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1. Diagnostics Reagent status pane 6 2 2 Power Up the Hemolyzer 5 Analyzer To power up the Hemolyzer 5 analyzer perform the following steps e Turn on the main power switch small switch on the rear panel of the Hemolyzer 5 analyzer located near the power connection to the up position labeled 1 to power on the electrical system of the Hemolyzer 5 analyzer 39 Hemolyzer 5 e If the optional Autosampler is installed turn the power switch on the right side of the Autosampler to the on position labeled 1 to power on the electrical system of the Autosampler e Turn on printers or any peripherals that have their own power switches The electrical system of the Hemolyzer 5 analyzer can remain powered up indefinitely Please follow local regulations or laboratory procedures when deciding whether to fully power down the Hemolyzer 5 analyzer after work hours 6 2 3 Start Up the User Interface To start up the internal user interface computer of the Hemolyzer 5 analyzer flip the standby switch near the top of the rear panel of the Hemolyzer 5 analyzer to the up position The standby switch springs back to the down position after activation The following sequence of events takes place after enabling the standby switch e The internal computer starts up displaying the EPIA logo in a rotated way e The embedded Windows XP operating system starts up As the display initializes the s
2. 66 Usermanual Neutrophils N Magenta Eosinophils Orange Non Basophil WBCs Blue gis Monocytes Artifact 3 M a Black xs de genre Nr SN T Basophils um d V Bs Magenta Lymphocytes Blue Figure 52 Result Screen Scatter Diagrams RBC and PLT impedance based measurements are represented by histograms These diagrams show the number of cells on the Y axis and the cell size on the X axis Smaller cells are displayed on the left side of the histogram and larger cells are displayed on the right side The height of the histogram at a given size represents the number of cells with that size Greater histogram height indicates more cells PLT RBC Discriminator Figure 53 Result Screen Histograms Both the RBC and PLT histograms can be zoomed Discriminators thresholds are displayed with red color Platelets are located on the leftmost part of the RBC histogram to the left of the red discriminator The PLT histogram is a magnified version of this region 8 3 2 Warnings The warnings area of the result screen shows flags and messages related to the evaluation of the sample Clicking or tapping the question mark icon on the left side of the warnings section of the results screen displays a detailed warnings panel Click or tap OK to close the detailed warnings panel 67 Hemolyzer 5 Warnings C WBC clogging T c c RBC clogging C X Differential error er x Baso error 5
3. Clicking or tapping the Exit icon on the main menu brings up the Shutting down Analyzer panel Select Log off to end the active user session Figure 24 Hemolyzer 5 Exit Are you sure you want to exit shipment Figure 25 Log Off After the current user is logged off the login panel is displayed 6 3 2 Shut Down The shutdown procedure must be used to maintain the reliable operation of the instrument To properly shut down the Hemolyzer 5 analyzer click or tap the Exit icon on the main menu and select Shutdown Are you sure you want to exit E shipment Figure 26 Shut Down The shutdown procedure performs two key functions e Ifthe pneumatic system components of the Hemolyzer 5 analyzer were initialized a shut down procedure is performed that rinses the pneumatic components This prepares the Hemolyzer 5 analyzer for shorter periods of inactivity such as overnight or over a weekend e The Hemolyzer 5 operating software and the Windows XP Embedded operating system are shut down The analyzer saves all settings closes the file system and database and automatically shuts down the internal user interface computer The Hemolyzer 5 analyzer may ask to perform a cleaning cycle based on the analyzer s usage patterns and the state of the pneumatic components If this occurs the Hemolyzer 5 analyzer will request that a tube with cleaning reagent be introduc
4. Hierarchy Color Code i fth linearity range Table 10 Linearity Range Flag High blank fla A high blank flag is raised when the blank measurement result of the 2 particular parameter was higher than the blank limit Color Code Parameter is under the half of the low Low Blue limit of normal range i The blank value of the related primary Middle N A parameter is high Table 11 High Blank Flag 8 3 1 Scatter Diagrams and Histograms The Hemolyzer 5 analyzer displays the results of the optical measurements in scatter diagram representation Scatter diagrams represent two dimensional data There are two scatter diagrams in the patient report the 4 DIFF and BASO scatter diagrams The 4 DIFF scatter diagram displays cells identified after the first lysing and optical measurement process Due to the measurement technology cells are classified based on their optically detected properties low and high angle scattered light intensity The optical detector can measure the intensity of the light scattered or diffracted by each cell One portion of this scattered light is proportional to size of the cell the other is proportional to the complexity of the internal structures in the cell Cells in a leukocyte sub population have similar light scattering properties allowing them to be grouped together and identified separately from other cell types Different colors are used to identify various populations of blood cells
5. is required to resolve major problems occurring during operation Electrical and moving parts should always be serviced by trained person There are however some maintenance actions the operator should perform to keep the analyzer in a reliable and clean state A Any elements inside the analyzer like tubes valves chambers containers should be handled as a potentially biologically and chemical dangerous material and have to observe the related law and follow the hospital handling instruction during disposal 15 1 1 Opening The Front Panel To access the pneumatic system and to be able to perform some maintenance actions you have to be able to open the front panel of the instrument Make sure that nothing is placed on the top or in front of the analyzer Grab the lower sides of the front panel gently pushing the sides Pull the lower part towards you and lift it up Upon opening a lever becomes visible Make sure to tilt the front panel upwards so that you can push the lever into the secure position 15 1 2 Closing The Front Panel A Do not push on the front panel while the security level is in the lock position Gently lift the front panel so that the security support lever can be moved to the free position Gently lower the front panel When it reaches its lowest position gently push on the front side to click the lock levers in place 104 Usermanual 15 1 3 Removing The Side Panels With the fron
6. Hemolyzer 5 AN analyticon Usermanual Helease 1 2 21 Hemolyzer 5 Analyticon Biotechnologies AG Am Muehlenberg 10 35104 Lichtenfels Germany info analyticon diagnostics com www analyticon diagnostics com agile affordable accurate Usermanual This user manual is intended to give detailed information for end users of the Analyticon Biotechnologies AG Hemolyzer 5 optical hematology analyzer All information contained herein is the intellectual property of Analyticon Biotechnologies AG and should not be used or reproduced without prior agreement of Analyticon Biotechnologies AG the manufacturer This manual was written with the intention to give the most precise and up to date detailed description of operation and use of the analyzer for laboratory purposes Despite careful revision and multiple grammar and content control mistakes can still be present in this manual Analyticon may from time to time issue errata or a new revision of the manual Would you find things unclear please contact your service engineer for assistance Descriptions contained herein are relevant to Hemolyzer 5 software versions latest available at the publication of the manual e User graphical interface sw 1 1 623 e OPN pneumatic sw 1 1 623 e Firmware 2 66 1125 e PIC sw 1 8 e Laser sw 3 5 e TCU sw 3 41 Hemolyzer 5 Warranty THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ALL OTHER WAR
7. RBC slice error 5 WBC slice error Warnings pDA Figure 54 Warnings Section of Results Screen The Hemolyzer 5 analyzer provides Warning flags Morphological flags and Interpretive messages in the Warnings panel The following tables describe these flags and messages in detail It also provides guidance on actions the operator can take to correct the problem described by the flag 68 Usermanual EE Warning flags are raised when the analyzer detects a problem in the analysis process that may cause incorrect or suspect results or the SUE parameters in the valid blank measurement was too high If other parameters predict a normal sample then perform a E cleaning procedure and repeat the measurement A 4 Diff Alarm The ini Se nyc diSHREQNSQ OIM DNE If ADIFF results reported then treat them as reduced reliability If scatter diagram not all the parameters reported or the sample is predicted as pathological then perform a manual count on a stained smear Check cleanliness of the reagents and the Hemolyzer 5 Perform m cleaning of the Hemolyzer 5 Repeat blank measurement See VE DEE Re chapter 6 2 5 Pneumatics start and blank measurement Treat WBC result as reduced reliability Check cleanliness of the reagents and the Hemolyzer 5 Perform RBC blank is high RBC gt RBC blank high limit cleaning of the Hemolyzer 5 Repeat blank measurement See chapter 6 2 5 Pneumatics start and blank measureme
8. Use only Sarstedt Monovette tube from sample rotor check box in the Main menu Settings System panel The Autosampler automatically recognizes Sarstedt Monovette tubes and automatically changes the sampling depth You may use sample tubes from other vendors if certain conditions are fulfilled For manually presented sample tubes at the sample rotor measurement check if the new tube type e Is mechanically compatible 13x75 mm family e Can be pierced or used in open vial mode e Can be handled by the tube centralizing mechanisms on the Hemolyzer 5 analyzer It is suggested to contact your sales representative before using the new sample tube type For automated sample handling with the optional Autosampler contact your sales representative before using a new sample tube type The Autosampler may not reliably recognize sample tube types other than the officially supported sample tubes Although these sample tube types are designed for multiple piercing it is recommended to replace the cap after 3 4 piercing cycles Small rubber bits parts can crumble into the blood and adversely affect the performance of the Hemolyzer 5 analyzer 7 1 2 Sampling Depth The Hemolyzer 5 is equipped with a piercing needle capable of aspirating samples from closed sample tubes To prevent needle blockage from rubber sample tube cap material and blood particulates the piercing needle hole is located on the side of the needle rather tha
9. e Does not exceed 15 C 5 F for 224 hours e Does not exceed a dry heat of 70 C 158 F for 224 hours e Dramatic change of temperature between 15 C 5 F and 30 C 86 F e Does not exceed a damp heat steady state of 90 RH and 40 C 104 F during 48 hours e Does not exceed a damp heat cyclic of 90 100 RH and 25 40 C 77 104 F 12412 hours 140 Usermanual 21 1 8 Performance Data 21 1 8 1 Precision 4 7 10 ul lt WBC lt 38 10 ul x em All 5 part parameters NEU LYM MON EOS BAS abs and 96 at 4 7 10 ul lt WBC lt 38 10 ul 87 4 gt NEU gt 4796 im CV 896 35 6 96 gt LYM gt 15 16 3 gt MON 5 3 i i s LI JE 100 10 ul lt PLT lt 492 10 ul 141 Hemolyzer 5 21 1 8 2 Accuracy Values And Ranges Accuracy Experienced coefficient Range Against Reference Cell Dyn 3700 BC RBC HGB HCT PLT 19 5 lt HCT lt 52 6 w i INGNNVEMM Note 1 the 5part WBC is not reportable if the total WBC count is below 1 10 ul The quantation error grows to high 142 Usermanual 21 1 8 3 Linearity Values And Ranges r 2 gt 0 95 1 10 ul lt WBC lt 100 103 ul RBC gt 0 0 4 10 ul lt RBC lt 7 5 10 ul HGB gt 0 13 g l lt HGB lt 227 g l PLT 21 1 8 4 Carryover Values And Ranges WBC 0 596 or less LO lt 10 10 ul HI gt 75 107 ul RBC 0 5 or less LO lt 2 3 10 ul EN
10. e Status of the Autosampler unit e The state of the reagent and waste containers e Error warning icons e Status of the pneumatic system standby manual measure rinse clean e Progress of the active operation e Time e Printer status Clicking or tapping on an error or warning icon navigates directly to the relevant menu where the problem can be addressed or provides the user with information on how to resolve the problem 33 Hemolyzer 5 AS state Home Figure 20 The Status Displa 5 6 4 Entering Information The Hemolyzer 5 sometimes requires the operator to enter information such as sample ID or patient data In order to enter information into a data field simply tap or click on it The data field will change color to yellow indicating that data entry is active for that field Information can be entered using the virtual on screen keypad or with an optional external keyboard 5 7 The Menu System The graphical user interface of the Hemolyzer 5 analyzer has primary functions that are accessible directly by means of icons or controls that are always available to the operator The Hemolyzer 5 analyzer also has secondary functions that are available via two or more taps or clicks through the menu structure or menu tree 5 7 1 Primary Menu Items The following menu items or functions are directly accessible e Start a manual single tube measurement e Start an automated measurement e Access the
11. Generate Release Big puffer drift Maximum 540 560mBar Minimum 530 560mBar Drift 5 15mBar Max vacuum P1 Maximum 550 1000 mBar Time 0 6000 ms Pump status Pump1 Noise Pulse 0 2000 pulses 19990 20050 pulses pls 5sec 20000pls TCU temperature Reference 0 2 C 0 55 C Actual Sink Laser DC level 0 0 05mV 0 10 0 45mV Laser off Laser on Electrode 45 55V Current 620 680uA Offset 3 0 mV Battery Power supply Battery voltage 2 7 3 3V 12V 11 4 12 6V 12V 12 6 11 4V Voltage Small puffer time 800 4000sec 800 4000sec 500 2000sec Generate1 Generate2 Release Small puffer drift Maximum 225 235mBar Minimum 215 235mBar Drift 5 15mBar Max vacuum P2 Maximum550 1000 mBar Time 0 6000 ms Null pressures Sheath Capillary Chamber HGB head HGB Dark 0 3000 pulses HGB light 3000 60000 pulses Laser parameters Reference 10 Laser power 32 0 128 0 HGB head HGB Dark HGB light Reagent lock Status UNLOCKED LOCKED NA Available measurements none 20 20mBar 20 20mBar 20 20mBar 0 3000 pulses 3000 60000 pulses Temperature WBC pre heater none LSDACQ v3 0 34 0 38 0 LSDACQ v3 1 LSDACQ none If any of the values falls outside the above limits the SW is going to list the errors on the self test report screen 101 Hemolyzer 5 14 1 2 Daily Log The log option is included for service or troubleshooting
12. Optical Head Aspiration Needle Horizontal Vertical Motion Unit Washing Head Power Supply Sample Rotor Autosampler Connector Figure 13 Left Side Assembly e Aspirating needle aspirates a blood sample from the sample tube e Horizontal vertical motion unit positions the aspiration needle e Washing head cleans the aspiration needle to prepare for the next sample e Sample rotor holds the sample tube for single tube manual presentation e Autosampler connector is the power and control connector of the optional Autosampler e Optical head contains the laser source optical detectors and auto alignment mechanism for the optical measurement 28 Usermanual 4 3 4 Front Assembly Aspiration Needle Sample Rotor Figure 14 Front Assembly Behind the Front Panel e Syringe pumps control the volume and flow rate of reagents through the pneumatic components e Shear valve is an integrated multi functional valve for segmenting precise volumes of blood 29 Hemolyzer 5 5 User Interface The user interface of the Hemolyzer 5 analyzer is designed to be intuitive and easy to use and provide access to all user level functions You can interact with the Hemolyzer 5 by using only the touch screen and the virtual on screen keypad or by using an external keyboard and mouse PS2 or USB The Start button is considered an important part of the user interface allowing one hand one touch processing of
13. See section 7 4 2 for more information about automated measurements 5 7 4 Access the Database Tapping or clicking the Database icon with the file cabinet graphic allows access to the following functions e Select completed and measurement stored as database records e Export database records for storage or import results for viewing e Delete database records e Send database records to the LIS e Review the details of selected measurements See section 9 for more information about accessing and using the Hemolyzer 5 database 5 7 5 Initiate Printing Tapping or clicking the Print icon with the printer graphic will print the active panel or measurement result according to the printer settings See section 13 6 for more information about printing on the Hemolyzer 5 analyzer 5 7 6 Main Menu Tapping or clicking the Menu icon with the main menu graphic displays and allows access to the main menu The main menu is automatically displayed when the Hemolyzer 5 analyzer is started up The main menu icons are arranged in an intuitive and attractive circular design 35 Hemolyzer 5 acim 100 None J Figure 21 Hemolyzer 5 Main Menu 5 7 7 Autosampler Control Panel If you have an optional Autosampler installed the Autosampler control panel can be opened by double clicking tapping the Autosampler status on the left side of the status display on the bottom of the screen The Autosampler control
14. The intensity of each pulse is proportional to the volume of the particle The volume distribution diagrams of the particles result in the WBC RBC and PLT histograms that measured in femtoliter volume units Electronic discrimination allows separation of erythrocytes RBC and platelets PLT A lytic reaction lyses erythrocytes to clearly measure leukocytes WBC 22 Usermanual 4 2 2 Photometric Light Absorbance Method A lysed blood sample dilution can be analyzed for hemoglobin HGB concentration based on its stable chromogen content The reagent lyses the red blood cells causing the release of cellular hemoglobin The hemoglobin concentration is measured by taking a photometric reading across the Hemolyzer 5 WBC chamber The HGB measurement is calculated as the difference between and blank and a sample measurement with and without illumination to reduce the effect of liquid refraction and incident light W C chamber gt Lysed blood Light source Detector Figure 4 Photometric Light Absorbance Method 4 2 3 Optical Light Scatter and Diffraction Method Optical measurement of light scattering and diffraction is used to determine five part leukocyte LYM MON NEU EOS BAS differential parameters An optical measuring head contains a focused laser source that is used to illuminate a stream of leukocytes WBC suspended in an optically clear diluent moving through a flow cell The cells scatter light
15. This is the same button which is used to start up the Hemolyzer 5 user interface computer This shuts down the user interface computer without properly shutting down the pneumatic system components Possible side effects e The pneumatic components may be left in an undefined state The next startup and pneumatic initialization may take longer with increased reagent consumption e The last settings changes and measurement results are not saved Immediate shut down should be avoided as a routine procedure It should only be used if loss of electrical power is imminent such as thunderstorms or if loss of uninterruptible power supply UPS backup power is imminent 45 Hemolyzer 5 6 3 48 Immediate Switch Off In case of immediate danger you can power off the Hemolyzer 5 analyzer by turning off laboratory power or by turning off the main power switch small switch on the rear panel of the Hemolyzer 5 analyzer located near the power connection to the down position labeled O 6 3 5 Repackaging the Hemolyzer 5 Analyzer Before repackaging your Hemolyzer 5 analyzer for transportation or storage always do the following e Perform a Prepare for shipment procedure e Fully power down the analyzer e Disconnect all reagent tubes power cords and peripheral connections e Always use the original packaging materials to repackage the Hemolyzer 5 analyzer Prepare the following packaging materials wer
16. log If the multi user mode is enabled the name of the operator logged on at the time the data manipulation occurs will also be stored in the log 9 8 1 Select By Click or tap the Select by button on the Manage Records panel to display the Select by panel The Select by panel allows you to select a group of records with dates and Result IDs that match criteria entered into the panel 77 Hemolyzer 5 Change EEE CE 1008 1008 100 1 40 Nore _J GLI Figure 59 Select By Panel The Select by panel provides various ways to select records Only one of the four selection methods can be chosen keyboard All records analyzed on the date entered will be selected Select interval The two Change buttons allow entry of a start and end date All records on the start date the end date and all dates in between will be selected Select all All records in the database will be selected Select Result ID Entering one Result ID will select a record with the same Result ID Entering two Result IDs will select a range of records including the start and end Result IDs Clicking or tapping the Run select will create a multiple selection of all database records that match the criteria if any The Cancel button returns to the database view and the current selection is not changed 9 8 2 Importing Clicking or tapping the Import button displays a blank modified version of the database panel 78 Usermanual Me
17. purposes It lists events and possible problems related to operation or measurements By using the swap box on the top of the panel you can change if All the log entries are displayed The error message are displayed only Pneumatic errors Software errors User actions System actions 14 1 3 Reagent Status Actual level of reagent bottles is accessible from the menu system The analyzer has built in reagent consumption calculators The calculated level of each reagent is indicated on the screen The height of the bar shows the level in the container These levels are also indicated on the screen in the status area Hemolyzer 5 send special message if any of the reagents are running low Check and change the reagent container and reset the reagent status bar on the screen If the reagent locking feature is activated then the resetting of the Lyse reagent activates the uploading of the measurement count from the hardware key If the reagent lock is in use then please connect the hardware key when resetting the Lyse reagent level 102 H Measure Database f Name Time sd Sorry no error string yet Function name Sorry no error string yet Function name Sorry no error string yet Function name Sorry no error string yet Function name Sorry no error string yet Function name Sorry no error string yet Function name Sorry no error string yet Function name Sorry no error string
18. rrrannrrnnannrrnnnnnrnvnnnrrnnnnnrnnnnnsrnrnnnsrrnnnnernnnnnsrnnnnnsennnnesnnnnnsennnnssennnnssnnnne 107 15 1 7 Cleaning the Washing Headi rrrnnnonnnrrnnnnnnnrrnrnnnnnrrnnnnnnnernnnnnnsrnnnnnnnssnnnnnnnssnnsnnnessnnnnnnessnnnnnnsssennnn 112 15 1 8 Cleaning The Measuring Chambers Hard Cleaning rrrrrrrrnnnnnrrrrrrnrnnnnnnnrrrrnnrnnnnnnnrrrnnnnnnnnnensenee 113 XM Ee NR 113 15 1 10 Special Cleaning ProcedUte s e rrr nn ttn x tent eovseersandanessdtessesatarsveasersenevesvenseesenscenys 113 15 1 11 Replacing Reagents ccccccsssscccssscecceescccseseecceasecessuecesseeeessueeessaeceeseecessueeesseaeeeeseusessaaeeeesaases 114 15 1 12 Disposal Of Reagent Containers lssssssesssseeeeeeeeeenenn nennen nennen nnns nnne sss annes saa annees nans 115 16 Reagent LOCKING vui nesciralerisiserrtusdaav ec vide siqua pas erac svapuao buses vive vecatanenserolaacetesisansees 116 17 Vee jr 118 18 TrobleshooMmh vn 120 18 11 Ver 120 1312 TER Vvrvrveevr srververr r prs 121 18 1 3 Mechanical Problems rrrnnnnrnnnnnnrnrnnnrnnnnnnrnrnnnrnnnnnernnnnnernnnnerrnnanernnnnsernnnnesennnnsnnnnnsennnnssennnnesnnnee 122 18 1 4 Sample Rotor SR Failures rrnnrnnnnnnnnnnnnnnnnnrnnnnrnnnnnnnnrnnnrnnnnennnrnnnnnnnnrnnnennnnrnnnennnnrnnneennnrnunesneeenn 122 18 1 5 Needle Mechanics Vertical Motor Mvert ProbleMs cccccccseccccceeseeceeeeeeecceeseeeeeeessaeeeeeeseeees 123 1S L5 Shear Valve SV Related Errors Lave praise 1
19. 1 No Image On Display No Backlight e contact Service 18 1 9 2 Touch Sensitive Surface Not Working e connect an external USB mouse o this will allow clicking on the screen elements o contact service for resolution of the problem 18 1 9 3 Touch Click Is Inaccurate e the touch screen needs calibration e connect an external USB mouse o perform the calibration under Main Menu Maintenance Touch screen calibration 18 1 9 4 The Cursor Seems To Be Moving With Good Ratios But In A Smaller Area e try to calibrate the touch screen Use a mouse to access the functions e lf the problem persists contact service 18 1 10 The Analyzer Does Not Power On e Check proper power connections and the state of the small switch at the power supply e Ifthe above fails contact Service 18 1 11 I2c Errors Displayed At Startup e Contact Service 126 Usermanual 18 2 Measurement results related problems 18 2 1 Fluctuating PLT background values When the Hemolyzer 5 is used under increased workload running even 300 samples a day meaning 5 hours of continuous operation is possible Despite built in maintenance programs the system may require intensive cleaning from time to time If you find that Blank PLT values are increasing and decreasing unprecedentedly please run a Hard Cleaning function Go to Main Menu Maintenance Tap the Hard Cleaning button to initiate the procedure You will need a syringe 10ml to dose cleaning liquid in
20. 5 Photometric Light Absorbance Method rrrrrnnnnnnrnnnnnrrnnnnnrrnnnnnnrnnrnnnernnnnnernnnnnssnnnnnnsvennnnesene 23 Figure 6 Hemolyzer 5 Optical Head Block Dlagram sees 23 Figure 7 Optical Signal Processing System rrrrnnrnrnnnnnnrnnnnnnrrnnnnnnrnnnnnernnnnnnennrnnnnnnnnnnevnnnnnesvnnnnnssennnnesene 24 Pee ANUS e IHE ENT OMEN 24 Figure 9 4DIFF Scatter DNs 25 Figure 10 Hemolyzer 5 Front Pane lesserti ARa 25 Figure 11 Hermiolvzer 5 Back Panel sessisisrssiirisi tino ito eee innn inaa 26 Figure Ec E Side Assemb Vo E T Uc 27 Figure 12 Main Board Back Panel I O Ports rrrrrrnnnnnnnrnnrrrnnnnnnnnnnnvrrrrnnnnnnnnnennrssnnnnnnnnnnvvvnvnnnnnnnnnensnsneene 27 Figure 14 Len Side Assembleur EM DUREE ES 28 Figure 15 Front Assembly Behind the Front Panel rrrnnrannnnnnnnnnnnnnnnnrnnnnnnrnnnnnnnrnnnnnernnnnnnsnnnnnnennnnnnesene 29 Figure 16 Alphanumeric Virtual On Screen K yPad ccccseseccceessececesececeeecceeeeseceeseeceseugeceesanseeeeas 31 Figure 17 Sticky Shift and Symbol Buttons rrrrnnnannrnnnnnnrrnrnnnrrnnnnnnrnnnnnnrnnnnnnernnnnnernnnnnesennnnnenennnnnenne 32 Figure 18 Numeric Virtual On screen Keypad rrrnnnnnnrrnnnnnrnnnnnnrrnnnnnernnnnnnrnnnnnnevnnnnnevnnnnnesvnnnnnsnnnnnesene 32 Figure 19 Date Virtual On Screen Keypadi rrrrnnnnrnnnnnnrrnnnnervnrnnnrrnnnnnerrnnnnnnrnnnnnsnnnnnnevnnnnnssennnnnsnennnnesene 32 Figure 20 Graphical User Interface Section
21. 70 Pe Walle Keyboard Figure 11 Main Board Back Panel I O Ports ethanol 4 3 2 Left Side Assembly To access the left or right side assemblies the side panels must be removed Please refer to section 15 1 3 for information about removing the side panels Drain Buffer Mix RBC amp WBC Chambers Pressure Sensors 7 000 Oo ool o om 9000000000097 Small Measure Buffer Diluent Buffers Sheath Buffer Diff 5p Lyse 5p Buffers Figure 12 Left Side Assembly e Pressure sensors measure the differential pressures of vacuum buffer for impedance base and optical measurement and empty chamber process e Small Measure buffer is a vacuum buffer used for impedance measurement e Sheath buffer is a reservoir for Hemolyzer Diluent for optical measurements e Diff 5P buffer is a reservoir for Hemolyzer 5 Diff 5P reagent e Lyse 5P puffer is a reservoir for Hemolyzer 5 Lyser reagent 27 Hemolyzer 5 4 3 3 e Diluent buffers are reservoirs for Hemolyzer Diluents e Valves 1 44 connect pneumatic components to carry out dilution reaction measurement and waste disposal processes e Drain buffer controls chamber draining procedures e Mix chamber performs the first step of RBC dilution e RBC chamber performs the second step of RBC dilution and contains the RBC aperture e WBC chamber performs the WBC dilution and holds the WBC aperture and HGB photometric measurement system Right Side Assembly
22. 7541 lt TAB gt 02 04 2009 16 13 24 lt TAB gt 402 lt TAB gt 02 04 2009 16 13 24 lt TAB gt Human lt TAB gt 70 65 lt TAB gt 63 09 lt TAB gt 1 7 lt TAB gt 5 86 lt TAB gt 0 lt TAB gt 0 lt TAB gt 89 3 lt TAB gt 2 4 lt TAB gt 8 3 lt TAB gt 0 lt TAB gt 0 lt TAB gt 1 83 lt TAB gt 63 lt TAB gt 33 3 lt TAB gt 181 8 lt TAB gt 34 4 lt TAB gt 190 lt TAB gt 75 8 lt TAB gt 16 lt TAB gt 17 lt TAB gt 16 3 lt TAB gt 43 lt TAB gt 8 9 lt TAB gt 0 02 TAB 7542 lt TAB gt 02 04 2009 16 16 53 lt TAB gt 402 lt TAB gt 02 04 2009 16 16 53 lt TAB gt Human lt TAB gt 70 65 lt TAB gt 64 01 lt TAB gt 1 48 lt TAB gt 5 16 lt TAB gt 0 lt TAB gt 0 lt TAB gt 90 6 lt TAB gt 2 1 lt TAB gt 7 3 lt TAB gt 0 lt TAB gt 0 lt TAB gt 1 83 lt TAB gt 63 lt TAB gt 33 3 lt TAB gt 181 8 lt TAB gt 34 4 lt TAB gt 190 lt TAB gt 75 8 lt TAB gt 16 lt TAB gt 17 lt TAB gt 16 3 lt TAB gt 43 lt TAB gt 8 9 lt TAB gt 0 02 TAB 7543 lt TAB gt 02 04 2009 17 31 12 lt TAB gt 402 lt TAB gt 02 04 2009 17 31 12 lt TAB gt Human lt TAB gt 70 65 lt TAB gt 64 01 lt TAB gt 1 48 lt TAB gt 5 16 lt TAB gt 0 lt TAB gt 0 lt TAB gt 90 6 lt TAB gt 2 1 lt TAB gt 7 3 lt TAB gt 0 lt TAB gt 0 lt TAB gt 1 83 lt TAB gt 63 lt TAB gt 33 3 lt TAB gt 181 8 lt TAB gt 34 4 lt TAB gt 190 lt TAB gt 75 8 lt TAB gt 16 lt TAB gt 17 lt TAB gt 16 3 lt TAB gt 43 lt TAB gt 8 9 lt TAB gt 0 02 lt TAB gt 145 Hemolyzer 5 22 Index aperture 23 24 30 BASO 26
23. Calibration The Hemolyzer 5 analyzer must be calibrated in order to provide correct reliable results Calibration should be done at the following times At initial installation After replacing any component critical to the dilution or measurement process Any time quality control shows a systematic error or is outside predefined limits At periodic time intervals determined by laboratory regulations The Hemolyzer 5 analyzer calibration process consists of running a commercial calibrator material or a human whole blood sample with known parameter values multiple times The known parameter values and the average values of multiple runs are used to calculate calibration factors The new calibration factors take effect once they are accepted by the operator If you are using a human whole blood as a calibrator the calibration target values must be measured on a reference analyzer according to applicable regulations standards or laboratory procedures An automated calibration procedure is provided that guides the operator through the calibration process and performs the calibration factor calculation Calibration factors can also be modified directly without running a calibration procedure Only the primary measured parameters are calibrated WBC RBC PLT HGB MCV MPV and RDWcv To view the calibration functions of the Hemolyzer 5 analyzer select the Calibration icon on the main menu to display the calibration panel The Calibrati
24. Formats A analyticon Lab header 1 02 02 2011 12 43 Lab header 2 Lab header 5 Lab header 3 Lab header 6 Lab header 4 Lab header 7 Sample ID 11 Patient ID 1 Date 10 01 2011 15 54 Name John Doe Mode Human Date of birth 23 01 1981 Parameter Result Limit Gender Male WBC 6 15 10 uL 3 50 10 00 NEU 1 28 208 1 20 8 00 LYM 4 02 653 050 5 00 MON 0 62 10 1 0 10 080 EO 0 15 24 020 090 BAS 0 09 14 0 00 030 RBC 3 94 10 uL 350 550 HGB 90 g L 115 165 HCT 29 0 35 0 550 MCV 73 8 fL 75 0 1000 MCH 228 pg 250 350 MCHC 310 g L 31 38 RDWsd 39 9 fL 51 0 820 RDWcv 13 3 96 11 0 160 PLT 501 10 uL 100 400 PDWecv 40 5 PDWsd 16 5 fL MPV 73 fL 8 0 110 PCT 0 37 96 Warning flags Morphological flags Interpretive flags Microcytic RBC Hyperchromic Thrombocytosis Microcytic PLT Doctor 133 Hemolyzer 5 AX analyticon Lab header 1 02 02 2011 12 44 Lab header 2 Lab header 5 Lab header 3 Lab header 6 Lab header 4 Lab header 7 Sample ID 11 Patient ID 1 Date 10 01 2011 15 54 Mode Human Parameter Result Units Limit WBC 10 uL 3 50 10 00 NEU 10 uL 120 8 00 LYM 10 uL 050 500 MON 10 uL 010 0 80 EO 10 uL 020 0 90 BAS 10 uL 000 0 30 NEU 35 0 800 LYM 15 0 500 MON 3 0 90 EO 1 0 80 BAS 0 0 2 0 RBC 10 uL 350 550 HGB g L 115 165 HCT 35 0 55 0 MCV fL 75 0 100 0 MCH pg 250 350 MCHC g L 31 38 R
25. HI gt 7 5 10 ul 0 596 or less LO lt 90 g l HI 2270 g l 0 596 or less LO lt 140 10 ul HI gt 730 10 ul 143 Hemolyzer 5 21 1 9 Reagent System See chapter 0 21 1 9 1 Diluent Hemolyzer Diluent 21 1 9 2 Lyser Hemolyzer 5 Lyser WBC 5Part lysing 21 1 9 3 Lyser 2 Hemolyzer 5 Diff 5Part 21 1 9 4 Cleaner Hemolyzer Hypocleaner Isotonic solution used to dilute whole blood and quantitative and qualitative determination of RBC WBC PLT and HGB concentration Reagent for stromatolysis of RBC and quantitative determination of WBC 5 part differentiation LYM MON NEU EOS BAS and HGB concentration measurement of human blood Quantitative determination of WBC leukocyte four part differentiation LYM MON NEU EOS Capillaries tubing and chambers removing blood component precipitates 144 Usermanual 21 1 10 Tab File Format This file format is composed of a header line and consecutive lines containing records selected for saving Each parameter is selected by the TAB 08h character allowing easy interfacing or importing into most data processing applications like Microsoft Excel Scatter diagrams and historgrams flags are NOT saved in this format The header line contains the same column names you can see in the analyzer database Data values are saved as they are stored in the analyzer database alphanumerical or numerical Decimal separator is defined by the actual
26. LEPPENE 91 Figure NENNE 92 Figure 73 C stemize Settings Pallel vr vl 93 Usermanual Figure 74 External Devices SCLUIRES P Aine liactencesserenracaseveseneseuwensessaatuscucnceeceasuatevateneessadnetasaeseatendebueccian 94 Figure 75 NNN 95 Free DIES EET 96 Figure 77 Sie T Hr 97 Figure 78 Profile Limits Settings Panel rrrrrrnnnnnnnrnnnnnnrnnnnnnrrnnnnnnrnnnnnernnnnnnennrnnnennnnnnevnnnnnesennnnnssennnnesene 98 FLIES 99 Figure 82 SANS NN 103 Figlile 83 SEQUSUES CNG A neri aei IDEE Hd Send IN IM ID IPM MEME DIEI ED eat 103 Table of Tables Table 1 Hemolyzer 5 Analyzer Parameters rrrrnnnrnnnnnnrnnnnnnrnnnnnnnrnnnnnnrnnnnnnnnnnnnnevnnnnnsennnnnesnnnnnnsnennnnesene 19 Table 2 Hemolyzer Diluent Information rrrrarnnnnnnrnnnnnnnnnnrnnnnnennnnnrnnnnnrnnnnnnnnnnnnnnnnennvnnnnnnnnnnnnnnnnnnnsnennnee 20 Table 3 Hemolyzer 5 Lyser Information r rrnrnnrnrnnnnnnrnnnnnnrrnnnnnernnnnnnrnnnnnnernnnnnsnnnnnnennnnnnesnnnnnnsnennnnesene 20 Table 4 Hemolyzer 5 Diff 5p Information rrnrnnnornnnnnrrnnnnnnrrnnnnnernnnnnernnrnnnrnnrnnnenennnnevnnnnnssnnnnnnssennnnesene 21 Table 5 Hemolyzer Hypocleaner Information rarrnnnnnnnnnnrnnnnnnnnnnnnnnnnnrnnnnnennnnnnnnnnennrnnnnnnnnnnnnnnennnnsnennnee 21 Table 6 Reagent Connector Color Codes rwwrurnnnnunnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnennnnnnnnnnnnnnnunnnnnnnnnnnnsnennnne 26 Table 7 Hemolyzer 5 Analyzer Menu Tree cccccssesessossssconssscnecsssestoussscucusssc
27. Start up the pneumatic system components e Perform and accept an initial blank measurement A normal shut down of the Hemolyzer 5 analyzer has the reverse steps e Clean and empty the pneumatic system components e Log off multi user mode is activated and properly shut down the internal user interface computer e Power down the electrical subsystem The Hemolyzer 5 analyzer also has a prepare for shipment shut down option that performs an extended cleaning and emptying of the pneumatic components This option can be used to prepare the Hemolyzer 5 analyzer for an extended period of inactivity or for shipping to a new location There are also emergency shutdown procedures in case of emergency 6 2 Starting Up the Hemolyzer 5 Analyzer 6 2 1 Visual Inspection Perform a visual inspection of the Hemolyzer 5 analyzer before starting up This is particularly important if the Hemolyzer 5 is operated by multiple operators e Check the reagent tubes by gently pulling on them to make sure that connections are not loose e Open the front cover and ensure that there is no leakage around the shear valve or the syringe pumps e Check for salt stains around the reagent tubing and the reagent containers e Check that the power cord is plugged in both into the back panel of the Hemolyzer 5 analyzer and to the wall outlet e Empty the waste container After start up reset the waste level in the Main menu
28. T Tm 67 9 Database FunctionS sesessesesoesesescesoscesesoccesoccesoccoesoecesosoesoscoesosoesoscesesoeoescesesosoesceoe 74 9 1 Database NNN 74 9 2 Scrolling the Database View sessesessesessssesssoesssoesssoesssoesssoesssoesssoesssoesssseosssesssseoseseo 75 9 3 Sorting Database Information ccccsccscscscsccccscsccccccscsceccccscscescccecscuceccecscscescececscesess 75 9 4 Manual Selection of Database ReCOIds cscscsccscscsssccscsceccccscscsccccccscsceccccscsceceececnces 76 9 5 Automatic Selection of Database Records cscsscscscscsccscsceccccccscsccccccscsceccececscesescecs 76 9 6 Viewing Detailed Results cccscsssccscscecsccscsceccccccscsccececscscescececsceseccecscucescececsceseesecs 77 9 7 SE SONG EE n 77 9 8 Managing Database Records ien tos aepo nn eae NUN P NVP An SUN VAY RE FRNVINUSU UN UU VAN UnSyUR SEP ENS YNT MN OSR ENS 77 9 8 1 Se 21 sol BY e EE ee een S eee eC ee ee ee eee eee 77 9 8 2 PVC ES EE UU TT 78 9 8 3 EDON EEE EE EEE EN AR 79 9 8 4 Fs LS JE EE EE 80 9 8 5 Save iT aD EEE EEE EEE ERE 80 9 8 6 ND 81 9 8 7 De 81 10 COIDFGLOD RR ERE EE AE EN 82 10 1 Calibrating the Hemolyzer 5 ccscsccscscsccccscsccccccscsceccccecscsccccecscsceccecscscescececscesescecs 82 VIE VINN 84 11 NON 86 11 1 Set QC Reference s ssesessesessssessssesssoesssoscssoeossoecsssesssseossseossssossssossosossssossssossssoesseoeee 87 LE
29. a Back and Save button The Save button saves any changes made and returns to the Settings panel and the Back button discards any changes and returns to the Settings panel 13 1 Customize Settings The Customize panel allows you to customize the Hemolyzer 5 analyzer user interface language and other preferences about the analyzer operation Click or tap the Customize button on the Settings panel to access the Customize panel 92 Usermanual eo English United States J E REGER 100 1008 100 None FE FE Am Figure 72 Customize Settings Panel On the Customize panel you can change the following settings e Language select the language that the Hemolyzer 5 analyzer user interface uses to communicate with the operator Available languages are English US English UK Hungarian Polish Turkish and Italian e Limit style select Number Graphical1 and Graphical2 display modes to change the display method for parameters outside the normal ranges on the result screens and printed reports e Sound volume modify the sound volume up or down e Onscreen keyboard active Select whether to use the on screen virtual keyboards for displaying information or an external keyboard e Patient s displayed data choose Name or Patient ID as the patient identifier displayed in the Measurement panel 13 2 Laboratory Settings The Laboratory settings panel allows entry of seven lines of t
30. alone The analyzer should always be moved by two persons holding the analyzers by its sides in an upright position Always use safe lifting procedures when lifting the analyzer Make sure to retain the original packaging material for safe transportation and storage in the future To prepare the analyzer for shipping storage or extended periods of inactivity please drain the reagents and repackage the Hemolyzer 5 in its original packaging Do not expose the Hemolyzer 5 to direct sunlight extreme temperature or humidity 28096 The analyzer operates with chemically and biologically active reagents Physical contact with these reagents should be avoided Please read reagent descriptions carefully for possible emergency actions 10 Usermanual To ensure reliable operation and reliable results Only human blood samples should be analyzed Only genuine Analyticon reagents should be used Required maintenance user and service level should be performed as recommended in this manual Only Analyticon certified service personnel should perform service actions Only genuine Analyticon service materials and spare parts should be used Genuine reagents and service materials and spare parts are available from Analyticon Only Analyticon certified service personnel that have successfully completed the Analyticon Hemolyzer 5 Service Training program are qualified to service the Hemolyzer 5 analyzer Before operating t
31. define QC target values not allowed to perform Calibration 13 9 Date and Time Adjustment Double click or tap the time display on the bottom right side of the screen to display a time date settings panel Change the time and date as needed and select OK to save or Cancel H lin M Database Figure 79 Time Date Settings The Hemolyzer 5 analyzer does not support automatic time zone or daylight savings time changes Please change the time and date manually as needed 99 Hemolyzer 5 14 Instrument Diagnostics This section allows performing diagnostic steps and checking operation history or so called log files Database Database Calibration Maintenance 14 1 1 Self Test Of The Analyzer Initiating a self test will test the key functions and components of the analyzer The process nae takes approximately one minute and gives evaluation of each parameter The acceptable ranges of each tested parameter or function can be found in the following table Tapping any tested parameter s small box gives detailed information of the parameter limits and comments Voltage Limit low Limit high Current Limit low Limit high Offset By using the Load last selftest function you can check the results of the previous self test sequence 100 Usermanual Self test checks parameters for the ranges defined below Big puffer time 3000 13000sec 3000 5500sec
32. disk There is a spring applied to the axis screw This will guarantee the necessary closing force for the two disks Gently press and rotate the axis screw clockwise until it clicks into the lower part Twist the axis screw until it stops The mechanical design of the screw prevents over tightening 8 Mop the surrounding of the shear valve again You can let the salt crystals and other small parts fall down Sweep any particles at the bottom of the Hemolyzer 5 though the ventilation holes Remove the gloves Close the front door Click tap the OK button this informs the Hemolyzer 5 that you completed the operation The Hemolyzer 5 will check the movement and end positions of the shear valve 111 Hemolyzer 5 15 1 7 Cleaning the Washing Head The washing head cleans the outer surface of the aspirating tip with diluent Any salt build up on the lower surface may cause malfunction during operation The wash head must be removed from the needle assembly for correct cleaning Open the front panel and secure it with the support bar The right side panel of the analyzer must be removed to access the wash head Loosen the 2 2 screws on the front and rear of the side panel The panel can be pulled off the analyzer Locate the sampling needle Be careful The sampling needle is sharp and can cause injury The wash head should be twisted off from the needle and pulled off downwards Use a soft cl
33. external LIS if configured to do so The Hemolyzer 5 performs a cleaning rinse of the internal pneumatic components and prepares to measure the next sample 63 Hemolyzer 5 8 Result Interpretation This chapter provides description about interpreting and understanding reports provided by the Hemolyzer 5 analyzer 8 1 TheResult Screen a Measure 24 Patient id 14 08 2009 11 20 Mode E 2 gl fl pg gl fl pi fl fl NG s OG Accept blank Figure 49 Hemolvzer 5 Result Screen The Hemolyzer 5 analyzer result screen is divided into 4 major areas 1 Sample identification information contains identifying information used to uniquely identify this sample s information 2 Parameter information contains parameter names values units and normal range Normal range linearity and high blank flags are also displayed in this area 3 Histograms and scatter diagrams Visual elements that provide information about the measured population dispersion These are active elements that can be individually magnified by clicking or tapping 4 Warning flags area this area displays warning interpretive and morphological flags associated with this sample If flag display overflows its assigned space an ellipsis will be displayed and the user can click on the information icon to see a detailed display of flags 8 2 Sample Identification Information This part of the results screen contains informa
34. first sample processed and sample J10 is the last 7 4 2 1 Full Scan Mode Full Scan mode is suitable for laboratories where e There are batches of samples with the same sample mode e Barcode labels are in use and e AnLIS system rather than the Hemolyzer 5 is used to associate patients with sample results In Full Scan mode it is possible to add more samples to the batch after starting the automated measurement As usual an accepted blank is necessary before starting automatic sample processing 53 Hemolyzer 5 Measure BETEL ERT Measure Database Standby AS state Standby 100 22 31 Error Cal PE Figure 37 Full Scan Automatic Processing Mode On the Full Scan mode panel you can e Return to the AS panel to select a different type of automated measurement by using the Back function e Select a common measure mode for all samples in the tray e Swap between the tray and list views by using the View list and View tray functions e Start the automated measurement by clicking or tapping on the Start button on the GUI 54 Usermanual Measure Database 9 e under meas 9 9 under meas Position Sample status Unknown Position Sample status Unknown Measure type Full scan Tray status Measure type Fullscan mode Tray status STARTED AS state 09 05 Loading Figure 38 Full Scan Mode Tray View Progress After starting the automated measurement in Full Scan mode the Autosampler
35. is required name sample ID target value etc If the check box is left unchecked then the on screen virtual keypads are not presented and an external keyboard is required for data entry If the check box remains checked the external keyboard can still be used by pressing the ESC key on the external keyboard to dismiss the on screen virtual keyboard and complete the data entry using the external keyboard 5 5 Using the On Screen Virtual Keypads There are three types of virtual on screen keypads e Alpha numeric with shift and symbol options e Numeric only e Date The particular virtual on screen keypad presented is tailored to the data entry required If only numeric values are accepted than a numeric only keypad is presented For selection of dates a date keypad is presented The touch pad of the Hemolyzer 5 handles single taps only The Shift and Symbol keys are sticky on the virtual on screen keypads like the caps lock on a PC key board Click tap on the appropriate buttons to type in the required value Complete the operation by clicking tapping the Done button The Symbols button presents special characters such as the question mark or ampersand DON GLT ES ETE e d E EE E E Es MEL NNI Eos oes LL ILU ne Backspace Cancel Figure 15 Alohanumeric Virtual On Screen Keypad 31 Hemolyzer 5 ES ES ESTE ETE a ee o CCITT Terese ee zT de ee Figure 16 Sticky Shift and Symbol Bu
36. laser beam position Fine calibration with calibration material Polystyrene micro particle or Polystyrene microsphere 5Um Hemolyzer Diluent 20 liter Hemolyzer 5 Lyser 5 liter Hemolyzer 5 Diff 5P 1 liter Hemolyzer Hypocleaner 100 ml Emergency cleaner WBC BAS 1 170 RBC PLT 1 21250 4 DIFF 1 50 Diluent D Check 3P Manufacturer R amp D Systems Levey Jennings charts QC database Pathological diagnostic flags Lab limits normal ranges Reagents alert 3 measurement prealert online reagent replacement Instrument alerts internal puffer for reagents Manual and SW supported automatic mode English menu and support for other languages Via USB 100 000 records including flags scatter and histograms VIA C7 1 8 GHz processor Windows XP Embedded 800 x 600 color graphic LCD portrait layout 139 Hemolyzer 5 External printing External keyboard Bar Code reader Peripheral ports Power requirements Main fuse Operating temperature Maximum relative humidity Guidelines for transport Via USB port any Windows XP compatible printer Via PS 2 or USB Optional Manual bar code reader via USB Built in Bar Code in the Auto sampler USB 2 0 4pc Ethernet PS 2 Power supply input 100 127VAC 200 240 VAC 47Hz to 63Hz Power Consumption maximum 400 VA F 10A H 250V 15 30 C 59 86 F 8096 The instrument in its export package should fulfill the following transport storage conditions
37. of the Hemolyzer 5 built in speaker On screen keyboard active Turn off on screen virtual keypads for use with an optional external keyboard Patient s displayed data Patient identifier visible in the database display Laboratory Eight lines of text of lab information be displayed on each printed page External devices Sending port baud rate Select transmission rate for serial LIS Automatic LIS Select whether to automatically transmit results each time a sample is processed LIS Select Ethernet LIS connection IP IP address of Ethernet based LIS host computer listening port Port Port number of Ethernet based LIS host computer listening port Bidirectional LIS Selects whether Autosampler information downloads are allowed System Waste container volume Selects a 10L 20L or no waste container direct to drain Database display limit Selects all or only last month of database record display Use only Sarstedt Monovette tub from sample rotor Change sampling adjustments to accommodate Sarstedt Monovette tubes Standby time Time period of inactivity before the Hemolyzer 5 automatically enters standby Offline rinsing frequency Time period of inactivity before the Hemolyzer 5 performs an offline rinse to keep the pneumatic system in peak operating condition Screen saver Time period of inactivity before screen saver takes effect Special flags G A B Select whether G A and B flags are displayed Units HGB unit Se
38. operation you performed When an error comes up the software will most of the times try to offer solutions or will try to resolve the problem and retry the current operation If this recovery process fails or the problem keeps coming back please contact your service engineer 18 1 1 Software error messages If Windows XP Embedded operation system errors come up please accept the error message and repeat the operation If there are any other errors please restart the Hemolyzer 5 At the next service visit please let the service engineer know about the problem Low level error messages provide status information about data acquisition system and pneumatic system Each Error message includes the affected part and the area of the equipment Check this area and part to find any irregularities like clogging mechanical problems blocked elements Try to repeat the operation The system will try to recover from the failure Would it not go away please contact your service personnel 120 Usermanual 18 1 2 Pneumatic error messages The analyzer software is designed to be error tolerant and as such it is able to deal with minor problems However if some physical obstructions or extreme operating conditions cause some mechanical parts to behave unexpectedly the system will give you an error message Pneumatical error please retry the operation If this error amp A persists please contact the servicel With the OK butt
39. sample tubes 5 1 Using the Touch Screen The touch screen is a pressure sensitive overlay on the screen of the Hemolyzer 5 It allows selection of menu items and pressing of buttons by gently pressing or tapping the surface over the selected item This method is called tapping The touch screen device used in the Hemolyzer 5 analyzer is selected for reliability endurance and compatibility with the medical laboratory environment Simple operations are supported but multi touch gestures or multiple tapping are not supported The touchable items on the Hemolyzer 5 user interface are designed to be large enough to tap with finger The use of a tapping tool may be useful if the operator has larger or thicker fingers or when wearing oversize gloves A tapping tool can be pencil eraser or a specially designed stylus available at computer or consumer electronics stores Do not use sharp or heavy objects to operate the touch screen The surface material is moderately resistant to liquids Avoid touching the screen with wet fingers or allow liquids to come in contact with the screen or the surrounding area If you find that the Hemolyzer 5 touch screen responds in a different area than the one you are tapping then please perform a touch screen calibration procedure before calling for service or support See chapter 15 1 5 for more details on touch screen calibration and other maintenance procedures 5 2 Using the Start Button Th
40. sees 65 Figure 52 Graphical Normal Range Display rrrrnrrrnnnnnnrnnnnnnrrnnnnnrrnnnnnernnrnnnrrnnnnnernnnnnernnnnnenennnnnsnennnneeene 65 Figure 53 Result Screen Scatter Diagrams rrrrnnrnnnnnnnnrnnnnnnrnnnnnnnrnnnnnnrnnnnnnnnnnnnnennnnnnevnnnnnesennnnnsnennnnesene 67 Figure 54 Result Screen Histograms rrnnrnnnrnnnnnnrrnnnnnnrnnnnnnrnnnnnnnnnnnnnnrnnnnnesennnnnennnnnnesennnnesennnnnenennnnesene 67 Figure 55 Warnings Section of Results SCreen rrnrnnnnrnnnnnnrnnnnnnnrnnnnnnrnnnnnnnnnnnnnsvnnnnnevnnnnnssnnnnnnssnnnnneeene 68 Figure 55 ACCESSING the Database Lee 74 Figure 57 Scrolling ET 75 Figure 58 Multiselect and Multiple Selection rrrnrnnnrrnnnnnnrnnnnnnnrnnnnnnrnnnnnnrrnnnnnennnnnnevnnnnnesennnnnsnennnnseene 76 Figure 59 Manage Records PvP 77 Ped 78 Fel SENT 79 Figure 62 Directory Panel Tor Data STO NE Lee 80 Figure SANN NNN OO ES 82 Figure 64 Calibration Panel and Calibration Run Result Panel rrrrrnnnnnnnnrrnnnnnnnrrrnnnnnnnrrrnnnnnnnsernnnnnn 83 Figure 65 Calibration Factor Panel enata ta Ee Econ sto ka REF exer v RE ranan Baa bera To eee EP onte eder Uto E EET R er R dp 84 Figure 66 View Calibration Panel rrrrannrnnnnnnrnnnnnnrrnnnnnnrnnnnnnrrnnnnnennnnnnevnnnnnnnnnnnnnsnnnnnnevnnnnnesennnnnssennnnesene 85 Pie UNN 86 Pee NENNE epo eG E MUbME EE chon iu up EP UP ed URUEE 87 Figure 69 View OC Diagrams FINO Ness essseionis ue aie stole Sed tussi Lap ats suc iemE iu MEC AME 88 Fe PN pp 90 Fe
41. shear valve as well if necessary Pay attention to clean the aligning surface Be sure that no lint fibers remain on the connection surfaces of the ceramic disks 5 After cleaning the shear valve the housing and surrounding area put the disks together 6 Put the axis screw into the upper disk Gently press and rotate the axis screw until it sinks into the upper disk until the shoulder 7 Firmly push down the axis screw against the spring and start to screw it in Before fastening tight the axis screw be sure that the grooves on the disks positioned similar to the position on the picture Fasten the axis screw hand tight You will clearly feel if you reached the end of the screw The spring adjusts the compressing force you can t block the movement of the shear valve by over tightening the axis screw 8 Clean the surrounding of the shear valve again You can let the salt crystals and other small parts to fall down Sweep any particles at the bottom of the Hemolyzer 5 though the ventilation holes Remove the gloves Close the front door Click tap the OK button this informs the Hemolyzer 5 that you completed the operation 109 Hemolyzer 5 15 1 6 1 Shear valve with one circle of nozzles Any salt build up on the inner surface of the shear valve may cause malfunction during operation To avoid this problem it is recommended to clean the shear valve after every 1500 samples Below ins
42. the Levey Jennings charts for control measurements AS state 100 100 none EBL JL Figure 68 View QC Diagrams Panel Means standard deviations StDev and coefficients of variation CVar are calculated based on the QC analyses The dotted lines delineate acceptable ranges on Levey Jennings charts Use the selector 88 Usermanual control at the top of the panel to view graphical control information for other lots of control materials 89 Hemolyzer 5 12 Patients The Hemolyzer 5 analyzer allows the operator to define and store patients in the patient database during manual measurement Patients can also be predefined while creating a list for one of the automatic processing modes Select the Patients icon on the main menu to display the Patients panel Demo Dino 11111999 Horv th Kazimir 11 14 1981 Fekete Krampusz 7 26 2001 Fo Kolompos 9 14 1993 Kovacs Lajos 2 10 1961 Gipsz Jakab 8 8 1991 Dingo Dongo 4 26 2001 John Smith 5 8 1971 1 2 3 4 5 6 7 8 Calibration Maintenance 00 100 100 0 em SBE PRE w muB Figure 69 Patients Panel The Patients panel displays patient information in the familiar table format of the Hemolyzer 5 analyzer database and operates the same way as the database panel Use the New function to define new patients and Edit to change existing patient information Details displays patient data in a read only mode The Patient panel can also be accessed by cli
43. will scan all the sample positions on the tray Any rows with missing racks will be skipped The Autosampler can detect the tube type and whether the tube has a cap Sample tubes will be skipped if it has no cap or the Autosampler cannot determine the tube type The Autosampler then mixes the sample tube and reads the barcode label if one is used The sample tube is then moved to the aspiration position where the sample is aspirated and measurement is performed The aspiration and measurement process is the same in automatic mode as in manual mode The sample tray progress can be followed in the tray view or the list view The results for completed samples can be reviewed by clicking or tapping on a completed sample The patient ID is not editable in the Full Scan mode as it is automatically set to the default patient The sample ID is not editable as it is read from the barcode label If the barcode label is missing or not readable the Hemolyzer 5 analyzer assigns a default value and allows manual entry of the sample ID 55 Hemolyzer 5 3l EIE MEE CNN 4079 11 02 2010 22 34 22524100022 4080 11 02 2010 22 35 22527100022 11 03 4081 11 02 2010 22 36 20417100022 6 18 4082 11 02 2010 22 37 20415100022 11 02 2010 22 38 21011100022 Multiselect l oll f f f ff ef olf ll ll DEECEEEEEEEC all all sl i al sil sil s s si c EEEEEEEEEE EEEEEEEEEE Cd 4 4 4 4 4 1 1 1 mm ol i ure o Measure mode ample pos Mea
44. you can leave Hemolyzer 5 on for the rest of the day It will go into a low power state after a specified time 15 1 10 Special Cleaning Procedure Despite regular cleaning Emergency cleaning procedure is advisable if the blank measurement result is too high or unacceptable result appear during the measurement or calibration Use the built in cleaning process in the maintenance prime and clean clean menu and check the proper result with a blank measure If the blank is still too high use the built in hard clean process and check the proper result with some blank measures If the blank is still too high use the built in internal diluents reservoir cleaning process and check the proper result with some blank measures 113 Hemolyzer 5 15 1 11 Replacing Reagents Hemolyzer 5 is designed to be able to run continuously without the need to stop if a reagent container needs to be replaced To support this feature internal buffers keep regents sufficient for Measure Database Print one measurement cycle The analyzer will warn the user when a reagent is about to run out An exclamation mark within a yellow triangle will be displayed by the reagent level indicator To facilitate replacement double tapping on the exclamation mark takes you to an explanation Measure Database Print screen Pressing the Go to button will take you further to the reagent status screen 114 Usermanual To replace reagent conta
45. 1 1 7 1 Main Unit Sample volume Closed and Open mode 110 ul Sample type Human whole blood K3 EDTA anticoagulant Tube Identification By means of the front panel keyboard enter ID By means of the barcode labels manual and or auto sampler Sampling method Ceramic shear valve with 3 separated primary loops Measured parameters CBC 5DIFF mode 24 parameters WBC LYM MON NEU EOS BAS LYM MON NEU EOS BAS RBC HCT MCV RDWsd RDWcv HGB MCH MCHC PLT PCT MPV PDWsd PDWcv Throughput 60 tests hour Measurement method Volumetric impedance change for WBC RBC PLT Spectrophotometry for HGB Light scattering 4 diff measurement LYM MON NEU EOS Light scattering BASO measurement Aperture diameter WBC 80 um RBC PLT 70 Um 138 Aperture length HGB measurement Usermanual WBC 80 um RBC PLT 70 Um Light source green LED with 540 nm wavelength Detector light to frequency converter Optical measurement Light source semiconductor laser diode with 650 nm wavelength and 7mW Class IIIB laser module if the protective housing is closed Auto alignment system Reagents Dilution ratios Sheath fluid Control material Quality Control Flagging Calibration Languages available Software upgrade Data storage capacity Data processing Data store Display Quartz flow cell with hydro dynamic focusing Detector fiber optic coupled PIN Si photodiodes Internal safety interlock Horizontal calibration of
46. 2010 9 49 AM Figure 65 View Calibration Panel To delete a calibration click or tap the Delete button The system will ask you for a confirmation password to avoid accidental deletion of calibration data The confirmation password is set at the factory to 555 and can be changed by your Analyticon certified service engineer 85 Hemolyzer 5 11 Quality Control Regular use of quality control QC ensures that the Hemolyzer 5 analyzer is operating optimally Stable recovery of standard QC material parameters assures the operator that the Hemolyzer 5 is operating consistently on a day to day basis and is functioning correctly By analyzing control materials on a regular basis day to day reproducibility and general condition of the analyzer can be monitored Target values and acceptable tolerance ranges for each parameter can be specified for an unlimited number of QC materials Control materials must be used before their expiration date Always observe the control manufacturer s instructions for storage and use Control materials must be well mixed before use Analyticon recommends the use of CBC 3K controls from R amp D Systems The Hemolyzer 5 analyzer does not limit the number of QC material lots or the number of QC measurement runs that are stored in the control database Each QC measurement run is saved to the selected QC material lot QC lots can be commercial control materials or a whole human blood sample
47. 24 BT DEN hr 125 I8 9 NN 125 18 1 9 Electronics Related Problems rrrrrnnnnrrnnnnnnnrrnrnnnnnrrnnnnnnnrrnnnnnnerrnrnnneerrnnnnnesrnnsnnnesennsnnnessnnsnnnsssennnn 126 18 1 10 The Analyzer Does Not Power On ararnnnnnnrnnnnnsnnnnnnrnnnnnsrnnnnnsrnnnnnsnnnnnsrnnnnnsnnnnnesnnnnnnsennnnnsnnnnnesennner 126 18 1 11 126 Errors Displayed At StartUp R e 126 18 2 Measurement results related problemS sessssesessesessesesssoesssossssoesssoessssesssoessssesssses 127 18 2 1 Fluctuating PLT background Values csceces auge dba p rato Uno DUE EY tu EE ES ECL I eo YR SERV ka uv eu vx VES Dens 127 18 2 2 Long smeared population essseessssseseseeeeene enne nennen nnn nnne innen nns sna anne sa aris s annes ans 127 Usermanual 19 MESNA 128 20 Known PD ee 129 21 APP 130 VEE 130 Pie 127 DENNE 131 TEN ENN 132 21 1 4 Printed Report Format seega top Uns G nu t Lee pet LU tu mI ease UE ERa d nitate px cu dadens 133 PH Mere dt m 137 GE NTN 137 PX P MM enel DAI Rm 138 2118 PENN 141 LLEF RNA ee 144 TD EN 145 22 NOX NN 146 Table of Figures Figure 1 Hemolyzer 5 with Autosampler Space Requirements rrrannrnnnnnrrnnnnnnrrnnnnnrrnnnnnnrrnnnnnsrnnnnnneene 13 Figure 2 Hemolyzer 5 Without Autosampler Space Requirements rrrnrnnrrrnnnnnrrnnnnnernnnnnnrrnnnnnevennnnseene 14 Figure 4 Volumetric Impedance Method rrrnrnnnnrnnnnnnrnnnnnnrrnnnnnnrnnnnnernnrnnnennnnnnennnnnnevnnnnnssnnnnnnsnennnneeene 22 Figure
48. 66 69 73 74 75 76 144 blank 24 37 42 44 47 52 53 54 56 57 60 62 67 68 69 72 73 74 81 86 87 91 110 117 122 123 142 C calibration 21 33 41 43 44 52 85 86 87 88 112 117 123 130 144 cleaning 3 27 40 42 46 55 66 72 73 74 75 110 111 112 114 115 116 117 123 126 128 131 134 clogging 72 74 75 117 124 126 D diluent 142 Diluent 11 22 30 111 134 144 149 dilutor 126 129 E EDTA 50 51 122 143 EOS 20 21 22 23 25 76 136 143 144 146 147 149 F flow cell 25 73 75 144 H hemoglobin 142 HGB 20 21 22 23 24 30 40 44 66 73 85 99 105 136 142 143 144 146 147 148 149 150 hypochlorite 23 impedance 23 24 29 30 66 70 144 K keyboard 14 16 29 33 34 37 40 54 68 81 96 133 143 145 laser 20 25 26 31 144 LYM 20 22 23 25 68 74 76 99 136 143 144 146 147 149 150 Lyse 11 22 28 30 106 120 134 144 149 M maintenance 12 13 19 27 33 41 42 72 107 109 110 117 122 123 131 MON 20 22 23 25 68 72 74 76 99 136 143 144 146 147 149 150 146 Usermanual N needle 12 27 30 44 50 55 66 116 127 NEU 20 21 22 23 25 68 72 73 76 99 136 143 144 146 147 149 150 noise 75 110 126 normal ranges 40 52 54 60 62 68 96 100 144 P PLT 20 21 22 23 24 40 44 66 70 72 73 74 76 85 99 131 136 142 143 144 146 147 148 14
49. 7 53 8 12 8 216 36 6 19 9 136 Patient ID 5 540 0 17 2 9 86 8 10 2 0 17 87 0 9 8 0 15 87 2 10 2 0 20 3 6 87 4 9 9 0 15 86 6 99 0 14 2 5 86 6 9 7 03 06 2010 14 20 Date 588 25 01 2010 16 48 0 03 0 5 29 0 0 002 25 01 2010 16 49 0 03 0 5 28 5 0 002 25 01 2010 16 50 0 02 0 4 29 0 0 002 25 01 2010 16 51 0 03 0 6 28 9 0 002 25 01 2010 16 52 0 02 0 4 29 0 0 002 25 01 2010 16 53 0 03 0 6 292 0 002 Usermanual 21 1 5 Specifications 21 1 6 Measured Parameters White Blood Cells WBC cells l cells ul Red Blood Cells RBC cells l cells ul Hemoglobin concentration HGB g dl g l mmol l Mean Corpuscular Volume MCV fl Hematocrit HCT percentage absolute Mean Corpuscular Hemoglobin MCH pg fmol Mean Corpuscular Hemoglobin Concentration MCHC g dl g l mmol l Red Cell Distribution Width RDW SD fl Platelet Distribution Width PDW SD fl Red cell Distribution Width RDW CV absolute Platelet Distribution Width PDW CV absolute Platelet PLT cells l cells ul Number of leukocytes WBC WBCcal x cells I cells ul Number of erythrocytes RBC RBCcal x cells I cells ul Measured photometrically at 540 nm in each cycle blank measurement is performed on diluent HGB HGBcal x HGBmeas
50. 9 150 pressure 33 126 printer 14 38 40 65 99 100 145 Q QC 7 11 20 41 43 44 52 53 54 56 77 89 90 91 92 103 120 122 123 133 134 144 R RBC 20 21 22 23 24 30 40 41 44 66 70 72 73 74 75 76 85 99 136 142 143 144 146 147 148 149 150 reagent 3 12 22 23 24 28 30 36 39 41 42 46 47 48 49 72 97 106 111 118 119 120 122 123 129 145 reagent consumption 3 46 49 106 S sample ID 34 37 52 54 55 56 59 62 68 sampling needle 12 27 50 110 116 117 shear valve 27 42 44 66 111 112 114 115 126 128 143 shear valve 32 112 113 114 115 116 standby 28 33 36 40 43 48 98 T touch screen 20 27 33 34 78 130 tubing 23 28 32 42 44 47 48 111 123 149 U USB 20 29 33 54 83 84 120 130 145 W wash head 110 116 126 127 waste 12 17 19 28 30 36 40 41 42 47 48 97 119 121 132 waste container 19 36 40 42 47 48 97 132 WBC 20 22 23 24 25 30 40 41 44 66 72 74 75 76 85 99 105 136 142 143 144 146 147 148 149 150 diagram panel 147
51. DWsd fL 510 820 RDWcv 96 11 0 16 0 PLT 10 uL PDWcv PDWsd MPV PCT Warning flags Morphological flags Interpretive flags Microcytic RBC Hyperchromic Thrombocytosis Microcytic PLT Doctor 134 Usermanual AX analyticon Lab header 1 02 02 2011 12 43 Lab header 2 Lab header 5 Lab header 3 Lab header 6 Lab header 4 Lab header 7 Sample ID WBC NEU LYM MON EO BAS Mode NEU LYM MON EO BAS Patient ID RBC HGB HCT MCV MCH MCHC RDWs RDWcv Date PLT PDWcv PDWsd MPV PCT 11 6 15 1 28 4 02 062 0 15 0 09 Human 208 05 3 10 1 2 4 1 4 1 3 94 90 29 0 73 8 228 310 39 9 13 3 10 01 2011 15 54 501 40 5 16 5 7 3 0 37 135 Hemolyzer 5 analyticon Sample ID Measure type wec NEU LYM MON NEU S LYM MON REC HGB HCT MCHC ROWsd RDWev PLT POWCV POWsd ny20489 Human 5 74 4 05 1 15 0 35 70 5 20 0 6 1 4 74 137 0 41 334 52 9 12 6 216 37 1 21 6 ny20489 Human 5 56 3 95 1 05 0 36 71 1 18 9 6 4 4 81 137 0 42 328 512 12 4 201 37 2 20 6 ny20489 Human 545 3 91 1 02 0 35 717 18 7 6 4 4 77 138 0 42 333 50 7 12 2 238 37 0 21 6 ny20489 Human 5 52 3 84 1 08 0 36 69 6 19 6 6 6 4 85 140 0 42 330 49 6 12 1 216 37 0 20 3 ny20489 Human 549 3 83 1 08 0 41 697 19 7 7 5 4 78 139 0 41 335 49 9 12 1 224 36 4 20 1 ny20489 Human 5 57 3 91 1 13 0 36 70 2 20 3 6 4 4 70 137 0 41 33
52. During WBC count there is too much more than 1096 of the total Perform Clean process Perform Hard Clean process 7 WBC noise high detected pulse on the first 10 channel of the 255 channel full range This may be caused by lyse resistant RBC electronic noise contaminated WBC chamber or contaminated reagents Table 12 Warning Flags Morsholosiealfie iud flags are raised when the presence of morphologically abnormal cell types such as immature granulocytes are B Blasts NOT FOUND e The count in the region of low high angle scatter of Hemolyzer G Perform a manual count on a stained smear Immature granulocytes 5 where the Immature granulocyte typically located is gt 3 of the total WBC count The count in the region of low high angle scatter of Hemolyzer Atypical lymphocytes 5 where the atypical lymphocytes typically located is gt 196 of the Perform a manual count on a stained smear total WBC count Table 13 Morphological Flags Interpretive flag Interpretive flags infer the presence of distributional abnormalities such as leukocytosis Flag Meaning Leukopenia WBC Leukocytosis Neutropenia Neutrocytosis Lymphopenia 72 Usermanual Table 14 Interpretive Flags 73 Hemolyzer 5 9 Database Functions The Hemolyzer 5 database stores all measured data including sample results QC and patient data Each sample result stored includes the complete parameter list histograms flag
53. EE EE ee ae 15 1 1 9 Known LIMITATIONS rranonnernrnnrnnnrnnnrrrnnrnnnrnnnrnrnernnnvnnnensnnrnnnsnnnsnnnnnnnesnnnsnnnnrnnnennnsnnnnvnnnsnnnsnnnnennnsnnneene 15 LEIO Re 15 PROGUCE NN 16 dicil EEE EE 17 3 1 Pre 17 3 1 1 The Hemolyzer 5 Analyzer Package pLvvvrv4v4v4r4r4rdorrs eee 17 3 1 2 THE Yirro njsli iaiu re c ue n 17 General Overview and Principles of Operation eee ee ee eene ee eene enne nnn 18 4 1 General NENNE 18 4 1 1 Messured Parattiel Je INN edu etn UM NE RI On edu pa UR oE IM e eeu PETIERE 18 4 1 2 Approved Reagents and Control Materials sess 19 4 1 3 Genuine Analyticon ReagentS rrrrnnannrnnnnnnrnrnnnrrnnnnnrnnnnnnrnnnnnrrnnnnernnnnnernnnnnsennnnesnnnnnernnnnesennnnssnnene 20 4 2 Principles of Operation reravnvnsvnnnnnvnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnsnnnnnnnneneene 22 4 2 1 Volumetric Impedance Method rrrannnnrnnnnnnnrrnrnnnnnrrnrnnnnnrrnrnnnnnsnnnnnnnnsnnnnnnessnnnnnnessnnnnnnsssnnnnnnessennnn 22 4 2 2 Photometric Light Absorbance Method rrrrrnnannrnnnnnnrnrnnnrnnnnnnrnnnnnrrnnnnernnnnnsrnvnnssnnnnnssnnnnssennnnssenne 23 4 2 3 Optical Light Scatter and Diffraction Method rrrrannnrrnnnnnnnrrnnnnnnnrrnnnnnnnrrnnnnnnnrrnnnnnnnsrnnnnnnsssnnsnnner 23 4 3 Inside the Hemolyzer 5 Analyzer cecsccscscscsccccscsccccccscnceccecscsceccccecscsceccccscsceccececnces 25 4 3 1 Front EE a Saiea cies tecietvent es o
54. F WBC differentiating id j measurement If the problem persists then ask for service If the total WBC count is below 2 103 cells ul then perform a manual count on a stained smear X Baso error Not enough cells detected during the Baso WBC differentiating Perform a flow cell cleaning procedure Repeat the measurement If the problem persists then ask for service RBC measurement statistics clogging non homogeneous sample cold sample partial warning coagulation of the sample Repeat the measurement or perform a manual count on a stained smear Perform cleaning of the Hemolyzer 5 Perform a self test If vacuum problems persist then call for service Perform cleaning of the Hemolyzer 5 Perform a self test If vacuum problems persist then call for service 71 Hemolyzer 5 EE Warning flags are raised when the analyzer detects a problem in the analysis process that may cause incorrect or suspect results or the SUE parameters in the valid blank measurement was too high Flag Cause Differential percentage Algorithm error while distinguishing the WBC s in the 4DIFF Repeat the measurement If the problem persists on a given error procedure sample then perform a manual count on a stained smear Algorithm error while distinguishing the WBC s in the BASO Repeat the measurement If the problem persists on a given y Baso percentage error procedure sample then perform a manual count on a stained smear
55. Full Scan mode the Autosampler will scan all the sample positions on the tray and rows with missing racks will be skipped The Autosampler will only process tube types it recognizes with caps attached The automated mixing aspiration and analysis process is the same as the Full Scan Mode and the progress can be followed in tray or list view The main difference between the Free List mode and the Full Scan mode is that the Free List mode identifies samples by matching them sequentially to the list and comparing their measurement results to the normal range associated with the sample mode selected for that sample Analysis Analysis Analysis timet timet time 4112 14 02 2010 17 12 563434 14 02 2010 17 12 563434 14 02 2010 17 12 563434 8 83 4113 14 02 2010 17 12 659008 14 02 2010 17 12 659008 4 85 14 02 2010 17 12 659008 4 85 4114 14 02 2010 17 12 Out Pat 4523 14 02 2010 17 12 Out Pat 4523 14 02 2010 17 12 Out Pat 4523 6 66 14 02 2010 17 13 Figure 43 Free List Mode Progress List View 58 Usermanual z j 1 ell 4 ESSE EIE el el el el e ol ol ol t el ej 5 A ER oll ofl off of a ofl ofl off fl ol gt eo O O m n Q z amp o o ej e e e ej el 4 ET 4 E 4 AR 4 P zu L 4 f Y 5 wg 0 O m m Q T CO Lai 94 4 H SE S M EIU AS g kl e EX M u B Sample status Ready osition Sample status Fre
56. OC MECS UE grar en EE E E TEE 88 11 3 ViCW OG Referente S Le 88 A VENN 88 115 VMS cesi isse vixi visa d a AEEA 88 12 Polens 90 13 SEUN OS EE EE EE EE 92 ISl C st mize SENNA 92 13 2 Laboratory Settings ccscecsccscscscsccccscsccccecscsccecccscsceccececsceseececscscescecscucescececscssessees 93 13 3 Pee 93 Hemolyzer 5 134 SEN SN 94 55 UG Saeed 96 156 Printer Sears OSEE 96 13 7 Profile Limits sa eere rH ERSESEEE ses uses sassvsensscavesssaveeyonsess vay RS EM I EMT MM M 97 ESSMESC E nncmeetem M ai 98 13 9 Date and Time Adjustment iuciosssec end au cuo Cx sa ad FERu E NN ECERNEAR UY QN Tk E dv XugA YE ORUM RE NERONE OX vl pug RdUEN eds 99 14 Instrument Diagnostics ua avus aso asd e narkomane EE Sra uad RPaE 100 1411 TONEN 100 EE Day LOL EE ENE EE EEE 102 14 1 3 Reagent Status MT 102 EE So EE NST E ORE 103 14 1 5 NNN 103 15 IV CUIIT CANCE aee 104 15141 Opening Ihe Front Panel EEE EE ien FERT 104 15 1 2 Cosine TME Front PINE kerren E ever 104 Bl Removing The ENN 105 15 1 4 User Maintainable Parts Of The Analyzer rrrrnnnrrnnnnnnnnrnnnnnnnnrrnrnnnnnrnnrnnnnnrnnrnnnnsrnnrnnnesernrnnnessennnn 105 15 1 5 Maintenance Programs In The Analyzer rrannrnnnannrnnnnnnrnnnnnrrnnnnernnnnnsrnnnnnsennnnernnnnnnenrnnesennnnesennnee 106 15 1 6 Cleaning The Shear Valve
57. RANTIES EXPRESSED OR IMPLIED INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE Exemptions Analyticon s obligation or liability under this warranty does not include any transportation or other charges or liability for direct indirect or consequential damages or delay resulting from the improper use or application of the product or the use of parts or accessories not approved by Analyticon or repairs by people other than Analyticon authorized personnel This warranty shall not extend to e Any Analyticon product which has been subjected to misuse negligence or accident e Any Analyticon product from which Analyticon s original serial number tag or product identification markings have been altered or removed e Any product of any other manufacturer Company Contact Manufacturer Analyticon Biotechnologies AG Address Am M hlenberg 10 35104 Lichtenfels Germany y Tel 49 64 54 79 910 Fax 49 64 54 79 9171 analyticon Usermanual Table of Contents POR VOUP rp d ARTT T UT 10 1 1 1 Who Should Use This Manual rrrrnnnnrrnnnnnnnrrnnnnnnnrrnnnnnnnrrnnnnnnnsrrnnnnnnnsrnnnnnnnssnnnnnnnssnnnnnnnssnnsnnnsssennnn 10 1 1 2 Special Symbols Used In This Manual ccccsseccccsssecceeececcaeccccenscccauseeesausceeseuscessenseessaesessanees 10 1 1 3 PENN 10 1 1 4 Environinental EEE 11 1 1 5 Electrical REQUIE CI NG 12 1 1 6 eS REGUIT aa EEE NU NEN 12 1 1 7 EE Te 0 LEGE 14 1 1 8 ME S DE ve E
58. Select Accept to replace the current calibration factors with the accepted factors Selecting Discard eliminates the entire calibration process 1 090 0890 0910 3 0990 0 990 1130 1130 RDWev 0930 0930 Param38 1000 1 000 Scatter X Scatter Y AS state Calibration measurement 100 Home 21 03 Figure 64 Calibration Factor Panel The automatic calibration process can be skipped by selecting the Manual calibration mode on the calibration panel and clicking or tapping the Next button proceeds directly to the calibration factor panel for manual entry of calibration values Manually entered calibration values can be accepted in the same way as calculated factors from calibrator sample runs and are treated by the Hemolyzer 5 in the same way 10 1 1 View Calibrations The view calibrations feature is helpful for reviewing the calibration history for the analyzer Increasing or decreasing calibration value trends over time may indicate a problem that requires service intervention To view the calibration history click or tap the View calibration function on the calibration panel The calibration history is presented in a table view that can be navigated in the same way as the database panel Any calibration can be deleted Deleting the last calibration causes the Hemolyzer 5 analyzer to revert to the last accepted calibration 84 Usermanual 4 9 2010 11 36 AM 1 9171
59. Types and Modes The Hemolyzer 5 analyzer is designed to process the following sample types e Whole human blood to determine the hematology parameters of the blood e Quality control QC materials for quality control purposes e Calibrator materials for calibration of the hematology parameters QC samples are artificially modified human or human and animal blood samples with known parameter values QC samples can be stored for a period of time as indicated by the manufacturer The Hemolyzer 5 analyzer works in the following modes The sample mode must be selected before a measurement starts e Blank mode No sample need be presented to run a blank Blank mode checks that the measuring system is operating correctly and that blank measurement results are acceptable e Human blood mode Choose one of five human blood modes Human Male Female Alternate 1 or Alternate 2 Each mode has a unique set of normal ranges associated with it e Control QC mode The hematological parameters of QC materials are known prior to analysis Controls are used to check the long term stability of the Hemolyzer 5 analyzer Calibration with a calibrator material is not one of the Hemolyzer 5 sample modes but a specific procedure that can be accessed from the Calibration icon on the main menu 7 3 Sample Identification The following sample information items are used to uniquely identify samples e Sample Mode e Measurement time assigned automatica
60. alyzer uses a combination of methods to provide measurement results e Volumetric impedance the Coulter method is used to determine the cellular concentrations and volume distributions of leukocytes WBC erythrocytes RBC and platelets PLT e Photometric measurement of light absorbance is used to determine hemoglobin HGB concentration e Optical measurement of light scattering and diffraction is used to determine five part leukocyte LYM MON NEU EOS BAS differential parameters 4 2 1 Volumetric Impedance Method The volumetric impedance method also known as the Coulter method determines cellular concentrations and volume distributions of cells by detecting and measuring changes in electrical impedance when particles suspended in a conductive liquid pass through a small aperture The method is volumetric because a small known volume of blood is precisely diluted with a conductive diluent and forced through the aperture at a fixed rate Internal electrode Aperture Jo Blood cell suspension External electrode Figure 3 Volumetric Impedance Method A constant direct current flows between the electrodes on either side of the aperture Each cell passing through the aperture causes a change in the electrical impedance of the conductive blood cell suspension This change is sensed by the Hemolyzer 5 electronics and converted to an electrical pulse The quantity of pulses is proportional to the number of particles
61. ame column heading again changes the ascending or descending order of values in the column 9 4 Manual Selection of Database Records Clicking or tapping on a row in the database display single selects a row Clicking or tapping it again de selects the row Selecting another row will de select previously selected rows in single selection Selected rows are highlighted with white text on a black background Checking the Multiselect check box below the left side of the database table allows the selection of multiple rows Tapping or clicking once selects a row but previous selections remain selected unless you Click or tap it again to de select it Un checking the Multiselect check box will de select all selected records LUE fem fe p 02 04 2009 16 16 Human 70 65 64 01 02 04 2009 17 31 Human 70 65 64 01 14 08 2009 11 01 Blank 0 0 14 08 2009 11 19 Blank 0 0 14 08 2009 11 20 Human 25 03 2010 16 50 25 03 2010 16 57 25 03 2010 16 58 25 03 2010 16 58 26 03 2010 10 58 26 03 2010 13 13 26 03 2010 13 13 30 03 2010 11 33 lalawisjaLis 11 NK Figure 57 Multiselect and Multiple Selection Multiple selections are useful for viewing managing and quickly viewing statistics of only a few selected records 9 5 Automatic Selection of Database Records When the total number of records in a database becomes very large manual selection of records can become difficult The Select by function in the Manage records panel provides
62. anel allows the user to choose which units are displayed for certain parameters The following options are available on the Units panel e HGB unit choose g dL or g L to change the displayed units for the HGB and MCHC parameters e Count unit Choose cells uL or cells L to change the displayed units for the parameters in the table below Table 16 Count Unit Parameters H ij Teer Measure Figure 75 Units Settings Panel 13 6 Printer Settings The Printer Settings panel lets you choose which installed printer to use view the status of the printer and change the print behavior of the analyzer during operation The following options are available on the Printer Settings panel e Printer select an installed printer to use e Printer status indicates the status of the currently selected printer 96 Usermanual e Color printing check this check box to print in color or uncheck to print in black and white e Double sided printing check this check box to print on both sides of the paper or uncheck to print on one side only This option is only available if your installed printer supports double sided printing e Items in queue indicates how many printouts are currently waiting in the printer queue e Cancel all jobs Click or tap this button to cancel printing and clear all items waiting in the printer queue e Printout format select Default Wide names or User printout formats
63. ange sampling depth automatically Standby time This defines the time period of inactivity before the analyzer automatically leaves the ready state and drains the pneumatic components to prepare for overnight standby If this time is set to zero the analyzer will never enter the standby state automatically Offline rinsing frequency this defines the time period between automatic fluidic operations to ensure that fresh reagents are available in critical pneumatic components so that the analyzer can quickly return to the ready state from standby If this time is set to zero the analyzer will never perform automatic fluidic operations while in the standby state but may increase the amount of time needed to return to the ready state from standby Screen saver this defines the time period of inactivity before the analyzer automatically starts the screen saver Entering a time of zero prevents the analyzer from every starting the screen saver Special flags G A Checking the check box disables the generation storage LIS transmission and display of the G and A flags on the screen printout Database columns order Waste container volume lt Database display limit 4 Use only Sarstedt Monovette tube from sample rotor Standby time 4 Offline rinsing frequency lt Screen saver lt Blank request time 4 Special flags G L Figure 74 System Settings Panel 95 Hemolyzer 5 13 5 Units The Units p
64. as pathological then perform a manual count on a stained smear The distribution of the RBC detection changes in time It points to WBC measurement clogging non homogeneous sample cold sample partial statistics warning coagulation of the sample Perform cleaning of the Hemolyzer 5 Check the homogeneity the temperature and the coagulation of the sample Repeat the sample WN The distributi f the RB i h in time It poi TN NE Perform cleaning of the Hemolyzer 5 Check the homogeneity the temperature and the coagulation of the sample Repeat the sample BloodDetector malfunction received signals are all zeros or not Check BD and its connection to the LSDACQ card Check sampling T Blood detector error i received signals tube connection to BD The number of the BASO population is high or there are lyse u Baso high resistant cells in the sample There is a partial clogging or leakage in the RBC part of WBC vacuum warning measurement system A faulty worn out pump can create vacuum errors as well There is a partial clogging or leakage in the RBC part of RBC vacuum warning measurement system A faulty worn out pump can create vacuum errors as well Blood Detector detected a sample volume that was too small Check sample volume in sample vial Check sampling process Re Sampling warning msn Perform a flow cell cleaning procedure Repeat the Differential error Not enough cells detected during the 4DIF
65. as they flow through the path of the laser beam An optical detector senses changes in the intensity of the scattered laser light which are proportional to the cell volume and granularity of the cell s internal structure The Hemolyzer 5 electronics convert these changes to electrical pulses which are gathered and stored for analysis Five part population discrimination is based on analysis of the two dimensional volume and granularity distribution scatter diagram Stream of WB Laser source Optical detector Scattered laser light Figure 5 Hemolyzer 5 Optical Head Block Dlagram Cells with greater volume or size or more granularity will tend to scatter greater amounts of light The intensity of scattered light is detected by an optical signal processing system 23 Hemolyzer 5 Flow cell Laser Optics Detectors pe Low and high angle scatter lights from cells Figure 6 Optical Signal Processing System External structure and the size of the cell causes lower angles of scatter and internal granularity or complexity causes higher angles of diffraction Both low and high angles of light scatter are captured by optical sensors providing the Hemolyzer 5 analyzer with two independent measurements for each cell crossing the path of the laser beam High Angle Forward Scatter information about the internal structure A A p p y Py p Me Low An
66. asure Database IL fr om owe fom Figure 60 Database Importing Panel The database importing panel provides the following options 9 8 3 The Import button brings up a panel to select previously exported database record files to load and view Select by performs the select by database function to select a group of imported records according to criteria entered by the operator Details views the detailed result information for all or a selection of imported records Clear removes selected records from the imported records table but does not permanently remove the cleared records from the stored database file Back ends viewing of imported database information and returns to the Hemolyzer 5 stored database Export The database export panel allows you to select a directory location to store records in a selection for backup or reference purposes To back up all records in the database first use the select by function to select all records in the database and export them using the export function Clicking or tapping the Export button displays the database export panel 79 Hemolyzer 5 Selected path Actual path ME Oa Level up New directory name Figure 61 Directory Panel for Data Storage Introduce a USB storage device USB hard drive memory stick etc into an available USB port on the back panel of the Hemolyzer 5 analyzer Select the direc
67. ber of your host LIS computer Bidirectional LIS check this check box if the LIS computer will download lists for one of the list modes for automatic sample processing H Measure AS state fr 100 100 0 MEUS JESUM Figure 73 External Devices Settings Panel 13 4 System Settings System settings change various options about the operation and behavior of the Hemolyzer 5 analyzer The System settings panel lets you change the following settings Waste container volume select 10L 20L or None Selecting 10L or 20L changes the waste container tracking display behavior in the reagent status area at the bottom of the screen Selecting None assumes waste is being drained directly into the laboratory drain and disables waste container tracking 94 Usermanual Database display limit select All or Last month to change the number of database records displayed in the database panel Last month only displays the last 30 days of measurement results and All displays all measurement results stored in the Hemolyzer 5 database Use only Sarstedt Monovette tube from sample rotor Check this check box to change the sampling depth for manually presented tubes at the sample rotor to accommodate Sarstedt Monovette tubes Uncheck this check box to manually process standard sample tubes This setting does not affect automatic sample processing with the optional Autosampler which is able to recognize tube types and ch
68. boratories It provides precise and accurate 5 part differential measurement using a laser based optical measurement technology The Hemolyzer 5 analyzer uses the Coulter method for measurement of leukocytes WBC erythrocytes RBC and platelet PLT concentrations Measurement of the hemoglobin HGB content of red blood cells is accomplished by photometric measurement technology Five part leukocyte differentiation LYM MON NEU EOS BAS is accomplished using optical laser based flow cytometric technology A vivid color touch screen display is featured with an intuitive informative and attractive user interface A START button allows one touch operation for ease of use The Hemolyzer 5 analyzer s unique software system supports the use of many commonly used external printers with its USB connections The Hemolyzer 5 internal database is capable of storing 100 000 patient QC and calibration result records including flags and graphical scatter diagrams and histograms The system software is field upgradeable to ensure up to date operation An automatic optional Autosampler is available sold separately for automatically processing up to 100 sample tubes for increased laboratory efficiency The system software supports a variety of flexible LIS download techniques for efficient integration into laboratory workflow The Hemolyzer 5 features advanced Ethernet LIS connectivity using the HL7 protocol in addition to standar
69. button changes color to red to indicate that the system is busy processing the sample The sample is aspirated inside the analyzer and returned to the operator when the sampling process is complete As soon as the measurement results are available the result screen is displayed See section 8 for more information about the results screen Sample ID 45 amb 2345 Name Date 11 02 2010 21 18 Mode WBC 10 L 500 10 00 NEU 84 4 200 7 50 LYM 92 130 23 400 MON 54 015 4 070 EO 0 7 000 2 050 BAS 03 0 00 2 015 RBC z 10 450 d 5 50 HGB g dL 1404 174 HCT 45094 520 MCV fL 840 1 96 0 MCH pg 270 fl 320 MCHC gdl 300 35 0 RDWsd fL 200 9420 RDWov PLT 10 L 150 2 400 PDWcv PDWsd fL MPV fL PCT Warnings MBAC BE sn Figure 35 Result Screen 51 Hemolyzer 5 The Hemolyzer 5 analyzer will be ready to take the next sample after it has finished cleaning and preparing for the next sample The Start button will change to green indicating it is ready to start the next sample measurement On the result screen you have the following options e You can print the results by clicking tapping on the Print quick link at the top of the screen Please note that the printing is a feature that is always available See section 5 6 1 for more details about printing e Ret
70. c chambers General precautions Always wear protective gloves when working on internal parts of the analyzer 105 Hemolyzer 5 15 1 5 Maintenance Programs In The Analyzer Maintenance functions can be accessed from the menu system Measure Internal Diluent Shearvalve Flow cell reservoir cleaning Clean Hard cleaning Fill Fill ouchser T Tee Touchscreen calibration Maintenance Cleaning Shear valve cleaning drains the shear valve to let the user open and clean the ceramic valve Rinse washes the tubing system Clean cleans the system with external cleaning reagent introduced through reagent inlets Hard clean performs a cleaning of measurement chambers and connected tubing The software is going to prompt the user to add 0 5ml cleaning solution to the specified chamber s Add the correct amount of liquid Higher volume of liquid added can result in overfilling the chamber s and thus can cause leakage Drain puffers Internal Diluent reservoir Flow cell Can also drain internal chambers individually or all puffers together Empty chamber Drains chambers individually or all chambers together Prime Primes reagents individually or all reagents together Fill Fill Initial filling of the system with liquids This must be performed PRIOR to first use of the instrument after installation Touch screen Touch screen calibration The software will instruct you to tap specific areas of the display T
71. cking or tapping the Name or Patient ID field in the Measurement panel Two additional function buttons are available if the Patient panel is accessed from the Measurement panel The Select ID function associates the currently selected patient to the sample measurement and returns to the Measurement panel The Cancel function returns to the measurement panel without selecting any patient to associate to the sample measurement You can select either Name or Patient ID to be displayed as the patient identifier in the Measurement panel by changing the settings in the Patient s displayed data in the Main Menu Settings Customize panel 90 Usermanual Measure Database Figure 70 Edit Patient Panel The Save function saves any changes made To discard any changes made simply click or tap the Back button 91 Hemolyzer 5 13 Settings The Hemolyzer 5 analyzer can be tailored to your laboratory s needs by changing the settings Click or tap the Settings icon on the main menu to access the Settings panel Measure Database Database Calibration NESEN 400 I 1001 100 m None Figure 71 Settings Panel The options available on the Settings panel are Customize Laboratory External Devices System Units Printer Profile Limits User Clicking or tapping one of the buttons in the Settings panel displays the selected panel where settings changes can be made Each panel has
72. creen changes color e The Hemolyzer 5 application software starts up displaying the Hemolyzer 5 logo screen Individual component start y A up status is displayed in the bottom right corner of the logo DTI i e If the multi user option is enabled then a user ID and analyticon password is required e The Hemolyzer 5 main menu is displayed At this point the Hemolyzer 5 analyzer user interface is ready to i e i e use but the analyzer is not yet ready to measure samples This el Me EE requires initialization of the Hemolyzer 5 pneumatic system The following functions are available at this time e Use the patient database to add and modify entries e Review archive send to LIS and print existing measurement records e Review calibration and QC results and history e Change settings 6 2 4 User Login If the multi user feature is activated a user must be logged in before the user interface of the Hemolyzer 5 can be accessed You can log in on two different ways ID de Usuano e Enter the user ID and password assigned to your account Clave e Create a new user account The multi user feature of the Hemolyzer 5 analyzer tracks nadir usuan adir usuario A por por tecnico Registrar Administrador autorizado j J N p which user is logged on when important activities are Ny i performed such as sample or QC measurements or 40 Figure 23 Hemolyzer 5 User L
73. ctions See chapter 17 for details Shut down the instrument See chapter 6 3 for details Clean the instrument See chapter 4 3 118 Usermanual Notes Blank measurements If you want to check whether the reagent path was contaminated during the reagent replacement then perform 4 5 blanks measurements before accepting the blank result The reagents from the internal reservoirs should be used before the new reagent reaches the measurement system If you receive the samples in batches and more than 2 hours elapsed between the last sample of the previous batch and the first sample of the next batch then it is a good practice to repeat the blank measurement Quality Control Perform QC measurements according to your local regulations Please monitor the expiration date and stability after first use of the QC material If there are more hematological instruments in your laboratory then it is also a good practice to measure the same human sample on all the instruments to compare the instruments Use multiple parallel runs to reduce the effect of random error CV We suggest performing at least one blank measurement before starting QC measurements Calibration Calibrate the Hemolyzer 5 according to laboratory regulations Calibration is due with every new control material lot Also if QC results or comparison of results to other instruments results shows permanent error in measurements If you perform a measurement based calibration the
74. d serial interfaces providing the clinical laboratory with flexible connectivity options 4 1 1 Measured Parameters Hemolyzer 5 determines 24 hematology parameters including 5 part WBC differential The instrument requires 110 ul of whole blood sample in Closed and Open vial mode Cycle time is 60 seconds wec Lymphocyte count LYM Monocyte count MON Neutrophil count NEU Eosinophil count EOS Basophil count BAS Red Blood Cell count RBC Hemoglobin HGB Photometric measurement Mean Corpuscular Volume MCV 18 Usermanual Mean Corpuscular Hemoglobin Mean Corpuscular Hemoglobin Concentration Red Blood cells Distribution Width Red Blood cells Distribution Width T Mean Platelet Volume Platelet Distribution Width PDWcv Derived Platelet Distribution Width PDWsd Derived Thrombocrit PC Calculated The PDWcv PDWsd and PCT parameters are considered to be for Research Use Only RUO and will be marked by MARK MARK on the screen printout database and LIS transmission Table 1 Hemolyzer 5 Analyzer Parameters 4 1 2 Approved Reagents and Control Materials Always use reagents control materials and calibration materials that are recommended and approved by the manufacturer The Hemolyzer 5 analyzer control material calibrator material and reagents are part of a system and are carefully designed and selected for optimal performance Using unapproved reagents or controls may cause false flagging or incorrec
75. database e Initiate printing e Access the main menu e Access the control panel of the Autosampler opens with double click or tap e Access the time adjustment panel opens with double click tap e Access the warnings panel only visible if an error or warning was reported 5 7 2 Starting a Manual Single Tube Measurement Tapping or clicking on the Measure icon with the single sample tube graphic allows access to the following functions e Initiate a primary blank measurement Make adjustments and settings about the manual measurement o Enter the Sample ID unique or auto increment O Select the associated patient O Select the sample type or patient mode Start a manual measurement View the measurements results in detail View the measured parameters View the calculated parameters View parameters that are out of the normal range O O O 2 View error warning or clinical flags See section 7 4 1 for more information about manual measurements 34 Usermanual 5 7 3 Start Automated Measurements Tapping or clicking the AS icon with the multiple sample tube graphic allows access to the following functions e Initiate automated measurements in one of three modes o Full scan mode o Free list mode o Selected samples mode e Define sample parameters the parameter list depends which one of the three sample modes are selected e Monitor the progress of the automated measurements e View the details completed measurements
76. de Human Male Female Alternate 1 Alternate 2 will be used for all the samples The sample ID is generated from the sample tube barcode if available It is not possible to assign a patient to automatically processed samples The default patient will be used for all samples e Free List mode o The samples are defined in a list o The following parameters can be individually defined per sample Sample ID Patient Sample mode o The samples should be placed in the same order in the sample tray as the samples defined in the list o Empty sample positions will be skipped on the sample tray e Selected Samples mode o Asample can be defined for each position on the sample tray o Only defined samples positions on the sample tray will be processed Additional samples will be skipped and missing samples will be marked for later review o The following parameters can be defined per sample Sample ID Patient Sample mode Samples are automatically scanned and processed in the following order e Rack order starting with rack A to rack J o Rack A is the rack nearest to the front panel of the Hemolyzer 5 o Rack J is the rack nearest to the back panel of the Hemolyzer 5 e Sample order for each rack starting with sample 1 to sample 10 o Sample 1 is the sample closest to the Hemolyzer 5 o Sample 10 is the sample closest to rounded edge of the Autosampler cover e Sample A1 is the
77. e Start button is a physical button on the front cover of the Hemolyzer 5 It has the following functions e Start a single tube closed or open vial measurement using the sample rotor by pressing the Start button e Provide color coded feedback about the status of the measurement system e Green means that the Hemolyzer 5 is ready to start a new measurement e Red means that the system is busy running a measurement or a procedure e Orange color means that the analyzer is in standby mode 5 3 Using an External Mouse An external mouse can be used to perform the same functions as the touch screen Navigate the mouse pointer over the desired item and click the left mouse button instead of tapping the touch screen to activate the function This procedure is referenced as clicking click an item Touch screen operation continues to be available even if an external mouse is connected to the Hemolyzer 5 analyzer 30 Usermanual It is possible to move the mouse pointer to a place on the screen where it isn t viewable Move the mouse pointer up or to the left to make it visible again 5 4 Using an External Keyboard An external keyboard provides the same data entry features as the on screen virtual keypad presented by the touch screen user interface with faster typing The Settings Customize On screen keyboard active check box allows you to choose whether the on screen virtual keypad is presented or not when data entry
78. e included in your original shipment e Mini pallet e Upper and lower packaging foams e Upper and lower carton box e Plastic bag Place the pallet on the ground Place the lower part of the carton box on the pallet and place the lower packaging foam on the carton bottom Put the Hemolyzer 5 into the plastic bag and place it into the bottom foam part Place the top packaging foam on the analyzer and put the top carton cover box over the package Align the lower carton box flaps so that they fit beneath the upper box edges Use shipping straps to gently but firmly hold the entire package together Figure 31 Hemolyzer 5 Analyzer Repackaging 46 Usermanual 7 Sample Measurement 7 1 Sample Types Supported by the Hemolyzer 5 In this chapter you will find information about the samples usable with the Hemolyzer 5 instrument 7 1 1 Supported Sample Tubes Types The Hemolyzer 5 supports the following K3 EDTA 13x75mm sample tubes e Sarstedt Monovette e Becton Dickinson BD Vacutainer e Terumo Venosafe Only use sample tubes with K3 EDTA anticoagulant Please note that the Sarstedt Monovette sample tubes have a false bottom that is not the same as the bottom of the sample tube The sampling depth on the Hemolyzer 5 analyzer must be changed for a Sarstedt Monovette sample tube To change the sampling depth for manually presented Sarstedt Monovette tubes at the sample rotor check the
79. e 47 7 1 2 Sampling Depth escien ee QU tac URS dnobasleeanciwadedectactauvepsacedesinate 47 7 1 3 Open or Closed Sample Tubes cccccsseccccssscccesscecceecceseneceseuseecseuseccseuscessueeeessaesessaeeesaaeseesaases 48 7 1 4 Sample Collection and Handling savne 48 7 2 Sample Types and Modes ccsccscscecsccscscsccccccscnccecccscnceccecscscnccececscscescecscsceseececscesess 49 7 3 Sample Identification vess voran REPE NUEN FER RERRE ENS YAVATV eR dVPSEMOMEMES PASS Mu RUE SNP RR ERES PNEEMEERA S RAS 49 7 4 Running Samples erernensvnvnnnvnsnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnsnnnnnnnnnnnnnnnnnnnsnnnnnnnnennene 50 7 4 1 jihi usc s 50 7 4 2 MINN 52 7 5 Reus arr 61 7 6 Print R TTER E 62 7 7 The Measuremett PROCESS ocr ccevensensestenvassbarsnecevsceuaiebansvesnesusuasevseweceoassesacueveseessscessetiss 62 Usermanual 8 Result InterpretatiOn sesessesesoesesoscesoscesoscesescesoscecescecesoecsesosoesosoesoscesosoesosoesosoeeeeo 64 8 1 The Result SGU CCN cios Eoo annA ESERE N 64 8 2 Sample Identification INFOMATION cccceccccccscscsccccscsceccccscscececcecscsceccecscuceseececscesess 64 8 3 Parameter InformaltiOh sour ono iron a euo n un o vSP ENS RERFOSE PR S ENSOREEAP RON S UNE RDNDEN NERF ENS PAN NN TENE 65 8 3 1 Scatter Diagrams and HistOgras sscccccsssccccsecccssssccceecccsseeccseuscesseueeeseuecesseuecessanecesaeseesaases 66 8 3 2 LU ESTER a SET
80. e Automatic print check this check box to print every sample or control as it is run e Abort press this button to abort automatic print e Logo visible check this box to print the Analyticon logo on every printed report Figure 76 Printer Settings Panel 13 7 Profile Limits Settings The Profile Limits settings are used to view and modify the normal ranges associated with the Hemolyzer 5 analyzer s five sample modes Human Male Female Alternate 1 and Alternate 2 The control at the top of the panel selects one of the five sample modes The panel is then populated with the lower and upper limit values for each of the 24 parameters Modify the values as needed then click or tap Save to save the new values and return to the Settings panel or select Back to discard any changes and return to the Settings panel 97 Hemolyzer 5 Measure Database Figure 77 Profile Limits Settings Panel 13 8 User Settings The User Settings panel allows administrators to delete users or assign administrator rights Measure Database Figure 78 User Settings Panel Users with Administrator privileges can have access all over the system Only an administrator user can grant or revoke administrator rights 98 Usermanual Regular users have limited access to the system A regular user is allowed to modify Settings Customize only language skin sound volume allowed to run and monitor QC measurements but cannot
81. e homogeneity Repeat the sample with manual Out of RBC linearity range m pre dilution The RBC coincidence is close to the limit too high RBC count Treat RBC result as reduced reliability Check the sample Close to RBC linearity range i n homogeneity Repeat the sample with manual pre dilution High linearity range limit If any of RBC PLT or WBC results are higher than high linearity Perform manual pre dilution of sample and re measure it exceeded range limits Low linearity range limit If any of RBC PLT or WBC results are lower than Low linearity exceeded range limits Check cleanliness of the reagents and the Hemolyzer 5 Perform cleaning of the Hemolyzer 5 Repeat blank measurement See PLT blank high L lank It PLT2 15 1 IIs Li sj pr a di chapter 6 2 5 Pneumatics start and blank measurement Treat PLT result as reduced reliability 70 Usermanual EE Warning flags are raised when the analyzer detects a problem in the analysis process that may cause incorrect or suspect results or the SUE parameters in the valid blank measurement was too high Flag If other parameters predict a normal sample then perform a cleaning procedure and repeat the measurement MON LYM alert The MON and LYM populations are not clearly distinguishable on If MON MON LYM LYM results reported then treat them as the scatter gram reduced reliability If not all the parameters reported or the sample is predicted
82. e list mode Tray status STARTED Measure type Free list mode Tray status FINISHED E Y Pre Bc Figure 44 Free List Mode Progress Tray View Sample barcode labels are read and compared with the sample ID that was previously entered into the free list before starting automatic processing If the two do not match the barcode part of the tray view sample icon changes to red If the automated interrupted for any reason it can be restarted it by clicking or tapping on the Start button on the screen or by pressing the physical Start button 7 4 2 3 Selected Samples Mode Selected Samples mode is suitable for laboratories where e Barcode labels are used e Ina given batch there are samples which should be measured using different modes for different normal ranges e Data security is a concern Selected Samples mode can also be used to rerun only certain samples in a sample tray already processed in one of the other two modes Samples cannot be added to the sample tray once automatic processing is started in Selected Samples mode An accepted blank measurement is required as with all sample processing In Selected Samples mode the Hemolyzer 5 analyzer will only look for samples in the sample positions selected for analysis All other samples in sample positions that are not selected will be ignored If a sample position is selected for processing but contains no sample tube the sample position will be
83. ed at the sample rotor The cleaning procedure may take a few minutes Do not turn off the analyzer until it indicates that it is safe to do so 42 Usermanual 6 3 3 Prepare for Shipment If the Hemolyzer 5 analyzer is not used for a significant period of time or is being transported to a new location then the prepare for shipment procedure should be performed instead the regular shutdown procedure Click or tap the Exit icon on the main menu then select the Prepare for shipment button Are you sure you want to exit shipment 0 anostic 1 m Remove reagent tubing at rear reagent inputs Diluent Lyse Stopper Leave waste connected If you are ready press OK button S cance Ok J Figure 27 Prepare for Shipment If the Hemolyzer 5 is powered off without a proper shutdown or prepare for shipment procedure the following may occur e The pneumatic components may lock in an undefined state The next startup and pneumatic initialization may take longer with increased reagent consumption The Hemolyzer 5 application software and or the Windows XP Embedded operating system can suffer damage or data loss The Hemolyzer 5 analyzer may have to be restarted by a service engineer after an improper shut down or power off sequence The Prepare for Shipment procedure should be used for following reasons e The reagents may spill out if the Hemolyzer 5 is tilted p
84. ed samples mod Tray status UNKNOWN Measure type Selected samples mod Tray status STARTED sme r nm JL me semet AS state Standby 100 Standby 100 BERE iti 18 56 Home Figure 45 Selected Sample Mode Panel 7 42 4 Interrupting Automatic Processing for Stat Samples If one or more stat samples need to be processed you can interrupt automatic processing to analyze the stat sample s without having to wait until the entire sample tray has been processed To interrupt automatic processing for stat specimens perform the following steps Click or tap the Stop button The Hemolyzer 5 will prompt you to wait until the current sample is completed Acknowledge the message by clicking or tapping the OK button Place the stat sample into the sample rotor As soon as the current measurement completes change to the manual measurement panel by clicking or tapping the Measure quick link at the upper left corner of the screen Process the stat sample s in manual mode Return to the automated measurement panel by clicking or tapping the AS quick link Restart the measurement by clicking or tapping the Start button or by pressing the physical Start button The Hemolyzer 5 will continue automated measurement from where it was interrupted 7 4 2 5 Controlling The Autosampler Detailed information about the Autosampler is available from the Autosampler info panel You can also reset the Autosampler from this panel Double cl
85. em in the analysis process that may cause incorrect or suspect results or the parameters in the valid blank measurement was too high Flag Check cleanliness of the reagents and the Hemolyzer 5 Perform flow cell cleaning of the Hemolyzer 5 Repeat blank Differential blank high More than 100 cells detected during the 4Diff blank procedure measurement See chapter 6 1 5 Pneumatics start and blank measurement Warning flags Treat 4 Diff results as reduced reliability Check cleanliness of the reagents and the Hemolyzer 5 Perform flow cell cleaning of the Hemolyzer 5 Repeat blank Baso blank high More than 100 cells detected during the Baso blank procedure measurement See chapter 6 1 5 Pneumatics start and blank measurement Treat BASO result as reduced reliability Check cleanliness of the reagents and the Hemolyzer 5 Perform HGB blank high ast aecented blank result HOB gt 10 27 cleaning of the Hemolyzer 5 Repeat blank measurement See B P l iud chapter 6 2 5 Pneumatics start and blank measurement Treat HGB result as reduced reliability The PLT RBC gap is not clearly detectable on the PLT RBC histogram small MCV fractured RBC s aggregated PLT s cold Check the sample quality Repeat the sample If the problem PLT URI blood side effect of blood transfusion persists then perform a manual count on a stained smear The RBC coincidence is over the limit too high RBC count Check the sampl
86. er on the touch screen display will quickly scroll information in the vertical direction Clicking and dragging with an optional external mouse will achieve the same effect Tapping or clicking the buttons labeled 2 will advance the display by one line or one column 3 Tapping or clicking the buttons labeled 3 will advance the display by one page of information at one time 4 Tapping or clicking the buttons labeled 4 will advance the display to the first or last item in the list 02 04 2009 16 16 Human 7065 64 01 02 04 2009 17 31 Human 70 65 64 01 14 08 2009 11 01 Blank 0 14 08 2009 11 19 Blank 0 14 08 2009 11 20 Human 25 03 2010 16 50 25 03 2010 16 57 25 03 2010 16 58 25 03 2010 16 58 26 03 2010 10 58 26 03 2010 13 13 26 03 2010 13 13 30 03 2010 11 33 Blank 24 30 03 2010 11 33 Blank 5 Multiselect Ll ke Figure 56 Scrolling and Selectin 9 3 Sorting Database Information The database is sorted by Result ID by default Clicking or tapping the following database column headings changes the sort order of the database records Sample ID Sample ID entered by the operator or read from a sample tube barcode label 75 Hemolyzer 5 Identifier that associates a result record with a patient records Analysis Time Time and date this sample tube was analyzed Result ID Unique sequential identifier assigned by the Hemolyzer 5 to each records Table 15 Database Sort Criteria Clicking or tapping the s
87. erator from inadvertent contact with the aspiration needle during specimen processing Automatic sample processing with the optional Autosampler can be interrupted in order to run one or more stat samples with the sample rotor Automatic processing can be resumed after stat sample processing is complete 25 Hemolyzer 5 The START button allows easy one hand operation of the Hemolyzer 5 analyzer The color of the START button indicates the status of the Hemolyzer 5 analyzer Green means the Hemolyzer 5 is ready to process samples and red means the Hemolyzer 5 is busy Orange means the Hemolyzer 5 analyzer is in a standby state 4 3 1 Back Panel DPower connector the Hemolyzer 5 power connector should be connected to a grounded power outlet that meets the requirements listed in section 1 1 5 Main power switch this is a small switch located next to the power connector This switch turns off all electrical power to the Hemolyzer 5 analyzer Leaving this switch on allows the Hemolyzer 5 to remain in the standby state The switch is on when it is in the up position labeled 1 and is off when it is in the down position labeled 0 Standby switch flipping this switch to the up position takes the Hemolyzer 5 main computer out of the standby state and powers up internal analyzer components Please note that this switch springs back to the down position when released and does not stay
88. ext up to 50 characters of descriptive information about the laboratory such as laboratory name address etc All non empty lines are displayed at the top of every result printout 13 3 External Devices The External Devices panel allows entry of external LIS settings The Hemolyzer 5 analyzer support external LIS communications over a serial communications link using the Analyticon version 3 1 protocol It also supports an Ethernet communications link over the HL7 version 2 5 protocol The External Devices panel lets you change the following settings e Sending port baud rate select 9600 or 115200 baud for serial LIS connection 93 Hemolyzer 5 Automatic LIS The Hemolyzer 5 will transmit every measurement result as soon as it is available if this check box is checked LIS the Hemolyzer 5 analyzer will use an Ethernet connection rather than a serial connection of this check box is checked IP the IP address of the external LIS computer should be entered here if an Ethernet LIS connection is used IP addresses consist of four numbers from 0 to 255 separated by periods See your IT administrator for more information about the IP address of your host LIS computer Port the port number of the external LIS computer should be entered with here with nor commas if an Ethernet LIS connection is used Ports are a single number between 0 and 65535 See your IT administrator for more information about the port num
89. for more information about Hemolyzer 5 maintenance procedures Calibration 37 Hemolyzer 5 QC Reference select Select which stored QC reference this measurement belongs to View QC references Browse stored QC references View QC data Browse individual QC sample measurements See section 11 for more information about quality control on the Hemolyzer 5 analyzer Information Provides version information for all software items in the Hemolyzer 5 analyzer Table 7 Hemolyzer 5 Analyzer Menu Tree Set QC Reference Create a new stored QC reference View QC diagrams View Levy Jennings diagrams of QC data 5 7 11 Safety Access Codes Some functions require password protected confirmation For example deleting a record from the database requires entry of a password The security password for deleting database entries is 555 38 Usermanual 6 Start Up and Shut Down the Hemolyzer 5 6 1 Start Up and Shut Down Overview The Hemolyzer 5 is an advanced instrument with computer and pneumatic subsystems that need to be properly started up and shut down for continuing reliable performance Not following proper startup and shutdown procedures may lead to increased maintenance and unnecessary service calls The Hemolyzer 5 analyzer start up sequence requires four steps e Power up the electrical system e Start up the internal user interface computer and log in if the multi user mode is activated e
90. gle Forward Scatter information about size Direct Light goes through the cell it is stopped by the laser dump Focused laser beam Figure 7 Cellular Light Scatter The light scatter data are gathered and plotted as a two dimensional scatter diagram Similar cells have similar scatter characteristics and tend to group together This allows the analytical software to differentiate and identify the leukocyte populations and generate the 4DIFF and BASO scatter diagrams 24 Usermanual High angle scatter COMPLEXITY SIZE RBCFRAGMENTS Lowangle scatter Figure 8 4DIFF Scatter Diagram 4 3 Inside the Hemolyzer 5 Analyzer Touchscreen Front Panel The touch screen display is the primary user interface of the Hemolyzer 5 analyzer for user interactions and data entry The LCD screen can be cleaned damp sponge and gentle detergent The front panel is a hinged cover that provides easy access to the shear valve sampling needle and syringes for cleaning and maintenance The front panel START button and the sample rotor Ee can be cleaned with damp sponge and 7096 ethanol Sample tubes are placed into a tube adapter inserted on the sample rotor for closed vial or open vial single tube manual sample processing The sample tube is rotated from the front of the RONG PENE START button Sample rotor unit into the inside of the Hemolyzer 5 for aspiration This safety feature protects the op
91. he Hemolyzer 5 analyzer all operators should complete a Analyticon Hemolyzer 5 Operator Training program This program is offered by Analyticon or by Analyticon certified service personnel Replacement materials or spare parts tubes valves etc which might have been in contact with human blood or reagents should be handled as a potentially biologically hazardous and chemically dangerous material All applicable laws and regulations must be observed in the handling and disposal of these materials The Hemolyzer 5 is designed for laboratory operation Mobile operation is not supported Operate Hemolyzer 5 within the ambient temperature range described in section 1 1 4 The IVD equipment complies with the emission and immunity requirements described in relevant part of the IEC 61326 series This equipment has been designed and tested to CISPR 11 Class A In a domestic environment it may cause radio interference in which case you may need to take measures to mitigate the interference Electromagnetic environment should be evaluated prior to operation of the device adhering to local or federal regulations W This analyzer contains electronic components Please handle electronic waste 1 14 Environmental Factors Operate the Hemolyzer 5 analyzer within the ambient temperature range of 15 30 C 59 86 F and a relative humidity range of 1096 80 The optimum operating temperature is 25 C 77 F Avoid ex
92. he sample Manual or automatic mode samples are processed in the same way 62 Usermanual WHOLE BLOOD WHOLE BLOOD SAMPLE SAMPLE MIX DILUTION IMPEDANCE MEASUREMENT TEM TEMPERATURE T MEASUREMENT CONTROLLED LIGHT INCUBATION ABSORBEANCE TOTAL WBC HGB RBC PLT OPTICAL MEASUREMENT 4DIFF OPTICAL MEASUREMENT Figure 48 Hemolyzer 5 Measurement Process When you present the sample tube and press the Start button the Hemolyzer 5 rotates the sample rotor and takes the sample tube inside the analyzer The piercing needle pierces the sample tube cap if present and aspirates approximately 110 uL of primary blood sample Blood sensors ensure that the primary blood sample is continuous and free of major bubbles as it is moved to the shear valve The shear valve separates the primary sample into further samples of exact volumes of blood that are distributed to provide dilutions for the RBC WBC HGB and 5 Diff population measurements Lysing reagents are used to eliminate RBCs for dilutions that measure WBCs RBC PLT and WBC are measured with impedance technology through 70 and 80 um apertures respectively Two portions of the sample are used for determining a five subpopulation differential of WBC in two independent 4DIFF and BASO measurements Sample results are displayed on the screen as the process is nearing completion Results are stored in the internal database and transmitted to an
93. hes e Ina given batch there are samples which should be measured using different modes for different normal ranges To start sample measurement in Free List mode first perform and accept a blank measurement if one is needed Click or tap the AS quick link at the top of the screen and select Free list mode The Free List mode only requires that samples be placed in the same sequence as in the free list It does 56 Usermanual not require that samples be matched to exact rack and sample positions It is not possible to add additional samples to the batch in free list mode after automated measurement has started Measure Database Standby AS Standby 100 22 20 Figure 40 Free List Mode Selection On the Free List mode panel you can e Return to the AS panel to select a different type of automated measurement by using the Back function e Add or remove list items e Define the following parameters for the new list items o Measure mode o Sample ID o Patient ID e Swap between the tray and list views by using the View list and View tray functions e Start the automated measurement by clicking or tapping on the Start button on the GUI or by pressing the physical Start button 57 Hemolyzer 5 Analysis timet Analysis time1 12 02 2010 16 15 7654321 12 02 2010 16 16 St Mary_12A5 Analysis ResultiD1 time D ResultD1 ResultiD1 Figure 41 Figure 42 Preparing a Free List As with the
94. his is going to help calibrate the touch sensitive surface 106 Usermanual 15 1 6 Cleaning The Shear Valve Any salt build up on the inner surface of the shear valve may cause malfunction during operation To avoid this problem it is recommended to clean the shear valve after every 1500 samples You need the following materials to complete the shear valve cleaning A piece of soft cloth dampened with water A piece of soft dry cloth A piece of lint free soft dry cloth like a non woven sheet A pair of gloves A pair of tweezers A few tooth picks Water A The shear valve is in contact with the sample blood Wear gloves while cleaning the shear valve Handle the materials use to clean the shear valve as potentially infectious material The parts which should be disassembled re assembled are fixed with so called thumb screws No screwdriver or other similar tool required to tighten these screws Go to the Maintenance menu and select Shear Valve Clean function to initiate the procedure Internal Diluent I Shearvalve Flow cell reservoir cleaning cleaning Empty chamber Empty mix Empty RBC Empty WBC chamber chamber chamber Prime Disp Pre steam Touchscreen ER Touchscreen calibration AS state None The Hemolyzer 5 asks for confirmation to start the procedure After clicking tapping the OK button the Hemolyzer 5 empties the shear valve and the connecting tubes Some liquid can remain inside
95. ick or tap the Autosampler status in the bottom left corner of the screen to view the Autosampler info panel With this panel you can command the 60 Usermanual Autosampler to repeat the last command or reset the Autosampler You can also view Autosampler messages with detailed information about the last action or sample tube processed E LA Menu Autosampler Info Status Home Last error Software reset Technical data 04 Software reset Software reset HOME 01 00 HOME 01 00 Repeat last rim enin SON AS state 100 Homa Figure 46 Control The Autosampler With Info Panel The following is a list of messages from the Autosampler e Home message o Response after a successful reset o HOME XX YY The XX YY is the software revision number e VT zzzzzzz XY o Vacutainer style tube detected o Barcode content zzzzzzzzzzz o Tray position XY e MV zzzzzzz XY o Monovette style tube detected o Barcode content zzzzzzzzzzz o Tray position XY e F confirmation that the tube was moved from the mixing to the sampling position e The power on message contains the serial number of the Autosampler unit During the reset cycle the Autosampler moves the Autosampler components to their home position The mixing stations moves to an upright position the active rack moves back on to the sample tray and the entire tray moves to its home position 7 5 Result Display After the analysis is com
96. icro filtered particle free reagent solution containing lysing detergents stabilizers leucoprotective components special additives and preservatives Application Quantitative and qualitative determination of WBC 5diff LIEN NE Colorless solution foaming by shaking Between 15 C and 30 C 59 86 F Table 3 Hemolyzer 5 Lyser Information The product is environmental friendly since does not contain azide nor cyanide 20 Usermanual 4 1 3 3 Hemolyzer 5 Diff 5p Description Multiple micro filtered particle free reagent solution containing stabilizers leucoprotective components special additives and preservatives Application Quantitative determination of WBC leukocyte four part Men OM MON NEU EGR o J Appearance Colorless odorless solution Table 4 Hemolyzer 5 Diff 5p Information The product is environmental friendly since does not contain azide nor cyanide 4 1 3 4 Hemolyzer Hypocleaner Description Containing alkaline hypochlorite special additives and em Application Capillaries tubing and chambers removing blood LEON REN Open bottle stability 120 days Analyticon reagent code HE3401 100 ml Table 5 Hemolyzer Hypocleaner Information The Hypocleaner CC is not an online reagent not directly connected to the Hemolyzer 5 This reagent is aspirated from a sample tube into the Hemolyzer 5 directly 21 Hemolyzer 5 4 2 Principles of Operation The Hemolyzer 5 an
97. ight and the bottom of the database view or by a moving a vertical scroll bar Database records can be selected individually or in groups Detailed result views are available for selected database records Selected records can be printed sent to an LIS and exported into a tab file Various sort options are provided for quickly finding results Database records can be exported for storage and backup Exported database information can be later imported for review Imported records do not become part of your Hemolyzer 5 analyzer s database They are only imported for viewing but can be sorted selected and managed the same way as with regular data the stored inside the Hemolyzer 5 analyzer database 74 Usermanual The Hemolyzer 5 database displays two numerical counters separated by a slash under the left side of the database table The left number is the number of selected rows and the right number is the total number of rows in the database 9 2 Scrolling the Database View The limited size of the interactive database display acts like a viewport into the large amount of information inside your database You can scroll the database view to bring desired information into view The Hemolyzer 5 analyzer provides several powerful and easy to use scrolling methods The numbered items below match the items in Figure 56 below 1 The scrollbar tapping holding and moving the scrollbar labeled 1 with the tip of your fing
98. in the up position Hardware Key connector this connection is used to plug in the hardware key supplied with every new package of genuine Analyticon Hemolyzer 5 Lyser reagent A new reagent key l l Figure 10 Hemolyzer 5 Back Panel provides the analyzer with the ability to run 700 measurements When the measurement count has been exhausted the Hemolyzer 5 analyzer stops processing samples GReagent connectors five color coded Q9 Green 1connector Hemolyzer Diluent tubing connectors provide connection to the Orange 1connector Hemolyzer 5 Diff5p reagents There are three reagent Yelow 1connector Hemolyzer 5 Lyser connectors and two waste connectors OG Red 2 connectors Waste Table 6 Reagent Connector Color Codes 9 Main board back panel I O Ports these are the back panel computers of the Hemolyzer 5 analyzer main computer board They provide standard connection to peripherals such as external keyboard and mouse printers bar code readers PS2 Mouse port for optional mouse PS2 Keyboard for optional PS2 keyboard COM port for LIS RJ45 Ethernet port for LIS 26 Usermanual VGA port unused USB 2 0 ports for peripherals 1GbE Ethernet RJ 45 Port PS2 10 100Mb Ethernet Mouse COM Port Audio jacks unused Avoid getting liquids on the electrical connectors The rear panel of the analyzer should be cleaned with a cloth or sponge with
99. in the Main menu Settings System panel is checked if you are manually presenting Sarstedt Monovette tubes in the sample rotor Needle damage tube damage and spilled blood may result if Sarstedt Monovette tubes are presented and this option is not checked Select the Measure quick link at the top left of the screen to initiate a manual measurement The new measurement panel opens giving you have the following options e Review the results of the previous measurement by using the Last Measure function This feature can be useful if you were interrupted during the measurement a batch and you want to double check E x which sample is the last processed sample e Define the sample id of the sample to be processed by clicking or tapping on the Sample ID field o You can type it in the Sample ID using the virtual on screen keypad or an external keyboard o You can use an external USB bar code reader o You can use a auto generated sample ID e Activate or deactivate the automatic generation of sample IDs If the Autoincrement mode check box is checked then the Hemolyzer 5 will add 1 to the last sample ID if it was fully numeric Figure 34 Manual Measure Panel or offer O if the last sample ID had any non numeric characters e Connect a patient to the sample by clicking tapping on the Patient field o The name of this field can be Name or ID depending on the Main Menu Sett
100. iners e Prepare the new container and place it near the place of operation e Open the bottle remove cardboard flaps if necessary bL and 20L containers e Unscrew the cap from the used container and place it into the new container e Switch the old and new containers e Dispose of used containers according to local regulations 100 100 100 20000 ml 1000 ml 1000 ml i Reset Lyse When a reagent is replaced it is not enough to proton replace the external container only the reagent Reset all level counter must also be reset Push the button below the corresponding reagent bar to reset its level back to 10096 15 1 12 Disposal Of Reagent Containers A Always follow local regulations of hazardous waste disposal A 115 Hemolyzer 5 16 Reagent Locking Reagent locking is a commercial feature of the Hemolyzer 5 ensuring that only manufacturer recommended and approved reagents are used with the analyzer This way analyzer performance cannot be impaired by incompatible reagents All necessary hardware and software elements are installed and configured on each Hemolyzer 5 unit individually Each Hemolyzer 5 Lyser HE5101 5 L reagent bottle comes with a reagent key The key is in a plastic bag glued to the tear open flap of the cardboard box container Each key contains license for 800 measurements With active reagent lock there is an administrative limit of measurements run on the He
101. ings Customize Patient s displayed data setting 50 Usermanual If you don t select a patient then the default patient will be used As you select the patient field the patient menu is displayed You can select an existing patient or define a new one See section 12 or more detail about Patients on the Hemolyzer 5 analyzer e Select the sample mode o Blank a blank measurement will be processed This is the only option available if the pneumatic system is not initialized or the Hemolyzer 5 was inactive for an extended period of time After performing and accepting a blank measurement the other modes will be available o Control a QC sample is expected QC measurements initiated from this menu will not be saved into the QC database and are not part of the QC procedure This mode is intended only as a quick system checks See section 11 for more information about the QC process o Human blood modes Human Male Female Alternate 1 and Alternate 2 Select the mode which has the appropriate normal ranges e Start the measurement by clicking or tapping the Start button on the screen or by pressing the physical Start button located on the front panel of the Hemolyzer 5 After starting the measurement the sample door rotates and takes the sample tube inside the Hemolyzer 5 analyzer This is a key safety feature of the Hemolyzer 5 and protects the operator from the sample needle during routine operation The Start
102. instructions on the screen All 800 measurement licenses will be transferred from the key to the analyzer Remove the hardware key from the Hemolyzer 5 An already used empty hardware key cannot be used again 116 Usermanual Collect and return them to your dealer service personnel sales representative for re cycling OR dispose of them as electronic waste adhering local regulations 117 Hemolyzer 5 17 The Daily Routine In this chapter a typical daily routine is described Of course your daily routine can differ from the one described here This chapter also contains some trick and trips The below assumes that the laboratory works during office hours only The daily routine Power up and start up the Hemolyzer 5 See Chapter 6 2 2 for details Perform the pneumatics initialization and blank measurement tap the sampling tube icon Check reagent levels start your internal procedure to get new reagents from the storage if necessary Collect the samples Check if the correct K3 EDTA tubes are used Check if the samples are within the 6 hours of processing limit Check if the samples are at room temperature refrigerated samples Power on the Autosampler if installed Perform the QC procedure as scheduled Start the measurements in manual or automated mode See chapter 7 for details Check and release the results according to your internal regulations Perform the necessary maintenance a
103. lects the units for HGB and HGB derived or calculated parameters Count unit Selects the units for WBC RBC and PLT and derived or calculated parameters Printer Printer Selects which printer to print to Printer status Display the currently selected printer status Color printing Selects whether to print in color Double sided printing Selects whether to print multi page printouts on both sides of a page Items in queue Number of items in the printer queue Cancel all jobs Cancels all items in the selected printer s queue Printout format Allows selection of printout format normal or wide parameter names see section 13 6 for details Automatic print Selects whether to print for every new sample processed Logo visible Selects whether to print or omit graphical logo to printout Refresh printers list Refreshes the list of displayed printers Profile limits Enter normal ranges for various profile limits User Add and manage users of the Hemolyzer 5 analyzer See section 13 for more information about Hemolyzer 5 analyzer settings Maintenance Clean Perform extended cleaning of various pneumatic components Internal reagent reservoir Drain one or all internal reagent reservoirs Empty chamber Empty RBC WBC and mix chambers Prime Prime one or all reagent reservoirs Fill Fills the fluidic components of the system with reagents Touchscreen Calibrate the touchscreen location for taps and button presses See section 15
104. lly by the Hemolyzer 5 analyzer e Result ID unique database identifier automatically assigned by the Hemolyzer 5 analyzer e Sample ID assigned by the operator o The Hemolyzer 5 doesn t require the sample ID to be unique o The sample ID can submitted by Manual typing Bar code reading manual or Autosampler Auto increment o The sample ID is not applicable on blank measurements e Patient o A record from the patient database connected to a measurement o Not applicable for blank and QC measurements o Can be changed by setting the name or the database identifier of the patient displayed with the measurement results o The default patient ID 1 patient is used if no patient is selected 49 Hemolyzer 5 7 4 Running Samples The Hemolyzer 5 supports both manual and automatic sample presentation modes Automatic sample presentation requires the optional Autosampler The Hemolyzer 5 analyzer software automatically detects and initializes the Autosampler Before performing any measurement the Hemolyzer 5 should be e Powered up and started e The pneumatic system initialized and a blank measurement performed and accepted 7 4 1 Manual Mode To use Sarstedt Monovette manually presented tubes at the sample rotor check the Use only Sarstedt Monovette tube from sample rotor check box in the Main menu Settings System panel Always ensure the Use only Sarstedt Monovette tube from sample rotor check box
105. marked for review On the Selected Sample mode panel you can e Return to the AS panel to select a different type of automated measurement by using the Back function e Define the samples to be measured o Click or tap the sample tray position icon where the selected sample is located o Select the appropriate measure mode o Define the sample ID o Define the patient ID 59 Hemolyzer 5 Measure mode Male ample pos Measure mode D under meas lt o Save the changes by clicking or tapping the Add button Remove selected samples by clicking or tapping the Remove button Swap between the tray and list views by using the View list and View tray functions Start the automated measurement by clicking or tapping on the Start button on the GUI or by pressing the physical Start button 2 ef el ic a l ol RE EEEEEEEEEE B EEEEEEELELCE t5 EE i i i i i i i i i i i1 lt 1 Sl EE ECEE ECECCEECEEE 13 sl el sl s aj el ed e ed sf nz al el gt l al l gt l l EEEECEEEEDEE 4 4 4 74 4 4 74 1 0 B EEEEEEEEDE Eccc S EEECEEDED EEEEEEEEEE ure li 4 4 1 4 Ij 1 cell el ofl off off og ol ell ell oll off off off ol EEEEEEE eff ell ell lj el ll el al all sl sl ali al i Sample pos under meas wea COo eu COO Position B3 Sample status Unknown Position Sample status Unknown Measure type Select
106. molyzer 5 The Hemolyzer 5 keeps track of the number of measurements performed If the limit is reached then the Hemolyzer 5 will first warn the user about the fact then it will refuse to perform further measurements 82 Figure Reagent key inside the Lyse cardboard box The analyzer decreases the number of available measurements with each sample run even Blank Calibration and QC measurements When the counter decreases below 50 and any sample run is started the user will receive a warning message about this counter decreasing When the number available reaches zero the analyzer will not run more samples To increase the number of remaining measurements you have to upload measurement licenses from the hardware key to the Hemolyzer 5 The uploading can be initiated during Lyse reagent level reset See chapter 14 1 3 The hardware key is similar to a USB memory device but it is not a real USB memory device Do not insert it into a USB connector The hardware key will not harm USB ports however it can t be predicted how the USB drivers react if a hardware key is connected as USB device 83 Figure Reagent Lock To transfer measurement licenses to the Hemolyzer 5 socket Remove the hardware key from its protective packaging nsert the hardware key into the HK connector close to the stand by button on the rear of the analyzer see chapter 4 3 1 Initiate Reset of Lyse reagent and follow
107. n analyzer A dialog will open Browse to the correct folder and select the file by tapping the checkbox in front of the filename The file contains information for all three levels of the control material Low Normal and High All three levels will be loaded into the system and will become selectable in the QC menu 4 0 Create 87 Hemolyzer 5 11 2 QC Measure To run a QC measurement please ensure that a valid blank measurement has been run and accepted Associate the QC measurement to the correct control material lot by select the matching QC name in the selector below the QC measure button on the QC panel Place the control material sample tube in the sample rotor and click or tap QC measure The QC measurement results will be added to the QC database and associated with matching QC material lot 11 3 View QC References Click or tap the View QC References button to see a list of QC lot references stored in the Hemolyzer 5 analyzer control database Target values and ranges can be viewed for any stored QC references 11 4 View QC Data Selecting View QC data displays QC runs stored in the QC database in a table format that operates the same way as the Hemolyzer 5 analyzer database QC measurement results will have sequential ID numbers Option buttons are provided to switch back and forth between viewing QC data and viewing QC diagrams 11 5 View QC Diagrams Click or tap View QC diagrams to see
108. n 36 570 AUSTENG TIMES and DEG et ob iaio een Up ES AS etu aaa aiani 36 5 7 9 NEPPE CV E RUIN eee ee Ure ted 36 SO MEAN E E 36 T NNN 38 6 Start Up and Shut Down the Hemolyzer 5 ar aravnavnavavnavnanevnnvnnvevnnvnnvevnnvnnvnnnnsnnvenenenee 39 6 1 Start Up and Shut Down Overview Lausanne ERROR E RAM pe PERS ESO TEES 39 6 2 Starting Up the Hemolyzer 5 Analyzer ccsccscscecsccscscsccccccscsccccccscsceccccscscescececscesees 39 o VANN 39 6 2 2 Power Up the Hemolyzer 5 Analyzer nennen nnne nennen nnne snae sna nan 39 6 2 3 VNR 40 6 2 4 User LOBIN EE EE EEE EE EEE EE 40 6 2 5 Pneumatic System Start and Blank Measurement rrrnnnnnrnnnnnnrnnnnnnrnnnnnrnnnnnnrnnnnnsnnnnnsrnnnnnsnnnnnnsennn 41 6 3 Exiting the Hemolyzer 5 Analyzer csccscscscsccscscsccccccscsceccccscsceccesecscsseccecscsceccecececes 41 6 3 1 LOCO petet EE EE E EEE 42 6 3 2 SG BLOK ES ES 42 6 3 3 Plepare Tor Spe EE EEE EE ENER 43 6 3 4 Emergency Shut DOWN rrannrnnnnnrrnnnnnrnnnnnnrnnnnnrrnnnnsrnnnnnsrnnnnnsnnnnnernnnnesennnnesnnnnnsrnnnnesennnnennnnssennnnssennn 45 6 3 5 Repackaging the Hemolyzer 5 Analyzer lessen eene nennen nennen nnns nennen nna 46 7 Sample Measurement vvs 47 7 1 Sample Types Supported by the Hemolyzer 5 eese eene eee eee nennen nennen 47 7 1 1 Supported Sample Tubes Types rrrrrnrrrnrannrrnnnnnrnrnnnrrnrnnnrnnnnnernnnnnsrnrnnnsennnnesnnnnnsrnnnnssrnnnnesnnnnnesennnn
109. n at the bottom Also the sampling needle is given a safety clearance of two millimeters from the bottom of the tube to prevent accidental breakage of sample tubes This means that the sampling needle cannot aspirate the last 8 millimeters 0 31 inches of sample at the bottom of a tube This results in sample volume that cannot be aspirated of 0 5 ml for a Beckton Dickinson Vacutainer tube and 0 3 ml fora Sarstedt Monovette tube 47 Hemolyzer 5 The sampling hole is 4 8 mm 0 19 from the tip of the sampling needle On the cross section of the piercing needle you can see the 3 grooves designed to equalize the pressure in the closed sample tubes Figure 32 Sampling Needle 7 1 3 Open or Closed Sample Tubes The Hemolyzer 5 can process both open and closed sample tubes in manual mode using the sample rotor Manually presented sample tubes must be mixed properly before being presented to the Hemolyzer 5 analyzer Only closed sample tubes will be automatically processed by the optional Autosampler Open sample tubes placed in the Autosampler will be skipped and not processed 7 1 4 Sample Collection and Handling Please consider the following when collecting and handling blood samples The Hemolyzer 5 analyzer aspirates 110 ul of sample in both closed and open vial modes Under the following conditions the Hemolyzer 5 may aspirate less than 110 uL of sample but will detect and flag any i
110. n it is recommended to run a blank measurement before the calibration procedure See chapter 10 Cleaning Perform cleaning hard cleaning if High blank results experienced Clogging related flags are added systematically to measurement results After service actions service level maintenance Measurement results QC results are drifting perform hard cleaning Clog formation in the tubing first remove the plugging contamination Reagent connected to wrong place wrong reagents were used 119 Hemolyzer 5 18 Troubleshooting Your Hemolyzer 5 software is equipped with all the functions to keep the analyzer in good working conditions Despite careful planning and SW features the analyzer can still encounter problems where user interaction is required or the user needs to be informed of situations when further help is required These are called error messages Error messages can be further classified Your analyzer will provide all details to identify the error however most of the times these errors will be composed of numerical codes These are important for the service personnel they can interpret the messages and take necessary actions Would you receive error messages with codes please write them down If possible describe with a few words what you were doing before the error came up This is important so that your service engineer can help you when necessary The software memorizes every error but it cannot describe the
111. nadequate sample aspirations o The sample tube does not vent properly and contains residual vacuum o The viscosity of the blood is very high The Hemolyzer 5 is unable to aspirate the last 8 mm 0 31 inches or 0 3 to 0 5 ml of sample volume Make sure that the sample tube is filled to the sample level line indicated by the tube manufacturer The anticoagulant not only prevents the coagulation of blood but also dilutes it If the volume of blood is too low than this dilution can adversely affect measurement results Ensure that the blood and anticoagulant are properly mixed by inverting it at least 8 times Do not shake the sample as this could damage blood cells A minimum of 30 minutes should elapse between taking the blood sample and running it on the Hemolyzer 5 for analysis to ensure that the interaction of blood and anticoagulant has fully stabilized Check the data sheet of the sample tube for the exact period of time Use only K3 EDTA anticoagulated fresh whole blood as sample Analyze blood samples within 12 hours of collection It is a good practice to refrigerate but not freeze blood samples Freezing causes blood to hemolyse becoming unsuitable for hematological testing Samples should be analyzed at room temperature Do not deliver or store the samples at temperatures above normal body temperature 48 Usermanual All samples should be handled as potentially infectious material and treated as a biohazard 7 2 Sample
112. necussestousssctenssscneousrense 38 Table 8 Sample Identification Information rrwrurrnrnnrrnnnnrnnnnnrnnnnnrnnnnnrnnnnnrnrnnennrnnennvnnnnnnnnnnnnnnnnnnnsnnnnee 65 Table 9 Normal Range RETE TT 66 Table 10 Linearity Range Flag rrarnnnnnnnnrnnnnnnrnnnnnnrrnnnnnnrnnrnnnrrnnnnnsnnnnnnennnnnnesnnnnnnsnnnnnnesnnnnnesnnnnnnenennnnesene 66 Table 11 High Blank als Rt 66 Te NNN 72 Tok BNI 72 FEN FE S e A 73 Table T5 EE 76 Table 16 Coun Unit Parameters ereen E 96 Hemolyzer 5 1 For Your Safety 1 1 1 Who Should Use This Manual This user manual is intended for clinical laboratory professionals using the Analyticon Hemolyzer 5 automated hematology analyzer The manual includes information about the operation and user interface of the Hemolyzer5 analyzer It also contains basic steps necessary to perform the setup procedures to tailor the operation of the analyzer to the requirements of your laboratory This manual also describes daily routine maintenance requirements to keep your analyzer functioning properly 1 1 2 Special Symbols Used In This Manual l Blood samples and analyzer waste are potentially infectious Biohazard materials Corrosive Reagents may cause corrosion or skin irritation Apm General warning of possible hazard conditions R Sharp needle warning The sampling needle may be a hazard to the operator 1 1 3 General Precautions The analyzer weighs 35kg 77lbs Please do not attempt to move it
113. nt Treat RBC result as reduced reliability Drift in the probe voltage of the WBC capillary The two main Check the reagent connections C WBC clogging reasons for this drift are the misconnected reagent and the Perform a cleaning procedure See chapter maintenance clogging of the capillary Please repeat the measurement Drift in the probe voltage of the RBC capillary The two main Check the reagent connections C RBC PLT clogging reasons for this drift are the misconnected reagent and the Perform a cleaning procedure See chapter maintenance clogging of the capillary Please repeat the measurement If other parameters predict a normal sample then perform a cleaning procedure and repeat the measurement m If MON MON NEU NEU results reported then treat them as MON NEU alert DEN NN NN reduced reliability If not all the parameters reported or the the scatter gram sample is predicted as pathological then perform a manual count on a stained smear If other parameters predict a normal sample then perform a cleaning procedure and repeat the measurement E EO NEU alert The EO and NEU populations are not clearly distinguishable on If EO EO96 NEU NEU results reported then treat them as the scatter gram reduced reliability If not all the parameters reported or the sample is predicted as pathological then perform a manual count on a stained smear 69 Hemolyzer 5 Warning flags are raised when the analyzer detects a probl
114. nterfering devices capable of emitting radio frequencies e g radio or television transmitters receivers radars centrifuges X ray devices fans etc This analyzer is designed to be safe for transient voltages to INSTALLATION CATEGORY II and POLLUTION DEGREE 2 1 1 6 Space Requirements It is important to install the instrument in a suitable location A poor location can adversely affect its performance Select a well ventilated location near a power source and close to a suitable drain Place the unit on a clean level surface Leave at least 0 5 m 18 inches space on both sides and above the instrument to access pneumatics A minimum of 0 2 m 8 inches must be maintained between the rear panel and the wall to allow for heat dissipation and tube clearance Ensure there is enough clearance in front of the Hemolyzer 5 analyzer to open the front panel Allow enough space if you want to use optional external keyboard mouse or bar code reader Your selected location should allow placement of the reagents in an unobtrusive location below the laboratory bench that the instrument is placed on or on the same surface Placement below the laboratory bench also allows for storage of a spare set of reagents Never place the reagents above the Hemolyzer 5 analyzer See Figure 1 and Figure 2 for more information about proper analyzer location and clearance 12 max 1 2 m Figure 1 Hemolyzer 5 with Autosampler Space Requirement
115. o eaaccnstueaetans saegue asia uacoe aimee tonne ae aes ona eeaeeteets 25 4 3 2 PP 26 4 3 3 ETEN NNN 27 4 3 4 aa ES 0 EG EEE EE 28 4 3 5 Front ASSEDI TU m Em 29 User TCV ACE ETT TT TT TTRTEMMEMTT 30 5 1 Using the Touch SA CEN Luse 30 5 2 Using the Start BULLOD Le 30 5 3 Using an External Mouse Lura 30 5 4 Using an External Keyboard csccscscessccscsceccccscscsccccccscsceccccecscsscececscssescecscscesescecnces 31 5 5 Using the On Screen Virtual Keypads scscscsscscscecsccscsccccccscscsccccecscscescecscsceseccecces 31 5 6 Using the Graphical User Interface csscscscsssccscsscsccscsccccccscscsccececscscessccscsceccesecnces 32 5 6 1 Ge G EEE EEE EEE 33 5 6 2 eee vr 33 Hemolyzer 5 56 3 The Status DIG NN 33 5 6 4 Fers Nene 34 5 7 Ihe Menu NENNE 34 5 7 1 ERIS AVE IIT E 34 5 7 2 Starting a Manual Single Tube Measurement eeesssssssseeeeeeee nennen nennen nnns annes 34 5 7 3 Start Automated Measurements rrrannnrnnannrnnnnnnrnnnnnrrnnnnnrrnnnnernnnnnsrnnnnssennnnssnnnanesnnnnssennnnesennnnesnnnee 35 57 4 Accessthe Database essere trenes eer nena a aaa EYES UNES NS TERES V cesussesenvessetoseecscesssensse 35 5 7 5 ulis Pir AINE EE ET 35 5 7 6 AE Ha LE EE EN EN 35 5 7 7 Autosampler Control Panel rrrnnnnnrnnnnnnrnnnnnrnnnnnnrnnnnnnrnnnnesnnnnnernnnnssnnnnnnsnnnnnernnnnssnnnnnesnnnnnesnnnnnse
116. ode rrrrnnnrnnnnnnrrnnnnnrrnnnnnnrnnnnnnrnnrnnnernnnnnernnnnnnsvnnnnnsnennnnesene 54 Figure 39 Full Scan Mode Tray View ProgressS rnnnsnnrnnnnnnrnnnnnnnrnnnnnnrnnnnnnnnnnnnsnnnnnnnnnnnnesnnnnnnsnennnneeene 55 Figure 40 Full Scan Mode Tray and List Views ccccccsssecccceseccceesececeusececeeeceeeeesecesseecessugeceeseeseeetes 56 Figure 41 Free List Mode Selection rarrrnnnnnrrnnnnnnrrnnnnnnrnnnnnnrnnnnnnrnnnnnevnnnnnsnnnnnnnsnnnnnnsvnnnnnssennnnnsnennnneeene 57 Figure 42 Figure 43 Preparing a Free LISt cccscccssccseccseccseecseccaceceeececceeceusceusceusceuscesseesscessceseeeaes 58 Figure 44 Free List Mode Progress List ViQW ccccccssecccsseccesscecesscecenececeeceeeeeseeucessencessueceseneeeneness 58 Figure 45 Free List Mode Progress Tray View rrarrnnnnnrrnnnnnrnnnnernnnnernnnnernnnnennnnnvnnnnevnnnnsvnnnnsnnnusennnnssesnner 59 Figure 46 Selected Sample Mode PaLi l ioie c mbi ner etos oan ada Rito Se ker do E Eco su Ft rtu re besd lods sow IRR S arenes 60 Figure 47 Control The Autosampler With Info Panel rrrrrrnrnnnnrnnnnnnrnnnnnnrnnnnnnernnnnnernnnnnsrrnnnnnevnnnnneeene 61 Figure 48 Results Display and Magnified Scatter Plot sees 62 Figure 49 Hemolyzer 5 Measurement Process rnrnnnnnnnnnnnnnnnnnnnnnnnnnnvnnnnnnnnnnnnnnnnnnnnesnnnnnssnnnnnnsnennnneeene 63 Figure 50 Hemolvzer 5 Result STEN L ren 64 Figure 51 Parameter Information Display
117. ogin Screen Usermanual calibration The multi user feature allows full access to administrator users while restricting regular users from actions that change the way the Hemolyzer 5 analyzer operates such as changing calibration settings See section 13 7 for details about user management 6 2 5 Pneumatic System Start and Blank Measurement Before measuring any blood or control samples the pneumatic system components of the Hemolyzer 5 analyzer need to be initialized and a blank measurement run and accepted To start the pneumatic system and run a blank measurement click or tap the Measure icon with the single test tube graphic on the top left corner of the screen The following sequence takes place e The color of the Start button changes to red e The reagents are primed e The measuring system is flushed e The sample door syringe needle x y movement and shear valve motors are activated and tested e The vacuum system is activated and pump sensors and vacuum leakage is tested e Ablank measurement is initiated automatically e An empty result screen is displayed e The blank measurement is performed e The results of the blank measurement are displayed The results of a blank measurement must be accepted before blood or control samples can be processed If the results from the first blank measurement are not acceptable it does not necessarily mean that something is wrong about your Hemolyzer 5 anal
118. on you can return to the current operation and retry the actual process You can also tap on the Details button and there you will be able to get further informaion abou the error It will describe additional conditions of the failure The numbers in the second row are important for the service personnel EG MOVE DILUTOR 1 105 EG MEASURECONTROL 33 EG AUTOSAMPLER MEASURE 102 Processname DILUTOR FULL 3 121 Hemolyzer 5 18 1 3 Mechanical Problems Most mechanical problems arise because of some physical blockage of the moving parts Problems caused by severe blocks are most often accompanied by a grinding noise The noise is a result of a motor not being able to move however most of the time this will not cause mechanical damage to moving parts Typical situations can be traced back to salt build ups around the wash head or the shear valve Incorrect operation of cleaning of the system especially after long inactive periods of time can cause valves or tubes to get filled with somewhat dried salt These problems can be the sources of dilutor motor noise In extreme tube or valve clogging situations the pressure built inside the dilutors can cause some tubes to be released from their connections This symptom is not normal but will not cause damage to the system However it is recommended to contact Service Personnel to sort out the cause and resolve these problems 18 1 4 Sample Rotor SR Failures 18 1 4 1 SR Give
119. on panel displays an option to calibrate the Hemolyzer 5 analyzer or to view prior calibrations Measure I Patient Calibrate Figure 62 Calibration Options 10 1 Calibrating the Hemolyzer 5 Selecting the Calibrate option on the calibration options panel displays the calibration panel 82 Usermanual Database Print Database Print Calibration mode Manual Sample ID Calib 1 3 Patient ID Tee Date 12 15 2010 10 41 AM Mode Calibration 107L DIFF 76 26 76 76 76 10 2 L Human g L 96 fL pg 4 00 5 50 a 150 400 103L 120 174 96 fL 76 0 96 0 fL Seven measures Calibration type Control 5 00 11 00 8 0 15 0 0 0 16 0 AS state 1 100 100 nore ag Figure 63 Calibration Panel and Calibration Run Result Panel The limits of the calibration target values are linked to the normal range of the Human sample mode Commercial calibrator material and sample tube should be handled as a potentially biohazardous material All applicable laws regulations and laboratory practices should be followed in the handling and disposal of calibrator materials To perform the automated calibration procedure ensure that the Hemolyzer 5 pneumatic system is started up and that a valid blank measurement has been accepted Perform the following steps e Prepare a sample tube with commercial calibrator material o
120. operating language of the software Example tab separated file ResultID TAB Creation time lt TAB gt Sample Id lt TAB gt Creation time lt TAB gt Mode lt TAB gt WBC lt TAB gt LYM lt TAB gt NEU lt TAB gt MON lt TAB gt EO lt TAB gt BAS lt TAB gt LYM lt TAB gt NEU lt TAB gt MON lt TAB gt E0 lt TAB gt BAS lt TAB gt RBC lt TAB gt HGB lt TAB gt HCT lt TAB gt MCV lt TAB gt MCH lt TAB gt MCHC lt TAB gt RDWsd lt TAB gt RDWcv lt TAB gt PLT lt TAB gt PDWsd lt TAB gt PDWcv lt TAB gt MPV lt TAB gt PCT TAB 7538 lt TAB gt 02 04 2009 15 59 05 lt TAB gt 402 lt TAB gt 02 04 2009 15 59 05 lt TAB gt Human lt TAB gt 70 65 lt TAB gt 56 66 lt TAB gt 2 9 lt TAB gt 11 09 lt TAB gt 0 lt TAB gt 0 lt TAB gt 80 2 lt TAB gt 4 1 lt TAB gt 15 7 lt TAB gt 0 lt TAB gt 0 lt TAB gt 1 83 lt TAB gt 63 lt TAB gt 33 3 lt TAB gt 181 8 lt TAB gt 34 4 lt TAB gt 190 lt TAB gt 75 8 lt TAB gt 16 lt TAB gt 17 lt TAB gt 16 3 lt TAB gt 43 lt TAB gt 8 9 lt TAB gt 0 02 TAB 7540 lt TAB gt 02 04 2009 16 11 13 lt TAB gt 402 lt TAB gt 02 04 2009 16 11 13 lt TAB gt Human lt TAB gt 70 65 lt TAB gt 62 1 lt TAB gt 1 77 lt TAB gt 6 78 lt TAB gt 0 lt TAB gt 0 lt TAB gt 87 9 lt TAB gt 2 5 lt TAB gt 9 6 lt TAB gt 0 lt TAB gt 0 lt TAB gt 1 83 lt TAB gt 63 lt TAB gt 33 3 lt TAB gt 181 8 lt TAB gt 34 4 lt TAB gt 190 lt TAB gt 75 8 lt TAB gt 16 lt TAB gt 17 lt TAB gt 16 3 lt TAB gt 43 lt TAB gt 8 9 lt TAB gt 0 02 TAB
121. otentially causing electrical short circuit or corrosion e Reagents can flow out of the Hemolyzer 5 if the reagent intakes are disconnected e Evaporation may cause reagents left in the pneumatic components in the Hemolyzer 5 analyzer to become concentrated and form crystals that increase blank results damage pneumatic components and may require a service engineer to restore proper operation e Microbial growth may occur if reagents are left in an inactive analyzer for extended time periods causing high blank results and may require a service engineer to restore proper operation 43 Hemolyzer 5 e Accidental storage at very low temperatures may cause freezing that damages the pneumatic components It is strongly recommended that the Prepare for shipment procedure be used if the analyzer will be inactive for more than five days Higher temperature or lower humidity decreases the period of time the Hemolyzer 5 can be idle without performing the Prepare for shipment procedure The analyzer will guide you through the preparing for shipment process This process takes about 30 minutes and requires the following items e Prepare for shipment tube set included with your Hemolyzer 5 analyzer e Distilled water After initiating the Prepare for shipment procedure the system will prepare itself for the draining process Do not power off the analyzer during these steps unless the system indicates that is safe to do so S
122. oth dampened with water to clean the bottom of the wash head To put the wash head back Push the wash head onto the needle Push it up as much as you can taking care of the sharp needle and lock it back by twisting it into the grooves of the holding rods Replace the side cover and close the front panel 112 Usermanual 15 1 8 Cleaning The Measuring Chambers Hard Cleaning If the system keeps reporting high blank values direct cleaning of measuring chambers must be carried out Open the front panel and secure it with the latch Remove the left side panel Loosen the 2 2 screws on the front and rear of the side panel The panel can be pulled off the analyzer Locate the measuring chambers Using a pipette inject 1ml of Hypocleaner into each chamber as instructed by the software Follow instructions on screen See Hard Cleaning 15 1 9 Daily Cleaning At the end of the daily routine during shutdown the analyzer software will ask for a sample vial filled with Hemolyzer Hypocleaner as a sample This will clean the whole measurement related tube path EVEN THOUGH HEMOLYZER 5 CAN PIERCE THE CAP OF A SAMPLING TUBE THE RUBBER CAPS ARE NOT DESIGNED FOR MULTIPLE PUNCTURES THEREFORE IT IS RECOMMENDED TO REMOVE THE CAP OF THE VIAL WITH THE CLEANING SOLUTION OTHERWISE THE RUBBER WILL HARDEN UP AND SMALL PARTICLES WILL FALL INTO THE SOLUTION WHICH CAN CAUSE CLOGGING IF ASPIRATED BY THE SAMPLING NEEDLE After this operation
123. panel allows you to see of the Autosampler is operational and perform an Autosampler initialization See section 7 4 2 5 for more information about the Autosampler control panel 5 7 8 Adjust the Time and Date Double click tap the time display on the right side of the status display on the bottom of the screen to bring up a panel for adjusting the stored time and date of the Hemolyzer 5 analyzer See section 0 for more information about time and date adjustment 5 7 9 Open the Warning Panel If an error or warning is currently active an exclamation point icon appears on the status display Click the icon to review the active error or warning and jump to the appropriate menu where the error or warning can be addressed such as reagent replacement 5 7 10 Menu tree The following is a listing of the Hemolyzer 5 analyzer main menu tree Cancel Cancels shutdown of the Hemolyzer 5 analyzer Prepare for shipment Performs an extensive drain procedure of the Hemolyzer 5 pneumatic system in preparation for shipment or an extended period of inactivity 36 Usermanual Log off Logs off the current user session Shutdown Prepares the Hemolyzer 5 for a complete shutdown See section 6 3 to learn how to power down the Hemolyzer 5 analyzer correctly Settings Customize Language Change the active language Limit Style View parameter normal range status in numerical or graphical format Sound Volume Change the volume
124. pleted the result screen displays all measured parameters flags histograms and scatter plots This information is automatically stored in the database and stored result data can be retrieved at any time from the database 61 Hemolyzer 5 Histograms and scatter plots can be zoomed for closer inspection Click or tap the histogram or scatter plot to magnify it Click or tap the Close button on the upper right corner of the image to close it and return to the result display H T H f Measure Database i Measure Database Sample ID ny204277 Patient ID Sample ID ny204277 Patient ID Date 25 01 2010 16 23 Mode Date 25 01 2010 16 23 Mode 105mm 51 9 29 0 8 7 10 0 25 0 4 10 mm g L 50 400 90 BOI 0 001 0 004 Figure 47 Results Display and Magnified Scatter Plot Comparison of parameters to the normal range can be displayed numerically or graphically See section 13 1 for more information on display of normal range status Other kinds of flags are also displayed in the result screen See section 8 for detailed information about the Hemolyzer 5 result screen 7 6 Printing Reports Click or tap the Print icon at the top of the screen to send a report or any displayed screen to the external printer 7 7 TheMeasurement Process The Hemolyzer 5 analyzer measures 24 parameters of whole human blood samples Internal dilutions are made to allow measurement of particles in t
125. populations NEU LYM MON EO BAS Parameter names are listed with their standard abbreviation Parameter values are always displayed according to their selected unit In case of error during sample evaluation the software will display E or signs to indicate the problems Parameter values falling within the normal range are un flagged and displayed with black text Parameter values falling above the normal range are marked with a and displayed with red text and values falling below the normal range are marked with a and displayed in blue text Normal range information can also be conveyed graphically as well as numerically This setting can be changed in the Main menu Settings Customize panel HCT 24 3 Up 45 094 320 MCV 896 fL 840 a 960 MCH 366 pg 27 0 9 32 0 Figure 51 Graphical Normal Range Display The flags displayed in the parameter information area are as follows 65 Hemolyzer 5 Normal range flags are raised when a particular parameter is above or below Normal range flags Ns l l the normal range which is defined for the patient profile currently in effect Color Code NENNE Parameter is over normal range Lowest Parameter is over the double of the high T limit of normal range Table 9 Normal Range Flags Linearity range flags are raised when a particular parameter is above or below Linearity Range Flag the linearity range of the device
126. posing the Hemolyzer 5 analyzer to direct sunlight or to extreme high or low temperatures If the Hemolyzer 5 analyzer was subjected to extreme temperatures during shipment or storage the analyzer must be placed for at least one hour in a room whose temperature is within the operational range before installation or use Reagents should be stored at a temperature range of 15 30 C 59 86 F The analyzer should be placed in a well ventilated location Operation at an altitude above 3000 meters 9800 ft is not recommended 11 Hemolyzer 5 1 1 5 Electrical Requirements The analyzer should only be operated from a wall outlet meeting these power input requirements e 100 127VAC 200 240VAC 47Hz to 63Hz e Power Consumption maximum 400 VA Please ensure that the wall outlet is also capable of supplying the power consumption of any additional devices such as a printer Only the power cord supplied with the instrument should be used Avoid using extension cords The Hemolyzer 5 analyzer comes with a power cord appropriate for your power system Proper use of the appropriate power cord assures adequate grounding of the system If the power network is not reliable contact your representative for options such as the installation of an external UPS module Failure to properly ground the Hemolyzer 5 bypasses important safety features and may result in electrical hazard The instrument should not be placed near potentially i
127. r 5 analyzer packaging you will find an accessory box The analyzer is in a plastic bag in between cushioning protective material After opening the bag remove the desiccant packs The package should contain the following items e Accessories box on top of the analyzer including e Power cord e User Manual this document e Sample tube adapter for the individual sample unit 1 pc e Reagent tube kit in a plastic bag with special caps e Plastic waste container e Cardboard box for the waste container e Preparing for shipment tube kit e Hemolyzer 5 analyzer final check report e The Hemolyzer 5 analyzer Please inform your Sales Representative if any item is missing or damaged Retain the original Hemolyzer 5 analyzer packaging for future transportation and storage 3 1 2 The Autosampler Package The Autosampler is an optional unit that attaches to the Hemolyzer 5 If the optional Autosampler unit was ordered package should contain the following items e Autosampler unit e Asample tray e 10 pieces sample racks e Autosampler final check report Please inform your sales representative if any item is missing or damaged Retain the original Autosampler packaging for future transportation and storage 17 Hemolyzer 5 4 General Overview and Principles of Operation 4 1 General Overview The Hemolyzer 5 is a fully automated high quality hematology analyzer for in vitro diagnostic use in clinical la
128. r human whole blood Ensure that there is sufficient sample volume for three or seven consecutive runs e Place the calibrator sample tube in the sample rotor e Select Three measures or Seven measures according to your laboratory s standard practices e Select Calibrator for a commercial calibrator material or Human for whole human blood calibration e Enter the calibration target values provided with your commercial calibrator material or the previously determined parameter values for human blood calibration e Click or tap the Next button to begin the calibration process e The analyzer displays a blank result screen and begins sample measurement of the calibration material Wait for the screen to be populated with results when sample measurement is complete e Click or tap the Accept button if the measurement run is acceptable e Click or tap the Start next button to begin the next calibration run Selecting Start next without accepting a calibration run discards the run Selecting Abort will abort the entire calibration procedure and discards all calibration results 83 Hemolyzer 5 e The calibration procedure ends when three or seven accepted calibration runs are completed The calibration factors are calculated and presented in the calibrator factor The previous calibration factors and the coefficient of variation CV of the sample runs for each parameter are also displayed e
129. s rrnrrrnnnnnnrnnnnnnrrnnnnnrrnnnnnnrnnnnnnrnnnnnnennnnnnernnnnnesennnnnsnennnnesene 33 Figure 21T Fhe Staus DEDI dU eseguite reese anaes uiui connect sosacutecenanoresnani UNS InINa ep Mi DN bubIUNecn ubpRS MON cesoounion 34 Figure 22 Hemolvzer 5 Main MEN uvenn 36 Figure 23 Start Up Logo Screen 4 40 Figure 24 Hemolvzer 5 User Login STEEN eoe eruere ien e tx RUPEE AREEN ENEE 40 Feedo LOE MER 42 Fe UNN 42 Figure 25 Hemolyzer BONN 42 Hemolyzer 5 Fe Pee NNN 43 Figure 29 Connect Distilled Water Panel rrrrnrnnnnnnnnnnnrnnnnnnrnnnnnnnrnnnnnnrnnnnnnnnnnnnnnnnnnnnevnnnnnssennnnnssnnnnneeene 44 Figure 30 Remove Reagent Tubing Panel esee nennen eene nennen nnne snnt enn 44 Figure 31 Shut Down Ready Panel cote cete sene vba verti c cun e UN er NEEe DUre PUPA AEREE AE 45 Figure 32 Hemolyzer 5 Analyzer Repackaging rrnrnnnnrnnnnnnrrnnnnnnrnnnnnnrnnnnnnrnnrnnnernnnnnevnnnnnssennnnnsnnnnnneeene 46 FEE Fe Sen INC NE 48 Figure 34 Manual Measurement Panel cseccccsssccccessececcesececeeesececeusececeeeceeeeeseceseugecetseeceeseeeeeetes 50 Figure 35 Manual Measure Panel uccisi oer obest ga cess cteccseaseudseas niedesan van kei o eEe bu DEEF ENT PE odniawensentanodstenses 50 Pee 51 Figure 37 Autosampler Info and AS PANE eis credis eurer sit us ves du UOS crudi d pu sub dev kx sS ueeT s Guia xp pur ER ES 52 Figure 38 Full Scan Automatic Processing M
130. s 13 Usermanual Hemolyzer 5 1m max 1 2 m Figure 2 Hemolyzer 5 Without Autosampler Space Requirements 1 1 7 Weight Requirements The Hemolyzer 5 analyzer weighs 35 Kg 77 Ib without the Autosampler The Hemolyzer 5 with optional Autosampler weighs 47Kg 104 Ib Adding an external keyboard documents etc can bring the total weight up to 60 Kg 132 Ib If you decide to store the reagents on the same surface then the combined weight can reach 100 Kg 220 Ib Please select a table laboratory shelf or other location which can support the weight of the Hemolyzer 5 with accessories and is free from vibration 14 Usermanual To allow reliable operation and to provide a safe working environment make sure that the table supporting the unit is stable enough to carry the weight of the instrument and accessories 1 1 8 Waste Disposal Hemolyzer 5 analyzer waste contains human blood and reagents that are chemically and biologically active and should be considered to be a potential infection and biohazard threat Safe laboratory practices must be followed including the use of personal protective when operating the Hemolyzer 5 and handling blood reagents and waste 1 1 9 Known Limitations The Hemolyzer 5 is not intended for analysis of animal blood samples Anti coagulated and homogenized human blood samples must be free from contamination Blood samples must be analyzed within 12 ho
131. s and identifying data The Hemolyzer 5 has a data capacity of up to 100 000 total records To activate Database panel clicking or tapping the Database quick link on the top of the screen will take you to the database view from any screen Print 02 04 2009 16 11 Human 02 04 2009 16 13 Human 02 04 2009 16 16 Human 02 04 2009 17 31 Human 14 08 2009 11 01 Blank 14 08 2009 11 19 Blank 14 08 2009 11 20 Human 25 03 2010 16 50 Blank 25 03 2010 16 57 Blank 25 03 2010 16 58 Blank 25 03 2010 16 58 Human 26 03 2010 10 58 Blank 26 03 2010 13 13 Blank 26 03 2010 13 13 Figure 55 Accessing the Database The database can be accessed at any time even when processing samples in the background You can return to the measurement panel anytime to view ongoing sample measurements 9 1 Database Overview The Hemolyzer 5 analyzer database provides a powerful easy to use method of storing accessing and managing patient and sample result information The database of the Hemolyzer 5 analyzer is capable of storing up to 100 000 measurement control and patient records The database presents information in a table view of rows and columns Each row in the database panel represents one sample measurement Rows are also called records Each column in the database consists or sample identification information or measurement parameter results The database information can be scrolled using navigation buttons along the r
132. s Grinding Noise And Or SW Displays SR Error Messages e the front panel is not closed properly o theopening does not match with the sample rotor door e there is liquid in the SR if you can see traces of salt around the SR contact Service e check the washing head for contamination blood and salt as excessive salt build up can prevent the wash head to lift up effectively and the sample rotor door can get stuck 18 1 4 2 SR Error Appears During Initialization Process e check the washing head for contamination blood and salt e contact Service 18 1 4 3 The SR Does Not Turn Into The Analyzer Even With Open Front Panel e check the washing head for contamination blood and salt 122 Usermanual 18 1 5 Needle Mechanics Vertical Motor Mvert Problems 18 1 5 1 The Needle Carriage Keeps Dropping Back Down At Initialization Is the wash head and its surrounding free of any salt build ups salt build up or thick salt layer at the bottom or on the inside can block the movement of the needle in the wash head or the movement of the wash head around the needle if you like The through hole of the needle in the vertical carriage should be free of salt salt around the needle can even damage the needle and can influence the sampling process or sampling quality or amount of sample The wash head position relative to the needle and to the SR is not correct the wash head comes down too much and even if lifted leaves no room for the SR door
133. sults Saving to tab separated file is not recommended if more than few hundred results are selected in database view Itis not able to print imported data in table view format These problems will be fixed in upcoming SW releases 129 Hemolyzer 5 21 Appendices 21 1 1 Reagent Consumption Function Reagent consumption function ml SEHEN 7 mm a p 3 3 ve 3 E 3 mm 3 3 4 mum J err mam 1 3 1 eeen 3 4 din EM EJ EE OJ VE ee rae WIRE mmm 0 9 3 3 w T rsr e s poor Low If internal chambers are filled volume of chambers 50 ml each diluent 2x50 50 sheath Tun Prime functions fill internal chambers The following pneumatic function uses reagents from the inside puffer while the inside puffer is continuously refilled to a steady level 130 Usermanual 21 1 2 Display Range 1 00 99 99 10 ul cells I cells ul me 1 0 00 9 99 105 ul cells I cells ul BC RBC 0 100 percentage absolute EU ON S S Nw o Loc NR RR RN Mae wo NE WW LLL m an 0 m e pa 131 21 1 3 Fluidic System Hemolyzer 5 S ITA D lt OTA DX 6 zimy Tray 28M sn EA O3 VIA STA X Tash 28M ajdweg vt XI x 294 Pa mig Dey woy dues xij XIW Sd aunquede 284 SEA 28M woy 3 NO npa T EPA TRA ZEA ZEAOPA 9EA 9 EE RRR Suu II TE Jeuu AS AT T 6EA 0 g b ETNA AX 132 Usermanual 21 1 4 Printed Report
134. sure mode Sample pos 9 9 under meas 9 under meas Position A3 Sample status In Progress Position A3 Sample status Ready Measure type Full scan mode Tray status STARTED Measure type Full scan mode Tray status FINISHED Sample Id 22527100022 Sample Id 22527100022 AS measure AS state 22 35 Home Figure 39 Full Scan Mode Tray and List Views The Autosampler allows the addition of sample tubes to a Full Scan process already in progress To add more sample tubes perform the following steps e Click or tap the Stop button The Hemolyzer 5 will prompt you to wait until the current sample is completed e Acknowledge the message by clicking or tapping the OK button e Insert the new samples into a rack e Open the cover of the Autosampler e Place the new samples behind the last measured sample e Close the Autosampler cover e Start the automated measurement by clicking or tapping on the Start button on the GUI or by pressing the physical Start button The Hemolyzer 5 analyzer keeps track of the last analyzed sample on the sample tray of the Autosampler After restarting the full scan process the Hemolyzer 5 moves the Autosampler to the last processed position and continues scanning from there 7 4 2 2 Free List Mode Free List mode is suitable for laboratories where e The barcode labels are not used or the bar codes are not the primary identifiers e Samples are arriving from multiple sources in small batc
135. t inaccurate results Only genuine Analyticon reagents may be used in the Hemolyzer 5 analyzer Analyticon recommends the use of CBC 3K control material and CBC CAL calibration material from R amp D Systems These materials have been specifically assayed for use in the Hemolyzer 5 analyzer R amp D Systems can be reached at R amp D Systems Inc 614 McKinley Place N E Minneapolis MN 55413 Tel Customer Service Sales 800 428 4246 Fax Customer Service Sales 612 379 6580 For additional details about these materials please contact the manufacturer directly 19 Hemolyzer 5 4 1 3 Genuine Analyticon Reagents Only use the genuine Analyticon reagents below to ensure proper performance of the Hemolyzer analyzer Reagents are manufactured and provided by Analyticon Biotechnologies AG and are for in vitro diagnostic use only If the eyes or skin come into contact with any of the reagents flush abundantly with water If ingested drink water immediately and seek medical attention 4 1 3 1 Hemolyzer Diluent Description Multiple micro filtered particle free buffered isotonic solution containing stabilizers special additives and preservatives Application Quantitative and qualitative determination of RBC WBC LONE NEN Table 2 Hemolyzer Diluent Information The product is environmental friendly since does not contain azide nor cyanide 4 1 3 2 Hemolyzer 5 Lyser Description Multiple m
136. t panel open and secured thumb screws become visible Both side panels are fixed to the instrument with these screws 2 in the front and 2 in the back The screws are designed to stay on the analyzer to avoid losing them Left side covers valves and measuring chambers It needs to be removed if chamber cleaning is requested by the analyzer Right side covers sampling unit and wash head and sampling needle You need to open the right side if wash head needs to be cleaned or replaced After removing the cover potentially hazardous parts become accessible electronic boards motors moving parts sampling needle chambers tubes and valves These components may cause injury or can get damaged if handled incorrectly Only R certified personnel should open the covers Running measurements with opened cover is not recommended due to the risk of possible injury Always wear safety gloves while performing maintenance actions When reinstalling side panels always make sure to re tighten the thumb screws 15 1 4 User Maintainable Parts Of The Analyzer There are three user maintenance points in Hemolyzer 5 Shear valve this is a key component and is responsible for correct sampling and diluting procedures Wash head key component in keeping the sampling needle clean and thus ensuring reliable piercing and sampling procedures Measuring chambers contamination induced problems noise high blank values can be resolved by cleaning the plasti
137. tep 1 The analyzer will ask you to disconnect the reagents from the reagent connectors on the back panel except for the waste connection Leave the waste container tubing connected to the analyzer The system will drain all inner reagent buffers throughout the pneumatic system This step takes approximately 9 minutes Do not turn the analyzer off during this step Step 2 The instrument will ask you to connect distilled water to the reagent inputs Connect distilled water to reagent inputs If you are ready press OK button Figure 28 Connect Distilled Water Panel Use the Prepare for shipment tube set included with your Hemolyzer 5 analyzer to perform this step The system will prime and fully rinse the tubing and pneumatic system with distilled water This step takes approximately 7 minutes Do not turn the analyzer off during this step Step 3 The analyzer will ask you to disconnect the Prepare for shipment tube set from the reagent connectors on the back panel except for the waste connection Leave the waste container tubing connected to the analyzer Remove reagent tubing at rear reagent inputs Diluent Lyse 5P Diff 5P Leave waste connected If you are ready press OK button Figure 29 Remove Reagent Tubing Panel The analyzer will drain all liquids from the instrument This step takes approximately 10 minutes Do not turn the analyzer off during this step When the process is over the system will notify yo
138. the means to select a group of records automatically according to their identifying information See section 9 8 1 for more information on the Select by database function 76 Usermanual 9 6 Viewing Detailed Results Multiple selection is also useful for viewing the detailed results of a few records rather than navigating through the database After selecting several records clicking or tapping the Details button on the database panel will display the detailed results for the first record in the selection Clicking or tapping the Up or Down buttons on the details screen displays the details of the next record in the selection 9 7 Statistics After selecting a group of records click or tap the Statistics button on the database panel to view the coefficients of variation CV associated with each of the 24 parameters This function is useful to quickly measure the imprecision of multiple runs of the same sample 9 8 Managing Database Records Hemolyzer 5 analyzer database management functions are accessed by clicking or tapping the Manage records button to bring up the Manage records panel fa Manage records Importing Send to LIS Save tab file i f Cancel j pave d j Delete Select by data V J J Figure 58 Manage Records Panel XY All data manipulation actions that change the data stored in the Hemolyzer 5 database are logged in the Hemolyzer 5
139. the tubes and inside the shear valve 107 Hemolyzer 5 As the preparations completed the Hemolyzer 5 displays the following message Unscrew the Shear Valve clean surfaces assemble the Shear Valve If you are ready press OK button to continue Don t press the OK until the shear valve is assembled again Perform the shear valve cleaning according to the instructions below Below instructions are valid for analyzers manufactured before August 2010 1 Open the front cover and secure it with the latch Locate the shear valve 2 Unscrew and remove the Axis screw Clean the Axis screw by using water and wipe it dry 108 Usermanual 3 Slide down the upper disk of the shear valve Due to the extremely smooth surface of the ceramic discs it is not possible to simply lift up the upper part If the shear valve was not in use over a few days then apply a few drops of water to the contact of the upper and lower disks 4 Clean the connecting surfaces of the disks of the shear valve the housing of the valve the tube connections Remove any salt built ups Use the tweezers to push in the dampened and the dry cloths You may apply a few drops of water to soften up the contaminations You may use a tooth pick to remove salt crystals from narrow places Do not use any sharp metal hard object which can scratch the surface of the shear valve Clean the surrounding and the housing mounting of the
140. tion that uniquely identifies a particular sample run 64 Usermanual The Sample ID is the ID entered by the operator from a keyboard or hand held barcode reader for a manually processed specimen For automatically processed specimens the sample ID can be read from a sample tube barcode or entered into a list for one of the automatic processing list modes Sample IDs can be reused in the Hemolyzer 5 analyzer but other identifying information together with the Sample ID sample ID uniquely identify the sample run This is the patient associated with this sample run If none was entered or selected Patient ID the default patient ID is set to 1 Run Date Time This is the time and date that this sample was run This is the sample mode selected for this specimen Each sample mode applies a Sample Mode different set of normal ranges to this sample run Table 8 Sample Identification Information 8 3 Parameter Information The parameter information area of the Hemolyzer 5 analyzer result screen lists information on 24 parameters Flag Unit 5p Normal Range 10 ul 5 00 10 00 2 00 7 50 130 400 9 5 95 0 15 0 70 1 3 25 0 00 0 50 2 4 95 0 00 0 15 Figure 50 Parameter Information Display Each row shows the parameter name value flags normal range linearity range and high blank units and normal range The units area displays the differential percentage for the five leukocyte sub
141. to the analyzer s measuring chambers The process is described below DIFF 18 2 2 Long smeared population This image shows that neither the TCU nor the reagents nor the mixing cannot do their jobs Possible reason e the two lyse reagents are interchanged e check tube connections or container connections 127 Hemolyzer 5 19 Accessories The following items can be found along with the analyzer Power cord Reagent tube kit Cleaning tube kit Waste container 20L Cardboard box for waste container Sample tube adapter User s manual 128 Usermanual 20 Known Problems The following problems are known at the time of the releasing of the software and this user manual Long Sample ID is not visible on printout and on display Tooltip info contains square character instead of upper index 6 9 12 Sometimes the AS menu is not deactivated when AS is switched off On screen keyboard remains active while screensaver is running Itis necessary to login in multiuser mode to call the shutdown procedure Theuser is able to log out during pneumatic activities Naming conventions Number of digits on the QC is different The length of some language nodes are longer than expected Patient s SSN is not printed on normal printout f patient data isn t filled out the software could display NULL value Only English characters are accepted as user name Querying statistics Printing re
142. to turn The vertical rod holding the wash head if removed or modified is not inserted correctly The rod was not pushed up to the maximum and the wash head is sitting in a position too low 123 Hemolyzer 5 18 1 6 Shear Valve SV Related Errors 18 1 6 1 SV Error At The First Startup e the SV cannot turn o make sure that the pull tab has been removed o check free movement by hand rotate the shear valve e The SV is stuck o try to open the Shear Valve 18 1 6 2 Grinding Noise After SV Cleaning After SV Reinstallation e the rotating part cannot reach opto position e the lower disc is not aligned correctly see section SV cleaning o contact service for guidance 18 1 6 3 SV Leakage e the upper disc is not sitting well on the lower disc e open andreseat the upper disc e there must not be any opening left between the closing screw and the upper disc NO OPENING 124 Usermanual 18 1 7 Dilutor Errors e pinched clogged tube around dilutor or at the rear reagent tubes e physical obstruction foreign material 18 1 8 Priming Problems 18 1 8 1 The Analyzer Would Not Prime Liquids e The respective reagent is out e aspirating tube in container o has fallen off o hasa leakage o is broken e a reagent puffer is leaking look for liquid below the analyzer e damaged tube in the system look for leakage or traces of liquid contact Service 125 Hemolyzer 5 18 1 9 Electronics Related Problems 18 1 9
143. tory to store the exported data and press the Ok button to start the export The file format of exported data is an internal format and can only be read and interpreted by the Hemolyzer 5 analyzer using the Import function Each database record is stored as an individual file with a rp extension 9 8 4 SendtoLIS The Send to LIS button immediately transmits selected database records to the external LIS according to your LIS settings 9 8 5 Save Tab File The Save tab file function is used to archive database data to a tab separated text file The Save tab file button displays a directory panel like Figure 61 except that the file saved in the selected location is a tab separated text file rather than a database backup file Tab separated text files can be loaded and viewed by a text editor or imported into spreadsheet software The filename created by the Save tab file function is generated automatically in the following format TAB YYYYMMDDHHMMSS txt with the year month day hour minute and second of the time when the operation started 80 Usermanual To archive database data using this function insert a USB data storage device to one of the USB inputs on the back panel of the Hemolyzer 5 analyzer Select the file location of your USB data storage device and click or tap the OK button to begin the export See section 21 1 10 for detailed information on the format of the tab separated text file 9 8 6 Sa
144. tructions are valid for analyzers manufactured after August 2010 1 Open the front cover and secure it with the latch and locate the shear valve it is in the center of the analyzer 2 Unscrew and remove the Axis screw Clean the Axis screw by using water and wipe it dry 3 Slide off the upper disk of the shear valve Due to the extremely smooth surface of the ceramic discs it is not possible to simply lift away the upper part If the shear valve was not in use for a few days then apply a few drops of water to the contact of the upper and lower disks With time the salt will get dissolved and the upper disk gets released 4 Clean the connecting surfaces of the disks of the shear valve the housing of the valve the tube connections Remove any salt built ups Use the tweezers to push in the dampened and the dry cloths You may apply a few drops of water to soften up the contaminations You may use a tooth pick to remove salt crystals from narrow places Do not use any sharp metal hard object which can 110 Usermanual scratch the surface of the shear valve Clean the surrounding and the housing mounting of the shear valve as well if necessary Pay attention to clean the aligning surface Be sure that no lint fibers remain on the connection surfaces of the ceramic disks 5 After cleaning the shear valve the housing and surrounding area put the disks together 6 Put the axis screw into the upper
145. ttons i RBC 10 uL d oo B sp EIEJEIEJEIE EJEJEJEI Today Cancel 09022010 GJER Figure 18 Date Virtual On Screen Keypad 5 6 Using the Graphical User Interface The graphical user interface GUI of the Hemolyzer 5 is divided into three main sections Refer to Figure 19 to see these sections 1 Quick links to main functions top section 2 Interactive display area middle section 3 Status display bottom section 32 Usermanual The main menu shown below is displayed in the interactive display area when the Hemolyzer 5 analyzer is initially powered up fas state 100 None 08 59 Figure 19 Graphical User Interface Sections 5 6 1 Quick Links The upper part of the GUI is always visible during all operations and presents several quick link buttons Selecting one of the quick link buttons determines what is displayed in the interactive display area The selected button is framed on three sides for clear visual feedback The quick link for Autosampler functions is enabled only if the optional Autosampler is connected 5 6 2 The Interactive Display Area The middle section is used to display the main menu functions information results and all the panels that contain information about the active mode 5 6 3 The Status Display The bottom section is called the Status display and presents the user with the following
146. u about switching off the instrument Click or tap the OK button on the notification panel and wait until the Windows XP9 Embedded exits and power off the user interface computer 44 Usermanual Do not turn off power of the Hemolyzer 5 at this stage First click or tap the OK button then wait until the Windows XP Embedded operating system exits and shuts down the internal Hemolyzer 5 user interface computer After the shut down process is completed you can turn off the main power switch small switch on the rear panel of the Hemolyzer 5 analyzer near the power connection to the down position labeled 0 You can power off the system Figure 30 Shut Down Ready Panel Step 4 Disconnect the waste container tubing from the waste reagent connector on the back panel of the Hemolyzer 5 analyzer Small droplets of distilled water may remain in the tubing after the Prepare for shipment process completes These droplets will not cause any malfunction during transportation or the next start up procedure 6 3 4 Emergency Shut Down The procedures described in this section can damage the Hemolyzer 5 analyzer or cause data loss or damage to critical system computer files Use these procedures in case of emergency only 6 3 4 1 Immediate Shut Down The immediate shut down can be initiated by pressing the standby button near the top of the back panel of the Hemolyzer 5 analyzer
147. ured HGBblank Average volume of individual erythrocytes derived from the RBC histogram Calculated from the RBC and MCV values HCT percentage RBC x MCV x 100 HCTabsolute RBC x MCV Average hemoglobin content of erythrocytes calculated from RBC and HGB values MICH HGB RBC Calculated from the HGB and HCT values MCHC HGB HCTabsolute Unit of measurement is displayed according to the one chosen for HGB result g dl g l or mmol l The distribution width of the erythrocyte or platelet population derived from the histogram at 20 of peak 100 REC xDW SD RDWcal x P2 P1 fl xDW CV RDWcal x 0 56 x P2 P1 P2 P1 by the factor of 0 56 CV is corrected to the 6096 cut Number of thrombocytes platelets PLT PLTcal x cells I cells ul 137 Hemolyzer 5 Mean Platelet Volume MPV Average volume of individual platelets derived from the fl Thrombocrit PCT Calculated from the PLT and MPV values PLT histogram PCTpercentage PLT x MPV x 100 percentage absolute PCTabsolute PLT x MPV White blood cell 4 part differential Relative value are calculated from the optical 4 diff LYM lymphocytes scatter populations MON monocytes and some eosinophils NEU neutrophil granulocytes EOS eosinophil granulocytes BAS basophil granulocytes Relative value is calculated from the basofil optical scatter populations 21 1 7 Technical Data 2
148. urn to the measurement panel by clicking or tapping the using the Back button e Run the next sample in routine mode by o Editing the Next sample ID just below the actual results o Accepting the auto generated sample ID o Starting the next measurement by clicking tapping the Start button on the screen or by pressing the physical Start button on the front panel of the Hemolyzer 5 o Please note that in this mode the patient and sample mode will be carried over from the previous sample unless they are changed 7 4 2 Automatic Mode Only human samples in closed sample tubes can be processed in automatic mode from the Autosampler QC samples and open tubes must be processed in manual mode After starting up the Hemolyzer 5 select the Measure quick link Process a new blank must be processed if this is the first time a new measurement panel is opened since starting up or if an earlier blank has expired due to inactivity An accepted blank measurement is required before starting automatic sample processing Open the AS panel by using the AS quick link at the top of the screen 2 li B g TV Measure AS Menu AS state i 93 Standby 100 Error c EJ 5 22 29 Figure 36 Autosampler Info and AS Panel From the AS panel you can initiate automated sample measurement in 3 modes 52 Usermanual e Full Scan mode o The Autosampler will scan the whole sample tray o The same sample mo
149. urs of venipuncture 1 1 10 Emergency Situations Always follow all applicable laws and regulations with regard to emergency situations If the Hemolyzer 5 needs to be powered off due to an emergency situation like fire thunderstorm etc follow the procedures in chapter 6 3 4 In case of fire do not use water to extinguish the fire unless the Hemolyzer 5 is disconnected from the electrical network 15 Hemolyzer 5 2 Product Support Your sales representative is trained and qualified to answer questions about applications and the operation of the Hemolyzer 5 analyzer If you have additional questions regarding the Hemolyzer 5 please ask for manufacturer support through your sales representative Analyticon makes every effort to provide excellent support and up to date information and services regarding the Hemolyzer 5 analyzer For further support or questions please contact us support Qanalyticon diagnostics com 16 Usermanual 3 Installation Your Analyticon certified service engineer will perform the initial installation of the Hemolyzer 5 analyzer and train you and selected laboratory personnel on the proper use and maintenance of the analyzer The certified service engineer will also train you how to use your analyzer You ll also be explained about necessary maintenance actions 3 1 Package contents 3 1 1 The Hemolyzer 5 Analyzer Package After opening the Hemolyze
150. ve Raw Data The save raw data function saves the raw data information associated with a selection of database records Raw data files are only suitable for internal use by Analyticon staff Your service engineer may ask you to save raw data files to help diagnose a service issue A confirmation password is required to save raw data The default factory set confirmation password is 555 This password can be changed only by a Analyticon certified service engineer Insert a USB data storage device to one of the USB inputs on the back panel of the Hemolyzer 5 analyzer Click or tap the Save raw data button on the Manage records panel then enter the correct confirmation password Click or tap the Ok button to display a directory panel like Figure 61 Select the file location of your USB data storage device and click or tap the OK button to begin saving raw data 9 8 7 Delete The Delete function is used to delete records from a selection permanently from the Hemolyzer 5 analyzer database To permanently delete records select a group of records and click or tap the Delete button on the Manage records panel To prevent accidental deletion of data the Hemolyzer 5 requests the same confirmation password used in the save raw data function After entering the correct password and clicking or tapping the Ok button the records will be permanently deleted The password to allow deleting records is 555 81 Hemolyzer 5 10
151. whose parameter values and ranges are determined by other means The advantage of a commercial control material is that is shelf life is much longer than human blood allowing control of the analyzer for a longer period of time Controls in the Hemolyzer 5 are processed in manual mode only To access the QC panel select the QC icon on the main menu Maintenance axi 100 100 100 fu ps HEBR BE iin Ju Figure 66 QC Panel 86 Usermanual 11 1 Set QC Reference Before taking any QC measurements target values and acceptable ranges must be specified for a QC lot of control material Click or tap the Set QC reference button to display the Set QC panel H Measure D_CH_089 DCP089 12 23 2010 i REGER 100 100 1100 1 00 None Ea E 73 F9 Figure 67 Set QC Reference Panel The QC name is the name that will be displayed for selecting the control to associate with a QC measurement Enter the identifying information and the target values and tolerance ranges for any parameters that are to be controlled with the Hemolyzer 5 QC system To exclude a parameter from the QC procedure leave its target value and tolerance range field empty Press the Save reference button after data entry is completed u Selected path Tapping the Load QC reference button will EE mons uet allow filling QC material data electronically Actual path using a file provided by the manufacturer of the E
152. yet Function name Sorry no error string yet Function name Sorry no error string yet Function name Sorry no error string yet Function name Sorry no error string yet Function name Se Ue 14 08 2009 10 54 14 08 2009 10 54 14 08 2009 10 55 14 08 2009 10 55 14108 2009 10 56 14 08 2009 10 56 14 08 2009 12 10 14 08 2009 12 10 14 08 2009 12 44 14 08 2009 12 44 14 08 2009 12 47 Cv 1410812009 12 47 e Deas senest omes Database 100 100 20000 mi 1000 mi 100 1000 mi 0 Usermanual 14 1 4 Statistics This menu item will display number of measurements and number of possible failure events experienced during operation Statistical data can be reset by a certified service engineer only Measure Database Figure 80 Statistics display 14 1 5 Information This menu item displays instrument specific data serial numbers SW versions These data are important for maintenance purposes Your service engineer will ask for these before a service visit Measure Database Figure 81 Statistics display 103 Hemolyzer 5 15 Maintenance To ensure reliable operation regular maintenance or occasional corrective actions are required This chapter describes necessary procedures and steps required to keep your analyzer in a good operating condition Hemolyzer5 is a complex automated hematology analyzer Special Analyticon Hemolyzer5 A Service Training
153. yzer Please consider the following e Blood proteins or other particles can accumulate in the pneumatic tubing or components e Although the reagents contain antimicrobial agents some microbial growth may still be present e An extended period of inactivity without performing a prepare for shipment procedure may result in salt crystal development in the pneumatic components Running additional blank measurements will usually bring the blank measurements down to an acceptable level Blank measurements will be flagged if they exceed the following thresholds e WBC20 5 10 cells uL e RBC20 05 10 cells ul e PLT2 15 10 cells uL e HGB 2 100 g dL If the Hemolyzer 5 was not in use for an extended period of time the start up of the pneumatic system components can take significantly longer and require more blank measurements To prevent these problems use the prepare for shipment process when the Hemolyzer 5 analyzer will be inactive for an extended time 6 3 Exiting the Hemolyzer 5 Analyzer After you have completed lab operations and you are ready to exit the Hemolyzer 5 analyzer you can 41 Hemolyzer 5 e Log off e Shut down the Hemolyzer 5 e Power off the Hemolyzer 5 e Prepare the Hemolyzer 5 for shipment Click or tap the Exit icon on the main menu to access various exit options Click or tap the Cancel button to return to normal operation 6 3 1 Log Off

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