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1. Figure 16 Sticky Shift and Symbol Buttons 37 RBC 10 uL mem 0 MO E E E Co A ee es e Ea Ps ae BEE GHEE Today Cancel 09 02 2010 il Goal Figure 18 Date Virtual On Screen Keypad 6 6 Using the Graphical User Interface The graphical user interface GUI of the Abacus 5 is divided into three main sections Refer to Figure 19 to see these sections 1 Quick links to main functions top section 2 Interactive display area middle section 3 Status display bottom section The main menu shown below is displayed in the interactive display area when the Abacus 5 analyzer is initially powered up 38 Figure 19 Graphical User Interface Sections 6 6 1 Quick Links The upper part of the GUI is always visible during all operations and presents several quick link buttons Selecting one of the quick link buttons determines what is displayed in the interactive display area The selected button is framed on three sides for clear visual feedback The quick link for Autosampler functions is enabled only if the optional Autosampler is connected 6 6 2 The Interactive Display Area The middle section is used to display the main menu functions information results and all the panels that contain information about the active mode 6 6 3 The Status Display The bottom section is called the Status display and presents the user with the fo
2. ccooocccconocnnnonocnnnnnnnnnnnnnononnnnnnnnonnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnannnnanens 23 5 1 3 Genuline DIStron Reap ENIS sa ca in 24 5 2 Principles OF Operation au ns N E E E EN 26 572 4 Volumetric Impedance Method ea nee kan 26 5 2 2 Photometric Lent Absorbance Method iissa rar ni a 26 5 2 3 Optical Light Scatter and Diffraction Method a aa a E iaai a baii 27 5 3 Inside the Abacus5 Analyzer ii a 29 5 3 1 Front Panel see A 29 5 3 2 Bac Pl as ee es 30 533 ERE SIGE ASSEMDIY CCP COC CUE een ner ie 32 5 3 4 RIEHT SIE ASS Dd A Ue 33 5 3 5 FOM ASSEmB VE as ee E 34 6 USerINnte ACB A A 36 6 1 Usine the Touch Creer 36 6 2 Using the Start Button laden 36 6 3 Using an External Mouse una ucengni 36 6 4 Using an External Keyboard oo ea E rincon tacos 36 6 5 Using the On Screen Virtual Key PaCS tna Analia 37 6 6 Using the Graphical User Interface an 38 6 6 1 A A 39 6 6 2 Tine Interactive Display Area as a een 39 6 6 3 Te Status DISPARA ee 39 6 6 4 ENTERINE INIOLMAL ON ee ee een as 40 6 7 The Menu SYSTEM 0 05 54 Ion ern 40 6 1 Primary Menulltenssssa nee A E nee adtec onarweatunemsaeaaveaet 40 6 7 2 Starting a Manual Single Tube Me aSUreMe n cccccseecccessecccesscccasneccsauscccseuecceseuseeseaseesseueeessuusesssueesseueeessanseesaases 40 6 7 3 Start Automated Measurements cccccssecccsssccccensccccenscecseecesseceeseneeessaseeeseueeessaueeessasessauecessausesssuecesseuseessa
3. Measure i Measure A AS state A AS state f 2 None 2 None Figure 75 Settings Panel The options available on the Settings panel are e Customize e Laboratory e External Devices e System e Units e Printer e Profile Limits e X B e User Clicking or tapping one of the buttons in the Settings panel displays the selected panel where settings changes can be made Each panel has a Back and Save button The Save button saves any changes made and returns to the Settings panel and the Back button discards any changes and returns to the Settings panel 15 1 Customize Settings The Customize panel allows you to customize the Abacus 5 analyzer user interface language and other preferences about the analyzer operation Click or tap the Customize button on the Settings panel to access the Customize panel 104 amp English United Kingdom 5 x Patient D P A AS state Zien O O Figure 76 Customize Settings Panel On the Customize panel you can change the following settings Skins By changing the skin the appearance of the menus GUI elements will change The skins has no effect on the behavior of the Abacus 5 Language select the language that the Abacus 5 analyzer user interface uses to communicate with the operator Only English United States is available in the US version of the Abacus 5 analyzer Limit style select Number
4. The Autosampler then mixes the sample tube and reads the barcode label if one is used The sample tube is then moved to the aspiration position where the sample is aspirated and measurement is performed The aspiration and measurement process is the same in automatic mode as in manual mode The sample tray progress can be followed in the tray view or the list view The results for completed samples can be reviewed by clicking or tapping on a completed sample The patient ID is not editable in the Full Scan mode as it is automatically set to the default patient The sample ID is not editable as it is read from the barcode label If the barcode label is missing or not readable the Abacus 5 analyzer assigns a default value and allows manual entry of the sample ID 63 4079 4080 4081 EER al el lt i 11 02 2010 22 34 22524100022 11 02 2010 22 35 22527100022 11 02 2010 22 36 20417100022 Analysis Sample 6 93 5 04 11 03 6 18 4082 11 02 2010 22 37 20415100022 11 02 2010 22 38 21011100022 Jl 1 1 1 Multiselect J al al aia ol o oi if E Le ell e e e e ofl ofl ol oS E V o 4 dd dd 0 1 4 v wn Measure mode E ample pos Ba oy gt under meas AAA e Position A3 Sample status In Progress Sample pos Measure mode j gt under meas Patient Id Patient Id Position A3 Sample status Ready Measure type Full scan mode Tray status STARTED Sample ld 226
5. Don t click or tap the OK button until the shear valve has been cleaned and re assembled Perform the shear valve cleaning according to the instructions below 124 1 Open the front cover and secure it with the latch Locate the shear valve in the center of the analyzer Unscrew and remove the axis thumbscrew that secures the shear valve Clean the axis thumbscrew with water and wipe it dry Slide off the upper disk of the shear valve Due to the extremely smooth surface of the ceramic discs the may stick together somewhat If the shear valve was not in use for a few days then apply a few drops of water to the contact are between the upper and lower disks The salts will dissolve in a short time and release the upper disk OY 1 y Y y Vy Diii Figure 96 Removing the Shear Valve Axis Thumbscrew Figure 97 Disassembling the shear valve 125 10 11 12 13 Gently clean the mating surfaces of the disks of the shear valve the housing of the valve and the tube connections Remove any salt build up Use tweezers to push inthe dampened and the dry cloths Apply a few drops of water to soften any hardened deposits Use a tooth pick to remove any salt crystals from narrow places Do not use any sharp metal or hard objects which can scratch the smooth surfaces of the shear valve Clean the outside of the shear valve and the housing and mounting parts of the shear valve Pay atten
6. 339 1506 2011 16 24 ROVYsd ROMA B22 20 aod 719 4 B22 23 0 S40 274 alo Eb 22 5 Parameter Calculation Parameter Units Calculation Leukocyte white blood 3 9 WBC 10 ul or 10 WEC WBCer X WBCweasurep cells concentration Calculated from differential percentage and WBC Neutophil NEU x WBC LYM x WBC Lymphocyte a 10 ul or 10 I Monocyte MON x WBC Eosinophil and EO x WBC Basophil concentration BAS x WBC Neutophil Lymphocyte ee Relative value are derived from the optical 4 diff Monocyte and Ben scatter populations Eosinophil five part differential percentage Basophil five part Relative value is calculated from the basophil BAS differential percentage optical scatter populations Erythrocyte red blood RBC 4 il l 10 ul or 10 I RBC RBCcaL X RBCweasurep cells concentration Measured photometrically at a wavelength of 568 nm blank measurement is performed per cycle on HGB Hemoglobin concentration g dl or g l diluent and lyse mixture HGB HGBeat x HGBmeasureD 7 HGB ank Calculated from RBC and MCV HCT Hematocrit HCT RBC x MCV x 100 Average volume of individual erythrocytes derived MCV Mean Corpuscular Volume fl from the RBC histogram Average hemoglobin content of erythrocytes Mean Corpuscular j calculated from RBC and HGB values MCH HGB RBC Mean Corpuscular Calculated from HGB and HCT MCHC l g dl or g l Hemoglobin Concentration MCH
7. Standby Wakeup Cleaning Hard cleaning Flow cell cleaning Shear Valve cleaning Offline overnight rinsing Prime Diluent full Prime Lyse Prime Diff5P Prime all DrainDilu DrainLyse DrainDiff5P Note 2 Prime functions fill internal chambers The following pneumatic function uses reagents from the inside buffer while the inside buffer is continuously refilled to a steady level Table 22 Reagent Consumption 142 22 2 Display Ranges Table 23 Display Ranges 143 22 3 Fluidic System X vis to V1 1 Dilu 10 aa an Needle jee E gare y Sl SV inner OLA ring 5 vit X x v34 8 vi0 Mix Sample Airi 1 v3 Dilu 5 to V36 V40 V42 V37 V41 V43 1 I Mea Puff Smal XJ v23 vr J EN Lyse Puffer uy to V39 1 Lyse Inlet Yellow Diff Sp Inlet Orange Figure 110 Fluidic System Diagram 144 22 4 Printed Report Formats Demo 12072011 1722 Demo Demod Demo Demos Demo3 Demob Sample ID 24 Patient ID Date 09 0420710 1150 Mame Demo Made Human Liate of birth 01 01 1999 Farameter Result Limit Gender Male WBC 10 41 TTL S00 10 00 NEL 94 10FUL 200 750 LYM 3 29 10FUuL 130 400 MON 138 10 L O15 070 EO 0 18 10 uL 000 050 BAS 0 09 ORL O00 0 15 MEUS 52 5 400 750 Liha 31 6 210 400 MON 133 3 0 FO EO 1 7 0 0 amp o BAS 09 0 0 A REC ada TPL 400 550 HGE 10 4 ol lau ATA HET o S6
8. 10 pL 00 0 70 10 uL 000 0 50 10 uL 00 0 15 370 720 210 50 0 0 0 14 0 00 6 0 00 1 0 10 uL 3 50 550 gil 120 174 260 50 0 fL 860 1100 25 0 38 0 300 350 The volume of the Diff 5P is running low 0 0 16 0 400 0 43 Warningflags Interpretive flags Microcytic RBC Hyperchromic OB DA Figure 102 Reagent Low Indicator and Explanation Panel To replace reagent containers perform the following steps Prepare the new container and place it near the place of operation Open the container cap remove cardboard flaps if necessary on 5L and 20L containers Unscrew the reagent line from the used container and place it into the new container Switch the old and new containers Dispose of used containers according to local regulations EEE A Push the Reset button corresponding to the new reagent container to reset the reagent level software counters to 100 Never allow the reagent line and dip tube to touch the ground or any other surface to avoid microbial contamination of the reagents and the internal pneumatic components of the Abacus 5 analyzer Always transfer the reagent line from the old reagent container to the new container without coming in contact with any other surface 129 Always follow local laws and regulations governing the disposal of hazardous waste Measure Database 100 20000 ml Reset all
9. Graphical1 and Graphical2 display modes to change the display method for parameters outside the normal ranges on the result screens and printed reports Sound volume modify the sound volume up or down On screen keyboard active Select whether to use the on screen virtual keyboards for displaying information or an external keyboard Patient s displayed data choose Name or Patient ID as the patient identifier displayed in the Measurement panel Demo mode 15 2 Laboratory Settings The Laboratory settings panel allows entry of seven lines of text up to 50 characters of descriptive information about the laboratory such as laboratory name address etc All non empty lines are displayed at the top of every result printout 15 3 External Devices The External Devices panel allows entry of external LIS settings The Abacus 5 analyzer supports external LIS communications over a serial communications link using the Diatron version 3 1 protocol It also supports an Ethernet communications link over the HL7 version 2 5 protocol The External Devices panel lets you change the following settings Sending port baud rate select 9600 or 115200 baud for serial LIS connection 105 Automatic LIS The Abacus 5 will transmit every measurement result as soon as it is available if this check box is checked LIS the Abacus 5 analyzer will use an Ethernet connection rather than a serial connection of this check
10. Remove the old reagent key from the reagent lock connector located on the rear panel Remove the new reagent key from its electrostatic envelope and insert it in the connector Proceed with the replacement of the DiatroeLyse 5P reagent container as usual Clicking or tapping the Reset Lyse 5P button will upload the new license for 800 measurements as well as reset the software counter for the DiatroeLyse 5P to 100 Figure 105 Reagent Key Connector The hardware key looks similar to a USB memory device in appearance but is not a USB device Do not insert the reagent key into a USB device connector Only insert it into the special connector pictured above Used reagent keys cannot be re used Collect them and return them to your Diatron certified service engineer or your sales 132 representative for recycling or dispose of them according to local laws or regulations governing the disposal of electronic waste materials 19 The Daily Routine Inthis chapter a typical daily routine is described Your daily routine may differ from the one described here This chapter also contains some tricks and tips The description below assumes that the laboratory works during a single daily shift only The daily routine Notes Power up and start up the Abacus 5 analyzer see Chapter 6 2 2 for details Check reagent container levels and start obtain new reagents from storage if necessary Perform the pneumatics initialization
11. box is checked IP the IP address of the external LIS computer should be entered here if an Ethernet LIS connection is used IP addresses consist of four numbers from O to 255 separated by periods See your IT administrator for more information about the IP address of your host LIS computer Port the port number of the external LIS computer should be entered with here with nor commas if an Ethernet LIS connection is used Ports are a single number between 0 and 65535 See your IT administrator for more information about the port number of your host LIS computer Bidirectional LIS check this check box if the LIS computer will download lists for one of the list modes for automatic sample processing A AS state A gt O Figure 77 External Devices Settings Panel NOTE When using bidirectional LIS settings the Abacus 5 analyzer listens for an external device or LIS computer to send it instructions Consult your information technology staff regarding the configuration of the host computer and the Abacus 5 analyzer for proper LIS operation Your information technology staff person may need to consult your Diatron certified service engineer to ensure the Internet Protocol IP settings of the Abacus 5 analyzer are set properly The Abacus 5 analyzer listens on port 6600 for incoming LIS instructions 15 4 System Settings System settings change various options about the operation and behavior of
12. sample s without having to wait until the entire sample tray has been processed To interrupt automatic processing for stat specimens perform the following steps e Click or tap the Stop button The Abacus 5 will prompt you to wait until the current sample is completed e Acknowledge the message by clicking or tapping the OK button e Place the stat sample into the sample rotor e As soon as the current measurement completes change to the manual measurement panel by clicking or tapping the Measure quick link at the upper left corner of the screen e Process the stat sample s in manual mode e Return to the automated measurement panel by clicking or tapping the AS quick link e Restart the measurement by clicking or tapping the Start button or by pressing the physical Start button e The Abacus 5 will continue automated measurement from where it was interrupted 8 4 2 6 Controlling the Autosampler Detailed information about the Autosampler is available from the Autosampler info panel You can also reset the Autosampler from this panel Double click or tap the Autosampler status in the bottom left corner of the screen to view the Autosampler info panel With this panel you can command the Autosampler to repeat the last command or reset the Autosampler You can also view Autosampler messages with detailed information about the last action or sample tube processed 68 Autosampler Info Status Ho
13. 0 50 10 ul PLT lt 1 00 10 ul Table 29 Carryover Performance 22 7 5 Sample Stability Sample stability is characterized by the absolute and percent difference from the baseline values measured after 30 minutes of venipuncture for the parameters WBC LYM MID GRA RBC HGB HCT MCV RDW and PLT For MPV the baseline shall be 2 hours after venipuncture Either the absolute or percent difference must be under either the absolute or the percent difference criteria indicated in the table in section 22 7 2 The minimum expected stability is 7 hours from venipuncture 22 7 6 Mode to Mode Parameter Correlation Mean Parameter n Correlation intercept slope Closed Vial Open Vial Units HGB 40 0 9956 0 105 1 016 12 104 12 191 g dl RDWev 39 0 9925 0 212 1 015 16 263 16327 Table 30 Closed vs Open Vial Mode Performance Be E Mean Parameter n Correlation intercept slope Closed Vial Open Vial ES HGB 140 0 9985 0 054 11 007 12 104 12055 g dl RDWev_ 39 0 9923 0 354 1 025 16 263 16 140 Table 31 Closed vs Autosampler Mode Performance 22 7 7 Reference Ranges Evaluation of reference ranges for the Abacus 5 hematology analyzer was conducted using a data set of 240 normal human whole blood samples Of the 240 samples 120 were from female patients and 120 were from male patients gt 22 years of age Diatron recommends each laboratory
14. 1 The Abacus 5 Analyzer Package Contents After opening the Abacus 5 analyzer packaging you will find an accessory box The analyzer is in a plastic bag in between cushioning protective material After opening the bag remove the desiccant packs The package should contain the following items e The Abacus 5 analyzer e Accessories box on top of the analyzer including o Power cord User Manual this document Sample tube adapter for the individual sample unit 1 pc Reagent tube kit in a plastic bag with 3 caps and 5 color coded tubing Plastic waste container Cardboard box for the waste container Preparing for shipment tube kit 1 piece O O O O O O Abacus 5 analyzer final check report Please inform your Diatron Representative if any item is missing or damaged Retain the original Abacus 5 analyzer packaging for future transportation and storage 4 2 The Autosampler Package Content The Autosampler is an optional unit that attaches to the Abacus 5 If the optional Autosampler unit was ordered package should contain the following items e Autosampler unit e Asample tray e 10 pieces sample racks e Autosampler final check report Please inform your sales representative if any item is missing or damaged Retain the original Autosampler packaging for future transportation and storage 20 5 General Overview and Principles of Operation 5 1 General Overview The Abacus 5 is a fully au
15. 2 20 2011 02 14 C Magyar X B functions reinserted Based on review by David Lopez A Gyetvai based on 2 review by GyA Vienna sales office removed A Galgoczi installation by service gt service manual load qc values added X B explanations included along with screenshots sw versions updated in the top set date and time removed from installation section reagent lock section rephrased troubleshooting part rearranged reagent consumption updated printout samples updated EMC Class A specific information added to section 1 1 3 Reagent replacement procedure steps to replace containers added section 15 1 11 meas related troubleshooting received hard cleaning 1 approval page added garbage can icon added section 1 1 3 1 2 21 2011 03 10 C Magyar New SV cleaning added to SV cleaning chapter 1 2 22 2011 04 29 Update screens to match FDA release 1 2 23 2011 07 06 D Lopez de Intensive review and update for US release Quintana 1 2 24 2011 07 14 1 2 25 2011 08 31 D Lopez de Quintana D Lopez de Quintana Added section for Bar Code Symbologies updated TAB file format changed recommendation for shear valve cleaning from 300 to 1200 updated External Devices settings to add LIS TCP IP listener port information 1 2 26 2011 12 31 D Lopez de Updated analytical measuring range ee PEB fama oranan Quintana Only RUO parameters 1 2 28 2012 03 07 Correct Blank Limit and AMR errors 1 2 2
16. 4 9 2010 11 50 25 AM lt TAB gt Human lt TAB gt 6 99 lt TAB gt 4 26 lt TAB gt 1 92 lt TAB gt 0 64 lt TAB gt 0 12 lt TAB gt 0 05 lt TAB gt 61 lt TAB gt 27 4 lt TAB gt 9 2 lt TAB gt 1 7 lt TAB gt 0O 7 lt TAB gt 3 44 lt TAB gt 94 lt TAB gt 31 7 lt TAB gt 92 3 lt TAB gt 27 4 lt TAB gt 297 lt TA B gt 56 1 lt TAB gt 12 4 lt TAB gt 331 lt TAB gt 0 42 lt TAB gt 12 6 lt TAB gt 26 1 lt TAB gt 34 9 lt TAB gt lt TAB gt lt TAB gt lt TAB gt 8 lt TAB gt 25 lt TABS I lt 135 gt 27 97 2070 11350320 AM lt TAB gt Human lt TAB gt 6 85 lt TAB gt 3 8 lt TAB gt 2 16 lt TAB gt 0 6 lt TAB gt 0 27 lt TAB gt 0 02 lt TAB gt 55D 5 lt TAB gt 31 D lt TAB gt 8 8 lt TAB gt 3 9 lt TAB gt 0 3 lt TAB gt 4 19 lt TAB gt 107 lt TAB gt 30 7 lt TAB gt 87 5b lt TAB gt 25 5b lt TAB gt 292 lt T AB gt 49 4 lt TAB gt 11 8 lt TAB gt 378 lt TAB gt 0 49 lt TAB gt 12 9 lt TAB gt 25 2 lt TAB gt 34 8 lt TAB gt lt TAB gt lt TAB gt lt TAB gt 9 lt TAB gt ZAXTAB gt 1 lt TAB gt 4 9 2010 11 50 56 AM lt TAB gt Human lt TAB gt 10 41 lt TAB gt 5 47 lt TAB gt 3 29 lt TAB gt 1 38 lt TAB gt 0 18 lt TAB gt 0 09 lt TAB gt 52 5 lt TAB gt 31 6 lt TAB gt 13 3 lt TAB gt 1 7 lt TAB gt 0 9 lt TAB gt 3 75 lt TAB gt 101 lt TAB gt 33 7 lt TAB gt 89 7 lt TAB gt 26 8 lt TAB gt 2 99 lt TAB gt 52 lt TAB gt 11 8 lt TAB gt 365 lt TAB gt 0 49 lt TAB gt 13 5 lt TAB gt 25 4 lt TAB gt 34 2 lt TAB gt lt TAB gt lt TAB gt lt TA B gt 10 lt TAB gt 156 23 Index aperture 26 32 33 BASO 28 70 75 79 80 81 b
17. 5 analyzer database To permanently delete records select a group of records and click or tap the Delete button on the Manage records panel To prevent accidental deletion of data the Abacus 5 requests the same confirmation password used in the save raw data function After entering the correct password and clicking or tapping the Ok button the records will be permanently deleted The password to allow deleting records is 555 88 11 Calibration The Abacus 5 analyzer must be calibrated in order to provide correct reliable results Calibration should be done at the following times e At initial installation e After replacing any component critical to the dilution or measurement process e Anytime quality control shows a systematic error or is outside predefined limits e At periodic time intervals determined by laboratory regulations The Abacus 5 analyzer calibration process consists of running a commercial calibrator material or a human whole blood sample with known parameter values multiple times The known parameter values and the average values of multiple runs are used to calculate calibration factors The new calibration factors take effect once they are accepted by the operator If you are using a human whole blood as a calibrator the calibration target values must be measured on a reference analyzer according to applicable regulations standards or laboratory procedures An automated calibrat
18. A AS state A BL Figure 103 Reagent Replacement Panel 130 18 Reagent Locking The reagent locking feature assures you that the Abacus 5 analyzer always produces quality results and operates optimally by ensuring that only genuine Diatron reagents are used in your Abacus 5 analyzer The Abacus 5 analyzer measuring system and data analysis software are designed to work only with genuine Diatron reagents Diatron cannot guarantee optimal performance of the Abacus 5 analyzer with incompatible reagents Each DiatroeLyse 5P reagent container comes with a reagent key The key is in contained in an electrostatic plastic envelope located underneath the tear out flap on the top of the reagent container cardboard box Each key contains a license for 800 measurements Figure 104 Location of Reagent Key in DiatroeLyse 5P Reagent Container The Abacus 5 analyzer tracks the number of measurements performed and warns the operator when the stored number of measurements counts down to a 50 measurements and will stop performing sample measurements when the stored measurements are exhausted Blank Calibration and QC measurements are included in the overall measurement count The new hardware key included in your new DiatroeLyse 5P reagent container is used to replenish the stored measurement count To replenish the stored measurement count replace the reagent key before replacing the DiatroeLyse 5P reagent container
19. Functions Daily cleaning with DiatroeHypocleaner CC reagent during shutdown helps to keep the Abacus 5 analyzer clean and in good operating condition However blank measurements results may sometimes still be too high during daily use 127 or calibration When this occurs the Cleaning and Hard cleaning maintenance function are available to perform additional system cleaning on demand The Cleaning and Hard cleaning software maintenance functions are also available to perform deeper cleaning of the system tubing and pneumatic components If the blank measurements are still too high after the Cleaning maintenance function it will be necessary to perform the Hard cleaning maintenance function for a more in depth thorough system cleaning Running several blank measurements may be required after performing software maintenance cleaning functions to return blank values to within specifications If blank measurements do not return to normal after the Clean or Hard clean software maintenance functions and after running several blank measurements please contact your Diatron certified service engineer for additional assistance 17 8 1 Daily Cleaning The Shutdown function at the end of the daily routine will request that a sample vial with 2 3 ml of DiatroeHypocleaner CC reagent with no cap be placed into the sample rotor The software shutdown function will clean the tubing in the measurement syst
20. Progress Tray View Sample barcode labels are read and compared with the sample ID that was previously entered into the free list before starting automatic processing If the two do not match the barcode part of the tray view sample icon changes to red If the automated processing is interrupted for any reason it can be restarted it by clicking or tapping on the Start button on the screen or by pressing the physical Start button 8 4 2 4 Selected Samples Mode Selected Samples mode is suitable for laboratories where e Barcode labels are used e Inagiven batch there are samples which should be measured using different modes for different normal ranges e Data security is a concern Selected Samples mode can also be used to rerun only certain samples in a sample tray already processed in one of the other two modes Samples cannot be added to the sample tray once automatic processing is started in Selected Samples mode An accepted blank measurement is required as with all sample processing In Selected Samples mode the Abacus 5 analyzer will only look for samples in the sample positions selected for analysis All other samples in sample positions that are not selected will be ignored If a sample position is selected for processing but contains no sample tube the sample position will be marked for review On the Selected Sample mode panel you can e Return to the AS panel to select a different type of automated measurement
21. User Type 14 2 Creating a New User When the analyzer is started with the multi user mode enabled the following logon panel is displayed 100 UserlD Password r li Add user by Add user by mee administrator service person ae Figure 69 Logon Panel L Enter your user ID and password then press or click the Add user by administrator button This will bring up the add user panel UserlD Password Re enter password Administrator i Create 3 Figure 70 Add User Panel To create a new user enter a new user ID in the UserID text field then enter the new user password into the Password text field then again in the Re enter password text field If you want to create a administrator regular user click or tap the Administrator check box To create a regular user leave the Administrator check box unchecked Click or tap the Create button when you have finished entering the user information This will display a panel indicating the operation is complete Complete Figure 71 Add User Complete Panel Click or tap the Ok button to acknowledge You can continue to create users or press or click the Close button when you are finished creating users Pressing the Close button will display the logon panel again 101 14 3 Deleting or Changing Users Anyone with a valid administrator account can delete administrator or regular delete users Regul
22. a soria 117 16 4 Statistics as ae ia a 118 16 5 INTO MALO scsi roicdacas 118 17 M lntenance A a A il 120 17 1 Opening the Front Panel a temmeaadaeenesaeasenss 120 17 2 Closing the Front Panel n 120 17 35 REMOVING the Side Panels sii aaa 121 17 4 User Maintainable Parts of the Analyzer ccsccscscecsccscsceccccscsccccccscsceccccccscscescccscscescecscscesecsecsceses 121 17 5 Software Maintenance FUNCION iii lit 122 17 6 Cleaning the Shear VIVO nu 123 17 7 Cleaning the Washing Head Ac 126 17 8 Software Cleaning Maintenance FUNCTtIONS ccscscsccscscecsccscscsccccscsceccccecscsceccecscuceccccscecesescecscssessess 127 sd DANY eann E tds 128 178 2 Cleaning the Measurement y Misa ie 128 17 8 3 Extended Cleaning Hard Cleaning iia 128 17 9 Replacing Resgents u 2 ES AAA AAA ES A OA AS 129 18 Reagent LOCKING use Ai 132 19 the Day ROUCO 133 20 TEOUDIESNOO LINO A O T T 136 20 1 S ftware error Messages ida 136 20 2 Phe matic error messages ches ansehen 136 20 3 Mechanical Problems nee 137 203 1 Sample Roto rra Urea is 137 20 3 2 Needle Mechanics Vertical Motor Mvert Problems cccccccccssecccccesseccccceeseccceseeeecesseesecceeeeueeecessueeeeeetseeeeeeeseaees 137 20 323 onear Valve SV Related ENO S uns 138 20 3 4 DIIGEOF EIFOTRS ias 138 2035 PriImIngProplems er AA A A 139 20 3 6 ElEetronicsiRelated Problems nee a 139 20 3 2 Whe AmalyZer DGes N
23. and Magnified Scatter Plot ccccccccsseccccseccceesececaesececeesecceseesecessuseceseuaecesseueceesausecesaunecss 70 Figure AS Abacus s Measurement PROCESS a ee Ni 71 Fielire 46 Abacus o Result Screen ernennen eiserne 72 Figure 47 Parameter Information Display cccccsscccccsssccccesseccceesececceseccceesececausececsuececeeueccessusecessunecessenccesausecessuneses 73 Figure 48 Graphical Normal Range DiSplay cccccccssssccccssececesececcessccceesececeusececeeneceseeeseceseuecessugecessegceesansecessuneses 74 Figure 49 Result Screen Scatter Did Slain iaa et 75 Figure 50 Result Screen Histogram S adidas tt 75 Ficure 51 Warnings section OF Results Screens 76 Fieire 52 ACCESSING the Dn e a ee Nro 82 Figure 53 Scrolling and sele cun ou ce A O A O dia ao ou da DO lo 83 Fig re 54 Multiselect and Multiple Selection ii cici 84 Fig re 55 Manage Records Panel EEE EEE aieeeo eae 85 FIg r amp 56 5elect BV Panels Er RE EHE ES 85 Figure 57 Database importing Panel A AA AAA A ET 86 Figure 58 Directory Panel tor Data Storage nun ee A 87 FIEUre 59 Call raton OPUS aa 90 Figure 60 Calibration Panel and Calibration Run Result Panel oocccnccnnccnnonnncnnnnnncnnnonaronnonanonnnoncnnnnnncnnnonanonnnnnnoss 91 Feure 1 Calbration Factor Panels tus iaa a A ti 92 Fere bA VIeW Callbkation Panel tad A aio 93 FIEUFE 63 BEP Nele ae ee a 94 FIeUrE64 Set Q amp Relerence Pan ee een 95 Figtire 65 Load OG Re
24. and secured in the upright position thumb screws become visible that fix the side panels to the instrument 2 in the front and 2 in the back The screws are designed to stay on the analyzer to avoid losing them The system valves and measuring chambers are behind the left side panel Open the left side panel if chamber cleaning is requested by the analyzer The sampling unit wash head and sampling needle are behind the right side cover Open the right side cover if the wash head needs to be cleaned or replaced When closing the side panels always make sure to re tighten the thumb screws After removing the covers potentially hazardous parts become accessible such as electronic boards motors moving parts the sampling needle chambers tubes and valves The sampling needle and other components inside the analyzer may cause injury or can be damaged if handled incorrectly Use extreme caution when operating the analyzer with the front cover open Running measurements with an open cover is not recommended due to the risk of injury Always wear safety gloves while performing maintenance actions 17 4 User Maintainable Parts of the Analyzer There are three user maintenance points inside the Abacus 5 analyzer e Shear valve this critical component and is responsible for correct sampling and dilution e Wash head this component keeps the sampling needle clean ensuring reliable piercing and sampling e Measuring chambers contaminatio
25. anytime to view ongoing sample measurements 10 1 Database Overview The Abacus 5 analyzer database provides a powerful easy to use method of storing accessing and managing patient and sample result information The database of the Abacus 5 analyzer is capable of storing up to 100 000 measurement control and patient records The database presents information in a table view of rows and columns Each row in the database panel represents one sample measurement Rows are also called records Each column in the database consists or sample identification information or measurement parameter results The database information can be scrolled using navigation buttons along the right and the bottom of the database view or by a moving a vertical scroll bar Database records can be selected individually or in groups Detailed result views are available for selected database records Selected records can be printed sent to an LIS and exported into a tab file Various sort options are provided for quickly finding results Database records can be exported for storage and backup Exported database information can be later imported for review Imported records do not become part of your Abacus 5 analyzer s database They are only imported for viewing but can be sorted selected and managed the same way as with regular data the stored inside the Abacus 5 analyzer database 82 The Abacus 5 database displays two numeri
26. by using the Back function e Define the samples to be measured o Click or tap the sample tray position icon where the selected sample is located o Select the appropriate measure mode o Define the sample ID o Define the patient ID o Save the changes by clicking or tapping the Add button e Remove selected samples by clicking or tapping the Remove button e Swap between the tray and list views by using the View list and View tray functions 67 e Start the automated measurement by clicking or tapping on the Start button on the GUI or by pressing the physical Start button al gt gt l el el el el all oll oll of El 5 EGBEEEBEER AL ell fl ell ol el el ol o1 ol oif AZ f a a j J ale EESESEBNEEE Lol elf olf olf lf of off olf oll of EEEEEEEEEE SEBEEEEBEEE EEEEEEEEEE EEEEBEEEEEE fafa si si f all c ECEECEECEE GEEGEEEEEE i Es a a 0 O Measure mode ample pos Measure mode emale gt Sample pos under meas under meas Position Sample status Unknown Position Sample status Unknown Measure type Selected samples mod Tray status UNKNOWN Measure type Selected samples mod Tray status STARTED NO e ORI Figure 42 Selected Sample Mode Panel 8 4 2 5 Interrupting Automatic Processing for Stat Samples If one or more stat samples need to be processed you can interrupt automatic processing to analyze the stat
27. cause a malfunction during operation In order to clean the washing head it must be removed from the needle assembly The following materials are required to clean the washing head e lt Aclean soft damp cloth e O tips 126 e Gloves e Water Use extreme caution when working near the sampling needle The sampling needle is sharp and can cause injury Always wear gloves when performing maintenance on the Abacus 5 analyzer 1 Open the front panel and secure it with the support bar 2 The right side panel of the analyzer must be removed to access the wash head Loosen the 2 2 screws on the front and rear of the side panel and remove the right side panel 3 Locate the sampling needle The washing head is positioned near the top of the sampling needle 4 Using extreme caution gently twist off the washing head from the needle and pull it downwards Use a soft cloth dampened with water to clean the bottom of the wash head Figure 100 Removing the Washing Head 5 Use a soft cloth dampened with water or a Q tip to clean the bottom of the wash head Figure 101 Cleaning the Washing Head 6 Using extreme caution with the sampling needle gently push the wash head onto the needle Push it up as far as it will go and lock it back in place by twisting it into the grooves of the holding rods 7 Replace the side cover and the side cover screws Close the front panel 17 8 Software Cleaning Maintenance
28. down to an acceptable level Blank measurements will be flagged if they exceed the following thresholds e WBC gt 0 20 x 10 cells uL e RBC gt 0 05 x 10 cells uL e PLT gt 15x 10 cells uL e HGB gt 1 0 g dL 48 If the Abacus 5 was not in use for an extended period of time the start up of the pneumatic system components can take significantly longer and require more blank measurements To prevent these problems use the prepare for shipment process when the Abacus 5 analyzer will be inactive for an extended time 7 3 Exiting the Abacus 5 Analyzer After you have completed lab operations and you are ready to exit the Abacus 5 analyzer you can e Log off e Shut down the Abacus 5 e Power off the Abacus 5 e Prepare the Abacus 5 for shipment A AS state 24 None L de Figure 23 Abacus 5 Shutdown Options Click or tap the Exit icon on the main menu to access various exit options Click or tap the Cancel button to return to normal operation 7 3 1 Log Off Clicking or tapping the Exit icon on the main menu brings up the Shutting down Analyzer panel Select Log off to end the active user session Shutting down Analyzer shipment Figure 24 Log Off After the current user is logged off the logon panel is displayed 49 7 3 2 Shut Down The shutdown procedure must be used to maintain the reliable operation of the instrument To properly shut down
29. establish its own reference ranges 152 Lowerlimit Upperlimit Table 32 Reference Ranges 22 7 8 Background Limits 10 cells ul HB g dl 10 cells l 10 cells Table 33 Background Limits 22 7 9 Analytical Measurement Range m EEE ooo a e Parameter m Tun EEE HE CDI ERA IE KEN Table 34 Analytical Measuring Range 22 7 10 Interfering Substances The following substances can interfere with parameter measurement and alternate measurement procedures may be required WBC gt 5 NRBCs 100 WBCs PLT clumps large PLTs RBC WBC Count gt 75 0 x10 uL 154 22 8 Reagent System 22 8 1 Diluent DiatroeDil 5P diluent 22 8 2 Lyse Reagent 1 DiatroeLyse 5P 22 8 3 Lyse Reagent 2 DiatroeDiff 5P 22 8 4 Cleaner DiatroeHypocleaner CC Isotonic solution used to dilute whole blood and quantitative and qualitative determination of RBC WBC PLT and HGB concentration Reagent for stromatolysis of RBC and quantitative determination of WBC 5 part differentiation LYM MON NEU EOS BAS and HGB concentration measurement of human blood Quantitative determination of WBC leukocyte four part differentiation LYM MON NEU EOS Capillaries tubing and chambers removing blood component precipitates 155 22 9 Tab File Format This file format is composed of a header line and consecutive lines containing records selected for saving Each parameter is selected by the lt T
30. g radio or television transmitters receivers radars centrifuges X ray devices fans etc This analyzer is designed to be safe for transient voltages to INSTALLATION CATEGORY Il and POLLUTION DEGREE 2 2 6 Space Requirements It is important to install the instrument in a suitable location A poor location can adversely affect its performance Select a well ventilated location near a power source and close to a suitable drain Place the unit on a clean level surface Leave at least 0 5 m 18 inches space on both sides and above the instrument to access pneumatics A minimum of 0 2 m 8 inches must be maintained between the rear panel and the wall to allow for heat dissipation and tubing clearance Ensure there is enough clearance in front of the Abacus 5 analyzer to open the front panel Allow enough space if you want to use optional external keyboard mouse or bar code reader 14 Your selected location should allow placement of the reagents in an unobtrusive location below the laboratory bench that the instrument is placed on or on the same surface Placement below the laboratory bench also allows for storage of a spare set of reagents Never place the reagents above the Abacus 5 analyzer Placing reagents above the Abacus 5 analyzer could result in reagent overflow and spilling See Figure 1 and Figure 2 for more information about proper analyzer location and clearance 1 m 1m max 1 2 m Fi
31. operation The system will try to recover from the failure If the error continues to occur please contact your service personnel 20 2 Pneumatic error messages The analyzer software is designed to be error tolerant and recover from with minor problems However if some physical obstructions or extreme operating conditions cause some mechanical parts to behave unexpectedly the system will give you an error message such as this Pneumatical error please retry the operation If this error persists please contact the servicel Figure 106 Pneumatical Error Message Example Clicking or tapping the Ok button returns and retries the current operation Clicking or tapping the Details button provide youo with further informaion abou the error It will describe additional conditions of the failure The numbers in the second row are important for the service engineer 136 Details 105 33 102 3 EG MOVE_DILUTOR_1 105 EG_MEASURECONTROL 33 EG_AUTOSAMPLER_MEASURE 102 Processname DILUTOR_FULL 3 Figure 107 Detailed Error Message 20 3 Mechanical Problems Most mechanical problems arise because of some physical blockage of the moving parts Problems caused by severe blocks are usually accompanied by a grinding noise The noise is a result of a motor not being able to move but this does not usually result in mechanical damage to moving parts Typical failure situations can be traced to salt build ups around the wash
32. panel START button and the sample rotor can be cleaned with damp sponge and regular e g household cleaning material Sample tubes are placed into a tube adapter inserted on the sample rotor for closed vial or open vial single tube manual sample processing The sample tube is rotated from the front of the unit into the inside of the Abacus 5 for aspiration This safety feature protects the operator from inadvertent contact with the aspiration needle during specimen processing Automatic sample processing with the optional Autosampler can be interrupted in order to run one or more stat samples with the sample rotor Automatic processing can be resumed after stat sample processing is complete The START button allows easy one hand operation of the Abacus 5 analyzer The color of the START button indicates the status of the Abacus 5 analyzer e Green ready to process samples e Red busy e Orange standby 5 3 2 Back Panel Figure 10 Abacus 5 Back Panel 30 Power connector the Abacus 5 power connector should be connected to a grounded power outlet that meets the requirements listed in section 2 5 Main power switch this is a small switch located next to the power connector This switch turns off all electrical power to the Abacus 5 analyzer Leaving this switch on allows the Abacus 5 to remain in the standby state The switch is on when it is in the up position labeled 1 and is off w
33. perform and accept a blank measurement if one is needed Click or tap the AS quick link at the top of the screen and select Free list mode The Free List mode only requires that samples be placed in the same sequence as in the free list It does not require that samples be matched to exact 64 rack and sample positions It is not possible to add additional samples to the batch in free list mode after automated measurement has started a Measure Database Measure Database A AS state a 2 None E LES Figure 37 Free List Mode Selection A AS state 20 58 On the Free List mode panel you can e Return to the AS panel to select a different type of automated measurement by using the Back function e Add or remove list items e Define the following parameters for the new list items o Measure mode o Sample ID o Patient ID e Swap between the tray and list views by using the View list and View tray functions e Start the automated measurement by clicking or tapping on the Start button on the GUI or by pressing the physical Start button 65 Analysis time Sample 7 Mode ID Analysis Patient time nose WBC LYA Figure 38 Figure 39 Preparing a Free List Analysis time1 12 02 2010 16 15 7654321 1210212010 16 16 St Mary_12A5 As with the Full Scan mode the Autosampler will scan all the sample positions on the tray and rows with missing racks will be skipped The Autos
34. records in the database and export them using the export function Clicking or tapping the Export button displays the database export panel mi Database Print Selected path Actual path Ome New directory name a AS state None 15 15 Figure 58 Directory Panel for Data Storage Introduce a USB storage device USB hard drive memory stick etc into an available USB port on the back panel of the Abacus 5 analyzer Select the directory to store the exported data and press the Ok button to start the export The file format of exported data is an internal format and can only be read and interpreted by the Abacus 5 analyzer using the Import function Each database record is stored as an individual file with an rp extension 10 8 4 Send to LIS The Send to LIS button immediately transmits selected database records to the external LIS according to your LIS settings 10 8 5 Save Tab File The Save tab file function is used to archive database data to a tab separated text file The Save tab file button displays a directory panel like Figure 58 except that the file saved in the selected location is a tab separated text file rather than a database backup file Tab separated text files can be loaded and viewed by a text editor or imported into spreadsheet software The filename created by the Save tab file function is generated automatically in the following format TAB_YYYYMM
35. reference values from removable media such as a flash drive Save reference Save entered QC reference values View QC references Browse stored QC references Delete Delete a stored QC reference Details View detailed results for a stored QC reference View QC data Browse individual QC sample measurements Delete Delete currently selected QC run View QC diagrams View QC diagrams for currently selected Details View detailed result screen of a QC run View QC diagrams View Levy Jennings diagrams of QC data for the currently selected QC reference View QC data Browse individual QC sample measurements Next diagrams Browse the next set of QC diagrams View X B data Browse individual X B sample measurements Reject Reject a run from being included in X B calculations View rejected View previously rejected X B runs Undo reject Restore a previously rejected X B run and use in X B calculations View X B diagrams Navigate directly to X B diagrams View X B diagrams View X B diagrams of X B data See section 1 for more information about quality control on the Abacus 5 analyzer Diagnostics Selftest Perform electronic and or pneumatic system self tests Load last selftest Loads the results of the last selftest Start electronic Starts the electronic tests Start both Starts both electronic and pneumatic tests Log Review and obtain additional details about events in the system log Details Display details about the selected event in the event log Selft
36. the Abacus 5 analyzer The System settings panel lets you change the following settings Database columns order Which column parameter of the measurement database is displayed hidden Waste container volume select 10L 20L or None Selecting 10L or 20L changes the waste container tracking display behavior in the reagent status area at the bottom of the screen Selecting None assumes waste is being drained directly into the laboratory drain and disables waste container tracking 106 Database display limit select All or Last month to change the number of database records displayed in the database panel Last month only displays the last 30 days of measurement results and All displays all measurement results stored in the Abacus 5 database Use only Sarstedt Monovette tube from sample rotor Check this check box to change the sampling depth for manually presented tubes at the sample rotor to accommodate Sarstedt Monovette tubes Uncheck this check box to manually process standard sample tubes This setting does not affect automatic sample processing with the optional Autosampler which is able to recognize tube types and change sampling depth automatically Standby time This defines the time period of inactivity before the analyzer automatically leaves the ready state and drains the pneumatic components to prepare for overnight standby If this time is set to zero the analyzer will never enter the standby state auto
37. the Abacus 5 analyzer click or tap the Exit icon on the main menu and select Shutdown shutting down Analyzer shipment Figure 25 Shut Down The shutdown procedure performs two key functions e fthe pneumatic system components of the Abacus 5 analyzer were initialized a shut down procedure is performed that rinses the pneumatic components This prepares the Abacus 5 analyzer for a period of inactivity of up to 5 days e The Abacus 5 operating software and the Windows XP Embedded operating system are shut down The analyzer saves all settings closes the file system and database and automatically shuts down the internal user interface computer The Abacus 5 analyzer may ask to perform a cleaning cycle based on the analyzer s usage patterns and the state of the pneumatic components If this occurs the Abacus 5 analyzer will request that a tube with cleaning reagent be introduced at the sample rotor The cleaning procedure may take a few minutes Do not turn off the analyzer until it indicates that it is safe to do so 7 3 3 Prepare for Shipment If the Abacus 5 analyzer is not to be used for more than 5 days or is being transported to a new location then the prepare for shipment procedure should be performed instead the regular shutdown procedure Click or tap the Exit icon on the main menu then select the Prepare for shipment button shutting down A
38. 0 620 PLAY 59 7 fL 760 J60 MICH 268 pg Aa 320 MCHC 2799 ol S00 35 0 ROWsd 520 fL 200 420 RDVWey 11 8 Yo 0 0 16 0 PLT 365 10FUL 150 400 PET O49 o MPV 135 fL 5 0 2 50 FoWyscd 254 fL PDOWicy 34 2 Warming flags Morphological flags Interpretive flags Leukocytosis Anemia Hyoochramic Figure 111 Detailed Printout Format 145 deiatron Lab header Lab header 3 Lab header 4 Sample ID Mode Patient ID Date AS 10 42 Human 1 141062011 15 51 20418140022 Human 1 141062011 15 53 AS 10 A Human 1 14 06 2011 15 57 AS 3 At Human 1 14 06 2011 15 59 00025 110523 Human 1 17062011 1108 WBC REC PLT O20 5 59 22 11 97 4 76 145 6 25 5 59 22 15 36 eis 43 9 49 493 247 Lab header 1 Lab header 5 Lab header E Lab header 7 NEU LYM NEU LYM HGB HET PCT MP 4 53 1 21 Paa 19 3 230 Y 01 02 9 2 5 68 1 99 LLO 16 6 112 40 3 O71 139 4 53 1 21 lao 19 3 t230 0 02 4 2 12 79 1 43 ao a Ta 48 5 0 45 4 6 6 13 2 10 64 6 149 44 0 O30 122 MON EQ MONS EOS MEY MICH POYYsd POVYcy oo o 53 1 5 ES 25 8 24 4 40 1 103 0 14 5 6 ie 24 6 O ai 4 36 3 O33 0 09 0 15 IH 25 8 744 40 1 0 26 0 54 1 55 DAA es 276 39 4 1 85 1 33 90 33 549 3 30 3 25 0 36 8 Figure 112 Listed Printout Format 146 BAS BAS MEHE 0 09 14 ir 0 13 277 0 09 0 03 282 0 08
39. 10 uL 10 uL g L fL pg g L fL 10 uL interpretive flags _ Microcytic RBC Hyperchromic j ll a AS state A None Figure 46 Abacus 5 Result Screen The Abacus 5 analyzer result screen is divided into 4 major areas 1 Sample identification information contains identifying information used to uniquely identify this sample s information Parameter information contains parameter names values units and normal range Normal range linearity and high blank flags are also displayed in this area Histograms and scatter diagrams Visual elements that provide information about the measured population dispersion These are active elements that can be individually magnified by clicking or tapping Flags area this area displays warning interpretive and morphological flags associated with this sample If flag display overflows its assigned space an ellipsis will be displayed and the user can click on the information icon to see a detailed display of flags 9 2 Sample Identification Information This part of the results screen contains information that uniquely identifies a particular sample run 72 The Sample ID is the ID entered by the operator from a keyboard or hand held barcode reader for a manually processed specimen For automatically processed sambisib specimens the sample ID can be read from a sample tube barcode or entered into a list for one of the
40. 112 2010 15 57 11 12 2010 15 57 Human 4 1 11 12 2010 15 57 Human 3 27 gt Sn LE JE oo Oe Figure 53 Scrolling and Selectin 10 3 Sorting Database Information The database is sorted by Result ID by default Clicking or tapping the following database column headings changes the sort order of the database records Sample ID Sample ID entered by the operator or read from a sample tube barcode label Identifier that associates a result record with a patient records Analysis Time Time and date this sample tube was analyzed Result ID Unique sequential identifier assigned by the Abacus 5 to each records Table 16 Database Sort Criteria 83 Clicking or tapping the same column heading again changes the ascending or descending order of values in the column 10 4 Manual Selection of Database Records Clicking or tapping on a row in the database display single selects a row Clicking or tapping it again de selects the row Selecting another row will de select previously selected rows in single selection Selected rows are highlighted with white text on a black background Checking the Multiselect check box below the left side of the database table allows the selection of multiple rows Tapping or clicking once selects a row but previous selections remain selected unless you click or tap it again to de select it Un checking the Multiselect check box will de select all selected records 1111212010 15 56 1111212010 15
41. 20 3 8 PC Errors Displayed At Startup e Contact Service 20 4 Measurement results related problems 20 4 1 Fluctuating PLT background values When the Abacus 5 is used under increased workload running even 300 samples a day in 5 hours of continuous operation is possible Despite built in maintenance programs the system may require intensive cleaning from time to time If you find that blank PLT values are increasing and decreasing unexpectedly please perform a Hard cleaning maintenance function 139 Go to Main Menu and click or tap the Maintenance button Click or tap the Hard cleaning button in the Cleaning section to initiate the procedure You will need a syringe 10ml to dose cleaning liquid into the analyzer s measuring chambers The process is described below 20 4 2 Long smeared population A long smeared population with this appearance shows that a key part of the measurement process is not operating as expected This could be the TCU the reagents or the sample mixing Possible root causes are e The two lyse reagents are interchanged e Check tube connections or container connections Figure 109 Smeared Population 140 21 Accessories The following items can be found along with the analyzer e Power cord e Reagent tube kit e Cleaning tube kit e Waste container 20L e Cardboard box for waste container e Sample tube adapter e Operator s manual 22 Appendix 22 1 Reagent Consumption
42. 27100022 m AS state 2 E Measure type Full scan mode Tray status FINISHED Sample Id 22527100022 A AS state None Figure 36 Full Scan Mode Tray and List Views The Autosampler allows the addition of sample tubes to a Full Scan process already in progress To add more sample tubes perform the following steps e Click or tap the Stop button The Abacus 5 will prompt you to wait until the current sample is completed e Acknowledge the message by clicking or tapping the OK button e Insert the new samples into a rack e Open the cover of the Autosampler e Place the new samples behind the last measured sample e Close the Autosampler cover e Start the automated measurement by clicking or tapping on the Start button on the GUI or by pressing the physical Start button The Abacus 5 analyzer keeps track of the last analyzed sample on the sample tray of the Autosampler After restarting the full scan process the Abacus 5 moves the Autosampler to the last processed position and continues scanning from there 8 4 2 3 Free List Mode Free List mode is suitable for laboratories where e The barcode labels are not used or the bar codes are not the primary identifiers e Samples are arriving from multiple sources in small batches e Inagiven batch there are samples which should be measured using different modes for different normal ranges To start sample measurement in Free List mode first
43. 56 1111212010 15 56 11 12 2010 15 56 11 12 2010 15 56 11 12 2010 15 56 11 12 2010 15 56 11 12 2010 15 56 11 12 2010 15 57 1111212010 15 57 1111212010 15 57 1111212010 15 57 1111212010 15 57 11 12 2010 15 57 11112 2010 15 57 a Figure 54 Multiselect and Multiple Selection Multiple selections are useful for viewing managing and quickly viewing statistics of only a few selected records 10 5 Automatic Selection of Database Records When the total number of records in a database becomes very large manual selection of records can become difficult The Select by function in the Manage records panel provides the means to select a group of records automatically according to their identifying information See section 10 8 1 for more information on the Select by database function 10 6 Viewing Detailed Results Multiple selection is also useful for viewing the detailed results of a few records rather than navigating through the database After selecting several records clicking or tapping the Details button on the database panel will display the detailed results for the first record in the selection Clicking or tapping the Up or Down buttons on the details screen displays the details of the next record in the selection 84 10 7 Statistics After selecting a group of records click or tap the Statistics button on the database panel to view the coefficients of variation CV associated with each
44. 9 2012 11 22 T Jozsi General Update reagent consumption update EEE EA Added Indications for Use statement Qualified sample handling to include only venous blood Updated performance characteristics Removed references to refrigerated samples Added table of background limits ESA EAN APPROVALS Role DO Name Date Signature f f f 4 Abacus Iron Abacus 5 Innovative Solutions in Hematology Operator s Manual Revision 1 2 29 p Issued November 22 2012 n a tom ES This user manual is intended to give detailed information for end users of the Diatron Abacus 5 optical hematology analyzer Descriptions contained herein are relevant to Abacus 5 software versions e Firmware 2 66 1125 e PIC sw 2 3 e Laser sw 3 6 e TCU sw 3 52 Warranty THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WARRANTIES EXPRESSED OR IMPLIED INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE Exemptions Diatron s obligation or liability under this warranty does not include any transportation or other charges or liability for direct indirect or consequential damages or delay resulting from the improper use or application of the product or the use of parts or accessories not approved by Diatron or repairs by people other than Diatron authorized personnel This warranty shall not extend to e Any Diatron product which has been subjected to misuse negligen
45. AB gt 08h character allowing easy interfacing or importing into most data processing applications like Microsoft Excel Scatter diagrams and historgrams flags are NOT saved in this format The header line contains the same column names you can see in the analyzer database Data values are saved as they are stored in the analyzer database alphanumerical or numerical Decimal separator is defined by the actual operating language of the software Example tab separated file Sample ID lt TAB gt Patient lt TAB gt Analysis time lt TAB gt Mode lt TAB gt WBC lt TAB gt NEU lt TAB gt LYM lt TAB gt MON lt TAB gt EO lt TAB gt BAS lt TAB gt NEUS lt TAB gt LYMS lt T AB gt MONS lt TAB gt EOS lt TAB gt BASS lt TAB gt RBC lt TAB gt HGB lt TAB gt HCT lt TAB gt MCV lt TAB gt MCH lt TAB gt MCHC lt TAB gt RD Wsd lt TAB gt RDWcv lt TAB gt PLT lt TAB gt PCT lt TAB gt MPV lt TAB gt PDWsd lt TAB gt PDWcv lt TAB gt Warnings lt TAB gt Tray lt TAB gt User lt TAB gt SEQ lt TAB gt 27 lt TABSI lt TABS47 972010 11 50 05 AM lt TAB gt Human lt TAB gt 4 85 lt TAB gt 2 66 lt TAB gt 1 32 lt TAB gt 0 48 lt TAB gt 0 33 lt TAB gt 0 06 lt TAB gt 54 8 lt TAB gt 27 3 lt TAB gt 9 9 lt TAB gt 6 8 lt TAB gt 1 2 lt TAB gt 3 28 lt TAB gt 95 lt TAB gt 31 6 lt TAB gt 96 2 lt TAB gt 29 lt TAB gt 302 lt TA B gt 50 2 lt TAB gt 11 lt TAB gt 279 lt TAB gt 0 48 lt TAB gt 17 2 lt TAB gt 33 4 lt TAB gt 34 2 lt TAB gt lt TAB gt lt TAB gt lt TAB gt 7 lt T AB gt Z0 lt TAB gt 1 lt TAB gt
46. C HGB HCT 100 Calculated from RDWcv and the distribution width of the erythrocyte histogram at 20 of peak RDWsd RDWcv x P P 0 56 Hemoglobin Red Cell Distribution Width i Derived from the distribution width of the erythrocyte histogram at 20 of peak RDWcv RDWen x 0 56 x P u P1 P P1 Factor of 0 56 converts measurement at 60 of peak to 20 of peak Platelet thrombocyte 3 9 PLT 10 ul or 10 PLT PLT ca x PLTmMEASURED concentration Calculated from PLT and MPV PCT Thrombocrit PCT PLT x MPV x 100 Mean Platelet Volume fl Average volume of individual platelets derived from the PLT histogram E gt N Calculated from RDWev and the distribution width PDWsd Platelet Distribution Width of the platelet histogram at 20 of peak PDWsd PDWcv x P P 0 56 Derived from same histogram as above Platelet Distribution Width PDWcv PDWca X 0 56 x P P14 P gt Py CV Factor of 0 56 converts measurement at 60 of peak to 20 of peak Table 24 Parameter Calculation 148 22 6 Specifications o 19 inches amm ke wire o 19 hinches 4amm Weight Sampling method Ceramic shear valve with 3 separate primary loops Dimensions CBC 5DIFF mode 24 parameters WBC LYM MON NEU EOS BAS LYM Measured parameters MON NEU EOS BAS RBC HCT MCV RDWsd RDWcv HGB MCH MCHC PLT MPV PDWsd PDWcv PCT Throughput 60 tests hour Volumetric i
47. DDHHMMSS txt with the year month day hour minute and second of the time when the operation started 87 To archive database data using this function insert a USB data storage device to one of the USB inputs on the back panel of the Abacus 5 analyzer Select the file location of your USB data storage device and click or tap the OK button to begin the export See section O for detailed information on the format of the tab separated text file 10 8 6 Save Raw Data The save raw data function saves the raw data information associated with a selection of database records Raw data files are only suitable for internal use by Diatron staff Your service engineer may ask you to save raw data files to help diagnose a service issue A confirmation password is required to save raw data The default factory set confirmation password is 555 This password can be changed only by a Diatron certified service engineer Insert a USB data storage device to one of the USB inputs on the back panel of the Abacus 5 analyzer Click or tap the Save raw data button on the Manage records panel then enter the correct confirmation password Click or tap the Ok button to display a directory panel like Figure 58 Select the file location of your USB data storage device and click or tap the OK button to begin saving raw data 10 8 7 Delete The Delete function is used to delete records from a selection permanently from the Abacus
48. Diff 5P buffer Empty Chamber Empty RBC chamber empties the RBC counting chamber Empty WBC chamber empties the WBC counting chamber Prime Diff 5P primes the Diff 5P buffer and tubing with Diff 5P reagent 122 Empty Mix chamber lt help needed with this one What is the mix for gt Prime sheath primes the sheath buffer and optical head with diluent Prime Lyse 5P primes the Lyse 5P buffer and tubing with Lyse 5P reagent Prime diluent primes the diluent buffers and tubing with diluent or primes the entire system with diluent the operator is given a choice by the software maintenance function Prime all primes all reagent buffers with their corresponding reagents the operator is given a choice to perform a full system prime or prime individual buffers sequentially Fill initial filling of the system with reagents This must be performed PRIOR to first use of the instrument after installation or after the system has been drained for transportation or storage Touchscreen Touchscreen calibration calibrates the touch screen by prompting the operator to tap specific areas of the display Table 21 Software Maintenance Procedures 17 6 Cleaning the Shear Valve The inner surfaces of the shear valve builds up salt deposits from the reagents If these deposits are not regularly cleaned it will cause a malfunction To avoid this it is recommended that the operator clean the shear valve after every 1200 samples The fo
49. Front Panel tunen ee 121 Figure 93 Software Maintenance Functions eessssssessnesseesnensnennnnnnnnnnnnnnnnnnnnnennnnsnensnnnnnnsnnnnnesnnnsnensnsssnnsnsnsnesssssnensnnnn 122 Figure 94 Shearvalve Cleaning Maintenance Function uesseeseessssssessnensnesnennnennnnnnnnnnnnnnnsnnnnnennnnsnensnnnnnnsnsnsnennnsnensnnnn 124 Figure 95 Shearvalve Cleaning Maintenance Function Prompt occccccncccnnonnccnnnnnncnnnnnaconnnnanonnonanonnnnnnonnnonacrnnonanonnnnnaoss 124 Figure 96 Removing the Shear Valve Axis Thumbscrew ceesnssseessssssesnnsnsnssnnnsnesnnnnnnnsnnnnnnsnnnnnennnnnnensnnnnnnsnsnsnesnnsnensnnnn 125 Figure 97 DIsassembling thesshear VI atte 125 Figure 98 Cleaning The Shear Valve ee a de ete ae Re Aen eine ah 126 Figure 99 Reassempbilng the Shear Valve 2 ibid 126 Figure 100 Removine the Washinge Head andi ee earl LESE LE 127 Figure 101Cleaning the Washing Head 2 22 a2 EI En 127 Figure 102 Reagent Low Indicator and Explanation Panel ooccccconoccnnonaconnnnnocnnonononnnonaronnonanonnnnnnonnnonaronnonaninnnnnnoss 129 Figure 103 Reagent Replacement Panel nn eier 130 Figure 104 Location of Reagent Key in DiatroeLyse 5P Reagent COntaiNeT ooccccccncccnconaccnnnnanonnnnnaronnnnacnnnonanonnnnanoss 132 Figure 105 Reagent KEV CONNEC CO aria AAA E 132 Figure 106 Pneumatical Error Message Example cccccccsssccccessececceseccccesecceausececeueeceseeescceeeeecessunecesseneceesegsesessenecss 136 Figu
50. Patients The Abacus 5 analyzer allows the operator to define and store patients in the patient database during manual measurement Patients can also be predefined while creating a list for one of the automatic processing modes Select the Patients icon on the main menu to display the Patients panel _PID Name SSN Date of birth 1 01 01 1999 8 bannister 22 09 1960 9 Andre 0123456789 23 08 1980 a AS state 100 100 A AS state AA Manual mode en GB A None 2 None 13 58 Figure 67 Patients Panel The Patients panel displays patient information in the familiar table format of the Abacus 5 analyzer database and operates the same way as the database panel Use the New function to define new patients and Edit to change existing patient information Details displays patient data in a read only mode The Patient panel can also be accessed by clicking or tapping the Name or Patient ID field in the Measurement panel Two additional function buttons are available if the Patient panel is accessed from the Measurement panel The Select ID function associates the currently selected patient to the sample measurement and returns to the Measurement panel The Cancel function returns to the measurement panel without selecting any patient to associate to the sample measurement You can select either Name or Patient ID to be displayed as the patient identifier in the Measurement panel by changing the set
51. QC name is the name that will be displayed for selecting the control to associate with a QC measurement Enter the identifying information and the target values and tolerance ranges for any parameters that are to be controlled with the Abacus 5 QC system To exclude a parameter from the QC procedure leave its target value and tolerance range field empty Press the Save reference button after data entry is completed Tapping the Load QC reference button will allow filling QC material data electronically using a file provided by the manufacturer of the analyzer A dialog will open Browse to the correct folder and select the file by tapping the checkbox in front of the filename The file contains information for all three levels of the control material Low Normal and High All three levels will be loaded into the system and will become selectable in the QC menu Selected path EndiatroniDCheck_U011 as Actual path E diatron 4 vaeane C Create Figure 65 Load QC Reference Panel 95 12 2 QC Measure To run a QC measurement please ensure that a valid blank measurement has been run and accepted Associate the QC measurement to the correct control material lot by select the matching QC name in the selector below the QC measure button on the QC panel Place the control material sample tube in the sample rotor and click or tap QC measure The QC measurement results will be added to the QC da
52. Result IDs Clicking or tapping the Run select will create a multiple selection of all database records that match the criteria if any The Cancel button returns to the database view and the current selection is not changed 10 8 2 Importing Clicking or tapping the Import button displays a blank modified version of the database panel lu gy A Database Print SampleiD_ Tray Mode wBc LYM 24 Human 5 0 Blank ControlDemo Control Human Human Figure 57 Database Importing Panel The database importing panel provides the following options e The Import button brings up a panel to select previously exported database record files to load and view e Select by performs the select by database function to select a group of imported records according to criteria entered by the operator e Details views the detailed result information for all or a selection of imported records e Clear removes selected records from the imported records table but does not permanently remove the cleared records from the stored database file e Back ends viewing of imported database information and returns to the Abacus 5 stored database 86 10 8 3 Export The database export panel allows you to select a directory location to store records in a selection for backup or reference purposes To back up all records in the database first use the select by function to select all
53. Revision history OM A5 01 1229 Rev Date Tediedby sections afecte dy raat 2008 0CF07 Csaba Magyar ALL nia reisen OoOo o i o 1020 2009 APR 15 Csaba Magyar Troubleshooting SSSOSCS SCS SS o 1021 Dos mars CsabaMewar Le ara ouno Temaayer Wren update ooo o SSS 121 rouna Temaayer Reor O ee 122 2009JuN12 Magyar Accommodate changes and review reordering f 123 2009JUNAS Magyar em U O SS 125 2009 1un 30 CMaevr Umitedeatures removed OO oo o SSS 126 2009 AU6 14 CMagyer Men system review 127 20095ep 16 CMagyar Ustofaccessories O O O O OoOO SSS 128 2009 0cr14 CMagyer v cleaning 1 5 1 Result interpretation sect 6 Reag cons update O Fide sehemanies 1413 Measurement principles detailed 129 200900729 EMASYAR Xb description messurementmeihods OOOO S E O E A 1217 20091212 Temaayer anoder O oo S 1 2 12 2010 01 18 2010 02 17 Rewording parameter clean up screen shots pictures drawings re structuring Autosampler reagent lock 1214 20100303 CMagyar Troubleshootingadded o ooo o 1215 20100412 CMegyar Updeoswross OC OoOo SSS 1216 20100415 Cmagyar xBretedtunctionsremo f 1 2 17 2010 06 04 C Magyar Screenshot updates Measurement related troubleshooting temporarily DER removed 1 2 18 2010 06 11 C Magyar SV cleaning revised Lod 1 2 19 2010 06 29 C Magyar Reagent filtering method specs ultra micro filtered Ld 1
54. TE Alternate 1 and Alternate 2 are sample modes that are different than Human Male and Female and have user definable normal ranges e Control QC mode The hematological parameters of QC materials are known prior to analysis Controls are used to check the long term stability of the Abacus 5 analyzer Calibration with a calibrator material is not one of the Abacus 5 sample modes but a specific procedure that can be accessed from the Calibration icon on the main menu 8 3 Sample Identification Use caution and ensure accurate data entry when manually entering sample ID or patient ID information into the user interface of the Abacus 5 analyzer to avoid possible misidentification of sample results The following sample information items are used to uniquely identify samples e Sample Mode e Measurement time assigned automatically by the Abacus 5 analyzer e Result ID unique database identifier automatically assigned by the Abacus 5 analyzer e Sample ID assigned by the operator o The Abacus 5 doesn t require the sample ID to be unique o The sample ID can submitted by Manual typing Bar code reading manual or Autosampler Auto increment o The sample ID is not applicable on blank measurements Patient o A record from the patient database connected to a measurement o Not applicable for blank and QC measurements o Can be changed by setting the name or the database identifier of the patient d
55. V Ri wean aia 40 Figure 21 Abacus S Main Menu sertan A ia 42 Figure 22 Abacus 5 Analyzer Startup and Log On Screens ocononnoncnconeorncnonaciononaoronconorocnonariononasronoonorannonariononasionenaarnes 47 Figure 23 Abacus 5 nu tdo WIN Options aa A oot elven neat 49 A ee ee ee Be tee lee ee 49 Heure Zo SUR DOWN rn a nee ke 50 Figure 26 Prepare Tor SIO MCI a ee een oli 50 Figure 27 Connect Distilled Water Panel ee id 51 Figute 28 Remove Reagent T bine Panes ini 52 Figure 29 SHUE DOW Ready Panel sisia a ias 52 Figure 30 Sampling Need Ensa E boo 55 Figure 31 Sample Measurement Panelus s 2 32222823la ii EEE 58 Figure 32 Sample Processing Result Screen sen seele een 59 Fieure 33 Autosampler Info and AS Panel rs A AAA 60 Figure 34 Full Scan Automatic Processing Moden aus ae 62 Figure 35 Full Scan Mode Tray View Progress ssscccssssscssssssescossvectenssscuesesesecusvectensssencussseneoussesteusssencussseneoussestenssss 63 Figure 36 Full Scan Mode Tray and List VIEWS iia a 64 Figure 7 Free ELISE Mode seleciona lia 65 EISUFESS EIEUFE 39 Preparing a Free Est a ANA 66 Figure 40 Free List Mode Progress LIST VIEW ains AE ds 66 Figure 4 1s Free list Mode Progress Tray VOW ata aaa 67 Fieure 42 selected Sample Mode Plica 68 Figure 43 Control The Autosampler With Info Panel ccooocccnccnccnncnnnccnnnnaconnnnnconnnonaconnonnronnonanonnnnnnonnnonnrnnnananinnananoss 69 Figure 44 Results Display
56. YM 10 uL 100 3 70 MON 10 uL 000 0 70 EO 10 uL 000 0 50 BAS 10 uL 0 0 0 15 NEU 70 720 LYM l 210 50 0 MON 00 140 EO E 00 6 0 BAS 0 0 1 0 RBC 10 uL 350 5 50 HGB g L 120 174 HCT 260 50 0 MCV fL 860 1100 MCH pg 25 0 38 0 MCHC g L 300 350 RDWsd fL RDWev 00 16 0 PLT 10 uL 50 400 PCT 013 0 43 MPV fL 90 13 0 PDWsd fL PDWev Warning flags Interpretive flags Morphological flags Microcytic RBC Hyperchromic Next sample ID A AS state 50 50 None Figure 32 Sample Processing Result Screen The Abacus 5 analyzer will be ready to take the next sample after it has finished cleaning and preparing for the next sample The Start button will change to green indicating it is ready to start the next sample measurement On the result screen you have the following options e You can print the results by clicking tapping on the Print quick link at the top of the screen Please note that the printing is a feature that is always available See section 6 6 1 for more details about printing e Return to the measurement panel by clicking or tapping the using the Back button e Run the next sample in routine mode by O O O Editing the Next sample ID just below the actual results Accepting the auto generated sample ID Starting the next measurement by clicking tap
57. allows you to choose whether the on screen virtual keypad is presented or not when data entry is required name sample ID target value etc If the check box is left unchecked then the on screen virtual keypads are not presented and an external keyboard is required for data entry If the check box remains checked the external keyboard can still be used by pressing the ESC key on the external keyboard to dismiss the on screen virtual keyboard and complete the data entry using the external keyboard 6 5 Using the On Screen Virtual Keypads There are three types of virtual on screen keypads e Alpha numeric with shift and symbol options e Numeric only e Date The particular virtual on screen keypad presented is tailored to the data entry required If only numeric values are accepted than a numeric only keypad is presented For selection of dates a date keypad is presented The touch pad of the Abacus 5 handles single taps only The Shift and Symbol keys are sticky on the virtual on screen keypads like the caps lock on a PC key board Click tap on the appropriate buttons to type in the required value Complete the operation by clicking tapping the Done button The Symbols button presents special characters such as the question mark or ampersand 4 rs a Figure 15 Alohanumeric Virtual On Screen Keypad Fe ME p pE EE O ee Peet eh 000000000 pe sma EC oo ome I Symbols
58. alues falling above the normal range are marked with a and displayed with red text and values falling below the normal range are marked with a and displayed in blue text Normal range information can also be conveyed graphically as well as numerically This setting can be changed in the Main menu Settings Customize panel HCT 243 E 45 02 520 MCV 596 iL 34 0 A 96 0 MCH 36 6 pg 27 0 32 0 Figure 48 Graphical Normal Range Display The flags displayed in the parameter information area are as follows Normal range flags are raised when a particular parameter is above or below Normal range flags ae l l l l the normal range which is defined for the patient profile currently in effect Color Code Parameter is under normal range Parameter is over the normal range Lowest Red ie Parameter is over twice the high limit of L normal range Table 10 Normal Range Flags l l Linearity range flags are raised when a particular parameter is above or below Linearity Range Flag l i the linearity range of the device Color Code linearity range The related parameter is out of the High N A display range Table 11 Linearity Range Flag High blank fla A high blank flag is raised when the blank measurement result of the gt particular parameter was higher than the blank limit Parameter is under the half of the low Low Blue limit of normal range OW Color Code The blank value o
59. alysis to ensure that the interaction of blood and anticoagulant has fully stabilized Check the data sheet of the sample tube for the exact period of time Use only K3 EDTA anticoagulated fresh whole blood as sample Analyze blood samples within 7 hours of collection Samples should be analyzed at room temperature Do not deliver or store the samples at temperatures above normal body temperature All samples should be handled as potentially infectious material and treated as a biohazard 8 2 Sample Types and Modes The Abacus 5 analyzer is designed to process the following sample types e Whole human venous blood to determine the hematology parameters of the blood e Quality control QC materials for quality control purposes e Calibrator materials for calibration of the hematology parameters QC samples are artificially modified human or human and animal blood samples with known parameter values QC samples can be stored for a period of time as indicated by the manufacturer The Abacus 5 analyzer works in the following modes The sample mode must be selected before a measurement starts e Blank mode No sample need be presented to run a blank Blank mode checks that the measuring system is operating correctly and that blank measurement results are acceptable e Human blood mode Choose one of five human blood modes Human Male Female Alternate 1 or Alternate 2 Each mode has a unique set of normal ranges associated with it NO
60. alyzer for shipping storage or extended periods of inactivity please drain the reagents and repackage the Abacus 5 in its original packaging Do not expose the Abacus 5 to direct sunlight extreme temperature or humidity gt 80 The analyzer operates with chemically and biologically active reagents Physical contact with these reagents should be avoided Please read reagent descriptions carefully for possible emergency actions To ensure reliable operation and reliable results Only human blood samples should be analyzed Only genuine Diatron reagents should be used Required maintenance user and service level should be performed as recommended in this manual Only Diatron certified service personnel should perform service actions Only genuine Diatron service materials and spare parts should be used Genuine reagents and service materials and spare parts are available from Diatron Only Diatron certified service personnel that have successfully completed the Diatron Abacus 5 Service Training program are qualified to service the Abacus 5 analyzer Before operating the Abacus 5 analyzer all operators should complete a Diatron Abacus 5 Operator Training program This program is offered by Diatron or by Diatron certified service personnel Replacement materials or spare parts tubes valves etc which might have been in contact with human blood or reagents should be handled as a potentially biol
61. ame sample mode e Barcode labels are in use and e An LIS system rather than the Abacus 5 is used to associate patients with sample results 61 In Full Scan mode it is possible to add more samples to the batch after starting the automated measurement As usual an accepted blank is necessary before starting automatic sample processing a i Measure Database Measure Database A AS state a AS state a noe Je noe ka Figure 34 Full Scan Automatic Processing Mode On the Full Scan mode panel you can e Return to the AS panel to select a different type of automated measurement by using the Back function e Select a common measure mode for all samples in the tray e Swap between the tray and list views by using the View list and View tray functions e Start the automated measurement by clicking or tapping on the Start button on the GUI 62 0 ol Th AG 1 7 yl o e EN ol 7 A A vn NN nn A 3 ni bai E N A u Za rt o EN Fat A u A a 5 vA ni m Ey of mi Figure 35 Full Scan Mode Tray View Progress After starting the automated measurement in Full Scan mode the Autosampler will scan all the sample positions on the tray Any rows with missing racks will be skipped The Autosampler can detect the tube type and whether the tube has a cap Sample tubes will be skipped if it has no cap or the Autosampler cannot determine the tube type
62. ampler will only process tube types it recognizes with caps attached The automated mixing aspiration and analysis process is the same as the Full Scan Mode and the progress can be followed in tray or list view The main difference between the Free List mode and the Full Scan mode is that the Free List mode identifies samples by matching them sequentially to the list and comparing their measurement results to the normal range associated with the sample mode selected for that sample 4112 4113 4114 Analysis time1 1410212010 17 12 563434 8 83 J 4112 1410212010 17 12 659008 485 4113 14102 2010 17 12 Out Pat_4523 0 4114 Analysis time1 1410212010 17 12 563434 1410212010 17 12 659008 1410212010 17 12 Out Pat_4523 4112 4113 4114 Figure 40 Free List Mode Progress List View 66 Analysis timet Sample ID WBC NEU 14 02 2010 17 12 563434 8 83 5 64 1410212010 17 12 659008 4 85 2 35 14102 2010 17 12 Out Pat_4523 6 66 4 22 ol a l l ol z ol ol ol ol ol o ry al al al al al oj a ol el ol el of of lia Il at di F Ji 4 ii d Sin OF 9 M N Z c e o a al gt 40 00m nOozZ oco ul al al al ol al al al al al all a all all j T F F 7 Measure mode Patient Position A3 Sample status Position Sample status Measure type Free listmode ray status Measure type Free fist mode r Sample Id R Sample ld Figure 41 Free List Mode
63. analyzer can be monitored Target values and acceptable tolerance ranges for each parameter can be specified for an unlimited number of QC materials Control materials must be used before their expiration date Always observe the control manufacturer s instructions for storage and use Control materials must be well mixed before use Diatron recommends the use of Diacon 5 controls from Diatron The Abacus 5 analyzer does not limit the number of QC material lots or the number of QC measurement runs that are stored in the control database Each QC measurement run is saved to the selected QC material lot QC lots can be commercial control materials or a whole human blood sample whose parameter values and ranges are determined by other means The advantage of a commercial control material is that is shelf life is much longer than human blood allowing control of the analyzer for a longer period of time Controls in the Abacus 5 are processed in manual mode only To access the QC panel select the QC icon on the main menu Maintenance A AS state A None hu U 14 07 Figure 63 QC Panel 12 1 Set QC Reference Before taking any QC measurements target values and acceptable ranges must be specified for a QC lot of control material Click or tap the Set QC reference button to display the Set QC panel 94 N Measure Database 298 i ee Figure 64 Set OC Reference Panel The
64. analyzer was subjected to extreme temperatures during shipment or storage the analyzer must be placed for at least one hour in a room whose temperature is within the operational range before installation or use Reagents should be stored at a temperature range of 15 30 C 59 86 F Reagents may experience a temperature range of at most 5 35 C 41 95 F for a maximum of 3 days The analyzer should be placed in a well ventilated location Operation at an altitude above 3000 meters 9800 ft is not recommended 2 5 Electrical Requirements The analyzer should only be operated from a wall outlet meeting these power input requirements e 100 127VAC 200 240VAC 47Hz to 63Hz e Power Consumption maximum 400 VA Please ensure that the wall outlet is also capable of supplying the power consumption of any additional devices such as a printer Use only the power cord supplied with the instrument Avoid using extension cords The Abacus 5 analyzer comes with a power cord appropriate for your power system Proper use of the appropriate power cord assures adequate grounding of the system If the power is not reliable contact your representative for options such as the installation of an external UPS module Failure to properly ground the Abacus 5 bypasses important safety features and may result in electrical hazard The instrument should not be placed near potentially interfering devices capable of emitting radio frequencies e
65. and blank measurement tap the sampling tube icon Collect the blood samples Ensure that the correct anticoagulant tubes K EDTA are used Ensure that the samples ages are within the 7 hours of processing limit Power on the Autosampler if installed Perform the OC procedure as scheduled Start the measurements in manual or automatic mode see chapter 1 for details Validate and release the measurement results according to your procedures Perform any necessary maintenance see chapter 19 for details Shut down the instrument see chapter 7 3 for details Clean the instrument see chapter 5 3 Blank measurements If you want to check whether the reagent path was contaminated during reagent container replacement then perform 4 to 5 blank measurements before accepting the blank result The reagents from the internal reservoirs should be fully consumed before the new reagent reaches the measurement system If you receive the samples in batches and more than 2 hours have elapsed between the last sample of the previous batch and the first sample of the next batch then it is a good practice to repeat the blank measurement Quality Control Perform QC measurements according to your local regulations Monitor the expiration date and stability after first use of the QC material If there are more than one hematology instruments in your laboratory then it is also a good practice to measure the same human sample across all the instruments to co
66. and the upper disc NO OPENING Figure 108 Proper Seating of Shear Valve Thumbscrew 20 3 4 Dilutor Errors e pinched clogged tube around dilutor or at the rear reagent tubes e physical obstruction foreign material 138 20 3 5 Priming Problems 20 3 5 1 The Analyzer Would Not Prime Liquids e The respective reagent is out e aspirating tube in container o has fallen off o has a leak o oris broken e A reagent buffer is leaking look for liquid below the analyzer e Damaged tube in the system look for leakage or traces of liquid and contact Service 20 3 6 Electronics Related Problems 20 3 6 1 No Image on Display No Backlight e Contact your service engineer 20 3 6 2 Touch Sensitive Surface Not Working e Connect an external USB mouse o This will allow clicking on the screen elements o Contact service for resolution of the problem 20 3 6 3 Touch Click Is Inaccurate e The touch screen needs calibration e Connect an external USB mouse o Perform the calibration under Main Menu Maintenance Touch screen calibration 20 3 6 4 The Cursor Seems To Be Moving With Good Ratios But In a Smaller Area e Calibrate the touch screen use an external USB mouse to access the function e Ifthe problem persists contact service 20 3 7 The Analyzer Does Not Power On e Check proper power connections and the state of the small switch at the power supply e If the above fails contact Service
67. anisms on the Abacus 5 analyzer It is suggested to contact your sales representative before using the new sample tube type For automated sample handling with the optional Autosampler contact your sales representative before using a new sample tube type The Autosampler may not reliably recognize sample tube types other than the officially supported sample tubes Although these sample tube types are designed for multiple piercing it is recommended to replace the cap after 3 4 piercing cycles Small rubber bits parts can crumble into the blood and adversely affect the performance of the Abacus 5 analyzer 8 1 2 Sampling Depth The Abacus 5 is equipped with a piercing needle capable of aspirating samples from closed sample tubes To prevent needle blockage from rubber sample tube cap material and blood particulates the piercing needle hole is located on the side of the needle rather than at the bottom Also the sampling needle is given a safety clearance of two millimeters from the bottom of the tube to prevent accidental breakage of sample tubes This means that the sampling needle cannot aspirate the last 8 millimeters 0 31 inches of sample at the bottom of a tube This results in sample volume that cannot be aspirated of 0 5 ml for a Beckton Dickinson Vacutainer tube and 0 3 ml for a Sarstedt Monovette tube 54 8 1 3 Figure 30 Sampling Needle Open or Closed Sample Tubes The Abacus 5 can proces
68. ar users do not have privileges to create or delete users To delete a user log on with a valid administrator account user ID and password then click or tap the Menu button at the top of the screen then click or tap the Settings menu item Measure AS state 2 None Figure 72 Settings Panel Administrator User Click or tap the User button to access the user management panel Select the user you want to delete and click or tap the Delete user button Click or tap the Yes button when asked to confirm the deletion of the selected user 102 Measure Database A AS state 2 None 8 ea Figure 73 Settings Panel Administrator User You can also change the access privileges of a user Unchecking the Administrator check box when an administrator user is selected will change the user to a regular user Similarly checking the Administrator check box when a regular user is selected will change the user to an administrator user Either way you are asked to confirm the change Click or tap Yes button to confirm or No to cancel the change Are you sure you want to delete this user After that you will not able to undo this operation Figure 74 Confirm User Delete Panel 103 15 Settings The Abacus 5 analyzer can be tailored to your laboratory s needs by changing the settings Click or tap the Settings icon on the main menu to access the Settings panel
69. automatic processing list modes Sample IDs can be reused in the Abacus 5 analyzer but other identifying information together with the sample ID uniquely identify the sample run This is the patient associated with this sample run If none was entered or selected Patient ID e the default patient ID is set to 1 Run Date Time This is the time and date that this sample was run This is the sample mode selected for this specimen Each sample mode applies a Sample Mode different set of normal ranges to this sample run Table 9 Sample Identification Information 9 3 Parameter Information The parameter information area of the Abacus 5 analyzer result screen lists information on 24 parameters White Cell Parameters E ll IL ro L ro EL ET ur IL m Farameters Figure 47 Parameter Information Display Each row shows the parameter name value flags normal range linearity range and high blank units and normal range The units area displays the differential percentage for the five leukocyte subpopulations NEU LYM MON EO BAS Parameter names are listed with their standard abbreviation Parameter values are always displayed according to their selected unit In case of error during sample evaluation the software will display E or signs to indicate the 73 problems Parameter values falling within the normal range are un flagged and displayed with black text Parameter v
70. button is considered an important part of the user interface allowing one hand one touch processing of sample tubes 6 1 Using the Touch Screen The touch screen is a pressure sensitive overlay on the screen of the Abacus 5 It allows selection of menu items and pressing of buttons by gently pressing or tapping the surface over the selected item This method is called tapping The touch screen device used in the Abacus 5 analyzer is selected for reliability endurance and compatibility with the medical laboratory environment Simple operations are supported but multi touch gestures or multiple tapping are not supported The touchable items on the Abacus 5 user interface are designed to be large enough to tap with finger The use of a tapping tool may be useful if the operator has larger or thicker fingers or when wearing oversize gloves A tapping tool can be pencil eraser or a specially designed stylus available at computer or consumer electronics stores Do not use sharp or heavy objects to operate the touch screen The surface material is moderately resistant to liquids Avoid touching the screen with wet fingers or allow liquids to come in contact with the screen or the surrounding area If you find that the Abacus 5 touch screen responds in a different area than the one you are tapping then please perform a touch screen calibration procedure before calling for service or support See chapter 17 5 for more
71. cal counters separated by a slash under the left side of the database table The left number is the number of selected rows and the right number is the total number of rows in the database 10 2 Scrolling the Database View The limited size of the interactive database display acts like a viewport into the large amount of information inside your database You can scroll the database view to bring desired information into view The Abacus 5 analyzer provides several powerful and easy to use scrolling methods The numbered items below match the items in Figure 53 below 1 The scrollbar tapping holding and moving the scrollbar labeled 1 with the tip of your finger on the touch screen display will quickly scroll information in the vertical direction Clicking and dragging with an optional external mouse will achieve the same effect Tapping or clicking the buttons labeled 2 will advance the display by one line or one column 3 Tapping or clicking the buttons labeled 3 will advance the display by one page of information at one time 4 Tapping or clicking the buttons labeled 4 will advance the display to the first or last item in the list BEE u BT Sample ID Patient Analysis time Mode WBC LY 1111212010 15 56 11 12 2010 15 56 11 12 2010 15 56 11 12 2010 15 56 1111212010 15 56 11 12 2010 15 56 11 12 2010 15 56 1111212010 15 56 1111212010 15 57 1111212010 15 57 1111212010 15 57 11 12 2010 15 57 11
72. cceseuecessuaecesseeceeseneeeetes 15 Figure 2 Abacus 5 Without Autosampler Space Requirements uessssssessnssseennnsnennnnnnensnnnnnnsnnnsnennnnnnensnnnnnnsnsnsnesnnnnnn 16 Figure 3 Volumetric Impedance Method ccccsssccccsssecccceseccccescccceesececeeeceeceesecessusececeuecessegeceesenesessunecesseeceesenaeeenes 26 Figure 4 Photometric Light Absorbance Method cccccsseccccessecccesececceececceseceseesececeuececceeecceseuecessunecesseecesseneeeetas 27 Fielife 5 Apacus5 Optical Head Block Dig amade ek 27 Figure 6 Optical si enal Processing Systems ars ee dali 28 AA A ae ee ea lee 28 Heure s 4DI FF Scatter Dias lain aa ale 29 Fielre 9 ADACUS 5 Front Panel a 29 Fleure 10 Abacus 5 Back Panels aan en ea ee ee A 30 Figure 11 Malm Board Back Panel VO POS conii e ee 31 Feme 12 EeiE SIE As END area nee nee e as 32 Heare 13 LelSidenAssembiVa sra sd id 33 Figure 14 Front Assembly Behind the Front Panel cccccoccnnnonnccnnonononnnonaconnnnaconnonanonnnnnnonnnonarnnnonanonnonanonnnonaronnonanionnos 34 Figure 15 Alphanumeric Virtual On Screen Keypad ccecccccsssecccesseccccesecccceesccceeesecesaueceeeeeecceseeecessenecessegeceeseneeeetas 37 Figure 16 Sticky Shift and SVIMDOMBULLONS 22 einmal 37 Figure 1 7 Numeric Virtual On screen Keypad een ll 38 Figtire 18 Date ViirtualOn Screen Key Dada ida 38 Figure 19 Graphical V serlintert ce Secetions an A ses 39 Figure 20 The Status DIS I
73. ce or accident e Any Diatron product from which Diatron s original serial number tag or product identification markings have been altered or removed e Any product of any other manufacturer Company Contact Manufacturer DIATRON MI PLC Address Tablas u 39 H 10978 Budapest HUNGARY Tel 36 1 436 9800 Fax 36 1 436 9809 www diatron com support diatron com Table of Contents 1 Indications for USC ii anne AAA AA A nern 12 2 POR VOUF SOfey 22 222 ee ei 12 2 1 Who Should Use ThS Manda 12 2 2 Special Symbols Used In This Manual ccscscsssccscsccccccscsceccccccscsccscecscscescccecscescscccscssescecscsceseecececeses 12 2 3 General Precautions ini 12 2 4 Environmental Factors iissn diri 14 2 5 Electrical Requirements ia a REO ala 14 2 6 Space Requirements loo 14 2 7 Welent Requirements ass sonea idos 16 2 8 Waste DISD OSA iia ias 17 2 9 K iown Eimitationsu une ein 17 2 10 Emergency S tuations da 17 3 PFOGUCESUDDON Sun cria 18 2 INSTGNGEION 2 2 2022 200 AA ic 20 4 1 The Abacus 5 Analyzer Package Contents cscscsssccscsceccccscscnccccccscsscececscsceccecscecsccscecscsseseececscesessess 20 4 2 The Autosampler Package Content sion su ine 20 5 General Overview and Principles of Operation cccccccccccercccccsceccccecscsccccecccsccccececsceccececscescccecscecess 22 5 1 Generar Overview cia IA iaa 22 5 1 1 Mea Sure Para meters nieta 22 5 1 2 Approved Reagents and Control Materials
74. cts a problem in the analysis process that may cause incorrect or suspect results or the ale parameters in the valid blank measurement was too high g Blood Detector malfunction received signals are all zeros or not Check BD and its connection to the LSDACQ card Check sampling Blood detector error received signals tube connection to BD y BASO high The number of the BASO population is high or there are lyse Repeat the measurement or perform a manual count on a stained 6 resistant cells in the sample smear There is a partial clogging or leakage in the WBC part of WBC vacuum warning measurement system A faulty worn out pump can create vacuum errors as well There is a partial clogging or leakage in the RBC part of RBC vacuum warning measurement system A faulty worn out pump can create vacuum errors as well E Check sample volume in sample vial Check sampling process Re Sampling warning Blood Detector detected a sample volume that was too small ae Ra p pung Pp mee Perform a flow cell cleaning procedure Repeat the Differential error Not enough cells detected during the 4DIFF WBC differentiating on j measurement If the problem persists then ask for service If the total WBC count is below 2 x 10 ul then perform a manual a count on a stained smear X BASO error Not enough cells detected during the BASO WBC differentiating Perform a flow cell cleaning procedure Repeat the measurement If the problem persists
75. cus 5 Repeat blank measurement See chapter 6 1 5 Pneumatics start and blank measurement Treat BASO result as reduced reliability Check cleanliness of the reagents and the Abacus 5 Perform cleaning of the Abacus 5 Repeat blank measurement See H HGB blank high L lank It HGB gt 1 BED SOSE a Sn 0 8 d chapter 7 2 5 Pneumatics start and blank measurement Treat HGB result as reduced reliability BASO blank high More than 100 cells detected during the Baso blank procedure The PLT RBC gap is not clearly detectable on the PLT RBC histogram small MCV fractured RBC s aggregated PLT s cold blood side effect of blood transfusion Gr a Check the sample homogeneity Repeat the sample with manual Out of RBC linearity range The RBC coincidence is over the limit too high RBC count RER a 5 a pre dilution a or Treat RBC result as reduced reliability Check the sample Close to RBC linearity range The RBC coincidence is close to the limit too high RBC count i amp homogeneity Repeat the sample with manual pre dilution High li i limi If f RBC PLT or WB higher than high li it Shue RS santas N nio do Perform manual pre dilution of sample and re measure it exceeded range limits Low linearity range limit If any of RBC PLT or WBC results are lower than Low linearity MENE exceeded range limits Check cleanliness of the reagents and the Abacus 5 Perform cleaning of the Abacu
76. cus 5 automated hematology analyzer The manual includes information about the operation and user interface of the Abacus 5 analyzer It also contains basic steps necessary to perform the setup procedures to customize the operation of the analyzer to the requirements of your laboratory This manual also describes daily routine maintenance requirements to keep your analyzer functioning properly 2 2 Special Symbols Used In This Manual l Blood samples and analyzer waste are potentially infectious Biohazard materials Corrosive Reagents may cause corrosion or skin irritation A poe General warning of possible hazard conditions IN Sharp needle warning The sampling needle may be a hazard to the operator 2 3 General Precautions The sampling needle and other components inside the analyzer may cause injury or can get damaged if handled incorrectly Only certified personnel should open the covers Running measurements with opened cover is not recommended due to the risk of possible injury Always wear safety gloves while performing maintenance actions The analyzer weighs 35kg 77lbs Please do not attempt to move it alone The analyzer should always be moved by two persons holding the analyzer by its sides in an upright position Always use safe lifting procedures when lifting the analyzer Make sure to retain the original packaging material for safe transportation and storage in the future 12 To prepare the an
77. d be cleaned with a cloth or sponge with alcohol Serial and manufacturing label Abacus 5 E Hematology Analyzer Vac 100 120V 200 240V 510334 N Hz VA e 07 2012 L Jatron MI PLC Hungary Pr 1097 Budapest Tablas u 39 y 5 3 3 Left Side Assembly To access the left or right side assemblies the side panels must be removed Please refer to section 17 3 for information about removing the side panels Drain Buffer Pressure Sensors Mix RBC WBC Chambers Valves 1 22 o 0 oomo oo oo f ial Valves 23 44 pacas o o or Small Measure Buffer Diluent Buffers Sheath Buffer Diff 5p Lyse 5p Buffers Figure 12 Left Side Assembly e Pressure sensors measure the differential pressures of vacuum buffer for impedance base and optical measurement and empty chamber process e Small Measure buffer is a vacuum buffer used for impedance measurement e Sheath buffer is a reservoir for DiatroeDil Diff diluent for optical measurements 32 5 3 4 Diff 5P buffer is a reservoir for DiatroeDiff 5P reagent Lyse 5P buffer is a reservoir for DiatroeLyse 5P reagent Diluent buffers are reservoirs for DiatroeDil 5P diluent Valves 1 44 connect pneumatic components to carry out dilution reaction measurement and waste disposal processes Drain buffer controls chamber draining procedures Mix chamber performs the first step of RBC dilution RBC chamber performs the second step of RBC dilution and contains t
78. details on touch screen calibration and other maintenance procedures 6 2 Using the Start Button The Start button is a physical button on the front cover of the Abacus 5 It has the following functions e Start a single tube closed or open vial measurement using the sample rotor by pressing the Start button e Provide color coded feedback about the status of the measurement system e Green means that the Abacus 5 is ready to start a new measurement e Red means that the system is busy running a measurement or a procedure e Orange color means that the analyzer is in standby mode 6 3 Using an External Mouse An external mouse can be used to perform the same functions as the touch screen Navigate the mouse pointer over the desired item and click the left mouse button instead of tapping the touch screen to activate the function This procedure is referenced as clicking click an item Touch screen operation continues to be available even if an external mouse is connected to the Abacus 5 analyzer It is possible to move the mouse pointer to a place on the screen where it isn t viewable Move the mouse pointer up or to the left to make it visible again 6 4 Using an External Keyboard An external keyboard provides the same data entry features as the on screen virtual keypad presented by the touch screen user interface with faster typing 36 The Settings Customize On screen keyboard active check box
79. display on the bottom of the screen The Autosampler control panel allows you to see of the Autosampler is operational and perform an Autosampler initialization See section 8 4 2 6 for more information about the Autosampler control panel 6 7 8 Adjust the Time and Date Double click tap the time display on the right side of the status display on the bottom of the screen to bring up a panel for adjusting the stored time and date of the Abacus 5 analyzer See section 6 7 8 for more information about time and date adjustment 6 7 9 Open the Warning Panel If an error or warning is currently active an exclamation point icon appears on the status display Click the icon to review the active error or warning and jump to the appropriate menu where the error or warning can be addressed such as reagent replacement 6 7 10 Menu Tree The following is a listing of the Abacus 5 analyzer main menu tree See section 1 for more information about patient data Cancel Cancels shutdown of the Abacus 5 analyzer Prepare for shipment Performs an extensive drain procedure of the Abacus 5 pneumatic system in preparation for shipment or an extended period of inactivity Skins Change the display skin Demo mode The analyzer will not perform any pneumatic action Laboratory Seven lines of text of lab information be displayed on each printed page External devices LIS Select Ethernet LIS connection Special flags G L Sel
80. eaning If the blank values do not return to acceptable levels after performing the Cleaning maintenance function repeat the above steps except for clicking or tapping the Hard cleaning button in step 3 rather than the Cleaning button This maintenance function will perform a longer deep cleaning of the measurement system buffers and chambers 128 If the blank measurements do not return to normal after performing the Clean and Hard clean software maintenance functions and running several blank measurements please contact your Diatron certified service engineer for additional assistance 17 9 Replacing Reagents The Abacus 5 analyzer is designed to be able continue running without the need to stop if a reagent container needs to be replaced To support this feature internal buffers keep sufficient reagents for one measurement cycle and warns the operator when a reagent is about to run out An exclamation mark within a yellow triangle will be displayed by the reagent level indicator Double clicking or tapping on the exclamation mark will open an explanation panel The panel will suggest a specific solution such as changing one of the reagent containers Click or tap the Go to button on the explanation panel to navigate to the reagent status panel CG i we Database Print O Patient ID Warning list 07 11 2012 17 22 Mode 10 uL 300 15 00 10 HL 150 7 00 10 L 100 3 70
81. easurement e Start an automated measurement e Access the database e Initiate printing e Access the main menu e Access the control panel of the Autosampler opens with double click or tap e Access the time adjustment panel opens with double click tap e Access the warnings panel only visible if an error or warning was reported 6 7 2 Starting a Manual Single Tube Measurement Tapping or clicking on the Measure icon with the single sample tube graphic allows access to the following functions e Initiate a primary blank measurement e Make adjustments and settings about the manual measurement o Enter the Sample ID unique or auto increment o Select the associated patient o Select the sample type or patient mode e Start a manual measurement e View the measurements results in detail View the measured parameters View the calculated parameters View parameters that are out of the normal range O O O O View error warning or clinical flags See section 8 4 1 for more information about manual measurements 40 6 7 3 Start Automated Measurements Tapping or clicking the AS icon with the multiple sample tube graphic allows access to the following functions e Initiate automated measurements in one of three modes o Full scan mode o Free list mode o Selected samples mode o Remote worklist mode e Define sample parameters the parameter list depends which one of the three sample modes are selected e Monitor the p
82. ect whether G L flags are displayed or printed Sound Volume Change the volume of the Abacus 5 built in speaker On screen keyboard active Turn off on screen virtual keypads for use with an optional external keyboard Patient s displayed data Patient identifier visible in the database display Language Change the active language Limit Style View parameter normal range status in numerical or graphical format Automatic LIS Select whether to automatically transmit results each time a sample is processed Waste container volume Selects a 10L 20L or no waste container direct to drain Database display limit Selects all or only last month of database record display Use only Sarstedt Monovette tub from sample rotor Change sampling adjustments to accommodate Sarstedt Monovette tubes Standby time Time period of inactivity before the Abacus 5 automatically enters standby Offline rinsing frequency Time period of inactivity before the Abacus 5 performs an offline rinse to Sending port baud rate Select transmission rate for serial LIS keep the pneumatic system in peak operating condition Blank Request Time Time interval between system requests to process a blank specimen 0 h no blank request reminders 43 Items in queue Number of items in the printer queue Cancel all jobs Cancels all items in the selected printer s queue Profile limits Enter normal ranges for Human Male Female and Alternate 1 and 2
83. el If the reagent locking feature is activated please remove the old hardware key and insert the new hardware key provided in the Lyse 5P package before clicking or tapping pressing the Reset Lyse 5P button Clicking or tapping the Reset Lyse 5P button activates the uploading of additional measurement counts from the hardware key 117 16 4 Statistics This menu item will display cumulative information such as the measurements and number of error events experienced during operation Statistical data can be only reset by a Diatron certified service engineer Measure Successful startup Pneumatical error Successful shutdown 0 Dilutor error Started measurements 0 X Y unit error Completed measurement 0 Shear valve error Autosampler error Other error Software error A AS state 100 2 None Figure 89 Statistics Panel 16 5 Information This menu item displays the instrument serial number and software versions of various system components This data is important for maintenance purposes and your service engineer will ask for this information prior to a service call 118 Measure Database en US Figure 90 Information Panel 119 17 Maintenance To ensure reliable operation regular maintenance is required This chapter describes necessary procedures and steps required to keep your analyzer in agood operating condition Only Diatron certified service personnel that have received Abacus 5 service t
84. em Rubber sample caps are not designed for multiple punctures The DiatroeHypocleaner CC reagent will cause rubber vial caps to harden releasing small particles that will clog the analyzer Always remove the rubber cap when performing daily cleaning After this operation you can leave the Abacus 5 analyzer powered on for the rest of the day It will automatically enter a low power state if left unattended 17 8 2 Cleaning the Measurement System During normal operation the Abacus 5 analyzer may report high values after a blank measurement Repeating the blank measurement will usually bring the blank values down to within specification If the blank values remain too high it will be necessary to perform a cleaning maintenance function If the system consistently reports high blank values the measuring chambers must be cleaned 1 Remove the cap from a clean dry empty sample tube Fill the sample tube with 2 ml of deionized water and 1 ml of DiatroeHypocleaner CC reagent Do not replace the cap onto the sample tube 2 Insert the sample tube with DiatroeHypocleaner CC reagent into the sample rotor 3 Click or tap the Cleaning button on the maintenance functions panel in the Cleaning group 4 Follow the on screen instructions 5 Runa blank measurement and ensure the blank measurement values return to acceptable levels Re run the blank measurement a few times if necessary 17 8 3 Extended Cleaning Hard Cl
85. ement is calculated as the difference between and blank and a sample measurement with and without illumination to reduce the effect of liquid refraction and incident light WC chamber o Lysed blood Light source Detector Figure 4 Photometric Light Absorbance Method 5 2 3 Optical Light Scatter and Diffraction Method Optical measurement of light scattering and diffraction is used to determine five part leukocyte LYM MON NEU EOS BAS differential parameters An optical measuring head contains a focused laser source that is used to illuminate a stream of leukocytes WBC suspended in an optically clear diluent moving through a flow cell The cells scatter light as they flow through the path of the laser beam An optical detector senses changes in the intensity of the scattered laser light which are proportional to the cell volume and granularity of the cell s internal structure The Abacus 5 electronics convert these changes to electrical pulses which are gathered and stored for analysis Five part population discrimination is based on analysis of the two dimensional volume and granularity distribution scatter diagram Stream of WC e AE Optical detector Scattered laser light Figure 5 Abacus 5 Optical Head Block Dlagram Cells with greater volume or size or more granularity will tend to scatter greater amounts of light The intensity of scattered light is detected by an optical sig
86. er cells are displayed on the right side The height of the histogram at a given size represents the number of cells with that size Greater histogram height indicates more cells Figure 50 Result Screen Histograms Both the RBC and PLT histograms can be zoomed Discriminators thresholds are displayed with red color Platelets are located on the leftmost part of the RBC histogram to the left of the red discriminator The PLT histogram is a magnified version of this region 75 9 3 2 Warnings The warnings area of the result screen shows flags and messages related to the evaluation of the sample Clicking or tapping on the individual sections of the results screen displays a detailed warnings panel Click or tap OK to close the detailed warnings panel Warning flags Interpretive fags Morphological flags AD Anemia Microcytic REG Hype Figure 51 Warnings Section of Results Screen The Abacus 5 analyzer provides Warning flags Morphological flags and Interpretive messages in the Warnings panel The following tables describe these flags and messages in detail It also provides guidance on actions the operator can take to correct the problem described by the flag 76 das Warning flags are raised when the analyzer detects a problem in the analysis process that may cause incorrect or suspect results or the ale parameters in the valid blank measurement was too high If other parameters predict a normal sample then
87. ese materials please contact the manufacturer directly 23 5 1 3 Genuine Diatron Reagents Only use the genuine Diatron reagents below to ensure proper performance of the Abacus analyzer Reagents are manufactured and provided by Diatron MI Plc and are for in vitro diagnostic use only If the eyes or skin come into contact with any of the reagents flush abundantly with water If ingested drink water immediately and seek medical attention 5 1 3 1 DiatroeDil 5P Diluent Description Multiple micro filtered particle free buffered isotonic solution containing stabilizers special additives and Application Quantitative and qualitative determination of RBC WBC Kr Table 2 DiatroeDil 5P Diluent Information The product is environmentally friendly and does not contain azide nor cyanide 5 1 3 2 DiatroeLyse 5P Description Multiple micro filtered particle free reagent solution containing lysing detergents stabilizers leucoprotective components special additives and preservatives Application Quantitative and qualitative determination of WBC 5diff meme Table 3 DiatroeLyse 5P Information The product is environmentally friendly and does not contain azide nor cyanide 5 1 3 3 DiatroeDiff 5P Description Multiple micro filtered particle free reagent solution containing stabilizers leucoprotective components special additives and preservatives Application Quantitative determination of WBC leukocyte
88. esessanses 41 6 7 4 Access the Database dieser ee else dieses 41 6 7 5 Mate ta ai 41 6 7 6 Main Mad A A A RA A AT 41 6 7 7 Autosampler Control Peli iiO 42 Oos sAdjusttne TIMO Dat e el 42 6 7 9 Open the Warning Panels ata 42 6 7 10 IMENU Ie A een 42 6 7 A A OR 45 Start Up and Shut DOWN the Abacus iia A 46 7 1 Start Up and Shut Down Overview 46 7 2 Starting Up the Abacus 5 Analyzer 46 721 Val NEpec tion ee a ee ee N 46 7 2 2 Power upthe Abacus S Analyzer a eines 46 1 2 3 Start Wo the User terca 47 7 2 4 USER EOE OIN een SEE 48 7 2 5 Pneumatic System Start and Blank Measurement cceccccssssccceeseecceescccaesecseueeecseueeessueeeessuseesseuecessesesssaesessaneeess 48 73 Exiting the Abacus 5 Analyzer rn seele 49 7 3 1 Log A A N a a a N a Nr a a Gaetan eae ae 49 7 3 2 SNUE DOWN A a dd dd ein 50 7 3 3 Prepare tor SHIPMENE ee ea is 50 7 3 4 Emergency SMUT DOWN ia 52 7 3 5 Repackaging the Abacus 5 AmallyZer scccccssssececccssececcecssecccscassecccscausecccsscusececssausececsecsseseessuaesecseagsessessagseseees 53 Sample Measurement ASA AAA endende AAA AAA 54 8 1 Sample Types Supported by the Abacus 5 ccessccscscecsccccsceccccccscsccccececsceccccccscesescecscssescecscsceseesecces 54 8 1 1 Supported sample TUDES IDE Si ta 54 8 1 2 Sam PIN DEN A a 54 8 1 3 Open or Close d Sample TUDES ita 55 8 14 Sample Coleccion NO eo 55 8 2 Sample Types and MIOS iia 56 8 3 sample ldenti
89. essceccesececsesececeeecceceesecessueceseeneceesensceessesecessugeceesenes 123 Table 22 Regent CONSUIM PLION zn saciar here 142 F30l amp 23 DIisplav Ranpesa ra seele atado 143 Table 24 Parameter Calculation ser E 148 lio Paola lle LIONS oea en een 150 Table 26 Precision Perro manco tii 151 E A anaes 151 Fave 28 Linearity Performance a NEE NE A O A I eee aS 151 Top e29 Carryover PEONES e 152 Table 30 Closed vs Open Vial Mode Performan Ecenin HE oi ra nee wows 152 Table 31 Closed vs Autosampler Mode Performance ccccccssccccseccccsecsceuecsceeecceessseeecsteuecseeeseeeeceseuaceseueceteuesenenseees 152 Table 32 Reference RANES unse ee 153 Table 3 BECK round MiS AAA eee em nee 153 Table s4 Ana Mical Measunne RNE ada 154 10 11 1 Indications for Use The Diatron Abacus 5 System is a quantitative multi parameter automated hematology analyzer designed for in vitro diagnostic use in clinical laboratories for enumeration of the following parameters in K EDTA anti coagulated venous whole blood samples WBC LYM LYM MON MON NEU NEUH EOS EOS BAS BASH RBC HGB HCT MCV MCH MCHC RDWcv RDWsd PCT PDWcv PDWsd PLT and MPV The Diatron Abacus 5 is indicated for use to identify patients with hematologic parameters within and outside of established reference ranges 2 For Your Safety 2 1 Who Should Use This Manual This user manual is intended for clinical laboratory professionals using the Diatron Aba
90. est Navigates directly to self test screen Reagent status Reset levels for individual reagents and waste or all for reagent replacement Statistics Provides operating statistics such as cycle counts errors etc Information Provides version information for all software items in the Abacus 5 analyzer Table 7 Abacus 5 Analyzer Menu Tree 6 7 11 Safety Access Codes Some functions require password protected confirmation For example deleting a record from the database requires entry of a password The security password for deleting database entries is 555 45 7 Start Up and Shut Down the Abacus 5 7 1 Start Up and Shut Down Overview The Abacus 5 is an advanced instrument with computer and pneumatic subsystems that need to be properly started up and shut down for continuing reliable performance Not following proper startup and shutdown procedures may lead to increased maintenance and unnecessary service calls The Abacus 5 analyzer start up sequence requires four steps e Power up the electrical system e Start up the internal user interface computer and log in if the multi user mode is activated e Start up the pneumatic system components e Perform and accept an initial blank measurement A normal shut down of the Abacus 5 analyzer has the reverse steps e Clean and empty the pneumatic system components e Log off multi user mode is activated and properly shut down the inte
91. f the related primary Middle N A parameter is high Table 12 High Blank Flag 9 3 1 Scatter Diagrams and Histograms The Abacus 5 analyzer displays the results of the optical measurements in scatter diagram representation Scatter diagrams represent two dimensional data There are two scatter diagrams in the patient report the 4 DIFF and BASO scatter diagrams The 4 DIFF scatter diagram displays cells identified after the first Iysing and optical measurement process Due to the measurement technology cells are classified based on their optically detected properties low and high angle scattered light intensity The optical detector can measure the intensity of the light scattered or diffracted by each 74 cell One portion of this scattered light is proportional to size of the cell the other is proportional to the complexity of the internal structures in the cell Cells in a leukocyte sub population have similar light scattering properties allowing them to be grouped together and identified separately from other cell types Different colors are used to identify various populations of blood cells Cellular Debris Cellular Debris gt 5 o el eal Figure 49 Result Screen Scatter Diagrams RBC and PLT impedance based measurements are represented by histograms These diagrams show the number of cells on the Y axis and the cell size on the X axis Smaller cells are displayed on the left side of the histogram and larg
92. ference Panel este 95 Figure 66 VIEW OC Diagrams Papelas ze Rz ken 96 FIgure 67 Patents Panels emailen 98 Fere GS Edit Patient Panel ass ee Nee 99 FIEUFE69 LOBON Panel er seele 101 Fle re 70 Ada lseriPanek en essen ee ee a nee 101 Fieure 1 Ada User Eomplete Panel 22 ae Haas 101 Figure 72 Settings Panel Administrator USer cccccccssssscccccscssscccssecnsecccsseensecsssecessesesseceeecessecesssesseensscessegnasseesees 102 Figure 73 Settings Panel Administrator USEL ccccccccsssseccccceesseccecceeseccceceensecceseueneececseuesecceeseeeeceessuenseecessegeeeeeeteas 103 Eure 74 Conirm UserDelete PAN Cl aii oot ttn pia 103 A Panels a Nee A 104 Figure 76 CUstomize Settings Panel zn da 105 Figure 77 External Devices Settings Panel u a2 Rai 106 FIEUTe 78 System Settings Panels sus ee 107 Figure 79 Units Settings Panel AA ad dceiseana Mets dencth ee end Mita cates 108 PISUHe 80 Printer setine Pane adiciona 109 Figure 81 Profile Limits Settings Panel eek 110 FIeUrE32 B Settings Panel ee eek 111 FISURE 83 User Settinps Panels near ee ans o 111 Fig re 84 Time Date Settings sense A 112 FIGURES 5 Diagn sties Panel anscsnse in 114 Fedre So Self Test Pine len 115 ISU OHS 7 08 A ee 116 Figure 838 Reagent Stat s PANA a a Ea e hike 117 FISure 89 Statistics Panels tags 118 Fieure 90 IAformation Panel Na eig 119 Figure 91 Opening the Front Panel asien 120 Fietire 92 Closine the
93. ficitON an dd 56 8 4 Running Samples sssini na u 57 8 4 1 MEA AA A PEE Wr VE T PEN SIE EE OT OE A seen ehe 57 8 4 2 AUTO Matic MOE ee N ieee pean N T E eas ce eee oe aN Meee Maha ae 59 8 5 RESUIEDISBIaV is 69 8 6 Printing REDOUES sip enge 70 8 7 The Measurement POCOS pod 70 9 Result interpretation ata A een erste 72 9 1 Fhe RESUME ad 72 9 2 sample IGENtITICAtIONHNATONINALI ONS sandia id 72 9 3 Parameter IntoimatoNa iii 73 9 3 1 Scatter Diagrams and Histograms seiretan anatia a a aaa Na aa aaea 74 9 3 2 WINS ias 76 10 Database FUNCTIONS a iio 82 10 1 Database OA aia 82 10 2 Scrolling the Database View ssesessesesessessssessssessssecesseossosossssoesosossseoesososcssossssoecssesesssseosssesssssssssesseses 83 10 3 Sorting Database Information anne 83 10 4 Manual Selection of Database Records cccceccsccccccccccccccccccccccsccsccsccsccccccccccceccccccccccccccccsccsccsccscceccs 84 10 5 Automatic Selection of Database Records cccccccccccccccccccccccccsccsccsccsccccccccccccccccccccccccccccsccsccsccscceccs 84 10 6 Viewing Detailed Results si 84 10 2 lt SUACISUICS td o id id dido 85 10 8 Managing Database Records rin 85 10 3 1 Select BY es ee ee en II Be ee 85 108 2 MMO ORT see ee ee uns 86 TOS EDOL A ee nein aD a re E irre ry Lee epee ee rey oe 87 10 84 Senato LIS sie ae i e ed N etna nl ee Sirs aes ce ee ee e Nan EE 87 10 85 Save O II ee ernennen a 87 10 856 SaVe RAW Da aaa aaa cele cease ale ee
94. four part PT Aereo Vi MON NED EOS Storage Between 15 C and 30 C 59 86 F Diatron reagent code D302 X X packaging size 1 1L Table 4 DiatroeDiff 5P Information The product is environmentally friendly and does not contain azide nor cyanide 5 1 3 4 DiatroeHypocleaner CC Description Containing alkaline hypochlorite special additives and Fr Application Capillaries tubing and chambers removing blood Appearance Slightly yellow liquid with chlorine odor Table 5 DiatroeHypocleaner CC Information The Hypocleaner CC is not an online reagent not directly connected to the Abacus 5 This reagent is aspirated from a sample tube into the Abacus 5 directly 25 5 2 Principles of Operation The Abacus 5 analyzer uses a combination of methods to provide measurement results e Volumetric impedance is used to determine the cellular concentrations and volume distributions of leukocytes WBC erythrocytes RBC and platelets PLT e Photometric measurement of light absorbance is used to determine hemoglobin HGB concentration e Optical measurement of light scattering and diffraction is used to determine five part leukocyte LYM MON NEU EOS BAS differential parameters 5 2 1 Volumetric Impedance Method The volumetric impedance method determines cellular concentrations and volume distributions of cells by detecting and measuring changes in electrical impedance when particles s
95. gure 1 Abacus 5 with Autosampler Space Requirements 15 max L2 m Figure 2 Abacus 5 Without Autosampler Space Requirements 2 7 Weight Requirements The Abacus 5 analyzer weighs 35 Kg 77 Ib without the Autosampler The Abacus 5 with optional Autosampler weighs 47Kg 104 Ib Adding an external keyboard documents etc can bring the total weight up to 60 Kg 132 Ib If you decide to store the reagents on the same surface then the combined weight can reach 100 Kg 220 Ib Please select a table laboratory shelf or other location which can support the weight of the Abacus 5 with accessories and is free from vibration 16 To allow reliable operation and to provide a safe working environment make sure that the table supporting the unit is stable enough to carry the weight of the instrument and accessories 2 8 Waste Disposal Abacus 5 analyzer waste contains human blood and reagents that are chemically and biologically active and should be considered to be a potential infection and biohazard threat Safe laboratory practices must be followed including the use of personal protective when operating the Abacus 5 and handling blood reagents and waste System waste should be handled as a potentially biohazardous material All applicable laws regulations and laboratory practices should be followed in the handling and disposal of waste 2 9 Known Limitations The Abacus 5 is not i
96. he Abacus 5 analyzer near the power connection to the down position labeled O You can power off the system Figure 29 Shut Down Ready Panel Step 4 Disconnect the waste container tubing from the waste reagent connector on the back panel of the Abacus 5 analyzer Small droplets of distilled water may remain in the tubing after the Prepare for shipment process completes These droplets will not cause any malfunction during transportation or the next start up procedure 7 3 4 Emergency Shut Down A The procedures described in this section can damage the Abacus 5 analyzer or cause data loss or damage to critical system computer files Use these procedures in case of emergency only 52 7 3 4 1 Immediate Shut Down The immediate shut down can be initiated by pressing the standby button near the top of the back panel of the Abacus 5 analyzer This is the same button which is used to start up the Abacus 5 user interface computer This shuts down the user interface computer without properly shutting down the pneumatic system components Possible side effects e The pneumatic components may be left in an undefined state The next startup and pneumatic initialization may take longer with increased reagent consumption e The last settings changes and measurement results are not saved Immediate shut down should be avoided as a routine procedure It should only be used if
97. he RBC aperture WBC chamber performs the WBC dilution and holds the WBC aperture and HGB photometric measurement system Right Side Assembly Optical Head Aspiration Needle Horizontal Vertical Motion Unit Washing Head Power Supply Sample Rotor Autosampler Connector Figure 13 Left Side Assembly Aspirating needle aspirates a blood sample from the sample tube Horizontal vertical motion unit positions the aspiration needle Washing head cleans the aspiration needle to prepare for the next sample Sample rotor holds the sample tube for single tube manual presentation Autosampler connector is the power and control connector of the optional Autosampler Optical head contains the laser source optical detectors and auto alignment mechanism for the optical measurement 33 5 3 5 Front Assembly Aspiration Needle Sample Rotor Be N Figure 14 Front Assembly Behind the Front Panel e Syringe pumps control the volume and flow rate of reagents through the pneumatic components e Shear valve is an integrated multi functional valve for segmenting precise volumes of blood 34 6 User Interface The user interface of the Abacus 5 analyzer is designed to be intuitive and easy to use and provide access to all user level functions You can interact with the Abacus 5 by using only the touch screen and the virtual on screen keypad or by using an external keyboard and mouse PS2 or USB The Start
98. he upper box edges Use shipping straps to gently but firmly hold the entire package together 53 Figure 30 Repackaging the Abacus 5 Analyzer 8 Sample Measurement 8 1 Sample Types Supported by the Abacus 5 In this chapter you will find information about the samples usable with the Abacus 5 instrument 8 1 1 Supported Sample Tubes Types The Abacus 5 supports the following K3 EDTA 13x75mm sample tubes e Sarstedt Monovette e Becton Dickinson BD Vacutainer e Terumo Venosafe Only use sample tubes with K3 EDTA anticoagulant Please note that the Sarstedt Monovette sample tubes have a false bottom that is not the same as the bottom of the sample tube The sampling depth on the Abacus 5 analyzer must be changed for a Sarstedt Monovette sample tube To change the sampling depth for manually presented Sarstedt Monovette tubes at the sample rotor check the Use only Sarstedt Monovette tube from sample rotor check box in the Main menu Settings System panel The Autosampler automatically recognizes Sarstedt Monovette tubes and automatically changes the sampling depth You may use sample tubes from other vendors if certain conditions are fulfilled For manually presented sample tubes at the sample rotor measurement check if the new tube type e Is mechanically compatible 13x75 mm family e Can be pierced or used in open vial mode e Can be handled by the tube centralizing mech
99. head or the shear valve Incorrect operation during cleaning of the system especially after long inactive periods of time can cause valves or tubes to get filled with dry salt deposits These problems can be the source of dilutor motor noise In extreme tube or valve clogging situations the pressure build up inside the dilutors can cause some tubes to be released from their connections This symptom is not normal but will not cause damage to the system However it is recommended to contact your service engineer to determine the cause and resolve the problems 20 3 1 Sample Rotor SR Failures 20 3 1 1 SR Gives Grinding Noise And Or SW Displays SR Error Messages e The front panel is not closed properly e The opening is not aligned with the sample rotor door e There is liquid in the SR if you can see traces of salt around the SR contact your service engineer e Check the washing head for contamination blood and or salt as excessive salt build up can prevent the wash head from lifting up effectively and the sample rotor door can get stuck 20 3 1 2 SR Error Appears During Initialization Process e Check the washing head for contamination blood and or salt e Contact your service engineer 20 3 1 3 The SR Does Not Turn Into The Analyzer Even With Open Front Panel e check the washing head for contamination blood and salt 20 3 2 Needle Mechanics Vertical Motor Mvert Problems 20 3 2 1 The Needle Carriage Keeps Dropping Back Down At In
100. hen it is in the down position labeled 0 Standby switch flipping this switch to the up position takes the Abacus 5 main computer out of the standby state and powers up internal analyzer components Please note that this switch springs back to the down position when released and does not stay in the up position rea 2comectors waste Table 6 Reagent Connector Color Codes Hardware Key connector this connection is used to plug in the hardware key supplied with every new package of genuine Diatron DiatroeLyse 5p reagent A new reagent key provides the analyzer with the ability to run 700 measurements When the measurement count has been exhausted the Abacus 5 analyzer stops processing samples Reagent connectors five color coded tubing connectors provide connection to the reagents There are three reagent connectors and two waste connectors Main board back panel I O Ports these are the back panel computers of the Abacus 5 analyzer main computer board They provide standard connection to peripherals such as external keyboard and mouse printers bar code readers DVI D 2LAN 2 we 11 Be Line in Zi O Line out MN Y 0 Mic in s5 mn 1 PS2 Mouse port for optional mouse PS2 Keyboard for optional PS2 keyboard COM port for LIS Figure 11 Main Board Back Panel I O Ports 31 Avoid getting liquids on the electrical connectors The rear panel of the analyzer shoul
101. ically located is gt 3 of the total WBC count The count in the region of low high angle scatter of Abacus 5 where the atypical lymphocytes typically located is gt 1 of the Perform a manual count on a stained smear total WBC count Table 15 Morphological Flags 81 10 Database Functions The Abacus 5 database stores all measured data including sample results QC and patient data Each sample result stored includes the complete parameter list histograms flags and identifying data The Abacus 5 has a data capacity of up to 100 000 total records To activate Database panel clicking or tapping the Database quick link on the top of the screen will take you to the database view from any screen _ Sample ID Patient Analysis time Mode wsc 20465 11 12 2010 15 56 Human 4 09 20465 11 12 2010 15 56 Human 4 13 20465 1111242010 15 56 Human 4 02 20465 111242010 15 56 Human 4 05 20465 1111242010 15 56 Human 4 19 20465 11 12 2010 15 56 Human 20488 1111212010 15 56 Human 20488 11 12 2010 15 56 Human 20488 1111212010 15 57 Human 20488 1111212010 15 57 Human 22527 1111212010 15 57 Human 22527 11 12 2010 15 57 Human 22527 11 12 2010 15 57 Human 11 12 2010 15 57 Human 11 12 2010 15 57 A AS state A None A AS stale 2 None Figure 52 Accessing the Database The database can be accessed at any time even when processing samples in the background You can return to the measurement panel
102. ion procedure is provided that guides the operator through the calibration process and performs the calibration factor calculation Calibration factors can also be modified directly without running a calibration procedure Only the parameters that are traceable to reference methods are calibrated WBC RBC PLT HGB MCV and MPV To view the calibration functions of the Abacus 5 analyzer select the Calibration icon on the main menu to display the calibration panel The Calibration panel displays an option to calibrate the Abacus 5 analyzer or to view prior calibrations hu Hu 16 32 AS state 100 100 2 None Figure 59 Calibration Options 11 1 Calibrating the Abacus 5 Selecting the Calibrate option on the calibration options panel displays the calibration panel 90 Sample ID Calib 1 3 Name Date 7 13 2011 2 48 PM Mode CalibControl Three measures WBC 10 uL DIFE CEU E NEU 10 uL SER Five measures LYM 10 uL MON 10 uL EO 10 uL BAS 10 uL NEU X y Calibration type Control Pl 0 EO Human BAS i RBC A 10 uL HGB g dL 3 00 15 00 HOT 3 50 5 50 ee E MCHC 50 400 RDWsd RDWev 120 174 PLT PCT 86 0 110 0 MPV PDWsd 9 0 13 0 PDWcv Warning flags Calibration mode Seven measures O 0 0 16 0 A AS state A AS state None A None der Figure 60 Calibration Panel and Calibration Run Result Panel The li
103. isplayed with the measurement results o The default patient ID 1 patient is used if no patient is selected 56 8 4 Running Samples The Abacus 5 supports both manual and automatic sample presentation modes Automatic sample presentation requires the optional Autosampler The Abacus 5 analyzer software automatically detects and initializes the Autosampler Before performing any measurement the Abacus 5 should be e Powered up and started e The pneumatic system initialized and a blank measurement performed and accepted 8 4 1 Manual Mode To use Sarstedt Monovette manually presented tubes at the sample rotor check the Use only Sarstedt Monovette tube from sample rotor check box in the Main menu Settings System panel Always ensure the Use only Sarstedt Monovette tube from sample rotor check box in the Main menu Settings System panel is checked if you are manually presenting Sarstedt Monovette tubes in the sample rotor Needle damage tube damage and spilled blood may result if Sarstedt Monovette tubes are presented and this option is not checked Select the Measure quick link at the top left of the screen to initiate a manual measurement The new measurement panel opens giving you have the following options e Review the results of the previous measurement by using the Last Measure function This feature can be useful if you were interrupted during the measurement batch and y
104. itialization e The wash head and surrounding area should be free of salt build ups 137 e Salt build up or thick salt layer at the bottom or on the inside can block the movement of the needle in the wash head or the movement of the wash head around the needle e The through hole of the needle in the vertical carriage should be free of salt e Salt around the needle can damage the needle and can influence the sampling process sampling quality or amount of sample e The wash head position relative to the needle and to the SR is not correct e The wash head comes down too far and if lifted leaves no room for the SR door to turn e The vertical rod holding the wash head is not inserted correctly or was not pushed up to the maximum and the wash head is sitting in a low position 20 3 3 Shear Valve SV Related Errors 20 3 3 1 SV Error At The First Startup e theSV cannot turn o Make sure that the pull tab has been removed o Check free movement by hand rotate the shear valve e The SV is stuck o Try to open the Shear Valve 20 3 3 2 Grinding Noise After SV Cleaning After SV Reinstallation e The rotating part cannot reach the opto sensor position check if the thumb screw is secured correctly and that there is no gap between the upper and lower discs 20 3 3 3 SV Leakage e The upper disc is not sitting well on the lower disc e Open and reseat the upper disc e There must not be any opening left between the closing screw
105. lank 27 40 46 48 49 51 56 57 59 61 64 66 72 74 78 79 86 91 96 121 128 133 134 147 C calibration 23 36 44 47 48 56 90 91 92 93 134 139 cleaning 1 30 44 46 50 59 70 78 79 80 121 123 124 126 128 134 137 139 140 142 clogging 78 79 80 136 137 D diluent 147 Diluent 24 32 142 dilutor 137 138 E EDTA 54 55 133 EOS 22 24 26 27 81 143 154 F flow cell 27 78 79 80 H hemoglobin 147 HGB 22 24 26 33 43 48 70 79 90 108 143 147 154 hypochlorite 25 impedance 26 32 70 75 K keyboard 14 16 31 36 37 40 43 57 73 86 105 L laser 22 27 28 33 LYM 22 24 26 27 74 79 80 81 108 143 154 Lyse 24 31 32 132 142 154 M maintenance 12 13 20 30 36 44 46 78 118 120 121 133 134 139 MON 22 24 26 27 74 78 79 81 108 143 154 157 needle 12 30 33 48 54 58 70 126 127 138 NEU 22 24 26 27 74 78 80 108 143 154 noise 80 121 137 normal ranges 43 56 58 64 66 73 105 109 p PLT 22 23 24 26 43 48 70 75 76 78 79 81 90 108 139 143 147 154 pressure 36 137 printer 14 41 43 69 108 109 Q QC 22 44 47 48 56 57 59 82 94 95 96 97 132 133 134 142 R RBC 22 24 26 32 43 44 48 70 75 76 78 79 80 81 90 108 143 147 154 reagent 1 13 24 25 26 31 32 39 42 44 46 50 51 52 53 78 106 117 129 132 133 138 139 reagent c
106. le 1 is the sample closest to the Abacus 5 o Sample 10 is the sample closest to rounded edge of the Autosampler cover e Sample Al is the first sample processed and sample J10 is the last 8 4 2 1 Supported Bar Code Symbologies Some of the Abacus 5 analyzer automatic processing modes use the bar code on the sample tube to determine the sample ID of the sample tube The following bar code symbologies are supported by Autosampler bar code reader Bar Code Symbology Checksum Status Code 128 Uses check digits Code 39 No check digits used If check digit are present they are considered part of the sample ID Interleave 2 of 5 No check digits used If check digit are present they are considered part of the sample ID Code 93 Uses check digits Code 11 Uses check digits Table 8 Supported Autosampler Bar Code Reader Symbologies The use of bar code symbologies with check digits will identify incorrect bar code reads in the unlikely event that the Autosampler bar code reader incorrectly reads the sample tube bar code Diatron recommends the use of bar code symbologies that uses check digits to help prevent sample misidentification Incorrect reading of a sample tube bar code without check digits may result in sample misidentification Use bar code symbologies with check digits to prevent this 8 4 2 2 Full Scan Mode Full Scan mode is suitable for laboratories where e There are batches of samples with the s
107. lem that requires service intervention To view the calibration history click or tap the View calibration function on the calibration panel The calibration history is presented in a table view that can be navigated in the same way as the database panel Any calibration can be deleted Deleting the last calibration causes the Abacus 5 analyzer to revert to the last accepted calibration 92 Measure f e 7 04 03 2010 11 55 0 97 18 03 2010 11 13 0 97 2710412010 14 16 1 05 05 2010 15 38 1 04 05 2010 12 24 05 05 2010 15 58 06 12 2010 14 16 06 12 2010 14 16 06 12 2010 14 19 03 01 2011 12 34 10 01 2011 13 02 11 01 2011 12 21 24 01 2011 16 37 28 04 2011 09 02 A AS state 7 None Figure 62 View Calibration Panel To delete a calibration click or tap the Delete button The system will ask you for a confirmation password to avoid accidental deletion of calibration data The confirmation password is set at the factory to 555 and can be changed by your Diatron certified service engineer 93 12 Quality Control Daily use of quality control QC ensures that the Abacus 5 analyzer is operating optimally Stable recovery of standard QC material parameters assures the operator that the Abacus 5 is operating consistently on a day to day basis and is functioning correctly By analyzing control materials on a regular basis day to day reproducibility and general condition of the
108. ler Power Consumption maximum 400 VA Main fuse Maximum relative humidity Table 25 Specifications Flagging 150 22 7 Performance Characteristics 22 7 1 Precision Device repeatability and reproducibility are defined as a standard deviation SD or as a coefficient of variation CV whichever is greater Specifications are provided for primary and derived parameters only Repeatability Reproducibility Precision Parameter o w om wec 107 a I o y y o ne lt 020 eow o2 om oa cv oww oa osm lt oas ao o Mev Table 26 Precision Performance 22 7 2 Accuracy Device accuracy is defined as a maximum predicted difference bias between this analyzer and an alternate method The difference must be less than the absolute or percent difference criteria in the table below over an expected range Specifications are provided for primary and derived parameters only Parameter rose Poren m Men L L ow eo 10 so gt rowa 050 600 so xo w gt m so so oo moo ow Table 27 Accuracy Performance PL 22 7 3 Linearity Linearity is defined for the primary measured parameters Coefficient of Nonlinearity Nonlinearity Linearity Linearity Parameter Determination Absolute Relative Range Range ome R Error Error Low High ES w R a 15 ef Table 28 Linearity Performance 10 PLT 151 22 7 4 Carryover WBC lt 1 00 10 ul RBC lt
109. llowing e The Help icon e Status of the Autosampler unit e The state of the reagent and waste containers e Error warning icons e Printer status e Status of the pneumatic system standby manual measure rinse clean e Progress of the active operation e Time e Input language Clicking or tapping on an error or warning icon navigates directly to the relevant menu where the problem can be addressed or provides the user with information on how to resolve the problem 39 Aa Asael gt A F QC Wizard Test None gt ZZ Figure 20 The Status Displa 6 6 4 Entering Information The Abacus 5 sometimes requires the operator to enter information such as sample ID or patient data In order to enter information into a data field simply tap or click on it The data field will change color to yellow indicating that data entry is active for that field Information can be entered using the virtual on screen keypad or with an optional external keyboard 6 7 The Menu System The graphical user interface of the Abacus 5 analyzer has primary functions that are accessible directly by means of icons or controls that are always available to the operator The Abacus 5 analyzer also has secondary functions that are available via two or more taps or clicks through the menu structure or menu tree 6 7 1 Primary Menu Items The following menu items or functions are directly accessible e Start a manual single tube m
110. llowing materials are required to perform a shear valve cleaning e A clean soft damp cloth e A clean soft dry cloth e Lint free soft dry cloth e Gloves e Tweezers e Toothpicks e Water The shear valve is in contact with the sample blood Wear gloves while cleaning the shear valve Handle the materials use to clean the shear valve as potentially infectious material The shear valve is fixed with a thumb screw No screwdriver or other tools are required Click or tap the Maintenance button on the main menu to bring up the maintenance functions panel Click or tap the Shearvalve cleaning button in the Cleaning section to initiate the shear valve cleaning maintenance function 123 Measure Database Calibration B A AS state a AS state hu HU 2 wA 2 None 2 Non L A 15 44 Figure 94 Shearvalve Cleaning Maintenance Function The Abacus 5 analyzer asks for confirmation to start the procedure After clicking or tapping the OK button the shear valve and the connecting tubing are emptied of liquids A small amount of liquid may remain inside the tubing and the shear valve When the procedure completes the Abacus 5 prompts the operator to proceed with the shear valve cleaning with the following message Unscrew the Shear Valve clean surfaces assemble the Shear Valve If you are ready press OK button to continuel Figure 95 Shearvalve Cleaning Maintenance Function Prompt
111. logo on every printed report e Warning flags are visible check this box to print warning flags on every printed report e Diagnostic flags are visible check this box to print diagnostic flags on every printed report A AS state A None Figure 80 Printer Settings Panel 15 7 Profile Limits Settings The Profile Limits settings are used to view and modify the normal ranges associated with the Abacus 5 analyzer s five sample modes Human Male Female Alternate 1 and Alternate 2 NOTE Alternate 1 and Alternate 2 are sample modes that are different than Human Male and Female and have user definable normal ranges The control at the top of the panel selects one of the five sample modes The panel is then populated with the lower and upper limit values for each of the 24 parameters Modify the values as needed then click or tap Save to save the new values and return to the Settings panel or select Back to discard any changes and return to the Settings panel 109 A AS state None Figure 81 Profile Limits Settings Panel 15 8 X B Settings The X B panel displays the currently selected X B constants Change the values as needed then click or tap Save to save the new values and return to the Settings panel or select Back to discard any changes and return to the Settings panel The following X B settings are available e Lower and upper limit A parameter is usable in X B statistics if its va
112. loss of electrical power is imminent such as thunderstorms or if loss of uninterruptible power supply UPS backup power is imminent 7 3 4 2 Immediate Switch Off In case of immediate danger you can power off the Abacus 5 analyzer by turning off laboratory power or by turning off the main power switch small switch on the rear panel of the Abacus 5 analyzer located near the power connection to the down position labeled O or unplugging the power cord from the wall outlet 7 3 5 Repackaging the Abacus 5 Analyzer Before repackaging your Abacus 5 analyzer for transportation or storage always do the following e Perform a Prepare for shipment procedure e Fully power down the analyzer e Disconnect all reagent tubes power cords and peripheral connections e Always use the original packaging materials to repackage the Abacus 5 analyzer Prepare the following packaging materials were included in your original shipment e Mini pallet e Upper and lower packaging foams e Upper and lower carton box e Plastic bag Place the pallet on the ground Place the lower part of the carton box on the pallet and place the lower packaging foam on the carton bottom Put the Abacus 5 into the plastic bag and place it into the bottom foam part Place the top packaging foam on the analyzer and put the top carton cover box over the package Align the lower carton box flaps so that they fit beneath t
113. lue is between these criteria e Target The start value of the first batch in the X B algorithm e Action limit Maximum percent deviation of the running average values from the target value The user needs to check the X B diagrams regularly as no action is performed by the software if the action limit is reached 110 Measure SY H Figure 82 X B Settings Panel 15 9 User Settings The User Settings panel allows administrators to delete users or assign administrator rights Measure Database a AS state 20 58 Figure 83 User Settings Panel See section 1 for more details on creating deleting and modifying users 15 10 Date and Time Adjustment Double click or tap the time display on the bottom right side of the screen to display a time date settings panel Change the time and date if needed then click or tap the OK button to save the new settings Click or tap Cancel to exit the Time Date settings without saving 111 ww Calibration Maintenance Figure 84 Time Date Settings The Abacus 5 analyzer does not support automatic time zone or daylight savings time changes Please change the time and date manually when necessary 112 16 Instrument Diagnostics The instrument diagnostics section allows the operator to perform diagnostic procedures check the operational history of the instrument set or check the status of the reagents and view stored information about the syste
114. m Click or tap the Diagnostics button on the main menu to view the available options in the Diagnostics panel a i Measure Database Measure Database 16 1 Analyzer Self Test Measure Database TCU temperature ae A AS state 70 114 Figure 86 Self Test Panel Initiating a self test will test the key functions and components of the analyzer The process takes approximately one minute The individually tested items and their acceptable ranges can be found in the following table Clicking or tapping any of the individual test items provides detailed information including the item readings limits and comments Clicking or tapping the Load last selftest button lets you view the results of the previous self test for comparison Big and small buffer times for O to 1 000m 0 to 1 380 ft Altitude Small buffer time Big buffer time Generate 3 000 to 12 000 ms Generate 1 3 000 to 6 000 ms 1 200 to 2 800 ms 1 200 to 2 800 ms Release 700 to 1 300 ms Big and small buffer times for 1 000 to 2 000m 3 280 to 6 560 ft Altitude Big buffer time Release Generate 2 Small buffer time Generate 3 000 to 16 800 ms Generate 1 3 000 to 7 200 ms 1 200 to 3 640 ms 1 200 to 3 640 ms Release 700 to 1 560 ms Big and small buffer times for greater than 2 000m 6 560 ft Altitude Small buffer time Release Generate 2 Big buffer time Generate 3 000 to 26 400 ms Generate 1 3 000
115. matically Offline rinsing frequency this defines the time period between automatic fluidic operations to ensure that fresh reagents are available in critical pneumatic components so that the analyzer can quickly return to the ready state from standby If this time is set to zero the analyzer will never perform automatic fluidic operations while in the standby state but may increase the amount of time needed to return to the ready state from standby Screen saver this defines the time period of inactivity before the analyzer automatically starts the screen saver Entering a time of zero prevents the analyzer from every starting the screen saver Special flags G L Checking the check box disables the generation storage LIS transmission and display of the G and L flags on the screen printout Database columns order Waste container volume ml Database display limit Use only Sarstedt Monovette tube from sample rotor Standby time O Offline rinsing frequency Screen saver Blank request time Special flags G L Figure 78 System Settings Panel 107 15 5 Units The Units panel allows the user to choose which units are displayed for certain parameters The following options are available on the Units panel e HGB unit choose g dL or g L to change the displayed units for the HGB and MCHC parameters e Count unit Choose cells uL or cells L to change the displayed units for the parameters in
116. may require a service engineer to restore proper operation e Accidental storage at very low temperatures may cause freezing that damages the pneumatic components It is strongly recommended that the Prepare for shipment procedure be used if the analyzer will be inactive for more than five days Higher temperature or lower humidity decreases the period of time the Abacus 5 can be idle without performing the Prepare for shipment procedure The analyzer will guide you through the preparing for shipment process This process takes about 30 minutes and requires the following items e Prepare for shipment tube set included with your Abacus 5 analyzer e Distilled water After initiating the Prepare for shipment procedure the system will prepare itself for the draining process Do not power off the analyzer during these steps unless the system indicates that is safe to do so Step 1 The analyzer will ask you to disconnect the reagents from the reagent connectors on the back panel except for the waste connection Leave the waste container tubing connected to the analyzer The system will drain all inner reagent buffers throughout the pneumatic system This step takes approximately 9 minutes Do not turn the analyzer off during this step Step 2 The instrument will ask you to connect distilled water to the reagent inputs Connect distilled water to reagent inputs If you are ready press OK button Figure 27 Connec
117. me Last error Software reset Technical data 04 Software reset Software reset HOME_01 00 HOME_01 00 Repeat last der Reset Ok A AS state None Figure 43 Control The Autosampler With Info Panel The following is a list of messages from the Autosampler e Home message o Response after a successful reset o HOME_XX YY The XX YY is the software revision number e VT zzzzzzzXY o Vacutainer style tube detected o Barcode content 22222222222 o Tray position XY e MV zzzzzzz XY o Monovette style tube detected o Barcode content 22222222222 o Tray position XY e F confirmation that the tube was moved from the mixing to the sampling position e The power on message contains the serial number of the Autosampler unit During the reset cycle the Autosampler moves the Autosampler components to their home position The mixing stations moves to an upright position the active rack moves back on to the sample tray and the entire tray moves to its home position 8 5 Result Display After the analysis is completed the result screen displays all measured parameters flags histograms and scatter plots This information is automatically stored in the database and stored result data can be retrieved at any time from the database Histograms and scatter plots can be zoomed for closer inspection Click or tap the histogram or scatter plot to magnify it Click or tap the Close button on the
118. mits of the calibration target values are linked to the normal range of the Human sample mode Commercial calibrator material and sample tubes should be handled as a potentially biohazardous material All applicable laws regulations and laboratory practices should be followed in the handling and disposal of calibrator materials To perform the automated calibration procedure ensure that the Abacus 5 pneumatic system is started up and that a valid blank measurement has been accepted Perform the following steps Prepare a sample tube with commercial calibrator material or human whole blood Ensure that there is sufficient sample volume for three or seven consecutive runs Place the calibrator sample tube in the sample rotor Select Three measures or Seven measures according to your laboratory s standard practices Select Calibrator for a commercial calibrator material or Human for whole human blood calibration Enter the calibration target values provided with your commercial calibrator material or the previously determined parameter values for human blood calibration Click or tap the Next button to begin the calibration process The analyzer displays a blank result screen and begins sample measurement of the calibration material Wait for the screen to be populated with results when sample measurement is complete Click or tap the Accept button if the measurement run is acceptable Click
119. mpare their performance Use multiple parallel runs to reduce the effect of random error CV We suggest performing at least one blank measurement before starting QC measurements Calibration Calibrate the Abacus 5 according to laboratory regulations Calibration should be performed with every new control material lot or if QC results or comparison of results to other instruments shows significant deviation in measurement results 133 e lf you perform a whole blood measurement calibration it is recommended to run a blank measurement before the calibration procedure see chapter 1 Cleaning Perform cleaning or hard cleaning if e High blank results are experienced e Clogging related flags are consistently appearing with measurement results e After service actions or service level maintenance e Measurement results or QC results are drifting perform hard cleaning e Clog formation in the tubing first remove any plugging or contamination e Reagents incorrectly connected to the wrong place 134 20 Troubleshooting Your Abacus 5 provides all the necessary software maintenance functions required to keep the analyzer operating in optimum working order Despite excellent maintenance the analyzer can still encounter problems where operator intervention is required The Abacus 5 analyzer software informs the operator of situations when further help is required These are called error messages The Abacus 5 anal
120. mpedance change for WBC RBC PLT Light scattering BASO measurement Light scattering 4 diff measurement LYM MON NEU EOS Spectrophotometry for HGB Aperture length WBC 80 um RBC PLT 70 um o HGB measurement Detector light to frequency converter Light source semiconductor laser diode with 650 nm wavelength and 7mW Beam divergence 1 5 Class 1 Laser Product Class IIIB laser module if the protective housing is opened and interlocks defeated IEC 60825 1 Ed 2 2007 Quartz flow cell with hydro dynamic focusing Detector fiber optic coupled PIN Si photodiodes Internal safety interlock Measurement method Optical measurement Horizontal calibration of laser beam position Fine calibration with 5 um polystyrene microsphere calibration material DiatroeDil 5P 20 liter Reagen DiatroeDiff 5P 1 liter DiatroeLyse 5P 5 liter DiatroeHypocleaner CC 100 ml Emergency cleaner WBC BAS dilution 1 170 Auto alignment system Dilution ratios RBC PLT dilution 1 21 250 4 Diff dilution 1 50 Sheath fluid Control material Diacon 5 Manufacturer Diatron Quality Control QC diagrams QC database 149 Pathological diagnostic flags Lab limits normal ranges Reagents alert 3 measurement prealert online reagent replacement Instrumental alerts internal buffer for reagents Calibration Languages available Data store Windows XP Embedded External keyboard Built in Bar Code in the Auto samp
121. n EEE ee een Dada 88 10 8 7 A ea lee tee A ee nee 88 11 CONDITION EEEE AEEA E E EEEE EA une ake ee EEEE 90 11 1 Calibrating the ABacuUs5 soi ci a a a a 90 TLETA VeA Ga O a ee da o 92 12 CQUGIIEY CONTI Oleme n N N E T T aetna 94 12 1 2587 OC Reference r AE nee 94 122 DEME amp E s ren 42 ia 96 123 View OC Reterentes iii ds 96 124 MEeWOC Data aii a as 96 12 5 View OC Diagramsassancsnnn ana ra a a a aa aaa ka 96 12 6 VIiewWX B DaB if 96 12 7 VIEW ARAB Diam casos 97 13 A ee een 98 14 Multi User MOC ciceicciccusesucdiasenecvecsscvacencnestsuseeteddescasentask cussensenevedescoudddesesbeveucasscccniestentesscveceesese 100 A 100 14 2 Creatine a New Users 100 14 3 Deleting or Changing Users ci re 102 15 SOCUUNGS A AA AA AAA 104 15 1 Customize Settings ns realen like 104 15 2 Laboratory Settings en nt 105 15 3 External DEVICES aai 105 154 System Settings icre rennen 106 15 5 Units a a e a a a a 108 156 Printer Settings aice aia 108 15 7 Profile Limits Settini Sannaa e o a e deens 109 O ee ae A A a 110 15 9 User Settinps aunan E E EE EA O 111 15 10 Date and Time Adjustment e sessessescssessessessessescescesoesessessessessesoesossessessescessessesossessessessessessesseseese 111 16 Instrument DIAGNOSTICS sicesexcisvivcensvassvecsscwasedeesnawedcabeusestencsiecesevededsosecsdlentoadestesediedensended ceavuddestess 114 16 1 Analyzer Self Testi ANA AA a 114 16 2 LOB nennen 116 16 3 REENE SCALUS ais
122. n between the blood components These values fall within narrow limits in human blood therefore these values are able to show the drifting of the device The X B algorithm works with batches There are 20 samples in the batches The average deviation of the corresponding batch is calculated as follows The X B algorithm 1s illustrated below N XBi XBi 1 SGN 2 SGN Xg XBi 1 N tZ SGN X63 Xe inl XG Kein N present batch present specimen ith X B value current batch i 1 th value previous batch the arithmetnc sign or number in parenthesis the number of samples in the batch symbol used to represent multiplication Divide the average deviation of the corresponding batch by the number of the items in the batch N 20 Add the square of the resulting deviation to the mean Then the result represents a point on the diagram The value of the mean will be changed with all counted average deviation from the corresponding batch The average of the first batch X equals the target value All the average deviations belonging to the corresponding batch are added to the mean with correct signs The samples are used in calculation chronologically therefore the copulated deviation points show the deviation from the mean line 12 7 View X B Diagrams View X B diagrams displays X B charts for MCV MCH and MCHC View X B data function displays X B information in a table format similar to view QC data 97 13
123. n induced problems such as noise or high blank values can usually be resolved by cleaning the plastic measuring chambers Always wear protective gloves when working on internal parts of the analyzer 121 17 5 Software Maintenance Functions Maintenance functions can be accessed by clicking or tapping the Maintenance main menu item This opens the maintenance function panel Database backwash Cleaning gt E a Empty chamber Empty mix Empty RBC Empty WBC chamber chamber chamber f Fill Touchscreen Touchscreen calibration j A AS state Ar None Figure 93 Software Maintenance Functions Clicking or tapping any of the function buttons initiates the corresponding maintenance functions The maintenance functions are grouped into the following categories Cleaning through the sample rotor optical head with a frequently used back flush through the flow cell then refills and rinses the system refills and rinses the system Rinse washes the tubing system with diluent Cleaning cleans the system with external cleaner reagent introduced through the sample rotor Hard cleaning extended cleaning of the system with external cleaner reagent introduced through the sample rotor Draining Drain sheath drains the sheath buffer Drain Lyse 5P drains the Lyse 5P buffer Drain diluent drains the diluent buffer Drain All Drains all of the above buffer Drain Diff 5P drains the
124. n labeled 1 to power on the electrical system of the Abacus 5 analyzer e Ifthe optional Autosampler is installed turn the power switch on the right side of the Autosampler to the on position labeled 1 to power on the electrical system of the Autosampler e Turn on printers or any peripherals that have their own power switches 46 The electrical system of the Abacus 5 analyzer can remain powered up indefinitely Please follow local regulations or laboratory procedures when deciding whether to fully power down the Abacus 5 analyzer after work hours 7 2 3 Start Up the User Interface To start up the internal user interface computer of the Abacus 5 analyzer flip the standby switch near the top of the rear panel of the Abacus 5 analyzer to the up position The standby switch springs back to the down position after activation UseriD Password Start up Logo Screen Log On Screen Figure 22 Abacus 5 Analyzer Startup and Log On Screens The following sequence of events takes place after enabling the standby switch e The internal computer starts up displaying the EPIA logo in a rotated way e The embedded Windows XP operating system starts up As the display initializes the screen changes color e The Abacus 5 application software starts up displaying the Abacus 5 logo screen Individual component start up status is displayed in the bottom right c
125. nal processing system 27 Flow cell Detectors Low and high angle scatter lights from cells Figure 6 Optical Signal Processing System External structure and the size ofthe cell cause lower angles of scatter and internal granularity or complexity causes higher angles of diffraction Both low and high angles of light scatter are captured by optical sensors providing the Abacus 5 analyzer with two independent measurements for each cell crossing the path of the laser beam Figure 7 Cellular Light Scatter The light scatter data are gathered and plotted as a two dimensional scatter diagram Similar cells have similar scatter characteristics and tend to group together This allows the analytical software to differentiate and identify the leukocyte populations and generate the ADIFF and BASO scatter diagrams 28 High angle scatter COMPLEXITY RBCFRAGMENTS Lowanglescatter Figure 8 ADIFF Scatter Diagram 5 3 Inside the Abacus 5 Analyzer 5 3 1 Front Panel Touch Screen Display Front Panel Sample Rotor START Button Figure 9 Abacus 5 Front Panel 29 The touch screen display is the primary user interface of the Abacus 5 analyzer for user interactions and data entry The LCD screen can be cleaned damp sponge and gentle detergent The front panel is a hinged cover that provides easy access to the shear valve sampling needle and syringes for cleaning and maintenance The front
126. nalyzer Cancel Eeri for Log off shutdown METEO 4 e Pea Mat Son Remove reagent tubing at rear reagent inputs Diluent Lyse 5P Diff SP Leave waste connected If you are ready press OK button Figure 26 Prepare for Shipment 50 If the Abacus 5 is powered off without a proper shutdown or prepare for shipment procedure the following may occur e The pneumatic components may lock in an undefined state The next startup and pneumatic initialization may take longer with increased reagent consumption The Abacus 5 application software and or the Windows XP Embedded operating system can suffer damage or data loss The Abacus 5 analyzer may have to be restarted by a service engineer after an improper shut down or power off sequence The Prepare for Shipment procedure should be used for following reasons e The reagents may spill out if the Abacus 5 is tilted potentially causing electrical short circuit or corrosion e Reagents can flow out of the Abacus 5 if the reagent intakes are disconnected e Evaporation may cause reagents left in the pneumatic components in the Abacus 5 analyzer to become concentrated and form crystals that increase blank results damage pneumatic components and may require a service engineer to restore proper operation e Microbial growth may occur if reagents are left in an inactive analyzer for extended time periods causing high blank results and
127. ntended for analysis of animal blood samples Anti coagulated and homogenized well mixed human blood samples must be free from contamination Blood samples must be analyzed within 7 hours of venipuncture 2 10 Emergency Situations Always follow all applicable laws and regulations with regard to emergency situations If the Abacus 5 needs to be powered off due to an emergency situation like fire thunderstorm etc follow the procedures in chapter 7 3 4 In case of fire do not use water to extinguish the fire unless the Abacus 5 is disconnected from the electrical network 17 3 Product Support Your sales representative is trained and qualified to answer questions about applications and the operation of the Abacus 5 analyzer If you have additional questions regarding the Abacus 5 please ask for manufacturer support through your sales representative Diatron makes every effort to provide excellent support and up to date information and services regarding the Abacus 5 analyzer Software updates and application documents are available on the Diatron web site at http www diatron com 18 4 Installation Your Diatron certified service engineer will perform the initial installation of the Abacus 5 analyzer and train selected laboratory personnel on the proper use and maintenance of the analyzer The Abacus 5 analyzer should only be operated by properly trained laboratory personnel 4
128. of the 24 parameters This function is useful to quickly measure the imprecision of multiple runs of the same sample 10 8 Managing Database Records Abacus 5 analyzer database management functions are accessed by clicking or tapping the Manage records button to bring up the Manage records panel Manage records Importing Export Save tab file Save raw Cancel Select by Figure 55 Manage Records Panel All data manipulation actions that change the data stored in the Abacus 5 database are logged in the Abacus 5 log If the multi user mode is enabled the name of the operator logged on at the time the data manipulation occurs will also be stored in the log 10 8 1 Select By Click or tap the Select by button on the Manage Records panel to display the Select by panel The Select by panel allows you to select a group of records with dates and Result IDs that match criteria entered into the panel Figure 56 Select By Panel The Select by panel provides various ways to select records Only one of the four selection methods can be chosen 85 keyboard All records analyzed on the date entered will be selected the start date the end date and all dates in between will be selected Select all All records in the database will be selected Select Result ID Entering one Result ID will select a record with the same Result ID Entering two Result IDs will select a range of records including the start and end
129. ogically hazardous and chemically dangerous material All applicable laws and regulations must be observed in the handling and disposal of these materials The Abacus 5 is designed for laboratory operation Mobile operation is not supported Operate Abacus 5 within the ambient temperature range described in section 2 4 The IVD equipment complies with the emission and immunity requirements described in relevant part of the IEC 61326 series This equipment has been designed and tested to CISPR 11 Class A In a domestic environment it may cause radio interference in which case you may need to take measures to mitigate the interference Electromagnetic environment should be evaluated prior to operation of the device X This analyzer contains electronic components Please handle electronic waste adhering to local or federal regulations CAUTION Use of controls or adjustments or perfomance of procedures other than those specified herein may result hazardous radiation exposure 13 2 4 Environmental Factors Operate the Abacus 5 analyzer within the ambient temperature range of 15 30 C 59 86 F and a relative humidity range of 10 80 The optimum operating temperature is 25 C 77 F The Abacus 5 analyzer should be stored within the temperature range of 5 35 C 41 95 F Avoid exposing the Abacus 5 analyzer to direct sunlight or to extreme high or low temperatures If the Abacus 5
130. onsumption 1 51 53 117 S sample ID 37 40 56 57 59 60 63 66 73 sampling needle 12 30 54 121 127 shear valve 30 46 48 70 124 137 138 shear valve 123 124 126 standby 31 36 39 43 47 53 107 T touch screen 22 30 36 83 139 tubing 25 31 46 48 51 52 134 154 U USB 22 31 36 57 87 88 132 139 W wash head 121 126 127 137 138 waste 12 17 20 31 32 39 43 44 46 51 52 106 130 142 waste container 20 39 43 46 51 52 106 142 WBC 22 24 26 27 33 43 44 48 70 78 79 80 81 90 108 143 147 154 158 159
131. or tap the Start next button to begin the next calibration run Selecting Start next without accepting a calibration run discards the run Selecting Abort will abort the entire calibration procedure and discards all calibration results The calibration procedure ends when three or seven accepted calibration runs are completed The calibration factors are calculated and presented in the calibrator factor The previous calibration factors and the coefficient of variation CV of the sample runs for each parameter are also displayed Select Accept to replace the current calibration factors with the accepted factors Selecting Discard eliminates the entire calibration process 91 1 00 1 00 1 00 1 00 1 00 1 00 0 92 AS state zr E O Figure 61 Calibration Factor Panel The automatic calibration process can be skipped by selecting the Manual calibration mode on the calibration panel and clicking or tapping the Next button proceeds directly to the calibration factor panel for manual entry of calibration values Manually entered calibration values can be accepted in the same way as calculated factors from calibrator sample runs and are treated by the Abacus 5 in the same way 11 1 1 View Calibrations The view calibrations feature is helpful for reviewing the calibration history for the analyzer Increasing or decreasing calibration value trends over time may indicate a prob
132. orner of the logo e lf the multi user option is enabled then a user ID and password is required e The Abacus 5 main menu is displayed At this point the Abacus 5 analyzer user interface is ready to use but the analyzer is not yet ready to measure samples This requires initialization of the Abacus 5 pneumatic system The following functions are available at this time e Use the patient database to add and modify entries e Review archive send to LIS and print existing measurement records e Review calibration and QC results and history e Change settings 47 7 2 4 User Logon If the multi user feature is activated a user must be logged in before the user interface of the Abacus 5 can be accessed You can log in on two different ways e Enter the user ID and password assigned to your account e Create a new user account The multi user feature of the Abacus 5 analyzer tracks which user is logged on when important activities are performed such as sample or QC measurements or calibration The multi user feature allows full access to administrator users while restricting regular users from actions that change the way the Abacus 5 analyzer operates such as changing calibration settings See section 15 7 for details about user management 7 2 5 Pneumatic System Start and Blank Measurement Before measuring any blood or control samples the pneumatic system components of the Abacus 5 analyze
133. ot POWEr ON EEE Eee lenken 139 20 3 8 I C Errors Displayed At SUT CUD adria 139 20 4 Measurement results related problems ccscscsssccscscecsccscsceccccscnceccececscsceccccscscescecscscescececscesessececes 139 20 41 gt Eluectuating PLT background values nes else 139 20 4 2 LONE smesred population rss A elle 140 21 JACCOSSOVIOS an A A AA AA Aia 142 22 APPENAIK crcr Ea einer 142 22 1 Reagent Consumpti nz n sn aaa 142 222 DISD AN ES a A E ee O a 143 22 3 Fluldie VS TOM iaa 144 22 4 Printed Report Formats 2 a A ASAS AAA AAA a aa 145 22 5 Parameter Calcula Oia ts 147 2270 Specifications ii diia 149 22 7 Performance Characteristics usa 151 22 7 1 PRECISION AAA dt 151 DQ Le PCC UMACY ee nee Eee A E nie E 151 72 1 3 MC RR O A a aa 151 II O A A NA 152 2A Sample tabla 152 22266 Modet Moderna oe 152 22 7 2 Reterence Ranges att os 152 22 78 BACK E FONO LIMIS ss E 153 22 19 Analytical Measurement Range a nee rear 153 227 10 NON Nay Gi 92 SUB Stan Bee a ee ee 154 22 8 RESBENESVSIEN ann ous sm vanswsawiers sea owewauaaweus skwn cuss vaakers stseuouaabaaweuncksuecusease 155 22831 AR O O O er een 155 22 8 2 A Luna een en ee une 155 22 83 LYSE RCIBEM AA ee 155 22 84 2 BA ee ee Line ee eer et oe ORR rare 155 229 Tabrill amp eFormat IRA IA Aina 156 23 1 10 1 22 O 157 Table of Figures Figure 1 Abacus 5 with Autosampler Space Requirements ccccccssseccccseccecescceeeesececseececceee
134. ou want to double check which sample is the last processed sample e Define the sample id of the sample to be processed by clicking or tapping on the Sample ID field o You can type it in the Sample ID using the virtual on screen keypad or an external keyboard o You can use an external USB bar code reader o You can use an auto generated sample ID e Activate or deactivate the automatic generation of sample IDs If the Autoincrement mode check box is checked then the Abacus 5 will add 1 to the last sample ID if it was fully numeric or offer O if the last sample ID had any non numeric characters e Connect a patient to the sample by clicking tapping on the Patient field o The name of this field can be Name or ID depending on the Main Menu Settings Customize Patient s displayed data setting o Ifyou don t select a patient then the default patient will be used o As you select the patient field the patient menu is displayed You can select an existing patient or define a new one See section 1 or more detail about Patients on the Abacus 5 analyzer e Select the sample mode o Blank a blank measurement will be processed This is the only option available if the pneumatic system is not initialized or the Abacus 5 was inactive for an extended period of time After performing and accepting a blank measurement the other modes will be available o Control a QC sample is expected QC measu
135. perform a EIER cleaning procedure and repeat the measurement The ADIFF populations are not clearly distinguishable on the i a 4 Diff Alarm m y 5 If ADIFF results reported then treat them as reduced reliability If scatter diagram not all the parameters reported or the sample is predicted as pathological then perform a manual count on a stained smear Check cleanliness of the reagents and the Abacus 5 Perform cleaning of the Abacus 5 Repeat blank measurement See chapter 7 2 5 Pneumatics start and blank measurement Treat WBC result as reduced reliability Check cleanliness of the reagents and the Abacus 5 Perform cleaning of the Abacus 5 Repeat blank measurement See chapter 7 2 5 Pneumatics start and blank measurement Treat RBC result as reduced reliability Drift in the probe voltage of the WBC capillary The two main Check the reagent connections WBC clogging reasons for this drift are the misconnected reagent and the Perform a cleaning procedure See chapter maintenance clogging of the capillary Please repeat the measurement Drift in the probe voltage of the RBC capillary The two main Check the reagent connections C WBC blank is high WBC gt WBC blank high limit RBC blank is high RBC gt RBC blank high limit RBC PLT clogging reasons for this drift are the misconnected reagent and the Perform a cleaning procedure See chapter maintenance clogging of the capillary Please repea
136. ping the Start button on the screen or by pressing the physical Start button on the front panel of the Abacus 5 Please note that in this mode the patient and sample mode will be carried over from the previous sample unless they are changed 8 4 2 Automatic Mode Only human samples in closed sample tubes can be processed in automatic mode from the Autosampler QC samples and open tubes must be processed in manual mode After starting up the Abacus 5 select the Measure quick link Process a new blank must be processed if this is the first time a new measurement panel is opened since starting up or if an earlier blank has expired due to inactivity An accepted blank measurement is required before starting automatic sample processing 59 Open the AS panel by using the AS quick link at the top of the screen Measure Database Autosampler Info Status none Last error none Technical data none Repeat last command AS state A AS state o O Figure 33 Autosampler Info and AS Panel From the AS panel you can initiate automated sample measurement in 3 modes e Full Scan mode o The Autosampler will scan the whole sample tray o The same sample mode Human Male Female Alternate 1 Alternate 2 will be used for all the samples NOTE Alternate 1 and Alternate 2 are sample modes that are different than Human Male and Female and have user definable normal ranges The sample ID i
137. profile limits X B Change X B limits and targets User Add and manage users of the Abacus 5 analyzer only available to administrator users Delete user Initiates deletion of a user account Administrator Selects or unselects administrator privileges for the currently selected user See section 1 for more information about Abacus 5 analyzer user settings Maintenance Cleaning Perform extended cleaning of various pneumatic components Draining Drain various internal system reservoirs Empty chamber Empty RBC WBC and mix chambers Prime Prime one or all reagent reservoirs Fill Fills the fluidic components of the system with reagents Touchscreen Calibrate the touchscreen location for taps and button presses See section 1 for more information about Abacus 5 maintenance procedures Calibration Calibrate Calibration mode Select type of calibration procedure to run Calibration type Select human blood or calibrator material Target values Enter the target ranges for each calibrated parameter Cancel Cancels a calibration procedure Next Initiates processing of calibration run View calibrations View and delete previous calibrations See section 1 for more information about Abacus 5 calibration O D D QC Measure Initiate processing of a control sample QC Reference select Select which stored QC reference this measurement belongs to Set QC Reference Create a new stored QC reference Load QC reference load QC
138. r need to be initialized and a blank measurement run and accepted To start the pneumatic system and run a blank measurement click or tap the Measure icon with the single test tube graphic on the top left corner of the screen The following sequence takes place e The color of the Start button changes to red e The reagents are primed e The measuring system is flushed e The sample door syringe needle x y movement and shear valve motors are activated and tested e The vacuum system is activated and pump sensors and vacuum leakage is tested e A blank measurement is initiated automatically e An empty result screen is displayed e The blank measurement is performed e The results of the blank measurement are displayed The results of a blank measurement must be accepted before blood or control samples can be processed Ifthe results from the first blank measurement are not acceptable it does not necessarily mean that something is wrong about your Abacus 5 analyzer Please consider the following e Blood proteins or other particles can accumulate in the pneumatic tubing or components e Although the reagents contain antimicrobial agents some microbial growth may still be present e An extended period of inactivity without performing a prepare for shipment procedure may result in salt crystal development in the pneumatic components Running additional blank measurements will usually bring the blank measurements
139. raining can resolve major problems that occur during operation Electrical and moving parts should always be serviced by trained service personnel There are however some maintenance actions the operator should perform to keep the analyzer in good operating condition Any elements inside the analyzer like tubes valves chambers containers should be handled as a potentially biologically and chemical dangerous material Observe local laws and regulations regarding handling and during disposal 17 1 Opening the Front Panel Several components that require regular cleaning and maintenance are behind the front panel Make sure that nothing is placed on top or in front of the analyzer Grasp the lower sides of the front panel gently pushing the sides Pull the lower part towards you lifting up the front panel Upon opening a lever becomes visible Make sure to tilt the front panel upwards so that you can push the lever into the secure position Figure 91 Opening the Front Panel 17 2 Closing the Front Panel A Do not push on the front panel while the security lever is in the lock position 120 Figure 92 Closing the Front Panel Gently lift the front panel so that the security support lever can be moved to the free position Gently lower the front panel When it reaches its lowest position gently push on the front side to click the lock levers in place 17 3 Removing the Side Panels With the front panel open
140. re 107 Detaled Error Message did 137 Figure 108 Proper Seating of Shear Valve ThUMbsSCreW cccooocccnocnccnnononcnnnonaconnnnnncnnonononnnonaronnonanonnnnnnrnnnonarrnnonanonnnnnnoss 138 Fieuire 109 Smeared Populi ees 140 Figure 110 Fla System Dia prim iia 144 Hietire 111 Detaled PrintoutiFormat zes ia 145 Figure 112 Listed Printout FO Matas a A oda 146 Table of Tables Table Abacus gt Analyzer Parametros 23 Table 2 Diatro s Dil 5P Diluent Information as 24 Table gt 3 Diatroelyses5PplHTormatiohessr ss ee En N 24 Table DiathOeDit SP IHformation sa Ener 25 Table 5 BiatrochiypocleanerCE lnformaton ai nd er 25 Table 6 Reagent Connecter Color Codes ee eier 31 Table 7 Abacus 5 Analyzer Men Tree 2 2 2 2222282 a RE EEE EL EEE 45 Table 8 Supported Autosampler Bar Code Reader SyMboloOgisS cccooocccnonnccnnonononnnonaconnnnanonnonononononaronnonaronnonanonnnnnaoos 61 Table 9 Sample Identification Informatio adi A A A A 73 Tapie TO Normal Range ars ol eta epl abc elena 74 table LI Linear Range Aaa di 74 Table 12 80 Blank Flag ona 74 lA O ee ene eee eee ee ere 80 Fable 14 Interpretive Flags iO ion 81 Fable 15 Morphological Has ti A OR 81 Table 16 Database SOM Ente ana ab 83 Table L Restricions DY User Typen una A Id 100 Table tos Count Unit ParameterS ia eine 108 Table 19 Self Test item UMSS ice 116 Fable 20 LOS HMC SN id 117 Table 21 Software Maintenance ProceCures c cccssccccsssecccessececc
141. rements initiated from this menu will not be saved into the QC database and are not part of the QC procedure This mode is intended only as a quick system checks See section 1 for more information about the QC process 57 o Human blood modes Human Male Female Alternate 1 and Alternate 2 Select the mode which has the appropriate normal ranges NOTE Alternate 1 and Alternate 2 are sample modes that are different than Human Male and Female and have user definable normal ranges e Start the measurement by clicking or tapping the Start button on the screen or by pressing the physical Start button located on the front panel of the Abacus 5 a Measure A AS state Figure 31 Sample Measurement Panel After starting the measurement the sample door rotates and takes the sample tube inside the Abacus 5 analyzer This is a key safety feature of the Abacus 5 and protects the operator from the sample needle during routine operation The Start button changes color to red to indicate that the system is busy processing the sample The sample is aspirated inside the analyzer and returned to the operator when the sampling process is complete As soon as the measurement results are available the result screen is displayed See section 1 for more information about the results screen 58 Database Print Sample ID O Patient ID Date 07 11 2012 17 22 Mode WBC 10 uL 3 00 15 00 NEU 10 uL 150 7 00 L
142. rnal user interface computer e Power down the electrical subsystem The Abacus 5 analyzer also has a prepare for shipment shut down option that performs an extended cleaning and emptying of the pneumatic components This option can be used to prepare the Abacus 5 analyzer for an extended period of inactivity or for shipping to a new location There are also emergency shutdown procedures in case of emergency 7 2 Starting Up the Abacus 5 Analyzer 7 2 1 Visual Inspection Perform a visual inspection of the Abacus 5 analyzer before starting up This is particularly important if the Abacus 5 is operated by multiple operators e Check the reagent tubes by gently pulling on them to make sure that connections are not loose e Open the front cover and ensure that there is no leakage around the shear valve or the syringe pumps e Check for salt stains around the reagent tubing and the reagent containers e Check that the power cord is plugged in both into the back panel of the Abacus 5 analyzer and to the wall outlet e Empty the waste container After start up reset the waste level in the Main menu Diagnostics Reagent I status pane Tee Power Up the Abacus 5 Analyzer To power up the Abacus 5 analyzer perform the following steps e Turn on the main power switch small switch on the rear panel of the Abacus 5 analyzer located near the power connection to the up positio
143. rogress of the automated measurements e View the details completed measurements See section 8 4 2 for more information about automated measurements 6 7 4 Access the Database Tapping or clicking the Database icon with the file cabinet graphic allows access to the following functions e Select completed and measurement stored as database records e Export database records for storage or import results for viewing e Delete database records e Send database records to the LIS e Review the details of selected measurements See section 1 for more information about accessing and using the Abacus 5 database 6 7 5 Initiate Printing Tapping or clicking the Print icon with the printer graphic will print the active panel or measurement result according to the printer settings See section 15 6 for more information about printing on the Abacus 5 analyzer 6 7 6 Main Menu Tapping or clicking the Menu icon with the main menu graphic displays and allows access to the main menu The main menu is automatically displayed when the Abacus 5 analyzer is started up The main menu icons are arranged in an intuitive and attractive circular design 41 a AS state 00 2 None 59 Figure 21 Abacus 5 Main Menu 6 7 7 Autosampler Control Panel If you have an optional Autosampler installed the Autosampler control panel can be opened by double clicking tapping the Autosampler status on the left side of the status
144. s The reagent status panel displays the level of each of the on line reagents and waste containers It provides the means to reset the levels of each of the reagents in the event of a reagent container change It also provides the means to reset the waste container level in the event the waste is emptied A Reset all button is also provided in the event of a change of all reagent containers and emptying of waste 80 100 15 14000 0 ml 4000 0 ml 1000 0 ml 3000 0 ml Reset Diluent ral Reset Diff 5P Reset all A AS state A None Figure 88 Reagent Status Panel The Abacus 5 analyzer has built in reagent consumption calculators The calculated level of each reagent is graphically and numerically indicated on the reagent status panel The current reagent levels are also indicated in the status area at the bottom of the screen The Abacus 5 analyzer notifies the user when any of the reagents are running low or when the waste container is almost full If you receive a reagent low notification check the reagent container and replace it if necessary Click or tap the Reset Diluent Reset Lyse 5P or Reset Diff 5P button reset the software counters to a full container level Similarly if you receive a notification that the waste is almost full empty the waste container and click or tap the Reset Waste button on the reagent status panel to reset the software counters to an empty waste container lev
145. s 5 Repeat blank measurement See PLT blank high L lank result PLT gt 15 x 10 ul Dane USED NN u chapter 7 2 5 Pneumatics start and blank measurement Treat PLT result as reduced reliability If other parameters predict a normal sample then perform a cleaning procedure and repeat the measurement The MON and LYM populations are not clearly distinguishable on If MON MON LYM LYM results reported then treat them as the scatter gram reduced reliability If not all the parameters reported or the sample is predicted as pathological then perform a manual count on a stained smear The distribution of the WBC detection changes in time It points Perform cleaning of the Abacus 5 Check the homogeneity the to clogging non homogeneous sample cold sample partial temperature and the coagulation of the sample coagulation of the sample Repeat the sample The distribution of the RBC detection changes in time It points to Perform cleaning of the Abacus 5 Check the homogeneity the clogging non homogeneous sample cold sample partial temperature and the coagulation of the sample coagulation of the sample Repeat the sample Check the sample quality Repeat the sample If the problem PLT URI persists then perform a manual count on a stained smear MON LYM alert WBC measurement statistics warning RBC measurement statistics warning 79 das Warning flags are raised when the analyzer dete
146. s both open and closed sample tubes in manual mode using the sample rotor Manually presented sample tubes must be mixed properly before being presented to the Abacus 5 analyzer Only closed sample tubes will be automatically processed by the optional Autosampler Open sample tubes placed in the Autosampler will be skipped and not processed 8 1 4 Sample Collection and Handling Please consider the following when collecting and handling blood samples The Abacus 5 analyzer aspirates 110 uL of sample in both closed and open vial modes Under the following conditions the Abacus 5 may aspirate less than 110 uL of sample but will detect and flag any inadequate Sample aspirations o The sample tube does not vent properly and contains residual vacuum o The viscosity of the blood is very high The Abacus 5 is unable to aspirate the last 8 mm 0 31 inches or 0 3 to 0 5 ml of sample volume Make sure that the sample tube is filled to the sample level line indicated by the tube manufacturer The anticoagulant not only prevents the coagulation of blood but also dilutes it If the volume of blood is too low than this dilution can adversely affect measurement results Ensure that the blood and anticoagulant are properly mixed by inverting it at least 8 times Do not shake the sample as this could damage blood cells A minimum of 30 minutes should elapse between taking the blood sample and running it on the Abacus 5 for an
147. s generated from the sample tube barcode if available It is not possible to assign a patient to automatically processed samples The default patient will be used for all samples e Free List mode o The samples are defined in a list o The following parameters can be individually defined per sample Sample ID Patient Sample mode o The samples should be placed in the same order in the sample tray as the samples defined in the list o Empty sample positions will be skipped on the sample tray e Selected Samples mode o Asample can be defined for each position on the sample tray o Only defined samples positions on the sample tray will be processed Additional samples will be skipped and missing samples will be marked for later review 60 o The following parameters can be defined per sample Sample ID Patient Sample mode e Remote Worklist Free list o The samples are defined in a list received from the LIS o The samples should be placed in the same order in the sample tray as the samples defined in the list o Empty sample positions will be skipped on the sample tray Samples are automatically scanned and processed in the following order e Rack order starting with rack A to rack J o Rack A is the rack nearest to the front panel of the Abacus 5 o Rack J is the rack nearest to the back panel of the Abacus 5 e Sample order for each rack starting with sample 1 to sample 10 o Samp
148. s to the Abacus 5 analyzer and permits you to create additional users 14 1 Types of Users The multi user mode provides two types of users Administrator users have access to all system functions except service functions and a regular user has access to a limited set of system functions such as running samples Your Diatron service engineer creates the first administrator user account for the laboratory manager As an administrator user you can create other administrator user accounts or regular user accounts All administrator users have the same rights and privileges of the original administrator user including the ability to create other administrator users Use caution in assigning administrator user privileges and restrict the number of administrator users to trusted well trained users that have been fully trained on the operation and maintenance of the Abacus 5 analyzer The following table shows the menu items that are restricted for each user type Database No access to Delete button in Manage Records Menu Settings No access except Customize button Menu Calibrations No access to Calibrate button No access to Set QC Reference button _ No access to Delete button in View QC Data Menu QC No restrictions ee i a j No access to Reject button in View X B data No access to Undo Rejection button in View Rejected in View X B Data Table 17 Restrictions by
149. t Distilled Water Panel 51 Use the Prepare for shipment tube set included with your Abacus 5 analyzer to perform this step The system will prime and fully rinse the tubing and pneumatic system with distilled water This step takes approximately 7 minutes Do not turn the analyzer off during this step Step 3 The analyzer will ask you to disconnect the Prepare for shipment tube set from the reagent connectors on the back panel except for the waste connection Leave the waste container tubing connected to the analyzer Remove reagent tubing at rear reagent inputs Diluent Lyse 5P Diff SP Leave waste connected If you are ready press OK button Figure 28 Remove Reagent Tubing Panel The analyzer will drain all liquids from the instrument This step takes approximately 10 minutes Do not turn the analyzer off during this step When the process is over the system will notify you about switching off the instrument Click or tap the OK button on the notification panel and wait until the Windows XP Embedded exits and power off the user interface computer Do not turn off power of the Abacus 5 at this stage First click or tap the OK button then wait until the Windows XP Embedded operating system exits and shuts down the internal Abacus 5 user interface computer After the shut down process is completed you can turn off the main power switch small switch on the rear panel of t
150. t the measurement If other parameters predict a normal sample then perform a cleaning procedure and repeat the measurement bs If MON MON NEU NEU results reported then treat them as MON NEU alert Te MONA ED Populations ale ES OIC reduced reliability If not all the parameters reported or the the scatter gram i i sample is predicted as pathological then perform a manual count on a stained smear If other parameters predict a normal sample then perform a cleaning procedure and repeat the measurement EO NEU alert The EO and NEU populations are not clearly distinguishable on If EO EO NEU NEU results reported then treat them as the scatter gram reduced reliability If not all the parameters reported or the sample is predicted as pathological then perform a manual count on a stained smear Check cleanliness of the reagents and the Abacus 5 Perform fl Il cleani f the Ab SR t blank t Differential blank high More than 100 cells detected during the 4Diff blank procedure el MA P ae See chapter 6 1 5 Pneumatics start and blank measurement Treat 4 Diff results as reduced reliability ER Warning flags are raised when the analyzer detects a problem in the analysis process that may cause incorrect or suspect results or the ale parameters in the valid blank measurement was too high Flag Check cleanliness of the reagents and the Abacus 5 Perform flow cell cleaning of the Aba
151. tabase and associated with matching QC material lot 12 3 View QC References Click or tap the View QC References button to see a list of QC lot references stored in the Abacus 5 analyzer control database Target values and ranges can be viewed for any stored QC references 12 4 View QC Data Selecting View QC data displays QC runs stored in the QC database in a table format that operates the same way as the Abacus 5 analyzer database QC measurement results will have sequential ID numbers Option buttons are provided to switch back and forth between viewing QC data and viewing QC diagrams 12 5 View QC Diagrams Click or tap View QC diagrams to see the QC diagrams for control measurements hu HU 16 33 Figure 66 View QC Diagrams Panel Means standard deviations StDev and coefficients of variation CVar are calculated based on the QC analyses The dotted lines delineate acceptable ranges on QC diagrams Use the selector control at the top of the panel to view graphical control information for other lots of control materials 12 6 View X B Data Abacus 5 offers X B a k a X bar X to facilitate trend analysis of samples run 96 The X B moving average is an algorithm which is capable of tracking changes of the accuracy alternating of the measurements The algorithm observes the alteration of the derived values which are generally stable For example the MCV MCH and MCHC values show the proportio
152. the table below WBC LYM NEU MON BAS PLT RBC Table 18 Count Unit Parameters e PCT HCT unit Choose Abs Percentage to change the displayed units for PCT HCT e MCV unit Choose fL um to change the displayed units for MCV A Measure Database SEELE Ja TE a AS state 2 CL Figure 79 Units Settings Panel 15 6 Printer Settings The Printer Settings panel lets you choose which installed printer to use view the status of the printer and change the print behavior of the analyzer during operation The following options are available on the Printer Settings panel e Printer select an installed printer to use 108 e Printer status indicates the status of the currently selected printer e Color printing check this check box to print in color or uncheck to print in black and white e Double sided printing check this check box to print on both sides of the paper or uncheck to print on one side only This option is only available if your installed printer supports double sided printing e tems in queue indicates how many printouts are currently waiting in the printer queue e Cancel all jobs Click or tap this button to cancel printing and clear all items waiting in the printer queue e Pre printed paper header height select from O to 80 pixels e Automatic print check this check box to print every sample or control as it is run e Logo visible check this box to print the Diatron
153. then ask for service Differential percentage Algorithm error while distinguishing the WBC s in the 4DIFF Repeat the measurement If the problem persists on a given error procedure sample then perform a manual count on a stained smear Algorithm error while distinguishing the WBC s in the BASO Repeat the measurement If the problem persists on a given BASO percentage error procedure sample then perform a manual count on a stained smear During WBC count there is too much more than 10 of the total d pul the first 10 ch lof the 255 ch full Z WBC noise high Sa Ee as la A a E Perform Clean process Perform Hard Clean process range This may be caused by lyse resistant RBC electronic noise contaminated WBC chamber or contaminated reagents Table 13 Warning Flags D Perform cleaning of the Abacus 5 Perform a self test If vacuum problems persist then call for service Perform cleaning of the Abacus 5 Perform a self test If vacuum problems persist then call for service Thrombocytopenia PLT Thrombocytosis PLT or PLT Microcytic PLT MPV or MPV Macrocytic PLT MPV or MPV Table 14 Interpretive Flags Morphological flag A flags are raised when the presence of morphologically abnormal cell types such as immature granulocytes are The count in the region of low high angle scatter of Abacus 5 6 5 5 Perform a manual count on a stained smear where the Immature granulocyte typ
154. tings in the Patient s displayed data in the Main Menu Settings Customize panel 98 Measure Database Figure 68 Edit Patient Panel The Save function saves any changes made To discard any changes made simply click or tap the Back button 99 14 Multi User Mode The multi user mode provides the clinical laboratory manager the means to control access to the Abacus 5 analyzer by ensuring that only authorized users can operate the analyzer With the multi user mode the laboratory manager can assign some users the authority to perform critical system functions such as maintenance and calibration and restrict other users to routine activities such as running samples The multi user mode also provides audit tracking of activities by recording the user ID of the currently logged on user in the event log Events that are normally tracked in the event log such as maintenance and calibration will now also store the user ID of the user that initiated the event Logon and logoff become new events that are tracked in the system log when the multi user mode is enabled The multi user mode is disabled by default and can only be enabled by your Diatron certified service engineer If you want to use the multi user mode ask your Diatron certified service engineer during the analyzer installation or at any time to create the first administrator user with the user ID and password you provide This allows you administrator acces
155. tion to clean the aligning surface Ensure that no lint or fibers remain on the smooth mating surfaces of the ceramic disks After cleaning the shear valve housing and surrounding area gently put the two disks together Put the axis thumbscrew back into the center of the upper disk The spring on the axis thumbscrew guarantees the necessary closing force for the two disks Gently press down and rotate the axis thumbscrew clockwise until it clicks into the lower part Twist the axis thumbscrew until it stops The mechanical design of the thumbscrew prevents over tightening Figure 98 Cleaning the Shear Valve Figure 99 Reassembling the Shear Valve Clean the area surrounding the shear valve again You can let salt crystals and other small debris fall down Sweep any particles laying on bottom of the Abacus 5 though the ventilation holes Close the front door and remove the gloves Click tap the OK button to inform the Abacus 5 software that you completed the cleaning of the shear valve The shear valve cleaning maintenance function will check the movement and end positions of the shear valve 17 7 Cleaning the Washing Head The washing head cleans the outer surface of the tip of the sampling needle with diluent This is a critical function that protects the integrity of sample results by preventing contamination with previous blood samples Salt build up on the lower surface of the washing head may
156. to 10 200 ms 1 200 to 5 040 ms 1 200 to 5 040 ms 700 to 2 210 ms Release Generate 2 Release Small buffer drift Maximum Big buffer drift Maximum 225 to 235 mbar 215 to 235 mbar 5 to 15 mbar 540 to 560 mbar 530 to 560 mbar 5 to 15 mbar Minimum Drift Max vacuum P2 Minimum Drift Max vacuum P1 550 to 1 000 mbar O to 6 000 ms 500 to 1 000 mbar O to 6 000 ms Maximum Maximum Time Time Null pressures Sheath Capillary Chamber HGB head HGB dark HGB light Laser parameters Pump Status 20 to 20 mbar 20 to 20 mbar 20 to 20 mbar 1 to 1 1 to 1 Pump1 Pump2 Noise pulse O to 20 pulses 19 990 to 20 050 pulses O to 3 000 pulses 3 000 to 60 000 pulses pls 8sec 20000 pulses TCU temperature Actual Reference 0 2 C 0 35 F Reference Sink O to 70 C 32 to 158 F Laser Power Laser DC Level 10 32 to 128 Reagent lock Status Available 0 00 to 0 05 mV 0 05 to 0 65 mV UNLOCKED LOCKED NA No specification Laser off Laser on measurements Battery Power Supply 0 0to3 5V 11 4 to 13 0 V Electrode 45 to 55 V 620 to 680 uA Voltage Battery Voltage Current 12V 115 Temperature 34 0 to 38 0 C LSDACQ v3 1 saca mo specification En EEE Table 19 Self Test Item Limits If any of the values falls outside the above limits the software will list the errors on the self test report screen 16 2 Log The system log provides information for ser
157. tomated high quality hematology analyzer for in vitro diagnostic use in clinical laboratories It provides precise and accurate 5 part differential measurement using a laser based optical measurement technology The Abacus 5 analyzer uses the impedance method for measurement of leukocytes WBC erythrocytes RBC and platelet PLT concentrations Measurement of the hemoglobin HGB content of red blood cells is accomplished by photometric measurement technology Five part leukocyte differential LYM MON NEU EOS BAS is accomplished using optical laser based flow cytometric technology A vivid color touch screen display is featured with an intuitive informative and attractive user interface A START button allows one touch operation for ease of use The Abacus 5 analyzer s unique software system supports the use of many commonly used external printers with its USB connections The Abacus 5 internal database is capable of storing 100 000 patient QC and calibration result records including flags and graphical scatter diagrams and histograms The system software is field upgradeable to ensure up to date operation An automatic optional Autosampler is available sold separately for automated processing of up to 100 sample tubes for increased laboratory efficiency The Abacus 5 features advanced Ethernet LIS connectivity using the HL7 protocol in addition to standard serial interfaces providing the clinical labora
158. tory with flexible connectivity options 5 1 1 Measured Parameters Abacus 5 determines 21 hematology parameters including 5 part WBC differential The instrument requires 110 ul of whole blood sample in Closed and Open vial mode Cycle time is 60 seconds White Blood Cell count WBC Neutrophil absolute count NEU Lymphocyte absolute count LYM Monocyte absolute count MON Eosinophil absolute count EOS Basophil absolute count BAS Red Blood Cell count RBC Mean Corpuscular Volume MCV Mean Corpuscular Hemoglobin MCH Mean Corpuscular Hemoglobin Concentration 22 Platelet Distribution Width PDWsd Calculated Platelet Distribution Width Calculated Thrombocrit PCT Calculated Table 1 Abacus 5 Analyzer Parameters 5 1 2 Approved Reagents and Control Materials Always use reagents control materials and calibration materials that are recommended and approved by the manufacturer The Abacus 5 analyzer control material calibrator material and reagents are part of a system and are carefully designed and selected for optimal performance Using unapproved reagents or controls may cause false flagging or incorrect inaccurate results Only genuine Diatron reagents may be used in the Abacus 5 analyzer Diatron recommends the use of Diacon 5 control material and Diatrocal calibration material from Diatron These materials have been specifically assayed for use in the Abacus 5 analyzer For additional details about th
159. upper right corner of the image to close it and return to the result display 69 Measure Database Measure Database lt Sample ID 0 Patient ID 1 Y lt Sample ID 0 Patient ID 1 Date 07 11 2012 17 22 Mode Human Date 07 11 2012 17 22 Mode Human ELLE a a OFpL giL fL pg g L fL Sears A AS state A AS state A None A None Figure 44 Results Display and Magnified Scatter Plot Comparison of parameters to the normal range can be displayed numerically or graphically See section 15 1 for more information on display of normal range status Other kinds of flags are also displayed in the result screen See section 1 for detailed information about the Abacus 5 result screen 8 6 Printing Reports Click or tap the Print icon at the top of the screen to send a report or any displayed screen to the external printer 8 7 The Measurement Process The Abacus 5 analyzer measures 24 parameters of whole human blood samples Internal dilutions are made to allow measurement of particles in the sample Manual or automatic mode samples are processed in the same way 70 WHOLE BLOOD WHOLE BLOOD SAMPLE SAMPLE MIX DILUTION IMPEDANCE MEASUREMENT a EEE E MEASUREMENT CONTROLLED LIGHT INCUBATION ABSORBEANCE TOTAL WBC HGB RBC PLT OPTICAL MEASUREMENT ADIFF OPTICAL MEASUREMENT BASO Figure 45 Abacus 5 Measurement Process When
160. uspended in a conductive liquid pass through a small aperture The method is volumetric because a small known volume of blood is precisely diluted with a conductive diluent and forced through the aperture at a fixed rate Internal electrode Aperture 3 Blood cell suspension External electrode Figure 3 Volumetric Impedance Method A constant direct current flows between the electrodes on either side of the aperture Each cell passing through the aperture causes a change in the electrical impedance of the conductive blood cell suspension This change is sensed by the Abacus 5 electronics and converted to an electrical pulse The quantity of pulses is proportional to the number of particles The intensity of each pulse is proportional to the volume of the particle The volume distribution diagrams of the particles result in the WBC RBC and PLT histograms that measured in femtoliter volume units Electronic discrimination allows separation of erythrocytes RBC and platelets PLT A lytic reaction lyses erythrocytes to clearly measure leukocytes WBC 5 2 2 Photometric Light Absorbance Method A lysed blood sample dilution can be analyzed for hemoglobin HGB concentration based on its stable chromogen content The reagent lyses the red blood cells causing the release of cellular hemoglobin The hemoglobin 26 concentration is measured by taking a photometric reading across the Abacus 5 WBC chamber The HGB measur
161. vice or troubleshooting purposes It lists events and possible problems related to operation or measurements It also lists routine events such as logon If the multi user mode is enabled the user ID of the operator that is logged at the time an event occurs will also be stored with the log entry A DateTime SA Exception in CallSimpleQueryNe 29 04 2011 09 04 Exception in CallSimpleQueryNe 29 04 2011 09 04 SaveSettings Could not find a p 29 04 2011 09 04 Exception in CallSimpleQueryNe 29 04 2011 09 04 Exception in CallSimpleQueryNe 29 04 2011 09 04 Exception in CallSimpleQueryNe 29 04 2011 09 04 Exception in CallSimpleQueryNe 29 04 2011 09 04 Exception in Configuration file 29 04 2011 09 06 Exception in CallSimpleQueryNe 29 04 2011 09 06 Exception in CallSimpleQueryNe 29 04 2011 09 06 Change all reagents 29 04 2011 09 24 Ce_send in CommParam_ErrorE 29 04 2011 09 24 Login 2904 2011 11 40 6 29 04 2011 12 56 6 0807 Figure 87 Log Panel The selector at the top of the panel filters the log entries according to the following categories Displays only user related log entries Displays only system action log entries 116 Table 20 Log Filters The Details button provides more information about the currently selected log entry The Selftest button provides direct access to the self test panel in the event a maintenance procedure is needed in response to a log entry 16 3 Reagent Statu
162. you present the sample tube and press the Start button the Abacus 5 rotates the sample rotor and takes the sample tube inside the analyzer The piercing needle pierces the sample tube cap if present and aspirates approximately 110 uL of primary blood sample Blood sensors ensure that the primary blood sample is continuous and free of major bubbles as it is moved to the shear valve The shear valve separates the primary sample into further samples of exact volumes of blood that are distributed to provide dilutions for the RBC WBC HGB and 5 Diff population measurements Lysing reagents are used to eliminate RBCs for dilutions that measure WBCs RBC PLT and WBC are measured with impedance technology through 70 and 80 um apertures respectively Two portions of the sample are used for determining a five subpopulation differential of WBC in two independent 4DIFF and BASO measurements Sample results are displayed on the screen as the process is nearing completion Results are stored in the internal database and transmitted to an external LIS if configured to do so The Abacus 5 performs a cleaning rinse of the internal pneumatic components and prepares to measure the next sample 71 9 Result Interpretation This chapter provides description about interpreting and understanding reports provided by the Abacus 5 analyzer 9 1 The Result Screen Database rT n O Patient ID i 30 10 2012 15 49 Mode 10 uL 10 uL 10 uL 10 uL
163. yzer provides additional information in the form of numerical codes that help the operator to identify the root cause of the error These error codes are important for service personnel They can interpret the messages and take necessary actions If you receive error messages with codes please write them down If possible describe what you were doing before the error appeared This important information helps your service engineer to help you when necessary The software will store and re display every error message but it cannot describe the operation you were performing at the time When an error comes up the software usually attempt to offer a solution or will try to resolve the problem and retry the current operation If this recovery process fails or the problem continues to occur please contact your service engineer 20 1 Software error messages If Windows XP Embedded operation system errors appear please accept the error message and repeat the operation If additional such error messages occur please restart the Abacus 5 analyzer At the next service visit please let the service engineer know about the problem Low level error messages provide status information about the data acquisition system and pneumatic system Each error message includes the affected part and the area of the equipment Check this area and part to find any irregularities like clogging mechanical problems or blocked elements Try to repeat the

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