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Hematology Analyzer
Users Manual
2.1 release
INTRODUCTION, INTENDED USE ........................................................................................................ 3 DESCRIPTION OF THE ANALYZER ..................................................................................................... 3 2.1 PARTS OF THE ANALYZER ............................................................................................................................ 3 Front panel ..................................................................................................................................................... 4 Rear panel ...................................................................................................................................................... 5 2.2 FLUIDIC SCHEMATICS ................................................................................................................................. 6 2.3 FUNCTION OF FLUIDICS ............................................................................................................................... 6 2.4 CONTROL PANELS ....................................................................................................................................... 6 2.4.1 Sampling bar ..................................................................................................................................... 6 2.4.2 Status LED......................................................................................................................................... 6 2.4.3 Display............................................................................................................................................... 6 2.4.4 Keyboard ........................................................................................................................................... 7
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DESCRIPTION OF THE SOFTWARE..................................................................................................... 8 3.1 GENERAL .................................................................................................................................................... 8 3.2 MENU SYSTEM ............................................................................................................................................ 8 3.3 MENU STRUCTURE ...................................................................................................................................... 9
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OPERATING PRINCIPLES..................................................................................................................... 10 4.1 4.2 4.3 4.4 IMPEDANCE METHOD................................................................................................................................. 10 PRINCIPLE OF THE HGB MEASUREMENT ................................................................................................... 10 PARAMETERS ............................................................................................................................................ 11 ABSOLUTE AND LINEARITY RANGES OF MEASURED PARAMETERS ........................................................... 12
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ANALYZER INSTALLATION PROCEDURES.................................................................................... 13 5.1 5.2 5.3 5.4 5.5 5.6 5.7 5.8 UNPACKING .............................................................................................................................................. 13 CONNECTING REAGENT CONTAINERS ........................................................................................................ 13 CONNECTING POWER CORD ....................................................................................................................... 13 CONNECTING AN EXTERNAL PRINTER ........................................................................................................ 13 CONNECTING THE INSTRUMENT TO A HOST COMPUTER ............................................................................. 14 TURNING THE INSTRUMENT ON ................................................................................................................ 14 REAGENT PRIMING .................................................................................................................................... 14 TURNING THE INSTRUMENT OFF............................................................................................................... 15
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SOFTWARE SETTINGS .......................................................................................................................... 16 6.1 SETTING DATE AND TIME.......................................................................................................................... 16 6.2 SETTING THE NAME OF THE LABORATORY ................................................................................................ 17 6.3 RESULTS UNITS SETTING ........................................................................................................................... 17 6.4 SETTING REFERENCE LIMITS ...................................................................................................................... 18 6.5 FLUID SENSORS ......................................................................................................................................... 19 6.6 PRINTER SETTINGS .................................................................................................................................... 20 6.6.1 Troubleshooting guide for printing problems ................................................................................. 22 6.7 USER SETTINGS ......................................................................................................................................... 23 6.7.1 Multi-user mode .............................................................................................................................. 24
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ROUTINE UTILIZATION........................................................................................................................ 25 7.1 MEASURING PROCESS................................................................................................................................ 25 7.1.1 Sampling.......................................................................................................................................... 25 7.1.2 Blank measurement ......................................................................................................................... 25 7.1.3 Calibration ...................................................................................................................................... 26 7.1.4 Sample Analysis............................................................................................................................... 29 7.1.5 Prediluted mode .............................................................................................................................. 32 7.2 QUALITY CONTROL ................................................................................................................................... 33 7.2.1 QC database .................................................................................................................................... 34 7.3 AUTO STAND-BY ....................................................................................................................................... 35 7.4 PRINTOUTS ................................................................................................................................................ 35 7.5 PATIENT RESULTS DATABASE MANAGEMENT ............................................................................................ 36 7.6 DATA BACK UP ......................................................................................................................................... 38
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7.7 MAINTENANCE ..........................................................................................................................................39 7.7.1 Cleaning...........................................................................................................................................39 7.7.2 Priming ............................................................................................................................................39 7.7.3 Draining...........................................................................................................................................39 7.7.4 Manual cleaning of the aperture .....................................................................................................40 7.7.5 Weekly maintenance ........................................................................................................................40 7.8 DIAGNOSTICS ............................................................................................................................................41 7.8.1 Device Statistics...............................................................................................................................41 7.8.2 Self test.............................................................................................................................................41 7.9 SOFTWARE UPDATE ...................................................................................................................................42
8. 9. 10. 11.
APPENDIX "A": REAGENT SOLUTIONS AND CONSUMPTION ..................................................43 APPENDIX "B": TECHNICAL SPECIFICATIONS ............................................................................44 APPENDIX "C": FLUIDIC SCHEMATICS ......................................................................................45 APPENDIX "D": ACCESSORIES.......................................................................................................46
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2.4.3 Display
The display is a 240 x 128 dots, high contrast, CCFL backlit graphic LCD (Liquid Crystal Display) module.
Numerical buttons: for entering numerical data, and selecting menu items; Function buttons: for starting the action displayed with an icon above the function key at the bottom of the LCD; Cursor moving arrows: and , for moving between database items; and , for moving between parameter columns or menu levels; START/OK button: used for initiating a measurement cycle or confirming data; Del button: for deleting missed characters; Help button: for HELP function.
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The existence of sub-menus are indicated by a symbol at the end of the menu line. Some results can be displayed in table format. In this case the 3 (three) button has the same effect as the Page Up key, and the 9 (nine) button has the same effect as the Page Down key. Use these buttons to move between table pages. Further positioning keys during browsing the database are 1 (Jump to top) and 7 (Jump to bottom). Some menu items have selected and deselected (on and off) states. These items are marked with a symbol in front of the item number. The filled mark indicates selected state. Selecting the menu item toggles its state. Other menu items work as so-called radio-buttons. It means that only one of the buttons of the group can be on at once. In some cases, more buttons are displayed together, though they correspond to different groups. In this case, the groups are separated by a horizontal line.
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4. OPERATING PRINCIPLES
Each cell, passing through the aperture where a constant DC current flows between the external and internal electrodes causes some change in the impedance of the conductive blood cell suspension. These changes are recorded as increases in the voltage between the electrodes. The number of pulses correlates to the number of particles (CBC - Counting Blood Cell). The intensity of each pulse is proportional to the volume of that particle (WBC, RBC, PLT histograms). Pulses are counted only in channels (in terms of femtoliters, fl) which are between the pre-set lower and upper discriminators.
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4.3 Parameters
White Blood Cell WBC (cells/l, cells/l) Red Blood Cell RBC (cells/l, cells/l) Hemoglobin concentration - HGB (g/dl, g/l, mmol/l) Mean Corpuscular Volume - MCV Hematocrit HCT (percentage, absolute) Number of leukocytes. WBC = WBCcal x (cells/l, cells/l) Number of erythrocytes. RBC = RBCcal x (cells/l, cells/l) Measured photometrically at 540 nm; in each cycle blank measurement is performed on diluent HGB = HGBcal x (HGBmeasured HGBblank) Average volume of individual erythrocytes derived from (fl) the RBC histogram. Calculated from the RBC and MCV values. HCTpercentage = RBC x MCV x 100, HCTabsolute = RBC x MCV erythrocytes, Mean Corpuscular Hemoglobin Average hemoglobin content of calculated from RBC and HGB values. MCH MCH = HGB / RBC (pg, fmol) Mean Corpuscular Concentration MCHC MCHC = HGB / HCTabsolute
Unit of measurement is displayed according to the one (g/dl, g/l, mmol/l) chosen for HGB result (g/dl, g/l or mmol/l) The distribution width of the erythrocyte or platelet Red cell Distribut. Width - RDW-SD population derived from the histogram at 20% of peak And Platelet Distribut. Width - PDW-SD (fl) Red cell Distribut. Width - RDW-CV And Platelet Distribut. Width - PDW-CV (absolute) Platelet PLT (cells/l, cells/l) Mean Platelet Volume MPV Thrombocrit PCT (percentage, absolute) White blood cell differential: LYM, LY% : lymphocytes MID, MID% : monocytes and some eosinophil granulocytes GRA, GR% : neutrophil, eosinophil and basophil granulocytes
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 60% cut Number of thrombocytes (platelets) PLT = PLTcal x (cells/l, cells/l)
Average volume of individual platelets derived from the (fl) PLT histogram. Calculated from the PLT and MPV values. PCTpercentage = PLT x MPV x 100, PCTabsolute = PLT x MPV Absolute values counted in the channels determined by the three WBC discriminators:
1. 2. 3. GRA
LYM MID
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The linearity ranges for 1:3 predilution mode: Parameter WBC RBC PLT Linearity Ranges 4...400 2...40 200...3000 Maximum 600 60 4000
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Cleaner solution
Lyse solution
Diluent solution
AbaClean
Abalyse
Diaton McDiff16
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Main menu 1.Measure 2.Database 3.Maintenance 4.Calibration 5.Quality control 6.Settings 7.Exit
When the start-up procedure is completed, the MAIN MENU is displayed. Sub-menus are indicated with an arrow in the end of the line. In this case, you can use key to enter the selected sub-menu.
CAUTION! Wait 5 minutes before starting any measuring process. This time is required to reach the optimal working temperature.
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The software will prompt you for confirmation. Press 1, and the analyzer will perform a priming cycle to fill the chamber to avoid dust and salt build-up, and shuts itself down. The second item should be used when the instrument is to be shipped. In this case, the instrument will ask you to connect the cleaning tube kit with 100ml of distilled water. Follow the instructions appearing on the display. ! Message 5001/19300 Remove reagent tubing at rear reagent inputs (Diluent, Lyse and Cleaner) EXIT (7) PREPARING FOR SHIPMENT (2) Here, the instrument asks you to remove tubing connectors, so that they can be drained. Leave waste connector on.
! Message 5002/19300 Connect min 100 ml distilled water to reagent inputs using cleaning tube kit.
Next, you should connect at least 100 ml of distilled water, which the instrument uses to wash out any reagents remaining in the system. Waste must still be on.
! Message 5003/19300 Remove cleaning tube kit. Keep reagent inputs free.
Next, the analyzer asks you to remove cleaning tube kit (waste must still be on). When finished, the analyzer will ask you to power off the system.
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6. SOFTWARE SETTINGS
Settings 1.Date and time 2.Laboratory 3.Units 4.Limits 5.Fluid sensors 6.Printer settings 7.User settings The SETTINGS sub-menu allows you to set customer-defined limits, hardware and software configurations required for proper instrument operation. From this sub-menu, you can access the date and time, limits, patient type, and other settings related to the instrument.
Set date and time The current date and time are 12.05.2000 15:00
SETTINGS (6) DATE AND TIME (1) SET DATE AND TIME (1) Enter the actual date and time using the numerical keypad. The form of the date is as it was set in the previous menu. Confirm by pressing the button.
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The possible units for above parameters are as follows: Count unit HGB unit PCT, HCT unit RDW, PDW mode cells/liter, cells/l grams/liter (g/l), grams/deciliter (g/dl), millimols/liter (mmol/l) percentage (%), absolute (abs) Standard Deviation (sd), Coefficient of Variation (cv)
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The next three figures show the reference range settings of Female patient type.
2.
Patient limits Female WBC 5.0 RBC 4.00 HGB 120 HCT 36.0 MCV 76 MCH 27.0 MCHC 300
3.
- 10.0 10^9/l - 5.00 10^12/l 160 g/l - 48.0 % 96 fl - 32.0 pg 350 g/l
SETTINGS (6) LIMITS (4) FEMALE (3) Modify the highlighted lower and upper limits with the numerical keypad. Confirm with OK. By pressing and function key buttons, you can turn to other pages with additional parameters.
Patient limits PLT 150 PCT 0.0 MPV 8.0 PDWs 0.0 PDWc 0.0 RDWs 20.0 RDWc 0.0 LYM 1.3
10^9/l % fl fl % fl % 10^9/l
If 0.0 - 0.0 is specified as lower and upper limit, the parameter will not be checked for its proper range.
Patient limits MID 0.2 GRA 2.5 LY% 25.0 MI% 3.0 GR% 50.0 Lyse 0.90 ml
10^9/l 10^9/l % % %
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If any of the fluid sensors is switched off, an S warning can be seen in the top-left corner of the screen during measurement.
There is a software counter method for waste full checking. The Service Personnel must set the waste container capacity during installation. The instrument counts the drained waste volume and gives a warning message when it reaches the set waste container capacity. The User can reset the waste counter in the MAINTENANCE (3) / EMPTY WASTE CONTAINER (4) sub-menu. This is strongly recommended to use this method with the following rules: Always use the same or higher capacity waste tank that was set during installation. If You want to change waste tank size, please call your Service Person. Empty waste tank when the instrument gives you the warning: waste is full. If you replace waste tank do not forget to reset the software waste counter.
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Any printer being able to emulate any of the above modes can be connected to the instrument. To set up the instrument for your printer, go to the Settings/Printer Settings menu. Choose one of the possibilities using the up and down arrow keys within the text fields, and fill in the numerical fields using the numerical keys. The general characteristics of the printable area of printer paper are below:
Paper width Top margin Left margin Physical margins Result Printable area Vertical spacing Result Paper height
The paper is defined by its size: it can be standard (A4, Letter) or any other custom size paper (actual size). Printers cannot print on the whole surface of the paper. The blank area is described by the physical Margins, which may vary by printer models. The paper area inside the physical margins is called printable area. Top margin and Left margin settings are used for determining the exact place where the results inside the printable area are printed.
If more than one result is to be printed on one sheet of paper, use Vertical spacing to determine the distance between the reports.
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On the first page of Printer Settings, printer type, graphics mode and paper settings can be set. Select the Printer matching your printer hardware.
Normal x 11.69
Different Modes result in different printout sizes. Choose the one matching your needs. The available modes depend on the selected printer type. Possible options are: Mini, Small, Normal, Enhanced and Large for the size, Wide and Narrow for the width and the optionally Fast mode. Recommended mode is Normal.
Physical Margin is used to correct the printout for a printer having lower printable area. Bigger margin means bigger physical margin. Alter the normal setting only, if the right side of the printed result is missing, or appears in the next line.
Select Paper, or enter correct Size parameters: either in inches or in cm, specified at Unit. The second page of printer settings enables changing further margins, vertical spacing of reports, and other options.
Printer settings Margins: Left: 0.00 Vertical spacing: Rollpaper: Autoprint: Printout format: Table format: One result per page:
If all results are to be printed automatically after each measurement, set Autoprint to Yes.
Printout format can be specified as one of the following:
If you set One result per page to Yes, each measurement will be printed on another page.
Printer settings Print ranges: Print flags: Print warning flags:
Yes Yes No
The third page of printer settings holds the options for the individual result-printning. If Print Ranges is set to Yes, the upper and lower limits (if specified in Settings/Limits) will be printed next to each measured parameter for verification.
If Print Flags is set to Yes, and any measured value is out of the normal range, or there was any error, those will be shown on the printout as well. It is recommended to set it to Yes. If Print warning flags is enabled, any flags that was shown on the result screen will be included with the printout.
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Right side of the printed report is missing, or appears in the next line. The printed report is too small, there is a lot of space on the paper. The end of the printout appears on the next page. It seems that one more patient report could fit on the same page. The printed result is not centered horizontally. The printed result is not centered vertically. The distance between two results is too small or too big. After printing, the printer does not eject the paper. But if you repeat printing, it appears in more copies.
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SETTINGS (6) USER SETTINGS (7) This menu allows configuring the instrument for single-user or multi-user mode.
Care must be taken when changing to multi-user mode.
User settings 1.Single user mode 2.Multi user mode 3.Add new user
SETTINGS (6) USER SETTINGS (7) MULTI USER MODE (2) By selecting item 2, the instrument enters multiuser mode, and a new item appears on the screen: Add new user.
Multi-user mode allows more people using the same instrument with individual personal settings, so-called profiles. In a multi-user environment users have their own profiles describing their rights within the system. In an environment like this there must be a so-called supervisor having the right to add, delete users and modify their rights. The software of the instrument has three levels of user-rights: Basic, Advanced and Supervisor. A Basic-level user has absolutely minimal rights within the system. They can perform measurements and entering patient data before the measurement. An Advanced-level user has the rights to modify settings of the instrument: as described in chapters 6.1-6.6, do QC and Calibration. An Advanced user can also modify patient data when browsing in the database. A Supervisor has the ability to do all the above, and additionally to modify user rights and user passwords.
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In Multi-user mode, there must always be a user with Supervisor rights, otherwise only a Service-person can reset the instrument.
User information User ID 1 Name Frank Smith____________________ Level Basic Active Yes Password
SETTINGS (6) USER SETTINGS (7) ADD NEW USER (3) To each new user, the software assigns an individual ID. In the next field, a user name of 32 characters can be specified.
When the name is entered, the level should be defined. The default setting for Active is Yes. Use this option if you want to disable a user. The last data to enter is the password, a maximum of 8 alphanumeric characters.
If the analyzer is in multi-user mode, a logon screen will be displayed during start-up, asking for a user ID and a password.
When the User ID is entered (confirm with OK), the user name corresponding to the ID appears in the lower line. If the user name was correct, enter the password, and confirm with the function key. If the password was correct, the analyzer continues initialization and is ready to work.
In multi-user mode the Exit menu is changed: a Log-out menu point appears.
Exit 1. Shut down 2. Preparing for shipment 3. Logout
EXIT (7) When the user logged in has finished working with the instrument, it is not necessary to switch off. From the main menu, selecting EXIT (7) brings up the EXIT menu. LOGOUT should be used instead of shutdown, as in this case the log-in screen will be displayed waiting for the next user to log in.
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7. ROUTINE UTILIZATION
7.1 Measuring process
7.1.1 Sampling
The aspirating tip (a needle with rounded end) is used to draw sample from the tube containing the blood to be analyzed. It can not always be seen, as it has two positions: a) Retracted position: inside the instrument (the status LED is either red, yellow or off). b) Aspirating position: in front of the sampling bar; it can be activated only in certain menus associated directly with the sampling process; status LED is green.
1. Invert the closed sample tube 11 times to achieve a homogenous sample. Do not Shake! 2. Take off the cap of the sample tube. 3. Immerse the aspiration needle well into the sample. 4. Push the sampling bar or the START/OK button.
The instrument draws 25l of sample, and the aspirating needle is retracted while its outer surface is automatically rinsed with diluent. This ensures a low carry-over between samples. Simultaneously, the status LED turns red. During aspiration, hold the sampling tube in a stable position (for approx. 1 second) until you see the status LED flashing and hear the beeps indicating the end of the sampling process. After these signals, you can remove and recap the sampling tube.
Make sure to immerse the sampling needle well into the sample, otherwise it can cause erroneous sampling, giving inaccurate results. Important! When the needle stops for a while during its movement upwards, the needle must be out of the sample, otherwise the analyzer makes another aspiration in this state. This extra aspiration can also cause an inaccurate measurement.
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1. Optimal, all results are OK. 2. Blank is high, * flag is displayed at related parameter results. 3. Blank is too high, no result displayed in measurement mode. Blank measurement ranges: Parameter HGB WBC PLT RBC 1. No flag at parameter 0-10 g/l 0 - 0.5 x10 cells/l 0 - 25 x103 cells /l 0-0.05 x106 cells/l
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2. * flag at result 10-25 g/l 0.5-1.0 x10 cells /l 25 - 50 x103 cells /l 0.05-0.5 x106 cells /l
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3. E (error) flag at result > 25 g/l > 1.0 x103 cells /l > 50 x103 cells /l > 0.5 x106 cells /l
Accepted blank values are essential for proper calibration and QC measurement. For this reason, no calibration or QC measurement can be performed without accepted blank values. Quality control (QC) measurement and Calibration can be performed only if all blank values are in the 1st region.
7.1.3 Calibration
Calibration is the procedure used to standardize the instrument by applying the necessary correction factors. Preferred hematology control is R&D Systems CBC-3D Low, Normal and High. It is recommended to do calibration in the following cases: 1. At analyzer installation, before beginning the analyses. 2. After replacing any component, related to the process of dilution or measurement. 3. When quality control measurements show any systematic error (bias) or they are outside predefined limits. 4. At regular time intervals (determined by the lab itself). 5. If you want to use the instrument in Prediluted mode. Calibration can be performed in two ways: 1. User can enter calibration factors - without any calibration measurements using the numerical keypad. 2. One-, two- or three-fold measurements of control or special calibrations material with known parameters. In this case, the instrument automatically calculates new factors using the following formula: Assigned value x Stored factor New factor = Measured value(s) (or average of those)
CAUTION! New calibration will invalidate the previous one. Old values cannot be retrieved, but can be reviewed in the VIEW CALIBRATIONS menu.
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CALIBRATION (4) Item 1 initiates calibration procedure. Item 2 displays previous Calibrations Item 3 opens calibration settings dialogue.
CALIBRATION (4) CALIBRATE (1) (factorial) Set previously calculated factors using the numeric keys, confirm with OK. Only parameters concerning the selected MCV, MPV / HCT, PCT mode are displayed.
CALIBRATION (4) CALIBRATE (1) (automatic) Set the target values of the control material using numeric keys. Use OK to accept a value. Specify 0 as target value for parameters should be omitted from calibration. After setting the target values, press validate and start calibration measurements. to
Target values for the calibrated parameters can be set in the following ranges:
Parameter RBC HCT MCV RDW CV PLT PCT MPV PDW CV HGB g/l WBC Low limit 1.00 0.1 50 10 30 0 5 5 30 1.0 High limit 8.00 0.6 120 50 800 2 15 50 300 30.0
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Having set the required target values, perform measurements on hematology blood control, hold the sample tube in sampling position and press the sampling bar. Press to accept results. The actual and the total number of calibration measurements are shown in the first line.
Calibration RBC MCV RDWc PLT MPV HGB WBC
After calibration the new factors are displayed. The actual factors are shown in parentheses for reference. Offered calibration factors can be accepted by pressing . The factors are not modified, but get flagged:
B E
if 0 was targeted (no calibration) if blank was not in the 1st region if factor is out of 0.80-1.20 range
CALIBRATION (4) VIEW CALIBRATIONS (2) Use and keys to browse between parameter columns. Exit pressing function key with symbol.
CALIBRATION (4) CALIBRATION SETTINGS (3) Items 1-2 select between calibration target, Items 3-6 select between calibration modes. Select item 7 to perform CALIBRATION FOR PREDILUTED MODE. By choosing this point, you can calibrate the instrument with the same processes (factorial, automatic) as in normal mode.
When Calibrate prediluted mode is selected, Calibration/Prediluted mode will appear at the first line on the Calibration screens. The previous Prediluted calibration factors can not be monitored in the VIEW CALIBRATIONS submenu.
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To perform factorial calibration, you should set target parameter (1 or 2), and choose item 3, Factorial Calibration. In this case, User must have had the necessary amount of measurements with the control material, based on which an average value can be calculated. This average value is used for fine-tuning the calibration parameters.
To enter sample information before sample analysis, press the brings up the following screen:
Sample information Sample ID: 1 / Date: 2000.05.12. Patient ID: 20050502a Name: John Johnson Birth. 1958.04.16. Doctor: dr. Harrison
1 14:54
Here sample ID and patient data can be specified (name, sex, date of birth). Also, the name of the doctor having ordered the laboratory analysis can be given. Patient name will appear on the LCD below the PLT histogram (second page), and in the header of the printed results sheet.
Male
Type in the name using up to 32 alphanumeric characters, (A-Z, 0-9, space, comma, dot and parentheses ()). Use arrow keys to move between characters, backspace to delete missed characters. Press Enter after entering the name, cancel with Esc or , confirm with .
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7.1.4.3 Results
At the end of a measuring procedure, the following screen is displayed, including all measured and calculated parameters as well as the WBC, RBC and PLT histograms. Results and histograms will be stored automatically in the memory, without any operator confirmation. (First panel of two) If normal ranges are set (not 0.0), parameters will be verified and marked by:
+ if the value is over, - if the value is under the range specified. If there is any kind of error, or the blank measurement is too high, E error flag will appear at the erroneous parameter and no results will be displayed (---). If there are warnings or errors, a flag will appear preceding the actual result.
In the last line of the first result screen, warning flags can be displayed. If the last line is clear, it means that no errors or warnings were found during measuring cycle. The meaning of each warning flag and the recommended user action is included in the next table.
Flag Meaning Recommended user action W WBC three part Repeat the measurement. Possibly lyse problem. warning or WBC Check the discriminators in the WBC histogram. If the three part diff. discriminators are in the proper place (the populations can unsuccessful be separated by eye) then the results can be accepted. No WBC three part Possibly lyse problem, but in some pathological samples E (too high lymphocytes), it can be happened. HGB blank is high, Repeat the blank measurement and accept it. H or no HGB blank Possibly lyse or diluent problem. WBC blank is high, Repeat the blank measurement and accept it. B or no WBC blank Possibly lyse or diluent problem. WBC/RBC limit L Check the 1. RBC-LYM discriminator. If it is in the minimum warning point (or close to it), accept the results. Otherwise repeat the measurement. If the retried action makes very similar results and the discriminator is in a wrong place then the MID and GRA results are OK, but the WBC and LYM results can be higher because of the RBCs. Too many RBC cut Repeat the measurement. Possibly lyse problem. R from WBC If the WBC measuring time is too high (more than 8 sec.) it could be aperture clogging. In that case perform cleaning and repeat the measurement. M* WBC coincidence is The results are out of the linearity range. Make a dilution too high. Linearity with an external dilutor with a pre-defined dilution range. Do error. not forget to correct the results with the defined factor. WBC data package D Perform cleaning and repeat the measurement (aperture errors clogging). If it is a general problem, please call your Service Personnel.
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k m*
d s c
The same action as in case of the D warning flag. Aperture clogging. The same action as in case of the D warning flag. PLT blank is high, Repeat the blank measurement and accept it. or no PLT blank Diluent problem. Replace diluent, open a new tank. RBC blank is high, Repeat the blank measurement and accept it. or no RBC blank Diluent problem. Replace diluent, open a new tank. RBC/PLT limit The RBC/PLT valley is too high. It is rather a diagnostic warning flag. If the discriminator is in a wrong place (in the PLT or RBC histogram) then repeat the measurement for a correct PLT result. RBC peak warning Perform cleaning and repeat the measurement (clogging). If it is a general problem, change the RBC aperture. RBC/PLT The same action as in case of the M warning flag. coincidence is too high. Linearity error. RBC/PLT data The same action as in case of the D warning flag. package errors RBC/PLT time error The same action as in case of the D warning flag. RBC/PLT clogging The same action as in case of the C warning flag.
*M or m warning flag means that the coincidence is too high so the results are out of the linearity range - see Section 4.4. In that case, make a predilution with an external dilutor and use the Prediluted mode (see section 7.1.5).
In the next figure, one of the long-format printout patient results with histograms is shown.
Arcus 07.03.2000 15:38 #2 Female
At the bottom of the screen, warning flags are displayed and the WBC results have the flag, meaning that the WBC three-part differential does not seem to be correct. In this patient result, the L warning flag means that the RBCLYM discriminator is not sure and that is why the W warning flag (WBC three part warning) appears in the last line.
With a little diagnostic experience, the User can accept the results, because just a very small part of the RBC is in the LYM channel. (The discriminator is in the minimum point of the dotted RBC line) Similarly, the MID population seems to be correct, thus the results can be accepted. Second panel of the result screen including the PLT distribution curve and measuring times.
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If sample values are above the linearity range (see section 4.4) In case of very small sample volumes In case of capillary blood samples
In this Prediluted mode, you have to make an external 1:3 predilution, as in the following example: Predilution: 1 UNIT OF SAMPLE + 3 UNITS OF DILUENT !
Example: if 20l capillary tubes are used for blood collection, one would add 60l of pure diluent to create a proper predilution. Measure local menu 1.Patient type 2.Prediluted mode 3.Maintenance 4.Repeat last sample
To select Prediluted mode, you must enable it in the Measure local menu. Now, the instrument is ready to measure the prediluted sample.
1:3 warning flag will appear on the WBC histogram of the result screen.
The results are corrected with the predilution factor (1:3) automatically.
Prediluted mode has its own calibration factors. To calibrate the instrument for this mode, see the Calibration settings section of this manual.
To disable Prediluted mode, you must re-enter Measure local menu and deselect its box.
Measure local menu 1. Cleaning 2. Priming 3. Drain chamber
From the Measure local menu, you can also access some parts of the maintenance menu. There you can make priming, cleaning, or draining of the chamber.
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QUALITY CONTROL (6) This menu allows setting and monitoring data related to the QC procedure. Use commercially available control material. The preparation and measurement process is the same as with patient samples.
QUALITY CONTROL (6) SET QC LEVEL (5) Select the level you wish to use. The active level is displayed in the top right corner on QC related screens.
QC reference values QC Level: LOT No.: __________________ Exp. date: 12.05.2001. WBC 5.5 - 19.5 10^9/l RBC 5.00 - 10.00 10^12/l HGB 80 150 g/l HCT 24.0 - 45.0 % MCV 39 55 fl
QUALITY CONTROL (5) SET QC REFERENCE (1) Both target values and acceptable ranges can be specified. Only the parameters displayed on these screens can be specified. Modify displayed values using the numerical keyboard. Pressing the OK button validates values. To move on to further parameters, press the page down function key.
Quality control measurements can only be made after an optimal blank measurement result has been accepted (all parameters were in the 1st range).
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QUALITY CONTROL (5) QC MEASURE (2) After selecting target values (or targeted level), select this menu to do a QC measurement. After the measurement has been completed, the following result screen will be displayed. It is similar to the normal measurement, but in the first line there is Quality Control as an ID.
CAUTION! A result will be accepted only if it is confirmed with the key.
7.2.1 QC database
The database of measured and stored QC results can be displayed at any time in table or graphic (Levey-Jennings) formats. The QC measurement results will have subsequent ID numbers.
SmpID 3 4 5 6 7 8 9 10 Date 2000.05.02 07:06 2000.05.03 07:12 2000.05.04 07:02 2000.05.05 07:36 2000.05.08 06:56 2000.05.09 07:01 2000.05.10 07:02 2000.05.11 0650 PatID
QUALITY CONTROL (5) VIEW TABLE OF QC MEASURES (3) Move the selection bar over entries with and buttons. Moving among parameters with and buttons.
CAUTION! Any change in the QC material settings is followed by deletion of the QC database, so it is strongly recommended to print them out before modification.
The analyzer makes graphic figures of the primary parameters (WBC, RBC, HGB, HCT, MCV and PLT). QUALITY CONTROL (5) VIEW QC DIAGRAM (4) Assigned values (target value and accepted range) as well as averages, standard deviations (StDev) and coefficients of variation (CVar) are calculated based on the QC measurements and are displayed together with Levey-Jennings charts. The dotted lines show the acceptable range.
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7.4 Printouts
When required, the following items can be sent to an external printer by pressing the function key button.
Database result(s) (table format). Database (specified patient results with histograms). QC result (Levey-Jennings chart). QC result(s) (table format). Last measured blank result. Last measured patient result (with histograms). Last measured QC result. Device Information and Device Statistics. Self test result. Set parameters.
Different printout formats of typical patient-result printouts are shown in the next figures (the appropriate printout format can be selected in SETTINGS/PRINTER SETTINGS submenu see 6.6). Full printout format with histograms:
Date, time and sample ID
Hematology-1
07.03.2000 15:38 #2
Female
Laboratory name
Patient type
Normal ranges
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In this printout normal ranges (limits), flags and warning flags are all enabled. The printing modes of these parameters can be selected within PRINTER SETTINGS submenu. If normal ranges are set, flags are enabled, and patient values are over or below the limits specified, the result out of the range is marked with an +/- mark. Normal printout format without histograms (Text only):
Hematology-1 07.03.2000 15:38 #2 Female
This printout format is similar to the previous one, but it does not include the histograms. The laboratory name has moved into the first line.
DATABASE (2) From this menu monitoring of stored measurements can be done. Select item 1 to view the database in table format.
Date 2000.05.02 14:56 2000.05.04 14:59 2000.05.04 15:06 2000.05.04 15:08 2000.05.04 15:15 2000.05.04 16:00 2000.05.04 17:26 2000.05.04 17:29
DATABASE (2) VIEW DATABASE (1) Pressing or button accesses the remaining, non-visible parameter results. With or button you can scroll between the results one-by-one. Pressing the 3 and 9 buttons has the same effect as PageUp and PageDown scrolling keys. Select patient results by pressing the OK button. Its box will be filled.
From the database table screen, WBC, RBC and PLT histograms can be displayed by . By pressing the key, the second panel with PLT results can be pressing accessed.
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Step-by-step browsing among histograms of the selected tests is made by pressing LEFT and RIGHT ARROW function key buttons.( and )
Database local menu 1.Go to specified record 2.Selection 3.Change sort order 4.Backup selected records 5.Delete selected records
From the database table screen, you can go to the Database local menu by pressing the key.
Go to specified record Go to the first record measured after: 02.05.2000. 00:00 and has Sample ID: and has Patient ID:
<DATABASE LOCAL MENU> GO TO SPECIFIED RECORD (1) Item 1 brings up a screen asking for parameters defining any given sample (date, time ID) and jumps to it. If any ID is left as 0, it means searching only by date/time.
<DATABASE LOCAL MENU> SELECTION (2) Besides checking samples one-by-one, selection can also be done within Database local menu. SELECT ALL checks all boxes, DESELECT ALL clears all boxes.
Select specified data records Select data records measured between: 02.05.2000. 00:00 02.05.2000. 23:59 and has Sample ID in range: and has Patient ID:
<DATABASE LOCAL MENU> SELECTION (2) SELECT BY DATE, TIME AND ID (2) Select a range by date, time and/or ID number (see next screen) Entering 0 as ID# means searching only by date. Corresponding results will be marked with a filled box.
Change sort order 1. Unsorted 2. Sort by time 3. Sort by Sample ID 4. Sort by Patient ID
<DATABASE LOCAL MENU> CHANGE SORT ORDER (3) The way results are displayed can be selected within this menu. If set, samples appear according to the rule selected.
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DATABASE (2) BACKUP DATABASE (2) BACKUP SELECTED will save entries that have been selected in the database view (either oneby-one or by range selection).
DATABASE (2) BACKUP DATABASE (2) BACKUP ONE DAY (1) Specify the day whose records you wish to backup to a floppy disk.
! Message 5104/12210 35 data record(s) will be saved on 1 disk(s). Insert an empty floppy disk!
When you have selected the day or data to be saved, and confirmed it with the key, the instrument will prompt you for an empty disk.
The instrument gives this warning in case you tried to save data of a day, which had no data, or no data are selected.
STOP! Error 1300/12210 Cannot write archive data! Check disk! It may be unformatted, full, or bad! Do you want to retry?
This warning appears, if the disk you inserted had errors on it, or was write-protected. Check the write protection of the disk or if necessary, insert a new, formatted disk.
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7.7 Maintenance
From this submenu, the User can initiate maintenance procedures such as cleaning, priming, draining and preparing the analyzer for shipment.
Maintenance 1. Cleaning 2. Priming 3. Drain chamber 4. Empty waste container 5. Diagnostics 6. Service
MAINTENANCE (3)
7.7.1 Cleaning
Select item 1 (CLEANING) in the above MAINTENANCE menu. This action is recommended in case any clogging problem is experienced (C error flag). This is a relatively strong decontamination process, cleaning out possible dirt or clog from the system using high voltage electronic pulses, cleaner solution and high-pressure backflush.
7.7.2 Priming
Priming 1. Prime all 2. Prime diluent 3. Prime lyse 4. Prime cleaner
MAINTENANCE (3) PRIMING (2) During the priming cycle, the fluidics system gets rinsed with a relatively large amount of diluent. It differs from the process in a start-up procedure; as in the latter case a simple filling up of the fluidics is performed.
If fluid sensors are on, then the analyzer makes these procedures automatically, otherwise the User must initiate them activating the appropriate item within this submenu.
7.7.3 Draining
Draining is used to drain the chamber before servicing (e. g. manual cleaning, dismounting of the aperture).
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The specific cleaning cycle can be executed from MAINTENANCE/CLEANING submenu. Aspiration of the specific cleaner as patient sample. Applying high-voltage electric impulses to the aperture. (Done after each measurement.)
If manual cleaning of the aperture is required, instructions listed below should be followed:
1. 2. 3. 4. 5. 6. Drain the chamber: MAINTENANCE/DRAIN Open the side door (right side). Remove the reference electrode connection and the U-shaped metal fixing. Remove the aperture assembly from the measuring chamber. Pull out the measuring tube from the part containing the electrode. Cleaning of the aperture can be performed by placing it into a 10% hypochlorite solution, or into an ultrasonic cleaning bath for approximately 1 minute. 7. Rinse well with distilled water. 8. Put back the measuring tube to the electrode holding part, and the U-shaped metal fixing. 9. Install the aperture in the measuring chamber, and connect the reference electrode. 10. Execute a priming cycle. 11. Measure blank until you reach acceptable blank results.
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7.8 Diagnostics
The DIAGNOSTICS submenu provides important information about the analyzer, statistics and the built-in Self test.
Diagnostics 1. Device information 2. Statistics 3. Self test
Device information Model: Arcus Serial No.: 1031 Version: 2.1 Compiled: Nov 16 2000
MAINTENANCE (3) DIAGNOSTICS (5) DEVICE INFORMATION (1) Here, device-specific information can be retrieved. Model name, serial number, software version and the date of the compilation of the software.
6283 4 3 1 0 2 0 0
MAINTENANCE (3) DIAGNOSTICS (5) STATISTICS (2) This menu includes important information about the measurements: the total number of measurements, clogging, vacuum and the other error numbers.
The automatic Self test procedure can be initiated from the MAINTENANCE menu. During the test, you can see its progress. The components, that have passed the test, get checked. After completion of the Self test procedure, results will be displayed.
42 Self test results Date of testing: 17.11.2000 Model: Arcus Serial No: 1031 Version: 2.1 Compiled: Nov 16 2000 PCPNIF Firmware version MPU Firmware version:
Diatron Ltd.
The first panel of result screen includes the date of testing and Device Information.
--2.0
Self test results HGB dark: HGB light Electr. Voltage: current: offset Ampl. test: peak: dev:
V uA mV pls mV mV
OK OK OK OK OK OK OK OK
The second and third panels of the result screen include every test result. At the end of the result line, OK, HIGH, LOW, or ERROR is displayed, which means that the actual test result is at the normal range (OK), higher (HIGH), lower (LOW) than the pre-determined limits, or the result is an error (ERROR).
Self test results Noise test: Atm Vacuum: drift: Overall result:
1 978 308 2
On the third panel of the result screen, the overall test result is displayed which can be Successful (in case of every test result is OK), or Errors found (if HIGH, LOW or ERROR results appear).
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An isotonic saline solution used to dilute whole blood specimens and to rinse the fluidic system between measuring procedures. Diaton MCDiff-16 Ordering No.: 18111 (5 liters), 18101 (20 liters) Used to prepare blood hemolysate for WBC and HGB measurement. Abalyse Ordering No.: 28112 (1 liter), 28102 (5 liters) Used to perform cleaning process of the fluidics. Abaclean Ordering No.: 28113 (1 liter), 28103 (5 liters)
Average reagent consumption of Arcus (software: V2.1): Number of daily measurements Diluent ml/test Lyse ml/test Cleaner ml/test
1 2 5 10 20 50 100
259 146 79 56 45 39 36
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Calibration:
RBC and WBC clogging < 3% of measurements (normal use) High-voltage burn and chemical cleaning of the aperture in each measurement cycle using Cleaner reagent High-voltage burst on the aperture, high-pressure backflush and chemical cleaning of aperture using Cleaner reagent 6 QC levels (profiles) including: average, range, SD and CV for all measured and calculated parameters, 16- and 64-day LeveyJennings charts, separate QC database Automatic (by calibrator) with 1, 2 or 3 measurements, or factorial (manual) calibration of WBC, HGB, RBC, PLT, MCV, RDW, MPV, PDW Automatic and factorial calibration of Prediluted mode Monitoring of calibration factors by calibration events (not available for Prediluted mode) Pentium PC 2,000 results, including histograms (8Mbytes DiskOnChip module) RS 232 (computer) in 150, 300, 600, 1200, 2400, 3600, 4800, 9600, 14400, 19200, 38400, 57600, 115200 baud rate (8 data bit, no parity, 1 stop bit) Parallel output (printer) in HP PCL4, Epson 9-pin, Epson 24-pin, Canon BJC, Seiko DPU-414 or compatible mode 3.5 floppy disk drive PC standard external keyboard, USA layout 240x128 dots graphic, backlit LCD 24 buttons foil, START bar 450x310x350 mm 14 kg 110/230 V; 50/60Hz; 230VA II. (OverVoltage)
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V11 DilWash
1
V13 DilNeedle
2 3 1 3
V12 DilChamber
2
DILUENT
V14 LyseWbc
1 3 2
LDL
Lyse Sensor Diluent & Cleaner Sensor
LDD
V15 DilAperture
2 3
V5 Cleaner
M1
Hor
CLEANER
M2
Ver
Micro
Macro
Lyse
1 3 2
Dil
M3
V3 Bubble
Pressure Meter
HGB RBC/WBC
LYSE
Puffer Reservoir
V1 DrainChamber
Pump
LDx
WASTE
M1
Pump dimensions: Macro O16 x 40 mm 8 ml Micro O1.6 x 40 mm 80 l Lyse O9.2 x 40 mm 2.6 ml Dilutions: 1. 25 l SA. + 4.0 ml DIL MIX 1:160 2. 25 l MIX + 5.0 ml DIL RBC 1:32.000 3. 4 ml MIX + 0.9 ml LY. WBC 1:196
V2 DrainAperture
2 3
V4 DrainPuffer
1 3
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- Diluent tube (green) - Lyse tube (yellow) - Clean tube (blue) - Waste tube (red)
Arcus Caps for reagent containers (Marked with the same colors as the Reagent Tubes). Arcus Power cable. Arcus Spare Part: Pump rotor.