OM-A380-01-115 Date Name Signature Issued
Contents
1. Mew sample Sample ID Patient ID Options Patient ID A screen appears offering data entry for the patient Mame Birth date pr h Joi on co Cancel will return to the measurement 4Diatron Cance mm lcs screen MEASURE Sample ID Patient ID Options New Options Prediluted My H C On l A screen appears where offering data entry for the upcoming sample l Settings remain as they are set for the Sampling depth following samples as well piatron Cancel will return to the sample info screen Pre diluted mode offers two options Yes or No If you set it to Yes then the instruments expects a pre diluted sample with a ratio of 1 5 1 unit of sample and 5 units of isotonic saline solution the total volume should be minimum 1ml WBC only offers two options Yes or No If you set it to Yes then the instrument will not measure and display RBC and PLT related parameters You will receive a total WBC count with 3 part results and HGB reading WBC LYM MID GRA LYM MID GRA HGB Change lyse Volume of lyse reagent added to MIX dilution controls performance of WBC 3 part differential Default lyse setting for each sample type Human control Child etc are specified by SW Default lyse quantity can be adjusted in Patient limits menu Settings Measurement Limits Select an increased 40 1 0 2ml volume if the separation between lysed RBCs and WBC populations is poorly di2. To reduce time required for self test and to allow testing parts of the system that do not require reagents you can chose to run the Self test in fast mode 7 5 Reagent status The screen shows reagent volumes in containers as calculated by the instrument With each measurement the volumes are changing accordingly When reagent volume in a container is running low instrument will notify user and ask for replacement Reagent status 08 48 MAINTENANCE bys o80m hin Bar graphs show reagent status cteanerasam ese Lg Reset will reset reagent level to its full value waste 126m m f any of the reagents is replaced Reset press Prime to aspirate liquid into the system Volume opens up the container volume setup SCreen If Waste is high it should be disposed of properly see next section for instructions 50 MAINTENANCE Volume MAINTENANCE RUM REAGENT STATUS Lyse ml Volume Cleaner ml Set the volume of the containers used Values in ml If volume of a reagent is set to O zero software will not keep track of consumption Waste ml Accept saves your changes Cancel discards changes and returns to reagent status screen 7 5 1 How to empty waste container ooftware counts volume of waste and gives warning message when the waste tank is close to its maximum capacity Empty the waste tank when this warning message appears See next Section for neutralization steps
3. Eum Press Cancel to discard changes and return to the previous menu Enter the values as defined on the assay value sheet of the control material In case you want to omit the trend analysis of a parameters define O zero as target and range 7 3 2 Measure This option puts you to the measurement screen and sets up the parameters for Control Blood measurement Put the sample in the sample holder and press the START button When analysis is complete you will have to accept the results QC1 LOT 20923H Maintenance Quality control Measure The software saves all results automatically to the selected QC lot database Press Discard to remove data from QC Series Exit returns to the QC menu 7 3 3 Diagram QC Diagram displays the trends of parameters with respect to time The screen will show two parameters at a time Maintenance Quality control Diagram Use Up and Down shaded arrows to browse among parameters on both sides Press Exit to return to the previous menu This mode allows comparing tendencies trends of any two parameters 48 MAINTENANCE 7 3 4 Database This option displays the contents of the QC database You can browse in this view just like in the regular database view Functions selection browsing details printing are the same as well Maintenance Quality control Database Use Prev and Next to browse among parameters y Exit returns to the QC menu Y
4. instrument for any visible signs of damage incurred during shipping Would you find any damage file a claim with the carrier or your distributor 17 INSTALLATION immediately Check the accessories received against the packing list Contact Service if anything is missing CAUTION Prior to initial operation allow the instrument to reach room temperature approx 2 hours Rapid temperature changes in an operating unit can lead to water condensation which may damage electronic parts and cause malfunction 2 Place the instrument on a firm work surface in the designated work area near an appropriate AC electrical outlet The power outlet connection MUST be grounded NOTE Before making connections Make sure that all power is in OFF state before connections printer external keyboard are made Carefully read all literature accompanying the instrument and its accessories Pay particular attention to the operating procedures for the external printer 3 Keyboard and external printer Attach the keyboard cable to one of the USB A ports on the back of the instrument Attach both ends of the printer cable to the appropriate ports on the printer and Abacus 380 Attach the AC adapter to the printer if required and plug it into an AC outlet 4 Host Computer The instrument has a built in USB B port that allows connection to a host computer You can export results including histograms USB B I O settings are locat
5. 10 30 5 5 0 1 30 50 10 5 30 800 p 05 01 When all parameters are set press Accept key 45 MAINTENANCE The display shows Calibration measurement at top Calibration measure Maintenance wma 0 E Calibration Measurement Insert the sample tube to the sample door and press the START button Exit will abort the operation Calibration runs are saved automatically If you find that a result should not be used use the Discard button to delete the measurement so that it is not used for calibration Calibration result 1821 Maintenance Target Mean CY Factor Calibration Measurement Result WBC 10 730 7 31 2 6 1 00 4 22 D 4 0 98 0 2 g y D Result will display the average of each parameter of accepted measurements compared to the target value and the calibration factor calculated Accept saves new factors and aborts calibration Back will return to the calibration measurement screen so that you can measure more samples for calibration Calibration history You can compare target and measured values observe CV and see how the calibration factor would change Maintenance Calibration History You can check the date and values of previous calibrations EH P 46 MAINTENANCE 7 3 Quality control Quality control feature allows tracing the operation and reliability of the analyzer in time The best practice is to run a control sample every morning You c
6. 24 MENU SYSTEM When you have to enter data an on screen keyboard appears on the screen lt can be a numerical or alohanumeric keyboard depending on the function Doctor 5 48 Birth date 23 OPERATING PRINCIPLES 4 OPERATING PRINCIPLES 4 11 Impedance Method The impedance method a k a Coulter method counts and sizes cells by detecting and measuring changes in electrical impedance when a particle in a conductive liquid passes through a small aperture Internal electrode Aperture Figure 7 Impedance method Each cell passing through the aperture there is a constant DC current flowing between the external and internal electrodes causes some change in the impedance of the conductive blood cell suspension These changes are recorded as increases in the voltage between the electrodes The number of pulses is proportional to the number of particles The intensity of each pulse is proportional to the volume of that particle The volume distribution of the cells are displayed on diagrams WBC RBC and PLT histograms 4 2 Principle of HGB Measurement The lysed sample dilution can be measured by a photometric method The reagent lyses the red blood cells which release he
7. 7 5 2 Neutralization of Waste Waste contains human origin substances representing biohazard These substances are representing potential danger to environment For this reason safe handling of the waste liquid is very important Neutralization of biohazard waste e Put2 ml per liter of hypochlorite solution into the waste Close the cap and shake the container e After 1 hour you can dispose of the Waste liquid into the drain 51 SETTINGS 8 SETTINGS selecting Settings accesses various lists of options Settings 16 52 Settings inter General Press BACK to go back to MAIN menu Hore 8 1 Printer settings Printer settings menu allows setting up parameters of report printing Printer settings Settings Device Printer settings Format Printer ISB Printer settings Device Mode Fast color al a E Printer Selection between built in or USB printer If the printer is recognized the screen will show the printer s name Format Selects printout quality Press Accept to approve changes made Press Cancel to go back to previous menu keeping the old settings 52 SETTINGS Settings Printer Device Mode Fast modes save ink and provide faster printout Only normal color and fast color printouts will give color printouts Format Settings Limits Enahled Printer settings Format Warnings Enabled Press Accept to approve changes made Press Cancel
8. button your changes will be saved The Sample ID tab returns to the Sample ID screen above Patient ID can be 32 characters long the name of the patient can hold 40 characters 40 DATABASE Database DATABASE Detail UP DN Arrows rint Te database record view allows browsing in the database and you can also look at x a histograms and various diagnostic Histograms parameters of the sample The arrows in the sample data field indicated with BLUE marks allow browsing in the database Tapping them brings up the next or the previous record in the database The arrows marked with GREEN color allow looking at various panels of the result Diagnostic Parameter WBC RBC histogram PLT histogram flags view histogram 6 2 The Filter Select function DATABASE Date Filter Date allows defining the start and end dates sample ID for the search Sample ID and Patient ID can narrow the search If you enter 5 for sample id then all records whose Sample ID contains the expression 5 in our case will be selected 5 15 451 etc Using Type you can further narrow the list of samples With Records you can define to use All or already selected results for the search Clear will reset all fields Select will return to the table view and will fill the checkboxes of records matching the criteria Filter will also return to the table view but only
9. chemical cleaning and high pressure back flush of the aperture using Cleaner reagent High voltage burst of the aperture high pressure back flush chemical cleaning of the aperture using Cleaner reagent Calibration 1 or more measurement automatic and manual factors calibration of WBC HGB RBC PLT MCV or HCT RDW and MPV Easy to use menu driven user interface with touch screen and separate START button status LED Languages available Korean Chinese Spanish Vietnamese Polish and English Data storage capacity 1000 results including 3 part WBC RBC and PLT histograms including QC database shared storage Computer interface USB B port Ethernet Data back up method USB mass storage device Software upgrade method via USB A port using USB mass storage device flash drive Printer interface USB with support for HP printers DeskJet LaserJet PCL3 PS LIDIL EPSON Dot matrix printers Axiohm thermal printer module 58 mm wide roll paper full report with histograms lt TBD gt Cleaning procedure User interface Built in printer Display External keyboard USB keyboard via USB A port 12Voc 5A 60W max operating power Power supply unit External auto ranging power unit for 100 120 or 200 240 VAC 50 60Hz Operating temperature 59 86 F 15 30 C Optimal temperature is 77 F 25 C humidity Storage temperature 15 30 C 13 INTRODUCTION Accuracy The parameters listed below are di
10. monocytes percentage GRA neutrophil percentage HGB hemoglobin RBC red blood cell count HCT hematocrit MCV mean corpuscular volume MCH mean corpuscular hemoglobin MCHC mean corpuscular hemoglobin concentration RDWcv red cell distribution width PLT platelet count PCT platelet percentage MPV mean platelet volume PDWcv platelet distribution width RDW and PDW parameters have two forms of representation CV and SD Both parameters describe the distribution width but from different aspects User can select the units to use for displaying RDW and PDW parameters INTRODUCTION 1 2 2 Reagents Use only reagents supplied by the manufacturer with the analyzer otherwise accuracy cannot be guaranteed DiatroeDil DIFF Isotonic saline solution used to dilute whole blood samples and to rinse the fluidic system between measuring procedures DiatroeLyse DIFF Creates hemolysate for 3 part WBC differential and for total WBC and HGB DiatroeCleaner For cleaning process of the fluidics 1 2 3 Technical Operation As the cell counter is a fully automated instrument operating it requires minimal training or technical support Operator interaction is reduced to the following e Perform a Blank Measurement in case the instrument is not used for a specific time e Enter sample and or patient data e Insert the sample to be analyzed into the sample holder e Print results either one by one or in groups by selecting records from the databas
11. off Preparing for shipment will drain the unit so that it can be transported Log In brings up the login screen below Login name Touch Login name Select name from list paseo Enter password Instrument will show database upon correct password entry 60 PRINTING 9 PRINTING This chapter covers information on making printed reports on measured samples 9 1 Printouts When required the following items can be sent to an external printer or to the built in printer by selecting Print option Database result s table format Database specified patient results with histograms QC result Levey Jennings chart QC result s table format Calibration results Last measured blank result Last measured patient result with histograms Last measured QC result Device information and statistics Self test result Set parameters Thermal paper printout Printout on external printer Abacus 380 Sample ID Name Patient ID Birthdate 00 00 0000 Type Human Sex Test date 29 03 2011 09 52 Serial No Report date 05 05 2011 10 45 2 61 10 500L8 I I 10 00 140 104 130L 8 I 14 00 020 104 oas E T 070 101 1047 250 I I 17 50 53 8 96 250 TT TE 3400 7 6 96 30 l 14 7 0 38 6 96 soo 8 T T V50 3 27 10 4 A400 M T 550 g l i 8 TT J17a4 96 3600 8 T T 5200 f 76 IE 96 2 0 L WI T J320 MCHC 3 a30 VW T 350 RDWc
12. 0 70 ml 262 266 284 288 PLT i 150C E TT 400 PCT 96 MPV 7 8 fi amp 0 W 15 0 PDWc 5 96 Diagnostic flags Leukopenia Neutropenia Anemia Thrombocytopenia Warning W Lyse 0 70 ml Prvw 258 264 PrvR 283 286 22 01 2010 14 28 MD GRA LYMS MCH MCHC RDWc i 07 45 92 9 T f 34 3 18 mes am owners sep ve e ta Fe Ja 78 366 456 167 Deis asf wm 448 SS d E 0 00 T E 78 Core abo 167 002 039 86 388 979 473 058 448 483 59 458 491 174 40 04 82 355 436 16 7 680 063 92 390 61 QC graphical printout on built in printer 20012218 11 04 Y 7 4441 80 e2 240 icy 18 SD Q 13 13 5 soraa 248 N 3 D 00 13 Y a 2 0820 00 e 0 icy nt iso aa 13 T asar T cv 2 SD DM 15 Ll Pet 10 00 ea zt icy 34 sD 11 13 10 00 TI 95 D or 13 a PRINTING QC graphical printout on external printer A baca 560 62 PRINTING 63 Reagent Lock System 10 Reagent Lock System The Abacus 380 hematology analyzer is equipped with a Reagent Lock System to prevent use of inappropriate bad quality reagents in order to provide the possible best quality of results The Reagent Lock System stores the available tests number The packaging of each DiatroeLyse DIFF contains a Reagent Lock Hardware Key Hk Reagent Lock Hardware Key The con
13. 1 00 14 INSTALLATION 2 INSTALLATION 2 1 General information This chapter provides instructions for the installation of Abacus 380 hematology analyzer The procedures described below must be followed correctly to ensure proper operation and service Please carefully read and follow all instructions in this User s Manual before operating the analyzer This hematology analyzer is a precision instrument handle with care Dropping or other improper handling of the instrument will disturb calibrated mechanic and electronic components and or cause damage CAUTION Always handle the instrument with care 2 2 Environmental factors Operate Abacus 380 within the ambient temperature range of 15 30 C and relative humidity of 45 85 The optimum operating temperature is 25 C Avoid using the instrument in areas of extreme high or low temperatures or where it is exposed to direct sunlight If kept at a temperature less than 10 C the instrument should be allowed to sit for an hour at the correct room temperature before use Reagents should be stored at a temperature range of 18 30 C Place the instrument in a well ventilated location Do not place it near potentially interfering devices capable of emitting radio frequencies e g radio or television receiver radars centrifuge X ray devices fans etc Operation at an altitude over 3000 meters 9000 ft is not recommended because the throughput will be degraded I
14. Caps for reagent containers matching connector colors Waste Container 20 L External power supply and power cable sample tube adapters Optional spare thermal roll paper Reagent Tubing Kit Cleaning Tube Kit 12 INTRODUCTION 1 8 Specifications Measured parameters 18 WBC LYM MID GRA LYM MID GRA RBC HGB MCH MCHC RDWc RDWsd MCV PLT PDWc PDWsd MPV 25 ul of whole blood in normal 3 part mode 50 ul of whole blood in pre diluted mode 2 counting chambers for diluting whole blood and counting Isotonic Diluent Lyse Cleaner barcode reagent ID system Sample volume Chambers Reagent system Aperture diameter 70 um RBC PLT 100 um WBC MIX Measurement method WBC RBC PLT blood cell count impedance measurement HGB photometry HCT calculated RBC x MCV Sdiff LYM MID GRA impedance population analysis other parameters computation from stored data WBC HGB 1 160 RBC PLT 1 32000 80 tests hour open tube system with automatic sample rotor human K3 EDTA primary blood sample tubes Dilution ratio Throughput Sampling method Specimen types supported Recommended sample collection method Sample identification Individual sample ID entered by user Barcode with external manual method barcode reader optional accessory Sample types Human general male female baby toddler and child Clog prevention High voltage pulse on aperture in each analysis cycle
15. blocked in between the desk the instrument is on and the wall behind Such circumstances can result in instrument operation failure DO NOT PLACE the reagents above the instrument as there can be a risk of falling and spilling WARNING Install the unit on a table or workbench If the unit was installed without a supporting desktop under the unit there is a possibility that the analyzer could accidentally fall 2 2 3 Peripherals Connect external peripherals only when both the instrument and the peripheral device are off Possible peripherals are external printer the printer must be recommended by authorized technician the printer must be approved and listed the printer must have a CE mark external keyboard the external keyboard must be approved the external keyboard must have a USB port or suitable adapter link to host computer via USB port serial link cable must be approved by technician USB B port linking to host computer requires a USB A B cable and USB driver software contact service for availability 2 2 4 Reagents and waste handling Handle reagents according to national or international regulations INSTALLATION WARNING Reagents may cause corrosion and skin irritation If any of the liquids leaked onto the cover of analyzer or the furniture wipe it off immediately In case of skin contact rinse the liquid off with plenty of water Waste generated by the unit is biohazard ma
16. button The software allows sending results to an external printer via USB port or can have an optional 58 mm built in thermal printer module Its internal memory is capable of storing 1000 records with full histograms and individual patient data QC measurements are also stored in separate database The software operating the instrument is easy to upgrade using a USB pen drive The instrument allows connecting to a host computer for uploading records stored in the memory through a USB B slave port Archiving and restoring of records to and from USB pen drive is also possible NOTE If the equipment is used in a manner different from which the manufacturer specified the protection provided by the equipment may be impaired Misuse of equipment or use other than its intended purpose will invalidate conditions of warranty The accuracy and precision may also be impaired INTRODUCTION 1 2 1 Patient Testing The analyzer can process 80 samples per hour in 3 part WBC differential mode Samples can have individual sample data and additional parameters You can print results to an external or to the optional built in printer The user can customize the report format The analyzer determines the following 18 hematology parameters including 3 part WBC differential from a 25 ul whole blood sample WBC total white blood cell count LYM lymphocytes count MID monocytes count GRA neutrophil count LYM lymphocytes percentage MID
17. diluent DiatroeDill Diff and stored in the chamber MIX he sias 25 ul of the MIX dilution is aspirated into and stored in the needle during WBC measurement and hemoglobin analysis Lysing reagent DiatroeLyse DIFF is added to the mix dilution held in the chamber for WBC differential analysis This amount of lysing reagent is patient type dependent and the operator can change it After WBC counting HGB reading and washing process 4 ml of diluent is added to the second dilution using the 25 ul of mix dilution stored in the needle a This portion is analyzed for RBC count PLT count and their parameters Another washing process prepares the unit for the next analysis Table 1 Dilution rates used Measurement times MIX dilution 1 160 WBC count 12 seconds RBC dilution 1 32 000 HGB measurement 3 seconds WBC dilution 1 196 RBC PLT count 12 seconds depends on lyse amount 10 INTRODUCTION 1 5 1 Control Panels START button Pressing and releasing the START button triggers an analysis cycle Status indicator A two color red green LED light emitting diode bar is located under the display lts actual color indicates the status of the analyzer LED color Analyzer status e Green The analyzer is ready to measure sample Analysis can be initiated by pressing START button Red blinking Blood sample can be removed when the LED blinks red 3 times and the instrument beeps 3 times e Yellow The analyzer is performing a maint
18. however the user should not notice this functionality Exit Logout will leave the unit on and the login screen appears Multi user mode functionality can be enabled in the Exit menu by adding users in User Management T Exit User Management Auto Login Set will allow login free starting of the analyzer y ES Users can be added Add New User or edited Edit View User Adding a user allows filling in the below parameters Password must be defined on Advanced Info tab Monogram will be displayed on the login screen 57 SETTINGS Add user Advanced info Add user Basic info Basic infa Advanced into User Type ame Monogram Password Phone Email Use Remove User option to disable its access User Admin cannot be deleted Admin password cannot be changed NOTE Admin password 0000 SETTINGS User Type BASIC has limited access to the menu tree Calibration Prediluted Factors Quality control forbidden Self test Reagent status Settings forbidden Logout Auto login user 16 57 Exit Select User Management Auto Login Set Auto Login Set will allow login free starting of the analyzer Select the user to be logged in automatically With Auto Login Off selected the instrument will prompt for a user and a password upon 59 SETTINGS Login screen with Auto Login Off Use Shutdown to stop the analyzer power
19. mode RBC peak error Multiple or incorrect RBC peak s detected Try to run the sample again PLT RBC limit not correct PLT and RBC cells could not be separated or the histogram remained high in the PLT RBC valley range RBC PLT clogging The same action as in case of the C warning flag PLT blank is high or no PLT Run cleaning and repeat the blank measurement als Diluent or system cleanliness problem If it is stable high replace the diluent by opening a new tank ded is high or no RBC sace action as in case of warning flag p Table 5 Summary of warning flags related to RBC PLT Measurement conditions when the flags are related to clogging c C probably hemolysing problems E Try to repeat the measurement Measure 10 58 The exclamation mark flag near a parameter shows some doubt during the evaluation of that parameter Jwa The reasons can be a high PLT blank PLT value will be marked a case of T Edit indefinite discriminator setting default location is used for some reasons related parameters will be marked etc Another flagging method is evaluation against the normal ranges If some of the parameters is out of range it gets a flag if under the range or gets if over the range And the given parameter will be highlighted as well You can customize ranges for all kind of patients by setting the corresponding lower and upper ranges If you set 0 for a range limit it will
20. L RT TETTE 21 4 4 Absolute and Linearity Ranges of Parameters oooooonnccnnncncnnnnnnonnnnnnnnnnononananncnnnnnnos 28 5 ROUTINE UTILIZATION and MEASUREMENT s 29 dl Sample re 1a 0 ER mI 29 22 Saipie angi Sra dite seus dE Ga d uda E D UAE 32 2 2 Sample DECDOEOULOR 355 oii iecit ra iei dana beanie dread aaa heer 32 52 2 R nno IEW sample ns db 52 392594 A A E 35 5 2 4 Warmin Tag 35 DL Parameter Limits Normal ranges hai ipo Mat e rore RES oe cbs 37 5 2 6 blank Measurements dau ho icu ds aud pss ete nani ue 37 3 2 d Usine Pre diluted Mode scient tek ais 38 O A rer 6 08 5 005 29 5 0 002 0 0 2 0 0 6082 39 Od Database Serv ICOS eno eishe notre uv tod Gm ds 40 0 2 The Filter Select TUDIEUOD 2o Lone d rodean E 4 Os PpBBDS Te cod idas iaa idad 42 0 4 Manage reco Sas 42 7 MAINTENANCE ceca lecciones Tov Qu IPs eed 43 Es EA a 43 CE NES A E O TTE RR 43 dod C alibratt n Wit TACOS sus ascia ce t erpetoc tu di Ea 44 dad Calibration DY meas rerment caeco ione teo iaa 45 Se QUA controla c m 47 Val FRC FCB NCC Satire aren A SUI die 47 4 3 2 A RD TTE T T 48 15323 IBS MN EE t OD S DTE D TES 48 7 3 4 Pataba c ER 49 y TEN Diui ie perc c er c E ete cu 49 7 4 1 Device Information a iia 49 7 4 2 DEM TOS ton ars tains tex LE ILU MIRI LE ILLI LM 50 Pe REASON SEALS iii a a a A 50 deals How to empty Waste CONTAINED iu
21. OM A380 01 115 Sections affected Initial revision Revision histor Rev Date 1 0 2010 05 14 1 2010 07 27 Edited by Gabor Farkas Gabor Farkas Reagent Lock System added Profile settings added Prediluted calibration added updated screenshots 1 11 2010 08 10 1 12 2011MAY05 Csaba Magyar 10 Reagent lock system grammar review Csaba MAGYAR Epson dot matrix printer support specifications no 3diff below WBC 1 00 PLT histograms added to database screens fast full self test mode Printout font changed 2011AUG15 2012FEBO3 Csaba MAGYAR Csaba MAGYAR Vietnamese and Polish language support added 1 8 description of flag for parameters 5 2 4 LYM MON NEU were changed to LYM MID GRA screens were changed accordingly 1 13 1 14 Technical specifications requirements added changed 1 15 2012 NOV23 Tunde JOZSI pate Name Signature O Issued 2012NOV23 TundeJozsi J 0 0000 Checked and approved G bor Farkas p Checked and approved Oliv r Babinszki DO cAbacus 380 Hematology Analyzer User s Manual Rev 1 15 pistron TABLE OF CONTENTS Table of Contents Te INTRODUCTION m 4 AP RT 4 122 A E O 4 Lol Patient Tenis 5 172 2 REAGCIIS 1d A deben tale beds bud aid eiu Dia datedu ie io A cE end 6 1 2 3 Technical Opera On a 6 1 2 4 Cambra dono 6 Lo Mstumentie ares end aia iia ALO 7 tA Paris
22. Or the Ama ZN st o isa 10 MO The measurement DEOCOSS natos 10 L34 Control Panel eere a aT 11 1 32 DI rM 11 A NS A A T E 11 LO Control Maternal cds 12 its A 12 55 SPECMOD 13 2 ANSTAELA TION m 15 24 General ALORA O IN cim Egi eto eim desta hot daastteut duce md dees een ats 15 2 2 JEnyironimental TaetOEScuie teu dti eec he I A AE 15 22l Electrical equire IME NES acr O Ie ANE DUMP C AM Lalo Lo Said 15 2 22 Space regu menei tas 16 AS PEPSI 16 2 2 4 Reagents and Waste hand 16 2 2 3 Maintenance rada lso 17 2 20 STILI Uu RUN RR esa a ce tec ces dom cet tea EON NUES 17 ES E General POS o nee S 17 2 9 Unpacktmp andMsStall atom pussy ieee th ices eiat acutae Ace tiie onl obstat cea 17 2 9410 Turning the Instrument ON Main Menu esee 19 2 92 Turning the Instrumebt OPE xiii teniente nudas Mead whois 20 2 9 9 Preparing for Sp Oia 21 2 3 4 Handlme m Emerg ene 5o oit uet A fai teu ieds 27 219 95 W arming labels on the andlyZet scri id dy fenes edat 22 3 MENU SYSTEM occasion 23 od General normalom usted EE ois td ip aa odas diuidi ERR I RR Ett 25 DL Nayisatino mthe MODUS St io ier caste toute ho Se doi desee pv Lau Gu an e Dou iEn 23 2 12 dTOuclrscreencalibrattODs o ota 23 Piles Monus tue LEO ety Sp icd aah ut ena than ae Laws dant vd LO one obe Edo s s 24 TABLE OF CONTENTS 4 OPERATING PRINCIPLES ista ads 26 Aide Mopedance Metodo oe siendo 26 2 Prmciple or HGB Measurement ces ier eda d da 26 ME
23. Print Trends Manage They become active when at least one record is selected Detail will open up detailed data parameters histograms flags of the record at the top of the list Print will send the result to the selected printer USB or internal Filter offers tools to select records from the database You can select based on Sample ID Patient ID measurement time stamp sample type Trends offers a statistical tool to monitor variation of parameter values It is an ideal tool to track variation of parameters of a specific patient with time Manage opens up a menu where data can be deleted archived or transmitted to a computer Exit returns to the main menu 39 6 1 Database services DATABASE Detail will open up the parameter and histogram view of a record Database Edit sample Sample ID Patient ID Doctor Dr Heimlich Edit sample Sample ID Patient ID Mame Birth date Print Edit DATABASE Detail Table returns to the table view Print sends the record to the printer Edit opens up the dialog for data manipulation of the record Exit returns to the Main menu DATABASE Detail Edit When looking at record from the database view some fields are not editable Sample ID sample type These can only be set before running the sample Patient ID tab allows entering further data DATABASE Detail PID This option allows editing patient information When you push the ACCEPT
24. R Note QC database is a filtered view of the normal database The status bar shows the Filter on text 7 4 Diagnostics Diagnostics menu allows access to system information and hardware check up Maintenance Diagnostics Press HOME to go to Main menu Press BACK to go back to previous menu i 7 4 1 Device Information Device information shows system hardware and software setup Device information 11 10 Model Abacus 380 Hal 640005 Diagnostics Device Information Maintenance The various system parameters can be seen on the screen rae NS rt ud Fe C A AN 4 VA e d eT yk NAN A S 4 la L la Press EXIT to go back to the previous menu 49 MAINTENANCE 7 4 2 Self Test Self test is a procedure to verify proper operation of essential components of the instrument Self test should be performed e At installation e After replacing any component e After extended time out of use During self test the analyzer checks system components and displays the results On the right side of the results screen the SW displays if the tested parameter falls into the desired range e lf yes a Bi sign is displayed at the end of the line or e if itis out of range a x sign appears DIAGNOSTICS SELF TEST 2 The analyzer lists and checks subsystems When tests are finished display shows a summary of the results Various system parameters can be seen on the screen
25. ample are somewhat lyse resistive WBC 3 part warning Probably large PLTs or clumped PLTs are present in the sample Usually caused by the nature of the sample cat and goat samples tend to clump Intensive but careful mixing of the sample e g Vortex can help remove the clumps If the rerun sample gives the same results consider that WBC and GRA values seem higher because of the clumps Lyse modification can t solve the problem RBC WBC limit warning Typically insufficiently lysed RBC s interfere with the start of the WBC histogram Repeating the measurement with an increased lyse volume should provide better separation If the repeated run reports very similar results then the MID and GRA results are VALID but the WBC and LYM results may be higher because of interfering RBCs WBC clogging Aperture clogging Perform cleaning and repeat the measurement If it is a general problem please contact your Service Personnel Low temperature reagents can cause it as well mainly diluent in this case you will have to wait until they reach room temperature O NEN Table 4 Summary of warning flags related to WBC HGB 35 ROUTINE UTILIZATION amp MEASUREMENT Warning flags in lowercase refer to RBC or PLT problems Recommended user action linearity range exceeded in The analyzer found that the cell count is higher than the linearity PLT RBC stage range of the analyzer Make a predilution and run the same sample in prediluted
26. an also use multiple control material lots Quality contro UR Maintenance Quality control Select LOT to work on Press HOME to go to Main menu Press BACK to go back to previous menu Home lor Maintenance Diagnostics QC1 Press HOME to go to Main menu Press BACK to go back to previous menu a Home hd Control material is a defined and controlled quality prepared almost artificial blood product It has conserved and treated blood cells inside which allows this material to be stable for a much longer time than normal blood would be The Measure option will become active only if there are reference values entered for the actual QC Lot 7 3 1 References To be able to run specific samples and to see stability or variation of parameters it is necessary to define a reference material for the software This is going to be the basis for Quality Control The idea is to enter these so called expected or target values and save everyday repeated runs of the same material in a separate database so that these values can be compared to the reference data Reference values arrive with the control material The manufacturer recommends using Diacon3 with the analyzer The assay value sheet contains all necessary parameters for the control material 47 MAINTENANCE Maintenance Quality control Reference Expiratinn date EV L8 no Use Prev and Next to browse among Press Accept to save data
27. d water to reagent inputs using cleaning tube kit Cleaning tube kit connected The analyzer will flush any remaining reagents from the system into the waste container 21 INSTALLATION As a next step the analyzer asks you to remove the cleaning tube kit Leave Waste Warning 5003 y connected Remove cleaning tube kit Keep reagent inputs free Leave waste connected When finished the analyzer prompts you to power off the system Remove the waste connector after shutting down 2 3 4 Handling in Emergency In case of emergency situation like instrument catching on fire short circuit etc cut off power immediately by disconnecting mains power or DC input line and use a fire extinguisher if necessary 2 3 5 Warning labels on the analyzer l Sample and waste are Biohazard potentially infectious material Reagents may cause Corrosive l a Api corrosion or skin irritation Warning General warning of injury Sharp needle warning Sampling needle may cause injury 22 MENU SYSTEM 3 MENU SYSTEM 3 1 General Information This chapter contains information about the structure and usage of the software implemented menu structure This integrated software controls instrument operations including calculation and evaluation of measured data displaying results and information screens storage and recalling of data 3 1 1 Navigating in the Menu System The instrument uses a menu system to i
28. di abe ihre lao 51 119 2 INcutraliZatton OL WV ste oso quid ederdrus cote icut inten dad B enter dels Copa d iuueni dese aed 51 lt A ene Ree ee eR eRe ee ree ee Teer 52 Od Primier Esset torte ee aia hele ie dal a eee 52 026 CIS aS UUM are aia o dat O UI A 54 TABLE OF CONTENTS 5 9 Measurement Sets 54 8 3 1 A rr reser OUT 54 8 3 2 INO FTV a A M CS srl dados 55 8 3 3 E eaten botes ebore ns 55 8 3 4 SENE NN cR 56 54 Dateand TIME 56 INUIT US TO gst ccc cates MM euo eee MM et EU 2 OB Dulce en ee 61 EL c EM 61 10 Reagent Lock Sy STO Maia ada 64 T1 o O 65 11 1 Regular Troubleshooting Procedures oooooonncccnnnncnonononocnnnnnnnonononnnnnnnnnnnnnnnnanananonss 65 12 Weekly User M amtenange uoo e od 65 ts JCleanmemgecdle washitne head accede d EE dated ery ieee neta ennt 65 12 ELVIDIC S CHEMA TIOS 66 INTRODUCTION 1 INTRODUCTION 1 1 Intended Use This hematology analyzer is a fully automated cell counter designed for in vitro diagnostic use developed for small clinics and point of care lab offices 1 2 The Instrument Abacus 380 is a fully automated bench top hematology cell counters This device implements the so called Coulter method for counting cells passing through a small aperture and measures the hemoglobin content of red blood cells The analyzer features a color graphical LCD display module with touch screen and has a separate START
29. e e Perform simple weekly maintenance as described later in this description 7 1 2 1 2 4 Calibration Abacus 380 arrives to your laboratory factory calibrated and ready to use However calibration needs updating whenever you find that the results have slightly changed or a different or new control material is used With each control material you receive for the instrument you will find a control sheet listing the parameters the instrument should match Perform these calibrations as explained in a later chapter 7 2 INTRODUCTION 1 3 Instrument features Figures 1 and 2 show front and rear view of the analyzer with controls and conneciors Go 01 di NO D touchscreen Built in OO thermal printer Aviatron Abacus 380 f i a Sample holder with interchangeable adapters START button Front panel USB socket Figure 1 Front view INTRODUCTION Built in thermal USB A connectors USB B connector Instrument label fh Power source S N manuf data s connector Reagent Lock connector External grounding Reagent connector connectors Figure 2 Rear view INTRODUCTION To replace paper in the printer open the paper lid pull the lid upwards by the handle remove central plastic roller of old paper roll unwind new paper roll so that the starting edge is coming from down under towards you gently drop the new roll into the holder
30. ed in Settings menu For installation instructions for communication please contact Service 5 Power supply Connect the power supply to the instrument Attach power cord outlet to the external power supply of Abacus 380 and plug the other end into a properly grounded AC outlet WARNING Do not switch on the analyzer before connecting external power supply to it and to the AC outlet as well as before connecting an external printer or a keyboard to the analyzer 6 Reagent Containers Place the reagent containers near the instrument to an accessible location Do not place the containers to a higher position than that of Abacus 380 because would a tube come off its connector the fluids spill out Use the supplied connecting tubes and special bottle caps Be sure that the color on each tube and cap match You can for example place 18 INSTALLATION the reagent containers below the desk the analyzer is installed on as the instrument has sufficient power to draw the liquids from a lower location All containers should be left open do not block the small air vent hole on the special container caps in order to provide free airflow AN aste container Diluent LTSE leaner solution Figure 5 Reagent connections WARNING Reagents may cause corrosion and skin irritation If any of liquids leaked to cover of analyzer or the furniture wipe it off immediately In case of skin contact rinse the liquid with plenty
31. enance process Yellow blinking The instrument is in stand by and display light is off Hit the screen to have SW wake up from stand by 1 5 2 Display The analyzer is currently performing an analysis No new measurement can be started The display is 320 x 240 dots high contrast backlit high color graphic LCD module with integrated touch screen 1 5 3 Touch screen The LCD screen has a touch sensitive foil on the front surface If the operator touches the LCD active area gently the analyzer can recognize it and identify the position where the screen was pressed By touching slightly pressing one small spot on the touch screen the SW will activate the function menu key that the corresponding area represents 11 INTRODUCTION 1 6 Control Material The analyzer allows continuous monitoring of measurement performance with Diacon 3 hematology control control blood This must match the types of samples usually run on the instrument Specification for this material assay values and allowed tolerances along with expiry date is always packed with the approved control material 1 7 Accessories Below is a list of accessories shipped with your analyzer This list can also be referred as the Abacus 380 pack Abacus 380 Hematology Analyzer User s Manual this booklet Reagent Tubing kit with colored tubes Diluent tube green Lyse tube yellow Cleaner tube blue Waste tube red Cleaning Tube Kit
32. erably potassium based is the only anti coagulant recommended for use with electronic blood counters Use of home made containers pre dosed with EDTA is not suggested because if the container is not filled with enough blood the ratio of EDTA to blood may reach a level which results in osmotic transfer from the RBCs which shrinks them The ratio of EDTA to blood should not exceed 3 mg ml Generally we suggest using pre manufactured sample tubes containing the necessary amount of EDTA Also when taking blood please make sure that requirements attached to sample tubes are met Important Make sure to fill sample tubes to at least 7 8 mm height with blood otherwise correct sampling cannot be guaranteed Observe marking on sample tube There is another possibility that can help the user to help the analyzer get a reliable sample from the tube using the needle setting function This is available in Measurement Local menu and controls sampling height of the needle inside the sample tube If you have a sample tube with a higher lower bottom you can control the sampling height adjusting this option This can also help if sample level is too low within a sampling tube Needle offset is displayed in the lower left corner of the measurement screen To initiate analysis 1 Invert the closed sample tube at least 8 times to achieve a homogenous sample Do not shake the sample because micro bubbles can form inside which may cause erro
33. fferentiated resulting in increased WBC and LYM counts Select a decreased 0 1 0 2ml volume if the WBC histogram seems to be shrunk to the left i e the different WBC populations are overlapped This can inhibit proper separation of WBC populations 33 ROUTINE UTILIZATION amp MEASUREMENT MEASURE New Options Lyse volume Change lyse These are the or options you can select from See above description for information Sampling depth The analyzer requires a minimum of 2ml of whole blood in the sampling tube Abacus 380 can however be adjusted for low volume samples This becomes necessary when there is extremely low volume of sample in the tube This option also allows using sampling tubes with an elevated bottom In this case you have to set a higher sampling level to avoid the needle hitting the bottom of the tube New sample MEASURE New Options Sampling depth Sample ID Patient ID Options Prediluted Select the necessary option so that the instrument can take sample from the right Chan ge lyse location My H is on f j sampling depth ym When all parameters are set press the START button to save your settings and start the measurement as the needle can injure you WARNING Do not reach inside the instrument during operation ROUTINE UTILIZATION amp MEASUREMENT 5 2 3 Results Measure 10 44 When analysis is complete the following screen is displayed including al
34. g l HGB unit grams deciliter g dl millimols liter mmol l Percentage 9 6 poner oll absolute ABS standard deviation SD Oe ee coefficient of variation CV 8 3 2 Normal ranges Limits define normal ranges Outside this range parameters will be flagged or Normal ranges 16 54 Settings JEAN tenian Measurement EN ES EN Normal ranges WBC 1021 m a Em The Human profile button brings up the 7 profile selection menu Prev and Next allow browsing among parameters Parameter order WBC RBC HGB HCT MCV MCH MCHC PLT PCT MPV PDWs PDWc RDWs RDWc LYM MID GRA LYM MID GRA You can modify normal range of parameters left column is lower right column is upper limit of normal range Press Accept to accept changes or Cancel to keep previous settings and return to the settings menu 8 3 3 Profile Profile 09 51 Settings Measurement Profile The default lyse volume can be set for each profile j l Dm 39 SETTINGS 8 3 4 Settings Settings l Settings Result Calibration Measurement Settings Result Auto print will print the report automatically when the results are displayed Auto send Disabled i Auto send will automatically transmit results if a PC is connected Barcode allows setting scanned data to be entered as Sample ID or Patient ID Accept saves changes made Cancel returns to previous menu discarding changes made Settings Settings Result Calibrat Measureme
35. hing head 2 Measuring i p chambers A 3 SE Za RN CAS apertures 1 Exit Measure menu Open the side door after the needle has stopped moving 2 Gently rub the lower surface of the washing head with a damp cloth or wiper to remove the salt build up 3 Close the side door 65 FLUIDIC SCHEMATICS 12 FLUIDIC SCHEMATICS SZ p n Pos Dmm Puffer ot Fouuent ENT Reservoir IA SA A v10 J CLEANER Hi r piur S_ Tie er d N e x co women E wo j ZN Sample H motor 3 way un Stepper Motor E 2 way Valve X valve Closed Off Is Open On M E A WASTE j 66
36. ion before beginning the analyses 2 After replacing any component related to the process of dilution or measurement 43 MAINTENANCE 3 When quality control measurements show any systematic error bias or they are outside predefined limits 4 At regular time intervals determined by the lab itself 5 f you want to use the instrument in Pre diluted mode separate prediluted calibration factors are available Calibration can be performed in two ways 1 User can enter calibration factors without any calibration measurements using the numerical keypad 2 1 2 3 fold or more measurements of control blood or calibrator with known parameters In this case the instrument automatically calculates new factors using the following formula Assigned value x Stored factor NEW Taten Measured value s or average of those CAUTION New calibration will invalidate the previous factors Old values can be checked at Calibration History Calibration Maintenance Calibration Factors You can select the following functions Factors enter calibration coefficients manually Measure define target values and start calibration measurements m History display past calibration factors mum mum Prediluted calibration Factors and History Home 2 Mack z ENS for prediluted measurements Prediluted Press HOME to go to Main menu Press BACK to go back to previous menu 7 2 1 Calibrati
37. l Mix it well To perform the analysis on pre diluted sample In Main menu select Measure New In Options select Pre diluted mode Put pre diluted sample into the sample adapter Press START button The analyzer will automatically calculate the results with the 1 5 pre dilution factor idee IM 38 DATABASE 6 DATABASE Patient results are stored in the memory in chronological order and can be retrieved at any time Data storing capacity is 1000 measurements including the complete parameter list histograms flags sample data and date time of measurements If memory is full newest actual record will overwrite oldest record select Database to access records stored in the memory of the analyzer The first screen that appears shows the most recent saved results DATABASE Left and right arrows access remaining non visible parameter results up and down arrows scroll among records individually Menu key opens up local menu for accessing further functions see below Mana m Exit key returns to MAIN menu a mmrerne Records Each line starts with a checkbox and the Sample ID displayed A filled checkbox indicates that a specific record is selected for further operations The bottom row of the screen shows the status line This line provides information about the number of records stored in the database and the number of records selected As it can be seen on the screen some buttons are not active
38. l measured and calculated parameters E as well as the WBC RBC and PLT A es histograms 0 4110 3d Results histograms and other data will Rn NN le MN UN be stored automatically in the memory LYM 248107 146 gil To look at histograms in detail tap the arrows left right to see further details 5 2 4 Warning flags Analyzer SW displays warning flags for each individual measurement to notify user about status of results The following table summarizes warning flags and gives explanation of their possible cause and a few hints to overcome the problem Recommended user action No WBC 3 part Possible lyse problem May occur in pathological lymphocytosis differential HGB blank is high or no Repeat the blank measurement If HGB blank is not stable there are HGB blank probably bubbles in the WBC chamber Run a cleaning and try blank again Close the side door if open during measurement WBC blank is high or no Repeat the blank measurement or run prime lyse and try blank again WBC blank Possible lyse contamination or noise problem linearity range exceeded The analyzer found that the cell count is higher than the linearity range of in WBC stage the analyzer Make a pre dilution and run the same sample in prediluted mode RBC cells found in RBC cells were detected during the WBC measurement Either the lyse sample during WBC reagent is not effective enough volume should be increased or the stage RBC s in the s
39. lue 2 OPERATING PRINCIPLES 4 4 Absolute and Linearity Ranges of Parameters The analyzer provides specified accuracy within its linearity range Beyond this linearity range the instrument can display results but accuracy is impaired lf a value is over the maximum range of guaranteed linearity the instrument cannot measure it and the result will be marked with an E Error flag To measure a sample whose parameters exceed the maximum value indicated in the table below pre dilution is recommended See section 5 2 7 of this manual Linearity ranges of primary parameters in normal measuring mode PLT 1000 10 cells liter EAM Table 2 Linearity ranges of parameters W M BC RBC PLT HCT CV MPV Linearity ranges for 1 5 pre dilution mode Linearity Ranges Maximum WBC 2 200 10 cells liter 10 cells liter WBC z 100 2000 3000 10 cells liter Table 3 Linearity ranges of Pre dilution mode 28 ROUTINE UTILIZATION amp MEASUREMENT 9 ROUTINE UTILIZATION and MEASUREMENT 5 1 Sample handling Since some time will usually elapse between collection of samples and counting it is necessary to preserve the sample with an anti coagulant to prevent large groups of cells forming into clots or lumps of cell matter that will clog the cell counter Choice of anti coagulant is very important as some anticoagulants will affect the shape and size of blood cells In general K3 EDTA liquid pref
40. moglobin The chemical process forms a stable form of methemoglobin This is measured by a photometer on the chamber All Diatron branded reagents are cyanide free and thus are environment friendly However some reagents from other manufacturers may contain cyanide In that case cyanide and any other chemical composition formed using cyanide is environmentally dangerous Contact the reagent manufacturer for safety measures The manufacturer is not liable for any damage caused by using cyanide based reagents with any of its analyzers 26 OPERATING PRINCIPLES 4 3 Parameters Abacus 380 measures and calculates 18 parameters For each parameter we list the name abbreviation and measurement unit in the first column Short description for each parameter is in the second column White Blood Cells WBC Number of leukocytes cells l cells ul WBC WBC 4 x counted WBC cells l cells ul Red Blood Cells RBC Number of erythrocytes cells l cells ul RBC RBC 4 x counted RBC cells l cells ul Hemoglobin concentration HGB Measured photometrically at 540 nm in each cycle blank measurement is performed on diluent g dl g l mmol l HGB HGB X HGB measurea HG Bhiank Mean Corpuscular Volume MCV Average volume of individual erythrocytes derived from fl the RBC histogram Hematocrit HCT Calculated from the RBC and MCV values HCT percentage RBC x MCV x 100 percentage absolute HCT absolute RBC x MCV Mean Co
41. mory device MAINTENANCE 7 MAINTENANCE In the Maintenance menu you can initiate procedures for cleaning calibration or specific performance analysis Maintenance Maintenance Touch menu item of the desired function Home will return to the Main menu Back returns to the previous level 7 1 Cleaning Cleaning functions allow cleaning of fluidics to reduce blank value by removing contamination from tubing chamber and valves Maintenance Cleaning Hard cleaning Drain chamber Press HOME to go to Main menu omy l f Press BACK to go back to previous menu ERI Cleaning starts a washing cycle using the system cleaner reagent connected to the analyzer This action is recommended if clogging problems are experienced C or c error flag or the blank is high Hard cleaning initiates a process that uses a light solution of hypochlorite NaHCL and washes the sampling needle and related tubing with it The instrument will ask for the cleaning solution in a sampling tube Drain chamber will empty the measurement chamber You can use this option to manually add cleaning solution to the chamber when necessary extreme contamination in the chamber 7 2 Calibration The analyzer stability can be monitored with Diacon3 control blood Performing QC determinations regularly verifies continued optimal performance It is recommended to do calibration in the following cases 1 At analyzer installat
42. nected Lyse bottle must be replaced by the following procedure 1 Open a new bottle of DiatroeLyse DIFF The HK is located on the top of the cap of botile 2 Connect the new lyse bottle to the Lyse reagent input 3 Plug the Hardware Key into the Reagent Lock connector on the back of the Abacus 380 4 At the Maintenance Reagent Status screen press the Reset button 5 All the test credits are transferred to the analyzer 6 Remove the HK from the Reagent Lock connector WARNING If the HK was not connected during the previous procedure after a certain number of tests no more measurement cycle can be initiated In order to start new measurements connect an unused HK to the Reagent Lock connector and repeat steps 3 6 TROUBLESHOOTING 11 TROUBLESHOOTING 11 1 Regular Troubleshooting Procedures From Maintenance submenu user can initiate maintenance procedures such cleaning priming or draining chamber 11 2 Weekly User Maintenance Perform weekly maintenance before turning on the power switch The right side has a side door giving access to the fluidic system and the mechanical parts easily 11 2 1 Cleaning needle washing head Needle washing head cleans the outer surface of the aspirating needle with diluent Any salt build up on the lower surface may cause malfunction during operation Use a soft cloth or wiper dampened with water to clean this area You can see the washing head indicated in the following figure Was
43. neous sampling You have the possibility to use 3 different interchangeable adapters for different tube types Tube types are shown in the next pictures e Vacutainer tube adapter for 3 5 ml sample tubes e Micro adapter for micro tainers e Control adapter for 2 ml blood control vial 20 ROUTINE UTILIZATION amp MEASUREMENT Q E o 2 n r o 3 Ss ao MES y E Vacutainer with sample blood cap removed Sample tube with 5 ml control blood Figure 8 Tubes used in Vacutainer adapter Below you can see 3 types of microtainer tubes used in micro adapter These are only examples given by us you can try to use other type of microtainers as well Be careful to place the tube with the cap always in the position sample level for safe shown above otherwise the cap sampling can get stuck when the sample holder turns There must be at least 8 mm Figure 9 Tubes used in micro adapter 30 ROUTINE UTILIZATION amp MEASUREMENT Adapter for 2 ml control blood Figure 10 Vial used in control adapter 1 Remove the cap It is very important because the tip can not pierce the cap 2 Position the sample tube in the sample rotor 3 Press START key The sample rotor will turn the vial into the inside of the instrument and needle draws sample from the tube The aspirating needle is retracted while its outer surface is automatically rinsed with diluent by needle wash head This insures the low carry ove
44. nitiate actions and to access settings Navigate in the menu system by simply touching the LCD at the item you want to open activate From any submenu the Home button will go back to Main menu while Back moves one step back in the menu tree 3 1 2 Touch screen calibration In case you experience uncertainties during tapping the touch screen you tap a specific location still the required function key is not being activated you will have to calibrate the touch panel Tap and gently hold any location on the touch screen Make sure not to press it hard otherwise you can damage the screen After cca 10 seconds a calibrating screen appears Tap the reference points one after another If you made an error you Will hear an error beep and the process restarts Touch this Touch this Touch this Touch this If the calibration was successful you will return to the original screen 23 MENU SYSTEM 3 1 3 Menu structure Maintenance Cleaning Cleaning Hard cleaning Drain chamber Calibration Factors Measure Histor Prediluted Factors Histor References Measure Diagram Database Quality control QC1 QC6 Self test Reagent status Volumes Settings Format Header eee aJ Co B General settings Units Normal ranges Profile Settings Result Calibration Date and time Set Date Time Date Format Logout Shut down Preparing for shipment User Management
45. not be verified PLT related parameters can receive asterisk flags if the previous blank measurement had high PLT value and this value has been accepted 36 ROUTINE UTILIZATION amp MEASUREMENT 5 2 5 Parameter Limits Normal ranges Limits define normal ranges Outside this range parameters will be flagged or Normal ranges 3 Settings Human Measurement Normal ranges The Human profile button brings up the profile selection menu Prev and Next allow browsing among parameters Parameter order WBC RBC HGB HCT MCV MCH MCHC PLT PCT MPV PDWs PDWc RDWs RDWc LYM MID GRA LYM MID GRA You can modify normal range of parameters left column is lower right column is upper limit of normal range Press Accept to accept changes or Cancel to keep previous settings and return to the settings menu 5 2 6 Blank Measurement The system uses blank measurements to check cleanliness of the system and reagents Blank measurement should be performed e Once daily before sample analysis e After any reagent change activated manually from the MEASURE MEASURE BLANK menu e After the replacement of any hardware component that is closely related to the measuring process aspiration dilution counting rinsing In MEASURE mode press the BLANK button If Blank measurement was not acceptable press DISCARD to discard blank result or repeat the Blank measurement pressing BLANK button The analyzer is ready for sample anal
46. nstrument is safe for transient voltages to INSTALLATION CATEGORY Il and POLLUTION DEGREE 2 Environmental and electrical characteristics provide accuracy and precision of the instrument and maintain a high level of operational safety for lab personnel 2 2 1 Electrical requirements Abacus 380 comes with an approved power cord appropriate for your power system Proper use of the appropriate power cord assures adequate grounding of the system WARNING Improper grounding of the analyzer bypasses important safety features and may result in electrical hazard 15 INSTALLATION 2 2 2 Space requirements It is important to install the instrument in a suitable location A poor location can adversely affect its performance Consider the following space requirements Select a location near a power source and close to a suitable drain Place the unit on a clean and level surface Leave at least 0 5m 20in space on both sides and above the instrument to access pneumatics and optional built in printer Provide a minimum of 0 2m 8in between the rear panel and the wall to allow for heat dissipation and tube clearance Install the reagents in a suitable place that will make your work easy The best place is on the ground below the supporting desk of the instrument The pneumatic system is capable of aspirating reagents from containers being 1m 3ft below the reagent inputs Make sure the reagent tubes are not bent broken twisted or
47. nt Settings Calibration Mode Mode allows choosing between HCT PCT or MCV MPV based calibration Accept saves changes made Cancel returns to previous menu discarding changes made Auto print Disabled Barcode Disabled m 5 8 4 Date and Time Date and time of each analysis is stored with the results This menu allows setting the built in clock and the format of the date displayed Date and time 66 Settings Set date and time Date and time Set format You can set date and time and choose the format of time display y ES Settings Date format Date and time Time format Choose the desired time and date format 56 SETTINGS Set date and time 16 55 Settings 25 03 2010 Date and time Set date and time wee Type in the date and time Select formats for displaying the date Press Accept to save settings Press Cancel to go back to previous menu keeping the old values The analyzer has a built in battery responsible for running the built in clock when the unit is powered off If the analyzer asks for date and time setting after power on then this battery is having problems To resolve the problem contact Service 8 5 Multi user mode The analyzer allows operation in a multi user environment where users can have different rights and access levels This feature is accessed upon startup and can of course be customized The analyzer by deafult operates in a multi user environment
48. of the printer and hold the starting edge with your hand and make sure it comes out on the front of the printer close the lid making sure that the paper is captured between the lid and the front of the printer The analyzer works with an external power supply The power supply module has a so called auto range input allowing operation on 230V or 115V power system The power supply unit complies CE and UL safety certifications The input socket is a standard power cable connection and the output is a DC jack CAUTION Use only the provided power supply with the instrument GlobeTek Electronics Corp Model ID GT 81081 6012 T3 INTRODUCTION 1 4 Parts of the Analyzer The hematology analyzer is composed of three main units Fluidic System Performs sampling diluting mixing and lysing functions Generates the regulated vacuum used for moving cells through the aperture during the counting process Data Processing System Counts measures and calculates blood cell parameters generates and stores numerical results and histograms Control Panel Features an LCD display touch screen START button status LED bar and USB port interfaces 1 5 The measurement process For the Schematics of the fluidics system see Section 12 Sample aspiration and dilution Stages of the blood testing process 25 ul of anti coagulated K3 EDTA whole blood sample is aspirated into the sampling needle and mixed with 4 ml of
49. of water 2 3 1 Turning the Instrument ON Main Menu a In case you use an external printer for information read manual shipped with the printer connect it and turn it on b Turn the analyzer on using the power switch on the rear panel The ON position is marked by the symbol After turning on power there will not be LCD activity for a few seconds but the status LED a a goes on Diatron During start up the following screen is GROUP displayed Abacus 380 19 INSTALLATION Abacus 380 2 3 When SW is loaded Main menu is displayed Tap a touch screen item to go activate the menu element CAUTION Wait 5 minutes before initiating any measuring process to allow the instrument to reach the optimal working temperature In some cases a priming cycle is necessary prior to sample introduction The instrument will perform priming cycle automatically if additional liquid in the tubing system is required Run a priming cycle in case of e installation e extended time out of use e replacement of any component related to the Fluidic System e replacement of reagents with instrument turned on 2 3 2 Turning the Instrument OFF DO NEVER turn off the analyzer by simply flipping the power switch on the rear panel Doing so may result in erroneous operation during later use It can be so because the instrument uses diluent This liquid is an isotonic saline solution containing salt Would it not be washed
50. on with factors Factor based calibration allows adjustment of primary parameters with a factor Maintenance Calibration Factors Press white data field to modify calibration factor A numeric input screen will show up so that you can enter values All values must be in the 0 8 1 2 range Press Accept to proceed with new settings or Cancel to keep values unchanged 44 MAINTENANCE 7 2 2 Calibration by measurement The analyzer can run calibrator and perform calculation of factors automatically User can decide the number of measurements to use for calibration Calibration measure options i607 Maintenance Prediluted Calibration Measurement Sampling depth Prior to starting the calibration measurements you have to define some basic parameters for the upcoming measurements As the next step target values from the assay sheet of the calibrator or control must be entered before measurement Calibration measure target W 16 07 Maintenance WBC 10 BEENDEN NT Calibration Measurement Rec 101 EETNES REGN CUN CN HG DD eet 5 fo Prior to starting the calibration measurements you have to define some basic parameters for the upcoming measurements 1 Diatron a m F Target values for calibrated parameters can be set within the following ranges Parameter Low limit High limit WBC 10 300 5 5 0 06 o 2 Table 7 Calibration target ranges 1 0 30 50
51. out of special units of the instrument or would chambers not be filled with this solution may lead to dust condensation or salt build up Therefore always follow the instructions below when switching the instrument off In Main menu select SHUTDOWN The following screen appears INSTALLATION Shutdown EXIT SHUTDOWN Logout Admin Shutdown Select Shutdown The analyzer will perform the necessary steps to prevent failure to the pneumatic system and then gives a tone indicating that it is safe to shut it off LN i Ea Turn off power using the rear power switch Turn off the instrument using the power switch on the rear panel The OFF position is marked by O symbol 2 3 3 Preparing for shipment Use the second item in the Shutdown menu when the instrument is to be shipped or left unused for a longer time more than 1 week The instrument will ask you to use the cleaning tube kit and 100ml of distilled water Follow the instructions appearing on the display SHUTDOWN Preparing for shipment 2 Warning 5001 Remove tubing connectors so the system Remove reagent tubing at rear reagent can drain itself i puts Diluent Lyse and Cleaner Leave waste connected Leave the waste connector attached se SS Next you should connect the cleaning tube kit to the reagent inputs submerging Warning 5002 the free end in a bottle containing at least 100 ml of distilled water Connect min 100 ml distille
52. r between samples After a few seconds the rotor turns out Now you can remove the sample tube from the adapter 31 ROUTINE UTILIZATION amp MEASUREMENT 5 2 Sample analysis 5 2 1 Sample preparation Use K3 EDTA anti coagulated fresh whole blood as sample Prior to sampling mix the sample gently by inverting it at least 8 times Do not shake as this could damage blood cells and create micro bubbles that cause sampling error 5 2 2 Running a new sample MEASURE Measure This is the screen where you can start measurements Exit will return to the Main menu software allows the user to enter information for every sample If an external PC keyboard via USB is used connect it before turning the instrument on There are two options to enter sample information e immediately before analysis e in Database menu To enter sample information prior to sample analysis touch sample info field in the MEASURE screen The following screen appears New sample MEASURE New Sample ID Sample ID o 1 human A screen appears offering data entry for the upcoming sample Sample ID Patient ID Options Doctor Sample ID can be defined to identify the sample DiatronY ma Type Offers a list of profiles to select from ROU i Doctor will appear on the printout as well Cancel will return to the measurement screen above 32 ROUTINE UTILIZATION amp MEASUREMENT MEASURE New Patient ID
53. records matching the criteria will be shown The status bar of the table view will show Filter on NOTE There is an AND relation between the fields If you fill in more than one field then you can narrow the search e g measured between 2009 08 10 and 2009 09 20 AND having a sample ID 1221 DATABASE 6 3 Printing records DATABASE Print If there is no record selected then the software prints the actual top detail view record If there is more than 1 record selected then you will be able to choose between individual printing Result by result or Table format only using USB printer Cancel aborts the operation 6 4 Manage records The Manage button becomes active if there is more than 1 record selected in the database Pressing Manage brings up the following screen Manage menu 1606 DATABASE Manage Delete Back aborts the operation and returns to the table view Backup Deselect will clear the checkboxes of all selected records Send will transmit record s to a connected computer A progress bar shows the status of the process Delete will permanently delete selected record s from the database You have to confirm this operation Backup will save selected record s to an external USB memory device A progress bar shows the status of the process NOTE Do not remove the USB memory device as long as its status LED is blinking because it can cause data loss on the me
54. rectly measured or derived from directly measured parameters Parameters not listed below are calculated from these parameters and therefore do not have independent criteria of their own Evaluation Levels pots Absolute Percent CDP1 CDP2 cop3 Range Range Units Low Higi WBC 030 600 200 420 10 50 0 00 75 00 10 ara 3 1009 10 40 86 o 10 A MCRL BO 015 600 384 11585 1 000 00 10m HdB os 60 60 u7 172 10 250 sd cv 10 6o 791 986 500 1200 iL RDWv 10 6000 118 151 80 200 PLT 15 8000 50 134 429 O0 1000 10Vul MPV 10 100 71 108 50 300 fL Precision Repeatability performance is defined as repeatability CV or SD whichever is greater Within device precision is defined by CLSI EP5 A2 for long term evaluation of device precision rather than short term evaluation of repeatability Units L SRAT A AAA pL J sme A e Se ee ee Linearity Linearity is characterized by linear regression against a known dilution sequence Linear regression is also compared against 2nd and 3rd order regression R2 absolute error relative error NES Low Range High MEA OA esas HGB gt 09 9 027 309 00 2350 gd PT gt 09 35 lt 30 0 100 o Carryover Carryover is defined as high to low carryover Parameter Allowable Carryover
55. rpuscular Hemoglobin MCH Average hemoglobin content of erythrocytes calculated pg fmol from RBC and HGB values MCH HGB RBC Mean Corpuscular Hemoglobin Calculated from the HGB and HCT values Concentration MCHC MCHC HGB HCTabsolute Unit of measurement is displayed according to the one g dl g l mmol l chosen for HGB result g dl g l or mmol l The distribution width of the erythrocyte or platelet population derived from the histogram at 2096 of peak Red Cell Distribution Width RDW SD read 100 BC fl Platelet Distribution Width PDW SD fl Red cell Distribution Width RDW CV absolute PI FE Platelet Distribution Width PDW CV xDW SD RDW x P2 P1 fl absolute xDW CV RDW x 0 56 x P2 P1 P2 P1 by the factor of 0 56 CV is corrected to the 60 cut Platelet PLT Number of thrombocytes platelets cells l cells ul PLT PLT a x counted PLT cells l cells ul Mean Platelet Volume MPV Average volume of individual platelets derived from the fl PLT histogram Calculated from the PLT and MPV values Thrombocrit PCT PCT percentage PLT x MPV x 100 percentage absolute PCT absolute PLT x MPV White blood cell 3 part differential Absolute values counted in the channels determined by LYM LYM lymphocytes the three WBC discriminators MID MID monocytes and some foot eosinophils GRA GRA neutrophil granulocytes Percentages calculated from the absolute WBC va
56. terial Handling and disposal must happen according to regulations regarding reagent systems See Section 7 5 2 WARNING Waste contains poisonous substances because of chemical content and human origin substances meaning biohazard These substances are representing potential danger to environment For AN this reason safe handling of the waste liquid is very important 2 2 5 Maintenance The user should check the following components weekly bottom of washing head for salt build up should be wiped off with a damp cloth or wiper tubing system by opening the side door and look for any liquid leakage If you experience leakage contact authorized technician WARNING The power supply unit and internal electronic boards must NOT be opened or serviced by the user 2 2 6 Cleaning Clean the instrument and its power supply in off state on the outside only using a damp cloth with a soft detergent DO NOT let liquids get inside these units 2 2 7 General points The manufacturer guarantees work safety reliability and general characteristics under the following conditions only Services and repairs are performed by an authorized technician the electrical system of the laboratory follows national and or international regulations the system is operated according to instructions contained herein 2 3 Unpacking and installation 1 Carefully remove the analyzer from the shipping carton Inspect the
57. to go back to previous menu keeping the old settings Limits Enable Disable parameter limit normal range printing Warnings If Enabled warning flags appear on the report as well Histograms Enable Disable graph printing Technical information If Enabled probe voltages WBC RBC lyse volume ml and software firmware version appear in the printout Header Settings Printer settings Header The data entered will be printed on the top of each printed report Press Accept to approve changes made Press Cancel to go back to previous menu keeping the old settings 53 SETTINGS 8 2 General settings General settings control operation of the following functions 2 Settings Sound lala see Select any of the following options Language English Simple text Press Accept to approve changes made Press Exit to go back to previous menu 8 3 Measurement settings This section groups measurement related options and settings Measurement 8 3 1 Unit settings Unit settings menu allows to set up units of parameters displayed or printed 54 Settings Measurement Units Press units to change them individually Press Accept to approve changes made Press Cancel to go back to previous menu keeping the old units Possible units for the parameters 54 SETTINGS cells liter cells l cells ul cells ul grams liter
58. ysis and displays an empty sample measurement screen There are 3 regions for blank value handling 1 Optimal all results are within acceptable ranges 2 Blank is high flag displayed at relevant results 3 Blank exceeds acceptability no results displayed 1 No flag at parameter 2 flag at result 3 E error flag at result GB 0 10 g l 10 25 g l gt 25 g l H 0 0 5 x10 cells ul 0 5 1 0 xtO cells ul 1 0 x10 cells pi PLT 0 25 x10 cells ul 25 50 x10 cells ul gt 50 x10 cells ul RBC 0 0 05 x10 cells ul 0 05 0 5 xtO cells ul gt 0 5 x10 cells ul Table 6 Blank measurement ranges Accepted blank values are essential for proper calibration a ROUTINE UTILIZATION amp MEASUREMENT Calibration can only be performed if all blank values are in the first region no flags or errors If analysis errors occur or blank measurement is too high an E error flag appears along with the affected parameter and is displayed instead of results In this situation perform a cleaning see Section 7 1 5 2 7 Using Pre diluted Mode Pre diluted measurement mode allows to measure insufficient sample for normal mode or if some parameter is out of the linearity range WBC 300 x 10 cells ul Perform an external pre dilution of the sample using clean isotonic saline solution or diluent reagent Dilute the sample to 1 5 ratio 1 part sample to 5 part diluent using a clean sample via
Download Pdf Manuals
Related Search