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User Manual P/n: RAB108E

1. 0068 0068 0069 0069 0070 P 0070 567415 1 1 5675415 PIA 1 1 025646 1 2 025646 P 1 2 0060 0067 AUTO SIDS 1 Auto Numbering Auto SIDxx Order and sample matched Result identification Matched with an ord Rack x Position y Se Fig 4 5 Rack position Manual match ON 4 10 Pentra 80 User Manual RAB108E Workflow Workflow 1 7 Exception management The usual sample identification management is the automatic and secure matching of orders with the corresponding sample tubes Exceptions will occur when automatic matching is impossible For instances when a sample tube is found in a non defined position in the worklist or when a barcode label cannot be read serum 3 Ba Ss a E eom Rerun auto Fs 1 f E t AFA H dk A w w gajes Association i Fat d i HS he i i Fig 4 6 Order result workflow Setting the exceptions criteria must be performed in the configuration of the Setting func tion Manual match on Exception Section 5 2 2 5 Identification option page 5 7 defines a specific treatment of expectations Results obtained for each specific expectation condition are saved in a specific screen which allows the matching of identified orders to non identified results see 6 2 1 Association grid description page 4 53 Pentra 80 User M
2. Fig 4 39 Result display 6 1 7 Result display keys Heading Key Function lt Left arrow Displays the previous result in a full screen mode Ca Right arrow Displays the next result in a full screen mode Rerun request generates a new entry in the worklist Rerun having the same order see 6 1 8 Rerunning sample manually page 4 51 Result comment Allows the operator to add a comment to results i j number of displaying results total number of Result i j Result i j results on this tube Tab 4 11 Result display Function Keys 4 50 Pentra 80 User Manual RAB108E Workflow Order amp sample run association 6 1 8 Rerunning sample manually The user has the ability to manually select a Rerun from the sample being reviewed in the Full Screen Mode From the result displayed in full screen mode see Fig 4 39 page 4 50 select the Rerun key Fig 4 40 Rerun request When the Rerun key has been selected a message will be displayed asking for confirmation on the Sample ID Patient ID Patient Name and the Patient First name A new entry is then generated into the Worklist Proceed as described in Section 2 3 Running specimen page 2 9 to run the analysis on this new order The Rerun key is disabled if the results are unmatched see 6 2 Result order as A sociation page 4 53 or if a Rerun for this order is already in the Worklist 6 1 9 Pr
3. Fig 3 12 Manual entry of target value By selecting the tab Threshold you can also modify threshold and Alarm levels Pentra 80 User Manual RAB108E Q uality Assurance Quality control 1 7 Running control blood 1 7 1 Running in STAT mode Verify that the lot of control blood has been entered as described in 1 6 New blood control setup page 3 10 Prepare the Blood control according to the specific instructions detailed in the blood control package insert temperature mixing Select the Stat key the tube holder door will open Read the lot with the external barcode reader or manually type the Lot Select the OK key Place the vial into the appropriate possition and close the door to the backwards position When the analysis is complete the QC results will automatically be saved in the QC menu for that specific lot 1 7 2 Running in Rack mode With barcode label identification Verify that the lot of control blood has been entered as described in 1 6 New blood control setup page 3 10 Prepare the Blood control according to the specific instructions detailed in the blood control package insert temperature mixing Position the blood control in any rack verify that the Barcode label will be readable by the internal barcode reader Place the rack in the rack loader and select the Start Rack key When the analysis is complete the QC results will a
4. 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 telephones should not be used in proximity of the instrument All peripheral devices should be IEC compatible 1 1 Limited guarantee The duration of guarantee is stipulated in the Sales conditions associated with the purchase of this instrument To validate the guarantee ensure the following is adhered to 1 The system is operated under the instructions of this manual 2 Only software or hardware specified by ABX Diagnostics is installed on the instrument This software must be the original copyrighted version 3 Services and repairs are provided by an ABX Diagnostics authorized technician using only ABX Diagnostics approved spare parts 4 The electrical supply of the laboratory follows the national regulations 5 Specimens are collected and stored in normal conditions Pentra 80 User Manual RAB108E Introduction Warning and precautions 6 Reagents used are those specified in this user manual 7 Proper tools are used when maintenance or troubleshooting operations are performed See Section 7 1 2 Maintenance procedures page 7 3 If this instrument has been supplied to you by anyone other than ABX Diagnostics A or an authorised representative ABX Diagnostics cannot guarantee this product in terms of specification latest revision and
5. PVC 3x6 L 2000 MAXI WU WASTE ABX DIILUENT 4 LV1 Differential diluent Selects flow cell sheath 2 or DIFF bath Y Y LV4 Flow cell sample supply Opens pathway from the DIFF bath to the flow cell Pee ee 4 pf Wp LV3 Differential diluent Selects flow cell sheath 1 or sheath 2 LV5 Flow cell sample injector Opens waste path for sample LMNE syringe LV6 Rinse output control Selects rinse to probe rinse block or WBC BASO bath Designation PENTRA 80 LV11 Diluent output control Routes diluent to probe rinse block or heating coil LV13 Flow cell rinse Routes diluent from flow cell and LMNE syringe to the count syringe HYDROPNEUMAT A gt lt a IC DIAGRAM LV15 WBC and RBC PLT count valve Opens vacuum count line for WBC and RBC bath pandora fal LV17 Waste syringe 2 vent Opens waste vent through the rinse chamber andar oterance ouqnness LV19 Diluent reservoir fill Opens reservoir vent and fill it with drain syringe 2 l l Material LV24 Waste syringe 1 vent Opens waste vent through the rinse chamber M1 cell on syringe 1 and M2 cell on syringe 2 ECR1730 Add sleevings on LV10 amp LV11 ECR1716 2 06 300 was 1 52 LV23 2 Probe rinse block 2 a seat The tubing 1 02 250 was 240 T2 3 LMNE syringe 5 and tubing 114 85 was 1 02 T4 1 LMNE syringe 3 B ireatment DIAGNOSTICS LV28 Flow cell drain Opens path from flow cell Aa to DIFF bath
6. 1 52 120 LMNE TRANSFERT BUBBLING DRAIN COUNT WBC RBC 13 PROBE WIPE WBC BUBBLING DILUENT FILL DRAIN RESERVOIR FILLING LMNE RINSE VENT 15 NOTCHED TUBING z 2 06 140 sue es i ie ee 1 52 300 ee eee ee 1 renee I 7 2 D _P ea sa e e 0 5 ee Oe S Ey m 210011 o eee ee ae A 1 Wa DRAIN SYRINGE 2 Hp i 1 52 180 DILUENT RESERVOIR U 10 B 2 P ssal fr ABX EOSINIFIX EE DILUENT ABX BASOLYSE II a a me aw 4 7 el l Z 2 Ha Q ae yl 152 730 oi NOTCHED L H ee ena L pees T TUBING ia x lt x or l LI m m 1 a 2 PA s vat ae A Ah 1 a Yo Basic cles D 1 52 480 7 in FT ae 2 LMNE SYRINGE REAGENT SYRINGE us I It 45205 254 190 2 06 210 ne aan M4 2 06 20 HJ O T a oo 1 M2 130 320 W712 13020 P29 152 230 ae i inal Sa J E HA 2 06 550 gt 3U Ju au sU pau Ta I I Dn pagu aan dl I FILTER l i ii 1 l pi l 2 06 100 145265 15265 1452 65 15250 ee 122021 dolo ulat Belo z IU 31 2 32 2 33 2 34 2 35 2 3 l x 1 S FERIE 1 1 1 E3 cee an 5 5215 15260 15215 UML 15260 T1212 IE Re an en PA Ie PEN eet AN NA en DA Sonya Hee Dana Ne ek
7. 2 Pentra XL80 Table 2 Concerned sections Pentra XL 80 Section Page Paragraph Item deleted Addition of the following PLT Platelets Interference in the Platelet result may occur for samples from Patients undergoing parenteral treatment with injection of lipid emulsion 212
8. 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 Pentra 80 User Manual RAB108E Fig 1 6 Power ON OFF switch 3 3 Grounding Proper grounding is reguired when installing the system Check the wall outlet ground Earth for proper grounding to the facilities electrical ground If you are unsure of the outlet ground Ing contact your facilities engineer to verify the proper outlet ground 3 4 Humidity Temperature conditions The Pentra 80 must operate between temperatures of 16 to 34 C 61 to 93 F Maximum relative humidity should be 80 for temperatures up to 31 C 88 F and decreasing linearly to 50 relative humidity at 40 C 104 F If the system is kept at a temperature of 10 C 50 F or less it must be allowed to sit at room temperature for 1 hour before it can be used for operation 3 5 Electromagnetic environment check The Pentra 80 has been designed to produce less than the accepted level of electromag netic interference in order to operate in conformity with its destination allowing the cor rect operation of other instruments also in conformity with their destination In case of suspected electromagnetic noise check that the instrument has not been placed in the proximity of electromagnetic fields or short wave emissions e Radar X rays Scanners
9. v Procedure 9 WBC Baso Repeatability If WBC Baso are non repeatable a Perform a concentrated cleaning see 5 2 4 Clean Cycles page 7 33 b If this does not correct the WBC Baso count call your ABX Diagnostics representative department Calibration a Perform a calibration of the instrument see Calibration page 7 39 Pentra 80 User Manual RAB108E 7 39 Pentra 80 v Procedure 10 Differential LM NE Repeatability If Differential results are non repeatable a Perform a concentrated cleaning see 5 2 4 Clean Cycles page 7 33 b If this does not correct the Differential count call your ABX Diagnostics representative department 6 3 Flags v Procedure 11 Default analysis WBC a Perform a concentrated cleaning see 5 2 4 Clean Cycles page 7 33 b Re run the specimen c Check the operation of liquid valve lt 23 gt and lt 14 gt Opening and closing during cycle If defective replace the valve d If this does not correct the WBC results call your ABX Diagnostics representative de partment RBC PLT a Perform a concentrated cleaning see 5 2 4 Clean Cycles page 7 33 b Re run the specimen c Check the operation of liquid valve lt 14 gt Opening and closing during cycle If defec tive replace the valve d If this does not correct the RBC PLT results call your ABX Diagnostics representative department HGB a Check the HGB LED is illuminated when syst
10. For Worklist see 5 2 Worklist overview page 1 23 For file Archives see 5 4 Archives overview page 1 25 For sample Runs and Results see 5 3 Runs and results overview page 1 24 These menus are defined as followed 5 1 Order overview An order is the set of data which is used for requesting an analytical process The order includes 3 data areas of intervention as followed v The patient information Patient ID Patient name Birthdate Sex v The sample information Sample Id barcode or other Sample type Child Male female Sample test Complete Blood Count or Differential v The clinical information Sample collection date Department requesting the Order e Physician requesting the Order Orders can be received from the host or manually entered by the operator Pentra 80 User Manual RAB108E 1 21 Pentra 80 Patient Fig 1 18 Order management 1 22 Pentra 80 User Manual RAB108E 5 2 Worklist overview A worklist is the list of orders generated on a daily basis See Section 4 2 Worklist page 4 14 Orders are removed from the Worklist after analysis The minimum information required for an order is Sample Id Sample type Male Female ect Test to perform CBC or DIF Fig 1 19 Orders and Sample ID New entries can be manually entered into the worklist without an order association if nec essary Pentra 80 User Manual RAB108E Introduction Wor
11. Guidelines for the evaluation of blood cell analysers including those used for differential leuko cyte and reticulocyte counting and cell marker applications International Council for Standardization in Hematology Clin Lab Haemat 1994 16 157 174 v Sample Stability Conclusion The results conclude with a relative sample stability claim of 48 hour period at 4 C 3 9 Waste handling precautions When disposing of waste protective clothing must be worn lab coat gloves eye pro tection etc Follow your local and or national guidelines for biohazard waste dis posal If required waste can be neutralized before being discarded Follow your laboratory s protocol when neutralizing and disposing of waste Dispose of the waste container according to the local or national regulatory requirements Pentra 80 User Manual RAB108E 8 13 Pentra 80 4 Limitations A Whilst every effort is taken by ABX Diagnostics to investigate and indicate all known interferenceis it is by no means possible to guarantee that all interferenceis 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 4 1 Maintenance In Chapter 7 Maintenance specific maintenance procedures are listed The maintenance procedures identified are mandatory for proper use and operation of the ABX PENTRA 80 Failure to execute any of these rec
12. MAC MACp HGB 8 22 Level Yo 100 100 5 3 15 0 7 2 5 1 1 1 1 3 50 5 45 11 3 Level 100 100 5 3 15 0 7 2 5 11 1 1 3 50 5 45 11 3 Level 80 80 55 120 120 999 999 999 30 200 60 Level 80 80 55 120 120 999 999 999 30 200 60 RAM141B RAM141B Update for Instrument version V1 3 2 Table 12 WOMAN Level Yo Level NO 100 80 LL 100 80 MET 5 55 NL 3 120 MN 15 120 RM 0 7 999 LN 2 5 999 RN 11 999 NE 14 30 L1 3 200 LMNE Reject 50 MIC 5 MAC 45 MACp 11 HGB 3 60 Table 13 CHILD 1 1 day old to 1 month old Level Level NO 100 80 LL 100 80 LL1 5 35 NL 3 120 MN 15 120 RM 0 7 999 LN 2 9 999 RN 1 1 999 NE TA 30 L1 3 200 LMNE Reject 50 MIC 5 MAC 45 MACp 11 HGB 3 60 9 22 Update for Instrument version V1 3 2 RAM141B Table 14 CHILD 2 1 month old to 1 year old Level Level NO 100 80 LL 100 80 LL1 5 55 NL 3 120 MN 15 120 RM 0 7 999 LN 2 5 999 RN 1 1 999 NE 1 1 30 L1 3 200 LMNE Reject 50 MIC 5 MAC 45 MACp 11 HGB 3 60 Table 15 CHILD 3 1 years old to 6 years old Level Yo Level NO 100 80 LL 100 80 LL1 5 55 NL 3 120 MN 15 120 RM 0 7 999 LN 2 5 999 RN 1 1 999 NE 1 1 30 L1 3 200 LMNE Reject 50 MIC 5 MAC 45 MACp 11 HGB 3 60 10 22 RAM141B Table 16 CHILD 4 6 years old to 10 years old NO LL LL1 NL MN RM LN RN NE L1 LMNE Reject MIC MAC MACp HGB Level Yo 100 100 5 3 15 0 7 2
13. Pentra 80 When the STAT order information has been entered se lect the OK key to confirm your entry Both LED s on the front panel will flash indicating that the routine rack analysis is going to be interrupted When the instrument is ready the tube holder door opens the START RACK key flashes once the automa tic mode is interrupted Place the STAT sample into the appropriate position of the tube holder and close the tube holder door When the Stat analysis is complete the tube holder door will open Remove the tube Press the START RACK key to continue analysis on the rack that was interrupted by the STAT entry 3 4 Run in progress At any time during the rack analysis the previous sam ples processed can be reviewed by selecting the Run in Progress function From the Main Menu screen select the RUN IN PRO GRESS key PENTRA 80 Run in Progress Running Date 05 28 2002 17 46 39 Rack Pos Testing B 5 DIFF as PXOS2N Collecting Date Type Standard Department Physician Comments wee 103mm PatientID Patient Name First Name e Date of Birth Age EE Gender Unknown Version V0 34 Technician All flags are described in Section 4 5 3 Flags page 4 29 Pentra 80 User Manual RAB108E Suspected Pathology Flags and Alarms Morphology Flags LL NRBCs 05 29 2002 09 09 26 4 Result
14. Pentra 80 User Manual RAB108E Error messages Help Message Run an Auto Clean Check Motor in Service Menu Run an initialization Run an initialization Run an initialization Run an Auto Clean Help Message Run an initialization Check motor in Service Menu Run an initialization Check motor in Service Menu Run an initialization Check motor in Service Menu Run an initialization Check motor in Service Menu Run an initialization Check motor in Service Menu Run an initialization Check motor in Service Menu Run an initialization Check switch in Service Menu Run an initialization Check switch in Service Menu Run an initialization Check motor in Service Menu Run an initialization Check motor in Service Menu Run an initialization Check motor in Service Menu Run an initialization Check motor in Service Menu Set rack in the right side posi tion and restart automatic cycle No message 7 45 Pentra 80 Alarm Error Type Help Message Unload racks and restart auto Unloading area full Unloading area full matic cycle Run an initialization Open left front cover and remove rack from loading area Close left front cover and restart automatic cycle Tube too high tube may not be Tuna Nanas correctly inserted in rack Bad rack transfer movement Movement control Run an initialization left Bad OS WSUS onee Movement control Run an initialization right Close front covers Front c
15. Sample ID field must match that of the barcode label Entering the sample tube posi tion in the rack is not available while in this mode Pentra 80 User Manual RAB108E 4 5 Pentra 80 1 5 1 Setting Barcode Manual match OFF The Sample ID field corresponds to the barcode of the label In this mode it is impossible to allocate a position for the tube in the worklist The P80 tab Settings Soft parameters General tab barcode option is set as shown Section 5 2 2 5 Identification option page 5 Barcode Id 123 Barcode reading Problem on reading OK Identification re done Result 1d 123 Fig 4 2 Barcode Manual match OFF 4 6 Pentra 80 User Manual RAB108E 1 5 2 Setting Barcode Manual match ON The P80 tab Settings Soft parameters General tab barcode option is set as shown Section 5 2 2 5 Identification option page 5 7 OK OK Problem on reading Worklist check Worklist check Worklist matched Identification re done Y Y Result id 123 Fig 4 3 Barcode Manual match ON Pentra 80 U ser M anual RAB108E Workflow Workflow Pentra 80 1 6 Sample identification on Rack position Setting Rack Position Section 5 2 2 5 Identification option page 5 7 i e that the identifier is given by the sample position on the rack When a Barcode label is not used on a samp
16. Specifications Limitations ensure the anticoagulated character depending on agglutination and reanalyzed only for the platelet count The final PLT result must be corrected for the sodium citrate dilution effect However these platelet clumps do trigger flags L1 LL and LL1 MPV Mean Platelet Volume Giant platelets that exceed the upper threshold of the Platelet parameter may not be counted as platelets Consequently these larger platelets will not be included in the in strument s calculation of Mean Platelet Volume Very small erythrocytes microcytes erythrocytic fragments 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 pres ence of agglutinated erythrocytes may be detected by observation of abnormal MCH and MCHC values and by careful examination of the stained blood film Chemotherapy May also affect the sizing of PLTs Blood samples collected in EDTA will not maintain a stable Mean Platelet Volume mp3 Platelets collected in EDTA swell depending on the time post collection and storage temperature A LYM Lymphocyte count absolute value LYM Lymphocyte percentage e The Lymphocyte count is derived from the WBC count The presence of erythroblasts cer tain parasites and erythrocytes that are resistant to lysis may interfere with an accurate LYM count Limit
17. User Manual RAB108E Q uality Assurance Calibration 4 Calibration The Calibration function is used to determine the Precision and Accuracy of the analyzer with use of a specifically formulated product to recover each parameter within close tolerances of known target values and limits Coefficients of variation and percent difference recovery must be within their specified limits v Sections detailed in Calibration 4 1 Accessing the Calibration Main Menu page 3 25 4 2 Target values page 3 26 4 3 Running calibration page 3 27 4 1 Accessing the Calibration Main Menu From the Quality Assurance Menu see Fig 3 1 page 3 3 select the Calibration key ar E aa 3 7 01 Hoo cr Ge Modified on L Targetvaives E A57 1g 65 E 2 sess 2 1 oal a Fig 3 23 Calibration Access Key 3 25 Pentra 80 User Manual RAB108E Pentra 80 v Calibration Key Function Runs an automatic calculation of the new coefficients see 4 3 1 Calibration CJ Automatic calculation Automatic Calculation passed page 3 28 This key is enabled only if a minimum of 5 runs on calibrator has been performed Taraet Access to the Target values window j see 4 2 Target values page 3 26 Tab 3 4 Calibration Grid Keys If the Calibrator lot is different than the current calibrator material being used for calibra tion proceed with the following as described in 4 2 Target values page 3 26 4 2 Target v
18. to allow a manual match between orders and results Section 4 1 7 Exception management page 4 11 2 3 Department Physicians tab To prevent manual entering of clinical information for each order this tab provides fields to enter Department names and Physician names that are requesting the analysis of the samples Section 4 2 Worklist page 4 14 From the Soft Parameters menu select the Department Physicians tab abx Department 3 Fig 5 5 Department Physicians tab Use the following function keys to insert delete or modify a department Physician 5 8 Pentra 80 User Manual RAB108E Settings Soft parameters v Functions keys Function Modification of the selected line if the focus is on the department list the software allows the modification of a department 20 characters maximum Addition of new department Physician if the focus is on the department list the software allows the addition of a department 20 charac ters maximum Edit Deletion of department or Physician if the focus is on the department list the software allows the deletion of a department Insert il Delete Tab 5 3 Function Keys 2 4 Units tab Selection of a set of units among the following UNITS WBC RBC HGB HCT PLT MCV STD 1027mm 10 mm g dl 1027 mm um SI 109 1 101271 g TA 109 1 fl mmol l 109 1 1012 1 mmol l I 1041 fl J APAN 102 mm 104 mm g dl 1047 mm
19. um MCH MCHC RDW MPV PCT PDW STD pg g dl um SI pg gl 96 fl W mmol l fmol mmol fl 10 2 JAPAN pg g dl um LYC LYC MON MON NEU NEU EOS STD SI mmol l JAPAN EOS BAS BAS ALY ALY LIC LIC STD SI mmol JAPAN Tab 5 4 Units Open the Units tab Now select the Edit key and scroll through the Unit Selection list see Fig 5 6 page 5 10 Select the units of choice and then select the OK key to confirm your selection Pentra 80 User Manual RAB108E Pentra 80 IPENTRA 80 Soft Parameters Len a STANDARD _ SYSTEM INTERNATIONAL MMOL JAPAN Fig 5 6 Units tab 5 10 Pentra 80 User Manual RAB108E Settings Quality assurance settings 3 Quality assurance settings 3 1 Accessing the QA settings From the Settings window select the Quality Assurance key BEE ELETEN wed rie PATAH a LUULI d ULE ig LN Maly Mang ba Li TA Op rer EK Mar CS olden hee at yg t HP FOG F3 Map A i aey A Ei n er y 7 E JEL 4 LSE 1 T Fig 5 7 Quality Assurance settings There are three configurations available in this menu XB options see 3 2 XB options page 5 11 Number of calibration runs see 3 3 Number of calibration runs page 5 12 Calibr
20. 0 3 g dl PLT lt 7 103 mm LMNE lt 0 30 Nota These options are available in the Begin of day screen when the instrument is started on a new working day date changed the Begin of day time See A on Fig 2 1 System screen page 2 4 is over PENTRA 80 System tien Cena Be D 1 Ti o gt Eee sn ww eno l 6a rel on Fig 2 1 System screen i 2 4 Pentra 80 U ser Manual RAB108E Daily Guide Instrument Startup 1 4 Status Pentra 80 User Manual RAB108E 2 5 Pentra 80 2 6 2 Running the ABX Ouality Control 2 1 Closed tube Mode with barcode page 2 6 2 2 Open tube page 2 7 Prepare control blood according to the specific instructions detailed in the control blood package insert temperature mixing etc ABX DIFFTROL This control material is specifically designed for use on the ABX PENTRA 80 which includes a com plete Blood Count and 5 part White blood cell differential CBC amp DIFF Features include Barco des batch numbering logs etc 2 1 Closed tube Mode with barcode Position the control vial in any cassette as indica ted in the picture barcode label facing out and to the front Load the cassette into the rack loader Press the START RACK key When the analysis of the QC is complete verify that all results are within the acceptable limits as indicated in Section 3 1 3 QC data
21. 5 1 6 Sample tube Holder adjustment The Sample tube holder and sampling needle positions has been factory adjusted Do not at tempt to modify them unless instructed to do so by an ABX DIAGNOSTICS Representative Pentra 80 User Manual RAB108E 7 27 Pentra 80 PENTRA 80 Mechanical System en a os J see ES eee Fig 7 33 Super User Mechanical Holder Adjustment Depth For each hole position Id the depth is measured in millimeters Level This measurement is subtracted from the total depth of each hole position Id so that the sample probe will not touch the bottom of any sample tube placed in these posi tions e Position id This measurement is taken from the Sample probe Home position to the top flat surface of the tube holder Accept Values key This key is used to accept any changes made to the Depth and Level fields e Run key This key allows the acceptance of the number of steps from the Sample probe Home position to the top flat surface of the tube holder The obtained value is returned into Position id field Holder Open Time key This key allows the instrument to calculate the amount of time it takes for the tube holder to completely open This value will be entered into the Time field 5 1 7 Rack adjustment The Rack Adjustment menu allows to define for each type of rack the depth and level of sam pling inside the tube e Depth This measurement
22. 53u of whole blood is aspirated then delivered with into the following chambers as a Diluent indicated 28 Air e Sul discarded One segment of sample for the Dilution chamber which is used for the RBC PLT mE 25pl Differential dilution and the Hemoglobin a 10ul WBC BASO measurement a 10u RBC PLT HGB The second segment of sample is used Bean Uscaracu for the WBC BASO count The last segment of sample is used for the LMNE chamber from which the sam Fig 6 11 Segment distribution in DIFF mode ple is taken into the flowcell for the LMNE count Pentra 80 User Manual RAB108E 6 9 Pentra 80 3 1 3 Sample distribution Each segment of sample is distributed Into the chambers by means of a Tan gential flow of reagent This flow allows for perfect mixing of each dilution and avoids any viscosity problems This tan gential flow process is patented by ABX DIAGNOSTIG Fig 6 12 Sample distribution in a tangential flow 6 10 Pentra 80 User Manual RAB108E 3 2 CBC detection principles 3 2 1 RBC PLT The RBC s and PLT s are measured by an electronic impedance variation princi ple This means that an electronic field is generated around the micro aperture within the chamber in which the blood cells are pulled through The sample is diluted with an electroly tic Diluent electronic current conducting fluid mixed then pulled through a calibrated micro aperture Two electrodes are placed on either
23. 7 49 8 7 Analyzer Internal Error Types and Help Messages 7 49 Section 8 Specifications 1 Technical specificatiONS oooooo on 8 2 Li Pera Ole en angs Ma Aa naa 8 2 1 2 Throughput Analyses aa renee taaet kb 8 3 1 3 Tube identification oooooWo Wo oWoWo Woo mah 8 4 EA Keagenan en ie oat nb aa san edan 8 4 La ATE a GON Ana na thes 8 4 1 6 Measurements ANd computati ON 8 4 2 Physical specifications oWo Wo Wook 8 5 2 1 Power reguirements mna 8 5 2 2 Operating temperature and humidity oooooo Wo W oo 8 5 2 3 Dimension and weight Wo Woow 8 5 2 4 Minimum SPECIMEN VOIUME oo WWW an 8 5 25 QUNM FAM OS kelima eka asean Uh Get rena 8 5 2 6 HGB measurement ot tt uban 8 5 2 7 Counting aperture diameterS o oooo on 8 5 2 8 Reagent CONSUMPTION MI oooooWoW Wah 8 6 2 9 Recommended Anticoagulant oWo oom 8 6 3 Summary of performance data oo ooooWoWo oom 8 3 1 Precision Reproducibility oo WWW mhn 8 7 3 2 Precision Repeatability ooooooWo Woo oWoWo oom 8 8 Dic ea Ne ai 8 9 Oa GO OW O anon ame maa man aan sa nee an eat asa bab 8 10 3 51 Oral RANGES Losmen ama kanan 8 11 250 PCCM CY Dana enam e asap ema ama banana 8 11 3 7 Leukocyte differential COUNt oooo Wo oom 8 12 3 8 Sample stability study o oo Wo oo Woo oom 8 12 3 9 Waste handling precautiOnS oooWoo W oo 8 13 A EUAN ON
24. 85 5 74 97 AGREEMENT Se FALSE POSITIVE RATIO 23 2 2 20 6 1 6 FALSE NEGATI VE RATIO 44 41 9 41 5 333 Tab 8 13 Leukocyte differentiation table Laboratory Standards NCCLS documents Reference Leukocyte Differential Proportional and Evaluation of Instrumental Methods Approved Standard NCCLS document H20 A ISBN 1 56238 131 8 1992 3 8 Sample stability study In accordance with the ICSH guidance 10 samples were collected from the routine laboratory workload 5 normal samples and 5 abnormal samples The samples were divided into 2 ali quots one of which was stored at room temperature and one at 4 degrees centigrade Sample stability was assessed over a 72 hour period The following results were obtained 8 12 Pentra 80 User Manual RAB108E Specifications Summary of performance datar Room Temperature 4 Celsius Deviation WBC 0 1 44 1 85 7 19 Deviation RBC 1 42 1 4 3 06 Deviation HGB 1 42 0 71 313 Deviation HCT 0 93 0 53 0 03 0 42 0 37 Uda Deviation PLT nd 5 81 4 95 8 87 Wie W228 0 0 41 Oy 9 87 0 0 0 0 Deviation Lympho 9 49 22 36 29 95 0 8 61 0 15 19 53 0 0 0 0 0 55 0 7 6 41 0 87 0 69 2 83 Deviation Neutro 4 38 6 79 6 10 1 18 9 85 23 18 Deviation Mono 17l 18 75 173952 10 28 25 40 19 86 Deviation Eosino 5 38 T2 TIDE 24 22 72 85 Mob 8 52 Deviation Baso 6 32 0 00 18 48 9 78 7 61 210 87 O oe Oka KS KS Tab 8 14 Sample stability study
25. Cell phones etc 3 6 Environmental protection v Disposal Used accessories and consumables Must be collected by a laboratory specialized in elimination and recycling of this kind of ma terial according to the local legislation v Disposal Pentra 80 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 Pentra 80 User Manual RAB108E Introduction O perational conditions 1 9 Pentra 80 If any doubt please contact your ABX Diagnostics representative service depart ment 3 7 Transportation and storage conditions Storage temperature 20 C 50 C A Prior to the shipping of an instrument by transporter whatever the destination an external decontamination of the instrument must be carried out 3 8 Installation An ABX Diagnostics representative will install your instrument software and printer v Package contents Verify that all of the parts from the package list are present Part Number Designation XEA709A 1 Installation kit Pentra 80 HAX0023 1 Rack label type 1 1 to 20 HAX0024 1 Rack label type 2 1 to 20 XBA453A 1 Barcode reader GBLO72A 4 Lifting handles GBL0123 10 Rack 10 vials 13x82 XBA322B 1 Waste sensor CBKO44A Il Computer Mouse GBL0250 1 Keyboard drawer CBK043A or CBK045A 1 Querty or Azerty keyboard Tab 1 1 Package list table
26. GCI 0 0 0 35 0 35 Table 6 CHILD 2 Panic L Normal Normal h Panic H WBC 10 0 10 0 26 0 30 0 RBC 4 00 4 00 6 00 6 00 HGB 13 5 13 5 19 5 19 5 HCT 44 0 44 0 64 0 64 0 MCV 98 100 112 114 MCH 30 0 30 0 38 0 38 0 MCHC 32 0 32 0 36 0 36 0 RDW 10 0 11 0 16 0 17 0 PLT 150 200 400 450 MPV 6 6 11 12 PCT 0 00 0 15 0 50 1 00 PDW 1 11 18 20 NEU 0 0 99 9 99 9 LYM 0 0 99 9 99 9 MON 0 0 99 9 99 9 EOS 0 0 99 9 99 9 BAS 0 0 99 9 99 9 NEU 6 00 6 00 26 0 26 0 LYM 2 00 2 00 11 0 11 0 MON 0 40 0 40 3 10 3 10 EOS 0 00 0 00 0 85 0 85 BAS 0 00 0 00 0 65 0 65 LYAYo 0 0 2 5 2 5 CGI 0 0 3 0 3 0 LYA 0 0 0 35 0 35 GCI 0 0 0 35 0 35 5 22 Update for Instrument version V1 3 2 RAM141B Table 7 CHILD 3 Panic L Normal Normal h Panic H WBC 5 00 5 00 15 0 17 0 RBC 4 10 4 10 5 50 5 50 HGB 11 5 12 0 14 0 14 5 HCT 36 0 36 0 44 0 44 0 MCV 71 73 89 91 MCH 24 0 24 0 30 0 30 0 MCHC 32 0 32 0 36 0 36 0 RDW 10 0 11 0 16 0 17 0 PLT 150 200 400 450 MPV 6 6 11 12 PCT 0 00 0 15 0 50 1 00 PDW T 11 18 20 NEU 0 0 99 9 99 9 LYM 0 0 99 9 99 9 MON 0 0 99 9 99 9 EOS 0 0 99 9 99 9 BAS 0 0 99 9 99 9 NEU 1 50 1 50 8 50 8 50 LYM 2 00 2 00 8 00 8 00 MON 0 00 0 00 0 8 0 8 EOS 0 00 0 00 0 65 0 65 BAS 0 00 0 00 0 20 0 30 LYA 0 0 2 5 2 5 CGI 0 0 3 0 3 0 LYA 0 0 0 35 0 35 GCI 0 0 0 35 0 35 Table 8 CHILD 4 Panic L Normal Normal h Panic H WBC 4 50 4 50 13 5 15 0 RBC 4 00 4 00 5 40 5 40 HGB 1170 115 14 5 1520 HCT 37 0 37 0 45 0 45 0 MC
27. L1 LL1 MB These criteria are de fined for all types of blood see 4 2 1 Rerun on alarms page 5 14 b hematological results are beyond their parameter limits which are defined by the user or samples that are rejected These criteria are specific to each sample Type see 4 2 2 Rerun by parameters page 5 14 Pentra 80 User Manual RAB108E 5 13 Pentra 80 4 2 1 Rerun on alarms Refer to 5 3 Flags page 4 29 for Hematologi cal alarms interpretation prior to selection in this screen For modification of the Rerun conditions in Alarms e Select the Edit key Select the alarm box that you want to trig ger the re sampling Select the OK key to confirm your choice of re sampling conditions Vv E A m m 2 E FF Ai a M Mit i r a Fs a m v L Fig 5 11 Rerun on alarm 4 2 2 Rerun by parameters From the Rerun screen F Apply for all Types scroll the Types list and Z y y select a type to configure z Select the EDIT key Choose the limits Panic Normal set by the user or rejected parameters that will trigger a rerun Select or De select the boxes to trigger or not trig ger a rerun on parameter limits If you want a rerun for any parameter that is out of the normal low limits select the key and select any Fig 5 12 Rerun by parameters of the parameters that you would like to have a rerun on low limits eee
28. May cause high RDW results due to iron and or cobalamin and or folate deficiency PLT Platelets Very small erythrocytes microcytes erythrocyte fragments schizocytes and WBC frag ments may interfere with the proper counting of platelets and cause elevated PLT counts Agglutinated erythrocytes May trap platelets causing an erroneously low platelet count The presence of agglutinated erythrocytes may be detected by observation of abnormal MCH and MCHC values and by careful examination of the stained blood film Giant platelets in excessive numbers may cause a low inaccurate platelet count as these large platelets may exceed the upper threshold for the platelet parameter and are not counted Chemotherapy Cytotoxic and immunosuppressive drugs may increase the fragility of these cells which may cause low PLT counts Reference manual methods may be necessary to obtain an accurate platelet count e Hemolysis Hemolysed specimens contain red cell stroma which may increase platelet counts A C D blood Blood anticoagulated with acid citrate dextrose may contain clumped platelet which could decrease the platelet count Elevated triglycerides and or cholesterol may interfere with correct platelet counting Platelet agglutination Clumped platelets may cause a decreased platelet count and or a high WBC count The specimen should be recollected in sodium citrate anticoagulant to Pentra 80 User Manual RAB108E
29. Order information fields ooooo 4 17 2 3 5 Searching by sample ID Woo 4 18 2 3 6 Searching by patient name 4 18 2 3 1 Printing out the worklist oooooo 4 19 2 RACE MEN ahem akan 4 20 2 4 1 Auto N umbering ooooWoW W WWW hh 4 22 2 4 2 Rack view contextual toolbar keys 4 22 2 4 3 Rack view FUNCTIONS o b an 4 22 2 4 4 Printing the rack VIEW o o WoW Woo 4 23 3 Sample collection amp MIXING oo 4 24 3 1 Recommended anticoagulant i mmm 4 24 3 2 Blood sample Stabilitas 4 24 3 3 Microsampling kation iban 4 24 a eni 4 24 4 Running speciMEeNS oom 4 25 5 Run results and associated Flags o 4 26 5 1 Printer output format wens ticctstxansiscedssendixstnasxesactuavbtecedes 4 26 Ma o O OA 4 27 Pentra 80 U ser Manual RAB108E 4 1 Pentra 80 4 2 Na POS lee aan ae bakainaa Naa 4 29 5 3 1 Normal and panic ranges oooo o 4 30 5 3 2 Results exceeding Linear ranges of the instrument4 30 5 3 3 Analysis reject ccecccessseseeesesserseeseeraeseeraeeees 4 31 5 3 4 LM NE matrix flags oooooooo oo 4 32 5 3 5 Flags on WBC BAS histogram o 4 38 5 3 6 Flags on RBC histogram 4 39 5 3 7 Flags on PLT histograms o 4 39 20 VES DANA GO ab aa an ana ita 4 41 5 3 9 Analyzer alarMS oo oo oma 4 42 5 3 10 Pathology messages Wo 4 43 5 3 11 Statistical function flags ooo o 4
30. Result display page 4 50 Tab 4 10 Function Keys Pentra 80 User Manual RAB108E 4 47 Pentra 80 6 1 3 Result Grid information Use the slider see Fig 4 36 page 4 47 to display all the items in the Result list as indi cated below Sample ID Number Rack and position of the sample tube in the rack Patient information Patient ID First name Gender Date of birth Test performed Analysis date The following indicators DANEPT D means Defect analysis see 5 3 Flags page 4 29 displayed for 1 Results exceeding parameter linear capacity 2 Reject on one or several parameters 3 Incorrect HGB blank reference 4 CO alarm A means Pathology Alarms see 5 3 Flags page 4 29 displayed for 1 Flags involving distribution curves 2 Flags involving LMNE matrix thresholds 3 MIC PLA SCL SCH alarms N the result is outside the Normal values E the result is outside the Extreme values P the result has been printed out eT the result has been transmitted to the host computer 4 48 Pentra 80 User Manual RAB108E W orkflow Order amp sample run association 6 1 4 Sorting out Sorting samples is available in the following columns Date time Sample ID Patient ID Selected Sample ID AUTO SIDF Unknown AUTO SIDE Unknown AUTO SIOS Unknown AUTO SIDS 3 2 ELEONOR MIKA Male 565465 3 1 JONES Marleen Female Date of Birth
31. The left part of the screen shows the list of orders the left right slider allows the display of hidden information on the orders The right part aloows the creation modification of the orders in the Edit mode The Worklist patient file management depends on the specific working method for A sample identification in your laboratory see 1 Workflow page 4 3 PENTRA 80 WORKLIST i o _ cal a Po 0870272002 10 03 41 Fig 4 8 Worklist grid Pentra 80 User Manual RAB108E 4 15 Pentra 80 4 16 2 3 1 Creating an order From the Worklist grid select the Insert key see Tab 4 2 Function Keys page 4 16 to create a new order Fill in the order information using the right part of grid screen see Tab 4 3 Order fields page 4 17 Select the test to be performed by clicking the CBC DI FF key Refer to 1 4 Sample identification page 4 5 Then select the OK once all entries have been made 2 3 2 Contextual toolbar keys H eading Key Function Modification of an order Edit Rack and position fields Sample ID are not modifiable Orders transmitted from the host can not be modified too Entry of a new order pert Rack and Position fields are not available for data entry Deletes orders except if the rack is in the process of being ana Delete lyzed Print Prints worklist see 2 3 7 Printing
32. They can be disabled RUO parameters RUO parameters Logs Logs Default test Default test Barcode Option Barcode Option Alarms Alarms Number of consecu tive analyses with SS ee Tab 5 2 General tab function Keys 2 2 2 Automatic numbering When the instrument has not received an order the instrument then associates an automatic Sample ID number that is incremented for each new cycle This automatic Sample ID number is identified in the ID field as AUTO SIDn where n is the incremented number that is entered in this box Select the Edit key and then select the AUTO SID box figure see Fig 5 2 page 5 5 Now type in a beginning number to start the daily sequencing then select the OK key to confirm your entry In order to enter the initial daily auto numbering start sequence the Worklist from 4 the previous day must be erased See Section 2 1 3 Pentra 80 Startup page 2 2 2 2 3 RUO parameters The RUO parameters Research Use Only are as indicated PCT PDW ALY LIC If the Visible box on the soft parameter screen has a Check mark see Fig 5 2 page 5 5 the instrument software will trigger the following message when results are displayed on the screen PCT PDW ALY and LIC are for research use only his message will also be printed out and or transmitted to a host computer Select the Edit key and then place a Check mark in the Visible or Invisible box Now select
33. Woo ooWoW ooh 1 3 1 3 Instrument general CIEANING oooo oo 1 4 2 Replacement procedureS ooooo Wo WWW 1 5 2 1 Reagent replacement mc Woo mm Jan 1 5 2 2 Optical bench lamp replacement oooooWoWo Woo 7 11 2 3 Sampling probe replacement o ooooW W Woo 1 13 2 4 Rinse chamber filter cleaning Woo 7 15 2 5 Instrument RINSE Koroner oma E 1 16 3 Instrument panels amp cover Removals oa 1 18 3 1 Left front door removal o Wo WoWoWo Woow WWW maan 1 18 3 2 Right front door removal Woman 1 19 3 3 Right hand side panel removal Woo 1 19 3 4 Left hand side panel removal oooooWo W Woo 1 20 4 Service menu description woo WWW an 1 21 5 Super User menu deSCFIPti ON Woo Wo 1 22 3A Mechanical Men Ui maan a aan 1 23 5 2 Hydraulical Men ia mail 1 30 ENSA O Anil e PAA aa 1 35 O NO IES OOUNG koma obat annnak Kabah 1 36 6 1 Instrument operation Mode oo 1 31 Bc Ke ee ea babi 1 38 age antena E E E E 1 40 1 Hydraulic Diagram o oo oo oo 1 42 Oe Er ON CSSA OS tm pan ana Sana anna aa sa karunia 1 43 8 1 Analyzer error types and help messages 1 44 8 2 Transfer error types and help messages c oo 1 45 8 3 STAT mode error type and help message o Wo 1 46 8 4 Environment Error Types and Help Messages ie 1 46 8 5 User Error Types and Help Messages 1 49 8 6 Expiration Date Error Types and Help Messages
34. see 4 1 Generic toolbar description page 1 14 is located on the bottom of the screen The Contextual toolbar see 4 2 Contextual toolbar description page 1 15 on the right e The Main menu access keys see 4 3 Main Menu description page 1 16 are featured in the center portion of the touch screen Startup and Shutdown operation keys are also featured in the center portion of the touch screen I PENTRA 80 ee eee Version VO 33 ABX Fig 1 10 Main Menu A Status Bar is also located at the bottom of the screen which indicates the Date Time Software version Operator Code and the Cycle Bar Graph Startup Shut down and Calibration Either pressing on the screen with a finger or making the selection with the Mouse activates all Toolbar and Menu keys To modify edit or review data in screens and tabs refer to 4 4 Miscellaneous page 1 17 Pentra 80 User Manual RAB108E 1 13 Pentra 80 4 1 Generic toolbar description This toolbar that located at the bottom of the screen contains the same selections regardless of what initial menu is open Help Help Brings up the help file Details Details Details displays supplementary information Insert Insertion Inserts new data Edit Modification Edits Modifies data OK Validation Validates an action Cancel Cancel Cancels an action LE Delete Delete Deletes data Print Print Prints data Return Return Ouits the current menu Ouit Ouit Quits the ASP02 softwa
35. 1 10 Pentra 80 User Manual RAB108E Introduction O perational conditions 3 9 Interconnections 3 9 1 Electrical amp Computer connections see 2 2 PC connections label page 1 7 Fig 1 7 Computer connections ae 5 2 X USB 8 COM2 Labo Link 3 Kenang 6 Printer 9 COM1 To Mother Board 4 Pe 7 COM3 External Bar Code Reader 10 Power 3 9 2 Printer connection see 2 1 3 Output label page 1 6 3 9 3 Reagent connections see 2 1 Reagent replacement page 7 5 Pentra 80 User Manual RAB108E 1 11 Pentra 80 3 10 Racks The ABX PENTRA 80 racks are identified on the system by means of Barcode labeling These labels must be placed on the racks in the following manner Gian un o 0201 _ EA 03 _ Fig 1 8 Rack barcode Identification and Rack type Front side TI amp Un 0202 TU NO Mimin 0203 TT o ANAMIN 0102 A 0112 5 12 0103 0113 E 03 13 0104 A NA A 4A 0114 Fig 1 9 Rack Identification Number Back side 1 12 Pentra 80 User Manual RAB108E Introduction Software overview 4 Software overview PENTRA 80 includes a control station which software designed by ABX DIAGNGSTICS is in stalled on a loading PC with a twelve inch 800 x 600 operated touch screen The Main Menu of the system includes two menu selection bars located on the lower horizon tal and right vertical portions of the touch screen The Generic toolbar
36. 10 06 1984 DIFF O OF 14 30 VM wv 03 05 1970 CBC 05 15 2002 14 36 13 CT M M Pw D DIFF 05 13 2002 14 01 22 D M M MMD DIFF 05 13 2002 13 49 08 M M M MMD DIFF 05 13 2002 12 02 16 M M M MMD Fig 4 37 Result grid informations Click a column title for sorting the sample data see Fig 4 37 page 4 49 Click once for ascending order Click twice for descending order Click three times to return to the original order 6 1 5 Result Filters Filters based on DANEPT indicators see 6 1 3 Result Grid information page 4 48 can be applied to the result list as defined below Default f Extreme Default I Alarmed I Not Printed V Normal Default Values I Not Transmitted Fig 4 38 Result filters Default Select this box to display the results with the D indicator only Alarmed select this box to display the results with the A indicator only Normal Default values select this box to display the results with the N indicator only Extreme Default select this box to display the results with the E indicator only Not printed select this box to display the results without P indicator Not transmitted select this box to display the results without T indicator Pentra 80 User Manual RAB108E 4 49 Pentra 80 6 1 6 Result display From the result grid view click a result line to display the results in a full screen mode as indicated below PENTRA Results lt
37. 23 Verify the correct operation of these valves 4 Valves 24 to 30 Verify the correct operation of these valves 5 Valves 31 to 35 Verify the correct operation of these valves 5 1 4 Check Sensors Verify the activity of all of the mechanical sensors mainly switches on the instrument If all switches are working properly they will be indicated in Green From the Main screen select the Super User Menu and then Mechanical Check Sensors Pentra 80 User Manual RAB108E 7 25 Pentra 80 PENTRA 80 Mechanical System RS aes Nx Mu Be fersionVOS4 ft Fig 7 31 Super User Mechanical Check Sensors Verify that all sensors are indicated in Green If any sensor s are indicated in Red con tact your local ABX DAGNOSTIG Technical Support Representative for further instructions 5 1 5 Sampler test Obtain a Sample tube rack and place some tubes In position and leave 2 or 3 empty spaces rom the Main screen select the Super User Menu and then Mechanical Sampler Test Now select the Start Rack key and verify that the rack identification and all the tubes in the rack have been detected Rack number Type of rack CBC or DIFF Barcode numbers 7 26 Pentra 80 User Manual RAB108E Maintenance amp Troubleshooting Super User menu description I PENTRA 80 Mechanical System preme panen BEER EEEEES Fig 7 32 Super User Mechanical Sampler Test
38. 25 Cea rang TE OT ea ai 5 26 6 1 Access to Save Restore Screen oo Wo oo 5 26 A OT APOC I O sess aa na 5 26 6 3 Dump Ob san bonsai 5 27 6 4 Update of the Help on line of P80 software 5 28 Ws User OL ON ea ak abi 5 30 7 1 Accessing the User Screen Woo W mma 5 30 7 2 User menu function Key Sma al oma 5 31 1 3 Creating a new User profile Wo oWo oo 5 31 Bs DENN S PY DOS boa aan 5 33 HORIBA DIAGNOSTICS pentra 80 8 1 Accessing the Types parameters MENU ooW W Wm 5 33 8 2 Pathological NN Ae em ea Mean 5 36 8 3 Alarms amp Curve thresholdS Woo 5 37 8 4 Age range ane ena dobaeaiealisidemenneiatenenads 5 41 Section 6 DescriptionTechnology 1 Pentra 80 description oo ooo oo 6 2 te PRO MEN VOW eae Latina manuk extannenesesesaben ET ena nana 6 2 Le GIG SIS ee Naa 6 2 1 3 Right side VIEW ee ata ana email 6 3 14 Stat tube NO Men 6 3 Los REI V ON iaria E AEA E E EE EER 6 4 2 Automatic mode principles ooooo Wo oo oom 6 5 3 Measuring Pn Pe Ns tai 6 9 3 1 Multi distribution sampling sytem M D SS 6 9 3 2 CBC detection principles an aminn Pe Aa 6 11 3 3 WBC and differential COUNt ooooooo man 6 15 DIAGNOSTICS Section Maintenance amp Troubleshooting 1 Maintenance amp Troubleshooting procedures 7 3 1 1 Hydraulic cycles maintenance chart table oo 7 3 1 2 Maintenance procedures
39. 3 3 1 General counting Principles ooo o 6 15 3 3 2 BAS W BC Count oo Wo om mom mu 6 15 3 3 3 LM NE Matrix COUNt ooooo ena 6 16 Pentra 80 User Manual RAB108E 6 1 Pentra 80 1 Pentra 80 description 1 1 Front View Reagent cover Access to bottles Rack loading tray Rack ejection tray Capacity of 10 racks of 10 tubes Capacity of 10 racks Tube holder door opens whenperforming manual analysis Left front cover Right Front cover Access to the rack me chanical loading system Access to the rack ejec tion mechanical system Fig 6 1 PENTRA 80 front view 1 2 Left side view Optical bench Ensures the support and ad justment of the flowcell lamp and optical and electro nic elements Reagent Access Open this cover to repla ce empty bottles Reagent Syringe assembly LMNE Syringe assembly Ensures the correct proportio e Ensures the correct ning of the reagents proportioning of the stop diluent in the LMNE chamber e Lysing reagent for hemoglo bin ABX Lyse e Cleaning reagent ABX e Injects th njects the specimen CLEANER into the flowcell e Lysing reagent for DIFF e Injects the interior njects the interi count ABX EOSI NOFI X and exterior sheath flow into the flowcell Diluent used for the dilu tions ABX DILUENT except the LMNE stop diluent Lysing reagent for WBC BAS ABX BASOLYSE II 6 2 Pentra 80 User Manual R
40. 46 6 Order amp sample run ASSOCIATION o o 4 47 6 1 Reviewing sample results Woo 4 47 6 1 1 Accessing the Result list oo oo 4 47 6 1 2 Result list function Keys 4 47 6 1 3 Result Grid Information ooooWoWomco 4 48 6 1 4 SOI Ol ani 4 49 6 1 5 Result FilterS ooo ooWo Wo oom 4 49 6 1 6 Result display sasaran enda 4 50 6 1 7 Result display Keys 4 50 6 1 8 Rerunning sample manually oo 4 51 6 1 9 Printout or Transmit Result list 4 51 6 2 Result order association ooo oooWoWo oom 4 53 6 2 1 Association grid description 4 53 6 2 2 Association grid Keys 4 54 6 2 3 Results orders Matching Woo 4 54 Te Re SA aan 4 55 7 1 Accessing the Results Archives 4 55 7 2 Daily result Description oooo Woo 4 56 FO PANNE maan siku 4 58 7 3 1 Patient result function keys 4 59 1 3 2 DEAL DAMEN iwan intan 4 59 1 4 Reviewing a result in full screen mode 4 60 7 4 1 Patient result screen oo 4 60 7 4 2 Daily Result Screen JJ 4 60 Pentra 80 User Manual RAB108E Workflow Workflow Worflow chapter includes the following Workflow page 4 3 Worklist page 4 14 Sample collection amp mixing page 4 24 Running specimens page 4 25 Run results and associated Flags page 4 26 Order amp sample run association page 4 47 Id AD OF FP W N FF Results Archives page 4 55 1 Workflow This chapter des
41. 51 2 25 1 66 LYM 2 20 2 21 MONO 4 69 6 18 NEU 137 0 77 EOS 6 28 9 41 BASO LLLI 16 62 Tab 8 6 Repeatability table N 10 v Precision claims WBC lt 2 0 4 10 x10YpL RBC lt 2 0 3 6 6 2x 10 uL HGB lt 1 0 12 18 g dl HCT lt 2 0 36 54 PLT lt 5 0 150 500 x 103 uL Tab 8 7 Precision claims 3 3 Linearity Linearity range The Manufacturer s tested linearity zone of the instrument using linearity kits and or human blood Linearity limits Maximum and minimum values within instrument returns no dilution alarm Visible range Range values given by the instrument These values above linearity limits are given as an indication They are given associated with a D flag This Visible range is outside Manufacturer s range v Linearity kits Linearity was 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 v Human Blood Linearity was also obtained on human blood using a minimum of 5 dilution points The re sults of this study are as followed Pentra 80 User Manual RAB108E 8 9 Pentra 80 Linearity Linearity Difference Parameters ee Visible range Which ever is Range Limits greater WBC 10 mm 0 45 124 0 120 120 150 0 3 7 RBC 10 mm PPN Ne TAN RN 8 0 18 0 0 07 2 HGB g dl 1 3 26 0 24 24 30 0 3 t2 HCT 1 9 72 0
42. 80 Hydrauli Fig 7 36 Super User Hydraulical Prime Cycles ABX Diluent Primes ABX Diluent reagent ABX Cleaner Primes ABX Cleaner reagent ABX Eosinofix Primes ABX Eosinofix reagent ABX Basolyse 2 Primes ABX Basolyse 2 reagent ABX Lyse Primes ABX Lyse reagent All reagents Primes all reagents at the same time O UI BS WN FO Pentra 80 User Manual RAB108E 7 31 Pentra 80 5 2 3 Unprime cycle PENTRA 80 Hydraulic System ooncamten alj cal wll eal cal x ut Fig 7 37 Super U ser Hydraulical Unprime Cycle 1 Diluent reservoir Drains the diluent reservoir 2 All Unprimes all the reagents from the instrument 7 32 Pentra 80 User Manual RAB108E Maintenance amp Troubleshooting Super User menu description 5 2 4 Clean Cycles I PENTRA 80 Hydraulic System Fig 7 38 Super U ser Hydraulical Clean Cycle 1 Concentrated Cleaning Allows to clean chambers with a bleach solution 2 BackFlush This cycle allows the user to clear the counting chambers with counter pressure in case of aperture blockage 3 Rinse Cytometer This cycle allows the user to backflush the LMNE flowcell with ABX Diluent to rid the counting area of air bubbles and or blockage To perform a concentrated cleaning remove the right hand side panel see 3 Instrument panels amp cover Removals page 7 18 to access to the chambers Select Concentrated Cleaning
43. Admin 2002 04 03 15 15 41 Admin 2002 04 03 15 16 50 Admin 2002 04 03 15 17 44 Admin 2002 04 03 15 18 34 Admin 2002 04 03 15 19 21 Admin 2002 04 03 15 20 22 gie ja Naa Na NG Na Na Minimum Maximum Mean Standard deviation 2 Standard deviation Coef of variation Vv ersion 0 32 Su 15 16 22 Fig 3 20 Within run results This grid includes statistical data for each parameter maximum minimum mean standard deviation The coefficient of variation will be displayed in red if it is greater than the upper limit established by the operator Section 5 3 4 Coefficients of variation ranges page 5 12 Results can be excluded from the statistical data by using the check boxes to de select the analyses 3 3 4 Print Transmit or delete Results v Print or Transmit Open the Within Run Data Grid screen Using the Print Transmit key see Tab 3 3 Within Run keys page 3 21 Select either Print or Send depending which action you would like to create Pentra 80 User Manual RAB108E 3 23 Pentra 80 i Prnnt Send Print Send Fig 3 21 Print Send Within run results v Delete results Open the Within Run Data Grid screen Using the Delete key see Tab 3 3 Within Run keys page 3 21 discard the unselected selected or all results from the grid Delete options Fig 3 22 Delete Within Run Results 3 24 Pentra 80
44. Interpretation Not possible PLT lt 5 0x102 mm or PLT reject or PEC alarm during Startup Tab 4 8 PLT pathology messages H extreme high limit L extreme low limit v Miscellaneous M essage Condition Pancytopenia RBC lt L and WBC lt L and PLT lt L NRBCs LL or WBC reject L1 or WBC reject LL1 Tab 4 9 Miscellaneous pathology messages H extreme high limit L extreme low limit Pentra 80 User Manual RAB108E 4 45 Pentra 80 5 3 11 Statistical function flags v XB flag This alarm is a specific alarm that is associated with patient quality control This particular flag is noted when batch results are outside the XB limits established by the user If one of the mean values from 1 batch of 20 samples is outside of the established limits an XB alarm will be activated Section 3 2 5 XB limits page 3 19 Selecting and Deselecting an analysis can activate the XB alarm The user has the option of enabling or disabling the XB alarm in the Instrument Settings functions Section 5 3 2 XB options page 5 11 The XB alarm can stop the instrument operations if the user has selected the XB alarm con ditions in the Instrument Settings functions Section 5 2 2 General tab page 5 6 v QC failed This flag will appear when the guality control does not meet the criteria that were selected in the Instrument Settings functions The user has the option of selecting or de selecting these cri
45. Manual RAB108E Maintenance amp Troubleshooting Maintenance amp Troubleshooting procedures The following section provides PENTRA 80 maintenance and troubleshooting information including 1 Maintenance amp Troubleshooting procedures page 7 3 2 Replacement procedures page 7 5 3 Instrument panels amp cover Removals page 7 18 4 Service menu description page 7 21 5 Super User menu description page 7 22 6 Troubleshooting page 7 36 8 Error messages page 7 43 1 Maintenance amp Troubleshooting procedures 1 1 Hydraulic cycles maintenance chart table One of the main contributing factors to accurate and reliable results is an instrument that is maintained on a constant basis and correctly performed by the operator Several maintenance functions are available on the system for the user to clean and check the instrument The frequency of maintenance cycles depends upon the number of analysis cycles per day Perform the instrument maintenance according to the chart table Maintenance Sample output Analyses per D ay Cycles Startup 1 per day 1 per day Shut down 1 per day 1 per day Concentrated cleaning 1 per month 2 per month 1 2 Maintenance procedures O perations Freguency On reguest see 1 3 Instrument general clean Instrument general cleaning ing page 7 4 Each time a low level reagent ioccurs Reagent replacement see 2 1 Reagent replacement page 7 5 On reguest see 2 2 Op
46. Manual RAB108E Maintenance amp Troubleshooting Replacement procedures 9 Press the Validate button then repeat this cycle a second time 10 Run several manual cycles 11 Remove the straws from the distilled water bottle then plunge them into an empty bottle 12 Run several ALL Unprime cycles See Unprime cycle screen page 16 to drain the instrument 2 5 2 Syringes and carriage park Move the syringes and the carriage In a Safe position l Enter Service Super User Menu Others and press the Run park syringe position button See Park screen page 17 BGT TAEA a i Fig 7 20 Park screen 2 Before the transport of the instrument press the Run maintenance carriage position button 3 Block the carriage using the Plastic rails See Plastic rails page 17 Fig 7 21 Plastic rails 4 Close the door and turn off the instrument Pentra 80 U ser Manual RAB108E 7 17 Pentra 80 3 Instrument panels amp cover Removals Chapters in this section 3 1 Left front door removal page 7 18 3 2 Right front door removal page 7 19 3 3 Right hand side panel removal page 7 19 3 4 Left hand side panel removal page 7 20 Power off the instrument Disconnect the power supply cable 3 1 Left front door removal Pull the Left Front cover down as indicated in 1 and then pull out to remove it as indi cated in 2 see Fig 7 22 page 7 18 Fig 7 22 Left Fro
47. Neutro 51 NL NE NE Separation between Neutro amp Eosino 82 RMN Channel 127 Tab 5 15 AC Thresholds Absorbance Threshold Purpose 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 Tab 5 16 Channel Width 8 3 3 BAS curve threshold All of the leukocytes are shown between 0 and BA3 thresholds Section 6 3 3 WBC and dif ferential count page 6 15 L1 absolute value is calculated between the channel 0 and the BA1 threshold The percentage of basophils is calculated according to the number of particles from the BA2 threshold to the BA3 threshold These thresholds are factory adjusted to the following values Pentra 80 User Manual RAB108E 5 39 Pentra 80 Threshold Purpose BA1 Separation between L1 counting area and WBC 35 BA2 Separation between WBC amp BAS 110 BA3 End of the BAS Counting area 240 Tab 5 17 BAS thresholds 5 40 Pentra 80 User Manual RAB108E Settings Sample Types 8 4 Age range This tab is accessible if and only if one of the child types has been selected from the Type management list see Fig 5 33 page 5 34 PENTRA 80 Types OY6M22D E EO O l 2YOMOD i 11 YOMOD e A SAL lec ITA RAI si Fig 5 38 Types Age Range This tab will allow the user to define limits between
48. Oon koe 3 7 1 4 Graphics SCreen oooo oWoW mm nana 3 8 1 5 Print send or delete results ooo oom 3 9 1 5 1 Printing results on 3 9 1 5 2 Sending results to the LIS 3 9 1 5 3 Deleting results o oo oo oom 3 10 1 6 New blood control setup ooW oom 3 10 1 7 Running control blo0d ooo on 3 13 1 7 1 Running in STAT mode 3 13 1 7 2 Running in Rack mode With barcode label identification 3 13 2 Patient Quality Control XB ooo oo 3 14 2 1 Access to the XB MENU mmm 3 15 22 AB Ga ae aa 3 16 PANG oe AB Data Grd Se en na 3 17 2A GUC Min Oei 3 18 Doe ai 3 19 Do V0 LER ii 3 20 3 1 Accessing the Within Run Data Grid 3 20 3 2 Closed tube sample setting oo oWooWo 3 22 33 UIA CY non 3 22 33 Manual INOG Css Mean Em Ka ai 3 22 3 3 2 RACK MOde asics sanad 3 22 2 RESI Si isi 3 23 3 3 4 Print Transmit or delete Results 3 23 4 CalibratiOn o oooooaan 3 25 4 1 Accessing the Calibration Main Menu eere 3 25 4 2 Target values oo Wo oo 3 26 4 3 Running calibration oooooo oo oom 3 27 4 3 1 Calibration passed oe an 3 28 4 3 2 Forced calibratiOn oooo 3 29 4 3 3 Coefficients of calibration ranges 3 29 4 3 4 Printing sending or deleting calibration results3 30 ie HID OS Na an EE 3 32 5 1 Access to LOGS fUNCtION ooooW Woo 3 32 D2 ud Ol Ol TOOS NO oh 3 34 5 3 Quali
49. Run SD ARUN EE cel pee gra Eee Means Means SD PX052 High 0 67 0 53 0 53 0 81 WBC PX052 Normal 0 11 0 1 0 12 0 16 PX052 Low 0 06 0 04 0 04 0 07 PX052 High 0 06 0 04 0 05 0 07 RBC PX052 Normal 0 06 0 04 0 04 0 06 PX052 Low 0 03 0 02 0 03 0 04 PX052 High 0 12 0 07 0 09 0 13 HGB PX052 Normal 0 08 0 08 0 07 0 11 PX052 Low 0 05 0 05 0 04 0 06 PX052 High 0 76 0 61 0 65 0 95 HCT PX052 Normal 0 62 0 62 0 62 0 88 PX052 Low 0 28 0 34 0 37 0 48 PX052 High 16 29 8 32 10 6 16 72 PLI PX052 Normal 9 01 D2 8 64 TESS PX052 Low 3 61 3 87 4 69 6 PX052 High T73 1 2 1 34 2 Neutro PX052 Normal 0 76 0 53 0 41 0 77 PX052 Low 0 97 0 8 0 72 1 14 PX052 High 1 79 127 1 54 2 19 Lympho PX052 Normal 0 86 0 67 0 55 0 94 PX052 Low 1 24 0 72 0 78 1 28 PX052 High 0 32 0 25 0 14 0 32 Mono PX052 Normal 0 18 0 09 0 12 0 18 PX052 Low 0 21 0 13 0 08 0 19 PX052 High 0 24 0 14 0 17 0 26 Eosino PX052 Normal 0 32 0 29 0 21 0 37 PX052 Low 1 05 0 83 0 48 1 06 PX052 High 0 1 0 08 0 09 0 13 Baso PX052 Normal 0 05 0 05 0 03 0 06 PX052 Low 0 1 0 07 0 07 0 11 Tab 8 4 Reproducibility Standard deviation Pentra 80 User Manual RAB108E 8 7 Pentra 80 AAMU ai Within Run CV ofrun CV of Daily eter Parameters Hematology CV Tea Mana Imprecision Control CV PX052 High 4 04 3 16 3 18 4 83 WBC PX052 Normal 1 54 1 44 1 61 2 19 PX052 Low 252 1 64 1 78 2 78 PX052 High All 0 79 1 02 1 47 RBC PX052 Normal We 0 93 0 87 1 38 PX052 Low 1 38 0 88 1 16 1 64 PX052 Hig
50. Sampler test Chap 7 20 System Local settings Chap 5 15 Printer Chap 5 18 Chap 5 19 RS232 settings Chap 5 18 9 8 Pentra 80 User Manual RAB108E T Temperature conditions Chap 1 3 Thresholds Chap 5 32 Transmit conditions Chap 5 13 Troubleshooting Chap 7 29 Tube holder door Chap 6 2 Types Chap 5 28 U Units Chap 5 8 User profiles Chap 5 26 W Waste container Chap 7 9 Within Run Chap 3 20 access Chap 3 20 Key Chap 3 20 Run Chap 3 21 Workflow Chap 4 4 association Chap 4 14 Barcode Identification Chap 4 6 Exception management Chap 4 12 Rack position Chap 4 9 Sample ID Chap 4 4 Chap 4 6 Worklist Chap 4 5 Worklist Chap 4 15 access key Chap 4 15 Auto Numbering Chap 4 22 grid Chap 4 16 order Chap 4 17 Rack view Chap 4 20 search patient Chap 4 19 search sample Chap 4 19 X XB Chap 3 14 access Chap 3 15 Batch Chap 3 18 Graphs Chap 3 16 Grid screen Chap 3 17 Key Chap 3 15 limits Chap 3 19 Pentra 80 User Manual RAB108E Index amp Glossary Index 9 9 Pentra 80 Z Zoom Chap 4 28 9 10 Pentra 80 User Manual RAB108E Customer Addendum RAM141B Pentra 80 Update for Instrument version V1 3 2 Default settings of the instrument Please take note of the modifications on next pages Please cross out the 3 appropriate sections in the user manual prior to inserting this addendum at the beginning of the user manual ECR N 1653 Date 24 3 04 gt lt 4 HORIBA FORM 0220
51. Select the test CBC or DIFF by pressing the CBC DIFF key of the grid see Tab 3 3 Within Run keys page 3 21 Select the STAT key of the generic toolbar Section 1 4 2 Contextual toolbar description page 1 15 Once the STAT key has been selected the tube holder door opens Place the sample tube in the appropriate position of the tube holder Close the tube holder on the rear position the analysis cycle begins Rerun the sample several times The Within Run is complete once the operator exits the Within Run Data Grid screen 3 3 2 Rack mode Position the tube in any rack If there is more than one sample tube placed in the rack each tube will be analyzed A the number of times specified by the Sampling Number Open the Within Run Data Grid screen see Fig 3 18 page 3 20 Select the test CBC or DIFF by pressing the CBC DIFF key of the grid see Tab 3 3 Within Run keys page 3 21 Place the rack in the Rack Loader Select the Start Rack key Section 1 4 2 Contextual toolbar description page 1 15 Pentra 80 User Manual RAB108E Q uality Assurance Within run The rack is loaded and the results will automatically appear in the grid 3 3 3 Results PENTRA8O Within Run a tube setting Sampling Number hi Selected Analysis hi 5 sel Op TestDate 2002 04 03 14 28 20 Admin 2002 04 03 14 29 06 Admin 2002 04 03 14 23 51 Admin 2002 04 03 14 30 37
52. User Manual 2 Conservation amp expiration Storage conditions stored at 18 C 65 F to 25 C 77 F away from light Product will degrade if exposed to air keep cap probe assembly securely tightened Expiration date refer to expiration date reagent packaging label 3 Measurements principles amp results Directions for use see Section Maintenance amp Troubleshooting Reagent Location and connection in the instrument User Manual This reagent is for professional in vitro diagnostic use only Measuring Principles see Section Description amp technology in the instrument User Manual Results see Section Workflow in the instrument User Manual Performance data see Section Specifications in the instrument User Manual Note if performance changes call your ABX Diagnostics representative S A au capital de 44 000 000Euros RCS Montpellier 328 031 042 SIRET 328 031 042 000 42 APE 332 B Explore the future 4 Composition amp handling precautions Composition Potassium Cyanide 0 03 Quaternary Amonium Salt lt 3 pH 10 0 5 T 20 C Resistivity 213 10 Q T 20 C Description aqueous solution limpid Handling Precautions Avoid contact with eyes skin and clothing Wear laboratory gloves when handling the product The product may be harmful if ingested The product can be absorbed through an open wound or inhalation Please refer to t
53. a a a Ea Bee eee eee E m a E E E E a E E a E E E E a E E E G E a E a Ea Bee eee eee CE E E G G H Now select the OK key to confirm your selections 5 14 Pentra 80 U ser M anual RAB108E Settings Rules 4 3 Print conditions From the Rules screen select the Print conditions tab PENTRA 285 nui SIG JI T CE E E D E D E E E D E LE G E T U U p E 5 E Hi CE E B G BEB RB ee eee eee eee eee BEBE EEE Pit Fig 5 13 Print conditions Selection of printed results can have the following conditions e Manual only when the operator requires a printed result from the Results screen Unconditionnal All results will be printed Selected criteria the result must respond to one or several of the following conditions to be printed 1 one of the checked flags has been triggered 2 a rejected result occurs on one of the checked parameters 3 the results are out of panic or normal limits on one of the checked parameters To select or de select criteria refer to the Rerun tab see 4 2 Rerun conditions page 5 13 Pentra 80 User Manual RAB108E 5 15 Pentra 80 4 4 Transmit conditions From the Rules screen select the transmit conditions tab PENTRA 80 Rules ee e m m m m j o a a a a a eee m m m m m a CE E E E D E H m m m m m m u Fig 5 14 Transmit conditions Transmissi
54. by electrical current impedance changes Light abosrbance measurement The measurement of Transmitted light at a 0x angle which allows a measured response according to the internal structure of each cell and its absorbance as unabsorbed light passes through the spaces in the nuclear material of each cell This is Known as diffused light 25ml of whole blood is delivered into the LMNE chamber in a tan gential flow of EOS NOFI X This reagent lyses the RBC s stabilizes WBC s in their native forms and stains the Eosinophil nuclei with a specific coloration for there measu rement in the matrix The solution is then stabilized with Fig 6 18 DHSS principles Diluent and transferred into the LMNE flowcell Each cell is mea sured in absorbance cytochemistry and resistive vol ume impedance changes Technical characteristics of the WBC counts during the acquisition of the matrix Initial blood volume 25 Ul Method Impedance with hydrofocus Vol ABX Eosinofix 1000 ul Aperture diameter 60 um Diluent Volume 1000 ul Flow diameter 42 um Final dilution rate 1 80 Injection duration 12 s Temperature of reaction 3p Volume injected 72ul Incubation duration 12s Tab 6 4 WBC counts 6 16 Pentra 80 User Manual RAB108E Description amp Technology M easuring principles No cell in the Baseline flowcell Poorly stained agranular cell in the flowcell Low absorbance Hyper segmented with com
55. eading key Function Numerical results Selected hematology paramaters sent to the host Flags Section 4 5 3 Flags page 4 29 associated to the selected Ae parameters sent to the host Pathology Pathologies Section 4 5 3 Flags page 4 29 associated to the selected parameters sent to the host General flags Section 4 5 3 Flags page 4 29 Patient File Selected fields sent to the host Section 4 2 Worklist page 4 14 Histograms and thresholds ABX format Selected data sent to the host Tab 5 6 Format settings 5 4 Printer PENTRA 80 System xI lt I ka aa I M M v Mv Mv M M M M M v M M Vv M M M Fig 5 20 System Printer tab To modify printer properties select the Edit key and use one the following functions Pentra 80 U ser Manual RAB108E 5 21 Pentra 80 Heading key List Function Report header Printer Enable Auto Print Hematology param eters Report header Printer Name Default printer Add printer Printer properties Set Default Printer Delete Printer Range Raw Manual entry grid Suspected pathologies Curves and matrix Quality control Within Run analysis Calibration Startup Hematology parameters Tab 5 7 Printer settings 5 22 Pentra 80 User Manual RAB108E Six fields of 20 characters maximum each see Fig 5 21 page 5 23 List of installed printers Printer used by the sof
56. from the WBC BAS count chamber 3 3 2 BAS WBC Count The measurement principle is exactly the same as the RBC PLT measurement The Differentiation between the BASO s and the other leukocytes is obtained by the use of the ABX BASOLYSE II reagent with it specific Iysing action All the WBCs are counted between the electronic thresholds from 0s to lt BA3 gt The basophils are counted between Fig 6 17 WBC BAS histogram thresholds lt BA2 gt and lt BA3 gt Technical characteristics of the W BC BAS counts Initial blood volume 10 ul CBC or CBC DIFF Method Impedance Vol ABX BASOLYSE 2000 ul Aperture diameter 80 um Final dilution rate 1 200 Count vacuum 200 mb Temperature of reaction B56 Count period 2 X 6 seconds Tab 6 3 WBC BAS count v Results WBC The number of cells counted within a specified amount of time per volume x WBC co efficient of calibration BAS The number of cells counted within a specified amount of time per volume x the WBC calibration coefficient in a percentage as to the total number of leukocytes Basophils and WBC nucle Pentra 80 User Manual RAB108E 6 15 Pentra 80 3 3 3 LMNE Matrix count The WBC and 5 part Differential count in the flowcell are based on f 3 essential principles The double hydrodynamic slee ving DHSS which allows a linear flow of the cells through the light path ABX DAGNOSTIGS patent The cell volume which is measu rement
57. generated if two consecutive Hemoglobin blank measurements are dif ferent from the pre defined value in Settings Type Parametering Alarms and Curves Threshold Tab Alarm Level Grid HGB parameter absolute value Section 5 8 3 1 Alarm levels page 5 37 A suspect flag is generated if the three Hemoglobin measurements are different from the pre defined value in Settings Type Parameterising Alarms and Curves Threshold Tab Alarm Level Grid HGB parameter percent value Section 5 8 3 1 Alarm levels page 5 37 If 3 consecutive suspect flags are noted on Hemoglobin during Sample Analysis the Hemoglobin value will be rejected and replaced with During instrument STARTUP the HGB Blank measurement value is pre defined from fresh Diluent If the Blank value is not within the measured limits the message Startup Failed HGB Blank will be displayed v LMNE A reject on the LMNE channel indicates a poor correlation between the resistive and the optical measurements on the matrix It is shown by a on all the differential parameters in and The results are not reliable and specimen must be re analyzed NO flag see NO flag page 4 32 Pentra 80 User Manual RAB108E 4 31 Pentra 80 5 3 4 LMNE matrix flags v Suspiscion e When WBC populations are detected in abnormal quantities in one or more areas of the LMNE matrix a suspect flag will be displayed next to the param
58. has been configured as described in Section 2 1 Instrument Startup page 2 2 Reviewing the Results Archives is accessible by two modes By date Daily results see 7 2 Daily result Description page 4 56 By patient Patient results see 7 3 Patient Result page 4 58 7 1 Accessing the Results Archives Select the Archives key from the generic toolbar _ mM iI TC i oi gt Ps f A Es Yu Seed L r Se a ee laa Tai 3 2 a E a 8 L 8 a E a 7 r 7 Era Fig 4 46 Archives access When the Archives function is opened the Daily resuts screen is displayed Pentra 80 U ser Manual RAB108E 4 55 Pentra 80 7 2 Daily result Description PENTRA 80 Archive Aaa ES ben er O LI Th Ya a ina rey a CHI aa Selolmoie ae i i r i 137859 0007 LESBROS Marcel MAN STANDARD STANDARD STANDARD MEYNADIER Jeremy CHILDS _ STANDARD 12244881 12244881 ii oO _ STANDARD STANDARD 112244881 STANDARD 12244881 STANDARD 12244881 STANDARD 37859 am Oe 37859 ons oO oo STANDARD STANDARD o STANDARD AUTO_SID11 STANDARD _ AUTO_SID12_ AUTO_SID13 STANDARD STANDARD JAUTO SID14 AUTO_SID21 STA
59. key then press Validate key in the following window to con firm the cycle see Fig 7 39 page 7 33 Fig 7 39 Concentrated cleaning confirmation The cycle starts when the following window is displayed see Fig 7 40 page 7 34 and be fore pressing Validate key pour into each chamber 3ml of Minoclair or bleach diluted to 4 chloride see Fig 7 41 page 7 34 Pentra 80 User Manual RAB108E Pentra 80 PENTRA 80 into chambers Press Enter To Continue AN Pour 3 ml of ABX MINOCLAIR Fig 7 40 Concentrated cleaning pour Minoclair Fig 7 41 Pour Minoclair Select Validate key once Minoclair has been distributed into all the chambers Wait for the instrument to complete the cleaning Concentrated cleaning cycle duration is around 4min 7 34 Pentra 80 User Manual RAB108E Maintenance amp Troubleshooting Super User menu description 5 3 Others PENTRA 80 Others O an ma 4 16520 pese ps po Fig 7 42 Super U ser O thers l Cycles Counter shows the number of specified cycles performed by the instrument 2 Run Park Syringe Position This key allows the user to place the syringe pistons in a safe position for long term non usage or storage and when the instrument will be in transport from one location to another 3 Run Maintenance Carriage Pos This key allows the user to automatically move the Sample Carriage over the chamber area for sample probe
60. known relevant interference limits of detection limitations of the method and information about the use of available reference measurement procedures and materials by the user see Section Specifications in the instrument User Manual 2 Conservation amp expiration Storage conditions Stored at 18 to 25 C and away from the light Expiration date refer to expiration date reagent packaging label 3 Measurements principles amp results Directions for use see Section Maintenance amp Troubleshooting Reagent Location and connection in the instrument User Manual Measuring Principles see Section Description amp technology in the instrument User Manual Results see Section Workflow in the instrument User Manual Performance data see Section Specifications in the instrument User Manual Note if performance changes call your ABX Diagnostics representative S A au capital de 44 000 000Euros RCS Montpellier 328 031 042 SIRET 328 031 042 000 42 APE 332 B Explore the future 4 Composition amp handling precautions Composition Sodium Chloride lt 1 Natriumazid lt 0 1 Surfactant lt 0 1 pH 8 1 0 2 T 20 C Resistivity 60 5 1 Q T 20 C Description Limpid and odourless aqueous solution Handling Precautions Avoid contact with eyes skin and clothing Wear laboratory gloves when handling the product Keep the bottle closed when not
61. latest documentation Further informa tion may be obtained from your authorised representative 1 2 Safety Precautions 1 2 1 Electronic and moving parts The following parts must not be handled or checked by the user electrical Power supply electronic circuit boards Danger of explosion if battery is not replaced correctly When replacing the battery always use the same and or equivalent type recommended by the manufacturer Dispose of used batteries according to the manufacturer s specific instructions Moving parts It is strictly forbidden to disable sensors as it may cause operator injuries Protection covers must not be opened during instrument operations 1 2 2 Biological risks Consider all Specimens Reagents Calibrators Controls etc that contain hu AA man blood or serum as potentially infectious Use established good laboratory Di 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 ABX Diagnostics uses disinfectant product for instrument decontamination including touch screen and highly recommends it to decontaminate your instrument refer to Section 7 1 3 Instrument general cleaning page 7 4 to perform the instrument decontamination procedure Pentra 80 U ser Manual RAB108E 1 3 P
62. matched with orders PENTRA 80 Match View Select An Order Adit PN Ns ee Fig 4 44 Association grid This screen will show 2 lists Worklist orders not matched to results as it has been defined in the Worklist sample ID patient ID etc e Results with Rack Position of the tubes or and Barcode Identification of the sample as the instrument has read it On the right hand side of the screen Running date Rack Position fields associated to the selected Results Other fields of the order in grey defined in the Worklist A Orders in progress are not displayed in this screen Pentra 80 User Manual RAB108E 4 53 Pentra 80 6 2 2 Association grid keys Heading Key Function Deletes selected order of the Worklist a confirmation MU Delete message is displayed Do you want to delete the order which sample ID is XXX Associates the selected order with the selected results v OK see 6 2 3 Results orders matching page 4 54 A notification is done in the logs On the result list Displays the Rack and position of the tube displays Click a line Click a line the running date too Allows to match the tube with its default order if no order is selected Tab 4 12 Association function Keys 6 2 3 Results orders matching This screen will allow the user to manually match Sample tubes and Worklist Orders that have been classified as Except
63. menu Launches the reagent Status menu Launches the Services menu Launches the Settings menu Pentra 80 User Manual RAB108E The gauge on the bottom status bar progresses at the same time as the cycle Flashes when the Startup cycle has to be performed The gauge on the bottom status bar progresses at the same time as the cycle Section 3 5 Logs page 3 32 Section 3 Fig 3 1 Quality Assurance access key page 3 3 Section 2 3 4 Run in progress page 2 12 Section 2 1 4 Status page 2 5 Section 7 5 Super User menu description page 7 22 Section 5 1 Menu Settings overview page 5 3 Introduction Software overview 4 4 Miscellaneous 4 4 1 Software arborescence and Hints keys Tabs Function keys can be enabled or disabled according to the instrument or soft ware status Enabled Disabled Menu headings are displayed at the top of the screen when a menu is selected Hints can be displayed by moving and holding the cursor on menus keys see Fig 1 11 page 1 17 PENTRA 80 Quality Assurance Ye Bus conta Ca eS ALA 2 AI Version WO 33 ABX 04 17 Fig 1 11 Software arborescence and Hints 4 4 2 Tabs description Tabs are used to group similar functions that pertain to a specific menu Press a Tab or click one with the mouse to access that specific function Menu Pentra 80 User Manual RAB108E 1 17 Pentra 80 Aa ak ojlo
64. notification shall be done by the user or technician in this screen After any maintenance operation open the Maintenance logs screen Press the Insert key in order to enter an action the duration and a comment about this action Press ok key to save the new entry 5 7 Error logs A notification shall be done when an alarm is displayed 5 8 Host logs Each time a file from the Host is rejected a notification is done This rejection is generated in the software rather than the raster when for example An order is pending a ReRun The rack on which the tube is found is in progress of an analysis 5 9 Blank cycle logs For every Startup analysis performed a notification is done e A Startup has passed if the cycle is launched and the WBC RBC HGB and PLT parameters are within acceptable limits the notification line is displayed in green e A Startup has failed if the cycle is launched and if the three consecutive analyses done gave wrong results on the WBC or RBC or HGB or PLT parameters the notification line is red e A Startup has failed if HGB blank value is not within acceptable limits The notification line is red e The default limit values are WBC 0 3 107 mm RBC 0 03 10 mm HGB 0 3 g dl PLT 7 10 mm Pentra 80 User Manual RAB108E 3 35 Pentra 80 5 10 Patient logs For every modification to a patient file by the WorkList or by the HOST a notification is done e Wh
65. oo 5 Te PP Nx Mu my lt AD A Fig 1 12 Menu tabs 4 4 3 Scrolling list These small menus include a list of options and sometimes include a Free Field to enter or edit data within the menu The Edit key must be selected to access a Scrolling list Ihh mmiss ampm h mm ss ampm EH mmss Fig 1 13 Scrolling list 4 4 4 Checked box A Checked Box will enable or disable an option in a specific menu Placing a Check Mark within the box will enable the option Removing a Check Mark from the box will disable the option The Edit key must be selected to modify the Checked Box A 1 18 Pentra 80 U ser Manual RAB108E SstartUp M Automatic Shuti own D Automatic Fig 1 14 Checked box 4 4 5 Radio button Selection between options excluding each other Language Languages Options C American English Spanish Portuguese Fig 1 15 Radio button mmm he Edit key must be selected to modify the Radio button A 4 4 6 Data Fields These fields are rectangular areas within a specific menu that are used to display input or edit specific information within each field For example Name Date Time etc Some fields have predefined formats Date Number Text etc These data fields may be modified when they appear in WHI TE Use the Tab key to move the cursor from one field to the next Pentra 80 User Ma
66. orders are removed from the worklist The orders are also removed from the worklist when the operator manually matches them to a result see 6 2 3 Results orders matching page 4 54 Orders can be entered into the Worklist as followed Manually from the Worklist see 2 3 1 Creating an order page 4 16 or from the Re sults screen if you are requesting a Rerun see 6 1 8 Rerunning sample manually page 4 51 Automatically from a host computer non modifiable Worklist functions are described in the following chapter sections 2 2 Accessing the Worklist function page 4 14 2 3 Worklist grid page 4 15 2 4 Rack view page 4 20 2 2 Accessing the Worklist function Select the Worklist key on the generic toolbar PT ee a S Benone DIFF 05 02 2002 10 03 41 Fig 4 7 Worklist access The worklist is available in two screens with use of the following buttons 4 14 Pentra 80 User Manual RAB108E Workflow Worklist v Worklist view selection keys H eading Key Function GG eee Displays the worklist grid view SES see 2 3 Worklist grid page 4 15 Displays the Rack view iy see 2 4 Rack view page 4 20 i ere Enabled if the barcode option is on Rack Position see 1 3 Worklist page 4 4 Tab 4 1 Worklist selection keys The order Capture Modification is available on the right hand side of these screens from both worklist views 2 3 Worklist grid
67. out the worklist page 4 19 Tab 4 2 Function Keys 2 3 3 Grid functions When the user selects a line of information the order details are displayed on the right hand side of the screen Rack Pos Patient ID Rack Pos PetientID Patient Ne 025646 3 2 SMITH 3 2 Suru 025987 3 1 REDDING 02598745 3 5 JONES Marleen 565465 3 5 JONES ELEONOR MIKA AUTO_SID1 3 1 REDDING AUTO SID4 ELEONOR Fig 4 9 Sorting out by title clicked Select a column description or title to sort out the items within One click for ascending order Two clicks for descending order Three clicks to restore the initial order Multiple selections are not allow at this time Only one selection at a time Pentra 80 User Manual RAB108E 2 3 4 Order information fields Workflow Worklist Heading Button Rack Pos Ho maba Sample ID Type Test Button Sample comment reve Rerun Sample I nformation Department Physician Cinical infonreation Collecting date Patient comment tea Patient ID Patient name First name Date of birth Age Gender Patient data Ingell LI co mela Patient nfornmetion Tab 4 3 Order fields Function Number of rack in which the tube is placed Tube position in the rack Button displayed if the Rack position has been received from the host Entry of Sample ID Search sample key see 2 3 5 Searching by sample ID page 4
68. page 3 8 in a full screen mode Select the Print Send key Then select the OK key v QC Data Grid From the Data Grid screen Selected Unselected and ALL results can be printed by selec tion choice as indicated in Fig 3 6 page 3 9 Print Send Print selected results Print all the results C Print statistics only Fig 3 6 QC print options v L J graphs L J graphs can also be printed from the L J Graphs screen When in this screen select the data to be printed then select the Print Send key 1 5 2 Sending results to the LIS Enter into the Data Grid screen see Fig 3 4 page 3 7 Select the Print Send key and choose an option Selected or All results Now select the Send key Selected results will now be sent to the host computer Pentra 80 User Manual RAB108E 3 9 Pentra 80 1 5 3 Deleting results v Graphics screen You can only delete the last OC result from the Graphics screen Select the Delete key see Fig 3 5 page 3 8 using the Delete key v QC Data Grid Multiple results can be selected and deleted from the QC Data Grid Once the grid has been opened the Delete window becomes available see Fig 3 7 page 3 10 Delete options Selected AN Pa C All Fig 3 7 QC delete options 1 6 New blood control setup It is most necessary to enter all required information related to a new lot of control blood be
69. properties page 21 Default settings for Rerun conditions See 7 Re run conditions page 21 1 Pathological limits and thresholds From the menu Settings Types Pathological limits and Thresholds Table 2 STANDARD Panic L Normal Normal h Panic H WBC 3 00 4 00 10 00 13 00 RBC 3 50 3 80 6 50 6 50 HGB 9 50 115 17 0 18 0 HCT 34 0 37 0 54 0 54 0 MCV 70 80 100 110 MCH 25 0 21 0 32 0 34 0 MCHC 32 0 32 0 36 0 36 0 RDW 10 0 11 0 16 0 17 0 PLT 100 150 500 550 MPV 6 6 11 12 PCT 0 00 0 15 0 50 1 00 PDW 1 11 18 20 NEU 0 0 99 9 99 9 2 22 RAM141B Table 2 STANDARD LYM MON EOS BAS NEU LYM MON EOS BAS LYA CGI LYA GCI Table 3 MAN WBC RBC HGB HCT MCV MCH MCHC RDW PLT MPV PCT PDW NEU LYM MON EOS BAS NEU LYM MON EOS BAS LYA CGI LYA GCI 0 0 0 0 1 70 1 00 0 00 0 00 0 00 Panic L 3 00 3 50 11 0 37 0 70 25 0 32 0 10 0 100 oO Se 2 00 1 00 0 20 0 00 0 00 oO IS Normal 4 00 4 50 13 0 40 0 80 27 0 32 0 11 0 150 6 0 15 11 0 0 0 0 99 9 99 9 99 9 99 9 7 50 4 00 1 00 0 50 0 20 25 3 0 0 25 0 30 Normal h 10 00 6 50 17 0 54 0 100 32 0 36 0 16 0 500 11 0 50 18 99 9 99 9 99 9 99 9 99 9 1 50 4 00 1 00 0 50 0 20 2 5 3 0 0 25 0 30 Update for Instrument version V1 3 2 99 9 99 9 99 9 99 9 8 0 5 00 1 50 0 70 0 25 265 3 0 0 25 0 30 Panic H 13 00 6 50 18 0 54
70. provided wherever necessary throughout this text A Flags a procedure that if not followed properly can prove to be extremely hazardous to either the operator or the environment or both A Emphasizes an operating procedure that must be followed to avoid possible damage to the instrument or erroneous test results Emphasizes the important information especially helpful to the operator before during or after a specific operational function v Copyright 2000 by ABX Diagnostics All rights reserved No part of this book may be reproduced or transmitted in any form or by any means electronic mechanical photocopying recording or otherwise without the prior written permission of ABX Diagnostics ABX Diagnostics Parc Euromedecine Rue du caducee B P 7290 34184 MONTPELLIER Cedex 4 FRANCE Tel 33 0 4 67 14 15 16 Fax 33 0 4 67 14 15 17 Section1 Introduction 1 Warning and precautiOnS o ooo oa 1 2 1 1 Limited guarantee 1 2 Ime Pera ml bui 1 3 1 3 graphics and SyYMboIS ooooo oo WWW W oom mah 1 4 ADEI w ata E tenures 1 5 2 1 MOU utput DC aan NN Aa TE PE TN 1 5 2 2 PC connections label ooh 1 7 3 0 Perawonal CONGITONS Keenakan 1 8 Se EVON ea E T 1 8 Cg LO aO rne aa 1 8 ToO e a E E 1 9 3 4 Humidity Temperature conditions 1 9 3 5 Electromagnetic environment Check 1 9 3 6 Environmental protecti On oo omah 1 9 3 7 Transportation and storage conditions 1 10 SO Sta
71. replacement and or other maintenance procedures that may require the movement of the sample carriage 4 Each Calibration Coefficient can be forced to a value Enter the value you want to modify in the Calibration coefficients grid Confirm the modifications by pressing the Accept values A notification is automatically done in the calibration logs A Any modification of the coefficients will affect the results Pentra 80 User Manual RAB108E 7 35 Pentra 80 7 36 6 Troubleshooting check ED Vox OK oo switch OK Paper feed az Q HD Bottle Replacement Calibration verification check check check Ha Alarms Jb Sampling Yor Technical ae operations OK Blood aspiration OK OK See error O oct ee Yor printout transmit Proc 4 check check check check e All Parameters fy RBC Plt Hct Hgb WBC BASO Differential Vox Vox A Yo Vox Repeatability Repeatability Repeatability Repeatability check check check Pe Default analysis gg Pathology messages gt Yox OK Vox ae z OK Vox Pit re Pit Ba OK OK Hgb Hgb AA Hgb OK OK OK Hraj Y Proc 11 section 3 section 3 Pentra 80 U ser Manual RAB108E Maintenance amp Troubleshooting Troubleshooting Fig 7 43 Troubleshooting guide 6 1 Instrument operation mode v Procedure 1 Print
72. rev 3 Explore the future HORIBA GROUP Update for Instrument version V1 3 2 RAM141B Update for Instrument version V1 3 2 Historic of the addendum index e RAM141A Defaults settings associated to the V 1 3 0 release e RAM141B Defaults settings associated to the V1 3 2 release Mac default value updated to 45 instead of 10 See 2 Alarms levels page 8 Table 1 Concerned sections Settings for pathological limits and thres poate eae Se CHINES E holds Alarm levels Matrix Thresholds Section 3 Quality assurance 2 5 XB limits Default settings for XB limits Section 5 Settings 3 Quality assurance settings Default settings for OA coefficients Section 5 Settings 5 4 Printer Default settings for printer properties Section 5 Settings 4 2 Rerun conditions Default settings for Rerun conditions Default settings of the instrument Type parametering The following values are the software default values for pathological limits amp thresholds See 1 Pathological limits and thresholds page 2 Alarm levels See 2 Alarms levels page 8 Matrix thresholds See 3 Matrix thresholds page 12 classified by types standard man woman Child 1 2 3 4 and 5 Other modifications Default values for XB limits See 5 XB limits page 20 Default values for Assurance Quality coefficients See 4 Assurance quality coefficients page 20 Default settings for printer properties See 6 Printer
73. review demographics of the patient If the Patient ID is known follow the steps as indicated From the Daily results grid select the Patient Result key see Tab 4 14 Patient result function Keys page 4 59 PENTRA 80 Archive 04 07 2002 15 35 03 13 2002 15 06 4 67 4 79 45 L 13 3 38 8 83 3 5 L 115 L 15 2 244 3 0 5 7 43 011 40 4 7 6 1 8 1 2 2 co 2 80 2 31 0 43 0 10 eno Lo Ta Ll AI SA TOR all UA x l Fig 4 49 Patient result screen The Slider icon can be used to display all the results that are associated with this patient 4 58 Pentra 80 User Manual RAB108E Workflow Results Archives 7 3 1 Patient result function keys H eading Key Name Function Displays the search by date screen Pally resu see 7 2 Daily result Description page 4 56 Patient ID When a patient is selected Results are displayed on the right hand side Search patient Launches the search patient Screen see 7 3 2 Search Button patient page 4 59 Print Send Printing of the last 4 files with patient data Running data matrix and histograms Click a result Displays the results in full screen mode Click a result oe Section 4 7 4 Reviewing a result in full screen mode page 4 60 Tab 4 14 Patient result function Keys 7 3 2 Search patient In order to review the results associated to a known patient select the Search patient key se
74. side of the aperture and electric current conti nuously passes between the two electrodes As the blood cells pass through the aper ture they create resistance I mpedance in the electronic field between the two electrodes The voltage which measures the cells is proportional to the size of the cell Since the current is constant and remains unchanged the larger the cell is the more resistance it has The smaller the cell is the less resistance it has These electronic voltages vary in pulse size as the cells pass through the aper ture The pulses are amplified channeled according to size and thres hold grouped and then mathematically calculated along with the calibration coefficients to give a final numerical va lue for both RBC s and PLT s v Results Number of cells counted per volume unit x calibration coefficient v Histograms RBC Distribution curves on 256 coun ting channels from 30fI to 300fl PLT Distribution curves on 256 channels from 2fl to a mobile threshold This threshold moves according to the micro cyte population present in the analysis area Description amp Technology M easuring principles Fig 6 13 Impedance Principles Pulse height Analogue conversion Number of cells Cell size Data integration and plotting of RBC distribution curve Number of cells 1 i i Cell size Fig 6 14 RBC distribution cur
75. specific batch v Printing XB Data grid Select the Print Transmit key to print a list of the batches Pentra 80 U ser Manual RAB108E 3 17 Pentra 80 2 4 Batch content When selecting the XB Batch content this will display all 20 results within that specific batch From the XB Data Grid screen see Fig 3 15 page 3 17 or from the XB Graphs see Fig 3 14 page 3 16 select the XB key to open specifically selected batch contents PENTRA80 For Research Use Only Not for use in diagnostic procedures RUO Batch Contains Batch Number 5 Batch Date 2002 05 28 x Selected Analysis hi 9 Sel N Op TestDate wet RBC Hae hct mcv mcH mche ROW jer M1 Admin 2002 05 28 13 49 12 7 3 5 20 15 3 45 9 88 29 4 33 2 TES 319 M 2 Admin 2002 05 28 13 55 51 7 3 5 30 154 46 6 88 28 8 32 8 11 8 312 M 3 Admin 2002 05 28 13 57 45 5 1 5 12 15 1 44 4 87 23 5 34 0 12 6 215 M 4 Admin 2002 05 28 13 59 07 5 0 5 15 15 1 44 7 87 29 4 33 8 12 5 215 M5 Admin 2002 05 28 14 01 00 8 2 4 67 12 8 38 8 83 27 5 33 1 14 4 245 M 6 Admin 2002 05 28 14 02 53 5 6 4 86 14 0 41 4 85 28 7 33 7 12 5 212 M 7 Admin 2002 05 28 14 04 40 5 1 5 27 14 6 44 0 83 27 8 33 3 12 6 207 M8 Admin 2002 05 28 14 06 34 44 4 68 14 3 42 2 30 30 5 33 9 12 7 216 M9 Admin 2002 05 28 14 08 30 49 4 96 14 7 43 1 87 29 7 34 2 12 9 266 M10 Admin 2002 05 28 14 10 19 47 5 32 15 2 44 7 84 28 5 34 0 14 7 238 E 1 Admin 2002 05 28 14 12 22 E9 5 68 16 7 43 8 88 239 3 33 5 11 7 2
76. to identify then press the ENTER key o lo O O sev Pentra 80 User Manual RAB108E 2 9 Pentra 80 Choice of data entries areas followed 1 Sample information 2 Patient information 3 Test selection CBC yellow DIF green Press the OK key to confirm the order of each sam ple tube Place the tube in the rack then repeat the data entry for the next position Place the rack into the Rack loader Press the START RACK key Pentra 80 User Manual RAB108E Dally Guide Running specimen 3 3 Stat mode Stat mode may be selected at any time during the sys tem processing of the rack Press the STAT MODE key The Stat order screen will be displayed as PENTRA 80 STAT Mode Running Date 05 28 2002 16 51 14 Rack Pos Testing B B DIFF Sample ID PXO32N Collecting Date Type Standard Department Physician Flags and Alarms Comments PatientID __ Patient Name First Name E Date of Birth Age KEP Gender Unknown ba Ve Version VO0 34 Technician Enter the identification information of the sample that you run as a STAT e Sample ID Use the Search Sample key if the sam cJ ple has already been identified or use the External Barcode reader to a barcode label from that tube Collecting date e Sample Type Male female child etc e Test CBC or DI FF Pentra 80 User Manual RAB108E 2 11
77. 0 110 34 0 36 0 17 0 550 12 1 00 20 99 9 99 9 99 9 99 9 99 9 8 0 5 00 1 50 0 70 0 25 25 3 0 0 25 0 30 3 22 Update for Instrument version V1 3 2 RAM141B Table 4 WOMAN Panic L Normal Normal h Panic H WBC 3 00 4 00 10 00 13 00 RBC 3 50 3 80 5 80 6 00 HGB 9 50 a5 16 0 17 0 HCT 34 0 37 0 47 0 50 0 MCV 70 80 100 110 MCH 25 0 27 0 32 0 34 0 MCHC 32 0 32 0 36 0 36 0 RDW 10 0 11 0 16 0 17 0 PLT 100 150 500 550 MPV 6 6 11 12 PCT 0 00 0 15 0 50 1 00 PDW T 11 18 20 NEU 0 0 99 9 99 9 LYM 0 0 99 9 99 9 MON 0 0 99 9 99 9 EOS 0 0 99 9 99 9 BAS 0 0 99 9 99 9 NEU 1 70 2 00 7 50 8 0 LYM 1 00 1 00 4 00 5 00 MON 0 00 0 20 1 00 1 50 EOS 0 00 0 00 0 50 0 70 BAS 0 00 0 00 0 20 0 25 LYA 0 0 215 2 5 CGI 0 0 3 0 3 0 LYA 0 0 0 25 0 25 GCI 0 0 0 30 0 30 Table 5 CHILD 1 Panic L Normal Normal h Panic H WBC 10 0 10 0 26 0 30 0 RBC 4 00 4 00 6 00 6 00 HGB 13 5 135 19 5 19 5 HCT 44 0 44 0 64 0 64 0 MCV 98 100 112 114 MCH 30 0 30 0 38 0 38 0 MCHC 32 0 32 0 36 0 36 0 RDW 10 0 11 0 16 0 17 0 PLT 150 200 400 450 MPV 6 6 11 12 PCT 0 00 0 15 0 50 1 00 PDW 1 11 18 20 NEU 0 0 99 9 99 9 LYM 0 0 99 9 99 9 4 22 RAM141B Update for Instrument version V1 3 2 Table 5 CHILD 1 MON 0 0 99 9 99 9 EOS 0 0 99 9 99 9 BAS 0 0 99 9 99 9 NEU 6 00 6 00 26 0 26 0 LYM 2 00 2 00 11 0 11 0 MON 0 40 0 40 3 10 3 10 EOS 0 00 0 00 0 85 0 85 BAS 0 00 0 00 0 65 0 65 LYA 0 0 2 5 2 5 CGI 0 0 3 0 3 0 LYA 0 0 0 35 0 35
78. 0 45 24 4 2 0 1 0 0 45 Prime DILUENT 3 00 44 Prime PLAN EOSI NOFI X Lo Li 2al Prime TE BASOLYSE 2 1 25 1 7 23 7 1 0 Prime CLEANER 1 24 1 7 24 7 Prime LYSE 1 31 Pa 8 4 Prime ALL 7 13 50 7 24 0 24 0 25 0 8 4 STARTUP AAN 1 blank cycle 228 55 2 0 3 0 2 0 0 95 SHUT DOWN 2 56 32 2 1 0 1 0 14 2 0 49 Rinse AT CYTOMETER i mM AUTOCLEAN 1 33 27 6 1 0 1 0 1 0 0 50 MI NI CLEAN 0 21 10 3 1 0 2 0 1 0 0 33 ONARA ag 29 6 1 0 1 0 1 0 0 50 cleaning BACKFLUSH 024 Tab 8 3 Reagent consumption STARTUP cycle estimated duration and consumptions are given for one blank cycle control It could be a maximum of three cycles 2 9 Recommended Anticoagulant The recommended anticoagulant is K3EDTA with the proper proportion of blood to anticoagulant as specified by the tube manufacturer K EDTA is an acceptable alternative 8 6 Pentra 80 User Manual RAB108E Specifications Summary of performance datar 3 Summary of performance data source 510K submission K024002 3 1 Precision Reproducibility The Pentra 80 was initially calibrated with ABX MINOCAL lot Number MCAL321 Three levels of PENTRA 5D Hematology Control ABX Difftrol material Lot No PX52 were run in duplicate twice daily for 20 days The results were used to quantify within run preci sion SD of the run means SD of the daily means and Total Imprecision in accordance with the NCCLS EP 5 A Guidelines Total Parameter paler Within
79. 1 2 3 4 5 System page 5 17 6 7 User profiles page 5 30 8 Sample Types page 5 33 1 Menu Settings overview 1 1 Accessing the Settings menu Select the SETTINGS key on the Main screen ji 4 my e 1 1 i J RP Ta AE i sia aa fan r e uy 4 T BIPA k a j cm w on j i i Fig 5 1 Settings menu access key Pentra 80 User Manual RAB108E 5 3 Pentra 80 Soft Parameters Quality Assurance Rules System Save Restore Configuration Users Type Parametering 1 2 Menu Settings functions Function Opens the management screens for software options see 2 1 Accessing the Soft Parameters menu page 5 5 Allows to define CV for calibration OC and Within Run see 3 Quality assurance settings page 5 11 The XB mode must also be set here Opens management screens to define criteria for printing sending to Host and rerun conditions see 4 Rules page 5 13 Opens management screens for specific system options date and time RS 232 printer see 5 System page 5 17 Opens management screen for saving restoring the software config uration see 6 Save and restore page 5 26 Opens management screen to define operator profiles see 7 User profiles page 5 30 Allows configuration of instrument according to the types of blood run see 8 Sample Types page 5 33 Tab 5 1 Menu settings function Keys Pen
80. 18 Type associated to the blood characteristics Section 5 8 Sample Types page 5 33 Selection of CBC or DIFF mode Enabled if the software is in EDIT or INSERT mode Opens a Sample comments window Indicates that order is a Rerun Department reguesting the order Section 5 2 3 Department Physicians tab page 5 8 Physician reguesting the order Section 5 2 3 Department Physicians tab page 5 8 Date and time of the specimen collection Opens a Patient comments window Entry of Patient ID Search Patient key see 2 3 6 Searching by patient name page 4 18 Entry of patient name Entry of patient first name Entry of patient date of birth Patient age Male Female or Unknown If displayed indicates that patient data has been received from the Host Pentra 80 User Manual RAB108E Format 2 characters from 1 to 10 16 characters Selection list 20 characters max Default test is dis played 50 characters checked box Selection list or cap ture enabled 20 characters max Selection list or cap ture enabled 20 characters max Date time 50 characters 25 characters 20 characters 5 characters edit box 5 characters drop down list 4 17 Pentra 80 2 3 5 Searching by sample ID The operator has the ability to select a specific sample record from the Sample ID field Just select the Search Sample key see Tab 4 3 Order fields page 4 17 The
81. 2 Pentra 80 U ser Manual RAB108E 7 11 Pentra 80 Fig 7 9 Optical bench location Disconnect the lamp connector see Fig 7 10 page 7 12 Fig 7 10 Optical bench lamp disconnection Loosen the lamp holding bracket screws a few turns see Fig 7 11 page 7 12 Fig 7 11 Lamp fixation screws Turn the lamp bracket from the loosened screws and remove the lamp see Fig 7 12 page 7 13 7 12 Pentra 80 User Manual RAB108E Maintenance amp Troubleshooting Replacement procedures Fig 7 12 Lamp dismantling Once the old lamp has been removed replace it with a new lamp Use a lint free wipe to clean any residue or fingerprints from the new lamp before placing it into the optical bench This will ensure that the new lamp will perform at its optimum peak Tighten the lamp fixation screws Connect the lamp to its power supply 2 2 2 Lamp test Once the lamp replacement is complete verify that the instrument operates correctly Power on the instrument and verify that the Optical Bench lamp is lit If the lamp is illuminated wait until the instrument startup is complete then power off the instrument and re install the covers and panels 1 If the lamp is not illuminated 2 Verify that the lamp connection is connected properly 3 Remove the lamp and verify that the lamp filament is not damaged 4 Try another lamp if available 5 If all these simple remedies do not work contact your
82. 268 2 0027 04705 V Admin 2002 04 02 15 09 50 9 8 4 62 13 8 37 1 279H WBC 9 7 10e3 mm3 Rec 4 57 10e6 mm3 Has 13 6 g dL xi HCT fs 5 Minimum required sampling number for automatic calculation 5 Pt er Hoa an WBC VlHop miat Kat M Modified on Target values J 9 7 4 57 136 365 261 20827 93 29 Mean 9 7 4 60 13 6 36 8 270 5 Coef of variation 0 79 0 65 0 87 0 8 2 07 Actual coef 135 94 171 65 43 19 192 22 258 82 Admin 2 New coef 135 8 170 67 4315 180 7 250 49 J Atomatic calculation Ox Blah W ersion VO 32 w 2002 04 02 15 12 50 Fig 3 25 Calibration result grid e When calibration results are received on the display they are saved as calibration H data and not received as sample results Calibration results are not transmitted to a host computer they are kept in the calibration Results Grid If a calibration cycle is rejected it will not be displayed or stored An error mes sage will be displayed on the screen indicating that the calibration sample was rejected To remove results from the statistical calculation select the check box see Fig 3 25 page 3 28 to remove the mark To remove Parameters from the Coefficient calculations select the check box see Fig 3 25 page 3 28 to remove the mark When a Coefficient of variation is displayed in Red it is above its limit and that parameter will fail calibration 4 3 1 Calibration passed There are only 2 pas
83. 27 Right Neutro LMD RM Resistivity Fig 4 27 NE flag Standard value for NE 1 1 60 Section 5 8 3 Alarms amp Curve thresholds page 5 37 Workflow Run results and associated Flags 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 Neutrophil destruction due to incorrect storage of the sample or an old sample Contamination stroma or platelet aggregates This flag is associated with an on all WBC differencial parameters Meaning Neutro Eosino Presence of a significantly large population of cells located in the separation area between neutrophils and eosinophils be cause of a superimposition of the 2 populations This flag occurs when the number of particles counted in this area is higher than the limit setup in NE or when the number of particules counted regar ding the total number of WBC is above the NE limit Suspected abnormalities e Young eosinophils e Giant hypersegmented neutrophils 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 Pentr
84. 27 v 12 Admin 2002 05 28 14 14 18 Si 4 55 13 7 40 3 59 30 2 34 1 12 5 213 M 13 Admin 2002 05 28 14 16 14 6 8 5 42 15 8 47 0 87 29 2 33 7 124 323 M 14 Admin 2002 05 28 14 18 05 5 3 4 72 12 8 38 8 82 27 2 33 1 13 8 252 M 15 Admin 2002 05 28 14 19 52 7 0 4 41 12 6 37 7 86 28 5 33 3 12 5 275 M 16 Admin 2002 05 28 14 22 01 7 6 4 64 13 3 33 6 85 28 6 33 5 121 239 M 17 Admin 2002 05 28 14 23 52 6 6 5 15 15 1 44 3 86 29 4 34 2 13 2 245 M 18 Admin 2002 05 28 14 25 43 1 2 1 14 3 6 10 6 93 32 0 34 5 11 6 4 M 19 Admin 2002 05 28 14 27 35 6 6 4 86 14 6 43 5 30 30 1 33 5 13 8 195 M 20 Admin 2002 05 28 14 29 34 11 5 4 56 13 5 41 2 30 29 7 32 9 12 2 199 sO AI Alx Ane Version V0 32 2002 06 05 11 54 13 Fig 3 16 XB Batch content A Maximum of 5 results may be de selected from the last batch only Select the Check Box es to de select results to be excluded from the statistical calculations The number of analyses included in the batch values is shown in the square located to the right of Selected Analysis When results are de selected from the batch the statistical val ues are automatically re calculated v Printing XB batch content Use the Print Transmit key to print out the displayed contents of the selected batch 3 18 Pentra 80 User Manual RAB108E Q uality Assurance Patient Q uality Control XB 2 5 XB limits From the XB Data Grid screen see Fig 3 15 page 3 17 or from the XB Graphs see Fig 3 1
85. 4 5 4 2 Printer properties Class 1200 dpi Enh MG RITech On Toner Save Off Fig 5 22 Printer properties window Pentra 80 User Manual RAB108E EPSON EPL 5800 Advanced Default hut Selecion Z Pan 5 E I Continuous Class 1200 dpi 7 Settings System 5 5 Cycle option To modify one of the cycle option select the Edit key and use one the following functions PENTRA 80 System Fig 5 23 System Cycle option tab H eading key Function Default value Number of analyses performed to trigger the autoclean Autoclean Freguency 100 cycles Startup Startup cycle is automatic at begin of day if checked Checked entdowi Shutdown cycle is automatic at the programmed time neked if checked Workflow notion approximate number of DIF amp CBC Daily workload analyses per day Used to warn the operator if reagent level is too short for the working day Tab 5 8 Cycle option Pentra 80 User Manual RAB108E 5 25 Pentra 80 6 Save and restore 6 1 Access to Save Restore screen From the Settings window press the System key e Important Workstation Configuration restore is not ee if the database the Workstation restored Flagging set Ka Nes Racing Get ana ves afte menara ral Ge to reporting patient results UpdateHeip Fig 5 24 Save and restore configuration The Save and restore screen provid
86. 4 page 3 16 select the Target key to open the XB Limits screen see Fig 3 17 page 3 19 IPENTRA 80 Modify Target Fig 3 17 XB limits screen Select the Edit key to modify the limit values then select the value that you want to edit Use the Tab key to move to the following field Press the OK key to confirm the new values entries If any XB parameter within the last batch is out of its limits an XB Alarm will occur Section 4 5 3 11 Statistical function flags page 4 46 If the printer is selected a message XB is printed out This flag can also be transmitted via the data output if it has been activated from the RS output format If a printer is configured with the system a message stating XB will be noted on the print out The XB flag can also be transmitted to a host computer if it has been selected in the RS232 Output Format This alarm occurs when the last batch statistical calculations are complete no matter which operational screen the operator is in The values that are presently displayed in the XB limits are factory Default values These values can be edited for a specific group or patient population to detect any possible drift in calculations v Printing XB Limits Use the Print Transmit key to print out the XB limits Pentra 80 User Manual RAB108E 3 19 Pentra 80 3 Within run The Within Run is based on results that are obtained by cons
87. 5 Press the ARCHIVES key on the Generic toolbar 5 1 Searching results by day Open the calendar of the Daily results view select Running Date and then select the date of the results een E Date i 05 15 2002 a you wish to review 5 2 Searching results by patient Press the PATIENT RESULTS key Press the SEARCH PATIENT key and type in the patient name or first identification characters Press the OK key to display the results associated with the patient selected Once the results have been reviewed or printed press the DAILY RESULTS key to return to the daily results b ae ly Pentra 80 User Manual RAB108E 2 15 Pentra 80 6 Instrument Shutdown 6 1 Manual shutdown page 2 16 If the instrument is used on a daily basis A Shutdown cycle must be performed at least once a day The Shutdown cycle can be programmed for specific cycle intervention if needed See Sec tion 5 5 5 Cycle option page 5 25 or manually activated by selection 6 1 Manual shutdown From the Main Menu screen press the SHUTDOWN key to perform a complete instrument enzymatic cleaning with ABX CLEANER When the Shutdown cycle is complete select Stop win dows to turn off the instrument 2 16 Pentra 80 User Manual RAB108E Q uality Assurance Contents TOA ONTO ab 3 4 1 1 Access to the Quality Control Menu ooo W Wo oo 3 4 Na WAIN aa Ame ea 3 6 1 3 QC data screen Oi
88. 67 67 80 t2 0 3 PLT 1027 mm 7 2087 0 1900 1900 2800 10 10 for HGB gt 2 g dL RBC gt 0 5x10 mm PLT 103 mm 5 2792 0 2800 2800 3200 10 10 for HGB lt 2 g dL RBC lt 0 5x10 mm Tab 8 8 Linearity 3 4 Carryover Carry over effects were evaluated by assaying a sample with high cell concentrations three consecutive times 11 3 followed immediately by testing a diluted sample consecutively 3 times j1 3 Carry over is then J Carryover x100 The overall results gave the following Mean low levels 0 78 1 047 4 09 28 61 Mean high levels 43 64 8 56 25 94 739 00 Carry over 0 070 0 268 0 046 0 286 Tab 8 9 Cary over table This is the method as described in Guidelines for the Evaluation of blood cell analyzers includ ing those used for differential leukocyte and reticulocyte counting and cell marker applications ISLH 14 January 1994 v Carry over Claims Claims lt 2 0 lt 2 0 lt 2 0 lt 2 0 Tab 8 10 Carry over claims 8 10 Pentra 80 User Manual RAB108E Specifications Summary of performance datar 3 5 Normal Ranges Parameters Male Female WBC 10 mm 4 10 4 10 RBC 10 mm 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 210 32 0 21 05 32 0 MCHC g dl 32 0 36 0 32 0 36 0 RDW 11 0 16 0 11 0 16 0 PLT 1027 mm3 150 500 150 500 MPV
89. 80 has started the analysis process on a sample tube an order is gen erated to search the worklist for 2 of the following criteria The Rack position number where the tube has been placed The barcode Sample ID The order searching mode is generated based on specific settings that were select 4 ed by the operator Section 5 2 2 General tab page 5 6 When the associated order is found the instrument will automatically perform the required analysis that was generated from the information in the worklist such as defined blood type and the patient demographics that are associated with each sample 1 3 Worklist Worklist orders allow the following criteria a single identification of a sample tube selection of the test to be performed CBC or DIFF Selection parameter ranges according to the specific blood types i e Male Female Child etc the creation of a patient file and patient demographics Matching orders to specific patient files When creating orders there are only 2 modes available 1 A graphics screen see 2 4 Rack view page 4 20 that simulates a rack view with sample tube positions This mode must be used with the following Setting Rack Position Section 5 2 2 5 Identification option page 5 7 2 A grid that is intended to identify the sample tube by means of Barcode labeling Entering the sample tube position in the rack is not available while in this mode This mode must only be used with the
90. 9 11 1 1 3 50 5 45 11 3 Level 80 80 55 120 120 999 999 999 30 200 60 Table 17 CHILD 5 10 years old to 12 years old NO LL LL1 NL MN RM LN RN NE L1 LMNE Reject MIC MAC MACp HGB Level Yo 100 100 5 3 15 0 7 2 9 11 1 1 3 50 5 45 11 3 Level 80 80 55 120 120 999 999 999 30 200 60 Update for Instrument version V1 3 2 11 22 Update for Instrument version V1 3 2 RAM141B 3 Matrix thresholds From the menu Settings Types Alarms and Curves Thresholds Table 18 STANDARD Channel NOL 24 NON 27 LL oi LN 35 NOE 50 LMN 69 AL 69 LMU 13 LMD 100 MN 100 RM 118 RN 118 NL 29 RMN 51 NE 82 FLN 2 FNE 2 FMN 2 BA1 35 BA2 110 BA3 240 12 22 RAM141B Update for Instrument version V1 3 2 Table 19 MAN Channel NOL 24 NO 21 LL 31 LN 35 NOE 50 LMN 69 AL 69 LMU 13 LMD 100 MN 100 RM 118 RN 118 NL 29 RMN 51 NE 82 FLN 2 FNE 2 FMN 2 BA1 35 BA2 110 BA3 240 13 22 Update for Instrument version V1 3 2 RAM141B Table 20 WOMAN Channel NOL 24 NO 27 LL 31 LN 35 NOE 50 LMN 69 AL 69 LMU 13 LMD 100 MN 100 RM 118 RN 118 NL 29 RMN 51 NE 82 FLN 2 FNE 2 FMN 2 BA1 35 BA2 110 BA3 240 14 22 RAM141B Update for Instrument version V1 3 2 Table 21 CHILD 1 Channel NOL 24 NO 27 LL 31 LN 35 NOE 50 LMN 69 AL 69 LMU 73 LMD 100 MN 100 RM 118 RN 118 NL 29 RMN 51 NE 82 FLN 2 FNE 2 FMN 2 BA1 35 BA2 110
91. AB108E 1 3 Right side view Sampling syringe Whole blood sample take and distribution of portions of the specimen into the dilution chambers e Aspirates the sample from the first dilution and distributes it into the Description amp Technology Pentra 80 description Mother board e Amplifies proces ses and counts the following signals Resistive signals and LMNE optical RBC PLT chamber signals RBC Signal PLT Count Assembly signal e Receives the different rinsings and dilutions e Regulates the tempera ture of dilutions Provides the dilutions for WBC BAS RBC PLT and HGB Fig 6 3 PENTRA 80 right side view WBC BAS signals Measures hemoglobin 1 4 Stat tube holder There are 3 Positions for the Stat tube holder door open as shown Rack mode Intermediate position Sampling position rear Pentra 80 User Manual RAB108E 6 3 Pentra 80 LEDS e When the Green LED is lit the instrument is ready to sample e When the Green and Red LEDs are blinking alternatly instrument is busy sampling When the Red LED is lit instrument is in operation Sampling position 1 For 5ml tubes alll Sampling position 2 rar aml Tubes Sampling position 4 For microtainer Sampling position 3 Fig 6 4 Stat tube holder For Controls Calibra tors amp Latex material 1 5 Rear view Diluent and waste connections Serial number
92. ATION SECTEUR AVANT TOUTE INTERVENTION VERIFIER QUE LA TENSION EST CORRECTE N UTILISER EN REMPLACEMENT QUE DES FUSIBLES DE MEME TYPE ET DE MEME CALIBRE CAUTION TO REDUCE THE RISK OF ELECTRIC SHOCK DO NOT REMOVE COVER OR BACK REFER SERVICING TO QUALIFIED SERVICE PERSONNEL DISCONNECT THE SYSTEM FROM SUPPLY BEFORE SERVICING USE ONLY WITH CORRECT POWER VOLTAGE REPLACE ONLY WITH SAME TYPE AND RATING OF FUSE Fig 1 2 Serial number label Pentra 80 User Manual RAB108E 1 5 Pentra 80 2 1 2 Reagent and waste connection labels Waste output Connection used for Waste output tubing on Waste position Waste level detection Connection used for Waste level detection on Waste Alarm posi tion Diluent input Connection used for Diluent input tubing on Diluent position Fig 1 3 Reagent and waste label 2 1 3 Output label Fig 1 4 O uput Label 1 RS 232 output LIS Laboratory Information System connection 2 Printer connection Do not connect any printer which has not been recommended by an ABX Diagnostics qualified engineer 1 6 Pentra 80 User Manual RAB108E Introduction Labels 2 2 PC connections label Fig 1 5 Internal PC connections 1 Mouse 2 Keyboard Refer to 3 9 Interconnections page 1 11 for other peripheral connections Pentra 80 User Manual RAB108E 1 7 Pentra 80 1 8 3 Operational conditions 3 1 Environment page 1 8 3 2
93. BA3 240 15 22 Update for Instrument version V1 3 2 RAM141B Table 22 CHILD 2 Channel NOL 24 NO 27 LL 31 LN 35 NOE 50 LMN 69 AL 69 LMU 13 LMD 100 MN 100 RM 118 RN 118 NL 29 RMN 51 NE 82 FLN 2 FNE 2 FMN 2 BA1 35 BA2 110 BA3 240 16 22 RAM141B Update for Instrument version V1 3 2 Table 23 CHILD 3 Channel NOL 24 NO 27 LL 31 LN 35 NOE 50 LMN 69 AL 69 LMU 73 LMD 100 MN 100 RM 118 RN 118 NL 29 RMN 51 NE 82 FLN 2 FNE 2 FMN 2 BA1 35 BA2 110 BA3 240 17 22 Update for Instrument version V1 3 2 RAM141B Table 24 CHILD 4 Channel NOL 24 NO 27 LL 31 LN 35 NOE 50 LMN 69 AL 69 LMU 13 LMD 100 MN 100 RM 118 RN 118 NL 29 RMN 51 NE 82 FLN 2 FNE 2 FMN 2 BA1 35 BA2 110 BA3 240 18 22 RAM141B Update for Instrument version V1 3 2 Table 25 CHILD 5 Channel NOL 24 NO 27 LL 31 LN 35 NOE 50 LMN 69 AL 69 LMU 73 LMD 100 MN 100 RM 118 RN 118 NL 29 RMN 51 NE 82 FLN 2 FNE 2 FMN 2 BA1 35 BA2 110 BA3 240 19 22 Update for Instrument version V1 3 2 RAM141B 4 Assurance guality coefficients From the menu Settings Quality Assurance Table 26 Assurance quality coefficients table MAX CV WBC 5 RBC 5 HGB 3 HCT 5 MCV 3 MCH 3 MCHC 3 RDW 10 PLT 10 MPV 10 NEU 10 LYM 10 MON 35 EOS 15 BAS 10 NEU 10 LYM 10 MON 35 EOS 15 BAS 10 5 XB limits From the menu Settings Quality Assurance XB Target Table 27 XB limits table Val
94. D Shutdown cycle Specifications Startup cycle Verification Whole blood Range of results over which the instrument displays prints and transmits data A component of blood that the instrument measures and reports targeted performance of the instrument based on established ranges and parameters specifications Labile blood product composed of platelets produced by blood bank centers and intended for transfusion Cellular suspension in the plasma high platelet concentration obtained by sedimentation from a whole blood sample to determine on the hematology analyzer the platelet count in the presence of a contaminating microcytic RBC population A comprehensive set of of procedures a laboratory establishes to ensure that the instrument is working accurately and precisly This procedure checks that the system gives similar results within estab lished limits every time it measures the same sample A measure of variation within a group samples or within a population standard deviation Cleans the instrument s fluidic lines and apertures to help prevent residue buildup See performance specifications see 3 Summary of performance data Chap 8 Ensures that the instrument is ready to run includes performing a back ground test Procedure to analyze cell controls or whole blood with known values to determine if your results are within the acceptable range Non diluted blood blood and anticoagulant only Pentra 80
95. FLUSH Flush motor bad position Run an Initialization d Min d Max d Incorrect pos motor drain 2 DRAINING 2 motor bad posi d Min d Max d tion Run an Initialization Incorrect pos motor injector d Min d Max d Injector motor bad position Run an Initialization 7 48 Pentra 80 User Manual RAB108E Maintenance amp Troubleshooting Alarm Error Type Incorrect pos motor loading d Min d Max d Loader motor bad position Incorrect pos motor mixer d Min d Max d Mixer motor bad position Incorrect pos motor needle d Min d Max Kd Needle motor bad position Incorrect pos motor sampling d Min d Max d Sampling motor bad position Incorrect pos motor tranfer d Min d Max d Translation motor bad position Barcode internal connection Internal Barcode Error problem Internal synchronization failed i tion problem Motor d is busy Run a new cycle while analyzer jalanan Analyzer already in cycle Valve already activated System stop due to synchroniza Help Message Run an Initialization Run an Initialization Run an Initialization Run an Initialization Run an Initialization Run an Initialization Run an Autoclean Run an Initialization Run an Autoclean Run an Initialization Pentra 80 User Manual RAB108E Error messages 7 49 Pentra 80 7 50 Pentra 80 User Manual RAB108E Specifications Contents 1 Tech
96. Flags on PLT histograms page 4 39 5 3 10 Pathology messages page 4 43 Analyzer alarms 5 3 9 Analyzer alarms page 4 42 e Flags linked to statistical function 5 3 11 Statistical function flags page 4 46 The operator can adjust the Sensitivity of each flag Section 5 8 Sample Types page 5 33 Pentra 80 User Manual RAB108E 4 29 Pentra 80 5 3 1 Normal and panic ranges h indicates that the result is above the normal limit set by the user l Indicates that the result is below the normal limit set by the user H Indicates that the result is above the panic limit set by the user L Indicates that the result is below the panic limit set by the user These flags can also be criteria for the pathology messages 5 3 2 Results exceeding Linear ranges of the instrument Different alarms can be activated if a parameter results exceeds exceeds the Linear limit of the instrument Result may be forced to 0 Parameter value displayed with D Dilution Parameter value may be replaced with D Parameters Conditions 0 1x103 mm and RBC lt 0 01x10 mm WBC gt 120x103 mm gt 150X102 mm lt 0 01x10 mm Consequences WBC forced to 0 WBC replaced by D diff results replaced by RBC replaced by RBC gt 8x10 mm RBC value D gt 18x10 mm RBC replaced by D HGB lt 0 1g dL HGB forced to 0 gt 24g dL HGB replaced b
97. Host computer label connection Main power sup ply inlet Printer connection Fig 6 5 Rear View 6 4 Pentra 80 User Manual RAB108E Description amp Technology Automatic mode principles 2 Automatic mode principles v Rack loading The ABX PENTRA 80 will allow continuous loading of sample tube racks during all phases of Operation Racks are placed and then drawn onto a mechanism which allows the mixing and sampling of each tube within the rack Micro switches allow detection of the racks when placed in the loading tray Fig 6 6 Tube height detection and correction The Sample tube is detected and the tube height is adjusted by the presence of 2 rolling de tectors within the mechanism see Fig 6 6 page 6 5 Sensors are also present within the mechanism to index the rack position at any time during its presence through the loader Pentra 80 User Manual RAB108E 6 5 Pentra 80 v Sample mixing Fig 6 7 Sample mixing 360 end over end rotations for approximately 1 minute ensures optimum mixing of the samples The Tube Grabber contains 2 grabbers which work in conjunction with the tube sampling The first tube grabber grabs the number 1 tube and mixes it for 30 seconds The tube is then placed back into the rack The same process applies for the second tube in the rack Then both tubes numbered 1 and 3 are grabbed and mixed at the same time for another 30 seconds more The tubes are place
98. Laboratory La Biosafety Manual 2nd edition for further information 1 3 2 Instrument internal cleaning v Concentrated cleaning Counting chambers and hydraulics parts are decontaminated by using the Concentrated cleaning function as described in see 5 2 4 Clean Cycles page 7 33 7 4 Pentra 80 U ser M anual RAB108E Maintenance amp Troubleshooting Replacement procedures v Sampling probe Sampling probe must be decontaminated as follows 1 Prepare a solution of Sodium Hypochlorite to 100ml I 2 Fill a 5ml tube with this solution 3 Run 5 analysis on bleach using the Stat mode as described in See Section 2 3 3 Stat mode page 2 11 Please also refer to the W H O World Health Organization guidelines Laboratory d Biosafety Manual 2nd edition for further information 2 Replacement procedures This section describes how to replace a low level reagent see 2 1 Reagent replacement page 7 5 an optical bench lamp see 2 2 Optical bench lamp replacement page 7 11 the sampling probe see 2 3 Sampling probe replacement page 7 13 2 1 Reagent replacement 2 1 1 Reagent locations and connections When installing the Diluent on the system it is most important to maintain the depth of the container no lower than 80 cm 31 5 in below the instrument If the depth limit is exceeded erroneous results will occur Diluent and Waste tubing lengths are critical upon installation Follow
99. Location page 1 8 3 3 Grounding page 1 9 3 4 Humidity Temperature conditions page 1 9 3 5 Electromagnetic environment check page 1 9 3 6 Environmental protection page 1 9 3 7 Transportation and storage conditions page 1 10 3 8 Installation page 1 10 3 9 Interconnections page 1 11 3 10 Racks page 1 12 3 1 Environment The operation of the Pentra 80 should be restricted to indoor location use only Operation of the instrument at altitudes of over 3000 Meters 9800 feet is not recommended The in strument is designed for safety from voltages surges according to INSTALLATION CATEGORY and POLLUTION DEGREE 2 IEC EN 61010 1 Please contact your local ABX Diagnostics representative for information regarding operation locations when it does not comply with the recommended specifications 3 2 Location The Pentra 80 should be placed on a clean and leveled table or workbench Please note that the Pentra 80 and printer weigh approximately 55 kilograms 121 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 Provide a space of at least 20 cm 8 inches at the back of the instrument for arranging the power cable and tubings
100. M LMNE M LMNE Reject Version V1 3 0 ABX 1 42742003 11 35 36 Diag 2 Rerun conditions CE G E G G G ee ee E E E E 3 3 Be a G E a o a G E G E E G a g E gi E a a a NN BEB a eee eee eee Bee G eee eee eee eee TN NN NN ee aoe A IE A 21 22 Update for Instrument version V1 3 2 RAM141B 22122 Customer Addendum RAM173A Pentra 80 Update for Instrument version V1 4 0 Platelet counting and flagging modification 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 ECR N 1849 Date 16 7 04 FORM 0220 rev 3 Explore the future HORIBA GROUP Update for Instrument version V1 4 0 RAM173A 212 Update for Instrument version V1 4 0 V History of the addendum index None Platelet counting and flagging modification In order to improve the reliability of the platelet count the pentra 80 now includes new suspicion flags 1 Rack mode On rack mode if the Pentra 80 has detected a possible anomaly during platelet analysis the Plt result will be reported as The instrument will automatically rerun the sample An algorithm comparison is performed on both Plt results From this comparison two cases can occur e Second suspicion flag the Plt result needs to be confirmed according to Good Laboratory Working Practices
101. Minimum Standard Maximum GR 100 215 300 HT 100 220 300 HB 25 40 55 PLA 130 290 400 DR 0l 0 35 1 VMP 0i 1 0 2 LMNE 0 5 0 86 125 Pentra 80 User Manual RAB108E 3 29 Pentra 80 3 30 4 3 4 Printing sending or deleting calibration results v Printing and sending calibration results Calibration results can be printed out and or sent to a host computer by selecting the Print Send key Specific results and parameters may be included or excluded from statistical cal culations by selection of the Check Boxes in the Calibration Results Grid see Fig 3 27 page 3 30 Press the Print key of the Contextual Toolbar to open it Print Send Print Send Send Print Print selected results Send the selected results Print all the results ie C Send all the results C Print statistics only x coca x coca Fig 3 27 Print and send windows Calibration List View TARGET Calibrator Name Expiration date Modified on Modified by CALI 1 2002 04 05 2002 03 29 Admin WBC HGB HCT PLT 9 74 0 2 10e3 mm3 4 57 0 06 10e6 mm3 13 6 0 2 g dL 36 5 1 0 261 10 10e3 mm3 Sel Operator Test Date Ik Admin 2002 04 02 15 04 16 2002 04 02 15 05 12 5 06 9 7 x Intermediate values WBC RBC HG HCT PLT Target values 9 7 4 57 13 6 36 5 261 Mean 9 7 4 58 13 5 36 6 267 Coef of variation 0 77 0 37 0 24 0 5 1 24 182 22 171 39 43 42 181 65 252 76 Fig 3 28 Calibration printo
102. NDARD STANDARD AUTO SID24 AUTO SID32 STANDARD STANDARD JAUTO SID33 STANDARD Fig 4 47 Daily result grid The daily result grid contains all the matched results from a single day of work which include the Sample ID the Rack number and position of the tube the Patient ID first name the Test CBC DIFF and the sample type given to the sample Select a date that you want to review by using the scrolling icon to move through the list Deleting results from the Archives screen is notified in the Data handling logs see Fig 4 48 Data handling logs page 4 56 PENTRA 80 Logs 7 Data Handling SIG Ww v JIE eo gt i oa ral x Mu PA MT BKI 3 Fig 4 48 Data handling logs 4 56 Pentra 80 User Manual RAB108E Workflow Results Archives v Daily results function keys Heading Key Name Function NP Displays the search by date screen SEU os see 7 2 Daily result Description page 4 56 enables the deletion of all unselected or selected analyses Unchecks all the result lines in the list Unselect all column Selected Displays the results in full screen mode Click a line Click a line see 7 4 Reviewing a result in full screen mode page 4 60 Tab 4 13 Daily result function Keys Pentra 80 User Manual RAB108E 4 57 Pentra 80 7 3 Patient Result The Archives function allows the user to
103. OLUENT Analysis Capacity CBC p DIFF p BEIA Al KA V Version VO 34 A ABX 05 13 2002 11 38 26 Fig 7 3 Reagent status window Pentra 80 User Manual RAB108E 7 7 Pentra 80 7 8 From the reagent status window select the reagent you want to replace Once you select the reagent the following screen will be displayed see Fig 7 3 page 7 7 Now select the Edit key to modify any reagent specifications see Fig 7 4 page 7 8 a o PENTRA 80 Reagent poe oo Fig 7 4 Reagent edit Pentra 80 U ser M anual RAB108E Maintenance amp Troubleshooting Replacement procedures PENTRA 80 Reagent Fig 7 5 Reagent replacement Select the Lot Nb field and then use the Barcode reader to update some of the reagent specifications Lot number Expiration date see Fig 7 5 page 7 9 The reagent level is set to an automatic default level Verify this level and or change it to the correct level in milliliters if necessary Select the Level field and edit if necessary see Fig 7 6 page 7 10 Pentra 80 User Manual RAB108E 7 9 Pentra 80 PENTRA 80 Reagent Reagent ABX ALPHALYSE Lot Nb p30210K2 0 Capacity ml 400 Level ml ag Change Date fosj13 2002 11 01 38 Expiration 01 10 2003 11 01 38 Operator ABX Use barcode reader Replace reagent bottle before pressing this button Versio
104. OVEPVIEW mona nana 1 21 5 2 Worklist Overview oo Woman 1 23 5 3 RUNS and results Overview Loco Wc W Woo 1 24 5 4 Archives Overview o oooo W W m akn 1 25 3 9 Results prodct OR aa nabati 1 27 Sa Ka Naa SAN EA ME AN 1 28 Pentra 80 User Manual RAB108E 1 1 Pentra 80 1 2 This section provides important information to get you started with Pentra 80 1 Warning and precautions page 1 2 2 Labels page 1 5 3 Operational conditions page 1 8 4 Software overview page 1 13 5 Workflow overview page 1 21 6 Printer page 1 28 1 Warning and precautions User manual must be enterely read and personnel trained by ABX Diagnostics before attempt ing to operate instrument The user always operates with full knowledge and appreciation of instrument warnings alarms and flags Always refer to labeling and ABX Diagnostics instructions in order to avoid to compromise system integrity The Pentra 80 responds to the Standards and directives named in the Declaration of Confor mity added at the beginning of this manual A The reagents and accessoiries stipulated by ABX Diagnostics have been vali dated in accordance with the European Directive for in vitro medical devices 98 79 CE e The use of any other reagents and accessoiries may place at risk the perfor mance of the instrument engaging the Users reponsability In this case ABX Diagnostics takes no responsability for the device nor for the results rendered
105. REVIEWING sample results oma 4 47 6 2 Result order ASSOCIATION oooooo o Woo mmm 4 53 Ie Aa Me ni 4 55 7 1 Accessing the Results Archives ooo Wooo 4 55 Id Daily result DeSO OUON na emak 4 56 lads Pat en ECSU Beta oma na arnei 4 58 1 4 Reviewing a result in full screen mode 4 60 Section 5 Settings 1 Menu Settings OVErVIeWw oooo oom 5 3 1 1 Accessing the Settings MENU 5 3 1 2 Menu Settings functiOnS oo Wo oom mbah 5 4 2 Soft parameters enam taman bebagai 5 5 2 1 Accessing the Soft Parameters MENU oo 5 5 P an An na aa T 5 6 2 3 Department Physicians tab oo oo Wo Woo 5 8 Zi EIS an aa NN TENDER 5 9 3 Quality assurance settingS oWo W oom 5 11 3 1 Accessing the OA settings Wo oo 5 11 S YME aho 0iilol anna MAAN Aa MEN AAN PA 5 11 3 3 Number of Calibration TUNS ooooWo W Wo oWoWo om 5 12 3 4 Coefficients of Variation rangeS ooooWW Woo 5 12 A RUO an asn late E 5 13 4 1 Accessing the Rules Screen 5 13 4 2 Rerun COMO TON Senin ska aan siam mk tatakan in 5 13 4 21 PNECONO TON Sima bekam tua baba 5 15 4 4 Transmit conditions ae 5 16 I O aA an an en 5 17 5 1 Accessing the System screen ooooooWo Wo W oom mba 5 17 Jila LOCA SEN S aieri daraa 5 17 5 3 COMMU MICA OM isda ianiuiie denna ctamansescsdunenuisicsdoniasitstnadandctanleawnets 5 19 APE a aan me amalan team ant ena An ani 5 21 Sas Oa an nian ob nami 5
106. Result screen page 4 27 5 3 Flags page 4 29 run results are displayed and printed out A result function allows the operator to review the run results of the day 5 1 Printer output format Header abx printout assay 1 abx printout assay 2 abx printout assay 1 LABORATORY ABX ASSAY LABORATORY ABX ASSAY LABORATORY ABX ASSAY Report Printout Wunning Date Sample ID Collecting Date 04 09 2002 11 22 10 AUTO_SID21 Type Department Physician Standard Comments Patient Name First Name Gender Unknown NI 2 00 1 00 0 10 0 00 0 00 wp a WBC amp DIFF ea ai Ba su Microscopic Examination Anisocytosis Neutrophils Metamyelocytes Hypochromia Bands Myelocytes Polychromia Lymphocytes Promyelocytes Poikilocytosis Monocytes Blast Microcytosis Eosinophils ATY LYM Macrocytosis Basophils Total 100 PLT Clumps Comments 4915 WBC2 4865 LYM 1001 LL 57 20258 RBC2 20186 MON 269 ALY 35 1745327 HCT2 1735258 NEU 2878 RM 3 12560 PLT2 12556 EOS 61 LN 23 3843 HGBM 1896 NO 7 C127 12 gt Higher limit BBB lt Lower limit Legend Printed on 04 25 2002 17 42 28 Operator Technician Page 1 The operator can modify the Printer output format by selecting the Settings function key Section 5 5 4 Printer page 5 21 4 26 Pentra 80 User Manual RAB108E Workflow Run results and associated Flags 5 2 Result screen PENTRA 80 Report Fig 4 19 Results display scree
107. S oo boa aan 8 14 4 1 Maintenance 8 14 4 2 OOE na ana 8 14 4 3 Known Interfering substances oooWo Woo 8 14 5 Reagent Specifications scisnsvacsssivcaneiviwssarcemaieemmntniedemsannce 8 18 5 1 Reagent Leaflets ooooooWo oo oo 8 18 gt lt 4 HORIBA DIAGNOSTICS Section9 Glossary le DOSA Yon aan nela am nan Baen Boa an 9 2 LANOK re a an ANN an SA 9 4 o aint A eo ueamecondentansehanu sameness ena baba SAN ana Nan nb Satar 9 11 10 Introduction Contents 1 Warning and precautiOnS oooooooocn 1 2 1 1 Limited guarantee oom 1 2 1 2 Safety Precautions Li sanagt 1 3 1 3 graphics and symbolS krom ata 1 4 2 ADE IS an mua ena 1 5 2 1 Inpu t O utput Lape Se mamaku 1 5 2 2 PC CONNECTIONS label oooooo oo 1 7 3 Operational conditions 1 8 do Ne bab 1 8 D2 LO anne 1 8 de Gr Ne ETA T 1 9 3 4 Humidity Temperature conditions oo 1 9 3 5 Electromagnetic environment check oo oWo mo 1 9 3 6 Environmental Protection oooWo oo can 1 9 3 7 Transportation and storage conditions 1 10 38 Nstall AL Ona ea aan 1 10 3 9 Intis Ken ala Selo S criara aa era 1 11 BIO FAC Na aa E E MA 1 12 4 Software OVETVIEW oo Wo oa 1 13 4 1 Generic toolbar deSCFIptI ON oo 1 14 4 2 Contextual toolbar description 1 15 4 3 Main Menu deSCFIPptI ON oo 1 16 4 4 MiscellaNeOUS o oooo oo 1 17 5 Workflow Overview oo on 1 21 5 1 Order
108. Search Sample key is accessible if the Edit or Insert mode has been selected Once the Search Sample key has been selected the following screen will be displayed PENTRA 80 Search Sample o2 Sample ID Collecting Date Type Department Physician 025646 Man LABORATORY UNIT 1 RICHARD 025987 Standard 02598745 Standard 02659874 Woman LABORATORY UNIT 1 EDMOND Fig 4 10 Search by sample ID screen Only the samples recorded in the Worklist are displayed in the Search Sample window Samples in progress will not be displayed The Sample ID field enables the user to type in the first characters of the sample ID desired As each letter is typed the grid is refreshed to display the Sample list corresponding to the characters entered The Sample ID field enables the operator to view the Alpha or Numeric character sequenc ing as it is being typed As each character is being typed the Grid refreshes and displays the Sample list that corresponds to the characters entered When a specific Sample ID is located select the OK key to exit the screen and return to the Worklist 2 3 6 Searching by patient name The operator has the ability to select a specific Patient file from the Patient Name field J ust select the Search Patient key see Tab 4 3 Order fields page 4 17 Once the Search Patient key has been selected the following screen will be displayed PENTRA 80 Search Patie
109. See Section 5 3 4 Coefficients of variation ranges page 5 12 e When a Quality Control parameter is out of range a QC alarm is activated See Section 4 5 3 11 Statistical function flags page 4 46 Pentra 80 User Manual RAB108E 3 7 Pentra 80 One or more results may be excluded from the CV calculations by using the check boxes for selection or deselection of QC results Statistical calaculations are re computed after each selection deselection of results There is not limit on the number of results to be saved for a specific blood con trol lot 1 4 Graphics screen From the L J Graphs or Data screen grid select the Matrix key to display the last QC result PENTRA 80 Graphics Screen Fig 3 5 QC graphics screen Flag and alarm definitions are described in detail in Section 4 5 3 Flags page 4 29 v Entering a comment Comments can be entered into the Comment field when in the QC Graphics screen A Max imum of 50 characters may be entered Select the Comment field and enter your comments Press the OK key once your have finished your entry These comments can be displayed in the QC data grid see Fig 3 4 page 3 7 3 8 Pentra 80 User Manual RAB108E Q uality Assurance Quality control 1 5 Print send or delete results 1 5 1 Printing results v Graphics screen Results are printable from the Graphics screen see Fig 3 5
110. User Manual RAB108E 9 3 Pentra 80 2 Index A Age range Chap 5 35 Alarm level Chap 5 32 Archives Chap 2 11 Chap 4 54 Access Chap 4 54 Daily result Chap 4 55 Patient Result Chap 4 57 results by day Chap 2 11 results by patient Chap 2 11 Search patient Chap 4 58 Association grid Chap 4 52 Automatic numbering Chap 4 22 Chap 5 5 B BASO WBC Count Chap 6 14 Batch Chap 3 18 C Carryover Chap 8 6 Clean Cycles Chap 7 26 Consumption power consumption Chap 8 4 Contextual toolbar Chap 1 8 Chap 1 9 Cycle option Chap 5 23 D DANEPT Chap 4 47 Date and time Chap 5 15 Drain chambers Chap 7 23 Dump database Chap 5 25 E Error messages Chap 7 34 F Flags Chap 4 26 Alarm levels Chap 5 32 ALY flag Chap 4 37 BASO Chap 4 38 9 4 Pentra 80 User Manual RAB108E CO flag Chap 4 42 L1 flag Chap 4 38 LIC flag Chap 4 37 LL flag Chap 4 33 LL1 flag Chap 4 33 LMNE Chap 4 41 LMNE Chap 4 41 LN flag Chap 4 35 MAC Chap 4 39 MB flag Chap 4 38 MIC Chap 4 39 MN flag Chap 4 34 NE flag Chap 4 36 NL flag Chap 4 34 NO flag Chap 4 32 Normal and panic ranges Chap 4 30 Pathology messages Chap 4 43 OC failed Chap 4 45 reject Chap 4 31 Results exceeding instrument capacity Chap 4 30 RM flag Chap 4 35 RN flag Chap 4 36 SCH Chap 4 40 SCL Chap 4 40 Suspiscion Chap 4 32 XB flag Chap 4 45 Front View Chap 6 2 G generic toolbar Chap 1 8 H Host connector Chap 6 4 Identification option Chap 5 6 L L J Gra
111. User manual RAM170AA User manual Shut down after 36 hours of inactivity Table 1 Concerned sections Pentra 80 Section Page Paragraph Item change Warning on instrument left on standby more 2 Daily guide 2 16 6 Shutdown than 36 hours added at the end of the para graph 1 Possible start up problems for Pentra 80 systems The following warning is added section 2 Daily guide at the end of the paragraph 1 3 3 Background verification and at the end of the paragraph 6 Shutdown It is mandatory to power down the system if not used for more than a 36 hour period This A eliminates the possibility of the Dilution Chambers evaporating and causing startup problems 2 2 Customer Addendum RAM175A Pentra 80 XL80 Platelet interferences 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 DMD NS H SYS 184 Date 9 7 04 FORM 0220 rev 3 Explore the future HORIBA GROUP Platelet interferences update RAM175A Platelet interferences update V History of the addendum index None 1 Pentra 80 Table 1 Concerned sections Pentra 80 Section Page Paragraph Item deleted Addition of the following PLT Platelets Interference in the Platelet result may occur for samples from Patients undergoing parenteral treatment with injection of lipid emulsion
112. V 13 11 91 93 MCH 24 0 24 0 30 0 30 0 MCHC 32 0 32 0 36 0 36 0 RDW 10 0 11 0 16 0 17 0 PLT 150 200 400 450 MPV 6 6 11 12 PCT 0 00 0 15 0 50 1 00 PDW 7 ft 18 20 NEU 0 0 99 9 99 9 6 22 RAM141B Update for Instrument version V1 3 2 Table 8 CHILD 4 LYM 0 0 99 9 99 9 MON 0 0 99 9 99 9 EOS 0 0 99 9 99 9 BAS 0 0 99 9 99 9 NEU 1 80 1 80 8 00 8 00 LYM 1 50 1 50 6 50 6 50 MON 0 00 0 00 0 8 0 8 EOS 0 00 0 00 0 60 0 60 BAS 0 00 0 00 0 20 0 30 LYA 0 0 25 2 5 CGI 0 0 3 0 3 0 LYA 0 0 0 25 0 25 GCI 0 0 0 30 0 30 Table 9 CHILD 5 Panic L Normal Normal h Panic H WBC 4 50 4 50 13 5 15 0 RBC 4 00 4 00 5 40 5 40 HGB 11 0 115 14 5 15 0 HCT 37 0 37 0 45 0 45 0 MCV Ta I 91 93 MCH 24 0 24 0 30 0 30 0 MCHC 32 0 32 0 36 0 36 0 RDW 10 0 11 0 16 0 17 0 PLT 150 200 400 450 MPV 6 6 11 12 PCT 0 00 0 15 0 50 1 00 PDW 1 11 18 20 NEU 0 0 99 9 99 9 LYM 0 0 99 9 99 9 MON 0 0 99 9 99 9 EOS 0 0 99 9 99 9 BAS 0 0 99 9 99 9 NEU 1 80 1 80 8 00 8 00 LYM 1 50 1 50 6 50 6 50 MON 0 00 0 00 0 8 0 8 EOS 0 00 0 00 0 60 0 60 BAS 0 00 0 00 0 20 0 30 LYA 0 0 2 5 2 9 CGI 0 0 3 0 3 0 LYA 0 0 0 25 0 25 GCI 0 0 0 30 0 30 Fi22 Update for Instrument version V1 3 2 2 Alarms levels From the menu Settings Types Alarms and Curves Thresholds Table 10 STANDARD NO LL LL1 NL MN RM LN RN NE L1 LMNE Reject MIC MAC MACp HGB Table 11 MAN NO LL LL1 NL MN RM LN RN NE L1 LMNE Reject MIC
113. W om 5 25 6 2 CONTI GW rat ON senen enagd amankan 5 25 6 2 1 Analyzer setting functions ooooo 5 25 Pentra 80 User Manual RAB108E 5 1 Pentra 80 6 2 2 Workstation setting functions 5 26 6 3 Dump database W oooooWo W oom 5 26 6 4 Update of the Help on line of P80 software 5 27 Tp ASCE PON ES aan ae aan ap anda aa An 5 29 Telu ACCESSING Me U Ser SGP Elia aa meal Batakan 5 29 1 2 User menu function Keys 5 30 1 3 Creating a new U ser profile Woo 5 30 Os sam DOS an babak E 5 32 8 1 Accessing the Types parameters MENU saser 5 32 8 1 1 Functions KEYS mine santa lane bedain 5 33 8 1 2 Creating a new blood sample type 5 33 8 1 3 Modifying limit Alarm values 5 33 8 1 4 Sample Type COPYING woman 5 34 8 1 5 Type automatic association 5 34 8 2 Pathological IMIS keimanan mena 5 35 8 3 Alarms amp Curve thresholds o Woo 5 36 8 3 1 Alarm NEVEI Terkena va sokaa sanam nnendimenlomen anta 5 36 8 3 2 5DIFF Matrix thresholdS 5 3 8 3 3 BAS curve threshold mo 5 38 94 AGE TANGO lb an Ba cannes 5 40 5 2 Pentra 80 User Manual RAB108E Settings M enu Settings overview The following section is the PENTRA 80 Settings menu description including Menu Settings overview page 5 3 Soft parameters page 5 5 Ouality assurance settings page 5 11 Rules page 5 13 Save and restore page 5 26
114. Wavelength 550 nm Vol ABX Lyse 400 ul complement ABX DI LUENT 400 ul Final dilution rates 1 250 Temperature of reaction 35 C Tab 6 2 HGB measurement v Results Hemoglobin results are given as such Absorbance value obtained from the sample x coeffi cient of calibration 6 12 Pentra 80 User Manual RAB108E Description amp Technology M easuring principles 3 2 3 HCT Measurement All the RBC pulses are grouped into various sizes Each group pulse height is then averaged All the pulse height averages are then averaged one final time for a mean average of all the RBC pulse heights This function is a numeric integration of the MCV The HCT results are given as a percentage of this integration 3 2 4 RDW calculation The RDW Red cell Distribution Width is used to determine erythrocyte abnormalities linked to Anisocytosis The RDW will enable the user to follow the evolution of the width of the RBC histogram in relation to the number of cells and their average volume The RDW is also a calculation from the RBC histogram Calculations are as followed RDW K X SD MCV With K system constant SD Standard Deviation according to statistical studies on cell distribution within the RBC histogram MCV Mean Corpuscular Volume of erythrocytes 3 2 5 MCV MCH MCHC calculation e MCV Mean Cell Volume is calculated directly from the entire RBC histogram e MCH Mean Cell Hemoglobin is calculated from
115. Workflow Workflow It is Important to define the specific working method for sample identification in your laboratory Systematic use of barcodes must be defined as Barcode e If barcode are not used select Rack Position e If both Barcode and Rack position are used select the Rack Position 1 8 Sample tube and order association This screen allows manual matching between sample tubes and worklist orders that have been classified as exceptions This screen will show 2 lists Sample tubes found by the instrument and defined as Non matched Sample results that are Non matched to Orders To match the results of non identified tubes with orders see 6 2 Result order association page 4 53 Matching non identified results with order never modifies orders v 1 9 Patient file management The ABX PENTRA 80 Patient file management enables the filling of orders if the patient de mographic data is known e If no data is placed into the Patient ID field an automatic identification number is created as followed AUTO_PID_xxx This mode will create limitations for sample pro cessing It is highly recommended that you use the Patient ID field to create a single Patient ID for each patient sample This field is highly necessary to create patient files that can be archived and easily associated with searching on Patient ID criteria in order Patient demographical data can only b
116. a 80 User Manual RAB108E Pentra 80 v RM flag Absorbance NoN NoE Channel 127 Right Neutro Fig 4 28 RM flag Standard value for RM 1 1 099 Section 5 8 3 Alarms amp Curve thresholds page 5 37 v RN flag Absorbance NoN NoE RN channel 127 LMD RM Resistivity Fig 4 29 RN flag Standard value for RN 1 1 999 Section 5 8 3 Alarms amp Curve thresholds page 5 37 4 36 Pentra 80 U ser Manual RAB108E Meaning Right Mono Presence of a significantly large population of cells located on the right hand side of the monocyte area low LIC This flag oc curs when the number of particles counted in this area is higher than the limit setup in RM or when the counted particles re garding the total of WBC is above RM limit Suspected abnormalities e Large monocytes e Hyperbasophilic monocytes e Myelocytes or promyelocytes Large blasts This flag is associated with an on NEU NEU MON MON LIC LIC Meaning Right Neutro Presence of a significantly large population of cells located on the right hand side of the neutrophil area high LIC This flag occurs when the number of particles coun ted in this area is higher than the limit setup in RN or when the number of parti cles counted regarding the total number of WBC Is above the RN limit Suspected abnormalities e Large neutrophils e Immature cells from granulocyte hemo poiesis metamyelocytes my
117. ader when checked allows to run stat analyses in manual mode in case of problem with the autoloader initialization From one day to another the available options checked or unchecked are recorded See Nota on next page When the computer boots up to the Login informa tion window press CTRL ALT and DEL or CTRL ALT and SUPPR simultaneously to enter into the opera ting program of the analyzer Enter the User login password See Section 5 7 User profiles page 5 30 1 3 1 Automatic startup When the daily automatic Startup has been program med as described in Section 5 5 5 Cycle option page 5 25 the Startup cycle is automatically performed Wait until the Startup sequence is complete 1 3 2 Manual startup The Startup key should flash when the system Is booted up into the operating system Press the Startup key to initiate the daily startup cycle When the Startup is complete the Main screen func tions keys are activated for usage 1 3 3 Background count verification Daily Guide Instrument Startup PENTRA 80 Name JaBx Password M Disable Auto Loader Ea fox l Erase Worklist l Reset AutoNumbering Archive Results Pentra 80 User Manual RAB108E 2 3 Pentra 80 The background count results are printed out Verify that the Background count is within its limits values as indicated Instrument default values WBCs 0 3 103 mm RBC lt 0 03 10 mm HGB lt
118. ag will be generated The WBC BAS channel is considered as a reference and is used to calibrate the WBC LMNE channel The calculated ratio between the two channel calibration coefficients is stable ex cept during technical intervention In any case it is the WBC BAS result that is reported The WBC balance flags will appear in the Analyzer alarm area The WBC balance flags LMNE and LMNE shall not be triggered if and only if The test selected is CBC The WBC Balance option is not activated The WBC Balance can be enabled or dis abled by an approved ABX Service Technician Contact your local ABX Technical Ser vice Representative for selection of this option These flags are associated with an on all differential parameters and Pentra 80 User Manual RAB108E 4 41 Pentra 80 5 3 9 Analyzer alarms v CO flag Meaning poor correlation Correlation is noted as the percentage of validated cells measured between the Resistive mea surement and the Optical measurement as they pass through the LMNE flowcell If the cell measurements between the resistive and optical are less than 50 a CO flag will be indicated Suspected abnormalities Stroma interfering with the measurement Strong pollution Incorrect adjustment of the optical bench v Others From LMNE Matrix NO flag From WBC Balance LMNE LMNE From WBC BAS Histogram BASO 4 42 Pentra 80 User Manual RAB108E W
119. alues From the Calibration grid select the Target key see Tab 3 4 Calibration Grid Keys page 3 26 to open the Calibration Target screen for editing PENTRA8O Calibration Target Calibrator Name CBC Values IP WBC f o 2 10e3 mm3 Lot N Barcode cx318 RBC 5 tp 0 06 10e6 mm3 Expiration Date 2002 04 05 HGB 3 tp 2 g dL Ti Modified On HCT 36 5 j fo 2002 03 29 fh 61 tp fio 10e3 mm3 B PLT admin gt 4 a ie AMI VAN T vie Version VO 32 eit 2002 03 29 12 01 35 Fig 3 24 Editing the target values Select the Edit key to edit the target fields Read the barcode label on the calibrator with the external Barcode Reader or type in all the calibrator information using the calibrator Assay sheet that comes with the calibrator kit Once all entries have been made select the OK key to save the information 3 26 Pentra 80 User Manual RAB108E Q uality Assurance Calibration Exit the Target values menu by selecting the Return key 4 3 Running calibration If Quality control check procedure has failed see 1 7 Running control blood page 3 13 1 Verify that the reagents are sufficient fresh and uncontaminated 2 Run a system Startup and verify that the Backgrounds are at their lowest possible limits 3 Run Within Run and verify that the Coefficients of variation are within their limits Use a MINOCAL calibrat
120. antly large population of cells located in the separation threshold area between lymphocytes and neutro phils This flag occurs when the number of particles counted in this area is higher than the limit set up in NL or when the number of counted particles regarding the total number of WBC is above NL limit Suspected abnormalities e Small neutrophils without granules and or slightly segmented e Lymphocytes with a segmented nucleus or Activated Lymphocytes Neutrophils with membrane weakness This flag is associated with an on e LYM LYM and NEU NEU Meaning Mono Neutro Presence of a significantly large population of cells located in the separation threshold area between monocytes and neutrophils This flag occurs when the number of parti cles counted in this area is higher than the limit set up in MN or the number of particles counted in MN versus the total number of WBC is above the MN limit Suspected abnormalities Monocytes having granules in their cyto plasm or hyperbasophilic monocytes Young neutrophils with non segmented nuclei bandcells This flag is associated with an on ALY ALY and LIC LIC and replaces e NEU amp MON amp by v LN flag Absorbance NoN NoE Channel 127 Right Neutro Fig 4 26 LN flag Standard value for LN 2 5 999 Section 5 8 3 Alarms amp Curve thresholds page 5 37 v NE flag Absorbance NoN NoE Channel 1
121. anual RAB108E 4 11 Pentra 80 1 7 1 Sample identification on both barcode and Rack Position If a sample tube is identified by a barcode although the setting is Rack Position Section 5 2 2 5 Identification option page 5 7 the instrument checks that the worklist Sample ID corresponds to the tube barcode identification and that the rack position of the tube cor responds to the one entered in the Worklist If not the instrument generates an exception Example RACK WORKLI ST Rack 1 Rack 1 Position 1 Position 1 Barcode 123 Sample ID 124 sample ID Rack Fos Patient ID 006s O069 0070 The tube identified 123 position 1 1 does not correspond to the order position 1 1 which is identified 124 This tube is analyzed in the instrument default test The result and the order must be manually matched 1 7 2 Identification with barcode without order However PENTRA 80 does not generate an exception in this case provided that the rack po sition of this tube has not been reserved for an order in the worklist Example RACK WORKLI ST Rack 1 Rack Position 1 Position Barcode 123 Sample ID Back Fos Patient ID Patient This tube is analyzed in the instrument default test e If the setting is Manual match on Exception ON Section 5 2 2 5 Identification op tion page 5 7 the Sample ID provided with the result is the barcode 4 12 Pentra 80 User Manual RAB108E
122. ao o0 Too Fig 5 32 Type parameters Alarms amp curves thresholdsTab From this menu the operator will have the ability to Create a new blood type see 8 1 2 Creating a new blood sample type page 5 34 Modify Pathological limits see 8 1 3 Modifying limit Alarm values page 5 34 Modify Alarms amp Curve thresholds see 8 1 3 Modifying limit Alarm values page 5 34 When one of the Child types is selected a third tab will appear indicating Age Range see 8 4 Age range page 5 41 Pentra 80 User Manual RAB108E 5 33 Pentra 80 8 1 1 Functions keys Key H eading Function Allows to define a new blood type see 8 1 2 Creating Insert a new blood sample type page 5 34 Allows to modify the selected type except the Stan dard type which is always in read aul only see 8 1 3 Modifying limit Alarm values page 5 34 Copies values from one type to another see 8 1 4 Sample Type copying page 5 35 In Edit mode the selected type takes values of the standard type Set as default type The type selected in the list becomes the default type Type management Copy Apply standard values Tab 5 13 Types function Keys 8 1 2 Creating a new blood sample type Select the Insert key Standard Man Woman Child Child2 Child3 Child4 Childs Fig 5 33 Creating a new type Type in the name of the type 20 characters maximum From here you may Sel
123. atiONnS ooooWo Wo momo 8 19 Pentra 80 User Manual RAB108E 8 1 Pentra 80 PENTRA 80 specifications includes the following 1 Technical specifications page 8 2 2 Physical specifications page 8 5 3 Summary of performance data page 8 7 4 Limitations page 8 14 5 Reagent Specifications page 8 18 1 Technical specifications PENTRA 80 system is a fully automated hematology anlyzer used for the in vitro diagnostic testing of whole blood specimen 1 1 Parameters WBC White Blood Cell RBC Red Blood Cell HGB Hemoglobin Concentration HCT Hematocrit MCV Mean Corpuscular Volume MCH Mean Corpuscular Hemoglobin MCHC Mean Corpuscular Hemoglobin Concentration RDW Red Distribution Width PLT Platelets PDW Platelets Distribution Width MPV Mean Platelet Volume PCT Plateletcrit Tab 8 1 CBC Parameters PCT PDW ALY and LIC have not been established as indications for this product in the United States The use of PCT PDW ALY and LIC should be restricted to research and Investigational measurements only 8 2 Pentra 80 User Manual RAB108E Specifications Technical specifications WBC White Blood Cell LYM Lymphocytes and MON Monocytes and NEU Neutrophils and EOS Eosinophils and BAS Basophils and LIC Large Immature Cell and ALY Atypical Lymphocytes and RBC Red Blood Cell HGB Hemoglobin Concentration HCT Hematocrit MCV Mean Corpuscular Volume MCH Mean C
124. ation QC and XB coefficient values see 3 4 Coefficients of variation ranges page 5 12 3 2 XB options The XB function Section 3 2 Patient Quality Control XB page 3 14 is based on a BULL method and includes a calculation on 3 or on 9 extended parameters The 3 parameters include MCV MCH MCHC The 9 parameters include WBC RBC HGB HCT MCV MCH MCHC RDW PLT This function allows the operator to select the XB mode 3 9 parameters or XB calculation disabled Menu XB inaccessible Select the EDIT key and check the chosen radio key Select the OK key to confirm your selection Fig 5 8 XB options Pentra 80 User Manual RAB108E 5 11 Pentra 80 3 3 Number of calibration runs The number of calibration runs that can be entered by the user is from 1 to 99 runs if re quested The Minimum number of runs for good statistical calculations during calibration is 5 From the Quality Assurance window select the Edit key see Fig 5 7 page 5 11 Now select the titled field Minimum required sampling number for automatic calibration and highlight the number in the field Modify the number to the number of runs reguested for calibration Remember the Minimum iS 5 Now select the OK key to confirm your entry 3 4 Coefficients of variation ranges Coefficients of variation CV applied on statistical calculations as calibration Section 3 4 3 1 Calibration pa
125. ations listed for the WBC count pertain to the LYM and counts as well MON mononuclear cell count absolute MON Mononuclear percentage The mononuclear cell count absolute is derived from the WBC count The presence of large lymphocytes atypical lymphocytes blasts and an excessive number of basophils may in terfere with an accurate monocyte count Limitations listed for the WBC count pertain to the MON and counts as well NEU neutrophil count absolute NEU Neutrophil percentage The neutrophils cell count is derived from the WBC cell count The excessive presence of eosinophils metamyelocytes myelocytes promyelocytes blasts and plasma cells may in terfere with an accurate neutrophils count 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 count ing BAS Basophil cell count absolute BAS Basophil percentage The Basophil cell count is derived from the WBC cell count Pentra 80 User Manual RAB108E 8 17 Pentra 80 5 Reagent Specifications The ABX Diagnostics reagents specified for this instrument may have followed one or both of the approval methods below 1 have been registered by the A F S S A P S Agence Francaise de S curit San itaire des Produits de Sant according to the procedure
126. aximum of 60 batches can be stored within the software w XB section includes 2 1 Access to the XB menu page 3 15 2 2 XB Graphs page 3 16 2 3 XB Data Grid screen page 3 17 2 4 Batch content page 3 18 2 5 XB limits page 3 19 Pentra 80 User Manual RAB108E Q uality Assurance Patient Q uality Control XB 2 1 Access to the XB menu From the Quality Assurance Menu see Fig 3 1 page 3 3 select the XB key Fig 3 13 XB Graphic screen v XB Keys Function Access to XB limit modifying screen see 2 5 XB limits page 3 19 In XB Data grid prints a list of Batch see Printing XB Data grid page 3 17 In XB graphs mode prints graphs with 60 full points Print Transmit Tab 3 2 XB keys Pentra 80 User Manual RAB108E 3 15 Pentra 80 2 2 XB Graphs The XB Graphs see Fig 3 14 page 3 16 are a representation of each batch parameter and their limits plotted on a graph up to 60 batches All 60 batches will be displayed on the screen and on the printout see 2 5 XB limits page 3 19 Use the Parameter Tab keys to select between parameter groups For the XB limit values the Red line indicates the Maximum limit the Green line indicates the Target value and the Blue line indicates the Minimum limit The Yellow cursor can be positioned by the opera tor to select a specific batch Parameter values of a se lected batch are displayed in Red i
127. carriage motion Sample distribution a Run an analysis cycle and check that specimen distribution is performed correctly into chambers b A probe rinse is previously carried out in the rinse chamber 1 Blood appears in this chamber c The first specimen is delivered to the first dilution chamber 2 Brown colour the second to the WBC Baso chamber 5 Clearer and the third one to the LMNE chamber 3 The darkest d Check that bubbling is provided to these chambers once the specimen have been di luted Fig 7 44 Chambers Drain and rinse a Check chambers are drained and rinsed b If operations are faulty identify the source of the malfunction when possible and call your ABX Diagnostics representative department 6 2 Results v Procedure 6 All parameters Repeatability According to the CV specifications Section 8 3 2 Precision Repeatability page 8 8 Is the instrument non repeatable on all parameters If not perform directly the procedure corresponding to the non repeatable parameter If all parameters are not repeatable continue this procedure c Visually check that the sampling operation appears to be correct d Control the sampling syringe operations see 5 1 2 Check motors page 7 23 e Control the counting syringe operations see 5 1 2 Check motors page 7 23 7 38 Pentra 80 User Manual RAB108E Maintenance amp Troubleshooting Troubleshooting f Perform a conc
128. cifications in the instrument User Manual 2 Conservation amp expiration Storage conditions Room temperature between 18 C 65 F to 25 C 77 F Expiration date refer to expiration date reagent packaging label 3 Measurements principles amp results Directions for use see Section Maintenance amp Troubleshooting Reagent Location and connection in the instrument User Manual Measuring Principles see Section Description amp technology in the instrument User Manual Results see Section Workflow in the instrument User Manual Performance data see Section Specifications in the instrument User Manual Note if performance changes call your ABX Diagnostics representative S A au capital de 44 000 000Euros RCS Montpellier 328 031 042 SIRET 328 031 042 000 42 APE 332 B Explore the future 4 Composition amp handling precautions Composition Propane 1 2 diol 3 Formic Dye 0 004 pH 6 9 0 1 T 20 C Resistivity 57 H 3 Q T 20 C Description Deep blue aqueous solution smells of alcohol Handling Precautions Avoid contact with eyes skin and clothing Wear laboratory gloves when handling the product The product may be harmful if ingested or inhaled Keep the bottle closed when not in use Please refer to the MSDS associated with the reagent Specimen Collection and Mixing see Section Workflow in the instrument User Manual 5 Limita
129. cribes the overall operation of Patient sample management through the sys tem which include creating orders matching orders automatic and manual patient file management sample exceptions and many other features which identify the sample all the way to final results The chapter section description is as indicated in the following order 1 1 Sample tube management page 4 3 1 2 Workflow page 4 4 1 3 Worklist page 4 4 1 4 Sample identification page 4 5 1 5 Barcode Identification page 4 5 1 6 Sample identification on Rack position page 4 8 1 7 Exception management page 4 11 1 8 Sample tube and order association page 4 13 1 9 Patient file management page 4 13 1 10 Loading Worklist from the LIS page 4 13 PENTRA 80 enhances the system operations form sample analysis by allowing the system to manage multiple tasks when configuration in the following areas Sample identification mode Worklist access mode Results status Host computer connection 1 1 Sample tube management PENTRA 80 can automatically load racks once the sample tubes have been positioned The STAT mode can be utilized to analyze one to several specimens manually while in the rack mode The rack will stop at the introduction of the STAT mode and continue with the remain ing samples on the rack once the STAT mode is complete Pentra 80 User Manual RAB108E 4 3 Pentra 80 1 2 Workflow Once the ABX PENTRA
130. curate HCT and MCV values Red blood cell agglutination may be detected by observing abnormal MCH and MCHC values as well as by examination of the stained blood film In such cases manual methods may be required to obtain an accurate HCT value Pentra 80 User Manual RAB108E 8 15 Pentra 80 MCV Mean Corpuscular Volume Red blood cell agglutination May produce an inaccurate MCV value Red blood cell ag glutination may be detected by observing abnormal MCH and MCHC values as well as by examination of the stained blood film In such cases manual methods may be reguired to obtain an accurate MCV value Excessive numbers of large platelets and or the presence of an excessively high WBC count may interfere with the accurate determination of the MCV value In such cases care ful examination of the stained blood film may reveal the error MCH Mean Corpuscular Hemoglobin e The MCH is determined according to HGB value and the RBC count The limitations listed for the HGB and RBC will have an effect on the MCH and may cause inaccurate values MCHC Mean Corpuscular Hemoglobin Concentration e The MCHC is determined according to the HGB and HCT values The limitations listed for the HGB and HCT will have an effect on the MCHC and may cause inaccurate values RDW Red blood cell Distribution Width The red blood cell distribution width is determined according to the RBC count Nutritional deficiency or blood transfusion
131. d MM dd yyyy dd MM yyyy yyyy MM dd Pentra 80 User Manual RAB108E 5 17 Pentra 80 The time format options in the drop down list are as followed hh mm ss am or pm HH mmiss 5 2 2 Languages options The software language options are English French German Italian Spanish Portuguese From the Local Settings screen select the Edit key then select language that is appro priate for your operations Now select the OK key to confirm your selection Fig 5 17 Language format 5 2 3 Change date and time From the Local settings tab see Fig 5 15 page 5 17 select the Edit key Then select Change Date Time key Change the date and time so that the computer can become updated with the current date and time 5 18 Pentra 80 User Manual RAB108E Settings System Date Time Properties 128 5 amp F 8 9 10 11 12 13 14 1516 F IG 3 220 5a 22 23 25 26 27 28 23 30 2 49 15PM gt Fig 5 18 Date and time window 5 3 Communication se sama wa v MU Dy 0 Dy eo x _ l K 4 y p eno K G Ca The System Communication menu settings affects what information is sent to A and receive from the LIS This information has been configured in your system by a qualified technician using the LIS Output Format documentation P N RAA024 P
132. d back into the rack and then tubes numbered 2 and 4 are taken and mixed and so on 6 6 Pentra 80 User Manual RAB108E Description amp Technology Automatic mode principles v Sample tube identification An internal Barcode reader identifies both racks and sample tubes to ensure true identifica tion and security of results Fig 6 8 Sample tube identification Pentra 80 User Manual RAB108E 6 7 Pentra 80 v Sample Cap Piercing In order to keep the sample volume at a very small amount approximately 60ml ABX DA GNOSTIG utilizes a Double needle sample probe This probe consists of an external piercing needle with narrow internal sampling probe that aspirates the sample while the cap is being pierced Fig 6 9 Sample Cap piercing 6 8 Pentra 80 U ser Manual RAB108E Description amp Technology M easuring principles 3 Measuring principles 3 1 Multi distribution sampling sytem MD SS 3 1 1 CBC mode While in the CBC Mode 30u of whole blood is aspirated then delivered with into the following chambers as ao a Diluent indicated a a Air One segment of sample for the Dilution 7ul discarded chamber which is used for the RBC PLT 10u WBC BASO dilution and the Hemoglobin measurement 8 10ul RBC PLT HGB 8 3ul discarded The other segment of sample is used for the WBC BASO count Fig 6 10 Segment distribution in CBC mode 3 1 2 Diff Mode While in the DIFF Mode
133. d cell counting and basophil differentiation on ABX blood cell counters Measurement procedure to be followed in using the device Principle of the method specific analytical performance characteristics analytical sensitivity diagnostic sensitivity analytical specificity diagnostic specificity accuracy repeatability reproducibility including control of known relevant interference limits of detection limitations of the method and information about the use of available reference measurement procedures and materials by the user see Section Specifications in the instrument User Manual 2 Conservation amp expiration Storage conditions Room temperature between 18 C 65 F to 25 C 77 F Expiration date refer to expiration date reagent packaging label 3 Measurements principles amp results Directions for use see Section Maintenance amp Troubleshooting Reagent Location and connection in the instrument User Manual Measuring Principles see Section Description amp technology in the instrument User Manual Results see Section Workflow in the instrument User Manual Performance data see Section Specifications in the instrument User Manual Note if performance changes call your ABX Diagnostics representative S A au capital de 44 000 000Euros RCS Montpellier 328 031 042 SIRET 328 031 042 000 42 APE 332 B Explore the future 4 Composition amp handling precaution
134. de Man ST In Fig 4 14 Worklist light printout Pentra 80 User Manual RAB108E 4 19 Pentra 80 2 4 Rack view When no barcode are used the order must contain the sample tube position in the rack see 1 6 Sample identification on Rack position page 4 8 From the Worklist grid select the Rack view key PENTRA 80 WORKLIST pae pop EEES e EY DPN TO T ASAE EAST Rack Number Fig 4 15 Capture of the rack number Read the Rack Number with the External Barcode reader to display the Rack graphics screen This Rack View will display the order information and test type requested for each position on the rack WUU e7 m M D Rack Number YS E eee gt gt 1 EMPTY 67415 E s 4 5 N h ke ri k a 5 565465 5 EMPTY i 0 Empty l Fig 4 16 Rack view screen Select one empty position to enter a new sample tube Fill in the order field information see Tab 4 3 Order fields page 4 17 Sample Information Clinical information Patient Information 4 20 Pentra 80 U ser Manual RAB108E Workflow Worklist Select the test type to be performed on the sample Note the color of the indicators DIFF in Green CBC in Yellow If a test type is not selected an instrument Default test is performed DIFF The cursor automatically moves to the next rack position If no positions are available the cursor
135. detected on the high and low absolute values of the pa rameter in question Pentra 80 User Manual RAB108E 4 43 Pentra 80 wv RBC messages M essage Condition Anemia HGB HGB L Anisocytosis RDW gt RDW H Microcyte MIC Microcyte MIC gt 10 Microcyte MIC gt 15 Macrocyte on Mac Flag Hypochromia MCHC lt MCHC L Cold Agglutinin MCHC gt MCHC H and WBC lt 91 3x103 mm Microcytosis MCV lt MCV L Macrocytosis MCV gt MCV H Erythrocytosis RBC gt RBC H Interpretation Not possible RBC lt 0 01x10 mm or RBC reject or RBC gt 0 03 during Startup Tab 4 7 RBC pathology messages H extreme high limit L extreme low limit 4 44 Pentra 80 User Manual RAB108E Workflow Run results and associated Flags v PLT messages Message Condition Thrombocytosis PLT 5 PLT H Thrombocytopenia PLT PLT L Microcytosis MIC Schizocytes No threshold between RBC and PLT on the curves Small Cell Small cells at the beginning of the Platelet curve condition 1 PLT lt 150x102 mm WBC reject or NO PDW gt 20 or NO MPV 510 or Platelets Aggregate NO PLT lt 150x102 mm or NO WBC reject or L1 or LL1 PDW gt 20 or L1 or LL1 MPV 10 or L1 or LL1 PLT lt 150x103 mm Condition 2 Erythroblasts peo y WBC reject L1 or WBC reject LL1 Platelets Aggregate If conditions 1 and 2 are not satisfied Erythroblasts and if L1 or LL1 or WBC reject Macroplatelets MPV gt 11
136. e closed Tube Detection Sensor in Wrong Position Tube Level Detection Sensor in Wrong Position Two racks with same ID d in transfer rail Unable to launch print module Unable to launch SIL communi cation module Unloader Sensor in Wrong Posi tion Upper Piercing Sensor in Wrong Position Waste container full XB failed Maintenance amp Troubleshooting Error Type Sensor state Barcode Incorrect level of diluent into reservoir Printer problem Software OC Failed Sensor state Sensor state No read of Rack Barcode Label Out of Reagent Out of Reagent Out of Reagent Software RS232 external problem Software Software Sensor state Sensor state Barcode Software Software Sensor state Sensor state Waste Container Full XB failed Pentra 80 User Manual RAB108E Error messages Help Message Run an initialization Run an initialization Check diluent level and run a prime diluent cycle Check printer No message Ckeck Quality Control data in QC screen Run an initialization Run an initialization Check barcode label Check reagent Check reagent and restart auto matic cycle Check reagent and restart auto matic cycle Run an autoclean Check host connection No message No message Run an initialization Run an initialization No message No message No message Run an initialization Run an initialization Empty waste container and res
137. e No suspicion flag the Plt result can be taken as being correct Table 1 Suspicion flag occuring on rack mode Conditions Consequences PDW MPV PCT are reported to Coe oa No PLT histogram on PLT on PDW MPV PCT Results unmatched to worklist orders See User manual Section 4 6 2 Result amp order association are A not rerun automatically If an anomaly has been detected during platelet analysis the PLT parameters PLT PDW MPV PCT will be flagged with The Plt result has to be confirmed according to Good Laboratory Working Practices 2 Manual mode on Plt parameter means that Pentra 80 has detected a possible anomaly during the platelet count The sample must be rerun Two cases can occur e Second suspicion flag The two results should be compared and the Plt result should be confirmed according to Good Laboratory Working Practices e No suspicion flag the rerun Plt Result can be taken as being correct Table 2 Suspicion flag occuring on manual mode Conditions Consequences on PLT on PDW MPV PCT Customer Addendum RAM170AA Pentra 80 User manual Shut down after 36 hours of inactivity 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 ECR N none Date 29 4 04 FORM 0220 rev 3 Explore the future HORIBA GROUP
138. e Tab 4 14 Patient result function Keys page 4 59 PENTRA 80 Search Patient Pat LAMAISON Amandine 06 22 1934 67 A Female LESBROS Marcel 146 A Male RENAUD Jean Paul 09 15 1972 29 4 Male GOUMON Josephine 10 14 1933 168 A Female LAMAISON Amandine 05 22 2034 11J Female MILLAU Francoise 12 16 1978 123A Female CANDELA Alexandre 05 22 1966 354 Male DUFOUR Carmen 06 30 1926 75A Female MINGAUD Gustave 07 12 1919 Male Sie v iit AUBERT Jean Jacques 03 01 1960 424 Male EJI JOVANOVICH Alexis 10 12 1942 59A Male CLAUZEL Alain 11 29 1932 Male ANTHERIEU Benjamin 10 22 1982 Male Fig 4 50 Search patient screen Type the Patient name or the First characters into the Patient Name field located in the upper left hand portion of the screen If this patient exists in the Archives function it will be displayed on a single line along with the rest of patient information Patient ID First name Birthday Gender etc Pentra 80 User Manual RAB108E 4 59 Pentra 80 Now select the OK key to display the patient results 7 4 Reviewing a result in full screen mode 7 4 1 Patient result screen From the Patient Result screen see Fig 4 49 page 4 58 select the result that you want to display in full screen see Fig 4 51 page 4 60 Other results that are ass
139. e modified when it is Manually created on the instrument The Host computer can only modify patient demographical data that has been transmitted to the instrument by a LIS When a patient file is modified by the LIS or manually by the user all previous results attached to that file are flagged 1 10 Loading Worklist from the LIS The ABX PENTRA 80 contains communication connections for Bi directional transmission to and from a Host computer A single Patient ID always identifies Worklist orders generated from the Host computer When loading from the Host if identification number of the tube already exists in the worklist previous order will be updated to include the last modifications of the new order Remember it is impossible to update the order on the instrument when it has been transmit ted to the instrument from the Host computer Pentra 80 User Manual RAB108E 4 13 Pentra 80 2 Worklist 2 1 O verview A worklist is a list of orders generated on a daily basis These orders can include orders for samples that have not been analyzed Orders for samples that have been analyzed but a Rerun status has been requested Re runs can be automatic according to the settings in System Rules Section 5 4 2 Rerun conditions page 5 13 or Manual reruns from the Results screen see 6 1 8 Rerunning sample manually page 4 51 Once the sample order has been analyzed and automatically matched to an order the
140. e re active lymphoid forms stimulated lymphocytes and plasmocytes are also found as well Pentra 80 User Manual RAB108E M easuring principles 6 19 Pentra 80 6 20 Pentra 80 User Manual RAB108E Maintenance amp Troubleshooting Contents 1 Maintenance amp Troubleshooting procedures 7 3 1 1 Hydraulic cycles maintenance charttable 7 3 1 2 Maintenance procedures o oo Woo momo 1 3 1 3 Instrument general CIEANING oo oooW Woo 1 4 1 3 1 Instrument external Cleaning ooo 7 4 1 3 2 Instrument internal Cleaning 7 4 2 Replacement procedures oooo oWoWW oom 1 5 2 1 Reagent replacement Woo Woo oom 1 5 2 1 1 Reagent locations and connections 7 5 2 1 2 Integrated reagents amp Diluent container replacement7 6 2 1 3 Waste container replacement 7 11 2 2 Optical bench lamp replacement ooo oWo 7 11 2 2 1 Lamp replacement Woo 7 11 2 22 OWI CSU na na NAN NN 1 13 2 3 Sampling probe replacement mo 1 13 2 4 Rinse chamber filter Cleaning 1 15 2 5 AT SUA ee ai 7 16 2 5 1 Instrument TINSE oooooWo W mbah 1 16 2 5 2 Syringes and Carriage park oooo 7 17 3 Instrument panels amp cover Removals een 7 18 3 1 Left front door removal ooo WWW Woman 1 18 3 2 Right front door reMOVal o Wo Woo 1 19 3 3 Right hand side panel removal oooWoWoWo Wo 1 19 3 4 Le
141. eagent 00S na an aa pai 3 35 Di SUNS ee naa abi ai 3 35 5 6 Maintenance 1O9S owai eni etaminoeman aan kaksa 3 35 Sle FO OOS ee aa EEEO 3 35 So Obb ae On aa 3 35 5 9 Blank cycle 1095 kerontokan kanan 3 35 2 Pee anna 3 36 gt lt 4 HORIBA DIAGNOSTICS Section 4 Workflow TW Or KO oo an ae ane 4 3 1 1 Sample tube management o oooooWoWo W oom 4 3 De MO aa nb ba tutes 4 4 IM ME ON SE naa Na aa NA DN NS NAN 4 4 1 4 Sample IGENUM CANON si ikan aa aman 4 5 1 5 Barcode den ET Cal Oei bean tua akan Dan ana 4 5 1 6 Sample identification ON RACK POSITION oo 4 8 1 7 Exception management oo ocean 4 11 1 8 Sample tube and order associatiOn o ooo oo 4 13 1 9 Patient file management 4 13 1 10 Loading Worklist from the LIS 4 13 Zo N ONIN E ise pa anna 4 14 2a Ls OVE VOW ae Abal 4 14 2 2 Accessing the W orklist function oooWoWoWo Woo 4 14 Ze Or SEO aa ARA Bata BAR Kl 4 15 De ee an ai 4 20 3 Sample collection amp MIXING oooo ooh 4 24 3 1 Recommended anticoagulant mo oom 4 24 3 2 Blood sample stability Laris noona aan 4 24 3 3 Mio Sa DIN Goat Maa amen 4 24 DA MPN ea taat on MMA naa Deni 4 24 4 Running SpeciMEeNS an 4 25 5 Run results and associated FlagSs co 4 26 Ske Printer OUDUL TOMA ast me bun kan 4 26 Di IOS SOUS et ba 4 27 Ey Dia Te VAIS aerate aa Nai 4 29 6 Order amp sample run ASSOCIATION o ooooW oo 4 47 6 1
142. ect the OK key to confirm the new type created Select the Apply standard values to paste the values from the standard type to the new created type and then select the OK key to confirm the pasted values e Copy values from one type to the new created type see 8 1 4 Sample Type copying page 5 35 Modify limits or modify alarms levels amp curves thresholds see 8 1 3 Modifying limit Alarm values page 5 34 8 1 3 Modifying limit Alarm values From the Pathological limits tab or Alarms amp curves Thresholds tab select the Edit key Click the figure you want to modify and enter a new value Once all entries have been made select the OK key to confirm your modifications 5 34 Pentra 80 User Manual RAB108E Settings Sample Types 8 1 4 Sample Type copying From the Type management field select a sample type that you would like to copy from in the below example Woman Then select the Copy key Fig 5 34 Type copying In the Copy window scroll the list to choose the type where the values must be pasted Now select the OK key 8 1 5 Type automatic association v Sample with known types except Standard If the type is known when the order is created or captured in the worklist this one is used to provide results v Sample with no type The default type see Tab 5 13 Types function Keys page 5 34 is automatically as socia
143. ecutive analyses of the same blood sample v Sections detailed in Within Run 3 1 Accessing the Within Run Data Grid page 3 20 3 2 Closed tube sample setting page 3 22 3 3 Running cycles page 3 22 3 1 Accessing the Within Run Data Grid From the Quality Assurance Menu see Fig 3 1 page 3 3 select the Within Run key ma Ir F F Ip lp IF S Je IF HEEEHEH Fig 3 18 Within Run Data Grid 3 20 Pentra 80 U ser Manual RAB108E Q uality Assurance Within run v Within Run Keys Function Prints selected or all results or Statistics only Print Transmit Sends selected or all results see 3 3 4 Print Transmit or delete Results page 3 23 Bel Tab 3 3 Within Run keys Pentra 80 User Manual RAB108E 3 21 Pentra 80 3 2 Closed tube sample setting The operator is allowed to run within run samples in both Manual Mode and Rack Mode Close tube setting Sampling Number i Enter the number of sample takes to be per formed on the sample tube for Rack mode Fig 3 19 Closed tube mode setting A The Within Run Data Grid must be opened when performing a sample repeatabil ity cycle Each tube of the rack is analysed the number of times specified by the sampling number 3 3 Running cycles The Within Run test must be done on a fresh normal whole blood sample 3 3 1 Manual mode Open the Within Run Data Grid screen see Fig 3 18 page 3 20
144. ed results Pentra 80 User Manual RAB108E Introduction Workflow overview Pentra 80 6 Printer Use the printer supplied or approved by ABX DIAGNOSTICS 1 28 Pentra 80 User Manual RAB108E peritra Daily Guide Contents 1 instrument Star atasan 2 3 l l Waste NOV ea anon 2 3 DZ Pte ana 2 3 1 3 Pentra 80 SIA Di ditoe ea annisa dat 2 3 1 3 1 Automatic Startup oa 2 4 1 3 2 Manual startup nda samson bni Mananta akun 2 4 1 3 3 Background count verification 2 4 E Ue na NAN NN PA E AN 2 6 2 Running the ABX Quality Control 2 1 2 1 Closed tube Mode with barcode oo o o 2 1 ZF OPON Moon 2 8 3 Running SpeciMen ooo an 2 10 3 1 Sample identification with internal barcode reader 2 10 3 2 Non identified sample with external barcode reader 2 10 33 Sta OO nenas taken aan ena asn ma aan san 2 12 3 4 Run In progreSS oooo oo oo 2 13 AN Ka aa PA 2 14 4 1 Printing a result series oom oo 2 14 4 2 Unmatched results ooo oo 2 15 5 PARC CS ne onlen obat nana eani 2 16 5 1 Searching results by day sni mama 2 16 5 2 Searching results by patient Wooooo Wo o oo 2 16 6 Instrument ShutdOWN o oWo oo ooh 2 17 6 Manual ShutdOW ban an 2 17 DIAGNOSTICS Pentra 80 User Manual RAB108E 2 1 Pentra 80 2 2 This section describes basic daily operations including 1 Instrument Startup page 2 2 2 Running the ABX O
145. ells and ALY Atypical Lymphocytes com plete the matrix spectrum of cellular placement Immature granulocytic cells are detected by their larger volumes and by the increased gran ules which allow more light to pass through the cells and increase the intensity of scattered light Therefore cells such as metamyelocytes will be found to the right of the neutrophils and almost at the same level Myelocytes and promyelocytes will be found on the far right of the matrix in the saturation position The metamyelocytes myelocytes and promyelocytes will all be classed as LIC and there given results will be included in the neutrophil value The Blast cells will be generally located to the right of the monocyte population and as such will increase the LIC count Small blast cells will be found between the normal lymphocyte and mococyte populations ALY Platelet aggregates and debris from RBC cell fragments are found in the background noise area at the lower left corner of the matrix Most of the cell population thresholds are fixed and give the normal limits for the normal leukocyte morphologies Changes in the morphology of a specific population will be indicated on the matrix by a shift in the corresponding population A Blast alarm is generated from increased counts within the LIC area this is correlated with the Blast detection on the Basophil histogram Large lymphocytes are usually detected in the ALY Atypical Lymphocytes zone wher
146. elocytes promyelocytes This flag is associated with an on e NEU NEU LIC LIC Workflow Run results and associated Flags v LIC flag Meaning Large Immature Cells Absorbance NoN NoE BY Presence of a significantly large population of cells located on RN RM channel 127 areas This flag occurs when the number of particles counted in this area is higher than the limit set up in LIC or when the number of counted particles regarding the total number of WBC is above the LIC li mit Section 5 8 2 Pathological limits page 5 36 Suspected abnormalities LMD RM Resistivity Large monocytes e Hyper basophilic monocytes Fig 4 30 LIC flag e Myelocytes Metamyelocytes Promyelocytes e Large Blasts Large Neutrophils v ALY flag Absorbance NoN NoE Channel 127 Meanin 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 Right this area is higher than the limit setup in Neutro ALY or when the number of particles counted regarding the total number of WBC Is above the ALY limit Section 5 8 2 Pathological limits page 5 36 Suspected abnormalities e Large Lymphocytes Fig 4 31 ALY flag e Reactive Lymphoid forms Stimulated lymphocytes e Plasmocytes Pentra 80 User Manual RAB108E 4 37 Pentra 80 5 3 5 Flags on WBC BAS h
147. em is on Fig 7 45 HGB LED b Perform a concentrated cleaning see 5 2 4 Clean Cycles page 7 33 c Re run the specimen d Check the operation of liquid valve lt 14 gt Opening and closing during cycle If defec 7 40 Pentra 80 User Manual RAB108E Maintenance amp Troubleshooting Troubleshooting tive replace the valve e If this does not correct the HGB results call your ABX Diagnostics representative de partment Differential LMNE a Check optical bench lamp is lit when instrument is on If not replace the lamp see 2 2 Optical bench lamp replacement page 7 11 b Run a Cytometer rinse see 5 2 4 Clean Cycles page 7 33 c Re run the specimen d If this does not correct the WBC results call your ABX Diagnostics representative de partment Pentra 80 User Manual RAB108E 7 41 Pentra 80 7 Hydraulic Diagram See Hydraulic diagram on next page 7 42 Pentra 80 User Manual RAB108E 2 06 800 2 06 800 1 52 760 TRANSLATION Inch to mm Int diam 75 800 Alms tt 152 200 as G gt VENT TUBING 1 Lt in 2 06 800 ian Gg PVC CRISTAL PolyVinileChlorure TYGONe S SILICON A U ISOLATOR ISOLATOR u n n 1 30 15 1 SAMPLE SYRINGE DRAIN BUBBLING ISOLATOR TTR 1 52 335 1 52 90 1 DRAIN SYRINGE ag Be aan Pena 2 06 610 asl 1 52 500
148. en exception is generated because of the mismatch of the rack position of the sample and the order Section 4 1 7 Exception management page 4 11 a notification is done When the user match an order and a result in the association screen a notification is done If a recomputing of the result is done the notification shall contain this information 3 36 Pentra 80 User Manual RAB108E Workflow Contents L WY OO nu 4 3 1 1 Sample tube management Woo 4 3 IN ONON Kwon ente ana ea 4 4 TSW Oa Bana 4 4 1 4 Sample identificati ON Woo 4 5 1 5 Barcode Identification ooWooo Wo 4 5 1 5 1 Setting Barcode Manual match OFF 4 6 1 5 2 Setting Barcode Manual match ON 4 7 1 6 Sample identification on Rack position 4 8 1 6 1 Setting Rack position Manual match OFF 4 8 1 6 2 Setting Rack position Manual match ON 4 9 1 7 Exception management 4 11 1 7 1 Sample identification on both barcode and Rack Position 4 12 1 7 2 Identification with barcode without order 4 12 1 8 Sample tube and order association 4 13 1 9 Patient file management oo 4 13 1 10 Loading Worklist from the LIS 4 13 Le MO Katana mantan 4 14 ba Ge Bon 4 14 2 2 Accessing the Worklist function 4 14 Liae WN OKUSE Oi 4 15 2 3 1 Creating an Order oo Woo Woo 4 16 2 3 2 Contextual toolbar keys 4 16 2 3 3 GNA FUNCIONS ik bina atesoti 4 16 2 3 4
149. ent settings and Cali bration functions The Users profile wich allows access to daily working operations v User profiles sections 7 1 Accessing the User screen page 5 30 7 2 User menu function keys page 5 31 7 3 Creating a new User profile page 5 31 7 1 Accessing the User screen From the Settings window select the User key Fig 5 29 Setting User profiles 5 30 Pentra 80 User Manual RAB108E Settings User profiles 7 2 User menu function keys Function Insert Allows a new user to be added Edit Modifies a user profile me Deletes a user profile A confirmation profile is dis Delete played Tab 5 12 User menu function keys 7 3 Creating a new User profile To create a New Profile follow the steps as indicated From the Settings window select the User key Select the Insert key e In the Name login operator field type in your operator name 10 characters maxi Enter your password 10 characters maximum Default password is ABX Select the Group field and scroll through the list to select a User or Trained User profile Now select the Operator Code field and enter your code Once all information requested has been completely filled in on the User screen select the OK key to confirm your entries Your profile will now be added to one of the profile lists mmm A user can edit insert delete a login of the same level
150. entra 80 1 3 graphics and symbols Switch off position Alternating current In Vitro Diagnostic Medical Device Caution consult accompanying documents REAGENT Reagent Fragile handle with care Do not stack O Batch code Use by Feo wre i amp lO Calibrator O Z 5 Content 1 4 Pentra 80 User Manual RAB108E D RE t IS 4 CONTROL gt i E E S93 Switch on position Manufacturer This product conforms to the EEC Standards and Directives named in the Declaration of Conformity Biological risk Up Keep dry Temperature limitation Catalogue number Consult Instructions for Use Control All graphics including screens and printouts photographs are for illustrations purpose only and are not contractual Introduction Labels 2 Labels 2 1 Input O utput Labels CE EM PENTRA 80 306P800560 1 CERTIFIED Fig 1 1 Rear panel labels 2 1 1 Identification label ABX FRANCE Rue du Caducee Parc Euromedecine gt lt 4 BP 7290 HORTA 34184 Montpellier MADE IN FRANCE l Cedex 4 piaanostics T l 33 4 67 14 15 16 RIE 306P800560 TENSION SECTEUR VOLTAGE INPUT 100 240V FREQUENCE FREQUENCY 90 60 Hz C US PUISSANCE LISTED DOWER 300 VA LABORATORY EQUIPMENT 42DA ATTENTION AFIN D EVITER LES RISQUES DE CHOC ELECTRIQUE NE PAS OTER LES CAPOTS APPELER UN REPARATEUR QUALIFIE DEBRANCHER LE CABLE D ALIMENT
151. entra 80 User Manual RAB108E 5 19 Pentra 80 5 3 1 RS232 settings tab H eading key Function D efault value Bauds speed selection 9600 Parity parity selection None Protocol Protocol selection Xon Xoff Selection of protocol format between P80 amp host ABX format or ASTM format None Format communications in both directions or from Mode the P80 to the host Ae 2 AR time out in seconds before automatic deconnection 80 Max time Response time time out in seconds for the reception US Time Out before new Soh when there is a Soh Soh conflict Soh Soh conid 2 Automatic disconnect Automatic disconnection Unchecked a conie Does the Qc analysis send to the host Unchecked Seni Run Reit Sa Within Run analysis send to the EA Send StartUp Result Does the Blank analysis send to the host Unchecked Tab 5 5 RS 232 settings In ABX format the length is always 8 bits In ASTM format the length can be 7 or 8 bits but the protocol is BIDIR 5 3 2 ABX ASTM format tab The ABX Format allows the transmitted data batches to be variable in size This variable size allows the transmission of Histograms Thresholds and 5 DIFF matrixes as shown on the system ASTM format Refer to ASTM standard documentation The RS232 settings tab can be modified according to the selections chosen by the operator see 5 3 1 RS232 settings tab page 5 20 5 20 Pentra 80 User Manual RAB108E Settings System H
152. entrated cleaning see 5 2 4 Clean Cycles page 7 33 g If all these operations appear to be correct call your ABX Diagnostics representative department Calibration a If the system appears to be operating properly if fresh uncontaminated reagents are being used and the precision is within the specifications Pentra 80 may need a cali bration Section 3 4 Calibration page 3 25 v Procedure 7 RBC PLT HCT Repeatability If RBC PLT amp HCT are non repeatable a Check the second dilution is carried out correctly Sample from chamber 2 to chamber 4 b Check bubbling in the RBO PLT chamber 4 once the dilution is carried out Dilution remains transparent c Perform a concentrated cleaning see 5 2 4 Clean Cycles page 7 33 d If all these operations appear to be correct call your ABX Diagnostics representative department Calibration a Perform a calibration of the instrument see Calibration page 7 39 v Procedure 8 HGB Repeatability If HGB is non repeatable a Run an analysis cycle b Check dilution colour in the chamber 2 Milky when sample is first delivered to the chamber then brown transparent when lyse is injected c Perform a concentrated cleaning see 5 2 4 Clean Cycles page 7 33 d If this does not correct the HGB count call your ABX Diagnostics representative de partment Calibration e Perform a calibration of the instrument see Calibration page 7 39
153. er See printer s user manual to connect to switch on off or to feed paper v Procedure 2 Reagents Bottle replacement see 2 1 2 Integrated reagents amp Diluent container replacement page 7 6 Waste container see 2 1 3 Waste container replacement page 7 11 v Procedure 3 Instrument startup Startup failed a Check all reagent s expiration dates Replace bottle if necessary b Re run a Startup cycle c Perform a concentrated cleaning see 5 2 4 Clean Cycles page 7 33 Temperature not reached a Wait for five minutes to reach the operating temperature b If temperature is not reached call your ABX representative service department Calibration verification out of acceptable limits a Clean the system see 5 2 4 Clean Cycles page 7 33 and re run the control b Run a new vial c Calibrate the instrument Section 3 4 Calibration page 3 25 v Procedure 4 Sampling probe Sampling probe a Check probe motion see 5 1 2 Check motors page 7 23 b Open the righthand side panel to access to the chambers Section 7 3 3 Right hand side panel removal page 7 19 c Run an analysis cycle on blood d Control the specimen aspiration Blood delivering in the chambers e Check the probe is not bent v Procedure 5 Dilution Carriage motion Pentra 80 User Manual RAB108E 7 37 Pentra 80 a Check that hydraulic operations appear to work properly Reagent level in each cham ber and
154. ers are displayed in groups of 5 Two or four views can be accessed depending on the analysis mode CBC or DIFF Changing the parameter view can be made by selecting the parameter tabs WBC RBC HGB HCT PLT MPV MCV MCHC HCT MCH and NEU EOS BAS LYM MON see Fig 3 3 page 3 6 1 Indicates the target value shown by the centerline in the parameter field 2 Indicates the Maximum Target value shown by the upper line in the parameter field 3 Indicates the Minimum Target value shown by the lower line in the parameter field 4 Individual parameter value points as indicated by the cursor Blue indicates a value that is lower than the Fig 3 3 L J graphs low limit Red indicates a value that is higherthan the upper limit The date displayed is the date of the control run which is indicated by the cursor 3 6 Pentra 80 User Manual RAB108E Q uality Assurance Quality control 1 3 QC data screen grid From the L J graphs screen use the Details key to display the QC data screen grid v Analyses results l Check boxes select deselect QC data sg 0 TestDate wec Rec Hes HcT mcv _ mcm 2002 04 03 15 28 16 7 4 4 74 13 8 39 0 82 23 1 Admin 2002 04 03 15 32 21 7 4 480H 141 39 7 H 83 29 3 Admin 2002 04 04 06 48 57 7 1 4 71 13 8 40 0H 85H 29 2 Admin 2002 04 04 07 10 58 7 0 4 73 13 7 40 1H 85H 28 9 Admin 2002 04 04 07 38 02 7 3 4 70 14 0 39 7H 84H 29 8 Admi
155. es the operator with two tab choices as indicated Configuration see 6 2 Configuration page 5 26 Dump database see 6 3 Dump database page 5 27 6 2 Configuration 6 2 1 Analyzer setting functions H eading key Function Save settings on hard disk Restore setting from hard disk Save setting on floppy Restore settings from floppy Opens a dialogue window in order to save the current configuration Opens a dialogue window in order to select one of the save settings Opens a dialogue window in order to save the current configuration on a disk Opens a dialogue window in order to select one of the save settings on the disk Tab 5 9 Analyzer save restore 5 26 Pentra 80 User Manual RAB108E Settings Save and restore 6 2 2 Workstation setting functions H eading key Function Opens a dialogue window in order to select the save path of the current Save settings on hard disk i configuration Restore setting from hard disk Opens a dialogue window in order to select one of the save settings Opens a dialogue window in order to select the save path of the current Save setting on floppy configuration on a disk If the floppy is unformatted the software then invites the user to format it Opens a dialogue window in order to select one of the save settings on Restore settings from floppy Ts fice Tab 5 10 Workstation save restore 6 3 Dump database PENTRA 80 Save And Restore S
156. eter s in question If one result appears with one or several parameters that display a suspect flag the result should be further investigated Pathology suspicion clotted sample plasma cells etc v NO flag Absorbance NoN NoE Channel 127 Meaning Background NOise This flag occurs when the number of parti cles counted in the background noise area is higher than the limit set up in NO or when the number of counted particles ver sus the total number of WBC is above the NO limit Suspected abnormalities Platelet aggregates Dan Gs SMY Large number of platelets Erythrocyte membrane resistant to lysis stroma Standard value for NO 100 120 NRBCS Fig 4 21 No flag Section 5 8 3 Alarms amp Curve thresholds Pollution page 5 37 This alarm appears in the Analyzer Alarms area on the screen and the printout Ld 4 32 Pentra 80 User Manual RAB108E v LL flag Absorbance NoN NoE Channel 127 Fig 4 22 LL flag Standard value for LL 100 50 Section 5 8 3 Alarms amp Curve thresholds page 5 37 v LL1 flag Absorbance NoN NoE Channel 127 Right Neutro Fig 4 23 LL1 flag Standard value for LL1 5 45 Section 5 8 3 Alarms amp Curve thresholds page 5 37 Workflow Run results and associated Flags Meaning Left Lymphocytes Presence of a significantly large population on the left hand side of the lymphocyte area This flag appears
157. etimes vacuoles The cytoplasm is also large with non granular intra cellular material These cells will not scatter or absorb a large amount of light when passing through the flowcell They will therefore be positioned in the lower part of the optical Y axis Because the monocytes are a large cell they will be placed to the right of the volume X axis 6 18 Pentra 80 User Manual RAB108E Description amp Technology NEUTROPHILS The Neutrophils are larger in size than the lymphocytes The neutrophils con tain granular material in their cytoplasm along with a segmented nucleus Due to these cellular features more light will show through these cells as they pass through the flowcell This affect will place the neutrophils higher on the optical Y axis and spread them along the volume X axis according to their maturity Hyper segmentation and increased granules will place these cells even higher on the optical Y axis EOS NOPHILS The Eosinophils are somewhat like the neutrophils They contain granular ma terial and segmented nuclei within the cytoplasm The granular material is colorized with the ABX EOSINCFIX before they are passed through the light path in the flowcell Due to the col orization action of the reagent the eosinophils will be place in the highest part of the optical Y axis Hyper segmentation and increased granules will spread this population across the right top of the matrix Additional parameters LIC Large Immature C
158. ettings i EF April 2002 Mon Tue Wed Thu Fri t 2 3 5 8 9 10 11 12 15 16 17 18 19 22 23 24 25 Gp 27 ato G F y Today 04 26 2002 04 26 2002 00 00 00 Be 04 09 2002 10 02 16 LAN Se a AI dl lt 9 0a728 2002 125742 mean Fig 5 25 Dump database tab H eading key Function Upon confirmation deletes all orders runs and results and associated patients prior to the selected date A notification is made in the logs Delete data until this date Tab 5 11 Database function key Pentra 80 User Manual RAB108E 5 27 Pentra 80 6 4 Update of the Help on line of P80 software The CDROM attached to this manual includes the user manuals in all languages English Ital lan Spanish Portuguese German and French This one contains the User manuals in a PDF format for printing and reviewing operations It also includes last update of the Help on line file This one can be easily installed on your Pentra 80 using the key Help Update as follows Important Warkstation Configuration Laba is not recommended if the database contains Patient results After a restore the orkstation Sets are replaced by the range values from al Gaede Flagging Sets Existing Patient amar ea ee a However the Flagging Set aae Co ao alg a to the sets Verify Flagging set range values after restore and ae te to reporting patient Fig 5 26 Save and restore screen Insert the CDROM into t
159. ew screen Select the Print send key Worklist Man LABORATORY UNIT 1 Unknown ABX e AUTO SID13 Standard Unknown e e AUTO_SID14 Technician e Fig 4 18 Rack view print out The rack view printout ticket shows the patient informations the sample informations the clinical informations Pentra 80 User Manual RAB108E 4 23 Pentra 80 3 Sample collection amp mixing All blood samples should be collected using proper technigue AA Consider all Specimens Reagents Calibrators Controls etc that contain human YZ 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 safe ty procedures When collecting blood specimens Venous blood is recommended but Arterial blood may also be used in extreme cases Blood collection must be placed in a Vacuum or atmospheric col lection tubes For additional information on collecting venous and capillary blood samples refer to NCCLS document H3 A4 and NCCLS document H4 A4 sept 1999 The sample collection tube has to be filled to the exact quantity of blood indicated on the tube itself Any incorrectly measured blood sample collections will show a possible variation in the resu
160. f grea ter than the upper limit in Blue if lower than the lower limit Fig 3 14 XB Graphs v Print XB graphs Use the Print Transmit key to print out XB graphs 60 total points 3 16 Pentra 80 User Manual RAB108E Q uality Assurance Patient Q uality Control XB 2 3 XB Data Grid screen From the XB graphs menu see Fig 3 14 page 3 16 select the Details key to open the XB Data Grid screen see Fig 3 15 page 3 17 PENTRA80 For Research Use Only Not for use in diagnostic procedures RUD XB 9 parameters XB Operator Admin i 2002 04 05 11 51 32 Running date i 2002 04 08 11 09 22 2002 05 28 14 29 34 i 2002 05 27 17 16 23 i 2002 05 28 11 22 34 2002 05 28 14 29 34 2002 05 28 15 22 31 2002 05 29 12 18 14 2002 05 30 11 42 15 2002 05 30 16 03 53 Standard deviation Coef of variation V ersion VO 32 2002 06 05 11 53 34 Fig 3 15 XB Data grid screen The XB data grid contains the individual hematology data as well as the batch number The running date and limit values are also included The Statistical data includes the mean of all the batches Standard deviation and Coefficients of variation When the Batch values and or Means are not within their specific limits see 2 5 XB limits page 3 19 they will be displayed in Red if they are greater than their upper limit in Blue if they are lower than their lower limit Select the XB key to display the contents within a
161. following setting Barcode Section 5 2 2 5 Identification option page 5 7 The worklist sample management depends on laboratory organization This must be defined when the instrument is installed barcode or rack position 4 4 Pentra 80 User Manual RAB108E Workflow Workflow 1 4 Sample identification A Single sample number identifies orders that are generated from the worklist If the operator does not enter a number the instrument will automatically assign a number as followed AUTO SID xxxxx sample ID Rack Pos Patient D 36597 AUTO SID AUTO SIUS AUTO SIO6 AUTO SID AUTO SIDE be ek ek ik Ow 0 om wo nk 1 Fig 4 1 Automatic sample numbering If the operator enters an order with a Sample ID that already exist in worklist the previous order will be updated Modifications cannot be performed during the sample analysis process Orders are deleted once the sample analysis is complete 3 modes of sample identification are available Barcode identification see 1 5 Barcode Identification page 4 5 Rack Position identification see 1 6 Sample identification on Rack position page 4 8 Automatic numbering by the instrument 1 5 Barcode Identification The Barcode Identification mode is the most recommended mode on the ABX PENTRA 80 be cause it ensures the best security and flexibility Easy association between Sample orders and the sample tube can be Identified by the barcode The
162. for drain Creation according prototype and NMLOXXAS g diagram 08 07 02 861 JA Coating pO Description CK By Date ECR RevIN NMLO12A Sheet S Dim in millimeters This drawing is the property of ABX and may not be reproduced or distributed without authorization Maintenance amp Troubleshooting Error messages 8 Error messages When an error or an alarm is detected by the instrument it is reported into the Alarm screen The Alarm key is activated and blinks see Fig 7 46 Alarm key page 7 43 press Alarm key to access to the Alarm screen see Fig 7 47 Alarm screen page 7 43 Check the type of error and follow the instruction from the Alarm screen Fig 7 46 Alarm key 05 28 2002 11 56 27 Front Cover Open Front Cover Open Fig 7 47 Alarm screen Error messages In this section 8 1 Analyzer error types and help messages page 7 44 8 2 Transfer error types and help messages page 7 45 8 3 STAT mode error type and help message page 7 46 8 4 Environment Error Types and Help Messages page 7 46 8 5 User Error Types and Help Messages page 7 49 8 6 Expiration Date Error Types and Help Messages page 7 49 8 7 Analyzer Internal Error Types and Help Messages page 7 49 Pentra 80 User Manual RAB108E 7 43 Pentra 80 7 44 8 1 Analyzer error types and help messages Alarm Carriage motor failure Carriage mechanism not reach ing home Counting syringe motor failure Counting syr
163. fore any QC analysis can take place on such a lot Target values Parameter ranges Alarm levels 5DI FF Matrix thresholds and other control blood characteristics should be entered pri or to the analysis of the new lot v Selection of a control Select the Target key see Tab 3 1 Quality Control Keys page 3 5 in order to open the Target modify window Scroll through the Control name list and select the control you would like to modify From 1 to 12 reserved to CBC control from 13 to 24 reserved to DIFF If you need to modify the target values or lot proceed as described in Target initialization by floppy page 3 10 or in Manual target value entry page 3 11 v Target initialization by floppy Each order of Blood controls ABX DIFFTROL comes with a floppy disk so that the operator can insert the disk and update the new control lots without any manual entry of data Lot Target values and Ranges Alarms and Thresholds and Expiration Date are included on the floppy disk for each level of control Select the Target key see Tab 3 1 Quality Control Keys page 3 5 in order to open the Target modify window Pentra 80 User Manual RAB108E Q uality Assurance Quality control Now select the Edit key When modifying a control lot analyses from the previous lot must be erased A Warn ing message will be displayed Select the OK key to delete all previous control lot information Inser
164. ft hand side panel reMOVal oooo Wo W oo 1 20 4 Service menu description oo 1 21 5 Super User menu description oooooWoWW W WJ mom 1 22 5 1 Mechanical Menu oo coooo oco Wooo ooookmmussssh 1 23 5 1 1 Instrument InitialiZatION ooo 1 23 Sl CHECK Meta Ga ema 1 23 Di CNCCK VALVES rektum Maman 1 24 Na C NECK SENSO ee in 1 25 5 1 5 Sampler Test an kete amen Rm afi 1 26 5 1 6 Sample tube Holder adjustment 1 21 5 1 7 Rack GO USUNENE naasnnvainetweroninisawenstnivesaasanian 7 28 32A VO Faull Cal Men ln aa 7 30 5 2 1 Drain chamberS o o Woo oo 1 30 Sa PIME CVO E ba Ka 1 30 5 2 3 U nprime cycle someone 1 32 5 24 Clean Cycles eka 1 33 DDO se Bai 1 35 6 Troubleshooting oooooWoWo Woo mma 1 36 6 1 Instrument operation Mode 1 31 Pentra 80 User Manual RAB108E 7 1 Pentra 80 SE Ee en anna ana Naa 1 38 DO ga mona ea nana 1 40 h Ayaro ke Naga ee en 1 42 Oe EO NN ESA JS Lam te pain PN aa aoi ia senses 1 43 8 1 Analyzer error types and help messages 7 44 8 2 Transfer error types and help messages 7 45 8 3 STAT mode error type and help message 7 46 8 4 Environment Error Types and Help Messages 7 46 8 5 User Error Types and Help Messages 1 49 8 6 Expiration Date Error Types and Help Messages 1 49 8 7 Analyzer Internal Error Types and Help Messages 7 49 7 2 Pentra 80 User
165. h 0 76 0 42 0 56 0 83 HGB PX052 Normal 0 59 0 57 0 55 0 8 PX052 Low 0 81 0 73 0 61 0 99 PX052 High 1 67 1 35 1 44 2 09 HCT PX052 Normal 1 58 1 57 1 58 2 23 PX052 Low 1 54 1 83 2 02 2 63 PX052 High 3 29 1 68 2 14 3 38 PLT PX052 Normal 3 34 1 93 22 4 2 PX052 Low 4 94 53 6 42 8 22 PX052 High 3 2 07 232 3 47 Neutro PX052 Normal 1 06 0 74 0 57 1 08 PX052 Low 158 IPS 117 1 86 PX052 High 4 96 35l 4 27 6 05 Lympho PX052 Normal 3 67 2 81 235 4 05 PX052 Low 4 52 2 61 2 83 4 65 PX052 High 7 95 6 28 32 1 98 Mono PX052 Normal 7 34 3 95 4 92 1 61 PX052 Low 3 eV 8 88 5 25 12 75 PX052 High 11 38 6 51 8 13 12 33 Eosino PX052 Normal 10 65 9 65 11 12 4 PX052 Low 10 73 8 51 4 86 10 84 PX052 High 3 27 2 54 3103 4 21 Baso PX052 Normal 132 121 0 89 1 55 PX052 Low 3 29 2 18 2 34 3 64 Tab 8 5 Reproducibility CV Evaluation of Precision Performance of Clinical Chemistry Devices Approved Guideline NCCLS document EP5 A ISBN 1 56238 145 8 1999 3 2 Precision Repeatability Three normal blood are tested 10 times running one in CBC mode one in diff mode and one in open tube The average the varation ratio together with the standart deviation of the measure for each sample will be calculated Pentra 80 User Manual RAB108E Specifications Summary of performance datar 0 Parameters M anme Cu el Rack CBC CV Rack Diff CV O pen tube WBC 1 24 1 16 1 22 RBC 0 51 0 86 1 00 HGB 0 34 0 38 0 54 HCT 0 53 0 78 1 03 PLT 1
166. he MSDS associated with the reagent Special precautions Avoid contact with acid and aqueous acid environment extremely toxic cyanide acid vapour can be formed Please refer to the MSDS associated with the reagent Specimen Collection and Mixing see Section Workflow in the instrument User Manual Limitations see Section Specifications in the instrument User Manual Safe Waste Disposal see Section Specifications in the instrument User Manual Please refer to the MSDS associated with the reagent HORIBA GROUP ABX Diluent O Exclusive use Hematology ABX device Micros 60 ABC Vet Micros CRP Pentra 60 Pentra 60 C Pentra 80 Pentra XL 80 Pentra 120 Pentra 120 Retic Pentra DX 120 Hematology ABX Devices for in vitro diagnostic use 12 05 03 A95A00005 A 0901020 20L 20L CE etal ABX Diagnostics BP 7290 34184 Montpellier cedex 4 France Exclusive KORO OK NK S Slide Preparation System 1 Functions Buffered isotonic solution for sheating and diluting leucocytes and for the determination and differentiation of blood cells and the measurement of hematocrit on ABX blood cell counters Measurement procedure to be followed in using the device Principle of the method specific analytical performance characteristics analytical sensitivity diagnostic sensitivity analytical specificity diagnostic specificity accuracy repeatability reproducibility including control of
167. he instrument CD drive Open the Settings Save and Restore settings screen Press the Update help key to access to User manual screen The contents of this CDROM can be reviewed on all PC having an Acrobat reader software installed version 5 0 or high er 5 28 Pentra 80 User Manual RAB108E Settings Save and restore p ntra 80 User manual Francais English Deutsch Espanol Italiano Portugese Quit HORIBA GROUP Fig 5 27 Accessing the user manual and help Choose your language The following screen appears Fig 5 28 Accessing the Help on line or user manual The Pdf key opens the user manual in Acrobat reader software in order to be read or printed The HTML key opens the Help on line recorded on the CDROM The Install key will install the new Help on line from the CDROM on your instrument and erase the previous one Pentra 80 User Manual RAB108E 5 29 Pentra 80 7 User profiles There are two connections those belonging to Windows NT and those belonging to the PEN TRA 80 software In the PENTRA 80 software there are 3 groups of user profiles e The ABX technicians profile which gives access to specific technical functions which is accessed only by an ABX certified technician The TrainedUsers software profile which which allows access to Service menus useful for instrument maintenance operations It also allows access to Instrum
168. in use Please refer to the MSDS associated with the reagent Specimen Collection and Mixing see Section Workflow in the instrument User Manual 5 Limitations amp waste disposal Limitations see Section Specifications in the instrument User Manual Safe Waste Disposal see Section Specifications in the instrument User Manual Please refer to the MSDS associated with the reagent HORIBA GROUP ABX Eosinofix O Exclusive use Hematology ABX device Exclusive Hematology ABX Devices for in vitro diagnostic use 12 05 03 A95A00003 A Argos Helios 5diff v Micros 60 ABC Vet Micros CRP Pentra 60 Pentra 60 C Pentra 80 Pentra XL 80 Pentra 120 Pentra 120 Retic Pentra DX 120 0206010 1L 1 CE etal ABX Diagnostics BP 7290 34184 Montpellier cedex 4 France Se Re NRE SS Slide Preparation System 1 Functions Reagent for differentiation of leucocyte subpopulations on ABX blood cell counters Measurement procedure to be followed in using the device Principle of the method specific analytical performance characteristics analytical sensitivity diagnostic sensitivity analytical specificity diagnostic specificity accuracy repeatability reproducibility including control of known relevant interference limits of detection limitations of the method and information about the use of available reference measurement procedures and materials by the user see Section Spe
169. inge mechanism not reaching home Diluter syringe motor failure Diluter syringe mechanism not reaching home DRAIN 1 syringe motor failure DRAIN 1 syringe mechanism not reaching home DRAIN 2 syringe motor failure DRAIN 2 syringe mechanism not reaching home Drain sensor sensor number 1 2 or 3 time out Injection syringe motor failure Injection syringe mechanism not reaching home LMNE transfer sensor time out Needle motor failure Needle mechanism not reach ing home Piercing UP or DOWN bad posi tion Reagent temperature out of range Value Min amp Max Reagent Temperature sensor not connected Reagent Temperature sensor failure Sampling syringe motor failure Error type Carriage Motor home switch always detected Carriage Motor Mechanism initial ization failed Counting Syringe Motor home switch always detected Counting Syringe Motor Mecha nism initialization failed Diluter Syringe Motor home switch always detected Diluter Syringe Motor Mechanism initialization failed DRAIN 1 Syringe Motor home switch always detected DRAIN 1 Syringe Motor Mecha nism initialization failed DRAIN 2 Syringe Motor home switch always detected DRAIN 2 Syringe Motor Mecha nism initialization failed Drain Sensor Injection Syringe Motor home switch always detected Injection Syringe Motor Mecha nism initialization failed LMNE transfer sensor Needle Motor home switch always detec
170. intout or Transmit Result list Several printing and result transmission options are available from the results grid Press the Print Send key then choose one of the following options v Printing options Print result list for selected rows Print compact result list for selected rows Print result list for all rows Print compact list for all rows Print result ticket for selected rows Print result ticket for all rows Print the last result in a full page Fig 4 41 Printing options screen Pentra 80 User Manual RAB108E 4 51 Pentra 80 Result List 02 06 2002 18 50 00 Woman LABORATORY UNIT 1 05 15 2002 14 36 13 Female ABX False 03 05 1970 32A AUTO SID4 Man 05 15 2002 14 37 44 Male ABX MIKA e 10 06 1984 5 46 14 3 44 8 82 26 2 31 9 15 7 288 9 7 16 0 0 280 8 6 50 8 41 0 5 1 2 1 1 0 1 6 1 5 4 38 3 53 0 44 0 18 0 09 0 14 0 13 gt Higher limit E lt Lower limit XXX Fig 4 42 Selected rows printout v Sending options Print Send Send last result to the host Send selected results to the host Send all results to the host Fig 4 43 Sending options screen 4 52 Pentra 80 User Manual RAB108E Workflow Order amp sample run association 6 2 Result order association 6 2 1 Association grid description From the Result grid select the Association key This function will be disabled if all the results are already
171. ion chambers Fig 7 16 Rinse chamber filter location 3 Locate the filter below the rinse chamber 4 Remove the filter disconnecting tubings and open it unscrewing both parts a f Fig 7 17 Dismantling the filter 5 Rinse both parts of the filter under tap water 6 Leave the filter dry and re install reverse order Pentra 80 User Manual RAB108E 7 15 Pentra 80 2 5 Instrument Rinse Run this procedure before the transport of the instrument after a demonstration or before a long period without functioning 2 5 1 Instrument rinse 1 Run an Instrument general cleaning See Instrument general cleaning page 4 2 Remove straws from Reagent bottles and plunge them into an empty bottle 3 Remove straw from Diluent cubitainer and plunge it into the empty bottle 4 Enter Service Super User Menu Hydraulic Unprime Cycle then click the All button See Unprime cycle screen page 16 PENTRA 80 Hydraulic System CL MS Px Mu Mtv x Fig 7 18 Unprime cycle screen 5 Press the Validate button then repeat this cycle a second time 6 Dry the straws using absorbant paper 7 Plunge the straws in a bottle full of distilled water 8 Enter Service Super User Menu Hydraulic Prime Cycles then click the ALL REAGENTS button See Prime cycles screen page 16 PENTRA 80 Hydrauli Fig 7 19 Prime cycles screen 7 16 Pentra 80 User
172. ions 1 1 Access to the Quality Control Menu page 3 4 1 2 L J Graphs page 3 6 1 3 QC data screen grid page 3 7 1 4 Graphics screen page 3 8 1 5 Print send or delete results page 3 9 1 6 New blood control setup page 3 10 1 7 Running control blood page 3 13 1 1 Access to the Quality Control Menu Press the Quality Control key lt yaaa HOB HET PLT MEW MH MEHE PENA Fig 3 2 Quality Control access key 3 4 Pentra 80 User Manual RAB108E Q uality Assurance Quality control v Quality Control Key Key Name Function Access to the Target values window Target see 1 6 New blood control setup page 3 10 Selection of a new control lot Control Name see Selection of a control page 3 10 24 controls can be saved 12 in CBC 12 in DIF In Data screen Grid Selected or all results or statistics only see Print send or delete results page 3 9 Send to the host selected or all results In L J graphs Printing with 100 full points Print Transmit Tab 3 1 Quality Control Keys Pentra 80 User Manual RAB108E 3 5 Pentra 80 1 2 L J Graphs This is the graphical representation of Quality control data based on the daily value for each Control parameter its target value and range that are plotted on a graph for periodic review A total of 100 points per parameter can be displayed on the screen and on the printout The hematology paramet
173. ions see 1 7 Exception management page 4 11 Select a result in the lower half of the association grid that you want to associate an order with Now select the order in the upper half of the association grid to associate to the selected result Then select the OK key A confirmation message will be displayed see Fig 4 45 page 4 54 Warning Do you want to associate the order 5865 with the result of the tube PXO32N Fig 4 45 Matching confirmation Once the matching has be performed the selected lines will disappear The matched results will be added to the Result grid see 6 1 3 Result Grid information page 4 48 A notification is added to the instrument logs A If the order type is different from the results one the results will be recomputed with the new type settings thresholds limits The recomputed results will be flagged in the Remarks flags see 5 2 Result screen page 4 27 If the order test differs from the results test then the test of the matched results CBC When the user validates the association and no order is selected the following message will be displayed Do you still want to match the tube with its default order 4 54 Pentra 80 User Manual RAB108E Workflow Results Archives 7 Results Archives At the end of the day on the 24 00 clock all results from the previous day are automatically archived into the system memory if Begin of day screen
174. is the actual depth of the rack in millimeters corresponding to the rack Type Level This measurement is subtracted from the depth of sampling in millimeters in rela tionship to the rack Type 7 28 Pentra 80 User Manual RAB108E Maintenance amp Troubleshooting Super User menu description Accept Values key This key is used to accept any changes made to the Depth and Level fields I PENTRA 80 Mechanical System O W O o W o W W W O w O o O o o o o a Fig 7 34 Super U ser Mechanical Rack Adjustment Pentra 80 U ser Manual RAB108E 7 29 Pentra 80 5 2 Hydraulical menu 5 2 1 Drain chambers PENTRA 80 Hydraulic System Fig 7 35 Super User Hydraulical Drain Chambers Rinse Drains the rinse chamber HGB Drains the HGB chamber LMNE Drains the LMNE chamber RBC PLT Drains the RBC PLT chamber WBC BASO Drains the WBC BASO chamber All Drains all the chambers DN UI S amp S UN kb 5 2 2 Prime cycles This menu will allow the user to prime reagents into the instrument Run this procedure after service has been performed on the instrument mmm This function allows only the priming of reagents into the instrument It does not set the reagent quantities to 100 7 30 Pentra 80 User Manual RAB108E Maintenance amp Troubleshooting Super User menu description ENTRA
175. istogram v L1 flag CBC and DIFF mode L1 flag is established according to the ratio of the cells counted be tween the 0 channel and BAI w gt N gt Lb L1 indicates the presence of an ab normal number of cells in comparison with leukocytes Suspected abnormalities PLT aggregates 55 Fig 4 32 WBC histogram NRBCs L1 flag is associated with an on Standard value for L1 3 200 WBC value and on absolute values of Section 5 8 3 Alarms amp Curve thresholds MN Nae page 5 37 v MB flag DIFF mode only Meaning Mono BAS This flag occurs when the percentage of basophils found in the BAS channel is above the per centage of Lympho Mono Neutro raw counts found in the LMNE matrix channel v BASO DIFF mode only If the BAS exceeds 50 a BASO flag is generated The Basophils will not be removed from the LMNE Matrix populations and a will be dis played instead of the BAS and BAS This alarm appears in the Analyzer Alarms area on the screen and on the printout v 4 38 Pentra 80 U ser Manual RAB108E Workflow Run results and associated Flags 5 3 6 Flags on RBC histogram MIC and MAC flags are generated when the percentage of cells count ed in the microcytic area MIC and macrocytic area MAC compared to the total number of RBCs are above the set limits for both MIC and MAC percentages set up by the user RBC RBC2 RBC1 and RBC2 thresho
176. kflow overview Pentra 80 5 3 Runs and results overview e Analytical processes and obtained results are defined as Runs Individual parameter se lection allows an easier verification of the final result Sample results are determined from runs automatic reruns and manual runs required for an order Section 4 6 Order amp sample run association page 4 47 Fig 1 20 Runs amp Results 1 24 Pentra 80 User Manual RAB108E Introduction Workflow overview 5 4 Archives overview Archives contain previous run amp results that can be accessed by the user Using two different modes available on the PENTRA 8 amp 0 can access the archives Review by date or Review by patient 12 12 2000 Runs amp results Sample Id1 Patient Id1 Ji i Sample Id2 Patient Id2 s i i Sample Id3 Patient Id3 Ka gt 1 Sample Id4 Patient Id4 Fig 1 21 Review by date See Section 4 7 Results Archives page 4 55 Pentra 80 User Manual RAB108E 1 25 Pentra 80 Search by Patient Id Fig 1 22 Review by Patient 1 26 Pentra 80 User Manual RAB108E 5 5 Results production Results are produced in two forms of sample identification Matched Results Results matched to a specific order ta process Runs amp results Analytical Archives Fig 1 23 Matched results Unmatched Results Results without any order indicated Operator Fig 1 24 Unmatch
177. l AW OP Pn na an erat 1 10 BO Inter ie erT 1 11 Selo RACK ob aU 1 12 A Software OVETVIeW oo oo oo 1 13 4 1 Generic toolbar deSCFIptI ON 1 14 4 2 Contextual toolbar description ooo oo 1 15 4 3 Main Menu description oooo oom 1 16 4 4 MiscellaneodUuS Woooo oo nan 1 17 5 Workflow Overview oom 1 21 5 1 Order OVErVIEW oo Wo Woo 1 21 5 2 MOKIISE OVENVICW ke ki me aa ina 1 23 5 3 RUNS and results Overview oo 1 24 5 4 Archives OVErvIew oo Wo Won 1 25 5 5 Results production naa an Nan na TEA Ai 1 27 Or PTA ST an ab 1 28 gt lt 4 HORIBA DIAGNOSTICS Section 2 Daily Guide 1 Instrument Startup ooo oo oo 2 2 1 1 Waste levelS ooo oo nan 2 2 Les PA ea ee maa venereal bute 2 2 1 2 Petra 80 StAKtUD sariei e Kemiskinan 2 2 aa an ke 2 5 2 Running the ABX Quality Control ooo oo 2 6 2 1 Closed tube Mode with barcode Woo 2 6 2 NO CWE LUD ea niatan ana Reba abi 2 1 3 RUNNING SPECIMEN crnanaenenersseenntsaenecaubannesietaecteateccsereiads 2 9 3 1 Sample identification with internal barcode reader 2 9 3 2 Non identified sample with external barcode reader 2 9 Por DAU MOU E aaraa a A EEEE EER 2 11 34 RuN M Progress aeneae RER 2 12 ARE aaa O ondyuemenaberseeseaeenruien 2 13 4 1 Printing a result series oooo oom 2 13 4 2 Unmatched results essssesssesrrnerrrnnrrrnerrrnsrrrerrrrerrrrerrrerrrreni 2 14 SAR MVO o
178. lds define l the microcytic and macrocytic areas Fig 4 33 RBC hist i ia ea and are calculated according to the Standard values for MIC 5 MCV and the RDW from the RBC histogram Standard values for MAC 45 Section 5 8 3 Alarms amp Curve thresholds page 5 37 5 3 7 Flags on PLT histograms The PLT histogram contains 256 channels between 2fL and 30fL A mobile threshold at 25 fL by de fault moves according to the microcytic RBC s that are present in the platelet analysis area 3 25 fl 30 The PLT flags are generated under the following conditions Fig 4 34 PLT histogram Pentra 80 User Manual RAB108E 4 39 Pentra 80 4 40 3 18 25 fl 30 3 18 25 fl 30 3 18 25fl 30 Fig 4 35 PLT Flags Pentra 80 User Manual RAB108E An excessive presence of particles on the right side of the threshold area after 25 fL will generate the MIC Microcytes flag shown in the plate let alarm area In this case the mobile threshold looks for a valley between 18fL and 25fL standard area If the mobile threshold can not posi tion itself in the standard area between 18fL to 25fL a PLT reject and a MIC flag will be generated The PLT results are not reliable Verify the result using a Platelet Rich Plasma PRP or a manual platelet count If the mobile threshold cannot be po sitioned no valley between the PLT and RBC histograms the SCH Schizo cytes flag will be generated S
179. le Carriage Syringes etc This is also termed as a mechanical homing for all assemblies to their ready position 5 1 2 Check motors This menu will allow the user to check the operation of all the motor driven assemblies independently Power off the instrument Open the instrument right and left front doors and remove the right hand and left hand side panels see 3 Instrument panels amp cover Removals page 7 18 Once the side panels have been removed power on the instrument From the Main screen select the Super User Menu and then Mechanical Check Motors Pentra 80 User Manual RAB108E 7 23 Pentra 80 Te Boca Se Musi Ba Mes BE aa Me a 614 2002 11 3316 Fig 7 29 Super U ser Mechanical Check Motors 1 Diluter Syringes Left hand side of the instrument check for smooth and complete movement of the syringe 2 Injector Syringes Lefthand side of the instrument check for smooth and complete movement of the syringe 3 Counting Syringe Lefthand side of the instrument check for smooth and complete movement of the syringe 4 Drain 2 Syringe Motor Lefthand side of the instrument check for smooth and complete movement of the syringe 5 Piercing Mechanism Close the Tube Holder Door and verify smooth and complete piercing movement 6 Loading Mechanism Check for smooth and complete movement of Rack Loader 7 Transfer Mechanism Check for smooth and complete movement of the rack transfer
180. le tube the order must contain the sample tube position in the rack The Sample ID field is now available for manual entry but it is not mandatory to do so If the sample tube position in the rack was indicated the final results will contain sample identification If not the instrument assigns an auto numbering AUTO SID xxx to ensure that the final results for this sample contains a single identification 1 6 1 Setting Rack position Manual match OFF Identification Option The P80 tab Settings Soft parameters General C Barcode tab barcode option is set as shown Rack Position Section 5 2 2 5 Identification option Manual match on exception page 5 7 C ON OFF 4 8 Pentra 80 User Manual RAB108E Workflow Workflow Worklist sample identification SH a p 0068 0068 po 0069 0069 o __ sos i P if 1l i Pesan 1 1 0060 10067 aoa 3 Result identification Auto Numbering Rack x Position y Auto SIDxx Fig 4 4 Rack position Manual match O FF 1 6 2 Setting Rack position Manual match ON The P80 tab Settings Soft parameters General tab barcode option is set as shown Section 5 2 2 5 Identification option page 5 7 Pentra 80 User Manual RAB108E 4 9 Pentra 80 Worklist sample identification P80 analysis process Sample detected on position 3
181. local ABX DAGNOSTICGS representative 2 3 Sampling probe replacement Power off the instrument Remove the right hand side panel from the instrument see 3 Instrument panels amp cover Removals page 7 18 Hold the sample probe carriage and pull it backwards to access the sample probe Loosen the rinsing block retaining screws see Fig 7 13 page 7 14 Pentra 80 User Manual RAB108E 7 13 Pentra 80 Fig 7 13 Rinsing block screws Lift the locker top retaining bracket to free the sample probe see Fig 7 14 page 7 14 Fig 7 14 Probe locker Gently disconnect the tubing connected to the top of the sample probe and remove the probe see Fig 7 15 page 7 14 Fig 7 15 Probe replacement 7 14 Pentra 80 User Manual RAB108E Maintenance amp Troubleshooting Replacement procedures Place the sample tubing back onto the top of the sample probe Re insert the top retaining part of the sample probe back into its retaining slot Lower the locking arm to secure the probe Tighten the Rinse block retaining screws for a good seal on the sample probe Power on the instrument and verify that there are no fluid leaks during startup Re install the right hand side panel 2 4 Rinse chamber filter cleaning 1 This filter has to be cleaned once a month as follows 2 Dismantle the Right hand side panel as described in 3 Instrument panels amp cover Removals page 7 18 in order to access to dilut
182. lts 3 1 Recommended anticoagulant The recommended anticoagulant is K3EDTA with the proper proportion of blood to anticoag ulant as specified by the tube manufacturer K2EDTA is an acceptable alternative as long as the sample collection is made in normal con ditions Otherwise blood clots may be possible 3 2 Blood sample stability Specimens may be used between 15 20 minutes after collection The results on all parameters depend on the mode of conservation of the sample Depending on the parameter to be measured the sample stability may be upto 48 hours Refer to Section 8 3 Summary of performance data page 8 7 3 3 Microsampling The Open tube sampling mode enables the user to work with 100ul microsamples for pe diatrics and geriatrics 3 4 Mixing The cap piercing mode performs an automatic pre mixing cycle by rotation which lasts ap proximately 1 minute For the open tube mode blood samples must be gently and thoroughly mixed just before plac ing them into the tube holder and closing the tube holder door This will ensure a homogeneous mixture for measurement 4 24 Pentra 80 User Manual RAB108E Workflow Running specimens 4 Running specimens See Section 2 3 Running specimen page 2 9 Pentra 80 User Manual RAB108E 4 25 Pentra 80 5 Run results and associated Flags Runs results and associated flags chapter includes 5 1 Printer output format page 4 26 5 2
183. m values page 5 34 a To improve the separation between different cell populations which may vary according to the selection of anti coagulant for blood sample collection or minor internal instru ment adjustments b To modify the alarm areas of these cell populations for improvement in detection sen sitivity c To modify one or more matrix areas in order to define a more precise measurement of a specific cell population for research purposes 5 38 Pentra 80 U ser Manual RAB108E Settings Sample Types Thresh Purpose Low limit High limit NOL Separation between Noise amp Left Lympho 22 0 LL NON Separation between Noise amp Left Neutro 25 NOL NOE LL Separation between Left Lympho amp Lympho 30 NOL AL LN Separation between Neutro amp Left Neutro 35 NON LMN NOE Separation between Noise amp Eosino 48 NON Cha 127 LMN Intersec dot between Lympho Mono Neutro area 70 LN LMU AL Separation between Lympho amp Left Lympho 68 LL LMU LMU Upper dot of the separation slope ALY Mono 78 AL LMD LMD Lower dot of the separation slope ALY Mono 90 LMU RM MN Upper dot of the separation slope Mono Neutro 90 LMN RM RM Separation between Mono amp Right Mono 118 LMD Cha 127 RN Separation between Neutro amp Right Neutro 118 MN Cha 127 Tab 5 14 Matrix DC thresholds resistive Threshold Purpose Low limit High limit NL Separation between Lympho amp Neutro 29 0 RMN RMN Separation between Right Mono amp Right
184. mechanism 8 Mixer Mechanism Check for smooth and complete rotational movement of the sample tube mixer 9 Sampling Needle Check for smooth and complete movement of the sample probe 10 Carriage Motor Right hand side of the instrument Check for smooth and complete movement of the sampling carriage 11 Sampling Syringe Right hand side of the instrument on the carriage check for smooth and complete movement of the Sampling syringe 12 Drain 1 Syringe Motor Right hand side of the instrument check for smooth and complete movement of the Waste Drain syringe 5 1 3 Check valves This menu will allow the user to check the operation of all electrical valves on the instrument Power off the instrument 7 24 Pentra 80 User Manual RAB108E Maintenance amp Troubleshooting Super User menu description Open the instrument right and left front doors and remove the right hand and left hand side panels see 3 Instrument panels amp cover Removals page 7 18 Once the side panels have been removed power on the instrument From the Main screen select the Super User Menu and then Mechanical Check Valves Closely observe the valve operations movements have to be straight and regular PENTRA 80 Mechanical System Fig 7 30 Super User Mechanical Check Valves 1 Valves 1 to 12 Verify the correct operation of these valves 2 Valves 13 to 19 Verify the correct operation of these valves 3 Valves 20 to
185. n Results of current analysis are automatically displayed as shown Flags appear on a tree view mode based on five categories Morphology Flags Analyzer Alarms Suspected Pathologies Quality Assurance Flags Remarks These flags are listed in 5 3 Flags page 4 29 Results can be reviewed by selecting the Results function see 6 1 Reviewing sample re sults page 4 47 Pentra 80 User Manual RAB108E 4 27 Pentra 80 v Zoom in feature A zoom feature is available for each parameter graphic RBC PLT BAS LMNE by selecting the histogram or matrix representation see Fig 4 20 page 4 28 PENTRA 80 ISTAT Model as R Unknown f TL Mx ea Fig 4 20 Result display zoom Select the Return key to return the display to normal 4 28 Pentra 80 User Manual RAB108E Workflow Run results and associated Flags 5 3 Flags Flags are divided up into 5 different groups Flags linked to results that exceed the normal parameter limits 5 3 1 Normal and panic ranges page 4 30 e Flags linked to results that exceed the linear range of the instrument that leads to Re jected Analysis 5 3 2 Results exceeding Linear ranges of the instrument page 4 30 5 3 3 Analysis reject page 4 31 e Flags linked to an abnormal morphology in the blood cell populations 5 3 4 LMNE matrix flags page 4 32 5 3 5 Flags on WBC BAS histogram page 4 38 5 3 7
186. n short rinsing sequence of the counting chambers Concentrated Cleaning Thorough cleaning of the chambers with a bleach solution see Clean Cycles page 7 33 Autoclean Automatic Cleaning cycle This can be automatically run every n analysis cy cles see 5 5 Cycle option page 5 25 as well as a Super User sub menu see 5 Super User menu description page 7 22 Pentra 80 User Manual RAB108E 7 21 Pentra 80 5 Super User menu description When the user enters the Super User Menu screen the following menus will be available to the user 3 menus are available to the user for maintenance intervention on the instrument 5 1 Mechanical menu page 7 23 5 2 Hydraulical menu page 7 30 5 3 Others page 7 35 PENTRA 80 Super User Menu MOM ESET eal ah aj Ah A SKR 1 SSE 05 14 2002 11 33 12 Fig 7 27 Super User menu 7 22 Pentra 80 User Manual RAB108E Maintenance amp Troubleshooting Super User menu description 5 1 Mechanical menu 5 1 1 Instrument Initialization PENTRA 80 Mechanical System 0 Ba Ns PAI a y200211 33 14 Fig 7 28 Super User Mechanical Initialization Now select the Initialization key and then select the Run key to start the initialization cycle This cycle will place all mechanical assemblies in a ready for analysis position This will be a starting state for the Auto sampler Sampling probe samp
187. n 2002 04 04 07 41 00 7 3 4 67 13 8 39 5H 85H 29 7 Admin 2002 04 04 08 02 09 7 5 4 61 13 9 38 8 84H 30 1 Admin 2002 04 04 10 04 53 6 7 4 66 13 9 38 2 82 29 8 Admin 2002 04 04 10 07 47 6 6 4 68 14 0 38 7 83 23 9 4 Filter DIFF CBC or All On Bi parameters Laas CBC 5 Use sliders to view all beau Selected Analysis parameters 2 Operator that processed the control runs 3 Date and time that the QC run was processed IL IITIIITAR T 4 80 te 4 65 13 9 37 1 80 29 6 6 2 4 50 13 4 35 1 76 27 8 71 4 70 139 39 3H 64 29 5 0 1 0 05 0 0 2 2 4 0 3 0 3 0 06 0 12 0 65 1 19 0 42 4H 1 21 0 85 1 65 1 42 1 41 6 This field will display all comments associated with the specific QC run Click on the individual results line so that it will display it in Grey Fig 3 4 QC grid screen Standard deviation Coef of variation 7 This field shows the number of QC runs selected from the Check boxes Results are displayed in red when they are greater than the upper limits in blue when they are lower than the lower limits Rejected analyses are not stored in QC A notification of rejection is entered in the A logs v Statistics For selected results e Mean values are displayed in red when they are greater than than the upper limits in blue when they are lower than the lower limits The coefficients of variation are displayed in red when they are greater than the coeffi cients set by the operator
188. n VD 34 ABX 05 13 2002 11 39 53 Fig 7 6 Reagent Level Select the OK key to accept the changes see Fig 7 7 page 7 10 PENTRA 80 Reagent Reagent ABX ALPHALYSE Lot Nb 0302 10K2 0 Capacity ml 400 Level ml 400 Change Date 05 13 2002 11 01 38 Expiration 01 10 2003 11 01 38 Operator aBx Use barcode reader Replace reagent bottle before pressing this button Version VO 34 ABX 05 13 2002 11 40 02 Fig 7 7 Reagent replacement validation Once the OK key has been selected the instrument automatically primes the reagent see Fig 7 8 page 7 11 7 10 Pentra 80 User Manual RAB108E Maintenance amp Troubleshooting Replacement procedures PENTRA 80 Reagent Fig 7 8 Reagent priming 2 1 3 Waste container replacement Unscrew the waste container cap Replace waste container according to your laboratory s protocol Close the empty container with the cap and dispose of waste liquids according to your lo cal national organizations 2 2 Optical bench lamp replacement 2 2 1 Lamp replacement A Wait for the lamp to cool down before handling it Power off the instrument Open the instrument left hand and right hand side panels lift the top cover of the instrument as well see 3 Instrument panels amp cover Removals page 7 18 Locate the Optical bench at the top left of the instrument see Fig 7 9 page 7 1
189. nalytical sensitivity diagnostic sensitivity analytical specificity diagnostic specificity accuracy repeatability reproducibility including control of known relevant interference limits of detection limitations of the method and information about the use of available reference measurement procedures and materials by the user see Section Specifications in the instrument User Manual 2 Conservation amp Expiration Storage conditions Stored at 18 C 65 F to 25 C 77 F Expiration date refer to expiration date reagent packaging label 3 Measurements principles amp results Directions for use see Section Maintenance amp Troubleshooting Reagent Location and connexion in the instrument User Manual Measuring Principles see Section Description amp technology in the instrument User Manual Results see Section Workflow in the instrument User Manual Performance data see Section Specifications in the instrument User Manual Note if performance changes call your ABX Diagnostics representative S A au Capital de 44 000 000Euros RCS Montpellier 328 031 042 SIRET 328 031 042 000 42 APE 332 B Explore the future 4 Composition amp Handling precautions Composition Organic Buffer lt 0 2 Proteolytic Enzyme 0 2 pH 9 6 0 4 T 20 C Resistivity 72 2 Q T 20 C Description Transparent liquid Handling Precautions Avoid contact with e
190. nical specificatiOnS oooooo 8 2 LL Paramete en ena 8 2 1 2 Throughput Analyses ooooWo Wo Woo oma 8 3 1 3 Tube identification ooo oo Woo man 8 4 1 4 ReagentS ooo Wo Wo om momen 8 4 Tn era Co Ri 8 4 1 6 Measurements and computatiONn ooooW oo oo 8 4 2 Physical SPeCITI CANON Ss ai anamnesis 8 5 2 1 Power reguirements ooWoo mbah 8 5 2 2 Operating temperature and humidity oooooo 8 5 2 3 Dimension and weight ooo ooWoW Woo 8 5 2 4 Minimum SPECIMEN VOLUME oo WWW mh 8 5 ZOO ONO At Oa stone abi kie 8 5 2 60 AG Bm asune Men sana aan 8 5 2 7 Counting aperture diameters oooo Woo 8 5 2 8 Reagent CONSUMPTION MI W Woo W mma 8 6 2 9 Recommended Anticoagulant oo oWoWo Woo 8 6 3 Summary of performance data ooo WooWo 8 7 3 1 Precision Reprodudcibility oooooWo Woo 8 7 3 2 Precision Repeatability ooooWoooommmm 8 8 EEE e Ya aa abu 8 9 Biel OVER sesaat besok eo Eti mena Sa bass 8 10 39 Normal al ena AN an ana 8 11 BPO CC V ANN nan na na Ann EN 8 11 3 7 Leukocyte differential COUN o oo 8 12 3 8 Sample stability study o WWW Woman 8 12 3 9 Waste handling precautions ooooWo Woo 8 13 A LATIN AN on naa 8 14 4 l Manten CO atm Mean asa autis 8 14 4 2 BIO0G SPECI MEN San ke anta 8 14 4 3 Known Interfering substances cccceesseseeseeseeeeeeenees 8 14 5 Reagent Specific
191. nt Patient ID Patient Name First Name Date of Birth Age Gender JONES Marleen 03 05 1970 32 A Female ELEONOR MIKA 10 06 1984 174 Male Fig 4 11 Search patient window The Patient Name field enables the operator to view the Alpha or Numeric character se quencing as it is being typed As each character is being typed the Grid refreshes and displays the Patient list that corresponds to the characters entered When a specific Patient Name is located select the OK key to exit the screen and return to the Worklist 4 18 Pentra 80 User Manual RAB108E Workflow Worklist 2 3 7 Printing out the worklist Selecting the Print Send key from the Contextual toolbar will print out the Worklist Grid The following window appears see Fig 4 12 page 4 19 PENTRA 80 Fig 4 12 Worklist printout window A Full printing and Light printing mode are available v Full printing Order informations are printed out in the grid mode Patient clinical sample see Fig 4 13 page 4 19 Worklist AUTO SID13 Standard Unknown se e AUTO SID14 Standard Unknown Technician e e e Fig 4 13 Worklist grid printout v Light printing A light printout of the Worklist one order by line is also available Select the Light printing option and press the OK button see Fig 4 14 page 4 19 Worklist po ss aopa te n S d pasa test oF Standard gihikidsogkt auro PDS
192. nt 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 dailyinstrument quality control See performance characteristics An expression in percent of data SD spread related to the mean CV SD mean x100 A substance used for monitoring the performance of an analitycal process or instrument See Coefficient of variation An original factory setting The last day that you can use that specific lot number of reagent control or calibrator Abbreviation for femtoliter One quadrillionth 1015 of a liter An area on a screen for entering data on printouts or screens letters or symbols that appear next to parameter results to indicate specific conditions The ability of an instrument to recover expected results reference values or calculated values for such parameters as WBC RBC Hgb and Plt at varying levels of concentration of these parameters within specified limits Abbreviation for Laboratory Information System A manufacturer s code that identifies products such as reagents controls or calibrators Arithmetic average of a group of data Set of data used for the request of the analytical process Pentra 80 User Manual RAB108E Definition Index amp Glossary Glossary operating range parameter performance Platelet concentrate PRP Quality control QC reproductibility S
193. nt cover 7 18 Pentra 80 User Manual RAB108E Maintenance amp Troubleshooting Instrument panels amp cover Removals 3 2 Right front door removal Pull the Left Front cover down as indicated in 1 and then pull out to remove it as indi cated in 2 see Fig 7 23 page 7 19 Fig 7 23 Right front cover 3 3 Right hand side panel removal Locate the 2 locking screws at the top of the right side panel Place a flat tipped screwdriver into the screw slots and turn counter clockwise to unlock the screws see Fig 7 24 page 7 19 Fig 7 24 Righthand side panel Lift the panel up and out of its placement slot Pentra 80 User Manual RAB108E 7 19 Pentra 80 3 4 Left hand side panel removal Lift the reagent compartment cover to expose the 2 retaining screws on the rear of the left side panel Remove Left Panel by unscrewing 2x CHC M4X6 at the front and loosening 2x CHC M4X6 at the rear see Fig 7 25 page 7 20 Fig 7 25 Lefthand side panel Now slide the left side panel forward and lift it out of the instrument 7 20 Pentra 80 User Manual RAB108E Maintenance amp Troubleshooting Service menu description 4 Service menu description When the user enters the Service Menu screen the following menus will be available to the user PENTRA 80 Menu 1 Yahi Fig 7 26 Service Menu screen 3 Maintenance Hydraulical cycles are available on this menu Miniclea
194. ntrated cleaning exclusive use Minoclair may also be used as disinfectant and cleaning product on ABX Blood cell counters see Section Concentrated cleaning in the user manual on the following instruments ABC vet Micros 60 Micros CRP Pentra 60 Pentra 60C Pentra 80 Pentra XL80 HORIBA GROUP pentra 80 Index amp Glossary Contents Mee TOSS sob aah 9 2 MAN WAX A NN E NAN 9 4 Pentra 80 User Manual RAB108E 9 1 Pentra 80 9 2 1 Glossary 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 LIS lot number mean order 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 amou
195. nual RAB108E Introduction Software overview 1 19 Pentra 80 Rack Pos Deparment Physician Fig 1 16 data Fields The Edit key must be selected to modify a data field DP 4 4 7 Sliders When data can not be displayed within the same window a horizontal or vertical slider will appear Drag it or click the arrows to move through all the data PENTRA8O Within Run Close tube setting Sampling Number f Selected Analysis 4 Sel Op TestDate wec Rec kas fher mev mcu mche V Admin 2002 03 27 13 20 49 12 7 5 30 9 2 51 5 97 17 4 17 9 MV Admin 2002 03 27 13 21 41 12 7 5 22 31 50 8 97 17 5 17 9 M Admin 2002 03 27 13 22 34 12 9 5 20 9 1 50 6 97 17 5 17 9 M Admin 2002 03 27 13 23 27 13 1 517 31 50 6 38 17 7 18 1 Minimum 12 7 517 9 1 50 6 97 17 4 17 9 Maximum 131 5 30 9 2 51 5 98 17 7 18 1 Mean 12 8 5 22 9 1 50 9 97 17 5 18 0 Standard deviation 0 16 0 05 0 06 0 45 0 2 0 11 0 08 2 Standard deviation 0 33 0 11 0 11 0 89 0 39 0 22 0 15 Coef of variation 1 26 1 04 0 61 0 86 0 2 0 63 0 43 Fig 1 17 Sliders 1 20 Pentra 80 User Manual RAB108E Introduction Workflow overview 5 Workflow overview Connected or not PENTRA80 introduces an exchanged workflow process based on a secure managements of orders whether connected to a Host computer or just by itself see 5 1 Order overview page 1 21 With either configuration the system secures the in formation being processed
196. o expiration date reagent packaging label 3 Measurements principles amp results Directions for use see Section Reagent Location and connection in the instrument User Manual Measuring Principles see Section Technology in the instrument User Manual Results Refer to the instrument User Manual Performance data see Section Specifications in the instrument User Manual Note if performance changes call your ABX Diagnostics representative S A au capital de 44 000 000Euros RCS Montpellier 328 031 042 SIRET 328 031 042 000 42 APE 332 B Explore the future 4 Composition amp Handling precautions Composition Sodium hydrochlorite 4 Sodium hydroxide 0 26 pH 12 9 0 5 T 20 C Resistivity Not available Description Yellowish liquid Handling Precautions Avoid contact with eyes skin and clothing Wear laboratory gloves when handling the product The product may be harmful if ingested or inhaled Keep the bottle closed when not in use Please refer to the MSDS associated with the reagent Specimen Collection and Mixing see Section Specimen collection and Mixing in the instrument User Manual 5 Limitations amp waste disposal Limitations see Section Specifications in the instrument User Manual Safe Waste Disposal Follow your laboratory s protocol when neutralizing and disposing of waste Please refer to the MSDS associated with the reagent 6 Conce
197. ociated with the same patient can be displayed by using the right and left arrows To return to the Patient Result screen select the Return key in the full screen mode 7 4 2 Daily Result screen From the Daily Result screen see Fig 4 47 page 4 56 select the line of the result that you want to display in full screen see Fig 4 51 page 4 60 Other results of the day can be displayed by using the right and left arrows To return to the Daily Result screen select the Return key in the full screen mode PENTRA 80 Archive Running Date 05 27 2002 15 44 36 Testin B pr SampleID le ID REPOR LE i gt Flags and Alarms Y 108 mm3 R SAN Flags ce Suspected Pathology La Ba NRBCs Date of Birth Age 02 02 1973 29A Gender Version v0 35 ABX 1 05 30 2002 10 17 23 Fig 4 51 Archives Result in full page Printing out and or transmitting this result to a host computer is enabled from this screen by selecting the Print Send key 4 60 Pentra 80 User Manual RAB108E Settings Contents 1 Menu Settings Overview 4 oo 5 3 1 1 Accessing the Settings MENU ooo oo oo 5 3 1 2 Menu Settings functi ons Woo 5 3 2 DO Para Oke onta sum 5 4 2 1 Accessing the Soft Parameters Menu 5 4 22s GENEL al an AN NB 5 5 2 2 1 General tab functionalities oo 5 5 2 2 2 Automatic NUMbeTFING oo W oo 5 5 2 2 3 RUO
198. ommended procedures may result in poor reliabil ity of the system 4 2 Blood specimens Verification of any abnormal test result including flagged results or results outside of the normal range should be performed using reference methods or other standard laboratory pro cedures 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 4 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 histo gram with an L1 alarm or as an elevated baseline on the side leading edge of the lym phocytes population Non lysed erythrocytes will cause a falsely elevated WBC count Multiple myeloma The precipitation of proteins in multiple myeloma patients may give high WBC counts e Leukemia A very low WBC count may result from this disease because of possible in creased fragility of the leukocytes leading to destruction of some of these cells during counting These white cell fragments will also in
199. on of results to an external computer can have the following conditions Manual only when the operator requires a transmitted result from the Results screen e Unconditionnal All results will be transmitted Selected criteria the result will not be transmitted to the host if one of the following con ditions is verified 4 one of the checked flags has been triggered 5 a rejected result occurs on one of the checked parameters 6 the results are out of panic or normal limits on one of the checked parameters To select or de select criteria refer to the Rerun tab see 4 2 Rerun conditions page 5 13 5 16 Pentra 80 User Manual RAB108E Settings System 5 System 5 1 Accessing the System screen From the Settings window select the System key Fig 5 15 System screen The System screen includes four tabs for the configuration of Local settings see 5 2 Local settings page 5 17 e Communication see 5 3 Communication page 5 19 Printer see 5 4 Printer page 5 21 Cycle option see 5 5 Cycle option page 5 25 5 2 Local settings This tab allows the date time format modification see 5 2 1 Date and time format page 5 17 and language modification see 5 2 2 Languages options page 5 18 5 2 1 Date and time format Fig 5 16 date time format Select the Edit key then scroll through the Date or Time lists The date formats are as followe
200. ons Physical specifications 2 Physical specifications 2 1 Power reguirements e Power supply from 100 Vac to 240 Vac 10 AN abou EE E eas sane 50 Hz to 60 Hz Power CONSUMPTION Lo Maximum 230 VA Printer west eaawa Depends of printer an Nan NN AAN ANA See printer s manual 2 2 O perating temperature and humidity e 16 34 C 61 93 F room temperature Maximum relative humidity 80 for temperature up to 31 C 88 F decreasing linearly to 50 relative humidity at 40 C 104 F 2 3 Dimension and weight DIMENSIONS ion 82 x 57 x 54 cm PA NA AN AE EN TA 34 1 x 23 3 x 22 in MUA 55 Kg Aa AN NN aes 122 lbs 2 4 Minimum specimen volume CBC Mode OCBC one ena 30ul CBC 5DIFF Mode DIF o ooo ooco co 5 3ul 2 5 dilution ratios Ina rere tT cree 1 200 Ik LIVINE selat eni esa 1 80 PREO PET orenen an I 1 10000 MN E E TE A TT 1 250 2 6 HGB measurement e HGB chamber LED 555 nm e Modified Drabkin method cyanmethemoglobin Light SOUTCE W Electroluminescent diode Wavelenght seerne 550nm 10nm 2 7 Counting aperture diameters WBO BAS 80uMm LMNE oiriin 60um RBC PLT cceccececccseccccsesersesesessereceesesteetevene 50um Pentra 80 User Manual RAB108E 8 5 Pentra 80 2 8 Reagent consumption ml E Estimated Diluent Eosinofix Basolyse II Cleaner y duration s ml ml ml ml CBC DI FF 0 45 27 4 1 0 2 0 1 0 0 45 CBC
201. or a lower level but not at H a higher level Entering the name of the user is done in the login windows Section 2 1 3 Pentra 80 Startup page 2 2 e It s possible to change of user whitout reinitialised the instrument Double click the second box A of the Generic Toolbar see Fig 5 30 User list page 5 31 Fig 5 30 User list Pentra 80 User Manual RAB108E 5 31 Pentra 80 When the Login window appears all the users are displayed Double click the user Enter the password then press the Validate button see Fig 5 31 User password page 5 32 5 32 Pentra 80 User Manual RAB108E Settings Sample Types 8 Sample Types 20 different blood sample types are available 8 of theses sample types have already been Incremented Standard Man Woman Child1 Child2 Child3 Child4 and Child5 The Types screen will allow the operator to create the following changes a new type see 8 1 Accessing the Types parameters menu page 5 33 Pathological limits see 8 2 Pathological limits page 5 36 Alarm levels amp curve thresholds see 8 3 Alarms amp Curve thresholds page 5 37 8 1 Accessing the Types parameters menu From the Settings window select the Type key N ele a rs o 11 YIS N alalaaji TE o RA aa ae 250 si 0 ai 0 ic Dao oo 70 __ Le 0700 50 450 _180_ j0 2 00 j0 150 03 T
202. or to calibrate PENTRA 80 Follow the calibrator package insert for proper instructions on mixing and handling of the product If a new lot needs to be entered into the system follow the procedure as described in 4 2 Target values page 3 26 Open the Calibration Grid as described in Accessing the Calibration Main Menu page 3 25 Select the Stat Mode key Gently mix the calibrator and place it into the appropriate position in the tube holder Now close the tube holder doorto run the analysis When the tube holder door opens remove and recap the vial for pre mixing of the next cycle Calibration results may be erroneous if the calibrator is not mixed properly between each analysis cycle Once the analysis is complete the first result is displayed in the Results Grid Run the calibrator 4 more times The Minimum number of sampling is 5 for good statistical calculations The calibrator may be run from 1 to 99 times if needed Section 5 3 3 Number of calibration runs page 5 12 Pentra 80 User Manual RAB108E 3 27 Pentra 80 PENTRA8O Calibration ean ala Sec op letDae wec jrec Hos faer jm a caL 1 Admin 2002 04 02 15 0320 9 6 4 67 H 137 37 2 256 Lot MA Barcode F Admin 2002 04 02150416 36 4 56 136 36 4 263 Cx318 Admin 2002 04 0215 05 12 97 4 59 135 36 7 269 M Admin 2002 04 0215 06 03 97 4 58 135 36 8 269 Expiration date Vo Admin 2002 04 0215 0857 97 4 64 H 13 7 37 1
203. orkflow Run results and associated Flags 5 3 10 Pathology messages Pathological suspicion messages will be displayed and or printed out The triggering condi tions are linked to the laboratory limits that were entered by the user These messages will indicate a possible pathological condition and should be used A to assist with quick and efficient screening of abnormal samples along with detec tion of certain conditions that lead to specific diagnosis It is recommended to use known reference methods to confirm diagnoses v WBC Messages M essage 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 E0S H or if EOS 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 Lymhocyte ALY gt ALY H or ALY gt ALY H Left Shift MN or NL and RN Monocytosis MON gt MON H or if MON gt MON H Basophilia BAS gt BAS H or if BAS gt BAS H Blasts BAS gt BAS H and LIC 5 LIC H and RM Interpretation Not possible WBC lt 0 1x102 mm or WBC gt 85 0x103 mm or CO alarm Tab 4 6 WBC pathology messages H extreme high limit L extreme low limit Indicates that the pathology is
204. orpuscular Hemoglobin MCHC Mean Corpuscular Hemoglobin Concentration RDW Red Distribution Width PLT Platelets PDW Platelets Distribution Width MPV Mean Platelet Volume PCT Plateletcrit Tab 8 2 DIF parameters PCT PDW ALY and LIC have not been established as indications for this product in the United States The use of PCT PDW ALY and LIC should be restricted to research and Investigational measurements only 1 2 Throughput Analyses e 80 samples per hour Pentra 80 User Manual RAB108E 8 3 Pentra 80 1 3 Tube identification e By means of Keyboard internal and external Barcode 1 4 Reagents e ABX DILUENT 20 Litres e ABX CLEANER 1 Litre Integrated e ABX EOSI NOFI X 1 Litre Integrated ABX BASOLYSE II 1 Litre Integrated ABX Lyse 0 4 Litre Integrated 1 5 Internal Computer Capacity 10 000 results graphics Color LCD touch screen 12 inches Industrial PC board Windows NT 4 0 Processor freguency oo Celeron 433 MHz Memory capacity Lema 128 Mo Ne Hard drive am mera 4 5 Go mini Floppy disck e CD ROM drive RS 232C Keyboard e Mouse 1 6 Measurements and computation e Impedance for WBC PLT RBC BAS Photometry for HGB Impedance and light scattering for LYM MON NEU EOS ALY and LIC Computation from stored data that was directly measured for HCT MCV MCH MCHC RDW MPV PCT and PDW 8 4 Pentra 80 User Manual RAB108E Specificati
205. ounts and increase MCV HGB Hemoglobin Turbidity of the blood sample Any number of physiological and or therapeutic factors may produce high incorrect HGB results To obtain accurate hemoglobin results when in creased turbidity of the blood sample occurs determine the cause of the turbidity and fol low the appropriate method below e High WBC An extremely high WBC will cause excessive light scatter In these cases use reference manual methods The diluted sample should be centrifuged and the superna tant fluid measured with a spectrophotometer High lipid concentration A high concentration of lipids in the blood sample will give the plasma a milky appearance This condition can occur with hyperlipidemia hyperpro teinemia as in gammapathies and hyperbilirubinemia Accurate hemoglobin determina tions can be achieved by using reference manual methods and a plasma blank e Increased turbidity may also be seen in cases where the red blood cells are resistant to Iysing This condition will cause an incorrect high HGB result but may be detected by ob serving the abnormal MCH MCHC values and the increased baseline on the leading edge of the WBC histogram Erroneous hemoglobin results will cause the results of the MCH and MCHC to be incorrect as well e 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 inac
206. over open Front cover open Run an initialization 8 3 STAT mode error type and help message Alarm Error Type Help Message Tube holder mechanism failure Door not open No message 8 4 Environment Error Types and Help Messages Alarm Error Type Help Message 0 23 INSEE UM EN SESS Incoherent Results Run an initialization Communication With Analyzer Pe eee Cut Off System Run an initialization coun Eakin Wana yes System Run an initialization Failed SUC amp UCR ie Sensor state Run an initialization Error Error on raw results sending Result failed Run an initialization ay SUR UC eo Sensor state Run an initialization i eee ea engines Sensor state Run an initialization come Se ong Sl Sensor state Run an initialization a SU Pa Sensor state Run an initialization Loader Left Sensor Error Sensor state Run an initialization Loader Right Sensor Error Sensor state Run an initialization 7 46 Pentra 80 User Manual RAB108E Alarm Lower Piercing Sensor in Wrong Position Mismatch Between the First and Second Barcode Tube Read on Rack d Pos d No diluent in analyzer reservoir Printer alarm Printer module closed QC Failed Rack Moving Left Sensor Error Rack Moving Right Sensor Error Rack not identified Reagent level too low for daily workload Reagent level too low to run a analasys Reagent level too low to run a rack Result not stored RS232 alarm Sample ID d already in progress LIS communication modul
207. parameters oo o Wo Jo Woo oom mm 5 5 2 2 4 Instrument k05 ma kemanan 5 6 2 2 5 Identification Option marah 5 6 2 3 Department Physicians tab ooo Woo 5 7 2 UNIES an vb ai 5 8 3 Quality assurance SettiNngS oWoWooo 5 10 3 1 Accessing the OA settingS oWoW oo 5 10 ABONU Sona Maa ai 5 10 3 3 Number of calibration TUNS ob man 5 11 3 4 Coefficients of variation rangeSs o oo oo 5 11 4 RUGS sarana 5 12 4 1 Accessing the Rules screen ooooW oom W 5 12 4 2 Rerun Conditions enakan Mana mma Rein Par 5 12 4 2 1 Rerun ON alarMS oooo Wo oo 5 13 4 2 2 Rerun by parameters ooo oomo ooo 5 13 A3 Pn on 5 14 4 4 Transmit conditions Woo 5 15 Io Ay SUCH seacodsnccaeanten ante E an E n no anna Nani 5 16 5 1 Accessing the System screen oo WWW 5 16 5 2 Local settingS ooooW oo Woo Woo 5 16 5 2 1 Date and time format ooooo Wo oooo 5 16 5 2 2 Languages OptIOnS ooo oooWoW W oom 5 17 5 2 3 Change date and time 5 17 3 3 COMMUNICA Oia aa Ra ala anata 5 18 5 3 1 R5232 settings ta samaan 5 19 5 3 2 ABX ASTM format tab ooo ooWo o ooWo 5 19 PAPATO use ae 5 20 5 4 1 Printout example Woo oo 5 22 5 4 2 Printer properties Woo Woo 5 23 DO VEILS OD VOM Ma raa aan NN NN NA AN EN EA 5 24 6 Save and restore ooWoWoW Woo Woman 5 25 6 1 Access to Save Restore screen
208. pediatric areas The child type range is displayed in purple The low range of a child n 1 begins at the high range of child n 1 day The date format of the range is as followed xx year xx month xx day To modify the range of one child select the Edit key Move left right the cursor of the child type to display the wished high range Select the OK key to confirm your range selection Pentra 80 User Manual RAB108E 5 41 Pentra 80 5 42 Pentra 80 User Manual RAB108E Description amp Technology Contents 1 Pentra 80 desCcriptiOn oo oo on 6 2 le se OI ena Son Bin 6 2 1 2 Left side VIe W na Aa 6 2 1 9 RIONC SIGS ea 6 3 1 4 Stat tube holder oo Woo Wo WWW Wan 6 3 Io ai VON aa ana naa aa 6 4 2 Automatic mode principleS ooooWo Wo Woo 6 5 3 Measuring principles ooWo oo oocan 6 9 3 1 Multi distribution sampling sytem MDSS oo 6 9 3 1 1 CBC MOO C cian NAN NAN AA ANA 6 9 22 DIN Ne esa eer ne eee 6 9 3 1 3 Sample distribution ooo ooWoWoWoo 6 10 3 2 CBC detection principleS o oo Wo Woo 6 11 32 1 RB CPL oi el mana nanas 6 11 3 2 2 HGB Measurement ncc 6 12 3 2 3 HCT Measurement 6 13 3 2 4 RDW calculation 6 13 3 2 5 MCV MCH MCHC calculation 6 13 3 2 6 MPV Measurement 6 13 3 2 7 Pet Calculation oo mn 6 13 3 2 8 PDW calculation en ie om banda 6 14 3 3 WBC and differential COUnt ooooooooo 6 15
209. pentra 80 User M anual ABX Diagnostics B P 7290 34184 MONTPELLIER Cedex 4 FRANCE DIAGNOSTICS Revisions All RAB108BA V1 0 17 06 02 RAB108CA RAH 912 AA V1 01 All 01 08 02 RAB108DA RAH 938 AA V1 1 4 and 8 16 12 02 RAB108DB ECR1354 UL Correction 8 01 09 03 RAB108EA RAH 986 AA V1 3 0 CE Ivd labelling corrections All 07 11 03 This document applies to the latest higher software version When a subsequent software version changes the information in this document a new issue will be released v Notice of liability 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 ABX Diagnostics 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 the instructions contained in this manual or by the computer software and hardware products described herein v Trademarks Microsoft and Windows are registered trademarks of Microsoft Corporation Other product names mentioned within this publication may be trademarks or registered trademarks of other com panies v Graphics All graphics including screens and printouts photographs are for illustrations purposes only and are not contractual v Potentials hazards To alert the operator of potentially hazardous conditions one of the bold captioned headings which are described below is
210. phs Chap 3 6 Languages Chap 5 16 Limitations Chap 8 11 Linearity Chap 8 6 Pentra 80 User Manual RAB108E Index amp Glossary Index 9 5 Pentra 80 Logs Chap 1 11 Chap 5 6 M Main functions Chap 1 11 Maintenance Chap 7 3 chart table Chap 7 3 Manual match on Exception Chap 5 6 Manual Rerun Chap 4 50 MCV MCH MCHC calculation Chap 6 12 MDSS Chap 6 9 Measuring principles Chap 6 9 CBC detection principles Chap 6 10 LMNE Matrix Chap 6 15 WBC and differential Chap 6 14 Mixing Chap 4 24 MPV Measurement Chap 6 12 N Normal and panic ranges Chap 4 30 O Optical bench Chap 6 2 Optical bench lamp replacement Chap 7 9 Order overview Chap 1 16 Order amp runs association Chap 4 46 P Panels amp cover dismantling Chap 7 13 Pathological limits Chap 5 31 Pathology messages Chap 4 43 Pct Calculation Chap 6 12 PDW calculation Chap 6 13 Prime cycles Chap 7 23 Print conditions Chap 5 13 Printer Chap 1 22 Chap 5 19 connector Chap 6 4 Printout Chap 5 21 properties Chap 5 19 Printout Chap 4 26 9 6 Pentra 80 User Manual RAB108E Q Quality Assurance Chap 1 11 access Chap 3 3 Coefficients of variation ranges Chap 5 10 Number of calibration runs Chap 5 10 settings Chap 5 9 XB options Chap 5 9 Quality control Chap 3 4 access Chap 3 4 Delete results Chap 3 9 Graphics Chap 3 8 keys Chap 3 5 L J Graphs Chap 3 6 Print results Chap 3 9 Run Chap 3 13 screen grid Chap 3 7 Send results Chap 3 10 Ta
211. plex gra nularity and staining High absorbance Fig 6 19 Absorbance measurement Pentra 80 User Manual RAB108E 6 17 Pentra 80 v Results From the Absorbance and Resistive measurement of the leukopcytes a matrix is developed with cell volumes on the X axis and optical transmission on the Y axis Study of the matrix Image allows a clear differentiation of 4 of the 5 leukocyte populations Due to the low per centage of Basophils in comparison to the rest of the leukocytes they have a separate measurement of their own instead of being present in the matrix NEUTRO PHILS EO SINO PHILS LYMPHOCYTES MONOCYTES Ly ATYPICAL LYMPHOCYTES ALY LARGE IMMATURE ig CELLS LIC Fig 6 20 LMNE matrix results LYMPHOCYTES The Lymphocytes are a very small round shaped cell with condensed cyto plasm and large nucleus These cells are normally positioned in the lower part of the optical Y axis as well as the lower part of the volume X axis because of their small size The far left side of the lymphocyte zone LL should normally be empty Any detection of cells in the LL zone will indicate Small lymphocytes Platelet aggregates NRBCs Nucleated Red Blood Cells and improperly adjusted flowcell alignment Background noise may also be detected in this zone if the interference is great MONOCYTES The Monocytes are a very large irregular shaped cell with large convoluted nu clei The nucleus contains folds and som
212. re Tab 1 2 Contextual toolbar Keys 1 14 Pentra 80 User Manual RAB108E 4 2 Contextual toolbar description Introduction Software overview The Contextual toolbar function keys are accessed from the toolbar located on the right side of the screen These function keys are the most freguently used besides the Main Cycle Launch keys O Stop Stops the analyzer Q Alarm Launches Alarm menu a Worklist Opens Worklist rT Start Rack Runs the automatic mode Stat Runs the manual mode Results Opens results menu Opens Archives menu Tab 1 3 Generic toolbar keys Archives Pentra 80 U ser M anual RAB108E Flashes when an alarm is triggered See Section 7 8 Error messages page 7 43 Displays the number of orders See Section 4 2 Worklist page 4 14 See Section 2 3 Running specimen page 2 9 See Section 2 3 Running specimen page 2 9 Displays the number of results See Section 4 6 Order amp sample run association page 4 47 See Section 4 7 Results Archives page 4 55 1 15 Pentra 80 4 3 Main Menu description Access to the main functions of the system Startup Shutdown Logs Ouality Assurance Run in Progress Status Services Settings Tab 1 4 Main menu function keys 1 16 Runs the startup cycle Runs the shutdown cycle Launch the Logs menu Launches the Quality Assurance menu Launches the Run in Progress
213. relative to laboratory re agents used for biological analyses 2 Or approved in accordance with the European Directive 98 79 CE Annex III for in vitro medical devices Please refer to the packaging of each reagent concerned to establish the approval method v Waste handling precautions When disposing of waste protective clothing must be worn lab coat gloves eye pro tection etc Follow your local and or national guidelines for biohazard waste dis posal If required waste can be neutralized before being discarded Follow your laboratory s protocol when neutralizing and disposing of waste Dispose of the waste container according to the local or national regulatory requirements 5 1 Reagent Leaflets See ABX Basolyse II page 19 See ABX Cleaner page 21 See ABX Lysebio page 23 See ABX Alphalyse page 25 See ABX diluent page 27 See ABX Eosinofix page 29 See ABX Minoclair page 31 8 18 Pentra 80 User Manual RAB108E ABX Basoluse II O Exclusive use Hematology ABX device Micros 60 ABC Vet Micros CRP Pentra 60 Pentra 60 C Pentra 80 Pentra XL 80 Pentra 120 Pentra 120 Retic Pentra DX 120 Hematology ABX Devices for in vitro diagnostic use 12 05 03 A95A00002 A 0906003 1L 1 CE etal ABX Diagnostics BP 7290 34184 Montpellier cedex 4 France Exclusive TSS S Slide Preparation System 1 Functions Erythrocyte lysing reagent for white bloo
214. rgets Chap 3 10 R Rack Chap 1 7 Identification Number Chap 1 7 RDW calculation Chap 6 12 Reagent Chap 6 2 Chap 8 3 consumption Chap 8 5 cover Chap 6 2 Diluent and waste connections Chap 6 4 replacement Chap 7 4 Reagent Syringe Chap 6 2 Repeatability Chap 8 6 Rerun conditions Chap 5 11 Result display Chap 4 49 Result screen Chap 4 27 Results Chap 2 10 Results orders matching Chap 4 53 Run in Progress Chap 1 11 Run QC Chap 2 4 Running specimen Chap 2 7 RUO parameters Chap 5 5 S Sampling position Chap 6 4 Pentra 80 User Manual RAB108E Index amp Glossary Index 9 7 Pentra 80 Sampling probe replacement Chap 7 11 Sampling syringe Chap 6 3 Save Restore Chap 5 24 Search patient Chap 4 19 Services Chap 1 11 Settings Chap 1 11 Chap 5 3 Access Chap 5 3 General tab Chap 5 5 Identification option Chap 5 6 Save Restore Chap 5 24 Soft parameters Chap 5 4 system Chap 5 15 thresholds Chap 5 32 User profiles Chap 5 26 Shutdown Chap 1 11 Chap 2 12 Soft parameters Chap 5 4 Software Chap 1 8 arborescence and Hints Chap 1 12 overview Chap 1 8 Specifications Chap 8 2 Parameters Chap 8 2 Physical Chap 8 4 Reagent Chap 8 7 technical Chap 8 2 Startup Chap 1 11 Chap 2 2 automatic Chap 2 3 Statmode Chap 2 8 Status Chap 1 17 Super User menu Chap 7 16 Check motors Chap 7 17 Check Sensors Chap 7 19 Check valves Chap 7 18 Holder adjustment Chap 7 21 Hydraulical Chap 7 23 Mechanical Chap 7 17 Rack adjustment Chap 7 22
215. ria E E E 2 15 5 1 Searching results by day Wo Wook 2 15 5 2 Searching results by patient oooooWoo W Woo 2 15 6 Instrument ShutdOwN oo Wo oom 2 16 6 1 Manual SMUG OW Mio bai mnta been memahami 2 16 Section 3 Quality Assurance amp Logs le GUA CON TO ta anna ama beta gan 3 4 1 1 Access to the Quality Control MENU oooo W W mm mah 3 4 Na aa 3 6 1 3 QC data screen grid W Woo Woo Woo mbah 3 7 A Ga il CS ee ae ini 3 8 1 5 Print send or delete reSUIts ooooooWo Wo Wc oom 3 9 1 6 New blood control setup oWo Wo WWW an 3 10 1 7 Running control blood ooo oo oo omah 3 13 2 Patient Quality Control XB oo on 3 14 2 1 Access to the XB MENU oooWo W WWW mm mann 3 15 2AB Oa re a ne E 3 16 Zea Bale Gi Ser ep ate ma MAA al aki 3 17 2 Ai Batch CON EN boa asma bin sekar 3 18 2 Ne E 3 19 AN MERU CEM en na 3 20 3 1 Accessing the Within Run Data GTIG oooo oo 3 20 3 2 Closed tube sample setting oo Woo 3 22 3 3 RUMMINGCYGIES ccacasiinsasternendasnondaencdeegraaiessemuspiiniaoninsidadiasaninds 3 22 2 al Bra ee E E E 3 25 4 1 Accessing the Calibration Main Menu 3 25 A2 Kargo Val Ie ea an aa anta tatanan usa Gb ind 3 26 4 3 Running Cal Drag On kerana ia oa aman aan 3 27 Da LO nee ee ee ree re 3 32 5 1 Access to Logs TUNCT ON kes ee emil bah st ia Ba 3 32 an gt Gaile UOMO OS sn ao nenen tanaman edeier 3 34 5 3 Quality control 10GS oooo oa 3 34 5 4 R
216. s 4 1 Printing a result series page 2 13 4 2 Unmatched results page 2 14 Results of the day can be reviewed by selecting the RESULTS key on the generic toolbar located on the right vertical portion of the touch screen PENTRA 80 Results Cc l Default M Extreme Default m FT Alarmed C Not Printed Ll M Normal Default Values T Not Transmitted SIS Date of Birth Testi Running Date D AN E Unknown DIFF 05 13 2002 12 02 16 M M M M M C Unknown DIFF 05 13 2002 13 49 08 M M M M M D Unknown DIFF 05 13 2002 14 01 22 D M M M M C a LP Marleen Female 03 05 1970 CBC 05 15 2002 14 36 13 D M M O M C 1 4 Vv MIKA Male 10 06 1984 DIFF 05 15 2002 14 36 59 D MM KP rr Pe if 4 Bir of z nant j B A Be Re Mw AAAA ARA Version VO 34 Technician 05 15 2002 14 52 46 4 1 Printing a result series Place a Check in the Selected column of each result to be printed Selcet the PRI NT SEND key of the Contextual toolbar and select a printing option Pentra 80 User Manual RAB108E Daily Guide Results 2 13 Pentra 80 4 2 Unmatched results Unmatched results are sample results that are not mat ched to a Worklist order These results can be reviewed by selecting the ASSOCI ATION key 2 14 Pentra 80 User Manual RAB108E Daily Guide Archives 5 Archives 5 1 Searching results by day page 2 15 5 2 Searching results by patient page 2 1
217. s Composition Hydrochloric Acid 0 03 Detergent 0 5 pH 2 4 0 2 T 20 C Resistivity 61 2Q T 20 C Description Colorless aqueous solution Handling Precautions Avoid contact with eyes skin and clothing Wear laboratory gloves when handling the product The product may be harmful if ingested or inhaled Keep the bottle closed when not in use Please refer to the MSDS associated with the reagent Specimen Collection and Mixing see Section Workflow in the instrument user manual 5 Limitations amp waste disposal Limitations see Section Specifications in the instrument User Manual Safe Waste Disposal see Section Specifications in the instrument User Manual Please refer to the MSDS associated with the reagent HORIBA GROUP ABX Cleaner O Exclusive use Hematology ABX device Micros 60 ABC Vet Micros CRP Pentra 60 Pentra 60 C Pentra 80 Pentra XL 80 Pentra 120 Pentra 120 Retic Pentra DX 120 Hematology ABX Devices for in vitro diagnostic use 12 05 03 A95A00012 A 0903010 1L 1 CE etal ABX Diagnostics BP 7290 34184 Montpellier cedex 4 France Exclusive KORO OK NK S Slide Preparation System 1 Functions Enzymatic solution with proteolytic action for the cleaning of ABX blood cell counters Measurement procedure to be followed in using the device Principle of the method specific analytical performance characteristics a
218. s remove and recap the vial If any parameter results and or any statistical data are displayed in red perform the following steps l Verify that the analyzed QC results correlates with control lot scrolling list If they do not match perform a control identification procedure See Section 3 1 6 New blood control setup page 3 10 2 Rerun the control material 3 Perform a concentrated cleaning on the system See Section 7 5 2 4 Clean Cycles page 7 33 then rerun the control material again Exit the Quality Assurance screen Pentra 80 User Manual RAB108E Daily Guide Running specimen 3 Running specimen 3 1 Sample identification with internal barcode reader page 2 9 3 2 Non identified sample with external barcode reader page 2 9 3 3 Stat mode page 2 11 3 4 Run in progress page 2 12 3 1 Sample identification with internal barcode reader Position the sample tubes into the cassettes as indi cated in the picture barcode label facing out and to the front Place the cassette into the rack loader Press the START RACK key 3 2 Non identified sample with external barcode reader Select the WORKLIST key Then the RACK VIEW key With use of the external barcode reader select the es rack Number NN rack identification label and press the ENTER key o le lt a once the label has been identified ole Select the position of the tube in the rack that you 4 want
219. screen see 5 7 Error logs page 3 35 Launches Blank cycle log screen see 5 9 Blank cycle logs Blank cycle ees Tab 3 5 Logs access keys Pentra 80 User Manual RAB108E Logs 3 33 Pentra 80 v Logs function key Function Opens a comment window The user can enter a com AddComments Add comments ment to associate to the Logs entry on which he is positioned permits to the user to print the current logs as a list a a between two dates Tab 3 6 Logs function keys 5 2 Calibration logs EC l e aA A Version v0 36 Technician Fig 3 31 Calibration logs For every calibration a notification is done in this log new coefficients display For a LMNE channel calibration a notification is done For every target change a notification is done For every rejected analysis in calibration a notification is done When an analysis is launched with an expirated calibrator a notification is done 5 3 Ouality control logs Every time that the QC targets are changed a notification is done 3 34 Pentra 80 U ser Manual RAB108E Q uality Assurance Logs e Every time that an analysis made on a QCis rejected a notification is done 5 4 Reagent logs For every reagent change a notification is done 5 5 Settings logs At every modification in the settings a notification is done 5 6 Maintenance logs e For every maintenance a
220. screen grid page 3 7 Pentra 80 User Manual RAB108E ti j 7 If any parameter results and or any statistical Data are displayed in RED perform the following steps 1 Verify that the analyzed QC results correlates with control lot scrolling list If they do not match perform a control identification procedure See Section 3 1 6 New blood control setup page 3 10 2 Rerun the control material 3 Perform a concentrated cleaning on the system See Section 7 5 2 4 Clean Cycles page 7 33 then rerun the control material again Exit the Quality Assurance screen 2 2 Open tube Select the Quality Assurance Quality Control QC grid Select the control lot number and verify its iden tification scrolling list When a control name or lot number does not exist perform a control identification procedure See Section 3 1 6 New blood control setup page 3 10 Press the STAT MODE key Dally Guide Running the ABX Quality Control Lot db Barcode loca M Reserved KDI Control Name onrar 1 CBC J Pentra 80 U ser Manual RAB108E 2 7 Pentra 80 2 8 Place the control vial in the appropriate position of the tube holder and close the TUBE HOLDER DOOR The Cap of the ABX DI FFTROL allows for cap piercing If you do not want to pierce the cap re move it and proceed by placing the sample and closing the tube holder door When the tube holder door re open
221. sed when not in use Please refer to the MSDS associated with the reagent Specimen Collection and Mixing see Section Workflow in the instrument User Manual 5 Limitations amp waste disposal Limitations see Section Specifications in the instrument User Manual Safe Waste Disposal see Section Specifications in the instrument User Manual Please refer to the MSDS associated with the reagent HORIBA GROUP ABX Alphalyse O Exclusive use Hematology ABX device Micros CRP Pentra 60 Pentra 60 C Pentra 80 Pentra XL 80 Pentra 120 Pentra 120 Retic Pentra DX 120 Slide Preparation System Hematology ABX Devices for in vitro diagnostic use 12 05 03 A95A00009 A 0906004 0 4L 0902010 1L 0 4L or 1L Exclusive m CE padi ABX Diagnostics BP 7290 34184 Montpellier cedex 4 France Pi ee OR a le anon 1 Functions Lysing agent for white blood cell counting and hemoglobin determination on ABX blood cell counters Measurement procedure to be followed in using the device Principle of the method specific analytical performance characteristics analytical sensitivity diagnostic sensitivity analytical specificity diagnostic specificity accuracy repeatability reproducibility limits of detection limitations of the method and information about the use of available reference measurement procedures and materials by the user see Section Specifications in the instrument
222. sfer error types and help messages Alarm Loading motor mechanism not reaching home Loading motor failure Stop rack loading switch not detected Stop rack loading switch detected Sampler Transfer mechanism not reaching home Sampler Transfer motor failure Stop rack Transfer switch not detected Stop rack Transfer switch detected Mixer mechanism not reaching home Mixer motor failure Mixer Bad grabber position Mixer Bad grabber position Rack in wrong side position No rack Maintenance amp Troubleshooting Error type Sampling Syringe Motor Mecha nism initialization failed Thermostated Compartment Tem perature Thermostated Compartment Tem perature Thermostated Compartment Tem perature Thermostatic Compartment Door Error Type Sampler Loading Motor Mechanism initialization failed Sampler Loading Motor home switch always detected Sampler Loading Motor Sampler Loading Motor Sampler Transfer Motor Mechanism initialization failed Sampler Transfer Motor home sen sor always detected Sampler Transfer Motor End trans fer rack switch not detected Sampler Transfer Motor End trans fer rack switch always detected Mixer Motor Mechanism initializa tion failed Mixer Motor home sensor always detected Mixer Motor Grabers sensor posi tion not detected Mixer Motor Grabers sensor posi tion detected Rack in the wrong side in loading area No Rack in loading area
223. sing criteria for calibration l The Coefficients of variation must be within their limits Section 5 3 4 Coefficients of variation ranges page 5 12 2 The percent differences between the Target value and the Mean values must be less than 20 Instrument allows you to select an automatic calibration Press the Automatic calculation key 3 28 Pentra 80 User Manual RAB108E Q uality Assurance Calibration ASPO AN Do you want to calibrate Fig 3 26 Auto calibration validation Select the OK key to confirm the Autocalibration 4 3 2 Forced calibration This is an indication that the current calibration analysis is not within the acceptable limits 1 The Coefficients of variation are greater than their limits 2 The percent difference between the Target value and the Mean values is greater that 20 The calibration is called Forced and a warning message shall request confirmation to continue When running calibration a warning message appears on the screen stating a Forced cal Ibration has been detected another message will appear asking you if you wish to continue the calibration You have the option of continuing or rejecting the calibration at this time 4 3 3 Coefficients of calibration ranges Check that the coefficients of calibration are within the following acceptable limits Or else please contact your ABX DAGNOSTIGS representative department Coefficients of calibration
224. ssed page 3 28 OC Section 3 1 3 QC data screen grid page 3 7 and within run grids Section 3 3 1 Accessing the Within Run Data Grid page 3 20 are mod ifiable within this window Fig 5 9 CV default values Select the EDIT key and highlight the figure you want to modify Enter the new value and select the OK key 5 12 Pentra 80 User Manual RAB108E Settings Rules 4 Rules 4 1 Accessing the Rules screen From the Settings window select the Rules key L E 1 E p amannan mnnn i ey HE ql a j T m m aa 1 ra mi M iii M hip Tu Km Mahi IF TRR mii The Mi ik EL E m E pi i i Uk iN REBAR BE SRR RRR mu m eee p B s SB Bana pe H S i ine a a 2 ine Tn L m Ps x f LE WEEG CEG EEECEECEECE E E E a Ji y T 3 A 2 im Mi z 5 Fig 5 10 Accessing the Rules screen The Rules screen includes three tabs which will enable the operator to configure the fol lowing conditions Rerun conditions see 4 2 Rerun conditions page 5 13 Print conditions see 4 3 Print conditions page 5 15 Transmit conditions see 4 4 Transmit conditions page 5 16 4 2 Rerun conditions In this tab the user has the option of establishing the criteria for sample rerun conditions The re sampling of sample tubes will be based on these criteria Re sampling will be required if a hematological results trigger alarm conditions
225. t Results exceeding the Panic Ranges limits are marked with the following flags H for results above the extreme upper limit L for results below the extreme lower limit 5 36 Pentra 80 User Manual RAB108E Settings Sample Types 8 3 Alarms amp Curve thresholds 8 3 1 Alarm levels Each flag is adjustable according to the numbers entered in the percentage and or an abso lute value field of the parameter The flags are triggered by values exceeding these set numbers Fig 5 36 Standard alarm levels Section 4 5 3 Flags page 4 29 Default values have been incremented forthe 8 types Standard man woman child1 child2 child3 child4 and child5 see 8 1 3 Modifying limit Alarm values page 5 34 Pentra 80 User Manual RAB108E 5 37 Pentra 80 8 3 2 5DIFF Matrix thresholds Each axis of the matrix X and Y is divided into 128 channels numbered from 0 to 127 13 Y vertical indices and 13 X horizontal indices will allow the user to locate these chan nels by multiples of 10 The first index channel of the 5 Diff matrix is the origin at the bottom left corner This is the 0 channel The second channel will be 10 the third channel will be 20 the fourth channel will be 30 and so on The threshold adjustments are expressed in channels Fig 5 37 Matrix thresholds There are only 3 basic reasons to adjust the matrix thresholds see 8 1 3 Modifying limit Alar
226. t the floppy disk into the drive Le Select the Edit key then the Floppy disk key see Fig 3 8 page 3 11 Fig 3 8 Floppy access key Now select the level of control you want to load warning Please selectthe control you want to load C Low Control A Fig 3 9 Load control window If you use a control blood with a Barcode label make sure that the reserved box A has been checked see Fig 3 11 page 3 12 Confirm by selecting the OK key v Manual target value entry Select the Target key see Tab 3 1 Quality Control Keys page 3 5 to open the Target modify window Control Name CONTROL 13 DIFF Lot Mb Barcode pxosen Select the barcode field twice to keep the previous lot select the Edit key Fig 3 10 Control Lot Read the label with the external Barcode reader or manually type in the lot Use the Tab key to move to the next field or entry Confirm your entry by selecting the OK key If you use the control blood with a barcode label make sure that the reserved box has been checked see Fig 3 11 page 3 12 Pentra 80 User Manual RAB108E 3 11 Pentra 80 3 12 Use the scrolling box key to open a calendar and select the expiration date Modify or enter target values by selecting the area in which you want to replace the value Fig 3 11 Control expiration date PENTRA 80 Modify Target fesse
227. tart automatic cycle Check XB in XB screen 7 47 Pentra 80 8 5 User Error Types and Help Messages Alarm Error Type Help Message Instrument stopped by user Run an AutoClean Instrument stopped by user at the end of analysis Run an Initialization Instrument stopped by user at the end of rack 8 6 Expiration Date Error Types and Help Messages Alarm Error Type Help Message Change reagent and restart Reagent s s expired automatic cycle Check OC epiration date and use QC Lot Nb Barcode s expirated another QC Lot 8 7 Analyzer Internal Error Types and Help Messages Alarm Error Type Help M essage Com error on slave d Communication error with slave Run an Initialization Error management failed Unknown cycle Run an Initialization Error on cycle d Run an Initialization Error on start internal chrono Run an Initialization HGB Blank Error Management HGB blank cycle incorrect Run an Autoclean Home Motor d error Run an Initialization Incorrect pos motor carriage l Ng eee eee d Min d Max d Carriage motor bad position Run an Initialization Incorrect pos motor counting d Min d Max d Incor T R sey rect pos motor PRESSURE d Pressure motor bad position Run an Initialization Min d Max d Incorrect pos motor diluter d ah arene Min nd Max Kd Diluter motor bad position Run an Initialization Incorrect pos motor drain 1 d Min d Max d e eee ncorrect pos motor
228. ted Needle Motor Mechanism initial ization failed Piercing Syringe Motor Reagent Temperature Reagent Temperature sensor Reagent Temperature sensor Sampling Syringe Motor home Switch always detected Pentra 80 User Manual RAB108E Help Message Run an Auto Clean Check Motor in Service Menu Run an Auto Clean Check Motor in Service Menu Run an Auto Clean Check Motor in Service Menu Run an Auto Clean Check Motor in Service Menu Run an Auto Clean Check Motor in Service Menu Run an Auto Clean Check Motor in Service Menu Run an Auto Clean Check Motor in Service Menu Run an Auto Clean Check Motor in Service Menu Run an Auto Clean Check Motor in Service Menu Run an Auto Clean Check Motor in Service Menu Run an Auto Clean Run an Auto Clean Check Motor in Service Menu Run an Auto Clean Check Motor in Service Menu Run an Auto Clean Run an Auto Clean Check Motor in Service Menu Run an Auto Clean Check Motor in Service Menu Run an Auto Clean Check Motor in Service Menu Run an initialization Run an initialization Run an initialization Run an Auto Clean Check Motor in Service Menu Alarm Sampling syringe mechanism not reaching home Thermostated Compartment Temperature sensor not con nected Thermostated Compartment Temperature sensor failure Thermostated Compartment temperature out of range Value Min amp Max Thermostated Compartment Panel open 8 2 Tran
229. ted to provide results e When the Standard type is captured in the order or defined as default type an auto matic search on Department Date of birth or Gender field is performed l if a type name has been entered in the department field this one is used to provide results 2 if the date of birth corresponds to one of the child age ranges see 8 4 Age range page 5 41 this one is used to provide results 3 if the Gender is known the Male or Female type is used to provide results Pentra 80 User Manual RAB108E 5 35 Pentra 80 8 2 Pathological limits PENTRA 80 Types Standard TA KES Sa ana ALA E Fig 5 35 Pathological limits tab A set of limits is available for each sample type The operator according to the laboratory specifications can modify these limits The limits that have been entered into the 8 different types Standard Man Woman Child1 Child2 Child3 Child4 and Child5 are Factory Default values The Standard Type values are set values and cannot be modified by the user Man Woman Child1 Child2 Child3 Child4 and Child5 Factory Default values can be modi fied by the user e Results exceeding the Normal Ranges limits are marked with the following flags h for results above the normal upper limit for results below the normal lower limi
230. terfere with the white cell differential pa rameters e 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 dia betes etc which can increase the WBC RBC or PLT counts and the HGB concentration The 8 14 Pentra 80 User Manual RAB108E Specifications Limitations specimen must be warmed up to 37 C 99 F in a bain marie for 30 minutes and analyzed again immediately after analyzer or manual method Macrothrombocytes in excessive numbers may affect and increase Leukocyte numera tion RBC Red Blood Cells Erythrocytes The red blood cell dilution contains all the formed ele ments in the blood erythrocytes leukocytes and platelets During erythrocytes counting red blood cells platelets are not counted as their size falls below the minimum threshold Agglutinated erythrocytes May cause a low incorrect RBC count Blood samples contain ing the agglutinated red blood cells may be suspected by elevated MCH and MCHC values and shown by examination of the stained blood film Cold agglutinins IgM immunoglobulins which are high in cold agglutinin disease may cause lower RBC and PLT c
231. teria Section 5 2 2 General tab page 5 6 4 46 Pentra 80 User Manual RAB108E Workflow Order amp sample run association 6 Order amp sample run association 6 1 Reviewing sample results The Result function allows the operator to review all run results of the day to associate un matched results with Worklist orders also to request Reruns 6 1 1 Accessing the Result list Select the Results key on the generic toolbar PALA II heute Eha C ea rma bt mA ram Ey me m F Nome Deit Vains F Erone Dota I Not Preset Sobecisdl Sample D Peck Pom Petani Peter Mare Fintheame Gender Gem ot Dah Test Pa Cr Woa Unkrgani 1 f sii 7 SS uno ita Unkreran Dr i f BUTO SIEF bakar or 0S r Sr sees 3 i 2s Mugen Para KAN cie os i Co ao ama 3 2 BLEOHOR MIA belah Ae OF SN 2i oP NS QR 3 7 f Fig 4 36 Result list 6 1 2 Result list function keys Heading Key Name Action Function Launches the Result Association View see 6 2 Result order association page 4 53 Disabled if a cycle is in progress or if there is no unmatched result Association key Checks all the result lines in the list sales al column Selected Unchecks all the result lines in the list Unselect all column Selected Ant Send Print or send options see 6 1 9 Printout or Transmit Result list page 4 51 kaine aae Displays the corresponding result in full page see 6 1 6
232. the OK key to confirm your choice 5 6 Pentra 80 U ser Manual RAB108E Settings Soft parameters 2 2 4 Instrument Logs When a reagent is replaced an instrument calibration is performed and or a maintenance operation Is carried out a report of these interventions is automatically created in the ap propriate instrument log Reagents Calibration or Maintenance When these boxes are checked see Fig 5 2 page 5 5 a prompt requiring comments is au tomatically displayed see Fig 5 3 page 5 7 E AEX EOSINOFIX a eee Ui men yi Sugi _ 3 h 5 4 H IMA W pee Hi cii am Fig 5 3 Comments dialog box From the Soft parameters screen select the Edit key then select the appropriate boxes for your applications Once your selections have been made select the OK key to confirm your selections 2 2 5 Identification option Fig 5 4 Identification option This option must be setup according to the specific working order of the laboratory opera tions Section 4 1 Workflow page 4 3 v Identification O ption Barcode check this option if all tubes are going to be identified by barcode labels Rack position Check this option if samples With and Without barcode labels are going to be analyzed on the instrument Pentra 80 User Manual RAB108E 5 7 Pentra 80 v Manual match on Exception Must be ON
233. the HGB value and the RBC count e The mean hemoglobin weight in each RBC is given by the formula MCH pg HGB RBC x 10 MCHC Mean Corpuscular Hemoglobin Contained is calculated according to the HGB and HCT values Mean HGB concentration in the total volume of RBC is given by the formula MCHC g dL HGB HCT x 100 3 2 6 MPV Measurement The MPV Mean Platelet Volume is directly derived from the analysis of the platelet distribu tion curve 3 2 7 Pct Calculation Thrombocrit is calculated according to the formula Pct PLT 102 mm x MPV um 10 000 Pentra 80 User Manual RAB108E 6 13 Pentra 80 3 2 8 PDW calculation PDW Platelet Distribution Width is calculated from the PLT histogram The PDW is represented by the width of the curve between 15 of the number of plate lets starting from 2 fl S1 and 15 of the number of pla telets beginning with the variable top threshold S2 Fig 6 16 PDW calculation 6 14 Pentra 80 User Manual RAB108E Description amp Technology M easuring principles 3 3 WBC and differential count 3 3 1 General counting principles The WBC count is carried out twice by two different analysis methods which utilize the total WBC count in both areas e Once in the BAS count chamber during the same time as the BAS count e Once in the optical chamber during the same time as the LMNE count The WBC reference count is the count which is obtained
234. the recom mended lengths for best results DILUENT input tubing Cristal 3x6 2 meters 80 in maximum WASTE output tubing Cristal 4x6 2 meters 80 in maximum Bottles and container locations see Fig 7 1 page 7 6 1 ABX Lyse 2 ABX Basolyse ABX Eosinofix ABX Cleaner ABX Diluent Waste container DN UI BS W Pentra 80 User Manual RAB108E 7 5 Pentra 80 Fig 7 1 Reagent location 2 1 2 Integrated reagents amp Diluent container replacement During instrument startup the user compares the remaining guantity of each reagent to the daily workload setup If one or more reagents reach a Low Level during the working day an alarm occurs and the following alarm window will appear indicating the following message see Fig 7 2 page 7 7 7 6 Pentra 80 User Manual RAB108E Maintenance amp Troubleshooting Replacement procedures pote UU Environment and software 05 13 2002 11 34 58 Reagent Reagent Level too low to run an analysis Environment and software Reagent Reagent Level too low to run an analysis Change reagent and restart automatic cycle Fig 7 2 Reagent low level alarm When a Reagent Low Level alarm appears on the screen select the Check key see Fig 7 2 page 7 7 to display the Reagent Status window see Fig 7 3 page 7 7 PENTRA 80 Status Reagent Ee E EE NN Is ABNCLEANER MUNN AEX ACPHALYSE ABXBASOLYSE2 ABX
235. then moves to the next rack number Pentra 80 User Manual RAB108E 4 21 Pentra 80 2 4 1 Auto N umbering If a Sample ID is not entered into a sample tube position an Auto number is given to the order as indicated Fig 4 17 Rack auto numbering Select the Worklist Grid view key see Tab 4 1 Worklist selection keys page 4 15 to display orders associated with the captured rack For more details about sample identification referto 1 Workflow page 4 3 dd 2 4 2 Rack view contextual toolbar keys Heading Key Name Function Modification of an order for a position already filled except SE Edit if the rack is in the process of being analyzed Rack and position fields Sample ID are not modifiable lil Deletes orders for a position already filled except if the rack is in the process of being analyzed ll Delete Two choices Emptying the rack and position fields Deleting the order Print see 2 4 4 Printing the rack view page 4 23 Tab 4 4 Function Keys 2 4 3 Rack view functions The operator is able to select an Empty tube to directly enter a new order specifically to this position If a rack is currently being processed order entry is not allowed e If the tube position is not empty sample results and patient information are displayed 4 22 Pentra 80 User Manual RAB108E Workflow Worklist 2 4 4 Printing the rack view From the rack vi
236. tical bench lamp Optical bench lamp replacement replacement page 7 11 On reguest see 2 3 Sampling probe replace Sampling probe replacement ment page 7 13 Once a month see 2 4 Rinse chamber filter Rinse chamber filter cleaning cleaning page 7 15 Instrument Rinse see 2 5 Instrument Rinse page 7 16 Pentra 80 User Manual RAB108E 7 3 Pentra 80 1 3 Instrument general cleaning 1 3 1 Instrument external cleaning The external surfaces of the instrument must be decontaminated considering the biological environment A 1 Never spill liquid on the instrument 2 Never use Disinfectant product that contains alcohol v Touch screen Use a soft clot slightly wet with disinfectant product Wipe gently the screen and dry to remove any trace of moisture v All contaminated surfaces covers counting assembly area Slightly wet a sponge with disinfectant product and wipe the dirty surfaces v Stainless steel parts Slightly wet a sponge with disinfectant product and wipe the dirty surfaces Dry with a soft cloth Products having the following microbiological properties Bactericidal Fungicidal Active on Aspergillus fumigatus Active on Mycobacterium tuberculosis B K Antiviral VIH HBV and rotavirus Product Example validated by ABX Diagnostics ANIOS detergent disinfectant WIP ANI OS ref 1316 424 Please also refer to the W H O World Health Organization guidelines
237. tions amp waste disposal Limitations see Section Specifications in the instrument User Manual Safe Waste Disposal see Section Specifications in the instrument User Manual Please refer to the MSDS associated with the reagent HORIBA GROUP ABX Minoclair O Exclusive use Hematology ABX device Exclusive Minos ABC Vet Micros 60 Micros CRP Pentra 60 Pentra 60 C Pentra 80 Pentra XL 80 Pentra 120 Pentra 120 Retic Pentra DX 120 Hematology ABX Devices for in vitro diagnostic use 23 09 03 A95A00029 A REF 0401005 0 5L CE etal ABX Diagnostics BP 7290 34184 Montpellier cedex 4 France Concentrated cleaning use i SS SN Ss SS Slide Preparation System 1 Functions Cleaning and bleaching solution for ABX blood cell counters Measurement procedure to be followed in using the device Principle of the method specific analytical performance characteristics analytical sensitivity diagnostic sensitivity analytical specificity diagnostic specificity accuracy repeatability reproducibility including control of known relevant interference limits of detection limitations of the method and information about the use of available reference measurement procedures and materials by the user see Section Specifications in the instrument User Manual 2 Conservation amp Expiration Storage conditions Stored at 18 C 65 F to 25 C 77 F Expiration date refer t
238. tra 80 User Manual RAB108E Settings Soft parameters 2 Soft parameters 2 1 Accessing the Soft Parameters menu From the Settings window select the soft parameters key This will bring up the Soft pa rameters general menu Fig 5 2 Soft parameters General menu There are three tabs available from this menu General see 2 2 General tab page 5 6 Department Physicians see 2 3 Department Physicians tab page 5 8 Units see 2 4 Units tab page 5 9 Pentra 80 User Manual RAB108E 5 5 Pentra 80 2 2 General tab 2 2 1 General tab functionalities Key H eading Function Auto Numbering Auto Numbering ID see 2 2 2 Automatic numbering page 5 6 Enables disables RUO parameters for printing and sending operations see 2 2 3 RUO parameters page 5 6 Enables disables automatic prompts for logs see 2 2 4 Instrument Logs page 5 7 Test performed when no order is associated to a sample tube Depends on laboratory operation mode all sample identified with barcode or not see 2 2 5 Identification option page 5 7 QC or XB alarms options Section 4 5 3 11 Statistical function flags page 4 46 Are the QC failed and XB blocking alarms Defines the number of consecutive instrument mishaps or alarms for stopping analysis operations from 1 to 5 times Operator can choose the number of consecutive trig gers of each alarm These are selected by default
239. tware Calls Windows NT window for adding a local printer Calls the printers properties screen see 5 4 2 Printer properties page 5 24 The printer displayed into the printer list is the default printer The printer displayed into the printer list is removed Normal limits are printed out when checked see Fig 5 21 page 5 23 Raw counts are printed out when checked see Fig 5 21 page 5 23 Manual formula are printed out when checked see Fig 5 21 page 5 23 Pathologies are printed out if checked see Fig 5 21 page 5 23 Printed out when checked Quality control Within Run Calibrator Startup Unmatched results are automatically printed out when checked Selected parameters are not printed out 5 4 1 Printout example abx printout assay 1 LABORATORY ABX ASSAY Running Date 04 09 2002 11 22 10 Anisocytosis Hypochromia Polychromia Poikilocytosis Microcytosis Macrocytosis Printed on 04 25 2002 17 42 28 Fig 5 21 Result printout Report header Range Raw counts mewn re Manual entry grid Suspected pathologies abx printout assay 2 abx printout assay 1 LABORATORY ABX ASSAY LABORATORY ABX ASSAY Report Printout Sample ID AUTO_SID21 Department Patient Name First Name Age Gender Microscopic Examination Neutrophils Bands ATY LYM Total 100 Operator Technician Page 1 Pentra 80 User Manual RAB108E Settings System 5 23 Pentra 80 5 2
240. ty control IOGS oooWoW W Woman 3 34 3 4 Reagent 00S bombay carats 3 35 PAo ea OS OO c A I A E A EE EE 3 35 5 6 Maintenance 00S bean 3 35 Pentra 80 U ser M anual RAB108E Pentra 80 2 WON LOO on una nana masa an ban Inn 3 35 505 HOSTIO OS sauna engan an ban aan eA 3 35 3 9 BANK CV CIC 1 00S is an aa 3 35 510 Patent OOS a cee sebagian alta aed enam aaa 3 36 Pentra 80 User Manual RAB108E Q uality Assurance The Quality Assurance menu is accessible by selecting the Quality Assurance key from the Main Menu screen i i e oe jj wk i r L ir _ ae ME aE ae a _ hee Wewn WINA AE coo THE AT a Fig 3 1 Quality Assurance access key Four functions are available in this menu Quality Control see 1 Quality control page 3 4 XB see 2 Patient Quality Control XB page 3 14 Within Run see 3 Within run page 3 20 e Calibration see 4 Calibration page 3 25 Logs are described in 5 Logs page 3 32 Pentra 80 User Manual RAB108E 3 3 Pentra 80 1 Ouality control e The Quality Control allows the monitoring of a set of analyses based on known samples over a period of several months Statistical computations performed on these populations allow the extraction of qualitative information related to the stability of the instrument A total of 24 Control lots can be saved in Quality control All QC functions are described in the following sect
241. uality Control page 2 6 3 Running specimen page 2 9 4 Results page 2 13 5 Archives page 2 15 6 Instrument Shutdown page 2 16 1 Instrument Startup 1 1 Waste levels page 2 2 1 2 Printer start up page 2 2 1 3 Pentra 80 Startup page 2 2 1 4 Status page 2 5 1 1 Waste levels At the beginning of each operating day check the Waste container to see if it may need to be emptied mmm Wastes must be handled according to your local national regulations mes See Section 7 2 1 3 Waste container replacement page 7 11 1 2 Printer start up Check to see if the printer has enough paper for daily operations If not replace the printer paper according to the Printer User s manual that is supplied with the instrument Press the ON OFF switch Check the control LEDs are ON 1 3 Pentra 80 Startup Press the power ON OFF switch located on the lower right hand side of the instrument to the ON position Pentra 80 User Manual RAB108E The Begin of day screen includes the following options Erase worklist when checked deletes all the or ders recorded in the worklist menu checked by default Reset Autonumbering when checked starts the autonumbering to AUTO SID1 See Section 5 2 2 2 Automatic numbering page 5 6 Archive Results when checked automatically sa ves unarchived results to Archive function See Section 4 7 Results Archives page 4 55 disable auto lo
242. ue Tolerance WBC 7 3 RBC 5 1 HGB 14 3 HCT 45 5 PLT 320 100 MCV 90 10 MCH 29 2 MCHC 34 2 RDW 14 2 20 22 RAM141B Update for Instrument version V1 3 2 6 Printer properties From the menu Settings System Printer Default settings for the checked boxes are as follows See Diag 1 Printer default settings page 21 PENTRA 80 System Hematology Parameters Printed Default Printer C ii EPSON EPL 5800 Advanced winspoo WBC E Printer N RBC ESSE Manual Entry Grid Vv HGB EPSON EPL SEO Advanced 7 Suspected Pathologies Vv ay Curves and Matrix IV MCH Add Printer Auto Pri MCHC uto Prin RDW Quality Controls Printer Properties Within Run Analysis Calibration Startup Set Default Printer Delete Printer pL PP a a tu bi f Version V1 3 0 ABX 10 28 2003 11 08 36 Diag 1 Printer default settings KANG NE NE ika ika ika ika ika ika MEA MEA MEA MEA MEA MEA MEA MEA MEA 7 Re run conditions From the menu Settings Rules Rerun Default settings for the checked boxes are as follows See Diag 2 Rerun conditions page 21 PENTRA 80 Rules stnenennenenensnsensed Rerun Print Conditions Transmit Conditions Types T Applyforall Types standard By Parameters HGB iv HCT iv MCV MCH aE i E M MB u T NL T MN T LN T RM T RN TNO MV NE TMC Tl MAC Set M MICP SCH M LMNE
243. um or aa dL PCT 015050 015050 PDW 11 18 11 18 NEU 50 80 50 80 LYM 25 50 2B 50 MON 2 10 2 10 EOS BAS Tab 8 11 Normal ranges table 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 A Important Expected values will vary with sample population and or geographical location It is highly recommended that each Laboratory establish its own Normal ranges based upon the local population 3 6 Accuracy The Accuracy performance was proven by comparing the Pentra 80 with a recognised com parison instrument using 200 patient whole blood specimens operating within the instrument normal functioning range 1 Bibliography AIDE MEMOIRE D HEMATOLOGI E 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 Pentra 80 U ser Manual RAB108E 8 11 Pentra 80 R Comparison of means Accuracy Claims WBC 0 99 gt 0 95 PLT 0 99 gt 0 95 RBC 0 95 gt 0 95 HGB 0 99 gt 0 95 HCT 0 96 gt 0 95 Lympho 0 94 Neutro 0 97 Mono 0 81 Eosino 0 96 Baso 0 4 Tab 8 12 Accuracy table 3 7 Leukocyte differential count Data from 200 samples for Leukocyte Differentiation was collected in accordance with the recommended NCCLS guidance documents
244. uspected abnormalities e Presence of schizocytes Presence of PLT aggregates Verify this abnormality by viewing the peripheral blood smear to confirm your results The SCL Small Cell flag will indicate the presence of small cells in the 2fL and 3fL zone A second analysis should be carried out and the results verified Workflow Run results and associated Flags 5 3 8 WBC balance During the initial count of the WBCs in the WBC BASO chamber a second WBC count is per formed from the injected volume through the LMNE optical flowcell The two counts are compared If the difference between the LMNE and WBC BASO counts are higher than the defined threshold depending on the quantity of cells measured a LMNE or a LMNE flag will be generated based upon the following conditions The WBC count is within 0 and 2501 If the WBC LMNE count is 50 higher than the WBC BAS count a LMNE flag will be generated If the WBC LMNE count is 50 lower than the WBC BAS count a LMNE flag will be generated WBC count is within 2501 and 8000 If the WBC LMNE count is 20 higher than the WBC BASO count a LMNE flag will be generated If the WBC LMNE count is 20 lower than the WBC BASO count a LMNE flag will be generated WBC count is higher than 8000 If the WBC LMNE count is 15 higher than the WBC BASO count a LMNE flag will be generated If the WBC LMNE count is 15 lower than the WBC BASO count a LMNE fl
245. ut v Deleting calibration results For deleting results from the Calibration Results Grid select the Check Boxes to select or de select results and parameters then select the Delete key from the Contextual Toolbar and select Selected Unselected or ALL for deletion see Fig 3 29 page 3 31 Now confirm your selection Pentra 80 U ser Manual RAB108E Q uality Assurance Calibration Fig 3 29 Delete options Pentra 80 User Manual RAB108E Pentra 80 5 Logs These are the event logs for the PENTRA8O They contain all of the notifications made auto matically by the software while the PENTRA80 is in operation Logs functions are described in 5 1 Access to Logs function page 3 32 5 2 Calibration logs page 3 34 5 3 Quality control logs page 3 34 5 4 Reagent logs page 3 35 5 5 Settings logs page 3 35 5 6 Maintenance logs page 3 35 5 7 Error logs page 3 35 5 8 Host logs page 3 35 5 9 Blank cycle logs page 3 35 5 10 Patient logs page 3 36 5 1 Access to Logs function Fig 3 30 Logs main screen Press the Logs key of the main screen 3 32 Pentra 80 User Manual RAB108E Q uality Assurance v Logs access keys Function Launches Quality control log screen see 5 3 Quality control Quality Control logs page 3 34 Launches settings log screen see 5 5 Settings logs page 3 Settings 35 Error Launches error log
246. utomatically be saved in the QC menu for that specific lot Pentra 80 User Manual RAB108E 3 13 Pentra 80 2 Patient Q uality Control XB The XB Patient Quality Control is used to detect any change in the quality of results by use of patient data only This data monitoring is performed without any user intervention and can be applied to a set of 9 parameters WBC RBC HGB HCT RDW PLT MCV MCH MCHC or 3 parameters MCV MCH and MCHC The operator makes the selection of parameters based on their own population studies See Section 5 3 2 XB options page 5 11 The XB data can be processed as follows All the analyses associated to a patient analysis that is not associated with a Calibrator or a Quality Control blood which does not have any Reject and or DIL flags and an RBC and HCT result within the clinical life sustaining categories which have neither reject nor DIL flag a RBC result higher than 100 107 mm and HCT higher than 0 796 are archived with their flags When a total of 20 results are archived an XB batch is computed The batch data commutated is the mean result for all 20 analyses contained in that specific batch The date of computation of the batch values is noted as the batch date An XB alarm occurs when the calculation of the last batch shows a point located outside of the limits set by the operator see 2 5 XB limits page 3 19 The operator can disable this alarm A m
247. ve umber of cells Analogue conversion Cell size Data integration and plotting of PLT distribution urve Number of Fig 6 15 PLT Distribution curve Pentra 80 U ser Manual RAB108E 6 11 Pentra 80 v dilutions Technical characteristics of the RED BLOOD CELL and PLATELET counts Initial blood volume 10 ul Method Impedance Vol ABX DILUENT 2500 ul Aperture diameter 50 um Final dilution rate 1 10000 Count vacuum 200 mb Temperature of reaction 35C Count period 2 X 6 seconds xx Two successive dilutions are carried out Primary Dilution for RBC and PLT Blood ul 10 ul Vol ABX DILUENT 1700 dilution 1 170 Secondary Dilution RBC and PLT from the primary dilution Dilution ul 42 5 Ml Vol ABX DILUENT 2500 dilution 158 8 Final dilution 1 170 x 1 58 8 1 10000 Tab 6 1 RBC PLT dilutions 3 2 2 HGB Measurement During the analysis cycle lysing reagent is released into the Dilution chamber This reagent breaks down the RBC cell membrane and releases the Hemoglobin within the cell The hemo globin released by the lysing reagent combines with the Potassium cyanide from the lysing reagent to form a chromogenous cyanmethemoglobin compound This compound is then mea sured through the optical part of the first dilution chamber by way of spectrophotometry at a wavelength of 550nm Technical characteristics for the HGB MEASU REM ENT Blood volume 10 ul Method Photometry Vol ABX DILUENT 1700 ul
248. when the number of particles counted is higher than the limit set up in LL or when the number of coun ted particles versus the total number of WBC exceeds the LL limit Suspected abnormalities e Small lymphocytes Platelets aggregates NRBCs Erythrocyte membrane resistant to lysis stroma This flag is associated with an on e LYM LYM e NEU NEU e MON MON EOS EOS ALY ALY e LIC LIC Meaning Left Lymphocytes 1 Presence of a significantly large population of cells on the left hand side of the lym phocytes area This flag occurs when the number of particles counted is higher than the limit set up in LL1 and when the number of particles counted in LL regar ding the total number of Iymphocytes is above the LL1 limit Suspected abnormalities Platelet aggregates NRBCs Erythrocyte membrane resistant to lysis stroma e Stroma Small abnormal lymphocytes Pentra 80 User Manual RAB108E Pentra 80 v NL flag Absorbance NoN NoE Channel 127 Right Neutro Fig 4 24 NL flag Standard value for NL 3 120 Section 5 8 3 Alarms amp Curve thresholds page 5 37 v MN flag Channel 127 Absorbance NoN NoE LMD RM Resistivity Fig 4 25 MN flag Standard value for MN 100 120 Section 5 8 3 Alarms amp Curve thresholds page 5 37 4 34 Pentra 80 U ser Manual RAB108E Meaning Neutro Lympho Presence of a signific
249. wn relevant interference limits of detection limitations of the method and information about the use of available reference measurement procedures and materials by the user see Section Specifications in the instrument User Manual 2 Conservation amp expiration Storage conditions Stored at 15 C 59 F to 30 C 86 F away from light Expiration date refer to expiration date reagent packaging label 3 Measurements principles amp results Directions for use see Section Maintenance amp Troubleshooting Reagent Location and connection in the instrument User Manual Measuring Principles see Section Description amp technology in the instrument User Manual Results see Section Workflow in the instrument User Manual Performance data see Section Specifications in the instrument User Manual Note if performance changes call your ABX Diagnostics representative S A au capital de 44 000 000Euros RCS Montpellier 328 031 042 SIRET 328 031 042 000 42 APE 332 B Explore the future 4 Composition amp handling precautions Composition Quarternary ammonium salt lt 5 Non ionic based surfactant lt 3 pH 6 95 4 0 1 T 25 C Resistivity 40 19 Description Colorless odourless Handling Precautions Avoid contact with eyes skin and clothing Wear laboratory gloves when handling the product The product may be harmful if ingested or inhaled Keep the bottle clo
250. y D HCT lt 0 7 HCT forced to 0 gt 07 HCT replaced by D if SCL flag PLT reported to lt 5 0x103 mm No PLT histogram PLT MPV Pct PDW reported to No SCL flag occurs gt 1900x103 mm PLT replaced by D if SCL flag PLT reported to l lt 5 0x103 mm No PLT histogram MAA MPV Pct PDW reported to EO NCCI No SCL flag occurs mode 3 3 gt 1900x10 mm PLT value D 25000x102 mm PLT replaced by D Tab 4 5 Results exceeding linear ranges The instrument must have been configured by an ABX DIAGNOSTICS approved technician 4 30 Pentra 80 User Manual RAB108E Workflow Run results and associated Flags 5 3 3 Analysis reject A reject flag shown by occurs when two counts on a parameter differ more than the pre defined limits It indicates that the parameter result is inconclusive and should be investi gated for Manual rerun status and or instrument malfunction if consistent on every sample w RBC If the RBC parameter is rejected the MCV MCH MCHC and RDW parameter results are re placed by and or have the indicator v WBC If the WBC parameter is rejected the diff parameter results are replaced by and or have the indicator v PLT If the PLT parameter is rejected the PCT MPV and PDW parameter results shall be replaced by and or have the indicator v Hemoglobin A suspect flag is
251. yes skin and clothing Wear laboratory gloves when handling the product The product may be harmful if ingested or inhaled Keep the bottle closed when not in use Please refer to the MSDS associated with the reagent Specimen Collection and Mixing see Section Workflow in the instrument User Manual 5 Limitations amp waste disposal Limitations see Section Specifications in the instrument User Manual Safe Waste Disposal see Section Specifications in the instrument User Manual Please refer to the MSDS associated with the reagent HORIBA GROUP ABX Lysebio O Exclusive use Hematology ABX device Micros 60 ABC Vet Micros CRP Pentra 60 Pentra 60 C Pentra 80 Pentra XL 80 Pentra 120 Pentra 120 Retic Pentra DX 120 Slide Preparation System Hematology ABX Devices for in vitro diagnostic use 23 04 03 A95A00011 A Exclusive v 0906013 0 4L 0906012 1L 0 4L or 1L wo CE padi ABX Diagnostics BP 7290 34184 Montpellier cedex 4 France KORO OK NK S 1 Functions This reagent is used on ABX blood cell counters to lyse red blood cells and determine hemoglobin concentration Measurement procedure to be followed in using the device Principle of the method specific analytical performance characteristics analytical sensitivity diagnostic sensitivity analytical specificity diagnostic specificity accuracy repeatability reproducibility including control of kno

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