Hema-Screen 18 lihd 169 User’s manual v.2.2 01 / 02 eng

r settings related to the instrument. Date and time setting The date and time of each measurement is stored with the results. This menu allows setting the built-in clock of the instrument and date format. Date and time 1.Set date and time ○2.Day.Month.Year ○3.Month.Day.Year ●4.Year.Month.Day SETTINGS (6) DATE AND TIME (1) By selecting item 1, You will enter date and time setting mode (next screen). Items 2-4 are radio-buttons, so only one can be selected at once. 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. Laboratory name setting This menu allows entering laboratory information, which will be printed in the header of reports generated by the instrument. Set laboratory name The name of the laboratory is: Hematology-1 This name will be printed in the header of the printouts SETTINGS (1) LABORATORY (2) A maximum of 40 characters can be entered in each line of four either using an external standard PC (US-layout) keyboard connected to the instrument, or by scrolling each letter character using the ­ and ¯ buttons. Move between character places using ¬ and ® keys. Result unit setting Units Count unit cells/l ↓ HGB unit g/l PCT, HCT unit % RDW, PDW mode sd SETTINGS (6) UNITS (3) Units can be set in a sequential order. The arrow on the right indicates that there are more options for the entry. Select among them using the ­ and ¯ buttons. When done, pressing OK opens the next unit type for setting. When the last entry is set, confirms data, and returns to the Settings menu. The possible units for above parameters are as follows: Count unit cells/liter, cells/μl HGB unit grams/liter (g/l), grams/deciliter (g/dl), millimols/liter (mmol/l) PCT, HCT unit percentage (%), absolute (abs) RDW, PDW mode Standard Deviation (sd), Coefficient of Variation (cv) Setting reference limits This function allows the User to specify the patient reference (so-called normal) ranges used in your laboratory. Lower and upper limits - stored in the memory - are displayed and can be modified according to the patient type selected in the PATIENT TYPE menu. Limits 1.Human 2.Male 3.Female 4.Baby 5.Toddler 6.Child SETTINGS (6) LIMITS (4) In this menu, you can set the limits of the different patient types. The next three figures show the reference range settings of Female patient type. Patient limits Female WBC 5.0 - 10.0 10^9/l RBC 4.00 - 5.00 10^12/l HGB 120 - 160 g/l HCT 36.0 - 48.0 % MCV 76 - 96 fl MCH 27.0 - 32.0 pg MCHC 300 - 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. If 0.0 - 0.0 is specified as lower and upper limit, the parameter will not be checked for its proper range. Patient limits PLT 150 - 400 10^9/l PCT 0.0 - 0.0 % MPV 8.0 - 15.0 fl PDWs 0.0 - 0.0 fl PDWc 0.0 - 0.0 % RDWs 20.0 - 42.0 fl RDWc 0.0 - 0.0 % LYM 1.3 - 4.0 10^9/l Patient limits MID 0.2 - 0.7 10^9/l GRA 2.5 - 7.5 10^9/l LY% 25.0 - 40.0 % MI% 3.0 - 7.0 % GR% 50.0 - 75.0 % Lyse 0.70 ml 6.5 Fluid sensors Fluid sensors check for presence of the most important reagents: diluent and lyse. If both waste connectors are used, the waste container full alert, called waste sensor is operating. Cleaner reagent has no sensor, operator should check cleaner amount daily. If any of the fluid sensors get out of order, the analyzer can still continue operating, if the malfunctioning sensor is manually disabled. Fluid sensors □ 1. Diluent ■ 2. Lyse ■ 3. Waste SETTINGS (6) FLUID SENSORS (5) Any sensor can be switched on and off by toggling its state using the OK button. Here, Diluent sensor is disabled. 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. 6.6 Printer settings The instrument supports the following printers or printer modes: - HP DeskJet - HP LaserJet - Epson 9-pin - Epson 24-pin - Epson 24-pin in 9-pin mode - Canon BJC - Seiko DPU414 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: 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. Printer settings Printer: Seiko DPU414 Mode: Normal Wide ↑ Physical margin: Normal Paper: A4 Unit: inch Size 8.27 x 11.69 On the first page of Printer Settings, printer type, graphics mode and paper settings can be set. Select the Printer matching your printer hardware. Different Modes result in different printout sizes. Choose the one matching your needs. Options are Small, Normal, Normal Wide. Recommended mode is Normal. It is suggested to make a sample printout after setting up printer settings. 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 Top: 0.00 Vertical spacing: 0.50 Rollpaper: No Autoprint: No Printout format: Full with histograms Table format: Normal table format One result per page: No If rollpaper is used instead of sheets, set Rollpaper to Yes. 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: - Full with histograms - Text only - Short, text only If you set One result per page to Yes, each measurement will be printed on another page. Printer settings Print ranges: Yes ↓ Print flags: Yes Print warning flags: No Print measure time: In case of warning 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. The Print measurement time option has several settings. The time of measurement gives information about the counting process, and is a good verification of the results. If it was too high, it means that the measurement should not be accepted. Possible settings are: “No”, “Always”, “In case of warning”. Recommended setting is “In case of warning”! 6.6.1 Troubleshooting guide for printing problems Problem Possible reason, remedy Printer does not respond, no printout. Printer is off. Turn it on. Printer is not connected to the analyzer. Connect it to the parallel port at rear. Printer is not On-line. Switch it to On-line mode. Printer is out of paper. Feed the printer with paper. Strange signs or letters appear on the printout. The selected printer type does not match your printer. Select the appropriate type in Printer Settings menu. Printer is not set up properly for HP or Epson (or compatible) mode. Modify the printer setup. Consult the printer’s manual Right side of the printed report is missing, or appears in the next line. Decrease Margin settings in the Printer Settings menu. Try selecting another Mode making a smaller printout. The printed report is too small, there is a lot of space on the paper. Try selecting another Mode resulting in larger printout. The end of the printout appears on the next page. Enter the correct Paper size. Try increasing Margin. It seems that one more patient report could fit on the same page. Enter the correct Paper size. Try decreasing Margin, Top margin, Vertical spacing. The printed result is not centered horizontally. Modify Left margin. The printed result is not centered vertically. Modify Top margin. The distance between two results is too small or too big. Modify Vertical spacing. After printing, the printer does not eject the paper. But if you repeat printing, it appears in more copies. It is quite usual for bubble-jet or laser printers. Do not repeat printing. When the page is full, or you leave the actual menu, the printer will eject the paper automatically. 6.7 User settings User settings ●1.Single user mode ○2.Multi user mode 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 multi-user 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. These are: performing measurements and entering patient data before the measurement. A user of the Advanced level has the power 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. 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. 6.7.1 Multi-user mode Login User ID 0________ Password User name 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. Login User ID 1 Password ****_____ User name Frank Smith 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. ROUTINE UTILIZATION Measuring process 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: Retracted position: inside the instrument (the status LED is either red, yellow or off). 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. Invert the closed sample tube 11 times to achieve a homogenous sample. Do not Shake! Take off the cap of the sample tube. Immerse the aspiration needle well into the sample. Push the sampling bar or the START/OK button. The instrument draws 25μl 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. 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. Blank measurement Blank measurement is used for checking the cleanliness of the system and reagents. Blank measurement must be performed in the following cases: - Once daily, before the sample analyses (this is done automatically before the first measurement in MEASURE). - After any reagent change (it can be activated manually from the MEASURE/ MEASURE ---BLANK menu). - After any component replacement, which is closely related to a measuring process (aspiration, dilution, counting, rinsing). User must accept the blank values by pressing . Blank measurement can be repeated by pressing . If any of the tested parameters has High blank value, the message: Unsuccessful blank measure appears at the top of the screen. There are 3 regions for blank value handling: 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 1. No flag at parameter 2. * flag at result 3. E (error) flag at result HGB 0-10 g/l 10-25 g/l > 25 g/l WBC 0 - 0.5 x103 cells/µl 0.5-1.0 x103 cells /µl > 1.0 x103 cells /µl PLT 0 - 25 x103 cells /µl 25 - 50 x103 cells /µl > 50 x103 cells /µl RBC 0-0.05 x106 cells/µl 0.05-0.5 x106 cells /µl > 0.5 x106 cells /µl 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 Hospitex Diagnostics Haematology Control 16 p Low, Normal and High. It is recommended to do calibration in the following cases: At analyzer installation, before beginning the analyses. After replacing any component, related to the process of dilution or measurement. When quality control measurements show any systematic error (bias) or they are outside predefined limits. At regular time intervals (determined by the lab itself). If you want to use the instrument in Prediluted mode. Calibration can be performed in two ways: User can enter calibration factors - without any calibration measurements – using the numerical keypad. 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) WARNING! New calibration will invalidate the previous one. Old values cannot be retrieved, but can be reviewed in the VIEW CALIBRATIONS menu. Calibration 1.Calibrate 2.View calibrations 3.Calibration settings Calibration can be initiated by choosing Calibration in the Main Menu. CALIBRATION (4) Item 1 initiates calibration procedure. Item 2 displays previous Calibrations Item 3 opens calibration settings dialogue. 7.1.3.1 Factorial calibration If the CALIBRATION MODE has been previously set to Factorial Calibration, the factors can be set manually in the 0.80 - 1.20 range. Calibration RBC 1.02 MCV 1.05 RDWc 1.12 PLT 1.00 MPV 1.00 HGB 0.92 WBC 1.01 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. 7.1.3.2 Automatic calibration by measurement If the CALIBRATION MODE is set to one-, two- or three-fold measurements, the instrument will perform calibration measurements with hematology blood control. Calibration RBC 4.57 10^12/l MCV 85 fl RDWc 16.4 % PLT 255 10^9/l MPV 9.1 fl HGB 136 g/l WBC 7.4 10^9/l 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 to validate and start calibration measurements. Target values for the calibrated parameters can be set in the following ranges: Parameter Low limit High limit RBC 1.00 8.00 HCT 0.1 0.6 MCV 50 120 RDW CV 10 50 PLT 30 800 PCT 0 2 MPV 5 15 PDW CV 5 50 HGB g/l 30 300 WBC 1.0 30.0 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 1.02 (1.03) MCV 1.05 (1.01) RDWc 1.12 (1.09) PLT 1.00 (0.92) MPV 0.98 (0.96) HGB 1.08 (1.05) WBC 1.15 (1.11) 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: – if 0 was targeted (no calibration) B if blank was not in the 1st region E if factor is out of 0.80-1.20 range 7.1.3.3 View calibrations From the Calibration menu, you can monitor previous calibrations. The instrument logs all calibration events, and displays them in the following format. Date Time OpID RBC MCV RDWc PLT 23.05.2000 10:15 0 1.03 1.07 0.85 1.04 29.05.2000 11:21 0 1.01 1.07 0.86 1.01 02.06.2000 09:51 5184 1.00 1.00 1.00 1.00 CALIBRATION (4) VIEW CALIBRATIONS (2) Use ← and → keys to browse between parameter columns. Exit pressing function key with symbol. 7.1.3.4 Calibration settings By choosing CALIBRATION SETTINGS, you get to the following screen: Calibration settings ● 1.Calibrate MCV and MPV ○ 2.Calibrate HCT and PCT ● 3.Factorial calibration ○ 4.Calibrate with one measurement ○ 5.Calibrate with two measurements ○ 6.Calibrate with three measurements □ 7.Calibrate prediluted mode 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. 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. 7.1.4 Sample Analysis 7.1.4.1 Sample preparation Use K3-EDTA anti-coagulated fresh whole blood as sample. Prior to sampling, mix the sample gently by inverting it few times. Do not shake as this could damage the blood cells. 7.1.4.2 Sample information The instrument allows the User to enter sample information for each sample that has been, or will be measured. An external PC keyboard (standard USA layout) must be connected to the instrument before turning it on. Sample information can be entered in two ways: immediately before measurement, or in the Database menu To enter sample information before sample analysis, press the function key. This brings up the following screen: Sample information Sample ID: 1 / 1 Date: 2000.05.12. 14:54 Patient ID: 20050502a Name: John Johnson Birth. 1958.04.16. Male ↓ Doctor: dr. Harrison 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 result sheet. Sample information Sample ID: 1 / 1 Date: 2000.05.12. 14:54 Patient ID: 20050502a Name: John Johnson Age: 25 years ↓ Male Doctor: dr. Harrison On this screen, the patient age can be entered in years or in months depending on your selection. As the requirements vary from lab to lab and is strictly related to regular laboratory work, the user cannot change this option. Contact service for further information. Enter 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 . 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 warning or WBC three part diff. unsuccessful Repeat the measurement. Possibly lyse problem. Check the discriminators in the WBC histogram. If the discriminators are in the proper place (the populations can be separated by eye) then the results can be accepted. E No WBC three part Possibly lyse problem, but in some pathological samples (too high lymphocytes), it can be happened. H HGB blank is high, or no HGB blank Repeat the blank measurement and accept it. Possibly lyse or diluent problem. B WBC blank is high, or no WBC blank Repeat the blank measurement and accept it. Possibly lyse or diluent problem. L WBC/RBC limit warning Check the 1. RBC-LYM discriminator. If it is in the minimum 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. R Too many RBC cut from WBC Repeat the measurement. Possibly lyse problem. 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 too high. Linearity error. The results are out of the linearity range. Make a dilution with an external dilutor with a pre-defined dilution range. Do not forget to correct the results with the defined factor. D WBC data package errors Perform cleaning and repeat the measurement (aperture clogging). If it is a general problem, please call your Service Personnel. S WBC time error The same action as in case of the D warning flag. C WBC clogging Aperture clogging. The same action as in case of the D warning flag. p PLT blank is high, or no PLT blank Repeat the blank measurement and accept it. Diluent problem. Replace diluent, open a new tank. b RBC blank is high, or no RBC blank Repeat the blank measurement and accept it. Diluent problem. Replace diluent, open a new tank. l RBC/PLT limit warning The RBC/PLT valley is too high. It is rather a diagnostic flag. If the discriminator is in a wrong place (in the PLT or RBC histogram) then repeat the measurement for a correct PLT result. k RBC peak warning Perform cleaning and repeat the measurement (clogging). If it is a general problem, change the RBC aperture. m* RBC/PLT coincidence is too high. Linearity error. The same action as in case of the M warning flag. d RBC/PLT data package errors The same action as in case of the D warning flag. s RBC/PLT time error The same action as in case of the D warning flag. c 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. Hemascreen 18 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 RBC-LYM 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. Prediluted mode The software has a special Prediluted mode, useful in the following situations: 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 20µl capillary tubes are used for blood collection, one would add 60µl 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. Note: The instrument is capable of measuring two kinds of prediluted mode 1:3 and 1:10. The user cannot change these modes. Contact service for further information. 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. Measure local menu 1. Cleaning 2. Priming ► 3. Draining ► To disable Prediluted mode, you must re-enter Measure local menu and deselect its box. MAINTENANCE (3) 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 chambers. Quality control By measuring control materials, day-to-day reproducibility can be monitored. In this submenu, both target value and acceptable ranges for each parameter can be determined for the different QC levels. Hema-screen 18 provides six different Quality Control profiles, so-called levels. You can set up six individual reference sheets for each control material (e.g. low, normal and high control blood). QC measurement results will be added to the selected level, is indicated at the top right corner. The target values of the control material should be set only once, at the beginning of the QC measurements. Resetting parameters deletes previous QC results of the active level. CAUTION! Any change in the QC material setting deletes previous QC results, therefore it is strongly recommended to have them printed out before making any changes to parameters. Quality control 1.Set QC reference 2.QC measure 3.View table of QC measures 4.View QC diagram 5.Set QC level ► Actual QC level: 1 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. Set QC level ●1. QC Level 1 ○2. QC Level 2 ○3. QC Level 3 ○4. QC Level 4 ○5. QC Level 5 ○6. QC Level 6 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: 1 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). 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. 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 Date PatID □3 2000.05.02 07:06 □4 2000.05.03 07:12 □5 2000.05.04 07:02 □6 2000.05.05 07:36 □7 2000.05.08 06:56 □8 2000.05.09 07:01 □9 2000.05.10 07:02 □10 2000.05.11 0650 QUALITY CONTROL (5) VIEW TABLE OF QC MEASURES (3) Move the selection bar over entries with  and ↓ buttons. Moving among parameters with ß and à buttons. 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. Auto stand-by In measurement mode, the analyzer will automatically go to stand-by if it is left alone - without starting any new measurement - for more than 15 minutes. While in stand-by, the aspirating tip is inside the analyzer and the chamber is filled with diluent. When the sampling bar is pressed, the chamber will be cleaned, the tip comes out and the analyzer is ready for the next measurement. The same process is performed when entering and leaving measurement mode. 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). 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. Laboratory name Date, time and sample ID Patient type Normal ranges Hematology-1 07.03.2000 15:38 #2 Female Full printout with histograms: 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. Patient results database management Patient results are stored in the memory in chronological order, and they can be retrieved at any time. Memorizing capacity is 10,000 measurements including the complete parameter list, histograms, flags, sample data, dates and times of the measurements. Database 1.View database 2.Backup database 3.Restore and view DATABASE (2) From this menu monitoring of stored measurements can be done. Select item 1 to view the database in table format. SmpID Date PatID □7 2000.05.02 14:56 20000502a12 ■8 2000.05.04 14:59 HR0058AS4 □High05 2000.05.04 15:06 PWF55A □08 2000.05.04 15:08 LNK23-B □12A7 2000.05.04 15:15 MK4FED ■UF6A8 2000.05.04 16:00 550462L □HEM2 2000.05.04 17:26 HEMA0034A ■PR02 2000.05.04 17:29 ZZ3ZH 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 pressing . By pressing the key, the second panel with PLT results can be accessed. 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: 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. Selection 1.Select by date, time and ID 2.Select all 3.Deselect all 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: 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 CHANGE SORT ORDER (3) The way results are displayed can be selected within this menu. If set, samples appear according to the rule selected. Data Back up This submenu allows backing up stored data to a floppy disk, and monitoring database stored on floppy disk. Before menu selection, insert a 3.5” floppy disk into the drive located on the left-bottom panel of the analyzer. A floppy disk can hold 800 samples. Back up database 1.Back up one day 2.Back up selected records DATABASE (2) BACKUP DATABASE (2) BACKUP SELECTED will save entries that have been selected in the database view (either one-by-one or by range selection). Backup data Day to back up: 2000.05.24. 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. Possible error messages related to backing up data: ! Message 5106/12210 No such type of data. 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. 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. Draining ► 4. Diagnostics ► 5. Service MAINTENANCE (3) Select the required submenu. 7.7.1Cleaning 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 1. Drain all chambers 2. Drain RBC chamber 3. Drain WBC chamber 4. Drain MIX chamber MAINTENANCE (3) DRAIN (3) Draining is used to drain the required chamber, or chambers before servicing (e. g. manual cleaning, dismounting of the aperture). Drain all will also drain the volume limiter and the ground electrodes as well as each chambers. 7.7.4 Manual cleaning of the aperture The risk of clogging of the aperture by protein build-up is held at a minimum level in several ways. These are as follows: 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: 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. Rinse well with distilled water. Put back the measuring tube to the electrode holding part, and the U-shaped metal fixing. Install the aperture in the measuring chamber, and connect the reference electrode. Execute a priming cycle. Measure blank until you reach acceptable blank results. Weekly maintenance User should do weekly maintenance on the first workday, before starting up the analyzer. Cleaning washing head There could be salt build-up in the lower surface of the washing head, which may cause malfunction during operation. User should clean the lower surface of the aspirating tip cleaning head using a soft cloth immersed in warm tap water to remove salt build-up. See steps 1 and 2 below: Exit Measurement menu and wait until needle stops, then open side door. To clean, gently rub the lower surface of the washing head, then close the side door. Cleaning peristaltic pump driving shaft This procedure is only for older instrument. It is recommended to pull out the pump head and clean the motor shaft weekly. Open the side door. Press both levers of the pump rotor simultaneously with your fingers, so that you can pull out the whole pump head easily. Rub the motor shaft using a soft cloth immersed in alcohol. Securely push back the pump head in place until you hear a click, and both ends are firmly locked. 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 MAINTENANCE (3) DIAGNOSTICS (5) Select the desired item. Device information Model: Hemascreen 18 Serial No.: 1541 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. 7.8.1 Device statistics Device statistics Measurements 6283 WBC clogging 4 RBC clogging 3 Vacuum error 1 Comm error 0 MHori error 2 MVert error 0 Mdilu error 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. 7.8.2 Self test Self test is a procedure to check for proper operation of essential components of the instrument. Self test should be performed in the following cases: Installation. After replacing any component. In case of extended time out of use. 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. Self test results Date of testing: 17.11.2000 Model: Hemascreen 18 Serial No: 1541 Version: 2.1 Compiled: Nov 16 2000. PCPNIF Firmware version --- MPU Firmware version: 2.0 The first panel of result screen includes the date of testing and Device Information. Self test results HGB dark: 275 OK HGB light 17723 OK Electr. Voltage: 51.2 V OK current: 879 uA OK offset -1.9 mV OK Ampl. test: 20000 pls OK peak: 1641 mV OK dev: 53 mV 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: 1 pls/5 sec OK Atm 978 mBar OK Vacuum: 218 mBar OK drift: 3 mBar/10sec OK Overall result: Successful 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). 7.9 Software update The instrument software can be easily updated by the User, following the steps below: Shut down the instrument, and switch it off. Insert the upgrade floppy disk in the drive. Switch on the instrument and follow the on-screen instructions. When instructed, remove the disk from the drive. At the next start-up, the instrument will run the new software. Reagents supplied by Hospitex Diagnostics are the only ones recommended for use with the analyzer. REAGENT SOLUTIONS AND CONSUPTION 1. Diluent: An isotonic saline solution used to dilute whole blood specimens and to rinse the fluidic system between measuring procedures. Differential isotonic solution CODE 70010070 (20 liters). 2. Lysing reagent: Used to prepare blood hemolysate for WBC and HGB measurement. Differential lysing solution CODE 70010075 (500 ml). 3. Cleaner: Used to perform cleaning process of the fluidics. Detectoterge solution CODE 70010085 (5 liters). Average reagent consumption of Hema-screen 18: Number of daily measurements Diluent ml/test Lyse ml/test Cleaner ml/test 1 272 7,5 36,2 2 151 4,2 18,4 5 78 2,2 7,7 10 54 1,6 4,2 20 42 1,2 2,4 50 35 1,0 1,3 100 32 1,0 1,0 9 TECHNICAL SPECIFICATION Sample volume: 25 µl whole blood (50 µl in Prediluted mode) Aperture diameters: 80 µm (RBC/PLT), 100 µm (WBC) Throughput: approx. 55 tests/hour Characteristics: Accuracy Reproducibility Carry over Test range WBC 3% < 3% < 1% 4.0 – 20.0 RBC 2% < 2% < 1 % 4.00 – 5.00 HCT 2% < 2% < 1 % 30.0 – 50.0 MCV 2% < 1% N/A 70 – 100 HGB 2% < 2% < 1 % 100 – 160 PLT 4% < 4% < 3 % 200 – 400 Fault statistics: RBC clogging < 1% of measurements (normal use) WBC clogging < 1% of measurements (normal use) Clog prevention: High-voltage burn for both apertures in each measurement cycle Cleaning procedure: High-voltage burst on the aperture, high-pressure backflush and chemical cleaning of aperture using Cleaner reagent Automatic cleaning: To prevent protein and lipid build-up in WBC chamber, programmable between 0 (none) – 50 measurement cycles, factory set to 20 Quality control: 6 QC levels (profiles) including: average, ± range, SD and CV for all measured and calculated parameters, 16- and 64-day Levey-Jennings charts, separate QC database Calibration: 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) On-board CPU: Pentium™ PC Data storing capacity: 10,000 results including histograms (16Mbytes DiskOnChip module) Interfaces: 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 Display: 240x128 dots graphic, backlit LCD Keyboard: 24 buttons foil, START bar Dimensions: 370x470x380 mm Net weight: 17 kg Power requirements: 110/230 V; 50/60Hz; 230VA Installation category: II. (OverVoltage) Primary mains fuse: T5A/250V Protect class: I. Operating temperature: 10 - 35 °C 10 FLUIDIC SCHEMATICS 11 ACCESSORIES This appendix includes the contents of Hospitex Diagnostics Hema-screen 18 pack: Hema-screen 18 Hematology Analyzer. Hema-screen 18 User's Manual. Hema-screen 18 Reagent Tubes (marked with colours) : - Diluent tube (green) - Lyse tube (yellow) - Clean tube (blue) - Waste tube (red) Lyse Diluent Hema-screen 18 Cleaning Tube Kit: Clean Hema-screen 18 Caps for reagent containers (Marked with the same colors as the Reagent Tubes). Hema-screen 18 Power cable. Hema-screen 18 Spare Part: Pump rotor. (only for older instruments) Revision history: Revision Section Modification By At 2.2 7.1.4.2. Sample info birth/age added 2001.09.06. 2.2 7.1.5. Predilution modes 2001.09.06. 2.2 7.7.5.2. Peristaltic pump cleaning 2001.09.06. 2.2 11. Spare pump rotor only for older instruments 2001.09.06. 2.2 8. A Reagent consumption updated for V2.22 software 2001.10.15.