Diatron Abacus junior 30 User Manual
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Diatron Abacus junior 30 User Manual

Hematology analyzer
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Revision history
Rev.
Date
Edited by
1.0
2009-06-02
Arpad Gyetvai
1.1
2010-03-25
Gabor Farkas
1.11
2011-05-06
Csaba Magyar
Issued
Checked and approved
OM-ACS30-01-1110
Sections affected
Initial revision
First review, new GUI screenshots
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
Date
Name
06-MAY-2011
Csaba Magyar
Gábor Farkas
17-MAY-2011
Approved by
Csaba Magyar
Csaba Magyar
Gábor Farkas
Signature

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Summary of Contents for Diatron Abacus junior 30

  • Page 1 OM-ACS30-01-1110 Revision history Rev. Date Edited by Sections affected Approved by 2009-06-02 Arpad Gyetvai Initial revision Csaba Magyar 2010-03-25 Gabor Farkas First review, new GUI screenshots Csaba Magyar Gábor Farkas 1.11 2011-05-06 Csaba Magyar Epson dot-matrix printer support (specifications) no 3diff below WBC = 1.00 6.1 (end) PLT histograms added to result screens 7.4.2.
  • Page 2 Hematology Analyzer User‟s Manual Rev 1.11...

  • Page 4: Table Of Contents

    TABLE OF CONTENTS Table of Contents INTRODUCTION ....................4 1.1. Intended Use ....................... 4 1.2. The Instrument ......................4 1.2.1. Patient Testing ....................5 1.2.2. Reagents ......................6 1.2.3. Technical Operation ................... 6 1.2.4. Calibration ......................6 1.3. Instrument features ..................... 7 1.4.
  • Page 5 TABLE OF CONTENTS OPERATING PRINCIPLES ................25 4.1. Impedance Method ....................25 4.2. Principle of HGB Measurement ................25 4.3. Parameters ........................ 26 4.4. Absolute and Linearity Ranges of Parameters ............27 ROUTINE UTILIZATION and MEASUREMENT ..........28 5.1. Sample handling ....................... 28 5.2.
  • Page 6 TABLE OF CONTENTS 8.3. Measurement settings ....................54 8.3.1. Unit settings ...................... 55 8.3.2. Normal ranges ....................55 8.3.3. Settings ......................56 8.4. Date and Time ......................56 8.5. Multi user mode ......................57 PRINTING ......................60 9.1. Printouts ........................60 10.

  • Page 7: Introduction

    INTRODUCTION 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 0 and are a fully automated, bench-top hematology cell counters. The difference between 0 and is that the ND...

  • Page 8: Patient Testing

    INTRODUCTION 1.2.1. Patient Testing The analyzer can process 30 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.

  • Page 9: Reagents

    INTRODUCTION 1.2.2. Reagents Use only reagents supplied by the manufacturer with the analyzer, otherwise accuracy cannot be guaranteed. Diatro Dil-DIFF Isotonic saline solution, used to dilute whole blood samples and to rinse the fluidic system between measuring procedures. Diatro Lyse-DIFF Creates hemolysate for 3-part WBC differential and for total WBC and HGB.

  • Page 10: Instrument Features

    INTRODUCTION 1.3. Instrument features Figures 1 and 2 show front and rear view of the analyzer, with controls and connectors. Color LCD touchscreen Built-in thermal printer Sample holder with interchangeable adapters START button with status indicator Front panel USB socket Figure 1.
  • Page 11 INTRODUCTION Built-in Power switch thermal printer USB A connectors USB B connector Instrument label Power source (S/N, manuf.data) connector External grounding connector Reagent connectors Figure 2. Rear view...
  • Page 12 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 of the printer, and hold the “starting edge”...

  • Page 13: Parts Of The Analyzer

    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.

  • Page 14: Control Panels

    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) is located above START button. Its actual color indicates the status of the analyzer. LED color Analyzer status The analyzer is ready to measure sample.

  • Page 15: Control Material

    INTRODUCTION 1.6. Control Material The analyzer allows continuous monitoring of measurement performance with DiatroCont3 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.

  • Page 16: Specifications

    INTRODUCTION 1.8. Specifications 25 μl of whole blood in normal 3-part or non-diff mode Sample volume 50 μl of whole blood in pre-diluted mode Chambers 1 unified chamber for diluting whole blood and counting Reagent system Isotonic Diluent, Lyse, Cleaner 70 μm (RBC/PLT, WBC) Aperture diameter Throughput...

  • Page 17: Installation

    INSTALLATION INSTALLATION 2.1. General information This chapter provides instructions for the installation of 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.

  • Page 18: Space Requirements

    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.

  • Page 19: Maintenance

    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 material.
  • Page 20 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.

  • Page 21: Turning The Instrument On, Main Menu

    INSTALLATION 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. Figure 5.

  • Page 22: Turning The Instrument Off

    INSTALLATION 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.

  • Page 23: Preparing For Shipment

    INSTALLATION 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).

  • Page 24: Warning Labels On The Analyzer

    INSTALLATION 2.3.5. Warning labels on the analyzer Label Meaning Explanation Sample and waste are Biohazard potentially infectious material Reagents may cause Corrosive corrosion or skin irritation. Warning General warning of injury. Sharp Sampling needle may needle cause injury. warning...

  • Page 25: Menu System

    MENU SYSTEM 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.

  • Page 26: Menu Structure

    MENU SYSTEM 3.1.3. Menu structure Measure 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 Quality control References Measure Diagram Database Diagnostics Device information Self test Reagent status Volumes...
  • Page 27 MENU SYSTEM 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: Operating Principles

    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.

  • Page 29: Parameters

    OPERATING PRINCIPLES 4.3. Parameters 0 measures and calculates 18 parameters, while 12 parameters only. Differences: LYM, MON, GRA, LYM%, MON%, and GRA%. 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 –...

  • Page 30: Absolute And Linearity Ranges Of Parameters

    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. 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.

  • Page 31: Routine Utilization And Measurement

    ROUTINE UTILIZATION & MEASUREMENT 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.
  • Page 32 ROUTINE UTILIZATION & MEASUREMENT 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 There must be at least 8 mm...
  • Page 33 ROUTINE UTILIZATION & 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.

  • Page 34: Sample Analysis

    ROUTINE UTILIZATION & MEASUREMENT 5.2. Sample analysis 5.2.1. Sample preparation Use K-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.
  • Page 35 WBC populations is poorly differentiated, 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. Only in Abacus Junior 30...
  • Page 36 ROUTINE UTILIZATION & MEASUREMENT MEASURE 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. AJ30 can however be adjusted for low volume samples.

  • Page 37: Results

    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 NEU values seem higher because of the clumps. Lyse Only in Abacus Junior 30...

  • Page 38: Parameter Limits (Normal Ranges)

    ROUTINE UTILIZATION & MEASUREMENT modification can‟t solve the problem. Typically insufficiently lysed RBC‟s interfere with the start of the WBC RBC-WBC limit warning histogram. Repeating the measurement with an increased lyse volume should provide better separation. If the repeated run reports very similar results then the MON and NEU results are VALID but the WBC and LYM results may be higher because of interfering RBCs.

  • Page 39: Blank Measurement

    ROUTINE UTILIZATION & MEASUREMENT 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% MID% GRA% You can modify normal range of parameters: left column is lower, right column is upper limit of normal range.

  • Page 40: Using Pre-Diluted Mode

    ROUTINE UTILIZATION & MEASUREMENT 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/µl). Perform an external pre-dilution of the sample using clean isotonic saline solution, or diluent reagent.

  • Page 41: Database

    DATABASE 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.

  • Page 42: Database Services

    DATABASE 6.1. Database services Detail will open up the parameter and histogram view of a record. 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...

  • Page 43: The Filter / Select Function

    DATABASE DATABASE Detail UP / DN Arrows Te database record view allows browsing in the database, and you can also look at 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.

  • Page 44: Printing Records

    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).
  • Page 45 DATABASE Export: will save selected record(s) to an external USB memory device in the format selected in Export settings (see 8.2). A progress bar shows the status of the process 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...

  • Page 46: Maintenance

    Error! Use the Home tab to apply Címsor 1 to the text that you want to appear here. MAINTENANCE In the Maintenance menu you can initiate procedures, for cleaning, calibration or specific performance analysis. Maintenance Touch menu item of the desired function. Home will return to the Main menu Back returns to the previous level.

  • Page 47: Calibration With Factors

    Error! Use the Home tab to apply Címsor 1 to the text that you want to appear here. 2. After replacing any component, related to the process of dilution or measurement. 3. When quality control measurements show any systematic error (bias) or they are outside predefined limits.

  • Page 48: Calibration By Measurement

    Error! Use the Home tab to apply Címsor 1 to the text that you want to appear here. 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. Maintenance Calibration / Measurement Prior...
  • Page 49 Error! Use the Home tab to apply Címsor 1 to the text that you want to appear here. The display shows Calibration measurement at top. Maintenance Calibration / Measurement Insert the sample tube to the sample door and press the START button. Exit will abort the operation.

  • Page 50: Quality Control

    Error! Use the Home tab to apply Címsor 1 to the text that you want to appear here. 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 can also use multiple control material lots.

  • Page 51: Measure

    Error! Use the Home tab to apply Címsor 1 to the text that you want to appear here. Maintenance Quality control / Reference Use Prev and Next to browse among parameters. Press Accept to save data. Press Cancel to discard changes and return to the previous menu.

  • Page 52: Database

    Error! Use the Home tab to apply Címsor 1 to the text that you want to appear here. 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.

  • Page 53: Self Test

    Error! Use the Home tab to apply Címsor 1 to the text that you want to appear here. 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: At installation.

  • Page 54: How To Empty Waste Container

    Error! Use the Home tab to apply Címsor 1 to the text that you want to appear here. If Waste is high, it should be disposed of properly (see next section for instructions). MAINTENANCE REAGENT STATUS Volume Set the volume of the containers used (Values in ml).

  • Page 55: Settings

    Error! Use the Home tab to apply Címsor 1 to the text that you want to appear here. SETTINGS Selecting Settings accesses various lists of options Settings Press BACK to go back to MAIN menu. 8.1. Printer settings Printer settings menu allows setting up parameters of report printing. Settings Printer settings Settings...
  • Page 56 Error! Use the Home tab to apply Címsor 1 to the text that you want to appear here. 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...

  • Page 57: General Settings

    Error! Use the Home tab to apply Címsor 1 to the text that you want to appear here. 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.

  • Page 58: Unit Settings

    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 LYM% MID% GRA% Only in Abacus Junior 30...

  • Page 59: Settings

    Error! Use the Home tab to apply Címsor 1 to the text that you want to appear here. 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.

  • Page 60: Multi User Mode

    Error! Use the Home tab to apply Címsor 1 to the text that you want to appear here. Settings Date and time Choose the desired time and date format. Settings Date and time/ Set date and time Type in the date and time. Select formats for displaying the date.
  • Page 61 Error! Use the Home tab to apply Címsor 1 to the text that you want to appear here. Exit User Management Auto Login Set will allow login-free starting of the analyzer. Users can be added (Add New User) or edited (Edit / View User). Adding a user allows filling in the below parameters.
  • Page 62 Error! Use the Home tab to apply Címsor 1 to the text that you want to appear here. Quality control (forbidden) Diagnostics Device information Self test Service Reagent status (Settings forbidden) Exit Logout Add new user Shut down Remove User Preparing for shipment Auto login set User Management...

  • Page 63: Printing

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

  • Page 65: Troubleshooting

    Error! Use the Home tab to apply Címsor 1 to the text that you want to appear here. 10. TROUBLESHOOTING 10.1. Regular Troubleshooting Procedures From Maintenance submenu, user can initiate maintenance procedures such, cleaning, priming, or draining chamber. 10.2. Weekly User Maintenance Perform weekly maintenance before turning on the power switch.

  • Page 66: Fluidic Schematics

    Error! Use the Home tab to apply Címsor 1 to the text that you want to appear here. 11. FLUIDIC SCHEMATICS V2 DilWash V4 DilNeedle V3 DilChamber DILUENT V5 LyseWbc Pressure V1 Cleaner Meter V9 DilAperture CLEANER Puffer Reservoir Lyse Macro V8 Bubble Micro dilutor...
  • Page 67 Error! Use the Home tab to apply Címsor 1 to the text that you want to appear here. 12. Appendix A To save in text format (tab separated values) use the Export function in Database menu. To process the results in Microsoft Excel import the text files into Excel worksheets. Note: The text format files do not contain all the information available in binary format files.
  • Page 68 Error! Use the Home tab to apply Címsor 1 to the text that you want to appear here. 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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