the user from 1 to 75 as described Chapter 4 Instrument configuration 4 6 End of the day rinsing e t is necessary to run a standby shutdown cycle at the end of the day e Press the key the instrument performs a complete cleaning with CLEANER and puts the system into the standby mode e The instrument can be switched off if the working day is completed or left in A startup cycle is required systematically after a shutdown cycle if the this standby mode overnight or until the next analysis instrument has to be operated It is mandatory to power down the system if not used more than 36 hour period This eliminates the possibility of the dilution chambers evaporating causing startup alarm page 3 8 3 Soecimen Run amp Results RABO80GEN 5 RESULTS e When the analysis cycle is completed results are displayed and printed out according to the setup of the instrument Chapter 4 Instrument configuration Printout configuration PRINTER Sequence mode or Alphanumerical mode IDENTIFICATION MODE
61. ce mechanical systems check motors sample probe e Open the pneumatic access door e Run an analysis cycle on blood e Control the specimen aspiration blood delivered in the chambers e Check the probe is not bent Procedure 5 Dilution Carriage motion e Check that hydraulic operations appear to work properly reagent level in each chamber carriage motion Sample distribution e Run an analysis cycle and check that the specimen distribution is performed correctly into the chambers A probe rinse is previously carried out in the rinse chamber 1 blood appears in this chamber The first specimen is delivered to the first dilution chamber 2 brown colour the second to the WBC BASO chamber 5 clearer and the third one to the LMNE chamber 3 the darkest Check that bubbling is provided to these chambers once the specimen have been diluted Drain and rinse e Check the chambers are drained and rinsed If operations are faulty identify the source of the malfunction and call your HORIBA representative Service Department 2 3 Results Procedure 6 All parameters Repeatability according to the CV Specifications see section 1 5 the instrument non repeatable on all parameters If not perfom directly the procedure corresponding to the non repeatable parameter e f all parameters are not repeatable e Visually check that the sampling operation appears to be correct e Control the sampling s
62. cimen 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 an HORIBA patent pl WBC BASO Dilution 10 ul RBC PLT HGB first dilution 10 ul Reagent input gt angential Flow Mi Mixing chamber page 2 7 2 Description amp Technology 2 2 RBC Plt detection principles T Measurement of impedance variation generated by the passage of cells through a calibrated microaperture e The specimen is diluted in an electrolytic diluent current conductor and pulled through the calibrated microaperture Two electrodes are placed on either side of the aperture Electric current passes through the electrodes continuously e When the cell passes through the aperture electric resistance between the two electrodes increases proportionately with the cell volume e The generated impulses have a very low voltage which the amplifi cation circuit increases so that the electronic system can analyze them and eliminate the background noise RABOSOGEN TECHNICAL CHARACTERISTICS THE RED BLOOD CELL anb PLATELET COUNTS Initial blood volume 10 pl Method Vol ABX DILUENT 2500 ul Aperture diameter Final dilution rate 1 10000 Count vacuum Temperature of reaction 35 C Count period TWO SUCCESSIVE DILUTIONS CARRIED OUT
63. ct either the alphanumerical mode or the Sequence mode see Chapter 3 Specimen Run amp Results move to the required mode and press The selection is performed when a dot appears in the square Barcode with checksum Enables disables the last character of the barcode checksum Sequence 1t and identification display The sequence number indicates the number of analysis cycles from the beginning of the working day This one is updated to 1 each new day Enable PDW PCT LIC ALY Enables disables the RUO parameters see 5 Data output 5 3 ABX format for printing and sending towards the host 7 3 Autoclean frequency e Adjust the Autoclean frequency according to the number of analyses carried out factory adjusted to 75 analysis cycles Minimum value 1 Maximum value 75 page 4 20 4 Instrument Configuration RABO80GEN 7 4 Change password e The password is used to access the following functions CALIBRATION CHANGE COEFFICIENTS SETUP LAB LIMITS FLAG SENSITIVITY SETUP LAB LIMITS THRESHOLDS SETUP RS 232 SETUP OTHERS CHANGE PASSWORD SETUP OTHERS CALIBRATION CV LIMITS FORCED CALIBRATION e The original password is 123 To change it enter the previous password on this screen and press Enter e Type in the new password on this screen and press 7 5 Change language e The 6 following languages are available on the instrument e To modify the
64. d for diagnosis It is recommended to use suitable reference methods to confirm diagnoses There is no pathological message in the following cases WBC For a WBC lt 0 1 103 or WBC gt 91 3x10 mm or for a counting reject except if an Erythroblast flag is the NUCLEATED RBC e For a counting reject RBC value lt 0 1x10 mm On Pit For a counting reject or a value lt 5x10 mm 5 4 1 WBC messages high extreme limit L low extreme limit means the pathology is detected firstly on the high and low absolute values of the corresponding parameter page 3 30 MESSAGE TRIGGERING CONDITION LEUKOCYTOSIS WBC gt WBC H LEUKOPENIA WBC lt WBC L LYMPHOCYTOSIS LYM gt LYM H or if LYM gt LYM H LYMPHOPENIA LYM lt LYM L or if LYM 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 9o gt EOS H MYELEMIA NEU gt NEU 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 NUCLEATED RBC LL MONOCYTOSIS MON gt MON H or if MON gt MON H BASOPHILIA BAS gt BAS H or if BAS gt BAS BLASTS BAS gt BAS and LIC gt LIC H and RM 3 Specimen Run amp Results
65. d for monitoring the performance of an analitycal process or instrument See Coefficient of variation An original factory setting The last day that you can use that specific lot number of reagent control or calibrator Abbreviation for femtoliter One quadrillionth 1015 of a liter An area on a screen for entering data On printouts or screens letters or symbols that appear next to parameter results to indicate specific conditions The ability of an instrument to recover expected results reference values or calculated values for such parameters as WBC RBC Hgb and at varying levels of concentration of these parameters within specified limits A manufacturer s code that identifies products such as reagents controls or calibrators Annex mean operating range parameter performance characteristics performance quality control QC reproducibilty SD shutdown cycle specifications startup cycle verification whole blood RABO80GEN Arithmetic average of a group of data Range of results over which the instrument displays prints and transmits data A component of blood that the instrument measures and reports Actual performance of the instrument Targeted performance of the instrument based on established ranges and parameters specifications A comprehensive set of procedures a laboratory establishes to ensure that the instrument is working accurately and precisely This procedure checks that the system gives
66. d operation of the ABX PENTRA 60 Failure to execute any of these recommended procedures may result in poor reliability of the system Failure to execute any of these recommended procedures may result in poor reliability of the system 5 2 Blood specimens e 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 sections below list Known limitations of automated blood cell counters which use the principles of impedance and light absorbance as principles of measurement page 1 16 1 Specifications RABO80GEN 5 3 Known interfering substances WBC White Blood Cells Leukocytes WBC results that exceed the linearity limits of the system will require dilution of the blood sample Leukemia sample followed by a leukopenia Re assaying the diluted sample will help to obtain the correct assay value Unlysed Red Cells In some rare instances the erythrocytes in the blood sample may not be completely lysed These non lysed red blood cells may be detected on the WBC histogram with an L1 alarm or as an elevated baseline on the side leading edge of the lymphocytes population Non lysed erythrocytes will cause a falsely elevated WBC count Multiple myeloma The precipitation of proteins in multiple myeloma patients may give high WBC counts Leukemia A
67. door Cover e Bef tt th e Allows the operator to access hydraulics parts for ada dt de maintenance operations It is mandatory to keep the door locked during the measuring cycles as it ensures the heating of the dilutions Control panel e This panel allows the operator to communicate with the instrument To access to different cycles To identify the patients To setup the instrument etc Reagent access door e Access to the reagent bottles in order to replace them when empty LEDs When Green LED is instrument is ready to sample Sampling probe e When Green and Red LEDs are blinking alternatly This needle is used for the 53ul whole blood sampling LCD is busy sampling e When Re is lit instrument is running page 2 2 2 Description amp Technology RABO80GEN 1 2 Pentra 60 back side T Serial number label Printer Connector for printer Main supply cable Barcode Connector for Diluent input barcode reader Cristal tube 3 x 6 length 2 meters maximum RS 232 Output Connector Waste output Cristal tube 4 x 6 length 2 meters maximum page 2 3 2 Description amp Technology RABO80GEN 1 3 Mechanical and hydraulic modules Piercing carriage e Ensures needle positioning for the different sampling stages and distribution e Supports the sampling syringe and the blood distribution S
68. e 9 WBC BASO Repeatability e Is the instrument non repeatable on WBC BASO e Perform an autoconcentrated cleaning e If this does not correct the WBC BASO count call your HORIBA ABX Representative Service Department Calibration e See procedure 6 Procedure 10 Differential Repeatability e Is the instrument non repeatable on differential e Perform an autoconcentrated cleaning e If this does not correct the WBC BASO count call your HORIBA ABX Representative Service Department 2 4 Flags Procedure 11 Default analysis WBC e Perform an autoconcentrated cleaning e Re run the specimen e Check the operation of the liquid valve lt 23 gt and lt 14 gt opening and closing during the cycle If defective replace the valve f it does not correct the WBC results call your HORIBA ABX representative Service Department RBC PLT e Perform an autoconcentrated cleaning e Re run the specimen e Observe the operation of the liquid valve lt 14 gt opening and closing during the cycle If not replace the valve f it does not correct the RBC or PLT results call your HORIBA ABX representative Service Department HGB e Is the HGB LED illuminated when the system power is on If not call your HORIBA ABX representative Service Department If it is continue e Perform an autoconcentrated cleaning e Re run the specimen e f it does not correct the HGB results call your HORIBA ABX representative Serv
69. e leukocyte membranes which may cause low WBC counts In these particular cases CBC mode must not be used as WBC balance alarm see User manual is disabled It is recommended to run these samples in DIFF mode 4 2 Basophil Over evaluation in the Basophil count Excessive number of leukocytes leukocytosis can cause artificial rise in the number of counted basophils due to the shifting of the leukocyte population in the zone of the basophil one Monocytes and Blasts show large granules and may shift on the basophil counting area This may interfere with an accurate count An abnormally low number of leukocytes leukopenia may increase too the basophil results The elements present in the zone of basophil are brought back on a small total quantity of leukocytes which increases the sta tistical error and may cause variabilities in the percentage The weakness of leukocyte cells shown in certain diseases Chronic Lymphocytic Leukemia or during anti cancer treatment chemotherapy can be translated on the basophilic channel by under evaluation of the leukocytes be cause of their destruction and thus cause a statistical increase in the basophil ones Under evaluation in the Basophil count During leukemia basophils may lose their cytochemical characters and react abnormally with the reagent The destruction of the basophil cytoplasms prevents their differentiation with the other leukocytes The basophils with very small sizes f
70. e number of particles counted 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 e Platelet aggregates e Large number of platelets e Erythrocyte membrane resistant to lysis stroma e NRBCs e Pollution Absorbance NoN NoE Channel 127 No L LMD RM Resistivity page 3 15 3 Specimen Run amp Results RABOSOGEN Meaning Left Lymphocytes Presence of a significantly large population on the left hand side of the lympho cyte area This flag appears when the number of particles counted is higher than the limit set up in LL or when the number of counted particles versus the total number of WBC exceeds the LL limit Suspected abnormalities e Small lymphocytes e Platelets aggregates e NRBCs e Erythrocyte membrane resistant to lysis stroma This flag occurs associated with an on e LYM 90 e NEU e MON e EOS EOS s e ALY 96 ALY LIC 90 LIC Standard values for LL Absorbance NoN NoE Channel 127 96 100 50 Adjustment see Chapter 4 Instrument configuration NoL LL AL LMD RM Resistivity page 3 16 3 Soecimen Run amp Results RABO80GEN i Standard values for LL 1 00 5 45 Adjustment see Chapter 4 Instrument configuration flag Meaning Left Lymphocytes 1 Presence of a significantly large
71. e of blood 10 pl Method Photometry Volume ABX DILUENT 1700 pl Wavelength 550 nm Volume LYSE 400 ul Complement ABX DILUENT 400 ul Final dilution rate 1 250 Temperature of reaction 35 C Results e Hemoglobin results are given as such Absorbance value obtained from the sample x Coefficient of calibration page 2 9 2 Description amp Technology RABO80GEN page 2 10 2 4 Hct measurement e The height of the impulse generated by the passage of a cell through the microaperture is directly proportional to the volume of the analyzed RBC e The hematocrit is measured as a function of the numeric integration of the MCV 2 5 RDW calculation e The study of the RBC distribution detects erythrocyte anomalies linked to anisocytosis A Red Cell Distribution Width RDW will enable you to follow the evolution of the width of the curve in relation to the cell number and average volume K SD RDW MCV With e K system constant e SD determined Standard Deviation according to statistical studies on cell distribution e MCV Mean Corpuscular Volume of erythrocytes 2 6 MCV MCH MCHC calculation e MCV Mean Cell Volume is calculated directly from the RBC histogram e MCH Mean Cell Hemoglobin is calculated from the Hgb value and the RBC number The mean hemoglobin weight in each RBC is given by the formula Hgb pg x 10 RBC e MCHC Mean Corpuscular Hemoglobin Contained is calc
72. ecorded 1 2 Change date Open the DATE amp TIME menu Type in the new date and or time e Press E gt to confirm nter page 4 2 4 Instrument Configuration RABOSOGEN 2 UNITS e The operator has the choice between 3 different unit systems move the cursor in front of the required unit system and press ESC e Press e to exit page 4 3 4 Instrument Configuration RABO80GEN 3 LABORATORY LIMITS e Laboratory limits can be set by the operator according to its own specifications 3 1 Normal ranges e Results that exceed the Normal ranges limits are identified with a flag h for results above the upper limit I for results below the lower limit e CBC s and differential normal ranges are separated between the two following screens 3 1 1 CBC s Normal ranges e The CBC s normal ranges are factory adjusted to the following values To modify them move the cursor to one of them and enter the new value e Step to the next one etc Press lt gt to validate page 4 4 4 Instrument Configuration RABO80GEN 3 1 2 DIF s Normal ranges e The DIFF normal ranges are factory adjusted to the following values To modify them move the cursor to one of them and enter the new value e Step to the next one etc Press lt gt to validate 3 2 Panic ranges e Results that exceed the Panic ranges limits are identified with a flag H for results a
73. ee E 4 3 S EABOHAIORY COMIT o ese EE CP quU CLAMP pU INE Dod 4 4 Sia eap ge 4 4 3 1 CBC S Normmal ranges E t C I D NS 4 4 3 1 2 DIES NORMAN 4 5 cR T 4 5 Bass 4 6 CP TEES 4 7 WV REAA 4 7 SR a ae Il ee ee ee ee eee 4 8 la es qu peor se aed quu MER SM rete 4 8 4 CONTROL 4 10 DATA 4 12 5 1 5232 Configuration nre 4 13 5 2 Sending configuration 4 13 OMI asec C rt 4 14 5 3 1 Numerical 4 14 5 3 2 Flags and pathologies 4 15 5 3 3 Histograms and thresholds sino ax suaseucs uu 4 15 5 3 4 cu sml AMT CR TT M 4 15 Lc Mem p 4 15 5 4 Send latest ERE OE E 4 16 SE ail Poraa T UU m 4 17 6 1 Print latest RR E eee ee eee 4 17 P 4 17 FeO TRER KK T T E
74. er 4 Instrument configuration Meaning Mono Neutro Presence of a significantly large population of cells located in the separation threshold area between monocytes and neutrophils This flag occurs when the number of particles counted in this area is higher than the limit set up in MN or the number of particles counted in MN versus the total number of WBC is above the MN limit Suspected abnormalities e Monocytes having granules in their cytoplasm or hyperbasophilic monocytes e Young neutrophils with non segmented nuclei bandcells This flag occurs associated with an on e ALY 96 ALY e LIC LIC and replaces e NEU NEU MON MON by Absorbance Channel 127 No LMD RM Resistivity page 3 19 3 Specimen Run amp Results RABOSOGEN Meaning Left Neutro Presence of a significantly large population of cells located on the left hand side of the neutrophil area This flag occurs when the number of particles counted in this area is higher than the limit setup in LN or when the number of particles counted regarding the total number of WBC is above LN limit Suspected abnormalities e Neutrophil destruction due to incorrect storage of the sample or an old sample e Contamination stroma or platelet aggregates This flag occurs associated with an on all WBC differencial parameters T Standard values for LN Absorbance NoN NoE 2 5 999 Channel 127 Adjustment see Chapter 4 inst
75. erformed each day e This daily workload warns the operator if a reagent low level is expected during the day In this case an alarm is triggered out REAGENT LOW LEVEL at the end of the Startup cycle e The operator can replace the bottle or container immediately or performed the analyses until the specific reagent alarm is triggered see 7 3 Reagent replacement e Ranges are given in the below chart table Mope DEFAULT VALUE DIF 40 1 500 CBC 10 1 500 3 41 3 Specimen Run amp Results RABOSOGEN 7 3 Reagent replacement e Open the reagent LEVEL CHANGE menu e f a reagent level indicates 096 this one has to be replaced Risk of erroneous results if one reagent is poured to another container Never pour reagents 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 Pits Properly dispose of the empty reagent bottle e Replace the bottle or diluent container as follows 7 3 1 Bottle replacement e Open the reagent front door e Remove the empty bottle from the reagent compartment e Unscrew the bottle stopper and reagent straw assembly e Replace the bottle by a new one and screw the stopper straw back on the new bottle e Proceed as described in 7 3 3 Level update 7 3 2 Diluent container replacement e Remove the diluent straw
76. eter syringes Same operation check 7 Dilution syringes Same operation check 1 4 3 Check valves To control the correct operation of the valves e Open the door see on previous pages and the left cover of the instrument e The valves can be operated pressing the corresponding number of the assembly e Closely observe the valve operations the movements have to be straight and regular 1 4 4 Maintenance carriage position e The probe goes up the carriage comes under chambers and all stepper motors are freed for the user to do any maintenance e To bring the probe back press lt gt key once more 1 5 Technician e Reserved to HORIBA ABX Field Service Engineer 1 6 Sampling probe replacement e Switch off the instrument and remove the power cable e Open the pneumatic access door Right side of the instrument e Unscrew both fixation screws of the probe rinsing block on the carriage e Take out the probe and the rinsing block at the same time lift the probe locker to free the probe Replace the probe e Reassemble following previous steps backward e When startup is done check for that there is no leak 2 TROUBLESHOOTING DEPANNAGE Instrument operation mode Printer ampera comes yes el 1 startup passed reached Calibration verification QC e R ol md aa analysis cycle j Sampling j dilution technical operations waste level contro
77. film Chemotherapy May also affect the sizing of PLTs page 1 19 1 Specifications page 1 20 RABO80GEN LYM Lymphocyte count absolute value LYM Lymphocyte percentage The Lymphocyte count is derived from the WBC count The presence of erythroblasts certain parasites and erythrocytes that are resistant to lysis may interfere with an accurate LYM count Limitations listed for the WBC count pertain to the LYM and counts as well MON mononuclear cell count absolute MON Mononuclear percentage The mononuclear cell count absolute is derived from the WBC count The presence of large lymphocytes atypical lymphocytes blasts and an exces sive number of basophils may interfere with an accurate monocyte count Limitations listed for the WBC count pertain to the MON and counts as well NEU neutrophil count absolute NEU Neutrophil percentage The neutrophils cell count is derived from the WBC cell count The excessive presence of eosinophils metamyelocytes myelocytes promyelocytes blasts and plasma cells may interfere with an accurate neutrophils count EOS Eosinophil cell count absolute EOS Eosinophil percentage The eosinophil cell count is derived from the WBC cell count The presence of abnormal granules degranulated areas toxic granules may interfere with the eosinophil counting BAS Basophil cell count absolute BAS Basophil percentage The Basophil cell count is derived from the WBC ce
78. ice Department Differential e Control that the lamp is still illuminated when the instrument is on If not replace it as described below e Run a cytometer rinse menu maintenance hydraulics systems rinse cytometer e Re run the specimen e f it does not correct the LMNE results call your HORIBA ABX representative Service Department Lamp replacement e Switch off the instrument e Open the cover e Disconnect the lamp supply e Unscrew lamp fixation screws few turns Wait for the lamp to cool down before handling it e Turn the lamp and remove it e Replace the lamp by a new one e Put back the fixation system and block the screws e Reconnect the lamp supply 3 MENU OVERVIEW 2 CONTROL MODE 1 RUN CONTROL 2 CHANGE COEFF 3 FLAGS SENSITIVITY 5 MAINTENANCE 1 BACK FLUSH 1 AUTOCONTROL 3 DRAIN CHAMBER 2 CLEANING 4 CONCENTRATED CLEANING 3 HYDRAULICS SYSTEMS 4 MECHANICAL SYSTEMS 1 INITIALIZATION 5 TECHNICIAN 2 CHECK MOTORS 3 CHECK VALVES 4 MAINTENANCE CARRIAGE POSITION o om 4 e 1 CHAMBERS 2 CYTOMETER 1 1 TO 11 2 12 TO 16 3 17 TO 19 4 20 TO 26 5 27 TO 31 1 SAMPLINGNEEDLE 2 CARRIAGE 3 SAMPLING SYR 4 DRAINING SYR 5 COUNTING SYR 6 CYTOMETER SYR 7 DILUTION SYR o 1 ae a ur n N E gt zi 0 9 1 2 FIRST DILUTION 3 LMNE 4 WBC
79. idate the lot number page 3 33 3 Specimen Run amp Results RABOSOGEN 6 1 3 Change expiration date e Move to the EXP DATE field if this one has to be changed If not perform the 6 1 4 Change target values e Proceed as described in 6 1 2 Change lot number to enter the new date e See Chapter 4 Instrument configuration to change the date format 6 1 4 Change target values e Move to the TARGET field if the this one has to be changed If not press ESC directly e Enter the new WBC target value if required and press e The menu turns to RBC target value e Repeat the same procedure for RBC HGB HCT PLT ESC e When this last value has been modified press da the calibration results chart table is displayed 6 1 5 Run calibration e Prepare the calibrator according to the specific instructions temperature mixing etc e Open the vial and position the sampling needle deeply inside the bottle e Press the sampling bar located behind the needle e When the cycle LED stops flashing remove the vial and replace the cap on the calibrator e When the analysis cycle ends the first result is displayed on the result chart table e Run the second calibrator sample e The calibration of the ABX PENTRA 60 can be performed on 3 to 11 analyses e The autocalculation module performs statistics on these results in order to obtain the best calibration coefficients Risk of erroneous
80. ith the WEEE Directive 2002 96 CE Introduction RABO80GEN 2 WORKING CONDITIONS 2 1 Environment e The operation of the ABX PENTRA 60 should be restricted to indoor location use only Operation of the instrument at altitudes of over 3000 Meters 9800 feet is not recommended The instrument is designed for safety from voltages surges according to INSTALLATION CATEGORY II and POLLUTION DEGREE 2 EN 61010 1 Please contact your local HORIBA ABX representative for any information regarding the operation location when it does not comply with the recommended specifications 2 2 Location e The ABX PENTRA 60 should be placed on a clean and levelled table or workbench Please note that the ABX PENTRA 60 printer and reagents weigh approximately 40 kilograms 88 Ibs Avoid exposure to sunlight Place your instrument where it is not exposed to water or vapor Place your instrument where it is free from vibration or shock Place your instrument where an independent power receptacle can be used Use a receptacle different from the one used by a device that easily generate noise such as a centrifuge etc e Provide a space of at least 20 cm 8 inches at the back of the instrument for arranging the power cable and tubings e The Power switch and Input voltage 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
81. l 0 Incorrect Results b All parameters repeatability repeatability calibrated pathology messages default analysis differential 2 1 Instrument operation mode Procedure 1 Printer e See Printer user manual to connect to switch on off or to feed paper Procedure 2 Reagents e Bottle replacement See Chapter 3 Specimen Run amp Results e Waste container empty and neutralize as recommended in section f Specifications Procedure 3 Instrument startup Startup failed e Check the reagent expiration dates replace bottle if necessary e Re run a startup e Perform an auto concentrated cleaning see 1 3 4 Concentrated cleaning Temperature not reached e Wait for 5 minutes to reach the operating temperature e Call your HORIBA ABX representative Service Department Calibration verification out of the acceptable limits e Clean the system see 1 3 4 Concentrated cleaning and rerun the control e Run a new vial e Calibrate the instrument See Chapter 3 Specimen Run amp Results 2 2 Analysis cycle Error messages Printer DISPLAYED MESSAGE CAUSES USER ACTIONS The printer is disconnected Printout operations disabled switched off or has not been selected Defect on printer make sure there is paper Printout operations disabled Printer being used action impossible The printer operates yet Transmission DISPLAY
82. l mode requires the patient or control identification on each analysis 2 Sequence mode increments a sequence number on each analysis 4 1 Alphanumerical mode e Identification can be entered using the and 7 16 characters letters or numbers keys of the front panel Press or 3 for each letter to step to the next one e Press lt gt when the identification is correct The identification of the current analysis is shown on the RUNNING field The identification of the analysis to come is shown on ip field If no identification has been entered the analysis cycle will not start 4 2 Sequence mode e Sequence from 1 to 99999 can be entered using the numeric keys of the front panel Press to record the number The sequence of the current analysis is shown on the RUNNING field The sequence of the analysis to come is shown ip field 4 3 Analysis mode selection CBC DIFF e Press to perform the selection between CBC analysis or a DIF analysis The mode on the current analysis is indicated on the right side of the screen as well as the mode on the analysis to come page 3 6 3 Specimen Run amp Results RABO80GEN 4 4 Analysis e Present the specimen as shown on the beside diagram and press the sampling bar located behind the sampling needle or press the em key e When the light indi
83. language move the cursor to the wished language and press to display a dot in the square Press e to validate page 4 21 4 Instrument Configuration RABO80GEN 7 6 Reagent capacities e This function indicates the initial volumes of each reagent bottle or container in order to calculate the consumption and the left reagent in each bottle e Ranges are given in the below chart table REAGENT STANDARD MIN DILUENT 20 000 1 000 30 000 CLEANER 100 10 500 EOSINOFIX 1000 100 5000 BASOYSE2 000 100 500 SS LYSE 4 10 2000 7 7 Cycle counters e Shows the total number of analysis cycles CBC amp DIF mode run on the instrument as well as Startup Shutdown and Autocontrol cycles 7 8 Configuration e Prints or sends to the host the setup of the instrument coefficients thresholds and flags values internal parameters etc page 4 22 4 Instrument Configuration RABO80GEN 7 9 WBC Balance e The meaning of these flags is described Chapter 3 Specimen Run amp Results WBC Balance e This window allows the user to enable or disable the WBC balance control a dot in the square will enable the WBC balance e The triggering off thresholds of the balance flags are default values They can not be modified by the user page 4 23 MAINTENANCE amp TROUBLESHOOTING Uu EZ elite M 5 2 jM EE
84. ll count DESCRIPTION amp TECHNOLOGY 2 1 PENTRA 60 DESCRIPTION aye PE VAPERC merece 2 2 1 1 Pentra 60 general description 2 2 1 2 Pentra 60 back 2 3 1 3 Mechanical and hydraulic modules 2 4 MEASURING PRINCIPLES 2 7 2 1 Multi Distribution Sampling System MDSS 2 7 2 2 RBC detection principles 2 8 2 3 Hgb measurement uoa esses nen Uude RR Ene n SE EE EK Idi ME 2 9 2 4 Hct measurement 2 10 2 5 ROW Calculation cies 2 10 2 6 MOV MCHC calculation 2 10 2 7 MPV Measurement 8 2 11 2 0 PCL 2 11 2 9 PDW calculation aC 2 11 2 10 WBC differential COUNT 2 12 2 10 1 General principles 2 12 2 10 2 BASO WBC 2 12 2 10 3 LMNE matrix 2 Description amp Technology RABO80GEN 1 PENTRA 60 DESCRIPTION 1 1 Pentra 60 general description Pneumatic access
85. lls in comparison with leukocytes Suspected abnormalities aggregates e NRBCs DIFF mode only MB Meaning Mono Baso This flag occurs when the percentage of basophils found in the Baso channel is above the percentage of Lympho Mono Neutro raw counts found on the matrix channel BASO If the BASO exceeds 50 a BASO flag is generated The Basophils are not taken away from the matrix populations and is displayed instead of the BAS and BAS 3 Soecimen Run amp Results RABO80GEN 5 3 4 Flags on RBC histogram MIC amp MAC flags MIC and MAC flags are generated when the percentage of cells counted in the microcytic area MIC and macrocytic area MAC compared to the total number of RBCs are above the limits set up by user e RBC1 and RBC2 thresholds define the microcytic and macrocytic areas and are calculated according to the MCV and the RDW T Standard values for Mic 96 5 Mac 96 45 Adjustment see Chapter 4 Instrument configuration 5 3 5 Flags on Plt histogram e The histogram has 256 channels between 2fL and 30fL A mobile threshold at 25fL by default moves according to the microcytic RBCs present in the platelet analysis area page 3 27 3 Specimen Run amp Results RABOSOGEN e The flags are generated under the following conditions T An excessive presence of particles on the right side of the threshold area after 25fL will generate the MIC Microcy
86. lt is above the panic limit set by the user L indicates that the result is below the panic limit set by the user e These flags may be criteria for the pathology messages DATE 14 04 99 TIME 16 04 48 SED 2 ID 125 FLAGS WEC PLT 107 ma 105 mm g di it NEUTROPENIA 3 c MR Cb bee be cgo pet e o Roe lt gt lt gt lt gt c 3 pa g di du 103 ua a Li LI a Cd P3 LP Pl QOO gt u f 4 ay fu 265 a lt km Py m amos lt gt lt gt lt gt gt amp 1 88 Pp Lan 19 CER e Mee Eco Cm Kod M M o 15 01 3 11 3 Specimen Run amp Results RABOSOGEN See Chapter 4 Instrument configuration to defined page 3 12 BHB and MHB Hgb blank e At the end of the Startup cycle the Hgb blank value is controlled If this value is not within acceptable limits a reject flag shown is triggered on the Hgb parameter e On each analysis cycle the instrument performs a Hgb blank on diluent and checks this measured against the Hgb reference value If this Hgb blank value is too different from the mean of the reference values of previou
87. minutes after collection The results on all parameters depend on the mode of conservation of the sample Depending on the parameter to be measured the sample stability may be up to 48 hours 2 3 Microsampling e The Open tube sampling mode enables the user to work with 100yl microsamples for pediatrics and geriatrics 2 4 Mixing e The blood samples must be gently and thoroughly mixed just before placing them into the tube holder and closing the tube holder door This will ensure a homogeneous mixture for measurement page 3 4 3 Soecimen Run amp Results RABO80GEN 3 CALIBRATION VERIFICATION CONTROL BLOOD SAMPLING The calibration on HORIBA instruments Is an exceptional procedure which must be carried out particularly in case of certain technical interven tions installation maintenance service intervention The calibration should not be carried out to compensate a drift on a result due for example to a clogging of the instrument e Before carrying out a calibration it is essential to make sure that the instru ment is in perfect condition of operation and to follow the steps below 1 Carry out a concentrated cleaning refer to the corresponding paragraph of the manual 2 Perform two blank cycles to check the cleanliness of the instrument if the blank measurement is not correct please contact your HORIBA Representative 3 Check the repeatability of the instrument by running six times
88. nal regulations 5 Specimens are collected and stored in normal conditions 6 Reagents used are those specified in this user manual 7 Proper tools are used when maintenance or troubleshooting operations are performed If this instrument has been supplied to you by anyone other than HORIBA ABX or an authorised representative HORIBA ABX cannot guarantee this product in terms of specification latest revision and latest documenta tion Further information may be obtained from your authorised representative 1 3 Safety precautions electronic and moving parts e The following parts must not be handled or checked by the user Electrical power supply Electronic components e Operator injury may occur from an electric shock Electronic components can shock and injure the user Do not tamper with the instrument and do not remove any components covers doors panels and so on unless otherwise instructed within this document e Danger The battery may explode if it is not replaced correctly Replace only with the same or equivalent type recommanded by the manufacturer Dispose of used batteries according to the manufacturer s instructions e Moving parts It is strictly forbidden to disable sensors as it may cause operator injuries Protection covers must not be opened during instrument operations page V Introduction RABOSOGEN 1 4 Biological risks e Consider all Specimens Reagents Calibrators Controls etc th
89. ng to empty the waste container 1 2 Printer start up e Check the printer paper If more printer paper is needed replace the printer paper according to the Printer user manual supplied with the instrument e Press the ON OFF switch Check the control LEDs are ON e See Chapter 4 Instrument configuration to setup printing mode 1 3 Pentra 60 start up e Press the ON OFF switch located on the left side of the instrument e A STARTUP cycle is run automatically A rinse cyle is carried out Then a background count an analysis cycle on reagent without any blood specimen page 3 2 3 Specimen Run amp Results RABO80GEN e If the background counts are not within acceptable limits the message STARTUP FAILED is displayed Background count limits WBC 0 3 103 RBC 0 03 x10 mm Hgb 0 3 g dl 7 0 10 The instrument will not operate if the reagent temperature is under 35 C 69 F If required a bargraph is displayed after start up to check and wait for temperature progression e If a low reagent level is expected during the day the message REAGENT LOW LEVEL is displayed Proceed as described in Chapter 5 Maintenance amp Troubleshooting It is mandatory to power down the system if not used more than a 36 hour period This eliminates the possibility of the dilution chambers evaporating causing startup alarm page 3 3 3 Specimen Run amp Results RABOSOGEN
90. ollowing treatments may interfere with leukocyte counts as cell sizes can not be distinguished The abnormal basophils degranulation following allergies may interfere with leukocyte counts because cell sizes can not be distinguished and because they may lose their characteristic intracytoplasmic material 3 3 ABX Pentra 60 User Manual P n HORIBA PX 34184 MONTPELLIER Cedex 4 FRANCE Diagnostics Introduction page Il RABOSOGEN Notice of Liability e The information in this manual is distributed on an as is basis without warranty While every precaution has been taken in the preparation of this manual HORIBA ABX will not assume any liability to any persons or entities with respect to loss or damage caused or alleged to be caused directly or indirectly by not following the instructions contained in this manual or by using the computer software and hardware products described herein in a manner inconsistent with our product labeling Trademarks e Microsoft and Windows are registered trademarks of Microsoft Corporation e Other product names mentioned within this publication may be registered trademarks of other companies Graphics e All graphics including screens and printouts photographs are for illustration purposes only and are not contractual Copyright 2003 2005 by HORIBA ABX e All rights reserved No part of this book may be reproduced or transmitted in any fo
91. om the origin of the matrix background zone into the lymphocyte zone The NRBCs with their cytoplasmic membranes lysed like the erythrocytes will have their nuclei situated to the far left side of the lymphocyte zone EOSINOPHILS With reagent action on cytoplasmic membranes the leukocytes keep their native size and only eosinophils are colored for optical separation Eosinophils will be situated in the upper part of the optical Y axis due to their strong absorbance qualities and their size which is nearly equivalent to large neutrophils NEUTROPHILS The neutrophils with their cytoplasmic granules and their generally segmented nuclei will scatter light depending on their morphological complexity A hypersegmented neutrophil will give an increased optical response with respect to a young neutrophil population which will be in the upper posi tion of the optical axis depending on the presence of segmentation and or granules page 2 15 SPECIMEN RUN amp RESULTS 1 INSTRUMENT START 3 2 Tels Waste IOV CIS E 3 2 1 2 Printer start oot se 3 2 Tto Pentra 60 Stat 3 2 2 SPECIMEN COLLECTION AND MIXING 3 4 2 1 Recommended anticoagulant 3 4 2 2 BIOOd sample SlAOWNY concisnesdpesarcsenciwncsbpeveresenaanecaenesareseesinees 3 4 ERE EIU UAE UE 3 4 lt
92. ood cells platelets are not counted as their size falls below the minimum threshold Agglutinated erythrocytes May cause a low incorrect RBC count Blood samples containing the agglutinated red blood cells may be suspected by elevated MCH and MCHC values and shown by examination of the stained blood film Cold agglutinins IgM immunoglobulins which are high in cold agglutinin disease may cause lower RBC and PLT counts and increase MCV page 1 17 1 Specifications page 1 18 RABOSOGEN Hgb Hemoglobin Turbidity of the blood sample Any number of physiological and or therapeutic factors may produce high incorrect HGB results To obtain accurate hemoglobin results when increased turbidity of the blood sample occurs determine the cause of the turbidity and follow the appropriate method below High WBC An extremely high WBC will cause excessive light scatter In these cases use reference manual methods The diluted sample should be centrifuged and the supernatant fluid measured with a spectrophotometer High lipid concentration A high concentration of lipids in the blood sample will give the plasma a milky appearance This condition can occur with hyperlipidemia hyperproteinemia as in gammapathies and hyperbilirubinemia Accurate hemoglobin determinations can be achieved by using reference manual methods and a plasma blank Increased turbidity may also be seen in cases where the red blood cells are resistant to ly
93. r 3 Specimen Run amp Results e The percentage of basophils is calculated according to the number of particles from the BA2 threshold to the BAS threshold e These thresholds are factory adjusted to the following values CHANNEL THRESHOLD PURPOSE 0 counting area 0 Separation threshold between the L1 counting area and the WBC 35 BA2 Separation threshold between the WBC and basophils 110 End of the basophil counting area 240 page 4 7 4 Instrument Configuration RABO80GEN 3 4 2 PLT e The PL1 threshold is the number of the mobile channel that allows the calculation of the platelet population It is automatically positionned PLT1 3 4 3 LMNE matrix e Each axis of the matrix X and Y is divided into 128 channels numbered from 0 to 127 e 13 vertical indices Y and 13 horizontal indices X allow the user to locate these channels ten by ten The first index of the matrix origin at the bottom left is the O channel the fourth index of the matrix will be the channel 30 and so on e The threshold adjustment is expressed in channels e The threshold levels may be re adjusted 1 To improve the separation between different cell populations which may vary according to the anti coagulant in use or instrument internal adjustment 2 modify the flag areas in one way or another to improve their detection sensitivity In this case the numeric adjustment of the concerned fl
94. r eee ae 1 2 UnEezielue eo 1 2 11 2 X e 1 3 1 4 1 5 1 3 Tube ldentification e 1 5 1 5 1 5 Keyboard amp Display 1 5 1 Data POC 1 5 1 7 Measurements and COMPUTATION 1 5 2 PHYSICAL SPECIFICATIONS 1 6 2 1 Power 1 6 2 2 Operating temperature and humidity 1 6 2 3 Dimensions and 1 6 2 4 Minimum specimen volume 1 6 2 5 Dilution ratios EET 1 7 2 6 Hgb measurement 1 7 2 7 Counting aperture diameters 1 7 2 8 Reagent consumption ml 1 8 SUMMARY OF PERFORMANCE DATA 1 9 3 1 Precision CHeDFOGOUCGIDIIEV i55u VEU LEM ULT USE SENILIS 1 9 3 2 Precision Repeatability 1 10 3 3 Linearity 8 1 11 3 4
95. regarding the total number of WBC is above the ALY limit Suspected abnormalities e Large Lymphocytes e Reactive Lymphoid forms e Stimulated Lymphocytes e Plasmocytes Absorbance NoN NoE Channel 127 LMD RM Resistivity 3 Soecimen Run amp Results RABO80GEN T Standard values for RM 96 1 1 999 Adjustment see Chapter 4 Instrument configuration Meaning Right Mono Presence of a significantly large population of cells located on the right hand side of the monocyte area low LIC This flag occurs when the number of particles counted in this area is higher than the limit setup in RM or when the counted particles regarding the total of WBC is above RM limit Suspected abnormalities e Large monocytes e Hyperbasophilic monocytes e Myelocytes or promyelocytes e Large blasts This flag occurs associated with an on eNEU NEU eMON eLIC 96 LIC Absorbance Channel 127 NL 7 LYM LYMPHO L LL A No L LMD RM Resistivity page 3 23 3 Specimen Run amp Results RABOSOGEN Meaning Right Neutro Presence of a significantly large population of cells located on the right hand side of the neutrophil area high LIC This flag occurs when the number of particles counted in this area is higher than the limit setup in RN or when the number of particles counted regarding the total number of WBC is above the RN limit Suspected abnormalities e Large neutrophils
96. rm or by any means electronic mechanical photocopying recording or otherwise without the prior written permission of HORIBA ABX Introduction RABO80GEN REVISIONS INDEX TECHNICAL NOTE REVISION A DEATION e This document applies to the latest software version as indicated above e When a subsequent software version changes the information in this docu ment a new section and or sections will be released e Latest version documents on www horiba abx com e Declaration of conformity Latest version of the CE declaration of conformity for this instrument is available on www horiba abx com page III Introduction RABOSOGEN 1 WARNINGS AND PRECAUTIONS NOTE Emphasizes the important information especially helpful to the operator before during or after a specific operational function IMPORTANT Emphasizes an operating procedure that must be followed to avoid erroneous results CAUTION Emphasizes an information that must be followed to avoid possible damage to the instrument or erroneous results WARNING Flags a procedure that if not followed properly can prove to be extremely hazardous to either the operator or the environment or both 1 1 Warnings page IV e User manual must be entirely read and personnel trained by HORIBA ABX before attempting to operate instrument The user always operates with full knowledge and appreciation of instrument warnings alarms and flags Always refer to labeling and
97. rument configuration RMN LA RIGHT MON LEFT LYM LYMPHO LL IN LMD RM Resistivity page 3 20 3 Soecimen Run amp Results RABO80GEN T Standard values for NE 96 1 1 60 Adjustment see Chapter 4 Instrument configuration Meaning Neutro Eosino Presence of a significantly large population of cells located in the separation area between neutrophils and eosinophils because of a superimposition of the 2 populations This flag occurs when the number of particles counted in this area is higher than the limit setup in NE or when the number of particules counted regarding the total number of WBC is above the NE limit Suspected abnormalities e Young eosinophils e Giant hypersegmented neutrophils e Eosinophils with low intracytoplasmic material e Immature cells This flag is associated with an on e LIC LIC and replaces e NEU NEU EOS EOS by Absorbance NoN NoE Channel 127 No AL LMD RM Resistivity page 3 21 3 Specimen Run amp Results RABOSOGEN T Standard values for ALY 2 0 2 Adjustment see Chapter 4 instrument configuration page 3 22 ALY flag Meaning Atypical Lymphocytes Presence of a significantly large population of cells located on the right hand side of the Lymphocytes area This flag occurs when the number of particles counted in this area is higher than the limit setup in ALY or when the number of particles counted
98. s analyzes higher than BHB defined by the user the instrument triggers a suspiscion flag shown by on the Hgb parameter e is also associated with Hgb result if the difference between successive measures on the same sample is higher than MHB limit defined by the user e Sample has to be rerun No result will be given on Hgb instead when 3 suspicion flags associated with the Hgb reference value have been triggered off MCHC and MCH are also not reported 3 Specimen Run amp Results RABO80GEN Reject between two counts e A reject flag Shown by occurs when two counts on a parameter differ more than the pre defined limits It indicates that the result is not coherent and the sample has to be rerun e RBC A reject on RBC gives a default analysis value shown by a on RBC MCV MCH MCHC and RDW e Pit A reject on gives a default analysis value shown by on Pct MPV and PDW e WBC A reject on WBC gives a default analysis value shown by a on WBC and Diff results DATE 16 04 99 TIME 14 45 50 SEQ ID 26 FLAGS WEC Li LL LLI LIC LEGCOCYTOSIS NEUTRDPHILT NRBCS WHC Jee 107 mm RBC 10 mmn 1 HOT amt er on at ae PLT INTERPRETATION IMPOSSIBLE page 3 13 3 Specimen Run amp Results RABOSOGEN 5 3 2 LMNE matrix flags Suspiscion e When populations are detec
99. ser password Enter an identification DISPLAYED MESSAGE Incorrect Drains Thermal door opened Blocked motor Open during a cycle Incoherent time entered by the operator Incorrect value entered by the operator Password required to carry out an operation To run an analysis in alphanumerical mode Control the motor operations Menu MAINTENANCE MECHANICAL SYSTEMS CHECK MOTORS Close the door and rerun the cycle Enter the correct time Enter a correct value Enter the password Enter the identification as described section 3 of this manual the identification is mandatory Reagents USER ACTIONS No diluent check level Reagent low level reagent name Reagent low level Drain sensor time out Transfer sensor time out Diluent reservoir empty None Message triggered at the end of the Startup Chamber and or syringe draining problems Transfer problem with LMNE matrix sample Replace the diluent container menu REAGENTS LEVEL CHANGE Replace the bottle menu REAGENTS LEVEL CHANGE Control the reagent levels or and replace it Call HORIBA ABX representative Service Department Call HORIBA ABX representative Service Department Temperature DISPLAYED MESSAGE Causes USER ACTIONS Temperature out of range Thermic regulation problem Call HORIBA ABX representative department Procedure 4 Sampling Sample probe e Check the motion of the probe menu maintenan
100. sing This condition will cause an incorrect high HGB result but may be detected by observing the abnormal MCH MCHC values and the increased baseline on the leading edge of the WBC histogram Erroneous hemoglobin results will cause the results of the MCH and MCHC to be incorrect as well Fetal bloods The mixing of fetal and maternal bloods may produce a high inaccurate HGB value Hct Hematocrit Red blood cells agglutination May produce an inaccurate HCT and MCV values Red blood cell agglutination may be detected by observing abnormal MCH and MCHC values as well as by examination of the stained blood film In such cases manual methods may be required to obtain an accurate HCT va lue MCV Mean Corpuscular Volume Red blood cells agglutination May produce an inaccurate MOV value Red blood cell agglutination may be detected by observing abnormal MCH and MCHC values as well as by examination of the stained blood film In such cases manual methods may be required to obtain an accurate MOV value Excessive numbers of large platelets and or the presence of an excessively high WBC count may interfere with the accurate determination of the MCV va lue In such cases careful examination of the stained blood film may reveal the error MCH Mean Corpuscular Hemoglobin The MCH is determined according to HGB value and the RBC count The limi tations listed for the HGB and RBC will have an effect on the MCH and may cause inaccurate
101. slation e Disposal ABX PENTRA 60 instrument It should be disposed of in accordance with local legislation and should be treated as being contaminated with blood The appropriate biological precautions should be taken If any doubt please contact your HORIBA ABX representative service department e European Legislation In accordance with the European Directive 2002 96 CE known also as WEEE instruments having this symbol and sold into a European country by HORIBA or an authorised representative must be disposed of and recycled correctly at the end of its useful life Due to the local changing regulations in each country please contact your local representative for detailed and upto date information on how to appropriately dispose of the instrument 2 7 Transport and storage conditions page X e Storage temperature 20 C 50 C Prior to the shipping of an instrument by transporter whatever the W destination an external decontamination of the instrument must be carried out Introduction RABO80GEN 2 8 Installation e An HORIBA ABX representative will install your instrument computer software and printer 2 9 Package content e Verify that all of the parts from the package list are present PENTHA 60 1x User manual 1x XAA473A EPSON LX300 printer 1x Pentra 60 1x DACOXXA Supply cable 1x XEA791A Installation kit page XI Introduction RABOSOGEN INIRODUCTI
102. ted in abnormal quantity in one or several boxes of the matrix some flags may occur associated with If one result appears with one or several parameters associated with this the result should be further investigated pathology suspiscion clotted sample plasma cells Twelve different flags may occur regarding the shifting of leukocyte popula tions on the matrix channel or the presence of abnormal populations These flags are Reject NO LL LL1 NL MN RM LN RN NE ALY GCI see flag signification further in this Chapter Reject on LMNE matrix e A reject on the LMNE channel indicates a poor correlation between the resistive and the optical measurements on the matrix It is shown by a on all the differential parameters in 96 and e The result is not reliable and specimen must be rerun DATE 14 04 99 TIME 16 00 03 1 ID i FLAGS WBC LL ALY RECs PLT WEC 3 2 109 mg REC 5 03 i0 mnh i3 9 91 NEUTROPENIA HRBCS BASOPHILTA enone V pg g d n lO3 mm aee dI Re Em C4 a gt lt gt Py MEUS 3 EOS BASH 2 LICK page 3 14 3 Specimen Run amp Results RABO80GEN T Standard values for NO 100 120 Adjustment see Chapter 4 Instrument configuration Meaning Background NOise This flag occurs when th
103. tes flag shown in the platelet alarm area In this case the mobile threshold looks for a valley between 18fL and 25fL standard area 18 251 30 Y When the mobile threshold can not be positioned in the standard area from 18fL to 25fL a reject and a MIC flag are generated The Pit result is not reliable Verify the result using a Platelet Rich Plasma PRP or a manual count 18 251 30 If the mobile threshold cannot be positioned valley between the and RBC histograms the SCH Schizocytes flag is generated Suspected abnormalities e Presence of schizocytes e Presence of Platelet aggregates check the result on a slide 18 25fl 30 SCL Small Cell indicates the presence of small cells in the 2fL and 3fL zone A second analysis should be carried out and the results verified page 3 28 3 Specimen Run amp Results RABO80GEN 5 3 6 WBC balance WBC Balance be activated or deactivated see Chapter 4 Instrument configuration Control of the injected volume in the optical flowcell allows a second count of the WBC The two counts are compared if the difference between both counts is higher than a defined threshold depending of the quantity measured a LMNE or a LMNE flag is generated e WBC count is within O and 2501 If the WBC LMNE count is higher than 50 of the WBC BASO count a LMNE flag is generated If the WBC LMNE count is lower than 50 of the WBC B
104. ts e Lysing reagent for hemoglobin ABX ALPHALYSE e Cleaning reagent ABX CLEANER e Lysing reagent for DIFF count ABX EOSINOFIX e Diluent used for the dilutions ABX DILUENT except the LMNE stop diluent e Lysing reagent for WBC BASO ABX BASOLYSE Il page 2 5 2 Description amp Technology RABO80GEN 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 a Main functions of the board e Amplifies processes and counts the following signals Resistive signals and LMNE optical signals RBC signal signal WBC BASO signals e Measures hemoglobin e Pilots the motorised elements When opening the main board support panel be careful not to disconnect or damage electric cables page 2 6 2 MEASURING PRINCIPLES 2 1 Multi Distribution Sampling System MDSS PENTRA 60 analysis cycle needs 3 blood specimens distributed as follows one specimen for the first RBC PIt dilution and the Hgb measurement another specimen for the BASO WBC count the last specimen for the LMNE matrix These 3 specimens are provided by means of a multi distribution principle 53 ul of blood are aspirated inside the needle sufficient volume for all dilutions then divided up and distributed to the chambers with reagents Extremities of the specimen are not delivered to the dilutions Spe
105. tween Lymphocytes amp Neutrophils 29 0 RMN Separation between Right Mono amp Right Neutrophils 51 NL NE NE Separation between Neutrophils amp Eosinophils 82 RMN Channel 127 The FLN FNE thresholds indicate the width in channel number of the LN NE MIN alarm areas THRESHOLD PUROSE STANDARD FLN Channel number for the NL alarm area 2 FNE Channel number for the NE alarm area 2 FMN Channel number for the MN alarm area 2 e Move the cursor to the value to modify and enter the new value Press to validate 4 9 4 Instrument Configuration RABO80GEN 4 CONTROL MODE page 4 10 e Control mode allows to run only ABX DIFFTROL control blood e Before running specimens it is recommended that the operator runs a Nor mal control blood to verify that the system is within acceptable limits e Prepare a Normal control blood according to the specific instructions detailed in the control blood package insert temperature mixing etc e Make sure control blood thresholds and alarms parametering is correct and corresponds to lot target values you are going to use options CONTROL MODE CHANGE COEFFICIENT and CONTROL MODE FLAGS SENSITIVITY report to the following paragraph for further details about parametering a new lot Risk of erroneous results if the control blood is not continuously mixed between each analysis e From menu CONTROL MODE select option RUN CONTROL
106. ulated according to the Hgb and Hct values Mean Hgb concentration in the total volume of RBC is given by the formula Hgb MCHC g dL x 100 Hct 2 Description amp Technology RABO80GEN 2 7 MPV Measurement e The MPV Mean Platelet Volume is directly derived from the analysis of the platelet distribution curve 2 8 Pct calculation e Thrombocrit is calculated according to the formula 10 ul x MPV um Pct 10 000 2 9 PDW calculation e PDW Platelet Distribution Width is calculated from the Pit histogram e The PDW is represented by the width of the curve between 15 of the number of platelets starting from 21 S1 and 15 of the number of platelets beginning with the variable top threshold S2 y page 2 11 2 Description amp Technology RABO80GEN page 2 12 2 10 WBC and differential count 2 10 1 General principles The WBC count is carried out twice by two different sensors e In the BASO count chamber at the same time as the BASOS count e In the optical chamber during the acquisition of the LMNE matrix The reference count is the one obtained in the WBC and BASO count chamber 2 10 2 BASO WBC Count e Detection principle is the same as for RBC Differentiation betwen BASOs and other leukocytes is obtained by means of the BASOLYSE Il specific lysing action All the WBCs are counted between the electrical threshold lt 0 gt threshold lt BA3 gt
107. und clearly to the right of the neutrophils and nearly at the same level Myelocytes and promyelocytes will be found in saturation position on the far right of the matrix These last three populations will be counted as LIC Large Immature Cells and their given results are included in the neutrophil value The blast cells will be found generally to the right of the monocytes and as such will increase the LIC count Small blasts will be found between the normal lymphocytes and monocytes Platelets and debris from erythrocyte lysis represent the background noise population located in the lower left area of the matrix Most of the population partition thresholds are fixed and give the limits of the morphological normality of leukocytes Changes in the morphology of a popula tion will be expressed on the matrix by a shifting of the corresponding population LYMPHOCYTES The lymphocytes being small with regular shape are positioned in the lower part of both the optical axis and volume axis Normal lymphocyte populations are generally observed with a good volume homogeneity Large lymphocytes are detected in the ALY Atypical Lymphocytes zone where reactive lymphoid forms stimulated lymphocytes and plasmocytes are also to be found The far left side of the lymphocyte zone should normally be empty but when small lymphocytes are present population may exist in this area The presence of platelet aggregates is detected by a distribution pattern that moves fr
108. unselect results used for the statistic calculation proceed as described into 6 1 5 Autocalibration e Press e when analysis are completed nter e f CV results are lower than the defined limits a message is displayed as shown on the screen When leaving the REPEATABILITY menu results and statistics are erased e f CV results are out of range they are displayed in reverse video and a flag H is displayed next to it CV limits are the one used for the Calibration and can be changed as described Chapter 4 instrument configuration Calibration page 3 39 3 Specimen Run amp Results RABOSOGEN REAGENTS LEVEL CHANGE e The instrument calculates each reagent bottle capacity according to the number of cycles run The instrument performs a reagent capacity check on each cycle If a reagent low level is expected an alarm is triggered off Example for the ABX EOSINOFIX REAGENT LOW LEVEL EOSINOFIX 7 1 Reagents connections 1 ABX LYSE 2 ABX BASOLYSE Il 3 ABX EOSINOFIX 4 ABX CLEANER 5 ABX DILUENT 6 WASTE CONTAINER The container must not be installed further than 80cm from the instru ment The diluent input tubing is cristal 3 x 6 2 meters maximum and the waste output tubing 15 cristal 4 x 6 2 meters maximum page 3 40 3 Specimen Run amp Results RABO80GEN 7 2 Daily workload e The operator can entered the approximated number of CBC and DIFF analy ses p
109. uscular Hemoglobin Mean Corpuscular Hemoglobin Concentration Red Distribution Width Platelets Platelet Distribution Width Mean Platelet Volume Plateletcrit PCT PDW ALY and LIC have not been established as indications for this product in the United States The use of PCT PDW ALY and LIC should be restricted to research and Investigational measurements only page 1 3 UNITS 1 Specifications 1 1 3 Units RABO80GEN STD SI mmol l STD SI mmol l STD SI mmol l STD SI mmol l page 1 4 WBC 105 mm 10 I 109 1 pg fmol LYC EOS RBC 105 mm 10 2 1 10 2 MCHC g dl g l mmol l LYC BAS HGB g dl g l mmol l RDW BAS HCT MPV um fl fl MON ALY PLT 10 109 1 109 1 10 l 1022 1 NEU ALY MCV um fl fl PDW NEU LIC To select the set of units refer to Chapter 4 Instrument configuration EOS LIC 1 Specifications RABO80GEN 1 2 Throughput Analyses e CBC Mode 60 h CBC 5DIFF Mode DIF 60 h 1 3 Tube Identification e By means of the worklist or identification file e By means of the Barcode labels 1 4 Reagents e ABX DILUENT 20 litres e ABX CLEANER 1 litre Integrated e ABX EOS
110. values MCHC Mean Corpuscular Hemoglobin Concentration The MCHC is determined according to the HGB and HCT values The limita tions listed for the HGB and HCT will have an effect on the MCHC and may cause inaccurate values 1 Specifications Blood samples collected in EDTA will not maintain a stable Mean Platelet Volume Platelets collected in EDTA swell depending on the time post collection and storage temperature RABOSOGEN RDW Red blood cell Distribution Width The red blood cell distribution width is determined according to the RBC count Nutritional deficiency or blood transfusion May cause high RDW results due to iron and or cobalamin and or folate deficiency PIt Platelets WBC fragments may interfere with the proper counting of platelets and cause elevated PLT counts Very small erythrocytes microcytes erythrocyte fragments schizocytes Agglutinated erythrocytes May trap platelets causing an erroneously low platelet count The presence of agglutinated erythrocytes may be detected by observation of abnormal MCH and MCHC values and by careful examination of the stained blood film Hemolysis Hemolysed specimens contain red cell stroma which may increase platelet counts Giant platelets in excessive numbers May cause a low inaccurate platelet count as these large platelets may exceed the upper threshold for the platelet parameter and are not counted Platelet agglutination Clumped platelets
111. very low WBC count may result from this disease because of possible increased fragility of the leukocytes leading to destruction of some of these cells during counting These white cell fragments will also interfere with the white cell differential parameters These white cell fragments will also interfere with the white cell partial differential parameters LYM MON GRAN A suspiciously low WBC count may also be seen in patients with lymphocytic leukemias due to the presence of abnormally small lymphocytes which may not be counted by the instrument Chemotherapy Cytotoxic and immunosuppressive drugs may increase the fragility of the leukocytes which may cause low WBC counts Cryoglobulins Increased levels of cryoglobulin that may be associated with myeloma carcinoma leukemia macroglobulinemia lymphoproliferative disorders metastic tumors autoimmune disorders infections aneurism pregnancy thromboembolic phenomena diabetes etc which can increase the WBC RBC or PLT counts and the HGB concentration The specimen must be warmed up to 37 C 99 F in a bain marie for 30 minutes and analyzed again immediately after analyzer or manual method Macrothrombocytes In excessive numbers may affect and increase Leukocyte numeration RBC Red Blood Cells Erythrocytes The red blood cell dilution contains all the formed elements in the blood erythrocytes leukocytes and platelets During erythrocytes counting red bl
112. yringe operations See 1 3 Mechanical systems e Control the counting syringe operations see 1 3 Mechanical systems e Perform an autoconcentrated cleaning e f all these operations appear to be correct call your HORIBA ABX Representative Service Department Calibration f the system appears to be operating properly fresh uncontaminated reagents are being used and the precision is within the specifications the ABX PENTRA 60 may need a calibration as described Chapter 3 Specimen Run amp Results Procedure 7 RBC PLT HCT Repeatability If RBC PLT amp HCT are not repeatable e Check the second dilution is carried out correctly Sample from the chamber 2 to the chamber 4 e Check the Bubbling in the RBC PLT chamber 4 once the dilution is carried out the dilution remains transparent e Perform an autoconcentrated cleaning e If all these operations appear to be correct call your HORIBA Representative Service Department Calibration e See procedure 6 Procedure 8 HGB Repeatability e Is the instrument non repeatable on HGB e Run a analysis cycle e Check the dilution colour in the chamber 2 e Milky when the sample is first delivered to the chamber then brown trans parent when Lyse is injected e Perform an autoconcentrated cleaning e f this does not correct the HGB count call your HOHIBA ABX Representative Service Department Calibration e See procedure 6 Procedur

ABX Pentra 60

Contents

Download Pdf Manuals

Related Search

Related Contents