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1. 1 6 Cleaning tube kit 1 9 1 15 Specifications Sample volume Chambers Reagent system Aperture diameter Throughput Characteristics Sampling method Sample types Clog prevention Cleaning procedure Quality control Calibration Multi user feature advanced feature User interface Languages available Data capacity Host computer interface Data back up method Software upgrade method Printer interface Built in printer Display Keypad External keyboard Power requirement Power supply unit Operating temperature Dimensions W x D x H Net weight INTRODUCTION 25 ul of whole blood 50 ul of whole blood in pre diluted mode 3 chambers for diluting whole blood and counting 1 MIX 1 RBC 1 WBC Isotonic Diluent Lyse Cleaner 80 um RBC PLT 100 um WBC 60 tests hour Reproducibility Carry over sample error CV to sample Test range 4 0 20 0 4 0 15 0 25 0 50 0 5 90 9 16 200 900 Open tube system with automatic sample rotor Human general male female baby toddler and child built in reference ranges High voltage pulse on aperture in each analysis cycle chemical cleaning high pressure backflush of aperture with Cleaner reagent High voltage burst of the aperture high pressure back flush chemical cleaning of the aperture using Cleaner reagent 6 QC levels QC parameters include mean range SD and CV for all measured and calculated parameters 16 and 64 day Levey Je
2. The menu contains the following items 6 1 DATABASE comment e Go to specified record Change sort order Manage selected records Backup to USB drive Jumps to a particular sample record Enter the date and time sample ID and patient ID of the sample you want to view and press v The first sample meeting your parameters is then displayed If you leave any ID blank 0 records are searched by date time only Selects all sample records in memory or all having a specific date time and ID Select by date time and ID allows you to select a range of specific records and Deselects all deselects all records Entering O as an ID searces by date time only Corresponding results are marked with a filled box Changes the order in which results are displayed by time sample ID or patient ID Sends selected records to a PC deletes them or saves them to a diskette or USB device Before selecting Backup selected records insert a 3 5 inch diskette or connect a USB storage device An empty floppy diskette can store data for 800 samples Backs up all records from a specified day to USB storage device Select a day to backup then press RA confirm UTILITIES 7 1 7 UTILITIES 7 1 Maintenance By selecting item 1 of the UTILITIES you can access the MAINTENANCE menu 1 Maintenance 2 Calibration gt 3 Quality control j 4 Diagnostics i 5 Settings gt 6 Service 7 1 1 Regular Maintenan
3. Hemolyzer 3 A analyticon Usermanual 1 1 Release Hemolyzer 3 z Analyticon Biotechnologies AG Am Muehlenberg 10 35104 Lichtenfels Germany info analyticon diagnostics com www analyticon diagnostics com CONTENTS 1 1 1 Release INTRODUCTION u ae 1 1 1 1 PETS U E ee ee ee cite soon aguaneapcecswaecassiowasesaccocesaten tee desiite 1 1 1 2 TAS ee nee ea ee 1 1 1 3 Patient Te UNE nee ee een 1 2 1 4 Role a gL eee ee FREE ene eer ee ee eee eee E ee er ree ee rete ere err er errr rer ete 1 2 1 5 TECHNIC A OnE IE ION ee ee ee ee 1 3 1 6 Calibration and Quality CONtrOl cccccccsssscccesececeseccceneceeesseeceeececeeceseueceeeescesseecessneceneness 1 3 1 7 INSERENT SSS een a een 1 3 1 8 Parts or NE ANA CU ee area ne ne N 1 5 1 9 Funcion ofthe EIUIdIE ae nennen kmirseuslsehhe 1 5 1 10 Control Panels ee eccccsssssssecccceeseeeccssessseeceesseaseecccssasseceecesseussceesseuussceesessuaseseeesagaeeseesaas 1 6 LEE DEP a ea re E 1 6 1 12 KEY OB an een 1 6 1212 ONTON riet Er aan re Eee une E 1 8 1 14 ACCESS OE E 1 8 1 15 Pe ICAO ee ee een u ee en ee 1 9 INSTALLA HON een eine een 2 1 2 1 General information ENA N 2 1 2 2 EV COMIC Call HACC Ol ee een ehe re eieskeiinelnenn 2 1 2 3 eC are ree ae ee ee 2 1 2 4 Space requirements u a near 2 1 2 5 PEPIN Seen ee ee een 2 2 2 6 Reagents and waste handling ccsccccsseccccssccceescccesececsneceeeesceeeeececeecessuseeseesceseeecensuesenes 2 2
4. 2 7 PVT eH VES ANNO Seen E E 2 3 2 7 CEST ee ee ee eo 2 3 2 7 2 GOT FeO OUIIES aeee E sen E 2 3 2 8 Unpacking and Installation ss nee een 2 3 2 8 1 Keyboard and external printer ccccccssccccssscccesececeseceeeseceeeeeceseneceeeeeeeeseeesaneceseneeees 2 4 2 8 2 Os COCO ee ee 2 4 2 8 3 POWER UDD ee ee en 2 4 2 8 4 FCN CO fia UNS ea ee ee en nrieeeneinlsen 2 4 2 9 Turning the Instrument ON u 2 5 2 10 Turning the Instrument OFF ses 2 6 2 11 PREM GING TOPSITE nen een 2 6 CONTENTS 2 12 TERENS Man GUNG ee ee ee 2 7 3 MENU SYSTEM oeni ee ea 3 1 3 1 General OMIA O ee A E A E A E E 3 1 3 2 Navigating imn the Menu Syste M ee 3 1 3 3 VENA UCTU ioe iro E S E E E E 3 3 4 OPERATING PRINCIPLES u nalen 4 1 4 1 PMS CIC E MeO ee ee 4 1 4 2 Principle Of HGB Messuremeht u ue ssen en 4 1 4 3 PALameLers san ee are E 4 2 4 4 Absolute and Linearity Ranges of Measured ParaMetesS ccccccsssecceecesscceeeeseceeeeeeceeseeees 4 3 5 ROUTINE UTILIZATION and MEASUREMENT sccssccssccssccsscnscccsssccssscesscessonscesccessosssseees 5 1 5 1 eT VOUS seca ee ee ee ne ee 5 1 5 2 SAN DIE VS IS ee 5 3 52 Samoe preparati ON ee ee sea ee ee 5 3 5 2 2 Moditvine se Guanti y ne een 5 3 5 2 3 Sample informatori ni een 5 4 5 3 RES US ee ea ee 5 5 5 4 VIEASUTE MEN lee ee ee er 5 7 5 4 1 Measure local MenU ssesssssessssssseresssssrrssssseressssrrrressssrresssserressserereessseeressseereesseereeeese 5 7 6 DATABASE e
5. 0 8 ml Measurement times e WBC count 2 6 seconds depends on the total WBC count e HGB measurement 2 seconds e RBC PLT count 5 seconds 1 10 Control Panels START button Pressing and releasing the START button triggers an analysis cycle Status indicator A two color red blue LED is located near the START button Its actual color indicates the status of the analyzer LED color Analyzer status The analyzer is ready to work Analysis can be initiated Red blinking Blood sample can be removed when the LED blinks red 3 times and the a instrument beeps 3 times The analyzer is currently performing an analysis No new measurement can be started The analyzer is performing a maintenance process Orange blinking The instrument is in stand by and display light is off 1 11 Display The display is 320 x 240 dots high contrast backlit color graphic LCD module 1 12 Keyboard The foil keypad is composed of the following shown in Section 1 3 Figure 1 e Numeric keys for entering numerical data and selecting menu items e Function keys with specific functions These functions are menu dependent and are indicated by icons appearing above the keys e Hardware function keys short cut keys for easier navigation between menus e Cursor control keys T and 4 for moving between database items lt and gt for moving between parameter columns or menu levels e START key for initiating an analysis cycle e OK key for confirming
6. 00 32 00 Jpg 5 2 3 Sample information The software allows the user to enter information for each sample that has been or will be measured If an external PC keyboard PS2 is used it must be connected to the instrument before turning the instrument on Two options exist for sample information entry e immediately before analysis e inthe Database menu To enter sample information prior to sample analysis press the Measurement Analysis key and i button on the screen The following screen appears Edit sample info 6 Use the keypad OK key and the A and W keys to Date 03 move through the settings Sample ID Patient ID 12MN554 Patient type Human Patient name nn Fisch Birthdate 00 00 0000 SEX Doctor the keypad or external keyboard to enter text or Use the and gt keys to change the settings and numbers Press the to accept data cancel with Be button Begin analysis by pressing the Start button WARNING Do not reach inside the instrument as the needle can cause injury 5 5 ROUTINE UTILIZATION 5 3 Results When analysis is complete the following screen show all measured and calculated parameters as well as the WBC RBC and PLT histograms Results histograms and other terms will be stored automatically in the memory Human 2 11 11 2008 Use and keys on the screen to move through the results and histograms The following table summarizes warning flags and explains possible causes and s
7. Number of leukocytes cells l cells ul WBC WBC x cells l cells ul Red Blood Cells RBC Number of erythrocytes cells l cells ul RBC RBC x 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 HGBin asiired a HG Botank Mean Corpuscular Volume MCV Average volume of individual erythrocytes derived from the RBC fl 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 Corpuscular Hemoglobin MCH Average hemoglobin content of erythrocytes calculated from RBC pg fmol and HGB values MCH HGB RBC Mean Corpuscular Hemoglobin Concentration Calculated from the HGB and HCT values MCHC MCHC HGB HCT spsolute Unit of measurement is displayed according to the one chosen for g dl g l mmol l HGB result g dl g l or mmol l Red Cell Distribution Width RDW SD fl The distribution width of the erythrocyte or platelet population Platelet Distribution Width PDW SD fl derived from the histogram at 20 of peak n 100 FBC Red cell Distribution Width RDW CV absolute Platelet Distribution Width PDW CV absolute Po xDW SD RDW x P2 P1 fl xDW CV RDW X 0 56 x P2 P1 P2 P1 by the factor of 0 56 CV is corrected to the 60 cut cel
8. 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 When finished the analyzer prompts you to power off the system Remove the waste connector after shutting down 2 12 Emergency handling In case of emergency situation like instrument catching on fire short circuit etc cut off power immediately and use a fire extinguisher if necessary MENU SYSTEM 3 1 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 2 Navigating in the Menu System The instrument uses a menu system to initiate actions and to access settings There are four possible ways to navigate between menus and menu items There are 6 function keys above the LCD screen You can use these buttons to navigate between main functions of the instrument 2460 O GO These keys are short cut keys by pressing any of them you can directly access main functions whichever submenu you are in If you use an external keyboard you can access these functions with keys F8 through F12 indicated in Menu Structure as well Measurelocalmenu 0O By pressing the short cut
9. data e Del key for deleting characters e Help key for HELP function 1 7 INTRODUCTION Function keys Below is a list of icons and functions assigned to the soft keys function keys Ea Display histograms of the highlighted patient ID or QC Lot No Enter modify sample patient data patient type selection PAGE UP PAGE DOWN key in a multi page menu 16 64 Show data in table format Below we list the icons and functions assigned to so called hardware function buttons Function key Action triggered Measuring process at once Utilities menu Printing function 1 8 INTRODUCTION 1 13 Control Material Hemolyzer 3 allows continuous monitoring with HemolyzerCont3 control control blood Specification for this material assay values and allowed tolerances along with expiry date is always enclosed with the approved control material 1 14 Accessories Below is a list of accessories shipped with your Hemolyzer 3 Hemolyzer 3 Hematology Analyzer Hemolyzer 3 User s Manual this booklet Hemolyzer 3 Reagent Tubes with colored connector caps Diluent tube green Lyse tube yellow Clean tube blue Waste tube red Hemolyzer 3 Cleaning Tube Kit Hemolyzer 3 Caps for reagent containers matching connector colors Hemolyzer 3 Waste Container 20 L Hemolyzer 3 External power supply and power cable Hemolyzer 3 Spare part pump tube Hemolyzer 3 Tube adapters Hemolyzer 3 Thermal roll paper 1 5 Reagent tubing
10. keys you can activate ne main functions Information Measure Database Repeat last sample 2 O Prediluted mode Utilities Printing Exit of the instrument Below saa atic the short cut keys in the upper part of the screen Needle position Defaut To you will find tabs showing which main function is active or which are accessible directly a You can select a menu item move highlight with the and V keys and press the OK key to enter or activate the highlighted item Within a submenu you can press the Ra unction key to return to the previous menu level This method is suggested while learning instrument operation 3 1 3 2 MENU SYSTEM b Pressing the numeric key corresponding to the menu item allows selection and access of an item without the need to additionally press the OK key This method is more efficient after the user knows the menu structure If a menu item opens a submenu then the item has a symbol on the right of the menu line Some results are displayed in table format The following keys may be used to browse the database 3 T page up 9 page down iT jump to top of list 74 jump to bottom of list Several menus have items with boxes in front of the text These indicate two state options The selected active state is indicated with a filled box the deselected inactive state is indicated with an empty box Pressing OK toggles its state Other items have circles in front of the text These are
11. radio buttons divided into groups separated by horizontal lines The function of these groups is that only one item of the group can be selected and this is indicated with a filled circle in front of the selected item Selecting an item of the group will move the filled circle in front of this item emptying the circle of the old selected item 3 3 MENU SYSTEM 3 3 Menu structure The following outlines Hemolyzer 3 menu functions Information Help Displays help for the current screen 2 Analysis Measurement eS Measurement local menu 1 Repeat last sample Repeats last sample tested Previously filled in sample parameters sample ID Patient ID etc will be used for the consecutive sample Repeat mode appears in lowe left section of the screen 2 Prediluted mode Activates automatic calculations for 1 5 externally diluted sample 1 5 appears in lower left section of the screen 3 Measure Blank Performs a Blank measurement Needle height setting Adjust sampling depth for the next sample how deep the needle should go into the sampling tube Patient information screen The following fields are displayed Date Actual timestamp of sample always synchronized with system time Sample ID Numeric field to enter specific ID Instrument assigns it automatically If it is changed it will be used as a basis for samples and it will be automatically incremented for each consecutive sample Patie
12. sex doctor 1 Allows selecting records by specific parameters Timestamp or various ID s can be used for filtering and selection Also all records can be selected or deselected 2 Change sort order 1 Records are shown according to a so called sorting order This defines whether the latest time record should be displayed as the last record or Patient ID or Sample ID should be used for defining the order Unsorted lists records in their unsorted sequence It is used for servicing functions Diagnostics 1 Selected records can be Saved Deleted or Transmitted to a connected computer Settings Service 3 5 Prints selected test results Exit 1 Shutdown 2 Preparing for shipment 3 Logout only in multi user mode MENU SYSTEM Shuts off use if the unit will not be used for over 72 hours Drains and shuts off use if the unit will be unused for more than 2 weeks or if it will be shipped Logs out current user Pneumatic system remains active Do not use this item to turn the analyzer off OPERATING PRINCIPLES 4 1 4 OPERATING PRINCIPLES 4 1 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 Blood cell suspension External electrode 4 1 Impedance method Each cell pa
13. should happen on a regular basis as also explained in a later chapter 8 4 1 7 Instrument features 1 1 Front view Graphical LCD HARD Shortcut keys g Cursor keys A i z Vent holes x Power adapter Numerical connector keypad USB ports for printer Instrument keyboard Reagent connectors PS2 port keyboard 1 2 Rear view Figure 1 3 shows the open built in printer using roll paper inside Press the protruding button to open the lid Let the thermal printer paper fall into the housing with its open end toward the paper tearing towards the front of the instrument Hold the open end of the paper and close the lid so that the end of the paper gets clipped between the black paper guide and the printer mechanics You can select to use this printer in the Printer Settings menu see chapter 8 6 2 1 3 Built in printer INTRODUCTION Printer lid with rubber roller Thermal paper Printer mechanics Lid opener button 1 5 INTRODUCTION The analyzer works with an external power supply Figure 1 4 shows the power supply unit generating 12VDC The power supply module has a so called auto range input allowing operation on 230V or 115V power system The power supply complies CE and UL safety certifications The input socket is a standard power cable connection shipped with the analyzer the output is a special lockable socket as shown in the picture Only the provi
14. the sampling height adjusting this option This can also help if sample level is to 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 8 times to achieve a homogenous sample Do not shake the sample because micro bubbles can form inside which may cause erroneous sampling You have the possibility to use 3 different interchangeable adapters for different tube types Tube types are shown in the next figures 5 1 5 2 ROUTINE UTILIZATION n 7 ag 5 2 Sample tube with 5 ml control blood 5 1 Vacutainer with sample blood cap removed Please wipe the mouth of the tube because the bursting bubble can dirty the instrument with blood which can cause measurement error at next sample Below you can see 3 types of tubes microtainers used in micro adapters 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 shown above otherwise the cap can get stuck when the sample holder turns 5 3 ROUTINE UTILIZATION 2 ml control blood 1 Remove the cap It is very important because the tip will not pierce the cap 2 Position the sample tube in the sample rotor 3 Push START key The sample rotor will turn into the inside of the instrument and the needle draws sample from the tube The aspira
15. AINTENANCE Select calibration mode press button and the Set calibrator screen appears If automatic 1 or 3 measurement calibration is selected upon starting the calibration you will have to enter assay values for each parameter from the calibrator package insert 8 6 MAINTENANCE Target values for calibrated parameters can be set within the following ranges Parameter lowlimit High limit RBC 8 00 0 6 120 50 PLT 800 EEE O0 5 30 1 0 2 15 Table 7 Calibration ranges When all parameters are set press the soft key The display shows Calib 1 3 at top left Calib 1 3 Start analysis of the control material When the analysis is finished the display will show results If no abnormal values or flags show press You have to accept Confirm calibration measurement results If you fail to accept Confirm the result the actual sample cannot be used for calibration and you have to run the sample again Upon finishing the last sample Hemolyzer 3 calculates and displays the new calibration factors 8 4 Quality Control Procedure By analyzing control materials day to day reproducibility can be monitored In this submenu both target values and acceptable ranges for each parameter can be specified for different QC levels NOTE Target values of the control material should be set only once at the beginning of the QC measurements Resetting parameters deletes previous QC results of the act
16. C Confirm password CG User level Supervisor op Auto login Yes te KAES 8 13 MAINTENANCE 8 6 6 Date and time The 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 Press the Utilities key and then select Settings Select Date and time Date Time Date format _Day Month Year 0 Type in the date and time then press MEA Time mode 34h mode TS Select formats for displaying the date item 1 2 or 3 and time item 4 or 5 then press to accept the settings 9 1 PRINTING 9 Printing This chapter covers information on making reports on measured samples 9 1 Printouts When required the following items can be sent to an external printer or to a built in printer by pressing the SS function key button i Database result s table format e Database specified patient results with histograms e QC result Levey Jennings chart e QC result s table format e Calibration results e Last measured blan k result e Last measured patient result with histograms e Last measured QC result e Device information and statistics e Self test result e Set parameters The appropriate printout format can be selected in UTILITIES SETTINGS PRINTER SETTINGS Thermal paper printout Printout on external printer color ANALY TICON ANALYTICON HEMOLYZER 3 HEMOLYZER 3 A Samp 1a Patent IC Caan Type Human r Name Jhon Smith analytico
17. E as 8 8 MAINTENANCE 8 5 2 Self Test The Self test is a procedure to verify proper operation of essential components of the instrument The Self test should be performed TA At installation After replacing any component Date of testing 12 03 2009 Morde ABACUS 3 After extended time out of use Serial Mo 123456 version 0 1DEV 3 68 Press the Utilities key and select Diagnostics Compiled 17 11 2008 Overall result ERROR m Select Self test Hemolyzer 3 then lists and checks HGE dark 1 OK subsystems HGE light 6258 OK When the test is finished the Hemolyzer 3 displays a t2 summary of the results 8 6 Settings Selecting item five 5 Settings of the UTILITIES you can access to this menu 1 Maintenance 2 Calibration Printers fluid sensors date and time can be set and gt 3 Quality control P defined 4 Diagnostics a gt 5 Settings 6 Service 8 6 1 Printer settings 1 Settings Selecting item one 1 Printers from SETTINGS menu 2 Information brings up the Printers submenu Printer you can choose between built in printer or a USB connected external printer If the name of the USB printer appears in the list the printer is supported Selecting item two 2 Information from Printers you can print a test page to check correct settings Ere Margin unit this one can be inch or cm Margin unit Top margin Top margin is used for determining the distance an between the upper edge o
18. al link RS232 Archiving and restoring of records to and from USB flash memory device 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 1 2 INTRODUCTION 1 3 Patient Testing The analyzer can process 60 samples per hour 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 Hemolyzer 3 determines 20 hematology parameters including three part WBC differential The instrument requires 25ul of whole blood sample WBC total white blood cell count LYM lymphocytes count MON monocytes count NEU neutrophil granulocyte count LYM lymphocytes percentage MON monocytes percentage NEU neutrophil granulocyte percentage HGB hemoglobin RBC red blood cell count HCT hematocrit MCV mean corpuscular volume MICH mean corpuscular hemoglobin MCHC mean corpuscular hemoglobin concentration RDWcv red cell distribution width RDWsd red cell standard deviation PLT platelet count PCT platelet percentage MPV mean platelet volume PDWcv platelet distribution width PDWsd platelet standard deviation 1 4 Reagents Accuracy is guaranteed only if reagents supp
19. alculated by the instrument As measurements are performed the volumes are changing accordingly When reagent volume in a container is running low instrument will notify user and ask replacement f x Press the 58 soft key then press to confirm em Hemolyzer 3 updates the installation date reagent lifetime and the amount of reagent in each container 7 4 1 Empty waste container The software counts the waste container capacity and gives warning message when the tank is full Empty the waste tank when this warning message appears Service Personnel can modify the waste container capacity on Service level 8 1 MAINTENANCE 8 MAINTENANCE 8 1 User accessible parts On the left side of instrument there is a side door which allows reaching the fluidic system and the mechanical parts easily Figure 11 Figure 7 Fluidic and mechanical parts Reagent sensor Needle moving mechanics Amplifier assembly Chambers and apertures Valve block 1 5 Valve block 6 12 Puffer reservoir Micro dilutor O ON DMR WN bP Dilutor 10 Peristaltic pump 11 Reagent inlets 8 2 MAINTENANCE 8 2 Maintenance schedule WARNING User is allowed to repair only parts that can be found behind the side door User must not remove any covers of analyzer User must not disassemble the power supply unit Daily before daily routine Check reagent condition go to reagent status screen check if the liquid amount in rea
20. and follow all instructions in this User s Manual before operating Hemolyzer 3 The Hemolyzer 3 hematology analyzer is a precision instrument Handle accordingly Dropping or other improper handling of the instrument will disturb calibrated mechanic and electronic components and or cause other damage Always handle the instrument with care 2 2 Environmental factors Operate Hemolyzer 3 within the ambient temperature range of 15 30 C and relative humidity of 65 20 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 lower than 10 C the instrument should sit for an hour at the correct room temperature before use Reagents should be stored at a temperature range of 15 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 not recommended Instrument 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 3 Electrical requirements Hemolyzer 3 comes with a power cord appropriate for your powe
21. ase of the C warning flag RBC PLT coincidence is too The same action as in case of warning flag M high Linearity error Warning flags are grouped according to measurement conditions and according to the problems relating to the blood sample Measurement conditions when the flags are related to clogging c C probably hemolysing problems E b B p and pressure problems Fatal pressure error In this case we suggest repeating the measurement Paa re Oy ae exclatnation mark duet nese E some doubt during the evaluation of that parameter The reason can be a high PLT blank PLT value will be marked a case of indefinite discriminator setting aot oo 47 81 129 _ 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 O for a range limit it will be not verified 5 ROUTINE UTILIZATION 5 4 Measurement 5 4 1 Measure local menu 5 4 1 1 Blank Measurement The system uses blank measurements to check cleanliness of the system and reagents Blank measurement must be performed e Once daily before sample analysis this is done automa
22. ce Jobs From Maintenance submenu the user can initiate maintenance procedures such as cleaning priming draining chamber reagent status MOREEEBNBEN 1 Cleaning p Select the required submenu 2 Priming 3 Drain chamber 4 Reagent status 5 Software upgrade 7 1 2 Cleaning Item 1 in the above menu brings up cleaning functions Item 1 starts a washing cycle using the system cleaner reagent This action is recommended if 1 Cleaning 2 Hard cleaning clogging problems are experienced C or Q error flag Item 2 initiates a process that uses a light solution of hypochlorite NaOCL and washes the entire system with it The instrument will ask for the cleaning solution in a sampling tube Aeecex 7 1 7 2 UTILITIES 7 2 Priming During the priming cycle the fluidic system is rinsed with a large amount of diluent It differs from the 1 Prime diluent 2 Prime lyse process in a start up procedure as in the latter case a a simple filling of the fluidics is performed If fluid 4 Prime all sensors are on the analyzer makes these procedures automatically otherwise the User must initiate them activating the appropriate item within this submenu 7 3 Draining chamber Draining of the chamber should be run before removal or replacement of parts related to the measuring chambers or apertures Service personnel task 7 4 Reagent status The screen shows reagent volumes in containers as c
23. ded power supply shall be used with the instrument Protek Electronics Corp Model ID PUP80 12 N8 1 4 Power supply 1 8 Parts of the Analyzer Hemolyzer 3 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 parameters generates and stores numerical results and histograms Control Panel Features an LCD display a 29 button keypad and USB ports and serial computer interfaces 1 9 Function of the Fluidics For the Schematics of the fluidics system see Section 9 Sample aspiration and dilution M Stages of the blood testing process ia 25 ul of anti coagulated K3 EDTA whole blood sample is aspirated through the sampling needle and mixed with 4 ml of diluent and stored in the mix chamber mix dilution 35 ul of primary dilution is aspirated and then added with 4 ml of diluent into the RBC chamber RBC dilution C The primary dilution remaining in the mixing chamber flows via the tubing into the WBC chamber where the necessary preset amount of lysing reagent is added WBC dilution Table 1 1 6 INTRODUCTION Dilution rates used within Hemolyzer 3 e Primary dilution 1 160 e RBCdilution 1 18 000 e WBC dilution 1 192 dependent on lyse amount default volume is
24. e starts analyticon When the software version is loaded the DATABASE is Sample ID Patient ID Date displayed without any pneumatic initialization default 01 03 2008 15 43 3 6 Be ones l setting Pneumatic movement is initiated only when E as necessary for the relating process 01 03 2008 16 11 01 03 2008 16 12 01 03 2008 16 12 01 03 2008 16 12 un he level in this case the instrument will start with 01 03 2008 16 13 J 01 03 2008 16 13 J en s Loe on pneumatic initialization giving the possibility to 25 03 2008 11 55 The default setting can be changed at Service Menu 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 the cycle automatically if the fluid sensors are on and additional liquid in the tubing system is required Run a priming cycle in case of installation extended time out of use replacement of any component related to the Fluidic System replacement of reagents with instrument turned on 2 6 INSTALLATION l 2 10 Turning the Instrument OFF O The instrument should never be switched off 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 different kinds of solutions one of which is the so called diluent T
25. ee een E E T E A E N een 6 1 7 UITIEIIES 222er 7 1 71 IMAINEEMANCE E ne erg 7 1 7 1 1 Regular Maintenance Jobs ccccccccsseccccsseccesseccaeceseececeesceseeeceseneceeeeceesenceseueceseneeees 7 1 7 1 2 6 2721 0 10 122 eee EEE EINE cc poet ae een ese ee ose eevee eee 7 1 7 2 PEN ee E T A E eier 7 2 7 3 PD eI COON ee een ee 7 2 7 4 FOGG GCS ee ee A O E A E 7 2 7 4 1 EMO Waste CONC QC een ee 7 2 8 MAINTENANCE cnc near 8 1 8 1 Uer acce SID IE DALE orii ee NOS ee ee 8 1 8 2 Maintenance schedule cccccsssssssccccceesseccccssesececccssusseccesseussececssseuaececssauueeseessaueaeeseesaas 8 2 8 2 1 Daily before daily Foltiner senss ee een ee ae 8 2 8 2 2 Daily after daily routine u u cuni dee 8 2 8 2 3 NV EV ee ee ee nee ee 8 2 8 2 4 SE AT ae ee ee ee 8 3 CONTENTS 83 Ca 0121 0 OT Re en ener O ee een E ee ee eee eee ee 8 4 8 4 Quality Control Procedure ceccccescccsssecccenececenccccescecauseceeeneceeeeessenceseueceeeecesecessuecessuness 8 6 8 5 DISS MOSE IC ee ea ine re sera eier ee A een 8 7 8 5 1 Beve O O ee een 8 7 8 5 2 SO TE ee RER a EEE ee ee 8 8 8 6 SOLID een er ee een 8 8 8 6 1 PCV CEL SEE een een een 8 8 8 6 2 LUSTOMIZE ee een 8 9 8 6 3 ES e use bance taceaueeesmanesaaesoeqqaecteuccseeteeeseosaectaseteesaneossateetene eens aeecereerceurs 8 11 8 6 4 Laboratory TORE ACO i een usec ende een 8 12 8 6 5 USER MID IE SELL INES ee ee 8 12 8 6 6 Date and time uessucssssesennnnnnnnennnnnnnnnnn
26. emove the salt build up Apertur Close the side door 8 3 MAINTENANCE 8 2 4 Semi annual Run self test as it is written in chapter 7 4 2 If the overall result is Errors print out the result and call service Pump maintenance The pump installed in the instrument is maintenance free The guaranteed lifetime of tube is one year However would you experience e leakage from the pump e vacuum error displayed during measurement e vacuum or drift values are out of range in self test you may replace the tube Tube replacement procedure Open the side door Open the pump lock by turning the plastic holders to release the pump housing plastics see figure below Snap out the pump tube yellow in color from the housing Pump housing plastics Pump tube Tube holder clip Pump lock Replace the tube into the housing plastics then guide in both ends into the lock Turn back the lock to secure the tube in place Check the connections for proper placement Close and lock the side door in After tube replacement the pump should look like the figure on the right 8 4 MAINTENANCE 8 3 Calibration The Hemolyzer 3 is pre programmed to monitor HemolyzerCont 3 control Performing QC determinations regularly verifies continued optimal performance It is recommended to do calibration in the following cases 1 At analyzer installation before beginning the analyses 2 After replacing any component rela
27. enance The user should check the following components weekly bottom of washing head for salt build up should be wiped off with a damp cloth tubing system by opening the side door and looking for any liquid leakage If you experience leakage contact authorized technician Caution The following parts must NOT be opened or serviced by the user power supply instrument housing and electronic boards 2 7 1 Cleaning Clean the instrument and its power supply on the outside only using a damp cloth with a soft detergent DO NOT let liquids get inside the units 2 7 2 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 8 Unpacking and installation Carefully remove Hemolyzer 3 from the shipping carton Inspect the instrument for any visible signs of damage incurred during shipping Would you find any damage file a claim with the carrier or your distributor 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
28. f the sheet and the printed Quality Normal Ja 1 O Enable color print report 2 O Enable auto print 3 Print parameter limits KAEA 8 9 MAINTENANCE Left margin is used for determining the distance between the left edge of the sheet and the printed report 1 Enable color print The printout can be color or monochrome 2 0 Enable auto print If enabled instrument prints results automatically at the end of analysis 3 H Print parameter limits Enable or disable parameter limit printing 4 Print warnings Select F to print warning flags that appeared in the result Print warnings 5 4 Print histograms Enable disable graph Pririt loga printing Print technical information El E Print histograms E mm 6 Print technical information Selecting probe voltages WBC RBC Lyse volume and software firmware version appear in the printout KAEA be printed on the printout 7 H Print logo Selecting E the Analyticon logo will Press the soft key to save the settings 8 6 2 Customize Use the Customize menu to set the language and date format used by the Hemolyzer 3 along with the screen saver delay and the date range used for printing combined results from the Hemolyzer 3 1 Maintenance 2 Calibration 3 Quality control Press the Utilities key Select Settings 4 Diagnostics 5 Settings 6 Service FYFVYY F 1 Printer settings 2 Customize I 3 Date and time Select C
29. gent containers is enough for the expected number of daily measurements Check the content of waste tank if the level is above 80 it is recommended to dispose as described in chapter 7 4 1 Check the existence of air bubbles at rear reagent liquid connectors and syringes except waste line In case of bubbles run prime reagent function at regarding reagent Check instrument performance run blank measurement if the result is acceptable accept and save result with __ _ otherwise run cleaning and repeat blank measurement Run QC samples according to the regulations of laboratory If there are no other rules run at least normal control and check if the results are in range Use the QC menu of instrument Daily after daily routine Run Cleaning process in Maintenance menu Weekly Hard cleaning pour 1ml of 2 Sodium Hypochlorite solution into a sampling tube run hard cleaning procedure It removes remainders of blood samples measured during the daily routine Clean washing head The washing head cleans the outer surface of the aspirating tip with saline diluent Any salt build up on the lower surface may cause malfunction during operation Use warm tap water and a soft cloth to clean this area You can see the washing head indicated in the following figure Exit the Measurement menu Open the side Wash head door after the needle has stopped moving Gently rub the lower surface of the washing Chamber head to r
30. his 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 lead to dust condensation or salt build up Therefore always follow the instructions below when switching the instrument off Press EXIT key O on the front panel The following screen is displayed Select Shut down A message appears Warning 1 Shutdown 5905 When prompted press RA io confirm 2 Preparing for shipment Hemolyzer 3 will display a message Warning 5906 3 Logout and give a tone indicating that it is safe to shut it off Turn off the instrument using the power switch on the rear panel The Off position is marked by O symbol Item three 3 is only available in multi user mode 2 11 Preparing for shipment The second item in the shut down menu should be used 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 EXIT Preparing for shipment 2 The user must remove tubing connectors so the system could be drained Leave the waste connector attached 2 INSTALLATION 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
31. ity that the analyzer could accidentally fall 2 5 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 PS2 connector or suitable USB adapter link to host computer via serial or 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 2 6 Reagents and waste handling Reagents should be handled according to national or international regulations 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 Handling and disposal must happen according to regulations regarding reagent systems 2 3 INSTALLATION WARNING Waste contains poisonous substances because of chemical content and human origin substances meaning biohazard These substances are representing potential danger to environment For this reason safe handling of the waste liquid is very important 2 7 Maint
32. ive level CAUTION Any change in the QC material setting deletes previous QC results It is strongly recommended to print results prior to changes 8 1 Maintenance 2 Calibration 3 Quality control 4 Diagnostics 4 settings 6 Service Quality control 1 Set reference 2 Measure 3 OC database 4 OC diagram 5 Set level Actual level 6 TrrTrrTr Viewing the Accepted QC Database Press the Utilities key then select Quality Control 1 Set reference 2 Measure 3 OC database 4 OC diagram 4 Set level Actual level 1 8 5 Diagnostics 8 5 1 Device Information MAINTENANCE In the Quality Control menu select Set QC reference ranges Set QC Reference values Enter the value ranges for each test parameter as indicated on the paperwork accompanying the QC lot number you are using e use the keypad to change displayed values e to disable QC of a parameter set it to 0 0 e use the PGDN and PGUP to view additional parameters Press to accept the data then press again to confirm Measurement mode is activated Prepare the calibrator sample Control and insert it into the sample holder Press the Start button to start calibration Press to accept the results and save them in the QC database Select QC database 1 Device information 2 Statistics 3 Self test Device information Model ABACUS 4 Serial No 123456 Version 0 61 NG 3 65 Compiled 21 03 2008
33. lect a unit Use the and gt arrow keys to select a setting for the units The table below lists available unit settings cells liter cells l cells ul cells ul grams liter g l grams deciliter g dl millimols liter mmol l PCT HCT unit absolute ABS RDW PDW mode standard deviation SD coefficient of variation CV Press the on screen key to save the settings 8 12 MAINTENANCE 8 6 4 Laboratory information Enter your clinic or laboratory information as follows to Laboratory be printed automatically on report headers You can also Mame of the laboratory Gr O Ol use this procedure to edit or change this information EEE Co Enter the name and address of your clinic or laboratory CO Press OK to move to the next line Press to accept the settings RAE 8 6 5 User mode settings If you want to require users to log in and enter passwords to use Hemolyzer 3 and to be able to track individual usage of the unit you can enable the Hemolyzer 3 s Multi user mode This will require each user to have a unique user ID and password Press the Utilities key Select Settings Select Customize Select User modes This is where multi user mode can be activated After activation users can be added disabled not deleted and modified Follow the on screen instructions to enable multi user Edit user profile mode to add or modify users or to change a user s User ID Hame pocong Password
34. lied by the manufacturer are used Hemolyzer Dil DIFF diluent Isotonic saline solution used to dilute whole blood samples and to rinse the fluidic system between measuring procedures Hemolyzer Lyse DIFF lyse Creates hemolysate for 3 part WBC differential and for total WBC and HGB Hemolyzer Cleaner cleaner For cleaning process of the fluidics 1 3 INTRODUCTION 1 5 Technical Operation As Hemolyzer 3 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 Apply the sample for analysis e Print results either one by one or in groups by selecting records from the database e Perform simple weekly maintenance as described later in this description 8 2 1 6 Calibration and Quality Control Hemolyzer 3 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 8 3 Use Quality Control procedures to check for proper calibration and performance of the analyzer Running these samples
35. ls I cells ul PLT PLT x cells l cells ul fl histogram Thrombocrit PCT Calculated from the PLT and MPV values PCT percentage PLT x MPV x 100 percentage absolute PCT absolute PLT x MPV White blood cell differential Absolute values counted in the channels determined by the three e LYM LY lymphocytes WBC discriminators e MON MON monocytes and some eosinophils e GRA GRA neutrophil eosinophil and basophil granulocytes Percentages calculated from the absolute WBC value 4 3 OPERATING PRINCIPLES 4 4 Absolute and Linearity Ranges of Measured Parameters The instrument is guaranteed to provide specified accuracy within its linearity range Beyond this linearity range the instrument is able to display results but may not guarantee accuracy characteristics If the 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 3 1 3 of this manual The linearity ranges of primary parameters in normal measuring mode RBC 0 15 10 cells liter 20 Co a __ 4 2 Linearity ranges of parameters The linearity ranges for 1 5 pre dilution mode 4 3 Linearity ranges of Pre dilution mode ROUTINE UTILIZATION 5 1 5 ROUTINE UTILIZATION and MEASUREMENT amp 5 1 Sample handling Si
36. med without accepted blank values Quality control measurement and calibration can be performed only if all blank values are in the first region receiving no flags or errors If analysis errors occur or the 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 5 4 1 2 Using Pre diluted Mode Perform an external pre dilution of the sample using Hemolyzer 3 reagent diluent or an isotonic saline solution Dilute the sample to 1 5 ratio 1 part sample to 5 part diluent Mix it well To perform the analysis amp 1 Press the Measurement Analysis key 5 9 ROUTINE UTILIZATION WEC EOS REC PLT then press the soft key Measure local menu 1 O Repeat last sample 2 EI Prediluted mode 3 Measure blank Select Prediluted Mode Needle position Default Ic Predil mode appears on the left side of the REC PLT measure screen now Edit sample info ane eeu If you are processing a new sample Press the Sample ID as gt Patient ID Co soft key and enter the patient information Patient type 4 Patient name then press Bl Birthdate Sex Doctor Co RAE 5 10 ROUTINE UTILIZATION If you are processing a sample that has already been tested as non prediluted select Repeat Last Sample 1 Repeat last sample 2 O Prediluted mode 3 Measure blank
37. n Briniste 31 12 1083 Ser Male Sampie ID 13 Name Jhon Serth Pa ai DALAS TERT Patiert ID DIADTS Buthdate 31 12 1965 Teste 11 042008 1 35 Type Humen Sex Male Senai Me 20081 all Seen shenee Fest oa Test date 11 04 2008 1436 Serial No 200801 Waec See eher Report date 24 04 2008 12 25 Lu 0 238 10a m MON Tee Fr wec 6 86 10 04 Sa NEU 8a So LYM 238 10 04 a ued pr Er MON 047 10 04 h Tr HEUS 471 SE NEU 276 10 777 raum 407 Sra MONN 1 Sr 7 Ea NEU 471 xr RBC 447 10 12A SS Han 148 of a on ae WET as gt MOV 638 gt MCH 332 ps ar PLT MCHC 357 of ero ROW 24 PT en gt gt PCT 015 28 a MV 10 1 4 er min 329 max 332 RBC min 308 max S1t 10 1 FLUIDICS 10 Fluidic Schematics Hemolyzer 3 Fluidic Schematics T r 2 3 way i Stepper Motor LF Vaive X 2 way Valve Closed Off DILUENT LYSE CLEANER WASTE Yai esos Open On 11 1 LABELS 11 Warning labels on the analyzer Biohazard The sample and the waste are potentially infectious material Corrosive Reagents may cause corrosion or 2 2 4 2 3 Skin irritation AT nn Sharp needle The sampling needle may cause warning injury Table 6 Warning labels
38. nce 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 preferably potassium based is the only anti coagulant recommended for use with electronic blood counters Care must be taken when using homemade containers pre dosed with EDTA 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
39. nnings charts separate QC database 1 or 3 measurement automatic and manual factors calibration of WBC HGB RBC PLT MCV RDW and MPV absolute Independent calibration of pre diluted mode 3 level multi user operation with selective privilege levels user identification with ID and password Easy to use menu driven user interface with 6 software buttons with graphic icons 6 hardware function buttons cursor and numeric keys English 1000 results with RBC PLT WBC 3 part histogram USB B port or RS 232 serial link USB mass storage device AnalyticonLab data management software USB A port using USB mass storage device USB with support for HP printers color and monochrome printout Seiko LPTH 245 Easy Paper Operation thermal printer module 58 mm wide roll paper full report with histograms 320x240 dots high contrast backlit color graphics LCD 29 foil keys separate START button red green orange machine state light Standard PS 2 compatible or USB 12VDC 6A 72W max operating power External auto ranging power unit for 100 120 or 200 240 VAC 50 60Hz 59 86 F 15 30 C Optimal temperature is 77 F 25 C 340 x 414 x 380 mm 15 kg 2 1 INSTALLATION 2 INSTALLATION 2 1 General information This chapter provides instructions for the installation of the Hemolyzer 3 hematology analyzer Follow the procedures described below correctly to ensure proper operation and service Please carefully read
40. nnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnennnnnsnnnennnssnnnnnenssssnnnnnn 8 13 9 PIE ee a nase ae ea a ee ae 9 1 9 1 PE OUTS a E os enna oe ke oe geese eos 9 1 10 FIWGIGIC Schematics sans a 10 1 11 Warning labels on the analyzer scscsscscsccscsccscsccccecsccecsccccscsccecscescecsceccucescececcccsceccscess 11 1 INTRODUCTION 1 1 1 INTRODUCTION 1 1 Intended Use Hemolyzer 3 hematology analyzer is a fully automated cell counter designed for in vitro diagnostic use The instrument was developed for small clinics or laboratories 1 2 The Instrument Hemolyzer 3 is a fully automated bench top hematology cell counter It 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 and a foil keypad of 29 keys including 6 software buttons with icons 6 function keys above LCD and has a START button The instrument allows printing reports to an external printer USB port or can have an optional built in printer module Its internal memory is capable of storing 1000 records with full histograms and individual patient data QC measurements are stored in a separate database Upgrade of the software operating the instrument is possible USB flash memory device The instrument allows connecting to a host computer for uploading records stored in its memory through a USB SLAVE port USB B or seri
41. nt ID Alphanumeric field to store additional ID Patient type Human default setting male female baby toddler child control are available Patient name Alphanumeric field for storing Patient name Birth date Sex Selectable male female Doctor Alphanumeric field Displays reference ranges for selected profile 3 4 Database Database local menu Go to specified record Selection Change sort order Manage selected record Backup to USB drive Edit sample info Utilities 1 Maintenance Cleaning Priming Drain chamber a a a Reagent status 5 Software upgrade Calibration MENU SYSTEM Selects one record by time date Sample ID and or Patient ID more criteria narrows search Allows selecting records by specific parameters Timestamp or various ID s can be used for filtering and selection Also all records can be selected or deselected Records are shown according to a so called sorting order This defines whether the latest time record should be displayed as the last record or Patient ID or Sample ID should be used for defining the order Unsorted lists records in their unsorted sequence It is used for servicing functions Selected records can be Saved Deleted or Transmitted to a connected computer Records selected by date or other aspects can be saved to a USB memory device Opens dialog for editing patient information patient ID patient name birthdate
42. r system Proper use of the appropriate power cord assures adequate grounding of the system WARNING Improper grounding of Hemolyzer 3 bypasses important safety features and may result in electrical hazard 2 4 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 5 m space on both sides and above the instrument to access pneumatics and optional built in printer Provide a minimum of 0 2 m between the rear panel and the wall to allow for heat dissipation and tube clearance 2 2 INSTALLATION 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 pneumatics system is capable of aspirating reagents from containers being 1 0 m below the reagent inputs Make sure the reagent tubes are not bent broken twisted or 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 possibil
43. ssing 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 EOS 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 All Analyticon 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 Analyticon is not liable for any damage caused by using cyanide based reagents with any of its analyzers 4 2 OPERATING PRINCIPLES 4 3 Parameters Hemolyzer 3 measures and calculates 20 parameters listed below 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
44. ted to the process of dilution or measurement 3 When quality control measurements show any systematic error bias or they are outside predefined limits 4 Atregular time intervals determined by the lab itself 5 If you want to use the instrument in Prediluted mode Calibration can be performed in two ways 1 User can enter calibration factors without any calibration measurements using the numerical keypad 2 One or three fold measurements of control or special calibration material with known parameters In this case the instrument automatically calculates new factors using the following formula Assigned value x Stored factor New factor Measured value s or average of those CAUTION New calibration will invalidate the previous factors Old values cannot be retrieved but can be reviewed in the VIEW CALIBRATIONS menu Calibration 1 Calibrate 2 View calibrations Start Calibration by choosing Calibration in the UTILITIES menu Select Calibrate 1 item 8 5 Factorial calibration Calibration with one measure Calibration with three measure Calibrate MCV and MPY Calibrate HCT and PCT O Calibrate prediluted mode Heedle position Default Ie mj a d mi KAES Set calibrator Profile Control RBC B 0 00 10121 MCY B C 000 Df RDC BE 0 00 3 PLT B 0 00 jora MPY B 0 00 Jf HGB B 0 00 jg WEC B 0 00 3410 94 EOS B 0 00 jaoga Kara M
45. tically before the first analysis in MEASURE function 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 Press the Measure key and press the button on the screen and select Measure blank Measure local menu 1 O Repeat last sample 2 O Prediluted mode 3 Measure blank Heedle position Default I ek me Human 32 Human 32 If the Blank measurement was OK press RA accept the result The Hemolyzer 3 is then ready for analysis The instrument then displays a sample measurement screen as shown and is now ready to perform an analysis 5 8 ROUTINE UTILIZATION REC PLT C a a I 0 200 So There are 3 regions for blank value handling 1 Optimal all results are within acceptable ranges 2 Blank is high flag is 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 0 10 g l 10 25 g l gt 25 g l 3 0 25 x10 cells ul 25 50 x10 cells ul gt 50 x10 cells ul 0 0 05 x10 cells ul 0 05 0 5 x10 cells ul gt 0 5 x10 cells ul Table 6 Blank measurement ranges Accepted blank values are essential for proper calibration and quality control measurement For this reason no calibration or QC measurement can be perfor
46. ting needle is retracted while its outer surface is automatically rinsed with diluent 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 adapter of the sample rotor 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 8 times Do not shake the sample as this could damage the blood cells 5 2 2 Modifying lyse quantity MEM on the MEASURE screen Another option is to modify the lyse quantity by 0 1 ml or 0 2 ml is available during analysis The default lyse quantity can be adjusted by pressing Press to increase the lyse quantity 0 1 0 2 ml if the separation between lysed RBCs and WBC populations is poorly differentiated resulting in increased WBC and LYM counts Press 4 to decrease the lyse amount 0 1 0 2 ml 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 5 4 ROUTINE UTILIZATION The two important parameters influencing lysing are lysing time and lyse quantity Patient type Human Lyse GEB Parai oi High You cannot change the lysing time as it is WBC 5 00 10 00 109 adjusted to the lysing reagent supplied by RBC 5 00 C 550 Joa HGE 120 00 174 00 Yan Analyticon HET 36 00 C 52 00 7 MEW 76 00 C 96 00 Jn MCH 27
47. to avoid having to re enter patient information Heedle position Default ICA K a Press Start button to begin the analysis Hemolyzer 3 will automatically calculate the results with the 1 5 pre dilution factor DATABASE 6 1 6 DATABASE a Patient results are stored in the memory in chronological order and can be retrieved at any time Memorizing capacity is 1 000 measurements including the complete parameter list histograms flags sample data and date time of measurements If memory is full latest actual record will overwrite oldest record To access the Database table press the Database key Q on the front panel The first screen that appears shows the most recent saved tests Sample ID Patient ID Date WEC 111 01 03 2008 15 43 112 01 03 2008 15 49 Pressing the lt or key accesses the remaining 113 01 03 2008 15 53 01 03 2008 16 11 i non visible parameter results The T or 4 key scrolls 0 01 03 2008 16 12 eed 0 11 03 2008 16 12 between the results individually 0 01 03 2008 16 12 0 01 03 2008 16 13 0 01 03 2008 16 13 0 01 03 2008 16 13 0 25 03 2008 11 18 0 To display the histograms press the RB soft key To print an individual result highlight the result and press Print S PTA URSE TOACA 1 Go to specified record 2 Selection 3 Change sort order 4 Manage selected records From the database table screen enter the Se Back up 1a Ugi unine Database local menu by pressing the Menu key
48. to water condensation which may damage electronic parts Place the instrument on a firm work surface in the designated work area near an appropriate AC electrical outlet The connection MUST be grounded 2 4 INSTALLATION NOTE Before making connections Make sure that all power is in OFF setting 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 2 8 1 Keyboard and external printer Attach the keyboard cable to the round KEYBOARD port on the back of the instrument Attach both ends of the printer cable to the appropriate ports on the printer and Hemolyzer 3 Attach the AC adapter to the printer if required and plug it into an AC outlet 2 8 2 Host Computer The instrument has a built in serial port that allows connection to a host computer Results including histograms may be exported Serial USB I O settings can be found in Settings For installation instructions please contact Service 2 8 3 Power supply Connect the power supply to the instrument Attach power cord outlet to the external power supply of Hemolyzer 3 and plug the other end into a properly grounded AC outlet Do not switch on the instrument before connecting the external power supply to the instrument and to the AC outlet as well as before connecting an external printer or a keyboard to the ins
49. trument 2 8 4 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 Hemolyzer 3 because would a tube come off its connector the fluids spoil out Use the supplied connecting tubes and special bottle caps Be sure that the color on each tube cap and connector in the back of the instrument match You can for example place 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 For connections see below Waste Diluent soluhon Comtamer 2 1 Reagent container connection 2 5 INSTALLATION WARNING Reagents may cause corrosion and skin irritation If any of liquids leaked to cover of analyzer or the furniture it has to be wiped down immediately In case of skin contact the liquid has to be rinsed by plenty of water 2 9 Turning the Instrument ON In case you use an external printer for information read manual shipped with the printer connect it and turn it on Turn Hemolyzer 3 on using the power switch on the rear panel The On position is marked by the 1 symbol During start up the following screen is displayed The software version number appears few seconds later when the softwar
50. uggests hints to overcome the problem Uppercase letters refer to WBC or HGB problems Meaning 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 C 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 WBC coincidence is too Please re run the sample using prediluted mode see chapter 5 4 1 2 Fr Table 4 Summary of warning flags related to WBC HGB 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 5 6 ROUTINE UTILIZATION Warning flags in lowercase refer to RBC or PLT problems Flag Meaning Recommended user action PLT blank is high or no PLT 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 RBC blank is high or no RBC blank Same action as in case of warning flag p an RBC PLT clogging The same action as in c
51. ustomize 4 Fluid sensors 8 10 MAINTENANCE 1 General settings 2 Units 3 Laboratory 4 Change user password 5 Login as 6 Edit users once This is a collection of settings influencing instrument Operation customization Play sound Language serial iO sped aud The table below describes available settings Display turnoff time Barcode reader mode Notused Je RAE Play sound Allows switching the sound signal on off All messages and screens will be displayed in the selected language Serial I O speed Baud Offline USB Baud rate 9600 115200 Protocol used by Hemolyzer 3 to communicate with a connected computer if the instrument is not connected to a computer choose Offline if the instrument is connected computer using USB cable choose USB Display turnoff time You can set the time after how many minutes the LCD light will turn off when not using the instrument Barcode reader mode The barcode reader identifier can be indicated in the Sample ID field or in the Patient ID field 8 11 MAINTENANCE 8 6 3 Units Use the unit menu to set the measurement units the Hemolyzer 3 will use Press the Utilities key 1 Maintenance 2 Calibration 3 Quality control Select Settings 4 Diagnostics 5 Settings 6 Service FYVQY TF Select Customize Select Units Count unit HGB unit _ 91 5 Set the units as needed PCT HCT unit SE nee Use T and J arrow keys to se

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