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OPERATING PRINCIPLES 

27 

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. 
 
If 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: 
 

Parameter 

Linearity Ranges 

Maximum 

Unit 

WBC 

0...100 

150 

10

9 

cells/liter 

RBC 

0...15 

20 

10

12 

cells/liter 

PLT 

0...700 

1000 

10

9 

cells/liter 

HGB 

0...250 

400 

g/l 

HCT 

0...100 

- 

% 

MCV 

30...150 

- 

fl 

MPV 

3...30 

- 

fl 

 

Table 2. Linearity ranges of parameters 

 

Linearity ranges for 1:5 pre-dilution mode: 
 

Parameter 

Linearity Ranges 

Maximum 

Unit 

WBC 

2…200 

300 

10

9 

cells/liter 

RBC 

1…30 

40 

10

12 

cells/liter 

PLT 

100…2000 

3000 

10

9 

cells/liter 

 

Table 3. Linearity ranges of Pre-dilution mode 

 

Summary of Contents for Abacus junior 30

Page 1: ...2011 05 06 Csaba Magyar 1 8 Epson dot matrix printer support specifications 1 8 no 3diff below WBC 1 00 6 1 end PLT histograms added to result screens 7 4 2 fast full self test mode added MODE button 8 1 Printout margin settings Diagnostic flag option 8 2 Data export options selectable 9 1 Printout font changed Gábor Farkas Date Name Signature Issued 06 MAY 2011 Csaba Magyar Checked and approved 1...

Page 2: ...A Ab ba ac cu us s j ju un ni io or r 3 30 0 A Ab ba ac cu us s j ju un ni io or r 3 30 0N ND D Hematology Analyzer User s Manual Rev 1 11 ...

Page 3: ......

Page 4: ...LLATION 14 2 1 General information 14 2 2 Environmental factors 14 2 2 1 Electrical requirements 14 2 2 2 Space requirements 15 2 2 3 Peripherals 15 2 2 4 Reagents and waste handling 15 2 2 5 Maintenance 16 2 2 6 Cleaning 16 2 2 7 General points 16 2 3 Unpacking and installation 16 2 3 1 Turning the Instrument ON MAIN Menu 18 2 3 2 Turning the Instrument OFF 19 2 3 3 Preparing for shipment 20 2 3 ...

Page 5: ...lank Measurement 36 5 2 7 Using Pre diluted Mode 37 6 DATABASE 38 6 1 Database services 39 6 2 The Filter Select function 40 6 3 Printing records 41 6 4 Manage records 41 7 MAINTENANCE 43 7 1 Cleaning 43 7 2 Calibration 43 7 2 1 Calibration with factors 44 7 2 2 Calibration by measurement 45 7 3 Quality control 47 7 3 1 References 47 7 3 2 Measure 48 7 3 3 Diagram 48 7 3 4 Database 49 7 4 Diagnost...

Page 6: ...3 2 Normal ranges 55 8 3 3 Settings 56 8 4 Date and Time 56 8 5 Multi user mode 57 9 PRINTING 60 9 1 Printouts 60 10 TROUBLESHOOTING 62 10 1 Regular Troubleshooting Procedures 62 10 2 Weekly User Maintenance 62 10 2 1 Cleaning needle washing head 62 11 FLUIDIC SCHEMATICS 63 ...

Page 7: ...o 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 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 cap...

Page 8: ...ON monocytes count NEU neutrophil count LYM lymphocytes percentage MON monocytes percentage NEU 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 dis...

Page 9: ... Perform a Blank Measurement in case the instrument is not used for a specific time Enter sample and or patient data Insert the sample to be analyzed into the sample holder Print results either one by one or in groups by selecting records from the database Perform simple weekly maintenance as described later in this description 7 1 2 1 2 4 Calibration A Ab ba ac cu us s J Ju un ni io or r 3 30 0 a...

Page 10: ... 1 and 2 show front and rear view of the analyzer with controls and connectors Figure 1 Front view Color LCD touchscreen START button with status indicator Built in thermal printer Sample holder with interchangeable adapters Front panel USB socket ...

Page 11: ...RODUCTION 8 Figure 2 Rear view Instrument label S N manuf data Reagent connectors Power switch USB A connectors External grounding connector USB B connector Power source connector Built in thermal printer ...

Page 12: ... 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 con...

Page 13: ...nto the sampling needle and mixed with 4 ml of diluent Diatro Dill Diff and stored in the chamber MIX dilution b 25 µl of the MIX dilution is aspirated into and stored in the needle during WBC measurement and hemoglobin analysis c Lysing reagent Diatro Lyse DIFF is added to the mix dilution held in the chamber for WBC differential analysis This amount of lysing reagent is patient type dependent an...

Page 14: ...y performing an analysis No new measurement can be started Yellow The analyzer is performing a maintenance 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 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 t...

Page 15: ...ssories Below is a list of accessories shipped with your analyzer This list can also be referred as the A Ab ba ac cu us s J Ju un ni io or r 3 30 0 pack A Ab ba ac cu us s J Ju un ni io or r 3 30 0 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 Caps for reagent containers m...

Page 16: ... Cleaner reagent Calibration 1 or more measurement automatic and manual factors calibration of WBC HGB RBC PLT MCV or HCT RDW and MPV User interface Easy to use menu driven user interface with touch screen and separate START button status LED Languages available English Spanish Portuguese French Russian Indonesian German Italian Czech Data capacity 1000 results with RBC PLT and WBC 3 part histogra...

Page 17: ...irect 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 centrifu...

Page 18: ...esk 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 Periphera...

Page 19: ...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 un...

Page 20: ...o or r 3 30 0 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 located in Settings menu For installation instructions for communication please contact Service 5 Power supply Connect the power supply to th...

Page 21: ...e wipe it off immediately In case of skin contact rinse the liquid with plenty 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 I symbol After turning on power there will not be LCD ac...

Page 22: ...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 out of special units of the instrument or would chambers not be filled with this solution may l...

Page 23: ...waste connector attached Next you should connect the cleaning tube kit to the reagent inputs submerging the free end in a bottle containing at least 100 ml of distilled water Cleaning tube kit connected The analyzer will flush any remaining reagents from the system into the waste container As a next step the analyzer asks you to remove the cleaning tube kit Leave Waste connected When finished the ...

Page 24: ... analyzer Label Meaning Explanation Biohazard Sample and waste are potentially infectious material Corrosive Reagents may cause corrosion or skin irritation Warning General warning of injury Sharp needle warning Sampling needle may cause injury ...

Page 25: ...ain menu while Back moves one step back in the menu tree If you use an external keyboard use the numbers indicated in front of the menu item as hotkeys Submenus are marked with a symbol on the right of the menu line 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 y...

Page 26: ...easure History Quality control QC1 References QC2 Measure QC3 Diagram Database Diagnostics Device information Self test Reagent status Volumes Settings Printer Device Printout Format Header General settings Measurement Units Normal ranges Settings Result Calibration Date and time Set Date Time Date Format Exit Logout Add new user Shut down Remove User Preparing for shipment Auto login set User Man...

Page 27: ...MENU SYSTEM 24 When you have to enter data an on screen keyboard appears on the screen It can be a numerical or alphanumeric keyboard depending on the function ...

Page 28: ... 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 hemoglobin The chemical process forms a stable form of methemoglobin This is measured by a photometer on the chamber All Diatro...

Page 29: ...BC and HGB values MCH HGB RBC Mean Corpuscular Hemoglobin Concentration MCHC g dl g l mmol l Calculated from the HGB and HCT values MCHC HGB HCTabsolute Unit of measurement is displayed according to the one chosen for HGB result g dl g l or mmol l Red Cell Distribution Width RDW SD fl Platelet Distribution Width PDW SD fl Red cell Distribution Width RDW CV absolute Platelet Distribution Width PDW ...

Page 30: ...e 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 Parameter Linearity Ranges Maximum Unit WBC 0 100 150 10 9 cells liter RBC 0 15 20 10 12 cells liter PLT 0 700 1000 10 9 cells liter HGB 0 250 400 g l HCT 0 100 MCV 30 150 fl MPV 3 30 fl Table 2 Linearity ranges of parameters Line...

Page 31: ...ake 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 I...

Page 32: ...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 There must be at least 8 mm sample level for safe sampling Be careful to place the tube with the cap always in the position shown above otherwise the cap can get stuck when the sample holder turns Figure 9 Tubes used in micro adapter ...

Page 33: ...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 over between samples After a few seconds the rotor turns out Now you can remove the sample tube from the a...

Page 34: ... the sample 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 immediately before analysis in Database menu To enter sample information prior to sample analysis touch sample info field in the MEASURE screen The following screen appears MEASURE New Sam...

Page 35: ...o Yes then the instrument will not measure and display RBC and PLT related parameters You ll receive a total WBC count with 3 part results and HGB reading WBC LYM MID GRA LY MID GR 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 ca...

Page 36: ...ere 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 MEASURE New Options Sampling depth Select the necessary option so that the instrument can take sample from the right location When all parameters are set press the START button ...

Page 37: ...surement If HGB blank is not stable there are probably bubbles in the WBC chamber Run a cleaning and try blank again Close the side door if open during measurement B WBC blank is high or no WBC blank Repeat the blank measurement or run prime lyse and try blank again Possible lyse contamination or noise problem M linearity range exceeded in WBC stage The analyzer found that the cell count is higher...

Page 38: ...cells could not be separated or the histogram remained high in the PLT RBC valley range c RBC PLT clogging The same action as in case of the C warning flag p PLT blank is high or no PLT blank Run cleaning and repeat the blank measurement Diluent or system cleanliness problem If it is stable high replace the diluent by opening a new tank b RBC blank is high or no RBC blank Same action as in case of...

Page 39: ...URE mode press the Blank button If Blank measurement was not acceptable press DISCARD to discard blank result The analyzer is ready for sample analysis 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 Pa...

Page 40: ...tion 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 vial Mix it well To perform the analysis on pre diluted sample 1 In Main menu select Measure 2 New 3 In Options select Pre diluted mode 4 Put pre diluted sample into the sample adapter 5 Press START button The analyzer will automatically cal...

Page 41: ...lled 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 Print Trends Manage They become active when at least one record is selected Detail will op...

Page 42: ... 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 button your changes will be saved The Sample ID tab returns to the Sample ID screen above Patient...

Page 43: ...rch 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 ...

Page 44: ...g Manage brings up the following screen DATABASE Manage Back aborts the operation and returns to the table view 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 re...

Page 45: ...DATABASE Manage Backup View View reads up previously saved records in binary format from a file located in the root folder of an external USB memory device Select backup file by touching left or right arrow and select OK Cancel aborts the operation NOTE Do not remove the USB memory device as long as its status LED is blinking because it can cause data loss on the memory device ...

Page 46: ...cleaner reagent connected to the analyzer This action is recommended if clogging problems are experienced C or Q 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 cham...

Page 47: ...ew factors using the following formula New factor Assigned value x Stored factor Measured value s or average of those CAUTION New calibration will invalidate the previous factors Old values cannot be retrieved Maintenance Calibration You can select the following functions Factors enter calibration coefficients manually Measure define target values and start calibration measurements History display...

Page 48: ...upcoming measurements As the next step target values from the assay sheet of the calibrator or control must be entered before measurement Maintenance Calibration Measurement Prior to starting the calibration measurements you have to define some basic parameters for the upcoming measurements Target values for calibrated parameters can be set within the following ranges Parameter Low limit High limi...

Page 49: ... the measurement so that it is not used for calibration Maintenance Calibration Measurement Result 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 You...

Page 50: ...d 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 go...

Page 51: ... 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 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 tre...

Page 52: ...among parameters Exit returns to the QC menu 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 7 4 1 Device Information Device information shows system hardware and so...

Page 53: ...e 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 repla...

Page 54: ... waste container Software 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 7 5 2 Neutralization of Waste Waste contains human origin substances representing biohazard These substances are representing potential danger to environment For this reason s...

Page 55: ...s setting up parameters of report printing Settings Press BACK to go back to MAIN menu Settings Printer settings Settings Printer settings Device 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 ...

Page 56: ...re firmware version appear in the printout Diagnostic flags If Enabled the diagnostic flags appear on the report as well except table format Settings Printer Device Mode Fast modes save ink and provide faster printout Only normal color and fast color printouts will give color printouts SETTINGS Printer settings Printout Set top and left margin of the page using external printer in centimeters Sett...

Page 57: ...uidance of usage Language Selects the language of the analyzer Export format The following settings are available See Appendix A for details Simple text Extended text Advanced text 8 3 Measurement settings This section groups measurement related options and settings Settings Printer settings Header The data entered will be printed on the top of each printed report Press Accept to approve changes m...

Page 58: ...S RDW PDW mode standard deviation SD coefficient of variation CV 8 3 2 Normal ranges Limits define normal ranges Outside this range parameters will be flagged or Settings 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 MI...

Page 59: ...omatically 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 Measurement Settings Calibration Mode allows choosing between HCT PCT or MCV MPV based calibration Accept saves changes made Cancel returns to previous menu discarding changes made 8 ...

Page 60: ...eration 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 however the user should not notice this functionality Settings Date and time Set date and time Type in the date and time Select formats for displaying the date Press Accept to s...

Page 61: ... screen Use Remove User option to disable its access NOTE User Admin cannot be deleted Admin password cannot be changed Admin password 0000 User Type BASIC has limited access to the menu tree Measure New Options Re run Blank Print Discard Database Detail Table view Edit record Print Filter Trends Manage Maintenance Cleaning Cleaning Hard cleaning Drain chamber Calibration Factors Measure History E...

Page 62: ... 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 startup Login screen with Auto Login Off Use Shutdown to stop the analyzer power off Preparing for shipment will drain the unit so that it can be transported Log In brings up the login screen below Lo...

Page 63: ...e 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 Diagnostic flags optional Thermal p...

Page 64: ...Error Use the Home tab to apply Címsor 1 to the text that you want to appear here 61 QC graphical printout on built in printer QC graphical printout on external printer ...

Page 65: ...he mechanical parts easily 10 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 Figure 12 Parts of measuring block 1 Exit Measur...

Page 66: ...bc V1 Cleaner V9 DilAperture V7 DrainAperture V6 DrainChamber V2 DilWash RBC WBC V10 DrainPuffer M1 Stepper Motor 2 way Valve Closed Off Open On 1 2 3 3 way Valve 1 3 Off 2 3 On 1 2 3 1 2 3 1 2 3 Lyse Pump Dil Ver 1 2 3 Puffer Reservoir Pressure Meter 1 2 3 V8 Bubble M3 1 2 3 Macro Micro dilutor DILUENT 1 2 3 V3 DilChamber M1 Sample H motor 1 2 1 2 1 2 1 2 ...

Page 67: ...n the units according to the current settings B Extended text SAMPLEID HT DATE HT TIME HT WBC HT RBC HT HGB HT HCT HT MCV HT MCH HT MCHC HT PLT HT PCT HT MPV HT PDWc HT RDWc HT LYM HT MON HT GRA HT LYM HT MON HT GRA HT Type HT WARNING HT RBC probe min HT RBC probe max HT WBC probe min HT WBC probe max HT Lyse C Advanced text SAMPLEID HT DATE HT TIME HT WBC HT RBC HT HGB HT HCT HT MCV HT MCH HT MCH...

Page 68: ...Error Use the Home tab to apply Címsor 1 to the text that you want to appear here 65 The marker value is a number between 0 255 gives the index of the related value in the WBC RBC histogram data set ...

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