HEMATOLOGY ANALYZER MEK-6318J/K 0614-004583G Model: MEK-6318J/K Manual code no.: 0614-004583G Reader Comment Card We welcome your comments about this manual. Your comments and suggestions help us improve our manuals. Please circle the number for each of the following statements corresponding to your evaluation and add comments in the space provided. Fax or send your completed comment card to: Fax: +81 (3) 5996-8100 International Div., Sales Promotion Section, Nihon Kohden Corp., 1-31-4, Nishiochiai Shinjuku-ku, Tokyo 161-8560, Japan This manual is organized. I can find the information I want. The information is accurate. I can understand the instructions. The illustrations are appropriate and helpful. The manual length is appropriate. Strongly Agree 1 1 1 1 1 1 Agree Neutral Disagree 2 3 4 Strongly Disagree 5 2 2 2 2 2 3 3 3 3 3 4 4 4 4 4 5 5 5 5 5 cutting line Comments: Thank you for your cooperation. We appreciate it very much. Name: Occupation/Position: Hospital/Company: Address: Phone: CONTENTS Contents GENERAL HANDLING PRECAUTIONS ................................................................................... i WARRANTY POLICY .............................................................................................................. ii EMC Related Caution ............................................................................................................. iii Conventions Used in this Manual and Instrument ................................................................... v Warnings, Cautions and Notes ...................................................................................... v Explanations of the Symbols in this Manual and Instrument ........................................ vi Section 1 General .................................................................................. 1.C1 Introduction .......................................................................................................................... 1.1 Measured Parameters ................................................................................................ 1.2 Features ............................................................................................................................... 1.3 Panel Description ................................................................................................................. 1.5 Front Panel and Keys ................................................................................................. 1.5 Side Panel .................................................................................................................. 1.7 Rear Panel ................................................................................................................. 1.8 Flowchart of Screens ........................................................................................................... 1.9 General Safety Information ................................................................................................ 1.10 Installation ............................................................................................................... 1.10 Reagents .................................................................................................................. 1.10 Measurement ........................................................................................................... 1.12 Maintenance ............................................................................................................ 1.12 Waste Fluid Treatment (Applies Only when Using Hemolynac•3 Hemolysing Reagent) ..................................................................................... 1.12 Section 2 Preparation ........................................................................... 2.C1 Environmental Requirements ............................................................................................... 2.1 Caution for Moving the Hematology Analyzer ............................................................ 2.2 Connecting an External Instrument to the Hematology Analyzer .......................................... 2.3 Connecting a PC ........................................................................................................ 2.4 Connecting a Printer ................................................................................................... 2.4 Connecting a Card Printer .......................................................................................... 2.5 Connecting a Handy Bar Code Reader ....................................................................... 2.5 Connecting the Power Cord and Grounding the Instrument ................................................... 2.6 Connecting the Power Cord ........................................................................................ 2.6 Grounding the Instrument ........................................................................................... 2.6 Equipotential Grounding ................................................................................... 2.6 Connecting Tubes ................................................................................................................. 2.7 Diluent, Detergent and Hemolysing Reagent .............................................................. 2.7 Connecting Tubes ....................................................................................................... 2.9 Diluent Tube ................................................................................................... 2.10 Detergent Tube ............................................................................................... 2.10 Hemolysing Reagent Tube .............................................................................. 2.11 Waste Fluid Tube ............................................................................................ 2.11 Operator's Manual MEK-6318J/K C.1 CONTENTS Turning On the Power ......................................................................................................... 2.12 Check Before Turning On the Power ......................................................................... 2.12 Turning On the Power ............................................................................................... 2.12 Check After Turning On the Power ............................................................................ 2.13 Loading Recording Paper in the WA-630VK Printer Unit (Option) ........................................ 2.14 Daily Accuracy Check ........................................................................................................ 2.15 Measuring Background Noise ................................................................................... 2.15 Counting the Hematology Control ............................................................................. 2.17 Section 3 Changing Settings ............................................................... 3.C1 General ................................................................................................................................. 3.1 Assigning an ID to a Sample ................................................................................................ 3.2 Displaying the ENTER ID Screen ............................................................................... 3.2 Entering a 4-digit Numeric ID ..................................................................................... 3.3 Entering a 13-character Alphanumeric ID ................................................................... 3.3 Setting Normal Range Upper and Lower Limits .................................................................... 3.4 Default Settings of Upper and Lower Limits ..................................................... 3.4 Selecting Single or Double Sample Counting ....................................................................... 3.6 Selecting the Capillary Blood Volume ................................................................................... 3.7 Setting High Altitude Mode On/Off ....................................................................................... 3.8 Setting the Date and Time .................................................................................................... 3.9 Selecting Units ................................................................................................................... 3.10 Counting Unit Table ........................................................................................ 3.11 Setting the User Units .............................................................................................. 3.11 Selecting the Histogram Display Format ............................................................................ 3.12 Selecting Vertical Axis Type for the Histogram ......................................................... 3.12 Differentiating the 3 Kinds of WBC Histogram .......................................................... 3.12 Changing Sensitivity and Threshold .................................................................................... 3.13 General ..................................................................................................................... 3.13 Factory Default Settings and Setting Range .................................................. 3.13 RBC Automatic Threshold .............................................................................. 3.13 Using 1/10 Sensitivity .................................................................................... 3.13 Changing Sensitivity and Threshold ......................................................................... 3.14 Determining Optimum Sensitivity ............................................................................. 3.15 Determining Optimum Threshold .............................................................................. 3.15 Changing Printing Settings ................................................................................................. 3.16 Setting Items ........................................................................................................... 3.16 Changing Settings .................................................................................................... 3.17 Settings for the WA-630VK Printer Unit (Internal Printer) ............................... 3.17 Settings for the WA-460V Card Printer ........................................................... 3.18 Settings for the Other External Printers (WA-710V, FUJITSU, EPSON or CANON) ............................................................................................... 3.19 Changing Communication Settings ..................................................................................... 3.20 Using the Optional Handy Bar Code Reader ....................................................................... 3.22 General ..................................................................................................................... 3.22 Changing Settings .................................................................................................... 3.23 Initializing Settings ............................................................................................................. 3.24 Factory Default Settings ........................................................................................... 3.25 C.2 Operator's Manual MEK-6318J/K CONTENTS Section 4 Measurement ........................................................................ 4.C1 General ................................................................................................................................. 4.1 Single and Double Counting ....................................................................................... 4.1 ID Numbers ................................................................................................................ 4.1 Alarms ........................................................................................................................ 4.2 Displaying H and L Out of Range Marks .................................................................... 4.2 OVER Message ......................................................................................................... 4.2 Data Storage .............................................................................................................. 4.2 Printing and Transferring Data ..................................................................................... 4.2 Counting Special Case Samples ................................................................................ 4.3 Explanation of Histograms and Each Measured Blood Parameter ........................................ 4.4 WBC (White Blood Cell) Distribution Histogram ......................................................... 4.4 WBC Histogram and Screen Code Messages ............................................................ 4.4 RBC (Red Blood Cell) Distribution Histogram ............................................................. 4.6 PLT (Platelet) Distribution Histogram .......................................................................... 4.6 Measuring a Venous Sample ................................................................................................ 4.7 Preparing a Venous Sample ....................................................................................... 4.7 Measuring a Venous Sample ...................................................................................... 4.7 Measuring a 10 µL Blood Sample ......................................................................................... 4.9 Measuring a Capillary Sample ............................................................................................ 4.10 Preparing a Capillary Sample ................................................................................... 4.10 Measuring a Capillary Sample .................................................................................. 4.12 Continuous Capillary Blood Measurement ................................................................ 4.13 Automatic Waste Fluid Treatment ....................................................................................... 4.14 Waste Fluid Treatment Trouble .................................................................................. 4.15 Daily Shutdown .................................................................................................................. 4.16 Checking List Before Turning Power Off ......................................................... 4.16 Turning the Power Off ............................................................................................... 4.16 Checking List After Turning Power Off ............................................................ 4.16 Checking List Before Long Term Storage ........................................................ 4.16 Section 5 Handling Data ....................................................................... 5.C1 General ................................................................................................................................. 5.1 Displaying Numerical Data and Histograms ......................................................................... 5.2 Displaying Numerical Data ......................................................................................... 5.2 Displaying Histograms for Individual Samples ........................................................... 5.2 Deleting Data ........................................................................................................................ 5.4 Deleting Data for Individual Samples .......................................................................... 5.4 Deleting All Data ........................................................................................................ 5.5 Editing IDs of Data ............................................................................................................... 5.6 Printing and Transferring Data ............................................................................................... 5.7 Automatic Printing and Transferring Data after Measurement ..................................... 5.7 Printing on the WA-630VK Printer Unit ....................................................................... 5.8 Automatic Printing after Measurement ............................................................. 5.8 Manual Printing ................................................................................................ 5.8 Printing Stored Data ................................................................................................... 5.8 Printing Numerical Data ................................................................................... 5.8 Printing Histograms of a Sample ...................................................................... 5.9 Operator's Manual MEK-6318J/K C.3 CONTENTS Printing Numerical Data for All Samples of a Single Day ................................. 5.9 Transferring Data to a PC or Card Printer ................................................................. 5.10 Transferring Data During Counting .................................................................. 5.11 Transferring Stored Data for Individual Samples ............................................. 5.11 Transferring Stored Data for All Samples of a Single Day .............................. 5.12 Section 6 Quality Control ..................................................................... 6.C1 General ................................................................................................................................. 6.1 _ X-R Program ......................................................................................................................... 6.2 General ....................................................................................................................... 6.2 _ Overview of X-R Program and Quality Control Procedure ................................ 6.2 _ _ Calculation of X and R ...................................................................................... 6.2 _ Calculation of Upper and Lower Limits of X and R ............................................ 6.2 _ X-R Graph Example ......................................................................................... 6.4 _ How to Read the X-R Graph ............................................................................. 6.6 Data Outside the Limits ................................................................................... 6.6 Counting the Hematology Control ............................................................................... 6.7 _ Displaying and Printing Stored X-R Data .................................................................... 6.8 _ Deleting the Stored X-R Data ...................................................................................... 6.9 _ _ XB (X Batch) Program ......................................................................................................... 6.10 General ..................................................................................................................... 6.10 _ Overview of XB ............................................................................................... 6.10 _ Calculation of XB ............................................................................................ 6.10 _ Displaying and Printing XB Data ............................................................................... 6.12 _ Setting XB Initial Values ........................................................................................... 6.13 _ XDyCV Program .................................................................................................................. 6.14 General ..................................................................................................................... 6.14 _ Uses of the XDyCV Program .......................................................................... 6.14 _ Displaying and Printing XDyCV Data ........................................................................ 6.15 Section 7 Calibration ............................................................................. 7.C1 General ................................................................................................................................. 7.1 Calibration Methods Using Calibrator ............................................................... 7.1 Calibration ID ................................................................................................... 7.2 Calibration with Hematology Control ..................................................................................... 7.3 Calibration in Venous Mode ........................................................................................ 7.3 Precise Method ................................................................................................ 7.3 Simple Method ................................................................................................. 7.4 Calibration in Capillary Blood Mode ............................................................................ 7.5 HGB/HCT Calibration with Human Blood .............................................................................. 7.7 General ....................................................................................................................... 7.7 Measurement with the Instrument .............................................................................. 7.7 HGB Measurement with a Spectrophotometer ........................................................... 7.7 HCT Measurement with a Microhematocrit Centrifuge ................................................ 7.8 Determining the HGB and HCT Calibration Coefficient ............................................... 7.8 Hemoglobin Conversion Table (g/dL ↔ %SAHLI) ...................................................... 7.10 Displaying and Printing Calibration Data History ................................................................. 7.11 C.4 Operator's Manual MEK-6318J/K CONTENTS Displaying Calibration Data History .......................................................................... 7.11 Printing Calibration Data History .............................................................................. 7.12 Deleting Calibration Data History .............................................................................. 7.12 Section 8 Error Messages and Troubleshooting ............................... 8.C1 General ................................................................................................................................. 8.1 Error Messages at Power On or Before or After Counting ..................................................... 8.2 Error Messages during Counting .......................................................................................... 8.3 System Error Messages ....................................................................................................... 8.4 Inaccurate Counting and Other Problems ............................................................................. 8.5 Section 9 Maintenance ......................................................................... 9.C1 Periodic Check ..................................................................................................................... 9.1 Checking the Circuit ............................................................................................................. 9.2 Disposing of Waste ............................................................................................................... 9.3 Battery Lifetime .................................................................................................................... 9.3 When the Battery Loses its Charge .................................................................. 9.3 How to Replace the Battery ............................................................................. 9.3 Disposing of Used Batteries ............................................................................. 9.3 Disinfecting and Cleaning the Outside of the Instrument ...................................................... 9.4 Disinfecting ................................................................................................................ 9.4 Cleaning ..................................................................................................................... 9.4 Checking, Cleaning and Maintenance Schedule ................................................................... 9.5 Periodic Check and Maintenance ..................................................................... 9.5 Maintenance when Problem Occurs ................................................................. 9.5 Maintenance Cleaning .......................................................................................................... 9.6 Displaying Operation History Screen .................................................................................... 9.7 General ....................................................................................................................... 9.7 Displaying the OPER HISTORY Screen ..................................................................... 9.7 Resetting the Counts .................................................................................................. 9.8 Before Maintenance ............................................................................................................. 9.9 Checking, Cleaning or Replacing Filters ............................................................................. 9.10 Checking and Cleaning the Sub Baths and Measurement Baths ........................................ 9.12 Checking and Cleaning the Rinse Unit and Sampling Nozzles ........................................... 9.14 Checking and Replacing the Pump Tube ............................................................................. 9.16 Cleaning the Aperture Caps ............................................................................................... 9.19 Replacing the Sampling Nozzles ........................................................................................ 9.23 Calibrating Touch Screen .................................................................................................... 9.26 Removing the Jammed Paper from the WA-630VK Printer Unit .......................................... 9.27 Priming ............................................................................................................................... 9.28 Draining the Measurement and Sub Baths ......................................................................... 9.29 Draining the Instrument ...................................................................................................... 9.30 Storing and Transporting the Instrument ............................................................................. 9.31 Preparing the Instrument for Long Term Storage and Transport ................................ 9.31 Using the Instrument after Storage .......................................................................... 9.32 Preparing the Instrument for Short Term Transport ................................................... 9.33 Decontamination Protocol ................................................................................................... 9.34 Operator's Manual MEK-6318J/K C.5 CONTENTS Clock Accuracy .................................................................................................................. 9.36 Repair Parts Availability Policy ........................................................................................... 9.36 Section 10 Reference ............................................................................ 10.C1 Operation Theory ................................................................................................................ 10.1 Electric Cell Counting ............................................................................................... 10.1 Counting Method ............................................................................................ 10.1 Red Blood Cell and Platelet Counting ............................................................. 10.2 Principle of Hydraulic Operation ............................................................................... 10.2 Hemoglobin Measurement ........................................................................................ 10.3 Chemical Processing ..................................................................................... 10.3 Spectrophotometric Measurement Method ..................................................... 10.3 RS-232C Data Transfer ....................................................................................................... 10.5 Special Key Operations for Servicing ................................................................................. 10.5 Interference Substances .................................................................................................... 10.6 Specifications .................................................................................................................... 10.9 Measured Parameters, Ranges and Reproducibility to Specimen from Venous Blood .............................................................................................................. 10.9 Detection Method ........................................................................................... 10.9 Standardization Analysis Method ................................................................... 10.9 Dilution Ratio ................................................................................................ 10.10 Counting Time .............................................................................................. 10.10 Display ......................................................................................................... 10.10 Data Storage ................................................................................................ 10.10 Environmental Conditions ............................................................................. 10.10 Power Requirements .................................................................................... 10.10 Dimensions and Weight ................................................................................ 10.10 Electromagnetic Compatibility ...................................................................... 10.10 Safety .......................................................................................................... 10.11 WA-630VK Printer Unit ................................................................................. 10.11 WA-460V Card Printer .................................................................................. 10.11 WA-710V Printer .......................................................................................... 10.11 Standard Accessories ...................................................................................................... 10.12 Consumables ................................................................................................................... 10.14 Options ............................................................................................................................. 10.15 C.6 Operator's Manual MEK-6318J/K GENERAL HANDLING PRECAUTIONS This device is intended for use only by qualified medical personnel. Use only Nihon Kohden approved products with this device. Use of non-approved products or in a non-approved manner may affect the performance specifications of the device. This includes, but is not limited to, batteries, recording paper, pens, extension cables, electrode leads, input boxes and AC power. Please read these precautions thoroughly before attempting to operate the instrument. 1. To safely and effectively use the instrument, its operation must be fully understood. 2. When installing or storing the instrument, take the following precautions: (1) Avoid moisture or contact with water, extreme atmospheric pressure, excessive humidity and temperatures, poorly ventilated areas, and dust, saline or sulphuric air. (2) Place the instrument on an even, level floor. Avoid vibration and mechanical shock, even during transport. (3) Avoid placing in an area where chemicals are stored or where there is danger of gas leakage. (4) The power line source to be applied to the instrument must correspond in frequency and voltage to product specifications, and have sufficient current capacity. (5) Choose a room where a proper grounding facility is available. 3. Before Operation (1) Check that the instrument is in perfect operating order. (2) Check that the instrument is grounded properly. (3) Check that all cords are connected properly. (4) Pay extra attention when the instrument is in combination with other instruments to avoid misdiagnosis or other problems. (5) All circuitry used for direct patient connection must be doubly checked. (6) Check that battery level is acceptable and battery condition is good when using battery-operated models. 4. During Operation (1) Both the instrument and the patient must receive continual, careful attention. (2) Turn power off or remove electrodes and/or transducers when necessary to assure the patient’s safety. (3) Avoid direct contact between the instrument housing and the patient. 5. To Shutdown After Use (1) Turn power off with all controls returned to their original positions. (2) Remove the cords gently; do not use force to remove them. (3) Clean the instrument together with all accessories for their next use. 6. The instrument must receive expert, professional attention for maintenance and repairs. When the instrument is not functioning properly, it should be clearly marked to avoid operation while it is out of order. 7. The instrument must not be altered or modified in any way. 8. Maintenance and Inspection: (1) The instrument and parts must undergo regular maintenance inspection at least every 6 months. (2) If stored for extended periods without being used, make sure prior to operation that the instrument is in perfect operating condition. Operator's Manual MEK-6318J/K i 9. When the instrument is used with an electrosurgical instrument, pay careful attention to the application and/ or location of electrodes and/or transducers to avoid possible burn to the patient. 10. When the instrument is used with a defibrillator, make sure that the instrument is protected against defibrillator discharge. If not, remove patient cables and/or transducers from the instrument to avoid possible damage. WARRANTY POLICY Nihon Kohden Corporation (NKC) shall warrant its products against all defects in materials and workmanship for one year from the date of delivery. However, consumable materials such as recording paper, ink, stylus and battery are excluded from the warranty. NKC or its authorized agents will repair or replace any products which prove to be defective during the warranty period, provided these products are used as prescribed by the operating instructions given in the operator’s and service manuals. No other party is authorized to make any warranty or assume liability for NKC’s products. NKC will not recognize any other warranty, either implied or in writing. In addition, service, technical modification or any other product change performed by someone other than NKC or its authorized agents without prior consent of NKC may be cause for voiding this warranty. Defective products or parts must be returned to NKC or its authorized agents, along with an explanation of the failure. Shipping costs must be pre-paid. This warranty does not apply to products that have been modified, disassembled, reinstalled or repaired without Nihon Kohden approval or which have been subjected to neglect or accident, damage due to accident, fire, lightning, vandalism, water or other casualty, improper installation or application, or on which the original identification marks have been removed. In the USA and Canada other warranty policies may apply. RESPONSIBILITIES - PROFESSIONAL USERS This instrument must be used by a professional user with a full knowledge of operating this instrument, only for his/ her intended use and according to the instructions for use. Instructions in the operator’s manual must be followed, especially the following points. • Storage and stability of reagents • Handling of reagents • Instrument installation • Connection of all tubes to inlets and outlets • Connection of all tubes to reagents and waste container • Checking the amount of reagents and waste fluid • Calibration • Quality control • Maintaining and servicing If deviating from the instructions, the professional user does it at the risk and liability of the laboratory and only after validation by the laboratory. Nihon Kohden has no responsibility over such deviations. ii Operator's Manual MEK-6318J/K EMC RELATED CAUTION This equipment and/or system complies with the International Standard EN 61326-1 for electromagnetic compatibility for electrical equipment and/or system for measurement, control and laboratory use. However, an electromagnetic environment that exceeds the limits or levels stipulated in the EN 61326-1, can cause harmful interference to the equipment and/or system or cause the equipment and/or system to fail to perform its intended function or degrade its intended performance. Therefore, during the operation of the equipment and/or system, if there is any undesired deviation from its intended operational performance, you must avoid, identify and resolve the adverse electromagnetic effect before continuing to use the equipment and/or system. The following describes some common interference sources and remedial actions: 1. Strong electromagnetic interference from a nearby emitter source such as an authorized radio station or cellular phone: Install the equipment and/or system at another location if it is interfered with by an emitter source such as an authorized radio station. Keep the emitter source such as cellular phone away from the equipment and/or system. 2. Radio-frequency interference from other equipment through the AC power supply of the equipment and/or system: Identify the cause of this interference and if possible remove this interference source. If this is not possible, use a different power supply. 3. Effect of direct or indirect electrostatic discharge: Make sure all users and patients in contact with the equipment and/or system are free from direct or indirect electrostatic energy before using it. A humid room can help lessen this problem. 4. Electromagnetic interference with any radio wave receiver such as radio or television: If the equipment and/or system interferes with any radio wave receiver, locate the equipment and/or system as far as possible from the radio wave receiver. If the above suggested remedial actions do not solve the problem, consult your Nihon Kohden Corporation subsidiary or distributor for additional suggestions. This equipment complies with International Standard EN55011 (1999) Group 1, Class B. Class B EQUIPMENT is equipment suitable for use in domestic establishments and in establishments directly connected to a low voltage power supply network which supplies buildings used for domestic purposes. The CE mark is a protected conformity mark of the European Community. The products herewith comply with the requirements of the IVD Directive 98/79/EEC. Operator's Manual MEK-6318J/K iii This page is intentionally left blank. iv Operator's Manual MEK-6318J/K Conventions Used in this Manual and Instrument Warnings, Cautions and Notes Warnings, cautions and notes are used in this manual to alert or signal the reader to specific information. WARNING A warning alerts the user to the possible injury or death associated with the use or misuse of the instrument. CAUTION A caution alerts the user to possible injury or problems with the instrument associated with its use or misuse such as instrument malfunction, instrument failure, damage to the instrument, or damage to other property. NOTE A note provides specific information, in the form of recommendations, prerequirements, alternative methods or supplemental information. Operator's Manual MEK-6318J/K v Explanations of the Symbols in this Manual and Instrument The following symbols found in this manual/instrument bear the respective descriptions as given. On panel Symbol Description Symbol Description Main power lamp Hemolynac•3N (hemolysing reagent) “On” only for part of the equipment Inlet “Off” only for part of the equipment Printer socket Reset AC power off (Disconnection from the mains) Clean AC power on (Connection to the mains) Capillary blood mode Alternating current Dispense Equipotential terminal Count Year of manufacture Screen brightness Serial number Auto print Fuse IVD Feed Print Attention, consult operator's manual IN VITRO DIAGNOSTIC MEDICAL DEVICE The CE mark is a protected conformity mark of the European Community. The products herewith comply with the requirements of the IVD Directive 98/79/EEC. * When using the Hemolynac•3N hemolysing reagent, attach the HEMO3N label above the LYSE label. On screen and recorded data Symbol Description Beside WBC or RBC measured value: Sample error Beside HGB measured value: Dirty measurement baths Beside WBC measured value: Poor hemolyzation Beside HGB measured value: HGB voltage adjustment error Beside HGB measured value: HGB circuit error vi Operator's Manual MEK-6318J/K Section 1 General Introduction ......................................................................................................................... 1.1 Measured Parameters ............................................................................................... 1.2 Features .............................................................................................................................. 1.3 Panel Description ................................................................................................................ 1.5 Front Panel and Keys ................................................................................................ 1.5 Side Panel ................................................................................................................. 1.7 Rear Panel ................................................................................................................ 1.8 Flowchart of Screens .......................................................................................................... 1.9 General Safety Information ............................................................................................... 1.10 Installation .............................................................................................................. 1.10 Reagents ................................................................................................................. 1.10 Measurement .......................................................................................................... 1.12 Maintenance ........................................................................................................... 1.12 Waste Fluid Treatment (Applies Only when Using Hemolynac•3 Hemolysing Reagent) .................................................................................... 1.12 Operator's Manual MEK-6318J/K 1.C1 1. GENERAL Introduction The MEK-6318J/K Hematology Analyzer is designed for simultaneous 18parameter measurement. It provides quick counting, and all operations are performed automatically. You only need to put the sampling nozzle into a sample container which contains whole blood and press the count switch. Results and data are displayed on an LCD screen. An optional printer allows full reports. This instrument is compact and easily operated. The instrument automatically performs self-check and cleans the remaining blood from the sampling nozzle, so it is safe and there is no risk of touching the blood. To achieve full performance, thoroughly read this operator’s manual before operating the instrument. To use the instrument safely and effectively and keep it in optimum condition, please follow the operating and maintenance instructions in this manual. NOTE Use only Nihon Kohden parts and accessories to assure maximum performance from your instrument. Operator's Manual MEK-6318J/K 1.1 1. GENERAL Measured Parameters WBC: RBC: HGB: HCT: White Blood Cell Count Red Blood Cell Count Hemoglobin Concentration Hematocrit (%) HCT = Red blood cell volume Blood volume MCV: Mean Corpuscular Volume (fL) MCV = HCT (%) RBC (× 106/µL) MCH: × 100 × 10 Mean Corpuscular Hemoglobin (pg) MCH = HGB (g/dL) × 10 RBC (× 106/µL) MCHC: Mean Corpuscular Hemoglobin Concentration (g/dL) MCHC = HGB (g/dL) HCT (%) PLT: LY%: MO%: GR%: LY: MO: GR: EO: RDW: PCT: MPV: PDW: 1.2 × 100 Platelet Count Lymphocyte Percent Monocyte Percent Granulocyte Percent Lymphocyte Count Monocyte Count Granulocyte Count Eosinophil Flag Red Blood Cell Distribution Width Platelet Crit Mean Platelet Volume Platelet Distribution Width Operator's Manual MEK-6318J/K 1. GENERAL Features • Easy Operation Once the sample is aspirated through the sampling nozzle, all other operations are performed automatically, including preparation such as diluting and adding hemolysing reagent. The function menu for all operations, such as calibration, changing settings and data confirmation, is called up by touch keys on the screen. • High Accuracy and Reproducibility The instrument provides high accuracy and reproducibility with a low dilution ratio of 200:1 of WBC, 40,000:1 of RBC and 360 µL of the diluted sample. Built-in circuits automatically compensate for cell miscount due to coincidence (simultaneous cell passage) and fluid temperature variation. The aperture is shielded from external noise. • Backlit LCD Screen The instrument has a backlit LCD approx. 115 × 86 mm (320 × 240 dots) which clearly displays the results and various messages. • Selectable Single or Double Counting You can select single or double counting. When double count is selected, the mean value of the first and second measurements on each parameter are displayed on the LCD. • Automatic Self Check When the instrument is turned on, the instrument automatically checks itself with a calibration signal. If a problem is detected, the LCD displays an error message, e.g. BUBBLE, NO DILUENT or CLOG, so you can quickly identify and fix the problem. • Built-in Quality Control Programs The instrument contains various programs for quality control for WBC, RBC, PLT, HGB, HCT (MCV), PLT, LY%, MO%, RDW and MPV calibration, normal _ _ _ range setting, mean and CV value calculation and X-R, XB, XD•CV control. • Data Storage and Recall The instrument can store measurement data of up to 400 samples and histograms of up to 20 samples. Stored measurement data can be called up with the touch keys on the screen. • Automatic Priming and Cleaning The instrument automatically primes the fluid path when the power is turned on. The instrument automatically cleans the fluid path when the power is turned off. Operator's Manual MEK-6318J/K 1.3 1. GENERAL • Automatic Sampling Nozzle Cleaning The instrument automatically cleans the remaining blood on the sampling nozzle. There is no risk of touching blood during measurement. • Automatic Clog Removal The instrument removes blood protein or dust particles from around the aperture to prevent clogging after each counting. Even if a clog occurs, the instrument automatically removes the clog and recounts the sample. • Automatic Waste Fluid Treatment When Hemolynac•3 is used as the hemolysing reagent, the waste fluid contains potassium cyanide (KCN) which needs to be treated before disposal. The detergent CLEANAC•3 (standard accessory) contains hypochlorite to dissolve the potassium cyanide in the waste fluid. The instrument automatically cleans the fluid path with CLEANAC•3 detergent after every 10 countings. When Hemolynac•3N is used as the hemolysing reagent, there will be no potassium cyanide in the waste fluid. 1.4 Operator's Manual MEK-6318J/K 1. GENERAL Panel Description This section describes all parts and controls on the instrument. Front Panel and Keys This instrument uses touch-screen keys in addition to the front panel keys. To operate a touch screen key, lightly press the center of the key on the screen. Refer to caution in “Environmental Requirements” in Section 2. 10 1 2 11 3 12 13 4 14 15 16 17 5 6 7 18 8 9 No. Name 19 Description 1 LCD display Displays various messages, measured data and touch screen keys. 2 Power lamp Lights when the main power switch on the rear panel and power key on the front panel are turned on. 3 Main power lamp Lights when the main power switch on the rear panel is turned on. Operator's Manual MEK-6318J/K 1.5 1. GENERAL No. 4 Power key 5 reset key 6 clean key 7 Operation indicator lamps 8 Sampling nozzle 9 1.6 Name count switch Description Turns power on or off when the main power switch on the rear panel is turned on. When the power is turned on, priming and self-check are automatically performed, and the READY screen appears. Stops counting if pressed during counting. Returns to the READY screen if pressed while changing settings. Cleans the fluid path, aperture and manometer with detergent. Priming is performed automatically after cleaning the fluid path. Press this key when clogging occurs, the manometer becomes dirty or bubbles occur in the manometer. When blinking: Aspirating the sample When off: Counting the sample When lit: Ready for next counting Aspirates the sample. Dispenses the diluent when in the capillary blood mode. Press to aspirate the sample and start counting. 10 Screen brightness control Adjusts the screen brightness. 11 Capillary blood mode lamp Lights when in capillary blood mode. 12 capillary blood mode key 13 dispense key 14 Auto print mode lamp Press this key to change the mode to capillary blood mode. The capillary blood mode lamp lights. Press this key to dispense about 2 mL diluent from the sampling nozzle. Available only for the capillary blood mode. Lights when in automatic printing mode for the WA-630VK printer unit (optional). When pressed, turns the printing mode between automatic and manual for the WA-630VK printer unit (optional). 15 auto print key 16 feed key Feeds paper when using the WA-630VK printer unit (optional). 17 print key Prints measured data on the WA-630VK printer unit (optional). 18 Printer unit, WA-630VK Roll printer (optional). 19 Paper magazine For the recording paper of the WA-630VK printer unit (optional). Operator's Manual MEK-6318J/K 1. GENERAL Side Panel 1 2 3 4 5 No. Name 1 Screen brightness control Adjusts the screen brightness. 2 DILUENT Diluent inlet 3 DETERGT Detergent inlet 4 LYSE Hemolysing reagent inlet 5 WASTE Waste outlet Inlet for the diluent. Connect one end of the tube (standard accessory) to the diluent inlet and attach the other end of the tube to the diluent container cap. Inlet for the detergent (CLEANAC or CLEANAC•3). Connect one end of the tube (standard accessory) to the detergent inlet and attach the other end of the tube to the detergent container cap. Inlet for the hemolysing reagent (Hemolynac•3 or Hemolynac•3N). Connect one end of the tube (standard accessory) to the hemolysing reagent inlet and attach the other end of the tube to the hemolysing reagent container cap. Outlet for the waste such as used lyse, detergent and aspirated samples. Connect one end of the tube (standard accessory) to the waste outlet and insert the other end of the tube into the waste container cap. Combinations of fluid Cyanide Description Non-cyanide LYSE Hemolynac•3 Hemolynac•3N DILUENT ISOTONAC•3 ISOTONAC•3 DETERGENT CLEANAC•3 CLEANAC Operator's Manual MEK-6318J/K Hemolynac•3 hemolysing reagent contains cyanogen which must be dissolved by sodium hypochlorite in the CLEANAC•3 detergent before draining the waste fluid. Hemolynac•3N hemolysing reagent does not contain cyanogen. Therefore, for daily use, use CLEANAC detergent when using Hemolynac•3N hemolysing reagent. Use CLEANAC•3 detergent only when doing procedures in Section 9 “Maintenance”. 1.7 1. GENERAL Rear Panel 1 2 Refer to caution below. 3 Refer to warning in “Connecting the Power Cord and Grounding the Instrument” in Section 2. 4 5 220 - 240 V T 1.6 A/250 V For details about the socket pin assignment, refer to the Technical Reference Manual of Data Communication Protocol. To obtain this manual, you must sign the license agreement. 6 IVD 7 CAUTION Connect only the specified instruments to the connectors or sockets marked with specified procedure. Otherwise electrical leakage current may harm the operator. No. Name by following the Description Connects the optional WA-450V or WA-460V card printer or personal computer. CAUTION 1 RS232C RS-232C socket (PORT 1) 2 OPTION Optional socket (PORT 2) 3 4 Printer socket Main power switch • In order to avoid any safety hazard, only connect personal computers which are approved by IEC 950. • The instrument should only be connected to an external instrument which complies with the CISPR 11 (1997), Group 1 and Class B standard. Connects the optional ZK-820V handy bar code reader with the YZ-0313 bar code reader cable. Connects the external printer. Contact your Nihon Kohden distributor. Supplies the power to the instrument when it is turned on. Under normal conditions keep this switch turned on. Contains the time lag fuse (T 1.6 A for 220 to 240 V). To replace the fuse (standard accessory), contact your Nihon Kohden distributor. CAUTION 5 6 7 1.8 Fuse holder AC SOURCE AC source socket Equipotential ground terminal • Fuses cut the power off when an abnormality occurs in the hematology analyzer. Remove the malfunction before replacing the fuse. • Before replacing a fuse, turn the power off and disconnect the AC power cord from the instrument. • Fuse replacement should be done by a qualified person. Connects the AC power cord to supply the AC power to the instrument. Connects the ground lead to the equipotential ground terminal on the wall for earth grounding. Operator's Manual MEK-6318J/K 1. GENERAL Flowchart of Screens READY screen. See Section 4 "Measurement". ENTER ID screen. See "Assigning an ID to a Sample" in Section 3. MENU screen ENTER ID screen. See "Assigning an ID to a Sample" in Section 3. CALIBRATION screen. See Section 7 "Calibration". DATA screen. See Section 5 "Handling Data". EDIT ID screen. See "Editing IDs of Data" in Section 5. QC screen. X-R screen XB screen XD CV screen See Section 6 "Quality Control". SETTINGS screen. See Section 3 "Changing Settings". NORMAL RANGE screen MEAS MODE screen DATE & TIME screen DISPLAY screen SENS & THR screen PRINT SETTINGS screen COMM SETTINGS screen INITIALIZE screen OTHER screen CAL HISTORY screen. See "Displaying and Printing Calibration Data History" in Section 7. OPER HISTORY screen. See "Displaying Operation History Screen" in Section 9. CIRCUIT CHECK screen. See "Checking the Circuit" in Section 9. PRINT DAY screen. See "Printing and Transferring Data" in Section 5. TRANSFER DAY screen. See "Printing and Transferring Data" in Section 5. See "Priming" in Section 9. PRIME screen. See "Draining the Measurement and Sub Baths" in Section 9. DRAIN BATHS screen. See "Draining the Instrument" in Section 9. DRAIN ALL screen. MAINTENANCE screen. Refer to the Service Manual. Operator's Manual MEK-6318J/K 1.9 1. GENERAL General Safety Information Installation WARNING • Never use this instrument in the presence of any flammable anesthetic gas, concentrated oxygen or hyperbaric oxygen. Failure to follow this warning may result in explosion. • Never use this instrument in a high-pressure oxygen medical care tank. Failure to follow this warning may cause explosion or fire. • Do not use this instrument near an ESU. Noise from the ESU may cause the instrument to malfunction. • For operator safety, equipotential grounding of all instruments must be performed. Consult with a qualified biomedical engineer. CAUTION • Only use the provided power cord. Using other power cords may result in electrical shock or other injury to the operator. • Connect only the specified instruments to the connectors or sockets marked with by following the specified procedure. Otherwise electrical leakage current may harm the operator. • In order to avoid any safety hazard, only connect personal computers which are approved by IEC 950. • The instrument should only be connected to an external instrument which complies with the CISPR 11 (1997), Group 1 and Class B standard. Reagents CAUTION Use only Nihon Kohden recommended reagents. Otherwise the measurement result cannot be guaranteed and incorrect reagent concentration can cause equipment damage. CLEANAC•3 WARNING Do not allow CLEANAC•3 detergent to come into contact with acid. Contact with acids can cause the release of poisonous chlorine gas. 1.10 Operator's Manual MEK-6318J/K 1. GENERAL CAUTION If the CLEANAC•3 detergent contacts the skin or eyes or is swallowed, wash thoroughly and immediately with water and see a physician. CLEANAC CAUTION If the CLEANAC detergent contacts the skin or eyes or is swallowed, wash immediately and thoroughly with water. Hemolynac•3 WARNING • Do not allow the Hemolynac•3 hemolysing reagent to come into contact with acid. Contact with acids can cause the release of poisonous cyanogen gas. • Do not swallow the Hemolynac•3 hemolysing reagent. If swallowed, contact your physician immediately. CAUTION • Be careful when handling the Hemolynac•3 hemolysing reagent because it contains potassium cyanide (0.04%). • If the Hemolynac•3 hemolysing reagent contacts the skin or eyes, wash thoroughly and immediately with water and see a physician. • Do not use Hemolynac•3 hemolysing reagent which has been stored in direct sunlight or opened more than 30 days ago. The hemoglobin data may be erroneously lowered or the reproducibility may become poor. • Read the instructions thoroughly to use the hemolysing reagent. Hemolynac•3N CAUTION If the Hemolynac•3N hemolysing reagent contacts the skin or eyes or is swallowed, wash thoroughly and immediately with water and see a physician. Operator's Manual MEK-6318J/K 1.11 1. GENERAL Hematology Control CAUTION • Use hematology control which is before the expiration date. • Do not use hematology control when the top layer is slightly red or the whole hematology control is red, because the red blood cells in the control are hemolysed. • Do not freeze the hematology control because this will hemolyse it. • Use and store the hematology control with extreme care according to its instructions. Measurement CAUTION When an alarm occurs, the acquired data may not be correct, especially when “!” appears. Do not use the alarmed data. Maintenance CAUTION • Be careful not to directly touch any place where blood is or may have contacted. • Protect yourself from infection before cleaning and doing maintenance. Waste Fluid Treatment (Applies Only when Using Hemolynac•3 Hemolysing Reagent) 1.12 WARNING Do not drain the waste fluid without treatment because the waste fluid contains cyanogen (CN). The waste fluid without treatment is dark brown. If for any reason the instrument cannot automatically treat the waste fluid, put some CLEANAC•3 detergent in the waste fluid, stir it to completely dissolve the cyanogen, leave it for at least 30 minutes, then dispose of it. Operator's Manual MEK-6318J/K Section 2 Preparation Environmental Requirements .............................................................................................. 2.1 Caution for Moving the Hematology Analyzer ........................................................... 2.2 Connecting an External Instrument to the Hematology Analyzer ......................................... 2.3 Connecting a PC ....................................................................................................... 2.4 Connecting a Printer .................................................................................................. 2.4 Connecting a Card Printer ......................................................................................... 2.5 Connecting a Handy Bar Code Reader ...................................................................... 2.5 Connecting the Power Cord and Grounding the Instrument .................................................. 2.6 Connecting the Power Cord ....................................................................................... 2.6 Grounding the Instrument .......................................................................................... 2.6 Equipotential Grounding .................................................................................. 2.6 Connecting Tubes ................................................................................................................ 2.7 Diluent, Detergent and Hemolysing Reagent ............................................................. 2.7 Connecting Tubes ...................................................................................................... 2.9 Diluent Tube .................................................................................................. 2.10 Detergent Tube .............................................................................................. 2.10 Hemolysing Reagent Tube ............................................................................. 2.11 Waste Fluid Tube ........................................................................................... 2.11 Turning On the Power ........................................................................................................ 2.12 Check Before Turning On the Power ........................................................................ 2.12 Turning On the Power .............................................................................................. 2.12 Check After Turning On the Power ........................................................................... 2.13 Loading Recording Paper in the WA-630VK Printer Unit (Option) ....................................... 2.14 Daily Accuracy Check ....................................................................................................... 2.15 Measuring Background Noise .................................................................................. 2.15 Counting the Hematology Control ............................................................................ 2.17 Operator's Manual MEK-6318J/K 2.C1 2. PREPARATION Environmental Requirements CAUTION Use this instrument under the following conditions. Temperature: 10 to 30°C Humidity: 30 to 90% Air pressure: 700 to 1060 hPa When using the instrument at over 1000 m above sea level, set HIGH ALT on the MEAS MODE screen of the SETTINGS screen to ON. Refer to Section 3. • Operate the instrument in a room with a temperature range of 10 to 30°C. Keep the temperature of diluent and hemolysing reagent between 15 and 30°C in order to obtain reliable data. • No measurement can be done in dusty areas because the aperture for specimen aspiration is very fine and can get clogged. Therefore, install the instrument in a dust-free area. • Do not install the instrument in direct sunlight. • Do not place containers of reagent or fluid on the instrument. To prevent electrical problems or electric shock, avoid spillage in or around the instrument because the fluid is highly conductive. • Select a stable, flat buffering stand to set the instrument on. • If possible, use an independent AC outlet only for this instrument. The instrument must not share an AC outlet with noise generating equipment such as a centrifuge, constant temperature bath (thermostat), refrigerator, air conditioner or ultrasonic cleaner. Operator's Manual MEK-6318J/K 2.1 2. PREPARATION Caution for Moving the Hematology Analyzer CAUTION Use two people and be careful when moving the hematology analyzer. Otherwise, you may throw out your back or cause injury from dropping the hematology analyzer. • Hold the hematology analyzer by the right and left side. • Stand by the side of the hematology analyzer and move the hematology analyzer carefully by putting your hands at the indicated positions on the bottom of the front and rear panels of the hematology analyzer. Hand position 2.2 Operator's Manual MEK-6318J/K 2. PREPARATION Connecting an External Instrument to the Hematology Analyzer A personal computer and a card printer (WA-450V, WA-460V or equivalent) can be connected to the RS-232C socket (PORT 1) and a handy bar code reader (ZK-820V, BL-N60NK or equivalent) can be connected to the optional socket (PORT 2) on the rear panel. An external printer can be connected to the printer socket. Before connecting the external instrument to the hematology analyzer, make sure that the power on the instruments are turned off. For changing the printing and communication format, refer to “Changing Printing Settings” and “Changing Communication Settings” in Section 3. WARNING For operator safety, equipotential grounding of all instruments must be performed. Consult with a qualified biomedical engineer. When more than one electrical instrument is used, there may be electrical potential difference between the instruments. Potential difference between instruments may cause current to flow to the patient connected to the instruments, resulting in electrical shock (micro shock). Always perform equipotential grounding when required. It is often required in the operating room, ICU room, CCU room, cardiac catheterization room and X-ray room. Consult with a biomedical engineer to determine if it is required. CAUTION • Connect only the specified instruments to the connectors or sockets marked with by following the specified procedure. Otherwise electrical leakage current may harm the operator. • In order to avoid any safety hazard, only connect personal computers which are approved by IEC 60950. • The hematology analyzer should only be connected to an external instrument which complies with the CISPR 11 (1997), Group 1 and Class B standard. • Before connecting instruments, make sure that the power is turned off. Otherwise the operator may receive electrical shock. Operator's Manual MEK-6318J/K 2.3 2. PREPARATION Connecting a PC A locally purchased PC can be connected to the RS-232C socket on the rear panel. The measured data can be automatically transferred to the PC after measurement. CAUTION • In order to avoid any safety hazard, only connect personal computers which are approved by IEC 60950. • The hematology analyzer should only be connected to an external instrument which complies with the CISPR 11 (1997), Group 1 and Class B standard. • Only use the 3-prong power cord for the PC. Connect the serial cable to the PC and the RS-232C socket on the hematology analyzer. For changing the transfer and communication format, refer to “Changing Communication Settings” in Section 3. Connecting a Printer The following printers can be connected to the printer socket on the hematology analyzer. • • • • • WA-710V printer FUJITSU printer SEIKO EPSON VP printer or equivalent SEIKO EPSON PM printer or equivalent CANON BJ printer or equivalent On the WA-710V, FUJITSU, EPSON and CANON printers, histograms are printed with the numeric data. Other data, such as calibration history and gain adjustment history can also be printed. Connect the printer cable to the printer and the printer socket on the hematology analyzer. For changing the printing and communication format, refer to “Changing Printing Settings” and “Changing Communication Settings” in Section 3. NOTE Connect an external printer via bidirectional parallel interface complying with IEEE1284 standard. 2.4 Operator's Manual MEK-6318J/K 2. PREPARATION Connecting a Card Printer The WA-450V or WA-460V card printer can be connected to the RS-232C socket on the hematology analyzer. On the WA-450V or WA-460V card printer, only the numeric data is printed. Histograms cannot be printed. Connect the card printer cable to the card printer and the RS-232C socket on the hematology analyzer. For changing the printing and communication format, refer to “Changing Printing Settings” and “Changing Communication Settings” in Section 3. Connecting a Handy Bar Code Reader The optional ZK-820V handy bar code reader (BL-N60NK or equivalent) can be used for reading the bar code label (up to 13 characters) on the sample tube. For details about the handy bar code reader, refer to the bar code reader manual. The bar code reader can read the following codes: • Industrial 2 of 5 • ITF • JAN/EAN/UPC • NW-7 • CODE 39 • CODE 93 • CODE 128 Connect the YZ-0313 bar code reader cable to the OPTION socket on the rear panel and the handy bar code reader. To set the settings for the handy bar code reader on the hematology analyzer, read the bar codes attached to the bar code reader manual with the handy bar code reader within 15 seconds after turning the hematology analyzer power on. After changing the settings, turn the hematology analyzer power off. For details, refer to “Using the Optional Handy Bar Code Reader” in Section 3. Operator's Manual MEK-6318J/K 2.5 2. PREPARATION Connecting the Power Cord and Grounding the Instrument Connecting the Power Cord CAUTION Only use the provided power cord. Using other power cords may result in electrical shock or other injury to the operator. Connect the provided power cord to the AC SOURCE socket on the rear panel of the instrument and plug the cord into a 3-prong AC outlet. Grounding the Instrument Equipotential Grounding WARNING For operator safety, equipotential grounding of all instruments must be performed. Consult with a qualified biomedical engineer. When more than one electrical instrument is used, there may be electrical potential difference between the instruments. The potential difference between the instruments may cause current to flow to the patient connected to the instruments, resulting in electrical shock (micro shock). Always perform equipotential grounding when required. It is often required in the operating room, ICU room, CCU room, cardiac catheterization room and X-ray room. Consult with a biomedical engineer to determine if it is required. When equipotential grounding is required, connect the equipotential ground terminal on the rear panel of the instrument to the equipotential ground terminal on the wall (equipotential grounding system) with the equipotential grounding lead (potential equalization conductor). 2.6 Operator's Manual MEK-6318J/K 2. PREPARATION Connecting Tubes Diluent, Detergent and Hemolysing Reagent Use only the following specified reagents with the hematology analyzer. Name Model Supply code Qty Diluent ISOTONAC•3, MEK-640 T436D 18L Hemolysing reagent Hemolynac•3, MEK-660 T489 500 mL × 3 T498 T438D 500 mL × 3 5L T438 5L Detergent* Hemolynac•3N, MEK-680 (non-cyanide) CLEANAC•3, MEK-620 CLEANAC, MEK-520 * When using Hemolynac•3 for hemolysing reagent, use CLEANAC•3 detergent for daily use. When using Hemolynac•3N for hemolysing reagent, use CLEANAC detergent for daily use and CLEANAC•3 detergent for periodic maintenance. Use CLEANAC detergent for cleaning after installing the instrument or when using the instrument after long term storage regardless of the type of hemolysing reagent. CAUTION Use only Nihon Kohden recommended reagents. Otherwise the measurement result cannot be guaranteed and incorrect reagent concentration can cause equipment damage. Diluent (ISOTONAC•3) NOTE • If the diluent contacts the skin or eyes or is swallowed, wash immediately and thoroughly with water. • Use the diluent at room temperature (15 to 30oC). • If frozen, warm the diluent at room temperature (15 to 30oC) and stir it sufficiently. • When the temperature of the diluent decreases to less than 18oC, it may influence the WBC distribution (LY, LY%, MO, MO%, GR, GR%), but not influence the WBC count. Detergent CLEANAC•3 WARNING Do not allow CLEANAC•3 detergent to come into contact with acid. Contact with acids can cause the release of poisonous chlorine gas. Operator's Manual MEK-6318J/K 2.7 2. PREPARATION CAUTION If the CLEANAC•3 detergent contacts the skin or eyes or is swallowed, wash thoroughly and immediately with water and see a physician. NOTE • Store the detergent at room temperature (15 to 30oC). • If frozen, warm the detergent at room temperature (15 to 30oC) and stir it sufficiently. CLEANAC CAUTION If the CLEANAC detergent contacts the skin or eyes or is swallowed, wash immediately and thoroughly with water. NOTE • Store the detergent at room temperature (15 to 30oC). • If frozen, warm the detergent at room temperature (15 to 30oC) and stir it sufficiently. Hemolyzing Reagent Hemolynac•3 WARNING • Do not allow the Hemolynac•3 hemolysing reagent to come into contact with acid. Contact with acids can cause the release of poisonous cyanogen gas. • Do not swallow the Hemolynac•3 hemolysing reagent. If swallowed, contact your physician immediately. CAUTION • Be careful when handling the Hemolynac•3 hemolysing reagent because it contains potassium cyanide (0.04%). • If the Hemolynac•3 hemolysing reagent contacts the skin or eyes, wash thoroughly and immediately with water and see a physician. • Do not use Hemolynac•3 hemolysing reagent which has been stored in direct sunlight or opened more than 30 days ago. The hemoglobin data may be erroneously lowered or the reproducibility may become poor. • Read the instructions thoroughly to use the hemolysing reagent. 2.8 Operator's Manual MEK-6318J/K 2. PREPARATION NOTE If the Hemolynac•3 hemolysing reagent is frozen during shipment or low temperature storage, background noise may increase. In this case, leave the hemolysing reagent at 25 to 30oC for 2 days and shake well. Before use, make sure there are no bubbles in the reagent. Hemolynac•3N CAUTION If the Hemolynac•3N hemolysing reagent contacts the skin or eyes or is swallowed, wash thoroughly and immediately with water and see a physician. NOTE If the Hemolynac•3N hemolysing reagent is frozen during shipment or low temperature storage, background noise may increase. In this case, leave the hemolysing reagent at 25 to 30oC for 2 days and shake well. Before use, make sure there are no bubbles in the reagent. Connecting Tubes CAUTION • Avoid hemolysing reagent or detergent contact with the skin. If it contacts the skin or eyes, wash thoroughly with water and see a physician immediately. • Use CLEANAC detergent (MEK-520) for daily use when you use Hemolynac•3N hemolysing reagent (MEK-680). Otherwise, the hemoglobin concentration may be lower than the real value. The Hemolynac•3 or Hemolynac•3N hemolysing reagent can be used with the MEK-6318J/K hematology analyzer. NOTE • Perform the calibration with calibrator when you change hemolysing reagent from Hemolynac•3 to Hemolynac•3N. Otherwise, the hemoglobin concentration may be lower than the real value. • When using the Hemolynac•3N hemolysing reagent, attach the HEMO3N label above the LYSE label. • Do not let dust get in the hemolysing reagent, diluent or detergent. • When using the diluent container, detergent container and waste container, follow the instructions on each package. • Place the diluent and detergent containers at the same level as the instrument. • Do not squeeze or bend the tubes. Otherwise the instrument may be damaged. Operator's Manual MEK-6318J/K 2.9 2. PREPARATION • Use the spare tube (standard accessory) and cut it properly when the length of the tube does not fit. • Do not use the spare tube (standard accessory) for the detergent container. Only use the detergent tube, 2114-082383B. Diluent inlet Hemolysing reagent inlet Detergent inlet Waste outlet Waste container Diluent Hemolysing reagent Detergent Detergent (CLEANAC) (CLEANAC 3) Diluent Tube 1. Connect the connection tube (2114-050872C) to the diluent inlet on the side panel of the instrument. 2. Attach the other end of the tube to the diluent container cap. Detergent Tube NOTE When using Hemolynac•3 • Use CLEANAC detergent (MEK-520) only when cleaning the fluid path after installation or before using the instrument after long term storage. Use CLEANAC•3 detergent (MEK-620) for daily use. The waste fluid contains cyanogen which must be dissolved with CLEANAC•3 before draining the waste fluid. When using Hemolynac•3N • Use CLEANAC detergent (MEK-520) for daily use. Use CLEANAC•3 (MEK-620) only for periodic maintenance. 1. Connect the detergent tube (2114-082383B) to the detergent inlet on the side panel of the instrument. 2. Attach the other end of the tube to the detergent container cap. 2.10 Operator's Manual MEK-6318J/K 2. PREPARATION Hemolysing Reagent Tube 1. Connect the hemolysing reagent tube (AAA-50125) to the hemolysing reagent inlet on the side panel of the instrument. 2. Pass the other end of the tube through the hemolysing reagent cap. Make sure that the end of the tube touches the bottom of the hemolysing reagent container. NOTE When using the Hemolynac•3N hemolysing reagent, attach the HEMO3N label above the LYSE label. Waste Fluid Tube 1. Connect the connection tube (2114-050872C) to the waste fluid outlet on the side panel of the instrument. 2. Attach the other end of the tube to the waste container cap. Operator's Manual MEK-6318J/K 2.11 2. PREPARATION Turning On the Power Check Before Turning On the Power Check the following items before turning on the power. Item Accessories and consumables Connection and settings Appearance Check Sufficient diluent, detergent and hemolysing reagent. Power cord is connected properly. Grounding lead is connected properly when equipotential grounding is required. Tubes are connected properly. Diluent, detergent and hemolysing reagent containers are connected and have no dust in them. Waste container is in place and empty. Enough recording paper in the optional printer. No scratches, dirt or leakage (especially in the measurement baths, sub baths and pump tube). No key or switch is broken. No damage to the power cord. Instrument is not in a wet place. Use after long term storage Turning On the Power Aperture caps are clean. Pump tube is not broken. 1. Press the main power switch on the rear panel of the instrument to on. The main power lamp on the front panel of the instrument lights. Always leave the main power on except for storage and transportation of the instrument. Main power lamp 2. Press the power key on the front panel of the instrument to on. The power lamp lights. Cleaning of the fluid path, priming and circuit self-check are automatically performed. When there is no error, the following messages are displayed on the screen. The screen changes in the following order. PRIMING → DRAINING → CHECKING LYSING REAGENT → CHECKING DILUENT → CHECKING DETERGENT → PRIMING When there is an error, the error message appears on the screen. 2.12 Operator's Manual MEK-6318J/K 2. PREPARATION After priming operation is completed, the READY screen appears. The instrument is ready for counting. 08-DEC-98 10:30 READY ID 0001 MENU Check After Turning On the Power Check the following items after turning on the power to start operating safely and properly. If any problem is detected, take the proper countermeasure according to Section 8 “Error Messages and Troubleshooting”. Item Turning on the power Check There is no fire, smoke or smell. The instrument is not too hot. There is no electric shock. The main power and power lamps light. No alarm message is displayed on the screen. Basic operation The messages are displayed properly. Keys and switches operate properly. The touch screen keys function properly. The measured background noise values are proper. The measured hematology control values are proper. The printer works properly. After long term storage Operator's Manual MEK-6318J/K The date and time are correct. No alarm message is displayed on the screen during operation. Cleaning operation is performed twice using the CLEANAC detergent. 2.13 2. PREPARATION Loading Recording Paper in the WA-630VK Printer Unit (Option) NOTE • The WA-630VK Printer Unit is optional. • Only use the specified recording paper. 1. Open the paper magazine. 2. Set the recording paper in the magazine tray in the direction as shown. 3. Insert the recording paper into the slot. 4. Press the feed key to feed the recording paper. 5. Lift up the recording paper and close the paper magazine cover. 6. Cut the recording paper. 2.14 Operator's Manual MEK-6318J/K 2. PREPARATION Daily Accuracy Check Check the instrument daily before measurement to assure measurement reliability. For measurement reliability, refer to Section 5 “Quality Control”. • Count the diluent to measure background noise. • Count the hematology control to check accuracy. Measuring Background Noise This procedure uses a diluent sample. Background noise increases in the following cases. Problem Old diluent. Germs begin to breed in the diluent 6 months after opening. Dust in the diluent container. Extremely high or low diluent temperature (normal range is 15 to 30°C). The sampling nozzle is clogged and bubbles occur in the sub bath. 1. Press the Countermeasure Replace diluent. Replace diluent. Adjust diluent temperature to 15 to 30°C. Replace the sampling nozzle with a new one. count switch to count the diluent. There is no need to aspirate the diluent from the sampling nozzle. Operator's Manual MEK-6318J/K 2.15 2. PREPARATION 2. The result appears on the screen. Sensitivity 08-DEC-98 Threshold 10:30 ID ( ( WBC 100 200 5) 4) 300 ( 5) (AUTO) RBC Histograms 100 200 ( PLT 2 10 5) 0001 WBC RBC HGB HCT MCV MCH MCHC PLT LY MO GR EO RDW PCT MPV PDW 0.0 L 0.0 L 0.0 L 0.0 L 5L [%] 10 3 / 10 6 / g/dL % fL pg g/dL 10 3 / [ 10 3 / ID uL uL uL uL ] Measurement result % % fL % 20 MENU Displays MENU screen ENTER ID Displays ENTER ID screen Make sure that the values are less than or equal to the following values. WBC: 0.2 (×103/µL) RBC: HGB: PLT: 0.05 (×106/µL) 0.1 (g/dL) 10 (×103/µL) Disregard the other parameter values because noise does not affect the other parameters. If the values are greater than the above values, check the following items and recount the diluent. • • • • 2.16 The diluent is clean. No bubbles in the diluent. The aperture caps are clean. The aperture caps are firmly attached. Operator's Manual MEK-6318J/K 2. PREPARATION Counting the Hematology Control For checking accuracy, use a hematology control which has the same conditions as human blood. Confirm that the obtained sample data is within the acceptable range on the assay sheet attached to the hematology control. For details, refer to Section 7 “Calibration”. CAUTION • Use hematology control which is before the expiration date. • Do not use hematology control when the top layer is slightly red or the whole hematology control is red, because the red blood cells in the control are hemolysed. • Do not freeze the hematology control because this will hemolyse it. • Use and store the hematology control with extreme care according to its instructions. 1. Gently take out the hematology control from the refrigerator. 2. Bring to room temperature by rolling the hematology control vial between the palms of the hands. 3. Turn the hematology control vial upside down at least 30 times to thoroughly mix the plasma and red blood cells. 4. Put the sampling nozzle into the bottom of the hematology control vial so that the tip of the sampling nozzle touches the bottom of the vial. 5. Press the count switch on the front panel of the instrument. The hematology control is aspirated and counting is performed. After counting, the result appears on the screen. 6. Check the data with the assay sheet. NOTE • Calibrate the instrument when the obtained sample data is different from the values described on the assay sheet after recounting. For details, refer to Section 7 “Calibration”. • Contact your Nihon Kohden distributor if the calibration coefficient is over the limit. Operator's Manual MEK-6318J/K 2.17 Section 3 Changing Settings General ................................................................................................................................ 3.1 Assigning an ID to a Sample ............................................................................................... 3.2 Displaying the ENTER ID Screen .............................................................................. 3.2 Entering a 4-digit Numeric ID .................................................................................... 3.3 Entering a 13-character Alphanumeric ID .................................................................. 3.3 Setting Normal Range Upper and Lower Limits ................................................................... 3.4 Default Settings of Upper and Lower Limits .................................................... 3.4 Selecting Single or Double Sample Counting ...................................................................... 3.6 Selecting the Capillary Blood Volume .................................................................................. 3.7 Setting High Altitude Mode On/Off ...................................................................................... 3.8 Setting the Date and Time ................................................................................................... 3.9 Selecting Units .................................................................................................................. 3.10 Counting Unit Table ....................................................................................... 3.11 Setting the User Units ............................................................................................. 3.11 Selecting the Histogram Display Format ........................................................................... 3.12 Selecting Vertical Axis Type for the Histogram ........................................................ 3.12 Differentiating the 3 Kinds of WBC Histogram ......................................................... 3.12 Changing Sensitivity and Threshold ................................................................................... 3.13 General .................................................................................................................... 3.13 Factory Default Settings and Setting Range ................................................. 3.13 RBC Automatic Threshold ............................................................................. 3.13 Using 1/10 Sensitivity ................................................................................... 3.13 Changing Sensitivity and Threshold ........................................................................ 3.14 Determining Optimum Sensitivity ............................................................................ 3.15 Determining Optimum Threshold ............................................................................. 3.15 Changing Printing Settings ................................................................................................ 3.16 Setting Items .......................................................................................................... 3.16 Changing Settings ................................................................................................... 3.17 Settings for the WA-630VK Printer Unit (Internal Printer) .............................. 3.17 Settings for the WA-460V Card Printer .......................................................... 3.18 Settings for the Other External Printers (WA-710V, FUJITSU, EPSON or CANON) .............................................................................................. 3.19 Changing Communication Settings .................................................................................... 3.20 Using the Optional Handy Bar Code Reader ...................................................................... 3.22 General .................................................................................................................... 3.22 Changing Settings ................................................................................................... 3.23 Initializing Settings ............................................................................................................ 3.24 Factory Default Settings .......................................................................................... 3.25 Operator's Manual MEK-6318J/K 3.C1 3. CHANGING SETTINGS General Before starting measurement, assign an ID to a sample on the ENTER ID screen and change settings, such as measurement mode, upper and lower limit, date and time, on the SETTINGS screen. You can also initialize all settings on the SETTINGS screen. Setting Items on the SETTINGS screen Description / Default Settings Item NORMAL RANGE MEAS MODE Set the upper and lower limits for each parameter. COUNT Select single or double sample counting. CAP VOL Select the measuring capillary blood volume. HIGH ALT For using the instrument over 1000 m above sea level. DATE & TIME DISPLAY Set the time and date. UNIT Select unit. HIST EXT. DATA Select the display format of the histogram. Display or not display the vertical lines on the WBC histogram to differentiate 3 kinds of WBC. Set the sensitivity and threshold for WBC, RBC and PLT when measuring non-human blood. Select to print either numerical data only or numerical data and histogram. Select on/off to print received data from the external unit. PARAMETERS Select the number of parameters to be printed. Print normal range Select on/off to print normal range setting for each parameter. Space at top of card Set the space at the top of card. Left margin Set size for the left margin. Line spacing Set the line spacing. MODEL HEADER Select the connected printer type. Select to automatically print numerical data only, numerical data and histogram or not to automatically print after each measurement. Select whether or not to print date and time as the header. PARAMETERS Select the number of parameters to be printed. PAPER Select the type of paper size. 1PAGE DATA Select to print either 1 data for 1 page or 2 data for 1 page. NORM. RANGE Select whether or not to print the normal range settings and printing position on the printing paper. LINES/PAGE Select the length of the recording paper. WBC SENS & THR DATA WA-630V WA-630V SETTING 1 WA-630V SETTING 2/3 WA-460V OTHER SETTINGS 1 OTHER OTHER SETTINGS 2 OTHER SETTINGS 3 AUTO PRINT BAUD RATE COMM SETTINGS 1 DATA BITS PARITY Set the communication settings for the WA-450V, WA-460V card printers and personal computer. STOP BITS COMM SETTINGS 2 PARAMETERS Select the number of parameters. TYPE Select transfer format. ID DIGITS Select the ID digits. HISTOGRAM Operator's Manual MEK-6318J/K Transfer histogram or not. 3.1 3. CHANGING SETTINGS Assigning an ID to a Sample All samples must have an ID. Otherwise you cannot identify which samples the displayed or saved data corresponds to. All saved and displayed data is identified by an ID number. After you set an ID, the instrument automatically assigns it to the next counted sample and increments the ID for each sample after that. Only the last 4 numbers are incremented. There are two ways to enter the ID. • Enter only the last 4 digit numbers. • Enter up to 13 character alphanumeric ID. When the power is turned off, the last 4 numbers are reset to “0001”. When using the optional ZK-820V handy bar code reader, the bar code label of the sample can be read by the bar code reader and this code is entered as the sample ID. For details, refer to the “Using the Optional Handy Bar Code Reader” section. To edit an ID of already saved data, refer to “Editing IDs of Data” in Section 5. Displaying the ENTER ID Screen There are three ways to display the ENTER ID screen. • Press the ID key on the READY screen. • Press the ENTER ID key on the MENU screen. • Press the ENTER ID key on the measurement result screen. 08-DEC-98 08-DEC-98 10:30 08-DEC-98 MENU 10:30 ENTER ID 10:30 ( ( WBC QC ID 5) 4) READY CALIBRATION SETTINGS DATA OTHER 100 200 300 ( 5) (AUTO) RBC ID 0001 100 EDIT ID 200 ( PLT MENU 2 OK 10 LY MO GR EO RDW PCT MPV PDW 7.5 5.45 14.8 46.4 85.1 27.2 31.9 638 [%] 32.0 6.4 61.6 11.9 0.24 6.6 15.6 10 3 / 10 6 / g/dL % fL pg g/dL 10 3 / [ 10 3 / 2.4 0.5 4.6 <0.7 % % fL % uL uL uL uL ] 20 MENU 08-DEC-98 5) 0001 WBC RBC HGB HCT MCV MCH MCHC PLT ENTER ID ENTER ID 10:30 Enter 4 digit ID no. on this screen. Or, press [ALPHA] key to enter 13 digit alphanumeric ID on next screen. 7 8 9 4 5 6 1 2 3 0 . CE 0001 OK 3.2 ALPHA Operator's Manual MEK-6318J/K 3. CHANGING SETTINGS Entering a 4-digit Numeric ID 08-DEC-98 2. Enter a 4-digit ID no. with the numeric keys on the screen. If you make a mistake, press the CE key on the screen to clear the numbers. ENTER ID 10:30 Enter 4 digit ID no. on this screen. Or, press [ALPHA] key to enter 13 digit alphanumeric ID on next screen. 7 8 9 4 5 6 1 2 3 0 . CE 0001 OK 1. Display the ENTER ID screen. 3. After the ID is entered, press the OK key on the screen to display the READY screen. ALPHA Entering a 13-character Alphanumeric ID 08-DEC-98 ENTER ID 10:30 ID 1. Display the ENTER ID screen. 2. Press the ALPHA key on the ENTER ID screen. [ABCDEFGH:0001] A B C D E F G H I J K L M N O P Q R S T U V W X Y Z : 0 1 2 3 4 5 OK 7 8 9 SPACE 6 3. Press the CE key on the screen to move the cursor to the leftmost place in the input field. ID [ : ] CE cursor NAME NO. (letters or numbers) (numbers only) 4. Press the desired key to enter a number or letter in the NAME part. Up to 8 characters can be entered. If you make a mistake entering the ID, either press the CE key to clear all numbers and letters, or use the ← or → and alphanumeric keys to change one number/letter. 5. After entering the first 8 characters, enter a colon “:” to move the cursor to the NO. part. When less than 8 characters are entered in the NAME part, use the → key to move the cursor to the place between the NAME part and NO. part and then enter the colon “:”. 6. Enter 4 numbers in the NO. part. Only the numbers can be entered. 7. After the ID is entered, press the OK key to return to the MENU screen. 8. Press the OK key to display the READY screen. Operator's Manual MEK-6318J/K 3.3 3. CHANGING SETTINGS Setting Normal Range Upper and Lower Limits Each parameter has a normal range. Values outside the normal range can be automatically marked with an H (upper limit) or L (lower limit) mark. The upper and lower limits can be set individually for each parameter. Default Settings of Upper and Lower Limits 08-DEC-98 10:30 ENTER ID MENU QC CALIBRATION SETTINGS DATA OTHER Default Setting Lower Limit Upper Limit Variable Range WBC 4.0 9.0 0 to 99.9 RBC 3.80 5.30 0 to 14.99 HGB 12.0 18.0 0 to 29.9 HCT 34.0 48.0 0 to 99.9 Parameter MCV 80.0 100 20.0 to 199 MCH 27.0 32.0 10.0 to 50.0 MCHC 32.0 36.0 10.0 to 50.0 PLT 120 380 0 to 1490 LY% 11.0 49.0 0 to 99.9 MO% 0.0 9.0 0 to 99.9 GR% 42.0 85.0 0 to 99.9 RDW 11.5 14.5 0 to 99.9 PCT 0.10 1.00 0 to 2.90 MPV 6.0 10.0 0 to 20 PDW 10.0 15.0 0 to 99.9 1. Press the SETTINGS key on the MENU screen to display the SETTINGS screen. EDIT ID OK 08-DEC-98 10:30 SETTINGS NORMAL RANGE SENS & THR MEAS MODE PRINT SETTINGS DATE & TIME COMM SETTINGS 2. Press the NORMAL RANGE key on the SETTINGS screen to display the NORMAL RANGE screen. DISPLAY OK 3.4 INITIALIZE Operator's Manual MEK-6318J/K 3. CHANGING SETTINGS 3. Press the desired parameter key. Pressing the parameter key moves the cursor between the lower and upper limits. To display other parameters, press the NEXT key. Lower limit 08-DEC-98 Parameter key Upper limit NORMAL RANGE 10:30 WBC [ 4.0 ] [ 9.0 ] RBC [ 3.80 ] [ 5.30 ] VALUE [ HGB [ 12.0 ] [ 18.0 ] HCT [ 34.0 ] [ 48.0 ] MCV [ 80.0 ] [ MCH [ 27.0 ] [ MCHC [ PLT [ 32.0 ] [ 120 ] [ 36.0 ] 380 ] OK NEXT ] ] 7 8 9 100 ] 4 5 6 32.0 ] 1 2 3 0 . CE PAGE 1/2 VALUE box ENTER 4. Enter a value with the numeric keys on the screen. The value appears in the VALUE box. 5. Press the ENTER key on the screen to register the value. 6. Repeat steps 3 to 5 to enter other limits. 7. Press the OK key on the screen to return to the SETTINGS screen. Operator's Manual MEK-6318J/K 3.5 3. CHANGING SETTINGS Selecting Single or Double Sample Counting The samples can be single or double counted. When single count is selected, the samples are counted once. When double count is selected, the instrument automatically counts the sample twice. The mean value of the first and second counts is displayed on the screen and printed. Refer to “Single and Double Counting” in Section 4. 08-DEC-98 MENU 10:30 ENTER ID QC CALIBRATION SETTINGS DATA OTHER 1. Press the SETTINGS key on the MENU screen to display the SETTINGS screen. EDIT ID OK 08-DEC-98 SETTINGS 10:30 NORMAL RANGE SENS & THR MEAS MODE PRINT SETTINGS DATE & TIME COMM SETTINGS 2. Press the MEAS MODE key to display the MEAS MODE screen. DISPLAY OK 08-DEC-98 INITIALIZE MEAS MODE 10:30 COUNT CAP VOL SINGLE 3. Press the COUNT key to select SINGLE or DOUBLE. Pressing this key moves the cursor between SINGLE and DOUBLE. DOUBLE 10 uL 20 uL VENOUS 10 uL 4. Press the OK key to return to the SETTINGS screen. HIGH ALT ON OFF OK 3.6 Operator's Manual MEK-6318J/K 3. CHANGING SETTINGS Selecting the Capillary Blood Volume Select the measuring capillary blood volume. You can also set the hematology analyzer to measure blood of small amount (10 µL) on this screen. 08-DEC-98 MENU 10:30 ENTER ID QC CALIBRATION SETTINGS DATA OTHER 1. Press the SETTINGS key on the MENU screen to display the SETTINGS screen. EDIT ID OK 08-DEC-98 SETTINGS 10:30 NORMAL RANGE SENS & THR MEAS MODE PRINT SETTINGS DATE & TIME COMM SETTINGS 2. Press the MEAS MODE key to display the MEAS MODE screen. DISPLAY OK 08-DEC-98 INITIALIZE MEAS MODE 10:30 COUNT CAP VOL HIGH ALT SINGLE DOUBLE 10 uL 20 uL VENOUS 10 uL ON OFF 3. Press the CAP VOL key to select the capillary blood volume. When “10 µL” or “20 µL” is selected, the selected volume of capillary blood needs to be diluted before measurement. When “VENOUS 10 µL” is selected, 10 µL blood sample can be measured without dilution. OK 4. Press the OK key to return to the SETTINGS screen. Operator's Manual MEK-6318J/K 3.7 3. CHANGING SETTINGS Setting High Altitude Mode On/Off When using the instrument at below 900 hPa air pressure (over 1000 m above sea level), set the high altitude mode to ON. 08-DEC-98 MENU 10:30 ENTER ID QC CALIBRATION SETTINGS DATA OTHER 1. Press the SETTINGS key on the MENU screen to display the SETTINGS screen. EDIT ID OK 08-DEC-98 SETTINGS 10:30 NORMAL RANGE SENS & THR MEAS MODE PRINT SETTINGS DATE & TIME COMM SETTINGS 2. Press the MEAS MODE key to display the MEAS MODE screen. DISPLAY OK 08-DEC-98 INITIALIZE MEAS MODE 10:30 COUNT CAP VOL HIGH ALT SINGLE 3. Press the HIGH ALT key to select ON or OFF. Pressing this key moves the cursor between ON and OFF. DOUBLE 10 uL 20 uL VENOUS 10 uL 4. Press the OK key to return to the SETTINGS screen. ON OFF OK 3.8 Operator's Manual MEK-6318J/K 3. CHANGING SETTINGS Setting the Date and Time The date and time can be set. The built-in backup battery circuit maintains the date and time when the instrument is turned off. Ranges you can set for the date and time are as follows. Day: Month: Year: Hour: Minute: 08-DEC-98 MENU 10:30 ENTER ID SETTINGS DATA OTHER to to to to to 31 12 99 23 59 1. Press the SETTINGS key on the MENU screen to display the SETTINGS screen. QC CALIBRATION 1 1 0 0 0 EDIT ID OK 08-DEC-98 2. Press the DATE & TIME key to display the DATE & TIME screen. SETTINGS 10:30 NORMAL RANGE SENS & THR MEAS MODE PRINT SETTINGS DATE & TIME COMM SETTINGS DISPLAY OK 08-DEC-98 INITIALIZE YEAR [ 98 ] MONTH [ 12 ] DAY [ 08 ] VALUE [ HOUR [ 10 ] MINUTE [ 30 ] OK 3. Press the desired key to move the cursor to that item. DATE & TIME 10:30 ] 7 8 9 4 5 6 1 2 3 0 . CE ENTER 4. Enter the correct value with the numeric keys on the screen. The value appears in the VALUE box. 5. Press the ENTER key on the screen to register the entered value. 6. Repeat steps 3 to 5 to change other items. 7. Press the OK key to return to the SETTINGS screen. The clock starts immediately from the new date and time. Operator's Manual MEK-6318J/K 3.9 3. CHANGING SETTINGS Selecting Units You can select the counting units from JAPAN, USA, SI, SIMOD and MIXED (Refer to the table in the “Counting Unit Table” section). You can select different units for different parameters. These units apply to WBC, RBC, PLT and all other parameters to be counted. 08-DEC-98 MENU 10:30 ENTER ID QC CALIBRATION SETTINGS DATA OTHER 1. Press the SETTINGS key on the MENU screen to display the SETTINGS screen. EDIT ID OK 08-DEC-98 SETTINGS 10:30 NORMAL RANGE SENS & THR MEAS MODE PRINT SETTINGS DATE & TIME COMM SETTINGS 2. Press the DISPLAY key to display the DISPLAY screen. DISPLAY OK 08-DEC-98 INITIALIZE DISPLAY 10:30 JAPAN USA SI SIMOD MIXED USER 3. Press the UNIT key to select the unit. Pressing this key moves the cursor between the units. UNIT HIST WBC COUNTED VALUE LINE PERCENTAGE When USER is selected, you can use your own unit settings. To set USER units, refer to the “Setting the User Units” section. NO LINE USER UNIT OK 3.10 SET 4. Press the OK key on the screen to return to the SETTINGS screen. Operator's Manual MEK-6318J/K 3. CHANGING SETTINGS Counting Unit Table Parameter JAPAN WBC 10 /µL RBC SI SIMOD MIXED 3 10 /L 9 10 /L 9 10 /L 10 /µL 6 10 /L 12 10 /L 12 10 /L g/dL g/dL g/L mmol/L* g/L HCT % % % % % MCV fL fL fL fL fL MCH pg pg pg fmol pg g/dL g/dL g/L mmol/L* g/L 9 10 /µL 10 /µL 4 HGB MCHC 4 DISPLAY JAPAN USA SI SIMOD MIXED USER 9 10 /µL 10 /µL 10 /L 10 /L LY% % % % % % MO% % % % % % GR% % % % % % LY 2 10 /µL 3 10 /µL 9 10 /L 9 10 /L 10 /L MO 10 /µL 2 10 /µL 3 10 /L 9 10 /L 9 10 /L 10 /µL 3 10 /µL 9 10 /L 9 10 /L 10 /L % % %CV %CV %CV 2 9 9 9 PCT % % % % % MPV fL fL fL fL fL % % %CV % PDW % * 1.611 g/dL = 1 mmol/L 10:30 3 12 10 /µL RDW 08-DEC-98 3 9 PLT GR Setting the User Units USA 2 You can set your own units for each parameter. To display the USER UNIT screen, USER must be selected for UNIT on the DISPLAY screen. 1. Press the DISPLAY key on the SETTINGS screen to display the DISPLAY screen. UNIT HIST COUNTED VALUE WBC LINE PERCENTAGE NO LINE USER UNIT OK 08-DEC-98 2. Press the UNIT key to select USER. SET 10:30 USER UNIT WBC 1 0 2/ u L 1 0 3/ u L 1 0 9/ L RBC 1 0 4/ u L 1 0 6/ u L 1 0 12/ L HGB g/dL PLT 1 0 3/ u L 1 0 4/ u L g/L RDW % %CV PDW % %CV 3. Press the SET key under USER UNIT. The USER UNIT screen appears. 4. Press the parameter key for the unit you want to change. Pressing this key moves the cursor between the selectable units. mmol / L 1 0 9/ L OK 5. Repeat step 4 to change units for another parameter. 6. Press the OK key to return to the DISPLAY screen. 7. Press the OK key to return to the SETTINGS screen. Operator's Manual MEK-6318J/K 3.11 3. CHANGING SETTINGS Selecting the Histogram Display Format You can select the display format of the histogram. Selecting Vertical Axis Type for the Histogram You can select the type for the vertical axis on the histograms. COUNTED VALUE: The vertical axis on the graph represents numerical count values. PERCENTAGE: The vertical axis on the graph is fixed at 100% full scale regardless of the total counted value. Therefore, the trend of particle volume distribution can be easily judged even though the total counted value is not shown. 1. Press the SETTINGS key on the MENU screen to display the SETTINGS screen. 08-DEC-98 DISPLAY 10:30 JAPAN USA SI SIMOD MIXED USER 2. Press the DISPLAY key to display the DISPLAY screen. UNIT HIST WBC COUNTED VALUE LINE PERCENTAGE 3. Press the HIST key to select COUNTED VALUE or PERCENTAGE. Pressing this key moves the cursor between COUNTED VALUE and PERCENTAGE. NO LINE USER UNIT OK SET Differentiating the 3 Kinds of WBC Histogram 4. Press the OK key on the screen to return to the SETTINGS screen. You can display lines on the WBC histogram to differentiate 3 kinds of WBC (see “Displaying Histograms for Individual Samples” in Section 5). 1. Press the SETTINGS key on the MENU screen to display the SETTINGS screen. 08-DEC-98 DISPLAY 10:30 JAPAN USA SI SIMOD MIXED USER 2. Press the DISPLAY key to display the DISPLAY screen. UNIT HIST WBC COUNTED VALUE LINE PERCENTAGE 3. Press the WBC key to select LINE or NO LINE. When LINE is selected, the vertical lines appear on the WBC histogram. NO LINE USER UNIT OK 3.12 SET 4. Press the OK key on the screen to return to the SETTINGS screen. Operator's Manual MEK-6318J/K 3. CHANGING SETTINGS Changing Sensitivity and Threshold General For measuring non-human blood, the sensitivity and threshold should be changed to match the characteristics of the blood. CAUTION Use only the initial sensitivity or threshold settings for measuring human blood. Factory Default Settings and Setting Range Parameter SENS (Sensitivity) THR (Threshold) Default Range Default Range WBC 05 1 to 15 04 1 to 15 RBC 05 1 to 15 AUTO 1 to 15, AUTO PLT 05 1 to 15 1/10 SEN: ON or OFF, default setting is OFF RBC Automatic Threshold When AUTO is selected, the borderline between PLT and RBC is automatically detected to set the threshold. When measuring non-human blood that has small RBC particles (such as MCV less than 70 fL), set the threshold to AUTO. Using 1/10 Sensitivity When measuring non-human blood that has large particles (e.g. particle volume larger than 400 fL), use the 1/10 sensitivity function. Operator's Manual MEK-6318J/K 3.13 3. CHANGING SETTINGS Changing Sensitivity and Threshold 08-DEC-98 1. Press the SETTINGS key on the MENU screen to display the SETTINGS screen. MENU 10:30 ENTER ID QC CALIBRATION SETTINGS DATA OTHER EDIT ID OK 08-DEC-98 2. Press the SENS & THR key on the SETTINGS screen to display the SENS & THR screen. SETTINGS 10:30 NORMAL RANGE SENS & THR MEAS MODE PRINT SETTINGS DATE & TIME COMM SETTINGS DISPLAY OK 08-DEC-98 INITIALIZE WBC SENS THR [ [ RBC SENS THR [ 5] [ AUTO ] 5] 4] THR OK VALUE [ ] 7 8 9 4 5 6 1 2 3 0 . CE AUTO OFF RBC THR PLT 3. Press the parameter key to select a parameter. Pressing the key moves the cursor between SENS and THR. SENS & THR 10:30 [ 5] NEXT ENTER 4. • To set the desired value: i) Enter the value with the numeric keys on the screen. The value appears in the VALUE box. ii) Press the ENTER key on the screen to register the value. • To set the RBC auto threshold: i) Press the RBC THR key to select AUTO. When set to AUTO, the RBC threshold is automatically set. • To set the desired RBC threshold: i) Press the RBC THR key to select OFF. ii) Press the RBC key to move the cursor to THR of the RBC. iii) Enter the desired value. 08-DEC-98 1/10 SEN OK 3.14 SENS & THR 10:30 ON BACK OFF • To set 1/10 sensitivity: i) Press the NEXT key. ii) Press the 1/10 SEN key to select ON or OFF. Pressing the 1/10 SEN key moves the cursor between ON and OFF. iii) To return to the previous screen, press the BACK key. 5. Press the OK key on the SENS & THR screen to return to the SETTINGS screen. Operator's Manual MEK-6318J/K 3. CHANGING SETTINGS Determining Optimum Sensitivity This instrument is set for human blood cells. Non-human cells which have a different particle size from human blood cells require adjustment for the settings. For counting non-human cells, determine the optimum sensitivity for each particle according to the following. Then, adjust the threshold. The following table shows the optimum sensitivity for counting globular particles. After setting the sensitivity, adjust the threshold to determine the optimum threshold. Determining Optimum Threshold Mean Particle Volume (fL) Particle Volume Range (fL) Optimum Sensitivity 400 200 to 600 1 200 100 to 300 2 130 70 to 200 3 100 50 to 150 4 80 40 to 120 5 70 35 to 100 6 60 30 to 90 7 50 25 to 80 8 45 20 to 70 9 1. Change the threshold by one step. 2. Count the sample. The counted value is displayed. 3. Repeat steps 1 and 2 with the same sample until you have enough counted values to plot a curve with a plateau (flat part of the curve). The optimum threshold is the center of the plateau. Counted value Plateau Optimum threshold Threshold 0 If the plateau is too short or cannot be obtained, increase sensitivity and repeat this procedure. Counted value 0 Operator's Manual MEK-6318J/K No plateau Threshold Counted value 0 Plateau is too short Threshold 3.15 3. CHANGING SETTINGS Changing Printing Settings Setting Items Printer Type Set the printing format when printing the data with an optional WA-630VK printer unit, WA-460V card printer, or WA-710V or other external printer connected to the instrument. The following items can be set. Setting Screen Item DATA WA-630V printer unit (installed type) WA-630V SETTING 1 PARAMETERS WA-630V SETTING 2/3 WA-460V card printer EXT. DATA Print normal range on/off Space at top of card WA-460V SETTING Left margin Line pacing 1 data for 1 page, 2 data for 1 page OTHER SETTINGS 2 NORM RANGE LINES/PAGE [*2] NUM/HIST OFF 19 OFF 05 00 10 1 PAGE DATA [*5] HEADER [*3] PARAMETERS OTHER SETTINGS 3 Select the width of the row. PAPER [*2] AUTO PRINT [*4] Other printers NUMERIC: only numerical data NUM/HIST: numerical data and histogram ON: External data is printed. OFF: External data is not printed. 8: Print WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT 19: Print WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, LY, LY%, MO, MO%, GR, GR%, EO, RDW, PCT, MPV, PDW For each parameter ON: Normal range graph is printed. OFF: Normal range graph is not printed. Select the number of blank lines at the top of the recording card. Select the amount of blank space at the left side of the recording card. Select the printer type from: FUJITSU, EPSON-VP, EPSON-PM, CANON-BJ NUMERIC: only numerical data is automatically printed after measurement NUM/HIST: numerical data and histogram are automatically printed after measurement OFF: Auto print is not performed. DATE&TIME: Print the date and time at the head of the data. TIME: Print the time at the head of the data. NONE: Keep blank spaces. 8: Print WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT 19: Print WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, LY, LY%, MO, MO%, GR, GR%, EO, RDW, PCT, MPV, PDW WIDE: Normal stock form (continuous forms) NARROW: Hematology data sheet (continuous type) MODEL[*1] OTHER SETTINGS 1 Default Setting Description EPSON-VP NUM/HIST DATE&TIME 19 WIDE 1 SAMPLE TYPE 1: Normal range settings are printed on the right part of the recording paper. TYPE 2: Normal range settings are printed below the measured result as bar graphs. OFF: Normal range settings are not printed. Select the length of the recording paper from 1 to 255 lines OFF 66 *1: *2: *3: *4: When using WA-710V printer, select “EPSON-VP” for “MODEL”. These settings are available only when “FUJITSU” or “EPSON-VP” is selected for “MODEL”. Available only when “WIDE” is selected for “PAPER”. When “EPSON-PM” or “CANON-BJ” is selected for “MODEL”, printing is not performed when “NUMERIC” is selected for “AUTO PRINT”. *5: Available only when “TYPE 1” or “OFF” is selected for “NORM RANGE”. 3.16 Operator's Manual MEK-6318J/K 3. CHANGING SETTINGS Changing Settings 08-DEC-98 Settings for the WA-630VK Printer Unit (Internal Printer) SETTINGS 10:30 NORMAL RANGE SENS & THR MEAS MODE PRINT SETTINGS DATE & TIME COMM SETTINGS 1. Press the PRINT SETTINGS key on the SETTINGS screen to display the PRINT SETTINGS screen. DISPLAY OK INITIALIZE 08-DEC-98 PRINT SETTINGS 10:30 2. Press the WA-630V key to display the WA-630V SETTING 1 screen. WA-630V WA-460V OTHER OK 08-DEC-98 WA-630V SETTING 1 10:30 NUMERIC DATA EXT.DATA NUM/HIST ON 8 PARAMETERS SET 2 OK OFF 19 SET 3 4. To select ON or OFF to print normal range setting for each parameter: i) Press the SET 2 key to display the WA-630V SETTING 2 screen. Select ON or OFF to print normal range setting for CBC parameters. Item key 08-DEC-98 10:30 3. Press an item key to change the setting for that item. WA-630V SETTING 2 Select ON to print normal range for each parameter. WBC O N O F F RBC O N O F F HGB O N O F F HCT O N O F F MCV O N O F F MCH O N O F F MCHC O N O F F PLT O N O F F ii) Press the SET 3 key to display the WA-630V SETTING 3 screen. Select ON or OFF to print normal range setting for parameters other than CBC parameters. 5. Press the OK key to return to the PRINT SETTINGS screen. OK SET 1 SET 3 Operator's Manual MEK-6318J/K 3.17 3. CHANGING SETTINGS Settings for the WA-460V Card Printer 08-DEC-98 1. Press the PRINT SETTINGS key on the SETTINGS screen to display the PRINT SETTINGS screen. SETTINGS 10:30 NORMAL RANGE SENS & THR MEAS MODE PRINT SETTINGS DATE & TIME COMM SETTINGS DISPLAY OK INITIALIZE 08-DEC-98 PRINT SETTINGS 10:30 2. Press the WA-460V key to display the WA-460V SETTING screen. WA-630V WA-460V OTHER OK Item keys 08-DEC-98 Setting value 10:30 WA-460V SETTING Select: 1. Space at top of card. 2. Left margin. 3. Line spacing. VALUE [ ] DEFAULT 1 [ 00 ] 00 2 [00] 00 3 OK [00] SET 1 7 8 9 4 5 6 1 2 3 0 . CE 3. Select the item to change and enter the new setting value. a) Press the item number key for the item to be changed. b) Enter the value using the numeric keys. The entered value appears in the VALUE box. c) Press the ENTER key to register the new value. 10 SET 2 ENTER 4. Press the OK key to return to the PRINT SETTINGS screen. 3.18 Operator's Manual MEK-6318J/K 3. CHANGING SETTINGS Settings for the Other External Printers (WA-710V, FUJITSU, EPSON or CANON) 08-DEC-98 1. Press the PRINT SETTINGS key on the SETTINGS screen to display the PRINT SETTINGS screen. SETTINGS 10:30 NORMAL RANGE SENS & THR MEAS MODE PRINT SETTINGS DATE & TIME COMM SETTINGS DISPLAY OK INITIALIZE 08-DEC-98 PRINT SETTINGS 10:30 2. Press the OTHER key to display the OTHER SETTINGS 1 screen. WA-630V WA-460V OTHER OK 08-DEC-98 10:30 OTHER SETTINGS 1 FUJ ITS U EPS O N - P M MODEL AUTO PRINT NUMERIC NUM/HIST OFF HEADER DATE&TIME TIME PARAMETERS 8 19 OK SET 3 SET 2 08-DEC-98 W ID E PAPER TYP E 1 SET 1 LINES/PAGE [ 2S A MP LE S TY P E 2 O FF SET 3 6. Press the SET 3 key to display the OTHER SETTINGS 3 screen. [ 66 ] ] 7 8 9 4 5 6 1 2 3 . CE 0 OK 5. Press an item key to change the setting for that item. OTHER SETTINGS 3 08-DEC-98 10:30 VALUE 4. Press the SET 2 key to display the OTHER SETTINGS 2 screen. NARROW 1SAMP LE N ORM. RANGE OK NONE OTEHR SETTINGS 2 10:30 1 PAGE DATA 3. Press an item key to change the setting for that item. EPSON-VP C A N ON - B J SET 1 SET 2 7. Enter the setting value. a) Enter the value using the numeric keys. The entered value is displayed in the VALUE box. b) Press the ENTER key to register the new value. ENTER 8. Press the OK key to return to the PRINT SETTINGS screen. Operator's Manual MEK-6318J/K 3.19 3. CHANGING SETTINGS Changing Communication Settings A personal computer, or WA-450V or WA-460V card printer can be connected to the RS232C socket on the hematology analyzer. Change the following settings for PORT 1 on the hematology analyzer. Also check that the settings on the receiving equipment are the same as the settings on the hematology analyzer. When connecting a WA-460V card printer, if necessary, also change the printing settings on the WA-460V SETTING screen of the PRINT SETTINGS screen. Refer to the “Changing Printing Settings” section. An optional ZK-820V handy bar code reader can be connected to the OPTION socket on the hematology analyzer with a YZ-0313 bar code reader cable. Change the settings for PORT 2 on the COMM SETTINGS 1 screen. For details, refer to the “Using the Optional Handy Bar Code Reader” section. Screen COMM SETTINGS 1 Item Setting Range Default Setting BAUD RATE 150, 300, 600, 1200, 2400, 4800, 9600, 19200 DATA BITS 7, 8 PARITY EVEN, ODD, NONE STOP BITS 1, 2 8 (WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT) 18 (WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, LY%, LY, MO%, MO, GR%, GR, RDW, PCT, MPV, PDW) 19 (WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, LY%, LY, MO%, MO, GR%, GR, RDW, PCT, MPV, PDW, EO) WA-460V, WA-450V, OTHER PARAMETERS COMM SETTINGS 2 TYPE ID DIGITS* 1 HISTOGRAM* 8 EVEN 4, 13 2 9600 1 8 WA-460V 4 YES, NO YES *1: When TYPE is set to WA-450V, the ID DIGIT is fixed at 4. *2: Only available when TYPE is set to OTHER. 08-DEC-98 10:30 ENTER ID MENU QC CALIBRATION SETTINGS DATA OTHER 1. Press the SETTINGS key on the MENU screen to display the SETTINGS screen. EDIT ID OK 3.20 Operator's Manual MEK-6318J/K 3. CHANGING SETTINGS 08-DEC-98 SETTINGS 10:30 NORMAL RANGE SENS & THR MEAS MODE PRINT SETTINGS DATE & TIME COMM SETTINGS 2. Press the COMM SETTINGS key on the SETTINGS screen to display the COMM SETTINGS 1 screen. DISPLAY OK 08-DEC-98 INITIALIZE COMM SETTINGS 1 PORT 1 10:30 150 300 2400 4800 BAUD RATE 7 DATA BITS OK SET 2 08-DEC-98 COMM SETTINGS 2 PORT 1 18 WA-460V OTHER ID DIGITS 4 HISTOGRAM YES SET 1 • To switch between the PORT 1 and 2 screens, press the PORT 1 or PORT 2 key. For details about settings for using an optional handy bar code reader, refer to the “Using the Optional Handy Bar Code Reader” section. PORT 2 8 TYPE NONE 2 10:30 PARAMETERS OK ODD 1 STOP BITS 1200 19200 8 EVEN PARITY 600 9600 • To switch between the COMM SETTINGS 1 and 2 screens, press the SET 1 or SET 2 key. 3. Press the item key to change the setting. 19 WA-450V 13 NO PORT 2 Operator's Manual MEK-6318J/K 4. Press the OK key to return to the SETTINGS screen. 3.21 3. CHANGING SETTINGS Using the Optional Handy Bar Code Reader General The optional ZK-820V handy bar code reader (BL-N60NK or equivalent) can be used for reading the bar code label (up to 13 characters) on the sample tube. This data can be used as an ID. For details about the handy bar code reader, refer to the bar code reader manual. The bar code reader can read the following codes: • Industrial 2 of 5 • ITF • JAN/EAN/UPC • NW-7 • CODE 39 • CODE 93 • CODE 128 To set the settings for the handy bar code reader on the hematology analyzer, the communication settings for PORT 2 must be changed and the bar codes attached to the bar code reader manual must be read with the handy bar code reader within 15 seconds after turning the hematology analyzer power on. The power for the handy bar code reader is supplied from the hematology analyzer when the bar code reader is connected to the hematology analyzer and the hematology analyzer power is turned on. The hematology analyzer can only receive the bar code information from the bar code reader when one of the following four screens are displayed. • READY • ENTER ID • RESULT • EDIT ID When the LED on the bar code reader lights with a buzzer sound, it indicates that the bar code label is read properly by the bar code reader. However, the hematology analyzer can only receive data from the bar code reader when one of the above screens are displayed. The hematology analyzer also gives a buzzer sound when the data from the bar code reader is properly received on the hematology analyzer. Therefore, turn the LED light and buzzer sound off on the handy bar code reader so that the operator does not mistake the bar code to be successfully received by the hematology analyzer when the bar code is read by the bar code reader but not received by the hematology analyzer. The bar codes to be used for setting the hematology analyzer are given in the following procedure, but can also be found in the bar code reader manual with other bar codes. 3.22 Operator's Manual MEK-6318J/K 3. CHANGING SETTINGS Changing Settings 1. Change the communication settings of the PORT 2 screen on the COMM SETTINGS 1 screen as follows. Refer to the procedure in the previous section “Changing Communication Settings”. BAUD RATE: DATA BITS: PARITY: STOP BIT: 9600 7 EVEN 1 NOTE Make sure that the data bits setting is changed to 7 (the default setting is 8). + 2. Turn off the hematology analyzer power by pressing the power key while holding down the reset key. The hematology analyzer power is turned off without cleaning operation. 3. Read the three bar codes shown at left, from top to bottom within 15 seconds after turning the hematology analyzer power on. Turn the hematology analyzer power on by pressing the power key while holding down the reset key. The power is turned on without cleaning and priming operation. When the bar codes are read properly, there will be 5 buzzer sounds. Start Setting 4. Read the two bar codes shown at left to turn the LED light and buzzer sound off on the bar code reader. LED off NOTE The LED light and buzzer sound on the bar code reader should be turned off so that the operator does not mistake the bar code as successfully read when it is not received by the hematology analyzer. Buzzer off 5. Read the other necessary bar codes in the bar code reader manual. NW-7 start/stop character not to send When using NW-7 bar codes, the bar code shown at left should be read so that the start and stop characters of the bar code are not sent to the hematology analyzer. 6. Read the bar code shown at left to complete setting changes. There will be 5 buzzer sounds. End Setting 7. Turn off the hematology analyzer power by pressing the power key while holding down the reset key. The hematology analyzer power is turned off without cleaning operation. Operator's Manual MEK-6318J/K 3.23 3. CHANGING SETTINGS Initializing Settings The following settings can be initialized to the factory default settings. NORMAL RANGE MEAS MODE DISPLAY PRINT SETTINGS COMM SETTINGS _ _ _ XB initial value (Refer to “XB (X Batch) Program” in Section 6.) SENS & THR 08-DEC-98 10:30 ENTER ID MENU QC CALIBRATION SETTINGS DATA OTHER 1. Press the SETTINGS key on the MENU screen to display the SETTINGS screen. EDIT ID OK 08-DEC-98 10:30 SETTINGS NORMAL RANGE SENS & THR MEAS MODE PRINT SETTINGS DATE & TIME COMM SETTINGS 2. Press the INITIALIZE key on the SETTINGS screen to display the INITIALIZE screen. DISPLAY OK 08-DEC-98 INITIALIZE 10:30 NORMAL RANGE MEAS MODE DISPLAY PRINT SETTINGS COMM SETTINGS INITIALIZE XB INITIAL VALUE SENS & THR Initialize all? YES 3.24 CANCEL 3. Press the YES key to initialize settings. To cancel initializing, press the CANCEL key. When initializing is finished, the INITIALIZED message appears on the screen and the screen returns to the SETTINGS screen. Operator's Manual MEK-6318J/K 3. CHANGING SETTINGS Factory Default Settings NORMAL RANGE Lower Limit Upper Limit LY% 11.0 49.0 5.30 MO% 0.0 9.0 12.0 18.0 GR% 42.0 85.0 HCT 34.0 48.0 RDW 11.5 14.5 MCV 80.0 100 PCT 0.10 1.00 MCH 27.0 32.0 MPV 6.0 10.0 MCHC 32.0 36.0 PDW 10.0 15.0 PLT 120 380 Lower Limit Upper Limit WBC 4.0 9.0 RBC 3.80 HGB Item Item MEAS MODE COUNT: SINGLE CAP VOL: 20 µL HIGH ALT: OFF DATE & TIME _ DISPLAY UNIT: USA HIST: COUNTED VALUE WBC: NO LINE SENS & THR WBC: SENS: 5 THR: 4 RBC: SENS: 5 THR: AUTO PLT: SENS: none THR: 5 1/10 SEN: OFF WA-630V SETTINGS 1 DATA: EXT.DATA: PARAMETERS: WA-630V SETTINGS 2/3 Print normal range: WA-460V SETTINGS Space at top of card: 05 Left margin: 00 Line spacing: 10 OTHER SETTINGS 1 MODEL: AUTO PRINT: HEADER: PARAMETERS: PAPER: 1 PAGE DATA: NORM.RANGE: LINES/PAGE: OTHER SETTINGS 2 OTHER SETTINGS 3 Operator's Manual MEK-6318J/K NUM/HIST OFF 19 all parameters OFF EPSON-VP NUM/HIST DATE&TIME 19 WIDE 1 SAMPLE OFF 66 3.25 3. CHANGING SETTINGS COMM SETTINGS 1 COMM SETTINGS 2 BAUD RATE: DATA BITS: PARITY: STOP BITS: PARAMETERS: TYPE: ID DIGITS: HISTOGRAM: 9600 8 EVEN 1 18 WA-460V 4 NO _ XB Initial values MCV: 89.5 fL MCH: 30.5 pg MCHC: 33.8 g/dL 3.26 Operator's Manual MEK-6318J/K Section 4 Measurement General ................................................................................................................................ 4.1 Single and Double Counting ...................................................................................... 4.1 ID Numbers ............................................................................................................... 4.1 Alarms ....................................................................................................................... 4.2 Displaying H and L Out of Range Marks ................................................................... 4.2 OVER Message ........................................................................................................ 4.2 Data Storage ............................................................................................................. 4.2 Printing and Transferring Data .................................................................................... 4.2 Counting Special Case Samples ............................................................................... 4.3 Explanation of Histograms and Each Measured Blood Parameter ....................................... 4.4 WBC (White Blood Cell) Distribution Histogram ........................................................ 4.4 WBC Histogram and Screen Code Messages ........................................................... 4.4 RBC (Red Blood Cell) Distribution Histogram ............................................................ 4.6 PLT (Platelet) Distribution Histogram ......................................................................... 4.6 Measuring a Venous Sample ............................................................................................... 4.7 Preparing a Venous Sample ...................................................................................... 4.7 Measuring a Venous Sample ..................................................................................... 4.7 Measuring a 10 µL Blood Sample ........................................................................................ 4.9 Measuring a Capillary Sample ........................................................................................... 4.10 Preparing a Capillary Sample .................................................................................. 4.10 Measuring a Capillary Sample ................................................................................. 4.12 Continuous Capillary Blood Measurement ............................................................... 4.13 Automatic Waste Fluid Treatment ...................................................................................... 4.14 Waste Fluid Treatment Trouble ................................................................................. 4.15 Daily Shutdown ................................................................................................................. 4.16 Checking List Before Turning Power Off ........................................................ 4.16 Turning the Power Off .............................................................................................. 4.16 Checking List After Turning Power Off ........................................................... 4.16 Checking List Before Long Term Storage ....................................................... 4.16 Operator's Manual MEK-6318J/K 4.C1 4. MEASUREMENT General Single and Double Counting In single counting mode, each sample is counted once. In double counting mode, the instrument automatically counts the sample twice and displays and stores the mean value. Only the mean value is printed, displayed and stored in memory. If there is a significant deviation between the two counts, a third counting is automatically performed and the mean of the two closest counts is used. When printing histograms of the double counted sample, the first count data is printed for the WBC and the second count data is printed for the RBC and PLT. To set the double count, refer to “Selecting Single or Double Sample Counting” in Section 3. Single Counting Press the count switch Counting Display sample data Double Counting Press the count switch First counting Second counting Deviation between the two sample data? NO YES Third counting Display mean value ID Numbers Each sample must have its own ID number. You can set any ID number for any sample. Refer to “Assigning an ID to a Sample” in Section 3. During measurement, the ID number can be automatically incremented by one for each sample. When you press the count switch, the ID number is automatically incremented and the sample is counted as the next sample. Operator's Manual MEK-6318J/K 4.1 4. MEASUREMENT Alarms When trouble occurs during counting, alarms such as “CLOG”, “BUBBLE”, “LEVEL 1”, “NOISE”, “!” are displayed and sounded. If an alarm occurs, remove the cause. Refer to Section 9 “Error Messages and Troubleshooting”. CAUTION When an alarm occurs, the acquired data may not be correct, especially when “!” appears. Recount the sample. Displaying H and L Out of Range Marks When the counted values are outside the normal range, H for above upper limit and L for below the lower limit are automatically marked. To set the normal range, refer to “Setting Normal Range Upper and Lower Limits” in Section 3. OVER Message The OVER message appears when the counted value is outside the measurable range. Refer to “Specification” in Section 10 for measurable range. Data Storage The instrument stores all measured and calculated data for the latest 400 samples and histograms of up to 20 samples. After that, the oldest sample data is deleted when a new sample is measured. If you want to save data, use the auto print mode to save data as a printout, especially the histograms. _ Quality control data (X and CV) is also stored. Printing and Transferring Data The acquired data can be printed and transferred when a printer or personal computer is connected to the instrument. When the auto printing function is set to on, the data can be automatically printed on the connected printer. When the WA-450V or WA-460V card printer or a personal computer is connected, the data is automatically transferred to the card printer or personal computer after every measurement according to the settings on the COMM SETTINGS screen. Refer to “Changing Communication Settings” in Section 3. 4.2 Operator's Manual MEK-6318J/K 4. MEASUREMENT To set the printing settings and communication settings, refer to “Changing Printing Settings” and “Changing Communication Settings” in Section 3. To print or transfer data, refer to “Printing and Transferring Data” in Section 5. Counting Special Case Samples • WBC Count To measure a blood sample from a neonate or a patient with serious hepatopathy, it may be necessary to use a method other than the blood cell counter. This is because the RBC membrane’s resistance against hemolysing reagent is increased (insufficient hemolysing) and it will cause an increase of the WBC count when the blood is measured with the blood cell counter. “!” appears beside the WBC count. • PLT Count The PLT count may be decreased because of pseudothrombocytopenia or unskillful procedure in sampling blood. It is recommended to make a blood specimen and observe it with a microscope when the PLT count is below 50,000/µL. Operator's Manual MEK-6318J/K 4.3 4. MEASUREMENT Explanation of Histograms and Each Measured Blood Parameter WBC (White Blood Cell) Distribution Histogram The instrument automatically analyzes the WBC 3-part differential histogram by searching for the peaks and valleys of the distribution histogram. The counts and ratios of lymphocytes, monocytes and granulocytes to the white blood cells can be obtained. When eosinophil is above 700/µL, an eosinophil flag, >0.7 appears in the eosinophil column. When below 700/µL, <0.7 appears. You can set the instrument to display lines showing the separation of the 3-part differential. Refer to “Selecting Units and Histogram Display Format” in Section 3. Lymphocyte distribution Monocyte distribution LY%: MO%: GR%: LY: MO: GR: EO: WBC Histogram and Screen Code Messages Granulocyte distribution Lymphocyte percent Monocyte percent Granulocyte percent Lymphocyte count Monocyte count Granulocyte count Eosinophil flag Individual variations in human blood affect counting, such as easily hemolyzed blood, difficult to hemolyze blood, and blood disease. The character of sample blood also varies depending on elapsed time after collecting the blood and storage conditions. When the histogram distributions are abnormal, its data is judged as unreliable, and a flag (F1, F2, F3, F4 or F5) is displayed on the right side of the obtained data. When the data analyzed with the distribution histogram cannot be judged, no obtained data is displayed on the screen. When these codes appear or no data is displayed on the screen, perform the blood smear method. 4.4 Operator's Manual MEK-6318J/K 4. MEASUREMENT F1: Too many RBC ghosts RBC ghosts Possible causes: • Poor hemolyzation (blood containing bilirubin plasma and high cholesterol is not easy to hemolyze.) • Platelet aggregation • Many large platelets F2: The lymphocyte distribution is not discriminated Granulocyte distribution Possible causes: • Small number of lymphocytes F3: The granulocyte distribution is not discriminated Lymphocyte distribution Possible causes: • The blood was left more than 8 hours after collecting. • The sample blood was not stored in ideal conditions. • Poor blood cell membranes. • Small number of granulocytes. • Reagents other than ISOTONAC•3 and Hemolynac•3 were used. F4: The lymphocyte, monocyte and granulocyte distributions are not discriminated Possible causes: • Reagents other than ISOTONAC•3 and Hemolynac•3 were used. F5: Eosinophil flag cannot be analyzed Possible causes: • Alarm occurred during counting and second counting is performed. Operator's Manual MEK-6318J/K 4.5 4. MEASUREMENT RBC (Red Blood Cell) Distribution Histogram Red blood cell distribution width (RDW) is automatically calculated from the RBC distribution histogram. The RDW indicates the deviation ratio of the red blood cell volumes on the histogram. RDW (%) = Standard deviation of red blood cell volumes (SD) Mean cell volume (MCV) SD SD 100 200 MCV PLT (Platelet) Distribution Histogram The following parameters are automatically calculated from the PLT distribution histogram. • Platelet Crit (PCT) The PCT indicates the ratio of the platelet total volume on the histogram to the aspirated whole blood volume. • Mean Platelet Volume (MPV) The MPV indicates the mean of the platelets volume on the histogram. • Platelet Distribution Width (PDW) The PDW indicates the deviation ratio of the platelet volumes on the histogram. PDW (%) = Standard deviation of platelet volumes (SD) SD SD MPV 4.6 Mean platelet volume (MPV) 10 20 Operator's Manual MEK-6318J/K 4. MEASUREMENT Measuring a Venous Sample Preparing a Venous Sample Put 2 mL of collected whole blood in a sample container which contains anticoagulant. CAUTION • Use only ethylenediaminetetraacetic acid salt (EDTA) as an anticoagulant. • Do not use heparin as an anticoagulant. It affects white blood cell and platelet measurement. Gently shake the covered sample container up and down more than 30 times. CAUTION Do not stir the sample excessively because it generates unwanted bubbles and cause hemolyzation. Measuring a Venous Sample CAUTION Do not count aggregated or coagulated blood. Otherwise the instrument may be damaged. NOTE • When measurement cannot be performed properly due to poor hemolyzation, measure the blood sample at least 30 minutes after collection. • Measure blood samples within 8 hours after collection. • Gently and thoroughly shake the blood again before measurement. • Blood samples from a neonate or patient with a serious hepatopathy may show an excessively high WBC count by poor hemolyzation due to red blood cell membrane resistance. In this case, it may be necessary to use another counting method. Capillary blood mode lamp off Operator's Manual MEK-6318J/K 1. Check that the instrument is in venous mode (i.e. the capillary blood mode lamp on the front panel of the instrument is not lit). 4.7 4. MEASUREMENT 2. Confirm the ID number on the READY screen. To change the ID number, refer to “Assigning an ID to a Sample” in Section 3. 3. Put the sampling nozzle into the bottom of the sample container so that the tip of the sampling nozzle touches the bottom of the sample container. Count switch Sampling nozzle Put the sampling nozzle to this level Do not press the sampling nozzle too hard against the bottom of the sample container. This decreases the aspirating volume. 4. Press the count switch on the front panel of the instrument. The sample is aspirated and counting is performed. 08-DEC-98 The “COUNTING” message is displayed on the screen during counting. 10:30 COUNTING 0001 08-DEC-98 10:30 ( ( WBC 100 200 ( 5) (AUTO) 100 200 ( PLT 10 5) 0001 LY MO GR EO RDW PCT MPV PDW 7.5 5.45 14.8 46.4 85.1 27.2 31.9 638 [%] 32.0 6.4 61.6 11.9 0.24 6.6 15.6 103 / 106 / g/dL % fL pg g/dL 103 / [103 / 2.4 0.5 4.6 <0.7 % % fL % 20 MENU 4.8 5) 4) 300 RBC 2 ID WBC RBC HGB HCT MCV MCH MCHC PLT ENTER ID uL uL uL uL] After counting, the result is stored in memory and displayed on the screen with histograms. ↑ on the RBC or PLT histogram indicates the auto RBC threshold setting. Refer to “Changing Sensitivity and Threshold” in Section 3. • When AUTO PRINT on the OTHER SETTINGS 1 screen of the PRINT SETTINGS screen is set to NUMERIC or NUM/HIST, the result is automatically printed on the connected external printer. • When the automatic print mode lamp is lit, (i.e. the printer is in auto mode), the result is automatically printed on the WA-630VK printer unit according to the setting of the WA-630V SETTING on the PRINT SETTINGS screen. Refer to “Changing Printing Settings” in Section 3. Operator's Manual MEK-6318J/K 4. MEASUREMENT Measuring a 10 µL Blood Sample You can measure any kind of blood sample of 10 µL. There is no need to dilute the sample before measurement. You only need to hold the sample cup containing blood sample to the sampling nozzle and press the count switch. The hematology analyzer aspirates 10 µL of blood sample and perform measurement. This mode is useful when measuring a high concentration blood sample. 1. Prepare a sample in a sample cup with more than 10 µL blood. 2. Select “VENOUS 10 µL” for “CAP VOL” on the MEAS MODE screen. Refer to “Selecting the Capillary Blood Volume” in Section 3. 3. Confirm the ID number on the READY screen. To change the ID number, refer to “Assigning an ID to a Sample” in Section 3. 4. Press the Count switch Sampling nozzle capillary blood mode key on the front panel. 5. Tilt a sample cup and put the sampling nozzle into the bottom of the sample container so that the tip of the sampling nozzle touches the bottom of the sample container. NOTE Do not press the sampling nozzle too hard against the bottom of the sample container. This decreases the aspirating volume. 6. Press the Put the sampling nozzle to this level 08-DEC-98 count switch on the front panel. 10 µL of blood sample is aspirated and counting is performed. The “COUNTING” message is displayed on the screen during counting. 10:30 COUNTING 0001 08-DEC-98 10:30 100 200 5) 4) 300 ( 5) (AUTO) RBC 100 200 ( PLT 2 ID ( ( WBC 10 5) WBC RBC HGB HCT MCV MCH MCHC PLT LY MO GR EO RDW PCT MPV PDW 0001 VENOUS 10 uL 7.5 103 / uL 5.45 106 / uL g/dL 14.8 % 46.4 fL 85.1 pg 27.2 g/dL 31.9 103 / uL 638 [%] [103 / uL] 2.4 32.0 0.5 6.4 4.6 61.6 < 0.7 % 11.9 % 0.24 fL 6.6 % 15.6 20 MENU ENTER ID Operator's Manual MEK-6318J/K After counting, the result is stored in memory and displayed on the screen with histograms. At the same time, the measurement mode changes from the capillary mode to the venous mode (i.e. the capillary blood mode lamp is off). NOTE When you measure “VENOUS 10 µL”, reproducibility of the measured data may not be accurate because the aspirated blood volume is less than the half of the usual venous sample. 4.9 4. MEASUREMENT Measuring a Capillary Sample In this capillary sample blood mode, collected 20 µL or 10 µL sample blood is diluted with about 2 mL of diluted solution and measured as a diluted blood sample multiplied by 100 or 200. Preparing a Capillary Sample NOTE • Carefully perform the following procedures to collect and dilute capillary blood from an earlobe or a finger tip. When capillary blood is measured, data accuracy depends on careful performance of these processes, i.e. collecting and diluting the blood sample. • For neonates and infants, collect capillary blood from finger tip or heel. Measuring an earlobe capillary blood may not be accurate. • For each parameter, the values for earlobe capillary blood may be almost 5 to 10% higher than that of a venous sample. If tissue gets into the sample, the WBC value is excessively high. • When using a sahli pipette, clean and completely dry it before use. 1. Select the capillary blood volume (10 or 20 µL) on the MEAS MODE screen of the SETTINGS screen. Refer to “Selecting the Capillary Blood Volume” in Section 3. 2. Confirm the ID number on the READY screen. To change the ID number, refer to “Assigning an ID to a Sample” in Section 3. 3. Press the capillary blood mode key on the front panel. Check that the capillary blood mode lamp is lit and the CAPILLARY BLOOD MODE screen is displayed. 08-DEC-98 10:30 CAPILLARY BLOOD MODE Preparing and Measuring Capillary Blood Sample 1. Hold a sample cup inclined and put the sampling nozzle along the inside of the sample cup. 2. Press the dispense key to dispense diluent into the sample cup. 4. Tilt a sample cup and put the sampling nozzle along the inside of the sample cup. 4.10 Operator's Manual MEK-6318J/K 4. MEASUREMENT 5. Press the dispense key on the front panel to dispense about 2 mL diluent into the sample cup. The screen changes. 08-DEC-98 10:30 CAPILLARY BLOOD MODE 1. Put the capillary blood into the sample cup of the dispensed diluent and stir thoroughly. 2. Put the sampling nozzle into the sample cup so that the tip of the sampling nozzle touches the bottom of the sample cup. 3. Press the count key to start measurement. Repeat steps 4 and 5 when dispensing diluent repeatedly. Sahli pipette 6. Collect 10 or 20 µL of whole blood with a sahli pipette or micro cap. Micro cap 7. Put the capillary blood into the sample cup of the dispensed diluent. Be careful not to create any bubbles. Put the cap on the sample cup. 8. Gently shake the sample cup up and down more than 10 times. CAUTION Do not stir the sample excessively because it generates unwanted bubbles and cause hemolyzation. NOTE • To prevent evaporation, put the cap on the sample cup when not measuring immediately. • When measuring blood which is left more than 1 minute after collecting, gently shake the blood again before measurement. Operator's Manual MEK-6318J/K 4.11 4. MEASUREMENT Measuring a Capillary Sample 1. Check that the capillary blood mode lamp is lit. 2. Put the sampling nozzle into the bottom of the sample cup so that the tip of the sampling nozzle touches the bottom of the sample cup. Count switch Sampling nozzle Put the sampling nozzle to this level Do not press the sampling nozzle too hard against the bottom of the sample cup. This decreases the aspirating volume. 3. Press the count switch on the front panel. The sample is aspirated and counting is performed. 08-DEC-98 The “COUNTING” message is displayed on the screen during counting. 10:30 COUNTING 0001 08-DEC-98 10:30 ( ( WBC 100 200 ( 5) (AUTO) 100 200 ( PLT 10 5) LY MO GR EO RDW PCT MPV PDW 0001 CAPILLARY 20 uL 7.5 10 3 / uL 6 5.45 10 / uL g/dL 14.8 % 46.4 fL 85.1 pg 27.2 g/dL 31.9 10 3 / uL 638 [%] [ 10 3 / uL ] 2.4 32.0 0.5 6.4 4.6 61.6 < 0.7 % 11.9 % 0.24 fL 6.6 % 15.6 20 MENU 4.12 5) 4) 300 RBC 2 ID WBC RBC HGB HCT MCV MCH MCHC PLT ENTER ID After counting, the result is stored in memory and displayed on the screen with histograms. At the same time, the measurement mode changes from the capillary mode to the venous mode (i.e. the capillary blood mode lamp is off). • When AUTO PRINT on the OTHER SETTINGS screen of the PRINT SETTINGS screen is set to NUMERIC or NUM/HIST, the result is automatically printed on the connected external printer. • When the automatic print mode lamp is lit, (i.e. the printer is in auto mode), the result is automatically printed on the WA-630VK printer unit according to the setting of WA-630V SETTING on the PRINT SETTINGS screen. Refer to “Changing Printing Settings” in Section 3. Operator's Manual MEK-6318J/K 4. MEASUREMENT Continuous Capillary Blood Measurement 1. Press the capillary blood mode key on the front panel. Check that the capillary blood mode lamp is lit. 2. Ignore the screen display and put the sampling nozzle into the bottom of the sample cup so that the tip of the sampling nozzle touches the bottom of the sample cup. Do not press the sampling nozzle too hard against the bottom of the sample cup. This decreases the aspirating volume. 3. Press the count switch on the front panel. The sample is aspirated and counting is performed. The “COUNTING” message is displayed on the screen during counting. After counting, the result is stored in memory and displayed on the screen with histograms. Repeat these procedures for measuring other capillary blood samples. Operator's Manual MEK-6318J/K 4.13 4. MEASUREMENT Automatic Waste Fluid Treatment The following applies only when Hemolynac•3 hemolysing reagent is used. WARNING Do not drain the waste fluid without treatment because the waste fluid contains cyanogen (CN). If for any reason the instrument cannot automatically treat the waste fluid, put some CLEANAC•3 detergent in the waste fluid, stir it to completely dissolve the cyanogen, leave it for at least 30 minutes, then dispose of it. The Nihon Kohden detergent CLEANAC•3 contains sodium hypochlorite (NaClO) which dissolves the cyanogen (CN) in the waste fluid. The instrument automatically cleans the fluid path after every ten countings and puts CLEANAC•3 into the waste fluid. Cyanogen (CN) is dissolved with sodium hypochlorite (NaClO) in the following chemical reaction. cyanogen (CN −) + hypochlorite ion (ClO−) → cyanic ion (CNO−) + Cl− 2 cyanic ions (CNO−) + 3ClO + H2O → 2CO2 + N2 + 3Cl− + 2OH− NOTE • Use the specified Nihon Kohden CLEANAC•3 detergent for cleaning. • Before disposing of the treated waste fluid, stir it to completely dissolve cyanogen, leave it for at least 30 minutes, then dispose of it. • No need for automatic waste fluid treatment when using Hemolynac•3N. Hemolynac•3N contains no cyanogen. 4.14 Operator's Manual MEK-6318J/K 4. MEASUREMENT Waste Fluid Treatment Trouble WARNING The waste fluid may not be properly treated when the instrument has trouble. In this case, the waste fluid is dark brown. Dissolve the cyanogen by following the procedure below. If the instrument has an error and cannot aspirate the detergent, the cyanogen in the waste fluid cannot be dissolved. In this case, the waste fluid is dark brown. Treat the waste fluid as follows in a well-ventilated place and contact your Nihon Kohden distributor. 1. Add 30 mL of sodium hypochlorite or chlorine bleach for each 1 L waste fluid and stir it. 2. Leave it for 30 minutes. 3. Add 4 g of ammonium chloride for each 1 L of the waste fluid to make the pH value close to 7 and stir it. 4. Drain it after 30 minutes. Operator's Manual MEK-6318J/K 4.15 4. MEASUREMENT Daily Shutdown To keep the instrument in optimum condition, check and clean it after every use. If an error is found during check, clean or replace the item. Checking List Before Turning Power Off • There is enough hemolysing reagent and detergent left in the containers. • The waste container is empty. • The waste tube is properly connected. Turning the Power Off To turn the power off, press the power key on the front panel. The instrument automatically performs cleaning and then turns the power off. To turn the main power off, press the main power switch on the rear panel. Check that the main power lamp on the front panel is off. Always leave the main power on except for storage and transportation of the instrument. Checking List After Turning Power Off • There was no leakage during use. • The outside enclosure of the instrument is wiped off and clean. • The fluid path is automatically cleaned when the power is turned off. Checking List Before Long Term Storage • The inside of the instrument has been cleaned with distilled water. • There is no fluid left inside the instrument. • The power is turned off. • No chemicals or water are placed around the instrument. • The instrument, diluent and detergent are stored properly. 4.16 Operator's Manual MEK-6318J/K Section 5 Handling Data General ................................................................................................................................ 5.1 Displaying Numerical Data and Histograms ........................................................................ 5.2 Displaying Numerical Data ........................................................................................ 5.2 Displaying Histograms for Individual Samples .......................................................... 5.2 Deleting Data ....................................................................................................................... 5.4 Deleting Data for Individual Samples ......................................................................... 5.4 Deleting All Data ....................................................................................................... 5.5 Editing IDs of Data .............................................................................................................. 5.6 Printing and Transferring Data .............................................................................................. 5.7 Automatic Printing and Transferring Data after Measurement .................................... 5.7 Printing on the WA-630VK Printer Unit ...................................................................... 5.8 Automatic Printing after Measurement ............................................................ 5.8 Manual Printing ............................................................................................... 5.8 Printing Stored Data .................................................................................................. 5.8 Printing Numerical Data .................................................................................. 5.8 Printing Histograms of a Sample ..................................................................... 5.9 Printing Numerical Data for All Samples of a Single Day ................................ 5.9 Transferring Data to a PC or Card Printer ................................................................ 5.10 Transferring Data During Counting ................................................................. 5.11 Transferring Stored Data for Individual Samples ............................................ 5.11 Transferring Stored Data for All Samples of a Single Day ............................. 5.12 Operator's Manual MEK-6318J/K 5.C1 5. HANDLING DATA General The instrument stores all measured and calculated data for the latest 400 samples and histograms of up to 20 samples. These stored data can be printed, transferred to a personal computer and deleted. The sample ID can be changed. When the sample has histograms, these histograms can be displayed and printed. Operator's Manual MEK-6318J/K 5.1 5. HANDLING DATA Displaying Numerical Data and Histograms You can display any saved numerical data. Numerical data for up to 400 samples (100 pages) can be stored in memory. All numerical data is stored in chronological order as “pages” of four samples each. You can also display a histogram. Up to 20 samples can be stored in memory. An “*” mark in front of the ID means that the histograms are stored. To print data, refer to the “Printing and Transferring Data” section. Displaying Numerical Data 08-DEC-98 MENU 10:30 ENTER ID 1. Press the DATA key on the MENU screen to display the DATA screen. The data for the latest 4 samples (latest page) is displayed. QC CALIBRATION SETTINGS DATA OTHER EDIT ID OK 08-DEC-98 ID 10:30 0001 WBC RBC HGB HCT MCV MCH MCHC PLT LY% MO% GR% RDW PCT MPV PDW OK 7.5 5.45 14.8 46.4 85 27.2 31.9 368 32.0 6.4 61.6 11.9 0.24 6.6 15.6 0002 8.5 4.38 12.9 39.8 91 29.5 33.4 220 50.9 4.3 44.8 11.9 0.17 7.9 15.5 0003 0004 5.0 4.58 13.8 42.8 93 30.1 32.2 157 22.7 5.3 72.0 12.8 0.12 7.8 15.9 6.4 4.65 14.0 43.0 92 30.1 32.6 242 29.7 4.3 66.0 12.2 0.20 8.1 15.3 PAGE 1/ 8 PRINT HIST BACK NEXT TRANS DEL Displaying Histograms for Individual Samples 2. Use the BACK and NEXT keys to display the desired data. Press the BACK key to display the previous page. Press the NEXT key to display the next page. 3. Press the OK key to return to the MENU screen. The histogram display and printing format are set to either numerical or percentage vertical axis. Lines can also be displayed on the histogram to differentiate the 3 kinds of WBC. Refer to “Selecting the Histogram Display Format” in Section 3. To print the stored histograms, refer to the “Printing Histograms of a Sample” section. 1. Display the numerical data which has the histograms you want to display on the DATA screen. Refer to the “Displaying the Numerical Data” section. An ID with the “*” mark has histograms. 5.2 Operator's Manual MEK-6318J/K 5. HANDLING DATA 08-DEC-98 ID 10:30 2. Press the HIST key. 0001 WBC RBC HGB HCT MCV MCH MCHC PLT LY% MO% GR% RDW PCT MPV PDW 0002 7.5 5.45 14.8 46.4 85 27.2 31.9 368 32.0 6.4 61.6 11.9 0.24 6.6 15.6 OK 08-DEC-98 ID 8.5 4.38 12.9 39.8 91 29.5 33.4 220 50.9 4.3 44.8 11.9 0.17 7.9 15.5 6.4 4.65 14.0 43.0 92 30.1 32.6 242 29.7 4.3 66.0 12.2 0.20 8.1 15.3 1/ 8 PRINT HIST NEXT TRANS DEL 10:30 0002 0003 8.5 4.38 12.9 39.8 91 29.5 33.4 220 50.9 4.3 44.8 11.9 0.17 7.9 15.5 5.0 4.58 13.8 42.8 93 30.1 32.2 157 22.7 5.3 72.0 12.8 0.12 7.8 15.9 0004 6.4 4.65 14.0 43.0 92 30.1 32.6 242 29.7 4.3 66.0 12.2 0.20 8.1 15.3 3. Press the ID key of the desired sample. The numerical data and WBC, RBC and PLT histograms of the selected sample appear on the screen. PAGE 1/ 8 Select ID to display one ID. OK 08-DEC-98 10:30 ID WBC 100 200 300 RBC 100 200 PLT WBC RBC HGB HCT MCV MCH MCHC PLT LY MO GR EO RDW PCT MPV PDW 10 OK 5.0 4.58 13.8 42.8 93 30.1 32.2 157 22.7 5.3 72.0 12.8 0.12 7.8 15.9 PAGE 7.5 5.45 14.8 46.4 85 27.2 31.9 368 32.0 6.4 61.6 11.9 0.24 6.6 15.6 2 0004 BACK 0001 WBC RBC HGB HCT MCV MCH MCHC PLT LY% MO% GR% RDW PCT MPV PDW 0003 0001 7.5 5.45 14.8 46.4 85.1 27.2 31.9 638 [%] 32.0 6.4 61.6 11.9 0.24 6.6 15.6 10 3 / 10 6 / g/dL % fL pg g/dL 10 3 / [ 10 3 / 2.4 0.5 4.6 <0.7 % % fL % 4. To return to the DATA screen, press the OK key. uL uL uL uL ] 5. To return to the MENU screen, press the OK key on the DATA screen. 20 PRINT: HIST NUM Operator's Manual MEK-6318J/K 5.3 5. HANDLING DATA Deleting Data This instrument’s memory can store numerical data for up to 400 samples and histograms for up to 20 samples. When the memory is full and a new data is acquired, the oldest data is automatically deleted for new data. You can delete all data or data for individual samples. Deleting Data for Individual Samples 08-DEC-98 ID 10:30 0001 WBC RBC HGB HCT MCV MCH MCHC PLT LY% MO% GR% RDW PCT MPV PDW 7.5 5.45 14.8 46.4 85 27.2 31.9 368 32.0 6.4 61.6 11.9 0.24 6.6 15.6 OK 08-DEC-98 ID OK 0004 6.4 4.65 14.0 43.0 92 30.1 32.6 242 29.7 4.3 66.0 12.2 0.20 8.1 15.3 PAGE 1/ 8 PRINT HIST BACK NEXT TRANS DEL 7.5 5.45 14.8 46.4 85 27.2 31.9 368 32.0 6.4 61.6 11.9 0.24 6.6 15.6 0002 8.5 4.38 12.9 39.8 91 29.5 33.4 220 50.9 4.3 44.8 11.9 0.17 7.9 15.5 PAGE 1/ 8 Select ID to delete one ID. 0003 5.0 4.58 13.8 42.8 93 30.1 32.2 157 22.7 5.3 72.0 12.8 0.12 7.8 15.9 0004 6.4 4.65 14.0 43.0 92 30.1 32.6 242 29.7 4.3 66.0 12.2 0.20 8.1 15.3 7.5 5.45 14.8 46.4 85 27.2 31.9 368 32.0 6.4 61.6 11.9 0.24 6.6 15.6 0002 8.5 4.38 12.9 39.8 91 29.5 33.4 220 50.9 4.3 44.8 11.9 0.17 7.9 15.5 PAGE 1/ 8 Delete data for this ID? 2. Press the DEL key. 3. Press the corresponding ID key on the screen to select the sample data. The “Delete data for this ID?” message appears. DELETE ALL 10:30 0001 WBC RBC HGB HCT MCV MCH MCHC PLT LY% MO% GR% RDW PCT MPV PDW 0003 5.0 4.58 13.8 42.8 93 30.1 32.2 157 22.7 5.3 72.0 12.8 0.12 7.8 15.9 10:30 08-DEC-98 ID 0002 8.5 4.38 12.9 39.8 91 29.5 33.4 220 50.9 4.3 44.8 11.9 0.17 7.9 15.5 0001 WBC RBC HGB HCT MCV MCH MCHC PLT LY% MO% GR% RDW PCT MPV PDW 1. Display the sample data to be deleted on the DATA screen. Refer to the “Displaying Numerical Data” section. 0003 5.0 4.58 13.8 42.8 93 30.1 32.2 157 22.7 5.3 72.0 12.8 0.12 7.8 15.9 YES 0004 6.4 4.65 14.0 43.0 92 30.1 32.6 242 29.7 4.3 66.0 12.2 0.20 8.1 15.3 4. Press the YES key to delete the selected sample data. The data is deleted and the screen returns to the previous screen. Press the CANCEL key to cancel deleting. The screen returns to the previous screen. CANCEL 5. After deleting desired data, press the OK key on the screen to return to the DATA screen. 6. Press the OK key on the DATA screen to return to the MENU screen. 5.4 Operator's Manual MEK-6318J/K 5. HANDLING DATA Deleting All Data CAUTION This procedure deletes all of the 400 obtained sample data and 20 histograms. 08-DEC-98 ID 1. Press the DATA key on the MENU screen to display the DATA screen. 10:30 0001 WBC RBC HGB HCT MCV MCH MCHC PLT LY% MO% GR% RDW PCT MPV PDW 7.5 5.45 14.8 46.4 85 27.2 31.9 368 32.0 6.4 61.6 11.9 0.24 6.6 15.6 OK 08-DEC-98 ID 8.5 4.38 12.9 39.8 91 29.5 33.4 220 50.9 4.3 44.8 11.9 0.17 7.9 15.5 OK 5.0 4.58 13.8 42.8 93 30.1 32.2 157 22.7 5.3 72.0 12.8 0.12 7.8 15.9 6.4 4.65 14.0 43.0 92 30.1 32.6 242 29.7 4.3 66.0 12.2 0.20 8.1 15.3 PAGE 1/ 8 PRINT HIST NEXT TRANS DEL 7.5 5.45 14.8 46.4 85 27.2 31.9 368 32.0 6.4 61.6 11.9 0.24 6.6 15.6 0002 8.5 4.38 12.9 39.8 91 29.5 33.4 220 50.9 4.3 44.8 11.9 0.17 7.9 15.5 PAGE 1/ 8 Select ID to delete one ID. 0003 5.0 4.58 13.8 42.8 93 30.1 32.2 157 22.7 5.3 72.0 12.8 0.12 7.8 15.9 0004 6.4 4.65 14.0 43.0 92 30.1 32.6 242 29.7 4.3 66.0 12.2 0.20 8.1 15.3 7.5 5.45 14.8 46.4 85 27.2 31.9 368 32.0 6.4 61.6 11.9 0.24 6.6 15.6 0002 8.5 4.38 12.9 39.8 91 29.5 33.4 220 50.9 4.3 44.8 11.9 0.17 7.9 15.5 PAGE 1/ 8 Delete data for all IDs? 2. Press the DEL key. 3. Press the DELETE ALL key on the screen. The “Delete data for all IDs?” message appears. DELETE ALL 10:30 0001 WBC RBC HGB HCT MCV MCH MCHC PLT LY% MO% GR% RDW PCT MPV PDW 0004 10:30 08-DEC-98 ID 0003 BACK 0001 WBC RBC HGB HCT MCV MCH MCHC PLT LY% MO% GR% RDW PCT MPV PDW 0002 0003 0004 5.0 4.58 13.8 42.8 93 30.1 32.2 157 22.7 5.3 72.0 12.8 0.12 7.8 15.9 6.4 4.65 14.0 43.0 92 30.1 32.6 242 29.7 4.3 66.0 12.2 0.20 8.1 15.3 YES CANCEL 4. Press the YES key to delete all the stored sample data. The data is deleted and the screen returns to the previous screen. Press the CANCEL key to cancel deleting. The screen returns to the previous screen. 5. Press the OK key on the screen to return to the DATA screen. 6. Press the OK key on the DATA screen to return to the MENU screen. Operator's Manual MEK-6318J/K 5.5 5. HANDLING DATA Editing IDs of Data You can change the ID of any saved data. 08-DEC-98 1. Press the EDIT ID key on the MENU screen. The numerical data for the latest 4 samples are displayed. MENU 10:30 ENTER ID QC CALIBRATION SETTINGS DATA OTHER EDIT ID OK 08-DEC-98 ID 10:30 0001 WBC RBC HGB HCT MCV MCH MCHC PLT LY% MO% GR% RDW PCT MPV PDW 0002 7.5 5.45 14.8 46.4 85 27.2 31.9 368 32.0 6.4 61.6 11.9 0.24 6.6 15.6 OK 8.5 4.38 12.9 39.8 91 29.5 33.4 220 50.9 4.3 44.8 11.9 0.17 7.9 15.5 PAGE 1/ BACK NEXT 08-DEC-98 0003 5.0 4.58 13.8 42.8 93 30.1 32.2 157 22.7 5.3 72.0 12.8 0.12 7.8 15.9 8 To display other data, press the BACK or NEXT key. Select ID to edit ID. 10:30 ID 0004 6.4 4.65 14.0 43.0 92 30.1 32.6 242 29.7 4.3 66.0 12.2 0.20 8.1 15.3 EDIT ID 2. Press the ID key for the ID you want to change. The EDIT ID screen appears. [ABCDEFGH:0001] A B C D E F G H I J K L M N O P Q R S T U V W X Y Z : 0 1 2 3 4 5 OK 7 8 9 SPACE 6 3. Press the ← or → key on the screen to move the cursor to the desired digit in the input field. CE Press the desired alphanumeric key. Numbers and letters can be entered for any digit. Press the CE key to delete all characters and move the cursor to the leftmost position. 4. Press the OK key on the EDIT ID screen to return to the MENU screen. 5.6 Operator's Manual MEK-6318J/K 5. HANDLING DATA Printing and Transferring Data The data can be printed on the following printers and transferred to a personal computer. Printer WA-630VK Printer Unit WA-450V Card Printer WA-460V Card Printer WA-710V Printer and other external printers* Printing Data Numerical data and histograms Numerical data Numerical data Numerical data and histograms * Contact your Nihon Kohden distributor. The numerical data and histograms can be transferred to the personal computer. When printing on the card printer, data is sent from the instrument to the card printer through RS-232C. Printing data on the card printer uses the TRANS key on the screen and data is sent according to the settings on the COMM SETTINGS screen. To print on the card printer, refer to the “Transferring Data to a PC or Card Printer” section. Change the necessary settings for printing and transferring data on the PRINT SETTINGS and COMM SETTINGS screens of the SETTINGS screen. Refer to Section 3. Automatic Printing and Transferring Data after Measurement When auto print is selected, the data is automatically printed on the connected external printer after every measurement. Refer to “Changing Printing Settings” in Section 3. When the WA-450V or WA-460V card printer or a personal computer is connected, the data is automatically transferred to the card printer or personal computer after every measurement according to the settings on the COMM SETTINGS screen. Refer to “Changing Communication Settings” in Section 3. When using the WA-630VK printer unit, refer to the “Printing on the WA-630VK Printer Unit” section. Operator's Manual MEK-6318J/K 5.7 5. HANDLING DATA Printing on the WA-630VK Printer Unit Data is printed on the WA-630VK printer unit according to the setting of WA-630V SETTING on the PRINT SETTINGS screen of the SETTINGS screen. To change the setting, refer to “Changing Printing Settings” in Section 3. The measurement result can be automatically or manually printed after every measurement. Even when in auto mode, printing can be performed whenever the the front panel is pressed. To feed the paper, press the print key on feed key on the front panel of the instrument. Automatic Printing after Measurement Press the auto print key on the front panel of the instrument. Check that the auto print lamp lights. Measurement results are automatically printed after every measurement. Manual Printing When you do not want to print data after every measurement, do the following procedure. Off 1. Check that the auto print lamp on the front panel of the instrument is not lit. If lit, press the auto print key to turn it off. 2. Press the print key on the front panel of the instrument when you want to print. The data displayed on the screen is printed. Printing Stored Data The stored numerical data and histograms can be printed on the DATA screen. When printing on a card printer, refer to the “Transferring Data to a PC or Card Printer” section. Printing Numerical Data The numerical data of the 4 samples displayed on the DATA screen can be printed on the connected WA-630VK or other external printer. 08-DEC-98 ID 10:30 0001 WBC RBC HGB HCT MCV MCH MCHC PLT LY% MO% GR% RDW PCT MPV PDW OK 5.8 7.5 5.45 14.8 46.4 85 27.2 31.9 368 32.0 6.4 61.6 11.9 0.24 6.6 15.6 0002 8.5 4.38 12.9 39.8 91 29.5 33.4 220 50.9 4.3 44.8 11.9 0.17 7.9 15.5 0003 0004 5.0 4.58 13.8 42.8 93 30.1 32.2 157 22.7 5.3 72.0 12.8 0.12 7.8 15.9 6.4 4.65 14.0 43.0 92 30.1 32.6 242 29.7 4.3 66.0 12.2 0.20 8.1 15.3 PAGE 1/ 8 PRINT HIST BACK NEXT TRANS DEL 1. Press the DATA key on the MENU screen to display the DATA screen. 2. Display the samples you want to print using the BACK and NEXT keys. 3. Press the PRINT key on the DATA screen. The displayed data is printed on the connected printer. Operator's Manual MEK-6318J/K 5. HANDLING DATA When using the WA-630VK printer unit, data can also be printed by pressing the print key on the front panel. 4. To return to the MENU screen, press the OK key on the DATA screen. Printing Histograms of a Sample When a sample data has histograms, histograms can be printed with numerical data on the connected WA-630VK or other external printer. When the sample is double counted, the first WBC counting result and the second counting result of the RBC and PLT are printed. NOTE Histograms cannot be printed on the card printers. 08-DEC-98 10:30 ID WBC 100 200 300 RBC 100 200 PLT WBC RBC HGB HCT MCV MCH MCHC PLT LY MO GR EO RDW PCT MPV PDW 2 10 OK 0001 7.5 5.45 14.8 46.4 85.1 27.2 31.9 638 [%] 32.0 6.4 61.6 11.9 0.24 6.6 15.6 103 / 106 / g/dL % fL pg g/dL 103 / [103 / 2.4 0.5 4.6 <0.7 % % fL % uL uL uL uL] 20 PRINT: HIST 1. Display the histograms you want to print on the screen by following the procedure in the “Displaying Histograms for Individual Samples” section. 2. Press the HIST key to print the histograms and numerical data. To print only numerical data, press the NUM key. NUM When using the WA-630VK printer unit, data can also be printed by pressing the print key on the front panel. Data is printed according to the WA-630V SETTING setting on the PRINT SETTINGS screen of the SETTINGS screen. Refer to “Changing Printing Settings” in Section 3. 3. Press the OK key to return to the DATA screen. Printing Numerical Data for All Samples of a Single Day All numerical data for one day can be printed on the connected external printer (EPSON-VP or EPSON-PM only) or WA-630VK printer unit. Only the date and numerical data are printed. Histograms cannot be printed with this function. This function is available for the latest 5 days. (Today is the latest day.) To print on the card printer, refer to the “Transferring Stored Data for All Samples of a Single Day” section. To check or change the printing format, refer to “Changing Printing Settings” in Section 3. Operator's Manual MEK-6318J/K 5.9 5. HANDLING DATA 08-DEC-98 10:30 ENTER ID MENU 1. Before printing, make sure there is enough recording paper. QC CALIBRATION SETTINGS DATA OTHER 2. Press the OTHER key on the MENU screen to display the OTHER screen. EDIT ID OK 08-DEC-98 10:30 OTHER CAL HISTORY TRANSFER DAY OPER HISTORY PRIME CIRCUIT CHECK DRAIN BATHS PRINT DAY DRAIN ALL MAINTENANCE OK 08-DEC-98 3. Press the PRINT DAY key to display the PRINT DAY screen. The last five dates and the number of samples for each day are displayed. 10:30 PRINT DAY 04-DEC-98 NUMBER OF SAMPLES 12 05-DEC-98 NUMBER OF SAMPLES 14 06-DEC-98 NUMBER OF SAMPLES 20 07-DEC-98 NUMBER OF SAMPLES 15 08-DEC-98 NUMBER OF SAMPLES 16 4. Press a date key on the screen. CANCEL 08-DEC-98 10:30 PRINT DAY 04-DEC-98 EXT PRINTER 5. Select the printer you want to print from. EXT PRINTER: EPSON-VP or EPSON-PM ROLL PRINTER: WA-630VK Printer Unit ROLL PRINTER 6. Press the CANCEL key on the PRINT DAY screen to return to the OTHER screen. CANCEL Transferring Data to a PC or Card Printer Numerical data with or without histograms can be transferred to a personal computer. Only numerical data can be transferred and printed on the card printer. You can transfer data during counting or transfer stored data. You can transfer data for individual samples or data for all samples in a single day. The single day function is only available for the most recent 5 days (including today). In the single day function, histograms cannot be transferred. 5.10 Operator's Manual MEK-6318J/K 5. HANDLING DATA CAUTION To transfer data, the communication format between the instrument and personal computer must match. Set the communication format of this instrument to that of the personal computer or card printer before transferring data. Before transferring, prepare the PC to receive the data. To change communication settings, refer to “Changing Communication Settings” in Section 3. Transferring Data During Counting To transfer data during counting, you only need to set up and connect the personal computer or card printer. Data is automatically transferred during counting when the instrument is connected to a PC or card printer and both instruments are ready for communication. Transferring Stored Data for Individual Samples 1. Press the DATA key on the MENU screen to display the DATA screen. 08-DEC-98 ID 2. Use the BACK or NEXT key to display numerical data to be transferred. 10:30 0001 WBC RBC HGB HCT MCV MCH MCHC PLT LY% MO% GR% RDW PCT MPV PDW 7.5 5.45 14.8 46.4 85 27.2 31.9 368 32.0 6.4 61.6 11.9 0.24 6.6 15.6 OK 0002 8.5 4.38 12.9 39.8 91 29.5 33.4 220 50.9 4.3 44.8 11.9 0.17 7.9 15.5 0003 0004 5.0 4.58 13.8 42.8 93 30.1 32.2 157 22.7 5.3 72.0 12.8 0.12 7.8 15.9 6.4 4.65 14.0 43.0 92 30.1 32.6 242 29.7 4.3 66.0 12.2 0.20 8.1 15.3 PAGE 1/ 8 PRINT HIST BACK NEXT TRANS DEL NOTE If HISTOGRAM is set to “NO” on the COMM SETTINGS 2 screen, pressing an ID key with a “*” mark in step 4 does not transfer the histograms. 3. Press the TRANS key. The TRANSFER DATA screen appears. 08-DEC-98 ID WBC RBC HGB HCT MCV MCH MCHC PLT LY% MO% GR% RDW PCT MPV PDW OK 4. Press the ID key of the data you want to transfer. 10:30 0001 7.5 5.45 14.8 46.4 85 27.2 31.9 368 32.0 6.4 61.6 11.9 0.24 6.6 15.6 0002 8.5 4.38 12.9 39.8 91 29.5 33.4 220 50.9 4.3 44.8 11.9 0.17 7.9 15.5 0003 5.0 4.58 13.8 42.8 93 30.1 32.2 157 22.7 5.3 72.0 12.8 0.12 7.8 15.9 0004 6.4 4.65 14.0 43.0 92 30.1 32.6 242 29.7 4.3 66.0 12.2 0.20 8.1 15.3 PAGE 1/ 8 Select ID to transfer one ID. Operator's Manual MEK-6318J/K After the data transfer is complete, other numerical data can be transferred by pressing the corresponding ID key. 5. After transferring all desired data, press the OK key on the screen to return to the DATA screen. 5.11 5. HANDLING DATA 08-DEC-98 10:30 ENTER ID MENU Transferring Stored Data for All Samples of a Single Day 1. Press the OTHER key on the MENU screen to display the OTHER screen. QC CALIBRATION SETTINGS DATA OTHER EDIT ID OK 08-DEC-98 10:30 OTHER CAL HISTORY TRANSFER DAY OPER HISTORY PRIME CIRCUIT CHECK DRAIN BATHS PRINT DAY DRAIN ALL MAINTENANCE OK 08-DEC-98 10:30 TRANSFER DAY 04-DEC-98 NUMBER OF SAMPLES 12 05-DEC-98 NUMBER OF SAMPLES 14 06-DEC-98 NUMBER OF SAMPLES 20 07-DEC-98 NUMBER OF SAMPLES 15 08-DEC-98 NUMBER OF SAMPLES 16 CANCEL 5.12 2. Press the TRANSFER DAY key on the OTHER screen. The TRANSFER DAY screen appears. 3. Press a date key on the screen. All the data for that day is transferred to the personal computer or card printer. 4. After transferring all desired data, press the CANCEL key on the TRANSFER DAY screen to return to the OTHER screen. Operator's Manual MEK-6318J/K Section 6 Quality Control General ................................................................................................................................ 6.1 _ X-R Program ........................................................................................................................ 6.2 General ...................................................................................................................... 6.2 _ Overview of X-R Program and Quality Control Procedure ............................... 6.2 _ _ Calculation of X and R ..................................................................................... 6.2 _ Calculation of Upper and Lower Limits of X and R ........................................... 6.2 _ X-R Graph Example ........................................................................................ 6.4 _ How to Read the X-R Graph ............................................................................ 6.6 Data Outside the Limits .................................................................................. 6.6 Counting the Hematology Control .............................................................................. 6.7 _ Displaying and Printing Stored X-R Data ................................................................... 6.8 _ Deleting the Stored X-R Data ..................................................................................... 6.9 _ _ XB (X Batch) Program ........................................................................................................ 6.10 General .................................................................................................................... 6.10 _ Overview of XB .............................................................................................. 6.10 _ Calculation of XB ........................................................................................... 6.10 _ Displaying and Printing XB Data .............................................................................. 6.12 _ Setting XB Initial Values .......................................................................................... 6.13 _ XDyCV Program ................................................................................................................. 6.14 General .................................................................................................................... 6.14 _ Uses of the XDyCV Program ......................................................................... 6.14 _ Displaying and Printing XDyCV Data ....................................................................... 6.15 Operator's Manual MEK-6318J/K 6.C1 6. QUALITY CONTROL General Quality control refers to the precision, accuracy and reproducibility in the system. Usually graphs are plotted with values calculated from the sample data to statistically manage the quality control in the system. The instrument provides three programs for quality control. _ • X-R _ • XB _ • XD•CV These programs automatically calculate the plotting data from the sample data. The data can be displayed and printed as a table to plot the obtained data for each parameter for quality control. Operator's Manual MEK-6318J/K 6.1 6. QUALITY CONTROL _ X-R Program General _ Overview of X-R Program and Quality Control Procedure _ _ The X-R program calculates and displays the daily X (mean values of the first and second counting of the same hematology control sample) and R (difference between the values of the first and second counting of the same hematology _ _ _ _ control sample). The X-R program also calculates X and R (averaged X and R for a number of days). You can use the data from this program to plot the obtained data for each parameter for quality control. The data for the last 14 days is stored in memory. Every day the instrument is used, count the hematology control “n” times per day (n≥ 2). Continue the counting for k days (10 to 14 days). The instrument automatically calculates the daily mean and difference and the averaged mean and difference for k days. CAUTION • Perform the quality control measurement at a fixed time every day. • Count the hematology control every day with two pairs of samples which have no difference in stirring, hemolysing and temperature. • Store hematology control in optimum conditions. If the storage conditions of the hematology control are not optimum, hemolyzation or expansion of the blood cells will occur and _ abnormal data will be frequently obtained on the X and R graphs. • Do not use hematology control after the expiration date. If you use _ hematology control after the expiration date, the obtained X and R graphs are not reliable. _ _ Calculation of X and R X= X k X: Mean for one day X: Mean for k days R= R k R: Difference for one day R: Difference for k days _ Calculation of Upper and Lower Limits of X and R The upper and lower limits for quality control are statistically calculated as follows. The 3-sigma statistical method is used. Refer to a statistical reference book. If the hematology control is counted n (≥2) times every day, the upper and lower _ limits of X are as follows. 6.2 Operator's Manual MEK-6318J/K 6. QUALITY CONTROL Upper limit of X (UCL) = Lower limit of X (LCL) = = Standard deviation estimate u = Truth estimate The upper limit of R is as follows. Upper limit of R (UCL) = _ Relation between n and d2 (for X) or d2 and d3 (for R) Operator's Manual MEK-6318J/K n d2 1/d2 d3 2 1.128 0.8862 0.853 3 1.693 0.5908 0.888 4 2.059 0.4857 0.880 5 2.326 0.4299 0.864 6 2.534 0.3946 0.848 7 2.704 0.3698 0.833 8 2.847 0.3512 0.820 9 2.970 0.3367 0.808 10 3.078 0.3249 0.797 6.3 6. QUALITY CONTROL _ X-R Graph Example Following are example data and plotted graphs for RBC. Obtained Data Day X R 4.76 4.79 0.06 4.79 4.80 4.80 0.01 3 4.80 4.85 4.83 0.05 4 4.71 4.77 4.74 0.06 5 4.80 4.89 4.85 0.09 6 4.82 4.83 4.83 0.01 7 4.77 4.74 4.76 0.03 8 4.77 4.80 4.79 0.03 9 4.68 4.74 4.71 0.06 10 4.91 4.92 4.92 0.01 11 4.73 4.77 4.75 0.04 12 4.79 4.80 4.80 0.01 13 4.77 4.73 4.75 0.04 14 4.77 4.82 4.80 0.05 X = 4.794 R = 0.0393 First Second 1 4.82 2 n = 2, d2 = 1.128, d3 = 0.853 _ X graph: Upper limit of X 4.794 + 1.88 0.0393 4.868 Lower limit of X 4.794 1.88 0.0393 4.720 R graph: Upper limit of R 3.27 0.0393 0.129 6.4 Operator's Manual MEK-6318J/K 6. QUALITY CONTROL Graph X for RBC 4.90 Upper limit of X 4.80 X: Mean of all X values Lower limit of X 4.70 Graph R for RBC Upper limit of R 0.10 0.05 R: Mean of all R values 0 Operator's Manual MEK-6318J/K 6.5 6. QUALITY CONTROL _ How to Read the X-R Graph Refer to the “Data Outside the Limits” section when these plots appear. • The plot is out of the upper or lower limit. _ • The X plot goes to the plus side or minus side. • The plot gradually increases or decreases. • The plot shows a repeated periodic variation. • The plot is close to the upper or lower limit. Data Outside the Limits _ Normally, each data plotted on the X and R graphs varies within the range between _ the upper and lower limits of X, and between zero and upper limit of R, _ respectively. (See the X and R graphs on the previous page.) If the data exceeds an upper/lower limit, it may be caused by the following. _ X Graph: • Diluent, hemolysing reagent or hematology control chemically degraded or past the expiration date. This can be caused by change of environmental conditions such as humidity or room temperature or unsuitable storage conditions. • Composition difference between different production lots of hematology control. • Instrument trouble. 6.6 Operator's Manual MEK-6318J/K 6. QUALITY CONTROL R Graph: • Insufficient hematology control stirring. • Temperature variation of diluent. • Dirty fluid path such as aperture, manometer, measurement baths or sub baths. • Instrument trouble such as dilution ratio error or circuit error. Counting the Hematology Control To ensure accuracy, observe the following cautions. CAUTION • Perform the quality control measurement at a fixed time every day. • Count the hematology control every day with two pairs of samples which have no difference in stirring, hemolysing and temperature. • Store hematology control in optimum conditions. If the storage conditions of the hematology control are not optimum, hemolyzation or expansion of the blood cells will occur and _ abnormal data will be frequently obtained on the X and R graphs. • Do not use hematology control after the expiration date. If you use _ hematology control after the expiration date, the obtained X and R graphs are not reliable. 08-DEC-98 10:30 ENTER ID 1. Press the QC key on the MENU screen to display the QC screen. MENU QC CALIBRATION SETTINGS DATA OTHER EDIT ID OK _ _ 2. Press the X-R key on the QC screen to display the X-R screen. 08-DEC-98 10:30 QC 08-DEC-98 10:30 X R Count hematology control twice. X-R XB XD CV OK Operator's Manual MEK-6318J/K FIRST SECOND X R WBC RBC HGB HCT MCV MCH MCHC PLT LY% MO% GR% RDW PCT MPV PDW OK PRINT HISTORY 6.7 6. QUALITY CONTROL 3. Count the hematology control twice by following the procedure in “Counting the Hematology Control” in Section 2. 08-DEC-98 10:30 X R _ After counting, the X and R data appear on the screen. Count hematology control twice. WBC RBC HGB HCT MCV MCH MCHC PLT LY% MO% GR% RDW PCT MPV PDW SECOND 7.2 4.47 13.5 40.5 91 30.2 33.3 252 31.0 2.3 66.7 12.5 0.14 5.8 16.6 FIRST 7.3 4.49 13.5 40.9 91 30.1 33.0 253 30.0 2.2 67.8 12.5 0.15 5.9 16.7 OK X 7.3 4.46 13.5 40.7 91 30.2 33.2 253 30.5 2.3 67.2 12.5 0.15 5.9 16.7 PRINT R 0.1 0.02 0.0 0.4 0 0.1 0.3 1 1.0 0.1 1.1 0.0 0.01 0.1 0.1 HISTORY _ To print the displayed X-R data, press the PRINT key. _ To display or print the history of X-R data, refer to the “Displaying and _ Printing the Stored X-R Data” section. _ 4. Press the OK key on the X-R screen to return to the QC screen. 5. Press the OK key on the QC screen to return to the MENU screen. Displaying _ and Printing Stored X-R Data _ _ You can display and print 3 days of X-R data. The last 14 days of X-R data is saved in memory. _ To print the stored X-R data, WIDE must be selected for PAPER on the PRINT SETTINGS screen of the SETTINGS screen. NOTE _ The stored X-R data cannot be printed on the WA-630VK printer unit. 08-DEC-98 10:30 X R Count hematology control twice. WBC RBC HGB HCT MCV MCH MCHC PLT LY% MO% GR% RDW PCT MPV PDW SECOND 7.2 4.47 13.5 40.5 91 30.2 33.3 252 31.0 2.3 66.7 12.5 0.14 5.8 16.6 FIRST 7.3 4.49 13.5 40.9 91 30.1 33.0 253 30.0 2.2 67.8 12.5 0.15 5.9 16.7 OK 08-DEC-98 DATE X-R WBC RBC HGB HCT MCV MCH MCHC PLT LY% MO% GR% OK X 7.3 4.46 13.5 40.7 91 30.2 33.2 253 30.5 2.3 67.2 12.5 0.15 5.9 16.7 PRINT HISTORY X R 10:30 98/12/06 R X 0.2 7.4 0.02 4.47 0.1 13.6 0.1 38.9 1 87 0.1 30.2 0.3 34.5 2 247 0.8 28.0 0.3 3.2 0.9 68.8 BACK R 0.1 0.02 0.0 0.4 0 0.1 0.3 1 1.0 0.1 1.1 0.0 0.01 0.1 0.1 98/12/07 R X 0.1 7.2 4.46 0.03 0.2 13.2 0.1 40.1 2 89 0.4 30.5 0.2 35.2 4 245 0.4 27.2 0.3 3.1 0.6 69.7 NEXT 98/12/08 R X 0.2 7.3 4.42 0.02 0.1 13.4 0.3 38.7 1 87 0.2 30.8 0.4 35.8 3 242 0.6 28.5 0.2 3.4 0.5 68.1 PRINT _ 1. Press the QC key on the MENU screen, then press the X-R key on the QC _ screen to display the X-R screen. _ 2. Press the HISTORY key on the X-R screen. The latest 3 data is displayed. Use the BACK and NEXT keys to display the desired data. _ _ To print the displayed 3 day’s X-R data, press the PRINT key on the X-R screen. _ 3. Press the OK key on the X-R screen to return to the QC screen. DEL 4. Press the OK key on the QC screen to return to the MENU screen. 6.8 Operator's Manual MEK-6318J/K 6. QUALITY CONTROL _ Deleting the Stored X-R Data 08-DEC-98 10:30 X R Count hematology control twice. WBC RBC HGB HCT MCV MCH MCHC PLT LY% MO% GR% RDW PCT MPV PDW SECOND 7.2 4.47 13.5 40.5 91 30.2 33.3 252 31.0 2.3 66.7 12.5 0.14 5.8 16.6 FIRST 7.3 4.49 13.5 40.9 91 30.1 33.0 253 30.0 2.2 67.8 12.5 0.15 5.9 16.7 OK 08-DEC-98 DATE X-R WBC RBC HGB HCT MCV MCH MCHC PLT LY% MO% GR% OK 08-DEC-98 DATE X-R WBC RBC HGB HCT MCV MCH MCHC PLT LY% MO% GR% X 7.3 4.46 13.5 40.7 91 30.2 33.2 253 30.5 2.3 67.2 12.5 0.15 5.9 16.7 HISTORY 98/12/07 R X 0.1 7.2 4.46 0.03 0.2 13.2 0.1 40.1 2 89 0.4 30.5 0.2 35.2 4 245 0.4 27.2 0.3 3.1 0.6 69.7 98/12/08 R X 0.2 7.3 4.42 0.02 0.1 13.4 0.3 38.7 1 87 0.2 30.8 0.4 35.8 3 242 0.6 28.5 0.2 3.4 0.5 68.1 NEXT PRINT 98/12/06 R X 0.2 7.4 0.02 4.47 0.1 13.6 0.1 38.9 1 87 0.1 30.2 0.3 34.5 2 247 0.8 28.0 0.3 3.2 0.9 68.8 98/12/07 R X 0.1 7.2 4.46 0.03 0.2 13.2 0.1 40.1 2 89 0.4 30.5 0.2 35.2 4 245 0.4 27.2 0.3 3.1 0.6 69.7 _ 3. Press the DEL key on the X-R screen. The “Delete all data?” message appears. DEL X R 10:30 2. Press the HISTORY key. The latest 3 data is displayed. Use the BACK and NEXT keys to display the desired data. X R BACK _ 1. Press the QC key on the MENU screen, then press the X-R key on the QC _ screen to display the X-R screen. R 0.1 0.02 0.0 0.4 0 0.1 0.3 1 1.0 0.1 1.1 0.0 0.01 0.1 0.1 PRINT 10:30 98/12/06 R X 0.2 7.4 0.02 4.47 0.1 13.6 0.1 38.9 1 87 0.1 30.2 0.3 34.5 2 247 0.8 28.0 0.3 3.2 0.9 68.8 _ You can delete all stored X-R data. 98/12/08 R X 0.2 7.3 4.42 0.02 0.1 13.4 0.3 38.7 1 87 0.2 30.8 0.4 35.8 3 242 0.6 28.5 0.2 3.4 0.5 68.1 _ 4. Press the YES key to delete all stored X-R data. Data is deleted and the screen returns to the previous screen. To cancel deleting, press the CANCEL key. The screen returns to the previous screen. Delete all data? YES CANCEL _ 5. Press the OK key on the X-R screen to return to the QC screen. Operator's Manual MEK-6318J/K 6.9 6. QUALITY CONTROL _ _ XB (X Batch) Program General _ Overview of XB 20 sample data each of daily sample data are grouped into a batch and averaged. _ With the mean XB values, the precision in the system can be managed due to the extremely small physiological variation in red blood cell constants of MCV, MCH _ and MCHC. The XB values are hardly affected by differences between samples so they faithfully reflect the precision in the system. _ _ You can also use the XD•CV program in conjunction with the XB program. (Refer to _ the “XD•CV Program” section.) _ Calculation of XB This instrument automatically divides the daily sample data into batches of 20 samples each. Daily sample 20 samples 20 samples 20 samples 20 samples Batch 1 Batch 2 Batch 3 Batch 4 _ For each batch of 20 samples, the XB value is automatically calculated by the following equation. X (B, i) = X (B, i F = SGN [Xj 1) + SGN [F] X (B, i _ • X (B, i) = XB of present batch _ • X (B, i-1) = XB of previous batch 1)] 2 (F/N) Xj X (B, i 1) • Xj = Each data in batch • SGN [ ] = Sign function • N = Number of samples in batch _ _ The XB value of the previous batch is required to calculate XB of the present batch. _ There are two methods of obtaining the initial XB value of the batch before Batch 1. 1) Use the past obtained value for the same facility. 2) The simple method is to substitute the mean values of MCV, MCH and MCHC _ for each initial XB value of the batch before Batch 1. NOTE_ _ If the mean value is used as the initial XB value, the XB value to be obtained gradually comes closer to a real or true value as the samples increase in number. _ After about 100 samples are counted, the reliability of the XB value is ensured. Usually, the mean values are somewhere near these values: MCV : 89.5 MCH : 30.5 MCHC : 33.8 6.10 Operator's Manual MEK-6318J/K 6. QUALITY CONTROL _ Plot the XB values displayed on the screen. Management Initial value limit value _ The average of XB is used as the initial value. The initial value will also be determined by the facility or examination room staff. The management limit value should be determined by the facility or examination room staff. (For example, ±3% of the initial value.) _ This instrument provides continuous XB management of up to 20 batches (400 samples). When the number of samples reaches 400 and the table becomes full, do the follow procedures. _ 1) Use each XB data in the last batch as the initial value. _ 2) Change each initial value on the plotted graph to the mean XB. (The plotted graph is updated every 20 batches.) 3) Delete all the stored data to prevent data interference between the new and previous graphs. Refer to the “Deleting All Data” procedure in Section 5. CAUTION • This procedure deletes all stored data. _ • Each XB is calculated from all the samples that have RBC count 500,000/µ µL or more. Therefore, data of hematology control should be deleted beforehand. NOTE • When each mean value of MCV, MCH and MCHC is used as the initial _ _ value of XB, there is no reliability in the plotted graph until the XB value comes closer to the true value and becomes stable. _ • The management data for calibration and X-R data are excluded from the calculation. Operator's Manual MEK-6318J/K 6.11 6. QUALITY CONTROL _ Displaying and Printing XB Data _ To print the XB data, WIDE must be selected for PAPER on the PRINT SETTINGS screen of the SETTINGS screen. NOTE _ The XB data cannot be printed on the WA-630VK printer unit. 08-DEC-98 1. Press the QC key on the MENU screen to display the QC screen. MENU 10:30 ENTER ID QC CALIBRATION SETTINGS DATA OTHER EDIT ID OK 08-DEC-98 _ _ 2. Press the XB key on the QC screen to display the XB screen. QC 10:30 X-R XB XD CV OK 08-DEC-98 n MCV MCH MCHC 10:30 1-1 20 89.2 29.6 33.2 6-2 20 91.8 30.4 32.8 XB 11-3 20 91.3 30.1 31.8 *: 17-2 20 90.9 30.3 32.7 MEAN n MCV MCH MCHC PAGE OK NEXT IN ITIAL 1/2 PRINT Current memory location of the first sample in each batch. The first number is the page number, and the second number is the location on the page. For example, “6-2” indicates that the second sample in a batch is the second sample on page 6. See Section 5 to display a sample in memory. n: Number of samples in each batch _ Mean column: Averaged XB for parameter (MCV/MCH/MCHC) and total number of samples _ To display other stored XB data, press the NEXT key. To print the displayed data (maximum of 10 data), press the PRINT key. _ 3. Press the OK key on the XB screen to return to the QC screen. 4. Press the OK key on the QC screen to return to the MENU screen. 6.12 Operator's Manual MEK-6318J/K 6. QUALITY CONTROL _ Setting XB Initial Values 08-DEC-98 n MCV MCH MCHC 10:30 1-1 20 89.2 29.6 33.2 6-2 20 91.8 30.4 32.8 _ When the XB program is used for the first time, use the default values or the values _ _ you have in your facility as the XB initial values. When the table on the XB screen becomes full, write down the mean values on the screen, then delete all stored data by referring to “Deleting All Data” in Section 5. Then set mean values as the initial values as follows. 1. Press the QC key on the MENU screen to display the QC screen, then press the _ _ XB key on the QC screen to display the XB screen. XB 11-3 20 91.3 30.1 31.8 17-2 20 90.9 30.3 32.7 MEAN n MCV MCH MCHC P A GE OK NEXT IN ITIA L 1/2 PRINT _ When the table on the XB screen becomes full, perform the following operations and update the plotted graph every 20 batches. _ 1) Enter each XB value in the last batch as the initial value according to step 3 below. _ 2) Change the initial value on each plotted graph to the mean XB value. 3) Delete all the stored sample data. Refer to “Deleting All Data” in Section 5. _ 2. Press the INITIAL key on the XB screen. 08-DEC-98 Select item and enter the initial value. 3. Enter the initial values for each parameter. XB 10:30 VALUE [ ] MCV [ 89.0 ] 7 8 9 MCH [ 30.5 ] 4 5 6 MCHC [ 33.8 ] 1 2 3 0 . CE OK i) Press the MCV, MCH or MCHC key to select the parameter. ii) Enter the value with the numeric keys on the screen. iii) Press the ENTER key on the screen to register the value. ENTER iv) Repeat steps i) to iii) to set another item. _ 4. After setting the values, press the OK key to return to the XB screen. _ 5. Press the OK key on the XB screen to return to the QC screen. 6. Press the OK key on the QC screen to return to the MENU screen. Operator's Manual MEK-6318J/K 6.13 6. QUALITY CONTROL _ XD•CV Program General This program automatically calculates the following values from the daily sample of the last 3 days data within the normal range for each parameter. _ _ XD: X Daily mean value of daily sample data CV: Coefficient of Variation (%) CV = Standard deviation 100 (%) XD Standard deviation = (X X) N 1 2 X = average X = measured value N = measured times _ Uses of the XD•CV Program _ • To determine the mean values of MCV, MCH and MCHC for the XB program _ Use the total average of XD values obtained in facilities as the mean value of the _ MCV/MCH/MCHC parameter for the XB “initial value”. This program provides precision management including variation for the facility or medical subject _ upon starting the XB program. • Basic data for quality control The physiological variation of the mean corpuscular constant is stable, so that _ the XD•CV value can be used for quality control. _ The XD•CV value calculated from the same sample or hematology control will be an index for reproducibility. • Various statistical calculations The data distribution area to be calculated can be individually specified for each parameter (related to the normal range setting), so that various statistical calculations such as determination of the specific normal range in the facility can be performed with this program. 6.14 Operator's Manual MEK-6318J/K 6. QUALITY CONTROL Displaying and Printing _ XD•CV Data _ To print the stored XD•CV data, WIDE must be selected for PAPER on the PRINT SETTINGS screen of the SETTINGS screen. NOTE _ The stored XD•CV data cannot be printed on the WA-630VK printer unit. 08-DEC-98 MENU 10:30 ENTER ID 1. Press the QC key on the MENU screen to display the QC screen. QC CALIBRATION SETTINGS DATA OTHER EDIT ID OK 08-DEC-98 QC 10:30 _ _ 2. Press the XD•CV key on the QC screen to display the XD•CV screen. X-R XB XD CV OK 08-DEC-98 10:30 98/12/07 98/12/06 DATE 12 19 n CV CV X X 1.2 7.8 16.9 7.8 WBC 8.5 5.02 9.1 4.92 RBC 13.7 11.2 14.2 10.9 HGB 40.1 12.0 41.0 12.6 HCT 3.5 3.2 86 87 MCV 3.7 29.5 4.1 29.3 MCH 3.4 34.2 3.6 MCHC 34.3 246 28.2 243 29.1 PLT 35.7 20.7 34.7 22.4 LY% 4.6 42.3 5.5 38.4 MO% 61.9 14.1 58.0 15.2 GR% 3.6 12.9 5.3 16.1 RDW 0.23 16.9 0.27 17.1 PCT 9.0 8.8 9.4 9.2 MPV 3.6 15.2 16.1 3.5 PDW OK XD 98/12/08 24 CV X 8.2 16.5 8.7 4.88 13.9 10.3 40.7 11.8 3.1 86 3.2 29.1 4.1 34.7 251 27.6 35.2 18.2 4.6 36.5 57.0 14.8 5.7 13.3 0.24 16.6 9.3 9.8 3.8 15.7 CV TOTAL 55 CV X 7.9 16.9 8.8 4.94 14.0 10.8 40.6 12.1 3.3 86 3.7 29.3 3.6 34.4 247 28.3 35.2 20.6 4.9 39.1 57.3 14.7 5.5 13.1 0.25 16.9 9.0 9.5 3.6 15.6 PRINT Data for the latest 3 days is displayed. n: Number of samples which have all the parameters within the normal range. _ To print the displayed data, press the PRINT key on the XD•CV screen. _ 3. Press the OK key on the XD•CV screen to return to the QC screen. 4. Press the OK key on the QC screen to return to the MENU screen. Operator's Manual MEK-6318J/K 6.15 Section 7 Calibration General .............................................................................................................................. 7.1 Calibration Methods Using Calibrator .............................................................. 7.2 Calibration ID .................................................................................................. 7.2 Calibration with Hematology Control .................................................................................... 7.3 Calibration in Venous Mode ....................................................................................... 7.3 Precise Method ............................................................................................... 7.3 Simple Method ................................................................................................ 7.4 Calibration in Capillary Blood Mode ........................................................................... 7.5 HGB/HCT Calibration with Human Blood ............................................................................. 7.7 General ...................................................................................................................... 7.7 Measurement with the Instrument ............................................................................. 7.7 HGB Measurement with a Spectrophotometer .......................................................... 7.7 HCT Measurement with a Microhematocrit Centrifuge ............................................... 7.8 Determining the HGB and HCT Calibration Coefficient .............................................. 7.8 Hemoglobin Conversion Table (g/dL ↔ %SAHLI) ..................................................... 7.10 Displaying and Printing Calibration Data History ................................................................ 7.11 Displaying Calibration Data History ......................................................................... 7.11 Printing Calibration Data History ............................................................................. 7.12 Deleting Calibration Data History ............................................................................. 7.12 Operator's Manual MEK-6318J/K 7.C1 7. CALIBRATION General When the instrument electrically measures data, the calibration coefficient is used in converting the data to the measured values to make the measured values as close as possible to the real values. Perform calibration when the quality control result is not optimum. Calibration can be performed for the following parameters in venous blood mode and capillary blood mode individually. • • • • • • • • • • WBC RBC HGB HCT MCV PLT LY% MO% RDW MPV When MCV is calibrated, the HCT calibration coefficient also changes. Calibration can be performed using the MEK-3DN hematology control as calibrator. Calibration can also be performed using human blood. Locally available calibrator can also be used. For details, contact your Nihon Kohden distributor. Calibration Methods Using Calibrator There are two methods of calibration. • Precise Method In the precise method, the calibrator is counted 3 times in double counting mode and the average value and assay sheet value are used for calculating the new calibration coefficient. • Simple Method In the simple method, the calibrator is counted 3 times in double counting mode and the acquired data and assay sheet value are used. There is no calculation involved. For measurement accuracy, we recommend the precise method. NOTE • Do not use MEK-5DN hematology control as a calibrator. • Calibrator MEK-3DN is for accuracy control of hematology analyzer Operator's Manual MEK-6318J/K 7.1 7. CALIBRATION refined from normal human blood. Treat and store the calibrator properly following the instruction described in the assay sheet because the calibrator contains living cells. • Perform the calibration again if there is a difference with the reference method. Calculate the new calibration coefficient for each parameter from the mean value of measured data. Calibration ID A 4-digit calibration ID (CAL ID), can be assigned to the calibration data. The CAL ID does not automatically increment. You must change the CAL ID before performing calibration. To set the CAL ID, press the ID key on the CAL screen and enter the number with the numeric keys. 7.2 Operator's Manual MEK-6318J/K 7. CALIBRATION Calibration with Hematology Control CAUTION • Use calibrator which is before the expiration date. • Do not use calibrator when the top layer is slightly red or the whole calibrator is red, because the red blood cells in the calibrator are hemolysed. • Do not freeze the calibrator because this will hemolyse it. • Use and store the calibrator with extreme care according to its instructions. Calibration in Venous Mode Precise Method 1. Press the CALIBRATION key on the MENU screen to display the CAL (NORMAL) screen. 08-DEC-98 08-DEC-98 MENU 10:30 ENTER ID QC 10:30 CAL (NORMAL) WBC [ ] [ 1025 ] RBC [ ] [ 1060 ] [ ] [ CALIBRATION SETTINGS HGB HCT [ ] [ 1050 ] DATA OTHER MCV [ ] MCHC PLT OK [ OK ] [ 1130 ] NEXT [ 0001 ] ] 960 ] MCH EDIT ID ID VALUE [ CAP 7 8 9 4 5 6 1 2 3 . CE 0 ENTER 2. Count the calibrator 3 times in double counting mode by following the procedure in “Counting Hematology Control” in Section 2. Make sure that the CALIBRATION screen is displayed when counting the calibrator for calibration. 08-DEC-98 ( ( WBC 100 200 5) 4) 300 ( 5) (AUTO) RBC 100 200 ( PLT 2 CAL ID 10:30 10 5) WBC RBC HGB HCT MCV MCH MCHC PLT LY MO GR EO RDW PCT MPV PDW 7.5 5.45 14.8 46.4 85.1 27.2 31.9 638 [%] 32.0 6.4 61.6 11.9 0.24 6.6 15.6 0001 10 3 / 10 6 / g/dL % fL pg g/dL 10 3 / [ 10 3 / 2.4 0.5 4.6 <0.7 % % fL % uL uL uL uL ] 20 MENU The measurement result appears on the CAL result screen. CALIBRATION Operator's Manual MEK-6318J/K 3. Calculate the mean value of the three mean data. NOTE If one of the three mean data is extremely different from the other two, count the fourth sample of the calibrator in double counting mode. Use the three mean data which are closest to each other. 7.3 7. CALIBRATION 4. Calculate the new calibration coefficient for each parameter from the mean value according to the equation below. New Calibration Coefficient = Previous Calibration Coefficient × Calibrator assay value Mean measured value 08-DEC-98 10:30 CAL (NORMAL) 7.3 ] [ 1025 ] WBC [ RBC [ 4.47 ] [ 1060 ] HGB [ 13.6 ] [ HCT [ 38.9 ] [ 1050 ] ID [ 0001 ] VALUE [ ] 960 ] 7 8 9 5 6 NOTE Write down the current settings before changing them. MCV [ 87.0 ] 4 MCH 30.4 1 2 3 MCHC 35.0 0 . CE PLT [ 253 ] [ 1130 ] NEXT OK 5. Press the CALIBRATION key on the CAL result screen. The CAL (NORMAL) screen appears. The latest measured values and previous calibration coefficient are displayed. When the CAL (CAPILLARY) screen is displayed, press the NORM key to display the CAL (NORMAL) screen. ENTER CAP Calibration coefficient column Measured value column 6. Select the parameter you want to calibrate by pressing the parameter key on the screen. Pressing the parameter key moves the cursor between the measured value and the calibration coefficient. To display other parameters, press the NEXT key. 08-DEC-98 WBC [ 10:30 CAL (NORMAL) 7.3 ] [ 1025 ] RBC [ 4.47 ] [ 1060 ] HGB [ 13.6 ] [ HCT [ 38.9 ] [ 1050 ] MCV ID [ 0001 ] VALUE [ ] 960 ] 7 8 9 [ 87.0 ] 4 5 6 MCH 30.4 1 2 3 MCHC 35.0 0 . CE PLT [ 253 ] [ 1130 ] NEXT OK 7. Use the numerical keys on the screen to enter the new calibration coefficient you calculated in step 4. The setting range for calibration coefficient is from 100 to 2000. If you make a mistake entering numerical data, press the CE key on the screen to delete the mistake. ENTER CAP 8. Press the ENTER key on the screen to register the value. 9. Repeat steps 6 to 8 to change the calibration coefficient for other parameters. 10. Press the OK key on the CAL (NORMAL) screen to return to the MENU screen. 08-DEC-98 10:30 CAL (NORMAL) 7.3 ] [ 1025 ] WBC [ RBC [ 4.47 ] [ 1060 ] HGB [ 13.6 ] [ ID [ 0001 ] VALUE [ ] 960 ] HCT [ 38.9 ] [ 1050 ] 7 8 9 MCV [ 87.0 ] 4 5 6 MCH 30.4 1 2 3 MCHC 35.0 . CE PLT OK 7.4 [ 253 ] NEXT Simple Method 1. Press the CALIBRATION key on the MENU screen to display the CAL (NORMAL) screen. [ 1130 ] CAP 0 2. Count the calibrator 3 times in double counting mode by following the procedure in “Counting the Hematology Control” in Section 2. ENTER Operator's Manual MEK-6318J/K 7. CALIBRATION 08-DEC-98 ( ( WBC 100 200 5) 4) 300 ( 5) (AUTO) RBC 100 200 ( PLT 2 CAL ID 10:30 10 5) LY MO GR EO RDW PCT MPV PDW 0001 10 3 / 10 6 / g/dL % fL pg g/dL 10 3 / [ 10 3 / 2.4 0.5 4.6 <0.7 % % fL % 7.5 5.45 14.8 46.4 85.1 27.2 31.9 638 [%] 32.0 6.4 61.6 11.9 0.24 6.6 15.6 uL uL uL uL ] 3. Check that the obtained 3 data are not extremely different from each other. If the data are extremely different from each other, refer to “Inaccurate Counting and Other Problems” in Section 8 and do the countermeasure. Then, count the calibrator 3 times again. 20 MENU 08-DEC-98 WBC WBC RBC HGB HCT MCV MCH MCHC PLT [ CALIBRATION 10:30 CAL (NORMAL) 7.3 ] [ 1025 ] RBC [ 4.47 ] [ 1060 ] HGB [ 13.6 ] [ HCT [ 38.9 ] [ 1050 ] ID [ 0001 ] VALUE [ ] 960 ] 7 8 9 4. Press the CALIBRATION key on the CAL result screen. The CAL (NORMAL) screen appears. The latest measured values and previous calibration coefficient are displayed. MCV [ 87.0 ] 4 5 6 NOTE MCH 30.4 1 2 3 MCHC 35.0 Write down the current settings before changing them. 0 . CE PLT OK [ 253 ] NEXT [ 1130 ] CAP ENTER When the CAL (CAPILLARY) screen is displayed, press the NORM key to display the CAL (NORMAL) screen. 5. Select the parameter you want to calibrate by pressing the parameter key on the screen. The cursor appears in the measured value column (left) on the screen. 6. Change the measured value to the assay value on the assay sheet with the numerical keys on the screen. The calibration coefficient automatically changes. 7. Repeat steps 5 and 6 to change the calibration coefficient for other parameters. 8. Press the OK key on the CAL (NORMAL) screen to return to the MENU screen. Calibration in Capillary Blood Mode When calibration is performed in venous blood mode, the new calibration coefficient is applied to the capillary blood mode. However, because the capillary blood samples are diluted manually, the obtained data may differ from the data obtained in the venous blood mode. In such a case, perform calibration in capillary blood mode. Calibration in venous blood mode must be checked before performing calibration in capillary blood mode. The relationship between the calibration coefficient in capillary blood mode and the measured value is shown in the equation below. Measured value in capillary blood mode = Measured value in venous blood mode × Operator's Manual MEK-6318J/K Capillary blood mode calibration coefficient 1000 7.5 7. CALIBRATION 08-DEC-98 WBC [ 10:30 CAL (CAPILLARY) 7.3 ] [ 1025 ] RBC [ 4.47 ] [ 1060 ] HGB [ 13.6 ] [ ID [ 0001 ] VALUE [ ] 960 ] HCT [ 38.9 ] [ 1050 ] 7 8 9 MCV [ 87.0 ] 4 5 6 MCH 30.4 1 2 3 MCHC 35.0 0 . CE PLT OK [ 253 ] NEXT [ 1130 ] NORM ENTER Calibration procedure is exactly the same as in venous blood mode, except for the mode in which you count the calibrator and the screen where you change the calibration coefficient. Count the calibrator in the capillary blood mode and change the calibration coefficient for the capillary mode on the CAL (CAPILLARY) screen. To count the calibrator in the capillary blood mode, refer to “Measuring a Capillary Sample” in Section 4 and “Counting the Hematology Control” in Section 2. To display the CAL (CAPILLARY) screen, press the CAP key on the CAL (NORM) screen. 7.6 Operator's Manual MEK-6318J/K 7. CALIBRATION HGB/HCT Calibration with Human Blood General When calibrating with human blood, use both of the following two measurement methods. 1. Measurement with the instrument 2. Measurement with a spectrophotometer and microhematocrit centrifuge Calculate the HGB/HCT value with these methods and then calculate the calibration coefficient. NOTE The accuracy in the measurement with the spectrophotometer and microhematocrit centrifuge depends on the processes, i.e. sampling, diluting and stirring. Perform the processes carefully. Measurement with the Instrument 1. Prepare 10 venous blood samples from a healthy person. 2. Count each sample in double counting mode. HGB Measurement with a Spectrophotometer 1. Prepare the diluent with hemolysing reagent specified by International Committee for Standardization in Hematology (ICSH). 2. Make a pair of two 200:1 diluted samples from each sample prepared in step 1 in the “Measurement with the Instrument” section. 3. Set up the spectrophotometer as follows. Wavelength: Approx. 540 nm Mode: ABS (absorbance) mode 4. Measure the optical density (OD) value of pair of each diluted samples with the spectrophotometer. 5. Calculate the mean value of each pair of samples. 6. Multiply each mean value by 29.3 to obtain the HGB value in the manual measurement. 64458: Molecular weight of HGB 64458 200 29.3 = 200: Dilution ratio 44 1000 1 10 44: Optical density coefficient in mm mol Operator's Manual MEK-6318J/K 1000: from mg to g 1: Cell thickness (cm) 10: from g/L to g/dL 7.7 7. CALIBRATION HCT Measurement with a Microhematocrit Centrifuge 1. Aspirate the whole blood sample into two-thirds of the capillary tube. 2. Wipe away any blood from the outside of the tube with paper or gauze. 3. Seal the ends of the tubes (blood aspiration side) with putty. 4. Set the microhematocrit centrifuge for 11,000 rpm for 5 minutes. 5. Rotate the tube in the centrifuge. 6. Immediately after rotation stops, measure the length of each layer. Putty RBC B WBC PLT Capillary tube A 7. Calculate each HCT according to the following formula. HCT= B A 100 (%) 8. Calculate the mean value of the two HCT values. Determining the HGB and HCT Calibration Coefficient 1. Fill in each blank in the following table to obtain the HCT calibration coefficient. NOTE Whenever calibrating the HGB/HCT, write down the current calibration coefficient on the table because the coefficient shows the variation of the precision in the instrument. 7.8 Operator's Manual MEK-6318J/K 7. CALIBRATION Sample No. Manual Measurement (M) Manual Measurement (I) Data = I−M × 100 (%) M 1 2 3 4 5 6 7 8 9 10 Mean among the 8 data excluding the highest one data and lowest one data (A) (%) Current calibration coefficient (B) Revised calibration coefficient (C) C = B × (1− A ) 100 2. Calibrate the instrument by changing the calibration coefficient setting to the revised calibration coefficient (C) in the table above. 08-DEC-98 WBC [ 10:30 CAL (NORMAL) 7.3 ] [ 1025 ] RBC [ 4.47 ] [ 1060 ] HGB [ 13.6 ] [ ID [ 0001 ] VALUE [ ] 960 ] 7 8 9 5 6 HCT [ 38.9 ] [ 1050 ] MCV [ 87.0 ] 4 MCH 30.4 1 2 3 MCHC 35.0 0 . CE PLT OK [ 253 ] NEXT [ 1130 ] CAP ENTER i) Press the CALIBRATION key on the MENU screen to display the CAL (NORMAL) screen. NOTE Write down the current settings before changing them. ii) Select the parameter you want to calibrate by pressing the parameter key on the screen. Pressing the parameter key moves the cursor between the measured value and the calibration coefficient. To display other parameters, press the NEXT key. iii) Use the numerical keys on the screen to enter the new calibration coefficient in the VALUE box. iv) Press the ENTER key on the screen to register the value. Operator's Manual MEK-6318J/K 7.9 7. CALIBRATION Hemoglobin Conversion Table (g/dL ↔ %SAHLI) The instrument displays the obtained data for hemoglobin in g/dL. To convert the data to %SAHLI units, use the following table. g/dL % SAHLI g/dL % SAHLI g/dL % SAHLI g/dL % SAHLI g/dL % SAHLI g/dL % SAHLI g/dL % SAHLI g/dL % SAHLI 5.0 31.3 7.0 43.8 9.0 56.3 11.0 68.8 13.0 81.3 15.0 93.8 17.0 106.3 19.0 118.8 5.1 31.9 7.1 44.4 9.1 56.9 11.1 69.4 13.1 81.9 15.1 94.4 17.1 106.9 19.1 119.4 5.2 32.5 7.2 45.0 9.2 57.5 11.2 70.0 13.2 82.5 15.2 95.0 17.2 107.5 19.2 120.0 5.3 33.1 7.3 45.6 9.3 58.1 11.3 70.6 13.3 83.1 15.3 95.6 17.3 108.1 19.3 120.6 5.4 33.8 7.4 46.3 9.4 58.8 11.4 71.3 13.4 83.8 15.4 96.3 17.4 108.8 19.4 121.3 5.5 34.4 7.5 46.9 9.5 59.4 11.5 71.9 13.5 84.4 15.5 96.9 17.5 109.4 19.5 121.9 5.6 35.0 7.6 47.5 9.6 60.0 11.6 72.5 13.6 85.0 15.6 97.5 17.6 110.0 19.6 122.5 5.7 35.6 7.7 48.1 9.7 60.6 11.7 73.1 13.7 85.6 15.7 98.1 17.7 110.6 19.7 123.1 5.8 36.3 7.8 48.8 9.8 61.3 11.8 73.8 13.8 86.3 15.8 98.8 17.8 111.3 19.8 123.8 5.9 36.9 7.9 49.4 9.9 61.9 11.9 74.4 13.9 86.9 15.9 99.4 17.9 111.9 19.9 124.4 6.0 37.5 8.0 50.0 10.0 62.5 12.0 75.0 14.0 87.5 16.0 100.0 18.0 112.5 20.0 125.0 6.1 38.1 8.1 50.6 10.1 63.1 12.1 75.6 14.1 88.1 16.1 100.6 18.1 113.1 20.1 125.6 6.2 38.8 8.2 51.3 10.2 63.8 12.2 76.3 14.2 88.8 16.2 101.3 18.2 113.8 20.2 126.3 6.3 39.4 8.3 51.9 10.3 64.4 12.3 76.9 14.3 89.4 16.3 101.9 18.3 114.4 20.3 126.9 6.4 40.0 8.4 52.5 10.4 65.0 12.4 77.5 14.4 90.0 16.4 102.5 18.4 115.0 20.4 127.5 6.5 40.6 8.5 53.1 10.5 65.6 12.5 78.1 14.5 90.6 16.5 103.1 18.5 115.6 20.5 128.1 6.6 41.3 8.6 53.8 10.6 66.3 12.6 78.8 14.6 91.3 16.6 103.8 18.6 116.3 20.6 128.8 6.7 41.9 8.7 54.4 10.7 66.9 12.7 79.4 14.7 91.9 16.7 104.4 18.7 116.9 20.7 129.4 6.8 42.5 8.8 55.0 10.8 67.5 12.8 80.0 14.8 92.5 16.8 105.0 18.8 117.5 20.8 130.0 6.9 43.1 8.9 55.6 10.9 68.1 12.9 80.6 14.9 93.1 16.9 105.6 18.9 118.1 20.9 130.6 7.10 Operator's Manual MEK-6318J/K 7. CALIBRATION Displaying and Printing Calibration Data History The current and previous calibration status and calibration coefficients can be displayed and printed. The calibration data can only be printed on the external printer. (Cannot be printed on the WA-630VK printer unit or card printers.) When the instrument is calibrated, all calibration data is automatically stored. Up to 13 data can be stored. This function is useful for checking trends of variation in the precision and to find any failure point if the instrument has trouble. If you start using a different hematology control, delete all the previous data on the CAL HISTORY screen. Displaying Calibration Data History 08-DEC-98 1. Press the OTHER key on the MENU screen to display the OTHER screen. MENU 10:30 ENTER ID QC CALIBRATION SETTINGS DATA OTHER EDIT ID OK 08-DEC-98 OTHER 10:30 CAL HISTORY TRANSFER DAY OPER HISTORY PRIME CIRCUIT CHECK DRAIN BATHS PRINT DAY DRAIN ALL MAINTENANCE OK 08-DEC-98 DATE 98/02/11 98/05/12 98/08/10 98/11/13 NORM CAL HISTORY 10:30 ID 0001 0002 0003 0003 2. Press the CAL HISTORY key on the OTHER screen to display the NORM CAL HISTORY screen. WBC 1023 1031 1019 1025 RBC 1065 1063 1058 1070 HGB 972 977 983 975 HCT 1031 1026 1029 1035 PLT 966 972 981 978 To display the capillary blood calibration data history, press the CAP key on the NORM CAL HISTORY screen. To return to the NORM CAL HISTORY screen, press the NORM key on the CAP CAL HISTORY screen. OK CAP PRINT DELETE ID: CAL ID Operator's Manual MEK-6318J/K 7.11 7. CALIBRATION 3. Press the OK key on the CAL HISTORY screen to return to the OTHER screen. 4. Press the OK key on the OTHER screen to return to the MENU screen. Printing Calibration Data History To print the calibration data history, WIDE must be selected for PAPER on the PRINT SETTINGS screen of the SETTINGS screen. NOTE The calibration data history cannot be printed on the WA-630VK printer unit. 08-DEC-98 DATE 98/02/11 98/05/12 98/08/10 98/11/13 NORM CAL HISTORY 10:30 ID 0001 0002 0003 0003 WBC 1023 1031 1019 1025 RBC 1065 1063 1058 1070 HGB 972 977 983 975 HCT 1031 1026 1029 1035 PLT 966 972 981 978 1. Display the CAL HISTORY screen by following the procedure in the “Displaying Calibration Data History” section. 2. Press the PRINT key on the CAL HISTORY screen to print the calibration history displayed on the screen. OK CAP PRINT DELETE Deleting Calibration Data History 08-DEC-98 DATE 98/02/11 98/05/12 98/08/10 98/11/13 OK 08-DEC-98 DATE 98/02/11 98/05/12 98/08/10 98/11/13 NORM CAL HISTORY 10:30 ID 0001 0002 0003 0003 WBC 1023 1031 1019 1025 RBC 1065 1063 1058 1070 CAP HGB 972 977 983 975 HCT 1031 1026 1029 1035 PRINT PLT 966 972 981 978 WBC 1023 1031 1019 1025 RBC 1065 1063 1058 1070 HGB 972 977 983 975 2. Press the DELETE key on the CAL HISTORY screen. A message appears. DELETE NORM CAL HISTORY 10:30 IDNO 0001 0002 0003 0003 1. Display the CAL HISTORY screen by following the procedure in the “Displaying Calibration Data History” section. HCT 1031 1026 1029 1035 PLT 966 972 981 978 3. Press the YES key to delete all data. Press the CANCEL key to cancel deleting data. The screen returns to the previous screen. Delete all NORMAL CAL history data? YES 7.12 CANCEL Operator's Manual MEK-6318J/K Section 8 Error Messages and Troubleshooting General ................................................................................................................................ 8.1 Error Messages at Power On or Before or After Counting .................................................... 8.2 Error Messages during Counting ......................................................................................... 8.3 System Error Messages ...................................................................................................... 8.4 Inaccurate Counting and Other Problems ............................................................................ 8.5 Operator's Manual MEK-6318J/K 8.C1 8. ERROR MESSAGES AND TROUBLESHOOTING General If a problem occurs, the built-in error detection function displays an error message with an alarm sound. The tables in the next section show the types of error messages, their causes and their countermeasures. Use them when an error message appears. There are two types of error messages: • Error message when turning the power on or before or after counting • Error message during counting CAUTION When an alarm occurs, the acquired data may not be correct, especially when “!” appears. Do not use the alarmed data. If the instrument detects an error, the error message appears on the screen with an alarm sound as shown below. <Example of error message at power on> 08-DEC-98 10:30 Press the CLEAN key. A:001 NO DILUENT MENU <Example of error message during measurement> 08-DEC-98 10:30 ( ( WBC 100 200 ( 5) (AUTO) 100 200 ( PLT 10 5) 0001 uL uL Error messages uL uL ] 20 MENU Operator's Manual MEK-6318J/K 5) 4) 300 RBC 2 ID WBC 7.5 10 3 / RBC 5.45 10 6 / g/dL HGB 14.8? % HCT 46.4 fL MCV 85.1 pg MCH 27.2 g/dL MCHC 31.9 10 3 / PLT NOISE 1 [%] [ 10 3 / 2.4 32.0 LY 0.5 6.4 MO 4.6 61.6 GR <0.7 EO % 11.9 RDW % 0.24 PCT fL 6.6 MPV % 15.6 PDW ENTER ID 8.1 8. ERROR MESSAGES AND TROUBLESHOOTING Error Messages at Power On or Before or After Counting Messages A:029 WBC PRIME ERROR A:049 RBC PRIME ERROR Insufficient diluent in the manometer or the connection tube is out of position. A:060 UPPER MANO ERR A:061 LOWER MANO ERR The manometer is dirty. A:005 CIRCUIT ERROR Error in the circuit. A:004 CHECK CONDITION SETTINGS A:009 PRINTER ERROR 8.2 Possible Cause/Criteria The stored data is lost when the backup battery loses its charge or electrical circuit is broken. If the message still appears after turning off the power and turning on again, the built-in battery needs replacement. The paper lever in the WA-630VK printer is up. A:001 NO DILUENT A:002 NO DETERGENT A:003 NO LYSING REAGENT Out of diluent, detergent or hemolysing reagent. A:010 NO PAPER No paper in the WA-630VK printer unit. Replace filters. The total counts reached 1000. Replace pump tube. The total counts reached 3000. Countermeasure Add the diluent or check that the connection tube is connected properly. Perform counting again after priming or cleaning the instrument. Check that the CLEANAC•3 detergent is connected to the instrument and press the clean key to perform cleaning. Check the internal circuit by referring to “Checking the Circuit” in Section 9. If an error is detected, refer to the Service Manual. Re-enter the calibration coefficient and all other settings. Then sample counting can be started. If the error still occurs, refer to the Service Manual. Contact your service personnel or your Nihon Kohden distributor for battery replacement. Press the paper lever down to hold the paper in place Replace the diluent, detergent or hemolysing reagent. Press the clean key to perform cleaning. Load the recording paper. 1. Replace the filters. 2. Reset the count number on the OPER HISTORY screen of the OTHER screen. 1. Replace the pump tube. 2. Reset the count number on the OPER HISTORY screen of the OTHER screen. Operator's Manual MEK-6318J/K 8. ERROR MESSAGES AND TROUBLESHOOTING Error Messages during Counting When CLOG, LEVEL, BUBBLE or NOISE occurs, the instrument counts up to 3 times, but if there is still an error, the instrument stops counting. Error Messages CLOG LEVEL 3 BUBBLE 1 BUBBLE 2 BUBBLE 3 BUBBLE 4 LEVEL 1 LEVEL 2 Possible Cause/Criteria The aperture is clogged. Air bubbles in manometer. Erroneous operation during counting. Countermeasure Press the clean key to perform cleaning. Then recount the sample. If the alarm still occurs, clean the aperture and replace the pump tube. Press the clean key to perform cleaning. Then recount the sample. Press the clean key to perform cleaning. Then recount the sample. Check the grounding, and separate the instrument from other equipment and their power sources. Then recount the sample. NOISE 1 NOISE 2 Noise is detected during counting. WBC 50? RBC 450? (? is displayed on the right side of the measured value.) Electrolyte solution resistance in and around the aperture exceeds a specified limit. Check that the temperature of the diluent is between 15 and 30°C. Then recount the sample. A:060 UPPER MANO ERR A:061 LOWER MANO ERR The manometer is dirty. Check that the CLEANAC•3 detergent is connected to the instrument and press the clean key to perform cleaning. The WBC measurement bath is dirty. Clean the measurement bath. HGB voltage adjustment error. Needs HGB voltage adjustment. Refer to the Service Manual. HGB circuit error. Needs measuring unit replacement. Refer to the Service Manual. HGB 13.4? (? is displayed on the right of HGB measured value.) HGB 13.4! (! is displayed on the right of HGB measured value.) HGB 13.4* (* is displayed on the right of HGB measured value.) MCHC 38.0! (! is displayed on the right of MCHC measured value.) WBC 90! (! is displayed on the right of WBC measured value.) WBC 90C PLT 4.9C (C is displayed on the right of WBC and PLT measured values.) A:001 NO DILUENT A:002 NO DETERGENT A:003 NO LYSING REAGENT A:010 NO PAPER Operator's Manual MEK-6318J/K Abnormal RBC. Error occurred when diluting the sample. WBC counting error. Poor hemolyzation. Check the instrument by counting the hematology control. Refer to “Counting the Hematology Control” in Section 2. Then recount the sample. WBC and PLT counting error. Platelet coagulated. Out of diluent, detergent or hemolysing reagent. Replace the diluent, detergent or hemolysing reagent. Press the clean key to perform cleaning. No paper in the WA-630VK printer unit. Load the recording paper. 8.3 8. ERROR MESSAGES AND TROUBLESHOOTING System Error Messages When there is a system error, the following messages are displayed. Refer to the Service Manual. • • • • • • • • • • • 8.4 E:001 DILUTER INITIALIZE ERROR E:002 BLOOD SAMPLING ERROR E:021 SAMPLER INITIALIZE ERROR E:022 SAMPLER RISING ERROR E:041 WBC SUB-BATH INITIALIZE ERROR E:061 RBC SUB-BATH INITIALIZE ERROR E:081 LYSE PUMP INITIALIZE ERROR E:082 LYSING REAGENT DISPENSING ERROR E:101 WASTE PUMP ERROR E:102 RINSE DRAINING ERROR E:121 A/D CIRCUIT ERROR Operator's Manual MEK-6318J/K 8. ERROR MESSAGES AND TROUBLESHOOTING Inaccurate Counting and Other Problems If operation is not accurate after attempting the countermeasures in the previous section, check the causes according to the following table. To check the electrical circuit, refer to “Checking the Circuit” in Section 9. Problem A Noise interference during counting B High background noise Possible Cause/Criteria 1. Insufficient grounding. 2. Equipment near the instrument is generating noise. 3. Noise in the power line. 4. The front cover is open. 1. Dirty diluent. 2. Dirty sub bath and/or measurement bath. 3. Dirty aperture. 4. Poor contact of external electrode to the socket of the instrument. 5. The fluid path is dirty. 6. Noise interference. 1. Insufficient stirring of sample. C Poor reproducibility of blood cell count 2. Dirty sub bath and/or measurement bath. 3. Dirty aperture. 4. High background noise. Countermeasure 1. Make sure the ground is sufficient. 2. Separate the instrument from other equipment and their power sources. 3. Use a different power line. 4. Close the front cover. 1. Replace the diluent. 2. Clean the sub bath and/or measurement bath. 3. Clean the aperture. 4. Firmly tighten the measurement bath. 5. Use the CLEANAC detergent and clean the fluid path by pressing the clean key. 6. Refer to Problem A. 1. Stir the sample sufficiently without creating bubbles. 2. Clean the sub bath and/or measurement bath. 3. Clean the aperture. 4. Reduce the background noise. Refer to Problem B. 1. Replace the pump tube. 2. Replace the filter. Clean the WBC measurement bath. Water leaks from inside the instrument Poor reproducibility of HGB value (Under influence of crosscontamination*) 1. Pump tube is broken. 2. Filter is clogged. The WBC measurement bath is dirty. F Incorrect LCD display Circuit error. G Instrument repeats same operation Press the reset key. If the problem still occurs, turn off the instrument, wait about 10 seconds, then turn it on again. 1. Paper is jammed. 2. Circuit error. 1. Remove the jammed paper. 2. Press the reset key. If the problem still occurs, turn off the instrument, wait about 10 seconds, then turn it on again. 1. Calibrate the touch screen function. D E H No printing I The touch screen keys do not function J Priming starts suddenly (When noise interferes with the instrument program, priming automatically starts and the READY screen appears.) 1. The pressed position and operating position do not match. 2. Circuit error. 1. Power cord is not connected properly. 2. Equipment near the instrument is generating noise. 3. Noise in the power line. 2. Press the reset key. If the problem still occurs, turn off the instrument, wait about 10 seconds, then turn it on again. 1. Connect the power cord properly. 2. Separate the instrument from other equipment and their power sources. 3. Use a different power line. * Cross-contamination: A small amount of sample from a previous counting is left in the fluid path and mixes with the next aspirated sample. This causes an error. Operator's Manual MEK-6318J/K 8.5 Section 9 Maintenance Periodic Check .................................................................................................................... 9.1 Checking the Circuit ............................................................................................................ 9.2 Disposing of Waste .............................................................................................................. 9.3 Battery Lifetime ................................................................................................................... 9.3 When the Battery Loses its Charge ................................................................. 9.3 How to Replace the Battery ............................................................................ 9.3 Disposing of Used Batteries ............................................................................ 9.3 Disinfecting and Cleaning the Outside of the Instrument ..................................................... 9.4 Disinfecting ............................................................................................................... 9.4 Cleaning .................................................................................................................... 9.4 Checking, Cleaning and Maintenance Schedule .................................................................. 9.5 Periodic Check and Maintenance .................................................................... 9.5 Maintenance when Problem Occurs ................................................................ 9.5 Maintenance Cleaning ......................................................................................................... 9.6 Displaying Operation History Screen ................................................................................... 9.7 General ...................................................................................................................... 9.7 Displaying the OPER HISTORY Screen .................................................................... 9.7 Resetting the Counts ................................................................................................. 9.8 Before Maintenance ............................................................................................................ 9.9 Checking, Cleaning or Replacing Filters ............................................................................ 9.10 Checking and Cleaning the Sub Baths and Measurement Baths ....................................... 9.12 Checking and Cleaning the Rinse Unit and Sampling Nozzles .......................................... 9.14 Checking and Replacing the Pump Tube ............................................................................ 9.16 Cleaning the Aperture Caps .............................................................................................. 9.19 Replacing the Sampling Nozzles ....................................................................................... 9.23 Calibrating Touch Screen ................................................................................................... 9.26 Removing the Jammed Paper from the WA-630VK Printer Unit ......................................... 9.27 Priming .............................................................................................................................. 9.28 Draining the Measurement and Sub Baths ........................................................................ 9.29 Draining the Instrument ..................................................................................................... 9.30 Storing and Transporting the Instrument ............................................................................ 9.31 Preparing the Instrument for Long Term Storage and Transport ............................... 9.31 Using the Instrument after Storage ......................................................................... 9.32 Preparing the Instrument for Short Term Transport .................................................. 9.33 Decontamination Protocol .................................................................................................. 9.34 Clock Accuracy ................................................................................................................. 9.36 Repair Parts Availability Policy .......................................................................................... 9.36 Operator's Manual MEK-6318J/K 9.C1 9. MAINTENANCE Periodic Check Check the following items every 6 months. • • • • • • • • • • • • • Operator's Manual MEK-6318J/K There are no scratches or dirt on the instrument. There is no leakage. The aperture caps are clean. The maintenance in the “Checking, Cleaning and Maintenance Schedule” section is properly performed. The messages are displayed properly. The touch screen keys operate properly. The printer works properly. The date and time are correct. The power cord and grounding lead are connected properly. The instrument is calibrated. The sensitivity and threshold settings are correct. The electrical circuit is checked. The background noise and accuracy are checked. 9.1 9. MAINTENANCE Checking the Circuit The electrical circuits can be checked daily with this check function. NOTE An error in the fluid path or manometer cannot be detected by this function. 08-DEC-98 1. Press the OTHER key on the MENU screen to display the OTHER screen. MENU 10:30 ENTER ID QC CALIBRATION SETTINGS DATA OTHER EDIT ID OK 08-DEC-98 CAL HISTORY TRANSFER DAY OPER HISTORY PRIME CIRCUIT CHECK DRAIN BATHS PRINT DAY DRAIN ALL 10:30 200 ( 5) (AUTO) 100 200 ( PLT 2 5) 4) 300 RBC 10 5) WBC RBC HGB HCT MCV MCH MCHC PLT 3 8 .0 OK 1 0 / 1 .6 0 OK 1 0 6 / 3 .0 0 OK V % 1 0 7 OK fL pg g /d L 1 6 0 OK 1 0 3 / [%] [103 / LY MO GR EO RDW PCT MPV PDW % % fL % HGB 0 .0 0 OK V 20 OK After checking, the result appears on the screen. CIRCUIT CHECK ( ( WBC 100 The CIRCUIT CHECK screen appears and the circuit check starts. The “CHECKING” message appears on the screen. MAINTENANCE OK 08-DEC-98 2. Press the CIRCUIT CHECK key on the OTHER screen. OTHER 10:30 uL uL uL uL] <Normal range> WBC: 8.0 (±5%) RBC: 1.60 (±5%) HGB: 1.5 to 4.5 V MCV: 107 (±15%) PLT: 160 (±5%) HGB (OFF): below 0.5 V For HGB, if the result is outside the normal range, the above circuit check should be performed again after cleaning the WBC measurement bath. If the check result subsequently goes out of the normal range, contact your Nihon Kohden distributor. 3. Press the OK key on the CIRCUIT CHECK screen to return to the OTHER screen. 4. Press the OK key on the OTHER screen to return to the MENU screen. 9.2 Operator's Manual MEK-6318J/K 9. MAINTENANCE Disposing of Waste Follow your local laws for disposing of medical waste. Battery Lifetime A small built-in battery backs up any stored data and setting conditions. Generally, the life of the built-in battery is about 6 years, but it may change depending on operating conditions. Refer to the Service Manual to replace the battery with a new one. CAUTION The battery should be replaced by qualified personnel. NOTE It is recommended to keep the calibration history. When the Battery Loses its Charge When the “CHECK CONDITION SETTINGS” message appears on the screen, turn off the power, then turn it on again. If the message still appears, the battery needs replacement. If the message does not appear, the battery can still be used. How to Replace the Battery Contact your service personnel or your Nihon Kohden distributor. The replacement procedure is described in the Service Manual. After replacing the battery, initialize the settings, calibrate the instrument and the touch screen function, and check the date and time settings. Disposing of Used Batteries Before disposing of the battery, check with your local solid waste officials for details in your area for proper disposal. It may be illegal to dispose of the battery into the municipal waste stream. Operator's Manual MEK-6318J/K 9.3 9. MAINTENANCE Disinfecting and Cleaning the Outside of the Instrument Do either of the following to turn the instrument power off before disinfecting or cleaning the instrument. ON • Press the main power switch on the rear panel. Check that the main power lamp on the front panel is off. OFF + • Press the power key on the front panel while pressing the reset key. Check that the power lamp on the front panel is off. (The main power lamp is still lit.) CAUTION • Be careful not to directly touch any place where blood is or may have contacted. • Protect yourself from infection before cleaning and doing maintenance. Disinfecting NOTE When using the CLEANAC•3 detergent in disinfection, wipe the instrument thoroughly with a cloth moistened with water just after disinfection. Wipe the instrument with a cloth moistened with alcohol. Cleaning CAUTION Never use organic solvents such as thinner or acetone because they damage the enclosure of the instrument. NOTE When wiping the instrument with a cloth moistened with water, wring out the cloth to prevent water from entering the instrument. 1. Dilute a neutral detergent with water. 2. Wipe off the dirt with a soft cloth moistened with the neutral diluted detergent. 3. Wipe the instrument with a dry cloth. 9.4 Operator's Manual MEK-6318J/K 9. MAINTENANCE Checking, Cleaning and Maintenance Schedule To keep the instrument in optimum condition, periodically check, clean and maintain it according to the following schedule. If an error is found during periodic check, clean or replace the item. You can use the OPER HISTORY screen to keep track of maintenance for filters and pump tube. CAUTION • Be careful not to directly touch any place where blood is or may have contacted. • Protect yourself from infection before cleaning and doing maintenance. NOTE When using Hemolynac•3N hemolysing reagent, make sure to clean the sub baths and measurement baths at the specified schedule because CLEANAC (MEK-520), which is used as a detergent for Hemolynac•3N, has low cleansing effect. Otherwise, reproducibility of the hemoglobin concentration may be lower than the real value. Periodic Check and Maintenance Maintenance Item Filters Sub baths and measurement baths Rinse unit and sampling nozzles Schedule Check every week or every 300 samples. Replace every 1000 samples. Check daily. Clean every month or every 1000 samples. Check and clean every month or every 1000 samples. Pump tube Check daily. Replace every 4 months or every 3000 samples. Aperture caps inside and manometer fluid path Clean every 6 months. Maintenance when Problem Occurs Maintenance Item Aperture caps Sampling nozzles Touch screen Printer Operator's Manual MEK-6318J/K Problem Clean when the CLOG or LEVEL 3 message appears frequently or background noise is high. Replace when clogged or bent. Calibrate touch screen when the pressed position and operating position do not match. Remove the paper when jammed. 9.5 9. MAINTENANCE Maintenance Cleaning Clean the inside of the hematology analyzer every 6 months. + 1. Press the Dispense key while pressing the Reset key on the front panel. The MAINTENANCE CLEANING screen is displayed. - MAINTENANCE CLEANING - Connect CLEANAC. 3 (MEK-620) to detergent inlet. Start Cleaning? (Cleaning takes about 20 minutes.) YES NO 2. Make sure that the CLEANAC•3 detergent is connected to the detergent inlet on the right panel and press the YES key to start cleaning the inside of the hematology analyzer. Press NO to cancel cleaning and return to the READY screen. The “Cleaning” message is displayed on the screen during cleaning and then, the “PRIMING” message is displayed on the screen during priming. The READY screen appears when cleaning is complete. 08-DEC-98 10:30 READY ID 0001 MENU 9.6 Operator's Manual MEK-6318J/K 9. MAINTENANCE Displaying Operation History Screen General You can display the total operating time, total number of counts, and number of counts that the filter and pump tube have been used. The first number after FILTER RESET and TUBE RESET shows the number of sample counts each item has been used for. The second number shows the sample count number when you should replace the item (filters 1000, pump tube 3000). When the filters and pump tube (consumables) are used more than the prescribed number of sample counts, the following messages appear on the READY screen. 08-DEC-98 10:30 READY ID 0001 MENU Check filters. Replace pump tube. When the message appears, replace the filters or pump tube. After replacing the item, reset the count on the OPER HISTORY screen. Displaying the OPER HISTORY Screen 08-DEC-98 10:30 ENTER ID 1. Press the OTHER key on the MENU screen to display the OTHER screen. MENU QC CALIBRATION SETTINGS DATA OTHER EDIT ID OK 08-DEC-98 10:30 OTHER CAL HISTORY TRANSFER DAY OPER HISTORY PRIME CIRCUIT CHECK DRAIN BATHS PRINT DAY DRAIN ALL OK 2. Press the OPER HISTORY key on the OTHER screen. The total operating time and number of counts times appear on the OPER HISTORY screen. MAINTENANCE Operator's Manual MEK-6318J/K 9.7 9. MAINTENANCE 08-DEC-98 10:30 TOTAL HOURS TOTAL COUNTS FILTER RESET OPER HISTORY 3. Press the OK key to return to the OTHER screen. 306 2604 176/ 1000 COUNTS 4. Press the OK key on the OTHER screen to return to the MENU screen. TUBE RESET 176/ 3000 COUNTS Version 01-01 OK Resetting the Counts 08-DEC-98 10:30 TOTAL HOURS TOTAL COUNTS FILTER RESET TUBE RESET OK OPER HISTORY 306 2604 176/ After replacing the filters and/or pump tube, reset the counts. 1. Display the OPER HISTORY screen by following the procedure in the “Displaying the OPER HISTORY Screen” section. 1000 COUNTS 176/ 3000 COUNTS Version 01-01 2. Press the FILTER RESET key to reset the filter counts. Press the TUBE RESET key to reset the pump tube counts. 3. Press the OK key on the OPER HISTORY screen to return to the OTHER screen. 4. Press the OK key on the OTHER screen to return to the MENU screen. 9.8 Operator's Manual MEK-6318J/K 9. MAINTENANCE Before Maintenance Before doing any maintenance inside the instrument, drain the baths as described in the following procedure. 1. Check that the CLEANAC•3 detergent is connected to the instrument and press the clean key on the front panel to clean the fluid path. NOTE CLEANAC detergent (MEK-520) contains no sodium hypochlorite. Use CLEANAC•3 detergent for cleaning the fluid path before maintenance because CLEANAC detergent has low cleansing effect. 08-DEC-98 MENU 10:30 ENTER ID 2. Press the OTHER key on the MENU screen to display the OTHER screen. QC CALIBRATION SETTINGS DATA OTHER EDIT ID OK 08-DEC-98 OTHER 10:30 CAL HISTORY TRANSFER DAY OPER HISTORY PRIME CIRCUIT CHECK DRAIN BATHS PRINT DAY DRAIN ALL OK 3. Press the DRAIN BATHS key on the OTHER screen to drain the measurement baths and sub baths. CAUTION Do not press the with fluid. clean key. Otherwise the instrument will be filled MAINTENANCE 4. When draining is complete, press the main power switch on the rear panel to turn the power off. The power lamp and main power lamp turn off. ON OFF + Operator's Manual MEK-6318J/K The power can also be turned off by pressing the power key while pressing the reset key. The power lamp on the front panel turns off but the main power lamp is still on. 9.9 9. MAINTENANCE Checking, Cleaning or Replacing Filters Check and clean the filters every week or every 300 sample counts. Replace them every 1000 sample counts. 1. Press the clean key on the front panel to clean the fluid path. NOTE Make sure that CLEANAC•3 detergent is connected to the detergent inlet. 08-DEC-98 OTHER 10:30 CAL HISTORY TRANSFER DAY OPER HISTORY PRIME CIRCUIT CHECK DRAIN BATHS PRINT DAY DRAIN ALL OK MAINTENANCE 2. Press the OTHER key on the MENU screen, then press the DRAIN BATHS key on the OTHER screen to drain the measurement baths and sub baths. CAUTION Do not press the with fluid. clean key. Otherwise the instrument will be filled 3. When draining is complete, press the main power switch on the rear panel to turn the power off. The power lamp and main power lamp are off. ON OFF + The power can also be turned off by pressing the power key while pressing the reset key. The power lamp on the front panel is off. (The main power lamp is still on.) 4. Remove the two screws on the right side of the front cover. 5. Open the front cover. 9.10 Operator's Manual MEK-6318J/K 9. MAINTENANCE 6. Remove the two filter joint assemblies by turning the tube connectors counterclockwise. Filter 7. Remove the filter from each assembly. Use tweezers to remove any dust from the filter. Rinse the filter with tap water to clean it. If it is still dirty, replace it with a new one. Filter 8. Reattach the filter joint assembly by turning the tube connector clockwise, so that the filter is held in position. NOTE • When attaching the filter joint assembly, be careful not to bend or damage the filter packing S at the bottom of the measurement bath. • When there is a leakage, check that there is no scratch or damage to the circumference of the filter. 9. Close the front cover and fasten it with the two screws which were removed in step 4. 10. Turn the power on. NOTE When using Hemolynac•3N hemolysing reagent, change the detergent to CLEANAC (MEK-520) before turning the power on. Press the Clean key on the front panel after turning the power on. 08-DEC-98 10:30 TOTAL HOURS TOTAL COUNTS OPER HISTORY 306 2604 FILTER RESET 1002/ 1000 COUNTS TUBE RESET 176/ 3000 COUNTS OK 11. Reset the filter count on the OPER HISTORY screen. Refer to the “Resetting the Counts” section. Version 01-01 Operator's Manual MEK-6318J/K 9.11 9. MAINTENANCE Checking and Cleaning the Sub Baths and Measurement Baths Check the sub baths and measurement baths every day. Clean the measurement baths and sub baths every month or every 1000 sample counts, or when there is any dried blood or dust on them. You can check the baths without removing them. NOTE Be careful not to damage the sub baths and measurement baths. The baths are made of special plastic. 1. Press the clean key on the front panel to clean the fluid path. NOTE Make sure that CLEANAC•3 detergent is connected to the detergent inlet. 08-DEC-98 OTHER 10:30 CAL HISTORY TRANSFER DAY OPER HISTORY PRIME CIRCUIT CHECK DRAIN BATHS PRINT DAY DRAIN ALL OK 2. Press the OTHER key on the MENU screen, then press the DRAIN BATHS key on the OTHER screen to drain the measurement baths and sub baths. CAUTION Do not press the with fluid. clean key. Otherwise the instrument will be filled MAINTENANCE 3. When draining is complete, press the main power switch on the rear panel to turn the power off. The power lamp and main power lamp are off. ON OFF + The power can also be turned off by pressing the power key while pressing the reset key. The power lamp on the front panel is off. (The main power lamp is still on.) 4. Remove the two screws on the right side of the front cover. 5. Open the front cover. 9.12 Operator's Manual MEK-6318J/K 9. MAINTENANCE Sub baths 6. Check the WBC and RBC sub baths and measurement baths. If any baths have any dried blood or dust, remove and clean them according to the following procedures. 7. WBC baths only: Remove the HGB cover by removing the screw. Measurement baths 8. Loosen the screws fastening the WBC or RBC measurement baths. (The screws cannot be removed.) HGB cover 9. Remove the WBC and RBC measurement baths and the WBC and RBC sub baths by pulling them toward you. 10. Remove dried blood from inside the baths with tweezers. 11. If dried blood remains inside the baths, soak the baths in CLEANAC•3 detergent for about 10 minutes. Measurement bath screws 12. Rinse the baths with water. After the baths are dried, return each bath to its original position and tighten the screws. Make sure that the baths are attached firmly, especially the sub baths. 13. Close the front cover and fasten it with the two screws which were removed in step 4. 14. Turn the power on. NOTE When using Hemolynac•3N hemolysing reagent, change the detergent to CLEANAC (MEK-520) before turning the power on. Press the Clean key on the front panel after turning the power on. Operator's Manual MEK-6318J/K 9.13 9. MAINTENANCE Checking and Cleaning the Rinse Unit and Sampling Nozzles Check and clean the rinse unit and sampling nozzles every month or every 1000 sample counts. 1. Press the clean key on the front panel to clean the fluid path. NOTE Make sure that CLEANAC•3 detergent is connected to the detergent inlet. 08-DEC-98 OTHER 10:30 CAL HISTORY TRANSFER DAY OPER HISTORY PRIME CIRCUIT CHECK DRAIN BATHS PRINT DAY DRAIN ALL OK 2. Press the OTHER key on the MENU screen, then press the DRAIN BATHS key on the OTHER screen to drain the measurement baths and sub baths. CAUTION Do not press the with fluid. clean key. Otherwise the instrument will be filled MAINTENANCE 3. When draining is complete, press the main power switch on the rear panel to turn the power off. The power lamp and main power lamp are off. ON OFF + The power can also be turned off by pressing the power key while pressing the reset key. The power lamp on the front panel is off. (The main power lamp is still on.) 4. Remove the two screws on the right side of the front cover. 5. Open the front cover. 9.14 Operator's Manual MEK-6318J/K 9. MAINTENANCE 6. Remove the rinse unit cap by turning it counterclockwise. 7. Loosen the two joint assemblies and remove the tube. 8. Remove the O-ring and spacer from the rinse unit. To remove the O-ring, insert a cotton swab into the rinse unit from the bottom and push out the O-ring. Rinse unit cap Spacer O-ring Joint assemblies Rinse unit holder Rinse unit 9. Soak the rinse unit, rinse unit cap, O-ring and spacer in CLEANAC•3 detergent for about 10 minutes. 10. Remove blood from inside the rinse unit and rinse unit cap with a cotton swab moistened with CLEANAC•3 detergent. 11. Rinse the rinse unit, rinse unit cap, O-ring and spacer with water and dry them. 12. Remove blood or salt from the area on the sampling nozzle indicated by the arrow on the left with a gauze or cotton swab moistened with CLEANAC•3 detergent. Sampling nozzles 13. Return the rinse unit, rinse unit cap, O-ring and spacer to their original positions. 14. Close the front cover and fasten it with the two screws which were removed in step 4. Chip plate 15. Turn the power on. Sampling nozzle guide NOTE When using Hemolynac•3N hemolysing reagent, change the detergent to CLEANAC (MEK-520) before turning the power on. Press the Clean key on the front panel after turning the power on. Operator's Manual MEK-6318J/K 9.15 9. MAINTENANCE Checking and Replacing the Pump Tube Check the pump tube for leakage every day. Replace the pump tube every 3000 samples or 4 months, whichever comes first. 1. Press the clean key on the front panel to clean the fluid path. NOTE Make sure that CLEANAC•3 detergent is connected to the detergent inlet. 08-DEC-98 OTHER 10:30 CAL HISTORY TRANSFER DAY OPER HISTORY PRIME CIRCUIT CHECK DRAIN BATHS PRINT DAY DRAIN ALL OK 2. Press the OTHER key on the MENU screen, then press the DRAIN BATHS key on the OTHER screen to drain the measurement baths and sub baths. CAUTION Do not press the with fluid. clean key. Otherwise the instrument will be filled MAINTENANCE 3. When draining is complete, press the main power switch on the rear panel to turn the power off. The power lamp and main power lamp are off. ON OFF + The power can also be turned off by pressing the power key while pressing the reset key. The power lamp on the front panel is off. (The main power lamp is still on.) 4. Remove the two screws on the right side of the front cover. 5. Open the front cover. 9.16 Operator's Manual MEK-6318J/K 9. MAINTENANCE 6. Check for leaks. If you find leakage, replace the pump tube with a new one according to the following procedure. Pump tube Black tube joint Tube holder Tube guide 7. Pull out the white tube joint from the tube holder, pull out the tube from the tube guide by turning the pump rotator counterclockwise and pull out the black tube joint from the tube holder. Pump rotator White tube joint 8. Remove the white and black tube joints and replace the pump tube assy with a new one. Tube holder Black part of the tube 9. Put the white tube joint back to the original position, push the pump tube into the tube guide by turning the rotator counterclockwise and put the black tube joint to the original position. Make sure that the black parts of the tube are held properly by the tube holders. Tube guide NOTE Black part of the tube Operator's Manual MEK-6318J/K • Do not damage the pump tube with the tube guide. • Do not turn the rotator clockwise to put the pump tube into the tube guide. Otherwise, the pump tube is disconnected from the black tube joint by the applied positive pressure. • Put back the pump tube properly. If the pump tube has slack, the pump tube will be damaged by the tube guide. • Make sure that the black parts of the tube are held properly by the tube holders. Otherwise the pump tube will be scraped by the pump rotator and the life of the pump tube will be shortened. 9.17 9. MAINTENANCE 10. Close the front cover and fasten it with the two screws which were removed in step 4. 11. Turn the power on. NOTE When using Hemolynac•3N hemolysing reagent, change the detergent to CLEANAC (MEK-520) before turning the power on. Press the Clean key on the front panel after turning the power on. 08-DEC-98 10:30 TOTAL HOURS TOTAL COUNTS FILTER RESET TUBE RESET OK 9.18 OPER HISTORY 306 2604 176/ 12. Reset the pump tube count on the OPER HISTORY screen. Refer to the “Resetting the Counts” section. 1000 COUNTS 3001/ 3000 COUNTS Version 01-01 Operator's Manual MEK-6318J/K 9. MAINTENANCE Cleaning the Aperture Caps For daily cleaning of the aperture caps, press the clean key on the front panel. However, if the CLOG or LEVEL 3 message appears frequently or background noise is high, clean the aperture by the following procedures. CAUTION Be careful not to damage the sub bath and the measurement bath when removing the aperture. The baths are made of special plastic. 1. Press the path. clean key on the front panel to clean the fluid NOTE Make sure that CLEANAC•3 detergent is connected to the detergent inlet. Hemolysing reagent inlet Diluent inlet Detergent inlet 2. Remove the diluent tube from the diluent inlet and hemolysing reagent tube from the hemolysing reagent inlet on the side panel of the instrument. 3. Remove the detergent tube from the detergent container cap and put it into the waste container. Waste container Waste outlet Do not disconnect the waste fluid tube from the waste outlet. CAUTION Hemolysing reagent 08-DEC-98 Make sure that the tubes are correctly connected. Fluid comes out from the detergent inlet. OTHER 10:30 CAL HISTORY TRANSFER DAY OPER HISTORY PRIME CIRCUIT CHECK DRAIN BATHS PRINT DAY DRAIN ALL Check that the tubes are connected correctly. MAINTENANCE OK 08-DEC-98 4. Press the DRAIN ALL key on the OTHER screen. 10:30 DRAIN ALL 1 Remove detergent tube from detergent container and insert in waste container. 2 Disconnect diluent and hemolysing reagent tubes from inlets. Do not disconnect tube from waste outlet. 3 Drain the fluid path? YES 5. Press the YES key to drain the instrument. To cancel, press the CANCEL key. When draining and priming is finished, the “Press the CLEAN key” message appears. CANCEL Operator's Manual MEK-6318J/K 9.19 9. MAINTENANCE 6. Ignore the screen message and press the MENU key and then press the OTHER key on the MENU screen to display the OTHER screen. CAUTION Do not press the with fluid. 08-DEC-98 OTHER 10:30 CAL HISTORY TRANSFER DAY OPER HISTORY PRIME CIRCUIT CHECK DRAIN BATHS PRINT DAY DRAIN ALL clean key. Otherwise the instrument will be filled 7. Press the DRAIN BATHS key on the OTHER screen. The sampling nozzle goes up. CAUTION OK MAINTENANCE Do not press the with fluid. clean key. Otherwise the instrument will be filled 8. When draining is complete, press the main power switch on the rear panel to turn the power off. The power lamp and main power lamp are off. ON OFF + The power can also be turned off by pressing the power key while pressing the reset key. The power lamp on the front panel is off. (The main power lamp is still on.) 9. Remove the two screws on the right side of the front cover. 10. Open the front cover. 9.20 Operator's Manual MEK-6318J/K 9. MAINTENANCE Sub baths Measurement baths 11. WBC baths only: Remove the HGB cover by removing the screw. HGB cover 12. Loosen the screws fastening the WBC or RBC measurement baths. (The screws cannot be removed.) 13. Remove the WBC and RBC measurement baths and the WBC and RBC sub baths by pulling them toward you. Measurement bath screws 14. Place a cloth or tissue paper under your hand and remove the aperture cap by pulling it towards you. 15. Carefully rinse the aperture cap. Remove all dirt, especially from the inside. Operator's Manual MEK-6318J/K 9.21 9. MAINTENANCE Syringe Concave 16. Insert a syringe of CLEANAC•3 or 10:1 diluted sodium hypochlorite detergent into the aperture cap. Aspirate and dispense the detergent by pressing the syringe’s plunger up and down (shown at left) to remove the dust around the aperture cap. The condition of the aperture cap can be checked with a 100× microscope. If clogged dust still remains in the aperture cap, soak it in CLEANAC•3 detergent for about an hour. CAUTION Handle the aperture cap with care. It may be damaged if a sharp object is used to clean it. 17. Rinse the aperture caps with running water and return them to the original positions. Red mark White mark • There are separate aperture caps for WBC and RBC. Be careful not to attach the aperture caps to the wrong positions. Attach the WBC aperture cap (white O-ring) to the white side. Attach the RBC aperture cap (red O-ring) to the red side. • Check that the red or white O-ring is at the front. Black O-ring Red O-ring Black O-ring White O-ring 18. Place the measurement baths and sub baths in their original positions. 19. Close the front cover and fasten it with the two screws which were removed in step 9. 20. Turn the power on. NOTE When using Hemolynac•3N hemolysing reagent, change the detergent to CLEANAC (MEK-520) before turning the power on. Press the Clean key on the front panel after turning the power on. 21. Count a diluent sample and check that the background noise is decreased. Refer to “Measuring Background Noise” in Section 2. 9.22 Operator's Manual MEK-6318J/K 9. MAINTENANCE Replacing the Sampling Nozzles 1. Press the clean key on the front panel to clean the fluid path. NOTE Make sure that CLEANAC•3 detergent is connected to the detergent inlet. 08-DEC-98 OTHER 10:30 CAL HISTORY TRANSFER DAY OPER HISTORY PRIME CIRCUIT CHECK DRAIN BATHS PRINT DAY DRAIN ALL OK 2. Press the OTHER key on the MENU screen, then press the DRAIN BATHS key on the OTHER screen to drain the measurement baths and sub baths. CAUTION Do not press the with fluid. clean key. Otherwise the instrument will be filled MAINTENANCE 3. When draining is complete, press the main power switch on the rear panel to turn the power off. The power lamp and main power lamp are off. ON OFF + The power can also be turned off by pressing the power key while pressing the reset key. The power lamp on the front panel is off. (The main power lamp is still on.) 4. Remove the two screws on the right side of the front cover. 5. Open the front cover. Operator's Manual MEK-6318J/K 9.23 9. MAINTENANCE 6. Move the chip plate to the position where it is easy to handle. Sampling nozzle holder 7. Remove the screws fastening the sampling nozzle and the sampling nozzle holder (black). Black joint NOTE Do not lose the screws and sampling nozzle holder. White joint Chip plate 8. Remove the two joints from the sampling nozzles. 9. Turn the sampling nozzle 90° counterclockwise and remove it by pulling it up. Looked from above RBC sampling nozzle WBC sampling nozzle 10. Attach the new sampling nozzle to the joint and put it back to the original position. For the WBC sampling nozzle, attach the white joint and insert the sampling nozzle through the sampling nozzle guide. Sampling nozzles For the RBC sampling nozzle, attach the black joint and make sure that the sampling nozzle holder is attached. Black joint White joint Chip plate Black label Sampling nozzle guide Black joint 9.24 Operator's Manual MEK-6318J/K 9. MAINTENANCE Tubes tucked under the tube guide Check that the tubes do not wrap over each other and are tucked under the tube guides. Tubes do not wrap over each other 11. Close the front cover and fasten it with the two screws which were removed in step 4. 12. Turn the power on. NOTE When using Hemolynac•3N hemolysing reagent, change the detergent to CLEANAC (MEK-520) before turning the power on. Press the Clean key on the front panel after turning the power on. Operator's Manual MEK-6318J/K 9.25 9. MAINTENANCE Calibrating Touch Screen Calibrate the touch screen when the pressed position and operating position do not match. + 1. Press the capillary mode key on the front panel while pressing the key. The TOUCH SCREEN CALIBRATION screen appears. reset 2. Follow the instructions on the screen. NOTE • Do not use any sharp object when pressing the mark. Use your finger. • Do not hold your finger on the key. Remove your finger immediately after pressing. TOUCH SCREEN CALIBRATION TOUCH SCREEN CALIBRATION Press the exact center of the "+" mark in the lower right corner. Press the exact center of the "+" mark in the upper left corner. The READY screen appears when the touch screen is calibrated. 9.26 Operator's Manual MEK-6318J/K 9. MAINTENANCE Removing the Jammed Paper from the WA-630VK Printer Unit 1. Remove the two screws on the right side of the front cover. 2. Open the front cover. 3. Raise the paper lever on the back of the front cover. Paper lever 4. Remove the jammed paper from the paper roller. paper roller 5. Press down the paper lever back to its original position. 6. Close the front cover and fasten it with the two screws which were removed in step 1. Operator's Manual MEK-6318J/K 9.27 9. MAINTENANCE Priming 08-DEC-98 10:30 OTHER CAL HISTORY TRANSFER DAY OPER HISTORY PRIME CIRCUIT CHECK DRAIN BATHS PRINT DAY DRAIN ALL To fill the fluid path inside the instrument with diluent when doing maintenance, press the PRIME key on the OTHER screen. The instrument starts the priming and displays the following screen. OK MAINTENANCE 08-DEC-98 10:30 PRIMING Please wait. After the priming is completed, the screen returns to the READY screen. 9.28 Operator's Manual MEK-6318J/K 9. MAINTENANCE Draining the Measurement and Sub Baths 08-DEC-98 10:30 OTHER CAL HISTORY TRANSFER DAY OPER HISTORY PRIME CIRCUIT CHECK DRAIN BATHS PRINT DAY DRAIN ALL OK MAINTENANCE To drain the used diluent from the measurement and sub baths when doing maintenance, press the DRAIN BATHS key on the OTHER screen. The instrument starts draining and displays the following screen. 08-DEC-98 10:30 DRAINING Please wait. After draining is completed, the “Press the CLEAN key” messages appears. 08-DEC-98 10:30 PRESS THE [CLEAN] KEY. MENU Ignore the screen message and do the maintenance. CAUTION Do not press the with fluid. Operator's Manual MEK-6318J/K clean key. Otherwise the instrument will be filled 9.29 9. MAINTENANCE Draining the Instrument To drain the used diluent and waste fluid from the instrument for maintenance and storage, use the DRAIN ALL function. Hemolysing reagent inlet Diluent inlet Detergent inlet 1. Remove the diluent tube from the diluent inlet and hemolysing reagent tube from the hemolysing reagent inlet on the side panel. 2. Remove the detergent tube from the detergent container cap and put it into the waste container. Waste container Do not disconnect the waste fluid tube from the waste outlet. Waste outlet CAUTION Hemolysing reagent Make sure that the tubes are correctly connected. The fluid comes out from the detergent inlet. 08-DEC-98 10:30 OTHER CAL HISTORY TRANSFER DAY OPER HISTORY PRIME CIRCUIT CHECK DRAIN BATHS PRINT DAY DRAIN ALL Check that the tubes are connected correctly. MAINTENANCE OK 08-DEC-98 3. Press the DRAIN ALL key on the OTHER screen. 10:30 DRAIN ALL 1 Remove detergent tube from detergent container and insert in waste container. 2 Disconnect diluent and hemolysing reagent tubes from inlets. Do not disconnect tube from waste outlet. 3 Drain the fluid path? YES 4. Press the YES key to drain the instrument. To cancel, press the CANCEL key. When draining and priming is finished, the “Press the CLEAN key” message appears. CANCEL CAUTION Do not press the clean key. Otherwise the instrument will be filled with fluid. 5. Ignore the screen message and do the maintenance. 9.30 Operator's Manual MEK-6318J/K 9. MAINTENANCE Storing and Transporting the Instrument Preparing the Instrument for Long Term Storage and Transport In long term instrument storage, if diluent is left inside the instrument, the inside of the instrument will become dirty because of dried diluent crystal or other dust. As a result, background noise will also be increased. Before transporting or storing the instrument for more than 2 weeks, clean it using the following procedures. Clean the inside of the instrument only with distilled water. 1. Remove the diluent tube from the diluent inlet on the side panel. Hemolysing reagent tube Detergent tube 2. Connect one end of the spare tube (standard accessory) to the diluent inlet and put the other end of the tube into the distilled water. Waste tube Diluent tube 3. Remove the detergent tube from the detergent inlet. To the waste container Remove from the hemolysing reagent Distilled water 4. Connect one end of the spare tube (standard accessory) to the detergent inlet and put the other end of the tube into the distilled water. 5. Remove the tube from the hemolysing reagent. 6. Press the clean key on the front panel to clean the inside of the instrument. Repeat this procedure more than twice. 7. Remove the tube from the diluent inlet. 8. Remove the detergent tube from the distilled water and insert the tube in the waste container. Do not disconnect the tube from the waste container. CAUTION Make sure that the tubes are correctly connected. The fluid comes out from the detergent inlet. 08-DEC-98 10:30 OTHER CAL HISTORY TRANSFER DAY OPER HISTORY PRIME CIRCUIT CHECK DRAIN BATHS PRINT DAY DRAIN ALL OK 9. Press the DRAIN ALL key on the OTHER screen to display the DRAIN ALL screen. MAINTENANCE Operator's Manual MEK-6318J/K 9.31 9. MAINTENANCE 08-DEC-98 DRAIN ALL 10:30 1 Remove detergent tube from detergent container and insert in waste container. 2 Disconnect diluent and hemolysing reagent tubes from inlets. Do not disconnect tube from waste outlet. 3 Drain the fluid path? YES 10. Press the YES key to drain the instrument. To cancel, press the CANCEL key. When draining and priming is finished, the “Press the CLEAN key” message appears. CANCEL CAUTION Do not press the with fluid. clean key. Otherwise the instrument will be filled 11. Ignore the screen message and do either of the following to turn the power off. ON OFF • Press the main power switch on the rear panel to turn the power off. The power lamp and main power lamp are off. + Using the Instrument after Storage • Press the power key while pressing the reset key. The power lamp on the front panel is off. (The main power lamp is still on.) NOTE After long term instrument storage (more than 2 weeks), the pump tube may be collapsed or the fluid path may be dirty. Perform the following procedures before using the instrument. 1. Set up the instrument and turn the power on. Refer to Section 2. After automatic draining and priming, the READY screen appears. 2. Clean the aperture by following the procedure in the “Checking and Cleaning the Aperture” section. 3. Use the CLEANAC (MEK-520) for the detergent and clean the fluid path by pressing the clean key on the front panel. Perform cleaning at least twice. 9.32 Operator's Manual MEK-6318J/K 9. MAINTENANCE Preparing the Instrument for Short Term Transport 08-DEC-98 10:30 OTHER CAL HISTORY TRANSFER DAY OPER HISTORY PRIME CIRCUIT CHECK DRAIN BATHS PRINT DAY DRAIN ALL OK 1. Press the DRAIN BATHS key on the OTHER screen. CAUTION Do not press the with fluid. clean key. Otherwise the instrument will be filled MAINTENANCE 2. Press the main power switch on the rear panel to turn the power off. Operator's Manual MEK-6318J/K 9.33 9. MAINTENANCE Decontamination Protocol Prior to servicing by Nihon Kohden personnel, the following Decontamination Protocol must be performed by the relevant qualified laboratory personnel. Failure to perform this protocol may result in the instrument not being serviced. CAUTION During this procedure normal precautions regarding the handling of biologically hazardous material must be observed. Requirements Decontamination of the MEK-6318J/K can be performed using the hypochlorite based CLEANAC•3 and deionised water. The following consumables are also required. • 5 Cotton Applicators (Q Tips) • 2 hemoglobin filters, YZ-0024 Do the following. • Replacing Filters • Cleaning the Sub Baths and Measurement Baths • Cleaning Rinsing Unit 9.34 Operator's Manual MEK-6318J/K 9. MAINTENANCE Certification of Decontamination This instrument Type: MEKSerial Number: Has been decontaminated according to the Nihon Kohden recommended protocol. Date: : : Laboratory Supervisor Name: Signature: Certification of Decontamination This instrument Type: MEKSerial Number: Has been decontaminated according to the Nihon Kohden recommended protocol. Date: : : Laboratory Supervisor Name: Signature: Operator's Manual MEK-6318J/K 9.35 9. MAINTENANCE Clock Accuracy At an operating temperature of 25°C, the accuracy of the clock IC of the hematology analyzer is about ±52 seconds per month. At the storage temperature of between −20 and +60°C, the accuracy of the clock IC of the hematology analyzer is about –7 minutes to +52 seconds per month. Check that the time on the screen is correct at the start of every day. To change the time setting, refer to “Setting the Date and Time” in Section 3. Repair Parts Availability Policy Nihon Kohden Corporation (NKC) shall stock repair parts (parts necessary to maintain the performance of the instrument) for a period of 7 years from the date of delivery. In that period NKC or its authorized agents will repair the instrument. This period may be shorter than 7 years if the board or part necessary for the faulty section is not available. 9.36 Operator's Manual MEK-6318J/K Section 10 Reference Operation Theory ............................................................................................................... 10.1 Electric Cell Counting .............................................................................................. 10.1 Counting Method ........................................................................................... 10.1 Red Blood Cell and Platelet Counting ............................................................ 10.2 Principle of Hydraulic Operation .............................................................................. 10.2 Hemoglobin Measurement ....................................................................................... 10.3 Chemical Processing .................................................................................... 10.3 Spectrophotometric Measurement Method .................................................... 10.3 RS-232C Data Transfer ...................................................................................................... 10.5 Special Key Operations for Servicing ................................................................................ 10.5 Interference Substances ................................................................................................... 10.6 Specifications ................................................................................................................... 10.9 Measured Parameters, Ranges and Reproducibility to Specimen from Venous Blood ............................................................................................................. 10.9 Detection Method .......................................................................................... 10.9 Standardization Analysis Method .................................................................. 10.9 Dilution Ratio ............................................................................................... 10.10 Counting Time ............................................................................................. 10.10 Display ........................................................................................................ 10.10 Data Storage ............................................................................................... 10.10 Environmental Conditions ............................................................................ 10.10 Power Requirements ................................................................................... 10.10 Dimensions and Weight ............................................................................... 10.10 Electromagnetic Compatibility ..................................................................... 10.10 Safety ......................................................................................................... 10.11 WA-630VK Printer Unit ................................................................................ 10.11 WA-460V Card Printer ................................................................................. 10.11 WA-710V Printer ......................................................................................... 10.11 Standard Accessories ..................................................................................................... 10.12 Consumables .................................................................................................................. 10.14 Options ............................................................................................................................ 10.15 Operator's Manual MEK-6318J/K 10.C1 10. REFERENCE Operation Theory Electric Cell Counting Counting Method The instrument uses the volumetric impedance method of cell counting. In this method, an electrolytic solution (diluent) containing suspended blood cells is aspirated through the aperture. Two electrodes, an internal electrode and external electrode, are located close to the aperture and a constant current flows between them. When a blood cell passes through the aperture, the resistance between the electrodes momentarily increases and a very small voltage change occurs corresponding to the resistance. The voltage signal is amplified and is sent to the electronic circuit. A threshold circuit eliminates signals caused by electrical noise, dust, debris and particles which are smaller or larger than blood cells. To find the peak values, the signals are sent to the A/D converter. The acquired data is stored in memory for each individual peak value. The data is corrected by the CPU and displayed on the LCD. Detection circuit CPU Constant current circuit Electrodes Amplifier Threshold circuit A/D converter Memory Electrolytic solution Aperture The number of signals for each size cell is stored in memory as a histogram. Counted cells of RBC and PLT can have overlap sizes so the CPU can discriminate the count for each type of cell. See the “Red Blood Cell and Platelet Counting” section. The 3 types of counted white blood cells have overlapping sizes so the CPU uses the histogram to discriminate the 3 white blood cell populations. Sometimes two or more cells pass through the aperture at the same time. This is called coincidence. When the sample solution is sufficiently diluted and mixed, this can be statistically predicted to a high degree of accuracy. The software contains a coincidence correction table to compensate for this. Operator's Manual MEK-6318J/K 10.1 10. REFERENCE Red Blood Cell and Platelet Counting Data of the RBC and PLT pulses are stored in the memory as a histogram. Normal blood shows a clear separation between the PLT volume range and RBC volume range (Fig. A) so an accurate PLT count is easily acquired. However, when abnormal blood such as microcytic blood is counted (Figs. B and C), the separation is unclear. In these cases, for accurate PLT counting, the CPU determines the PLT and RBC distribution pattern, and sets the upper threshold (PLT HI) to the lowest count. Count Count Normal blood PLT LO* Microcytic blood (Microcythemia) PLT LO* PLT HI* PLT amplitude (volume) RBC PLT volume range RBC volume range PLT HI* PLT PLT volume range Fig. A RBC amplitude (volume) RBC volume range Fig. B Count Macro platelet PLT LO*: Lower threshold PLT HI*: Upper threshold PLT HI* PLT LO* PLT RBC PLT volume range amplitude (volume) RBC volume range Fig. C Principle of Hydraulic Operation For accurate counting of the blood cells in a diluent solution, a constant volume of solution must be aspirated through the aperture. The manometer controls this volume by measuring diluent level by an optical sensor and aspirating the diluent by the rotary pump. Aspiration and dispensing of the sample are performed alternately by an electromagnetic valve. The waste fluid is drained from the instrument by the rotary pump. The priming of diluent and cleaning with detergent are also performed by the electromagnetic valves. The CPU controls the electromagnetic valves, pump rotations and rotation direction. If an air bubble enters the manometer, the CPU generates an alarm sound and displays an error message on the LCD. 10.2 Operator's Manual MEK-6318J/K 10. REFERENCE Optical sensor Aperture y @@ ;; ;@yy @@ ;; y;@yy Diluent, detergent Waste chamber Waste Rotary pump Hemoglobin Measurement Chemical Processing A hemolysing reagent is added to the diluted blood sample to break the red blood cell membrane and release the hemoglobin. The released hemoglobin reacts with the potassium ferricyanide and potassium cyanide in the solution to produce cyanmethemoglobin. Spectrophotometric Measurement Method The hemoglobin is measured by spectrophotometry. This method measures the optical density of the sample solution. The optical density is proportional to the amount of hemoglobin in the sample solution. Spectrophotometric measurement is based on the principle that different materials absorb different amounts of different wavelengths of light. When light strikes a material, some of the light is absorbed by the material and some passes through. The amount of absorbed light at each frequency forms a unique optical “fingerprint” for that material. The oxidized hemoglobin is converted into cyanmethemoglobin because the optical absorbance of cyanmethemoglobin has one clear peak at 540 nm and is easy to measure accurately. Operator's Manual MEK-6318J/K 10.3 10. REFERENCE In this instrument, hemoglobin is measured in the measurement baths. An LED shines one wavelength of light through the sample solution. A photodiode receives the light which is not absorbed by the solution. The amount of received light is converted to an electric signal which is amplified by the preamplifier. The amplified signal is sent to the A/D converter. The amplified signals from the sample and diluent are required for measuring the hemoglobin concentration. The sample data is sent to the CPU, followed by the diluent data. The CPU converts the ratio of these data to logarithmic data, multiplies it by the calibration coefficient and displays the result on the LCD. After calculation, the sample and diluent are drained from the instrument. The sample is a highly concentrated protein solution. If the sample is left in the measurement baths for a long time, the measurement baths gradually become dirty. To prevent this problem, the measurement baths are automatically cleaned by dispensing the diluent after each measurement. Hemolysing reagent CPU Constant voltage power source Preamplifier A/D converter LED lamp Photodiode Waste Waste chamber Hemoglobin absorption characteristics Rotary pump Absorbance (0.D) 0.5 Cyanmethemoglobin Oxidized hemoglobin 500 10.4 520 540 560 580 Wavelength (nm) Operator's Manual MEK-6318J/K 10. REFERENCE RS-232C Data Transfer Sample data can be transferred to the optional card printer or a personal computer via the RS-232C socket on the rear panel of the instrument. One sample data can be transferred each time the counting is complete. CAUTION • Connect only the specified instruments to the connectors or sockets marked with by following the specified procedure. Otherwise electrical leakage current may harm the operator. • In order to avoid any safety hazard, only connect personal computers which are approved by IEC 60950. For details about the RS-232C data transfer and format, refer to the Technical Reference Manual of Data Communication Protocol. To obtain this manual, you must sign the license agreement. Special Key Operations for Servicing The following key operations are only for service personnel. Keys Operation reset + power key ON The power turns on without priming operation. reset + power key OFF The power turns off without cleaning operation. reset + count Circuit check starts and displays the HGB voltage value. reset + clean Priming operation starts. reset + clean + power key ON Initializes the settings. reset + print Print or not to print the measurement history after measurement data printing. reset + capillary blood mode Displays the TOUCH SCREEN CALIBRATION screen. feed + power key ON Operator's Manual MEK-6318J/K Test printing on the WA-630VK printer unit. 10.5 10. REFERENCE Interference Substances WBC: RBC: HGB: HCT: 10.6 Unlysed red cells In some rare occasions, the RBC in the blood sample may not completely lyse and these non-lysed RBC may be detected as WBC and cause increase in WBC count. Multiple myeloma The precipitation of proteins in multiple myeloma patients may increase the WBC count. Leukemia WBC is fragile in leukemia patient and WBC may be destroyed during measurement. These WBC fragments may also interfere with WBC differential measurement. Chemotherapy Cytotoxic and immunosuppressive drugs cause low WBC count. Cryoglobulins Cryoglobulin may be increased in patients who are or have myeloma, cancer, leukemia, macroglobulinemia, lymphoproliferative disorders, metastatic tumors, autoimmune disorders, infections, aneurysm, pregnant, thromboembolic phenomena, diabetes, etc, which cause increase in WBC, RBC or PLT counts and HGB concentration. In such cases, warm the blood sample to 37°C in a water bath for 30 minutes and measure the sample immediately. Leukemia An increase in WBC in leukemia patient causes increase in RBC. Agglutinated RBC Agglutinated RBC may decrease RBC count. This can be checked by abnormal MCH and MCHC values and examination of the stained blood film. Cold agglutinins IgM immunoglobulins which are elevated in clod agglutinin disease may decrease RBC and PLT counts and increase MCV. Turbidity of the blood sample Any physiologic and/or therapeutic factors may increase HGB. In such a case, determine the cause of turbidity and follow the appropriate method below. 1. Increased WBC An extreme increase in WBC will cause excessive light scatter. In these cases, measure manually. Centrifuge the diluted sample and measure the supernatant fluid with a spectrophotometer. 2. Increased lipids The blood sample may be milky when there is excessive lipid. This may occur with hyperlipidemia, hyperproteinemia and hyperbilirubinemia. Accurate HGB measurement can be achieved by manual methods and a plasma blank. 3. Increased turbidity When RBC are resistant to lysing, turbidity may increase causing increase in HGB. Observe if MCH and MCHC values are abnormal. HGB result affects MCH and MCHC result. 4. Fetal bloods The mixing of fetal and maternal blood may increase HGB value. 5. High WBC levels Turbidity of blood increases and the hemoglobin concentration becomes high if WBC level of the blood sample is high. MCH and MCHC also become high level. Agglutinated RBC RBC agglutination may cause erroneous HCT and MCV values. Observe if MCH and MCHC values are abnormal. In such a case, measure manually. Operator's Manual MEK-6318J/K 10. REFERENCE MCV: MCH: MCHC: RDW: PLT: MPV: Agglutinated RBC RBC agglutination may cause erroneous HCT and MCV values. Observe if MCH and MCHC values are abnormal. In such a case, measure manually. Excessive number of large PLT Excessive number of large PLT and/or excessively high WBC may affect the MCV value. Check by careful examination of the stained blood film. MCH is determined from HGB and RBC values. Therefore, the limitations for HGB and RBC also affect MCH value. MCHC is determined from HGB and HCT values. Therefore, the limitations for HGB and HCT also affect MCHC value. RDW is determined from RBC value. Therefore, the limitations for RBC also affect RDW value. Agglutinated RBC Agglutinated RBC may decrease RBC count and erroneous RDW. This can be checked by abnormal MCH and MCHC values and examination of the stained blood film. Nutritional deficiency or blood transfusion Iron and/or cobalamin and/or folate deficiency may increase RDW. Very small fragments Very small RBC, RBC fragments and WBC fragments may be the cause in increased PLT count. Agglutinated RBC PLT may be trapped in the agglutinated RBC resulting in decrease in PLT. This can be checked by abnormal MCH and MCHC values and examination of the stained blood film. Very large PLT Large PLT may exceed the PLT threshold and may not be counted which results in low PLT count. Chemotherapy Cytotoxic and immunosuppressive drugs may increase the fragility of cells which may cause low PLT count. In such a case, measure manually. Hemolysis Hemolyzed specimens contain red cell stroma which may increase PLT count. Anticoagulated blood Blood anticoagulated with acid-citrate-dextrose may have clumped PLT which may cause decrease in PLT count. Agglutinated PLT Clumped PLT may decrease PLT count and/or increase WBC count. For such sample, collect the sample in sodium citrate anticoagulant and measure only PLT. The PLT result must be corrected for the sodium citrate dilution effect. Very large PLT Large PLT may exceed the PLT threshold and not be counted which results in low MPV. Very small fragments Very small RBC, RBC fragments and WBC fragments may interfere with MPV measurement. Agglutinated RBC PLT may be trapped in the agglutinated RBC resulting erroneous MPV. This can be checked by abnormal MCH and MCHC values and examination of the stained blood film. Chemotherapy Cytotoxic and immunosuppressive drugs may affect MPV. In such a case, measure manually. NOTE Blood samples collected in EDTA does not maintain stable MPV because platelets swell depending on the interval after collection and storage temperature. Operator's Manual MEK-6318J/K 10.7 10. REFERENCE WBC 3 part differential parameters are derived from the WBC count, therefore, the limitations for WBC also affect these parameters. LY and LY%: NRBC, certain parasites and RBC that are resistant to lysis may interfere with an accurate LY count. Error factors of WBC count apply to LY count. MO and MO%: Large lymphocytes, atypical lymphocytes, blasts and excessive number of basophils may interfere with an accurate MO count. GR and GR%: Excessive eosinophils, metamyelocytes, myelocytes, promyelocytes, blasts and plasma cells may interfere with an accurate GR count and GR%. 10.8 Operator's Manual MEK-6318J/K 10. REFERENCE Specifications Measured Parameters, Ranges and Reproducibility to Specimen from Venous Blood Reproducibility to Specimen from Measured Parameters Measuring Range Venous Blood (CV: Coefficient of Variation) 3 WBC: White blood cell count 0 to 99.9 × 10 /µL within 2.0%CV LY%: Lymphocyte percent 0 to 99.9% within 5.0%CV MO%: Monocyte percent 0 to 99.9% within 12.0%CV GR%: Granulocyte percent 0 to 99.9% within 5.0%CV LY: Lymphocyte count 0 to 99.9 × 10 /µL MO: Monocyte count 0 to 99.9 × 10 /µL GR: Granulocyte count 0 to 99.9 × 10 /µL RBC: Red blood cell count 0 to 14.99 × 10 /µL within 1.5%CV 0 to 29.9 g/dL within 1.5%CV 3 3 3 6 HGB: Hemoglobin concentration HCT: Hematocrit 0 to 99.9% MCV: Mean cell volume 20 to 199 fL MCH: Mean cell hemoglobin 10 to 50 pg MCHC: Mean cell hemoglobin concentration RDW: Red blood cell distribution width 10 to 50 g/dL 0 to 50% within 3.0%CV 0 to 1490 × 10 /µL PLT: Platelet count PCT: Platelet crit within 1.0%CV 3 within 4.0%CV 0 to 20.0 fL within 5.0%CV 0 to 50% within 5.0%CV 0 to 2.9% MPV: Mean platelet volume PDW: Platelet distribution width Specifications were determined using hematology control blood (MEK-3DN), counted 10 times consecutively. Detection Method Blood cell count: Hemoglobin: Hematocrit: WBC population: Platelet crit: RBC distribution width: Platelet distribution width: Electrical resistance detection Cyanmethemoglobin optical detection Histogram calculation Histogram calculation Histogram calculation Histogram calculation Histogram calculation Standardization Analysis Method WBC: ICSH1988 ICSH: The assignment of values to fresh blood used for calibrating automated blood cell counters. Clin Lab Haematol, 10:203-212, 1988 RBC: ICSH1988 ICSH: The assignment of values to fresh blood used for calibrating automated blood cell counters. Clin Lab Haematol, 10:203-212, 1988 HGB: NCCLS H15-A2 H15-A2: Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood Second Edition; Approved Standard (1994) HCT: NCCLS H7-A2 H7-A2: Procedure for Determining Packed Cell Volume by the Microhematocrit Method Second Edition; Approved Standard (1993) PLT: Brecher & Cronkite Method:Morphology and enumeration of human blood platelets, J Appl Physiol 3 365 (Dec) 1950; Brecher G, Cronkite EP Operator's Manual MEK-6318J/K 10.9 10. REFERENCE Dilution Ratio • Venous blood Sample volume: WBC/HGB: RBC/PLT: • Capillary blood Sample volume: WBC/HGB: RBC/PLT: 30 µL 200:1 40,000:1 10 µL 1200:1 240,000:1 20 µL 600:1 120,000:1 Counting Time Approximately 60 s/sample Display Display: LCD 320 x 240 dots with backlight and touch screen keys Screen size: approx. 86 × 115 mm Display contents: Numerical data, histograms, measuring conditions, alarm message and other messages, touch screen keys Data Storage Numerical data for all counted parameters for up to 400 samples and histograms for up to 20 samples Environmental Conditions Storage temperature: Operating temperature: Storage humidity: Operating humidity: Storage atmospheric pressure: Operating atmospheric pressure: Operating altitude: Power Requirements Power requirements: Power consumption: −20 to 60°C 10 to 30°C 15 to 90% (Non-condensing) 30 to 90% (Non-condensing) 700 to 1060 hPa 700 to 1060 hPa less than 3000 m MEK-6318J: 110 to 127 V ±10% AC, 50/60 Hz MEK-6318K: 220 to 240 V ±10% AC, 50/60 Hz 190 VA Dimensions and Weight Dimensions: 315 W × 370 D × 475 H (mm) Net weight: approx. 22 kg ± 1 kg Electromagnetic Compatibility IEC 61326-1 (1997) Amendment 1 (1998) Amendment 2 (2000) EN 61326-1 (1997) Amendment 1 (1998) CISPR11 (1997), Group 1, Class B EN 55011 (1998) Amendment 1 (1999), Group 1, Class B The power supply short interruption test is performed through the transformer which has three times or more as large capacity as the instrument. 10.10 Operator's Manual MEK-6318J/K 10. REFERENCE Safety Safety standards: IEC 61010-1 2nd Edition (2001) EN 61010-1 2nd Edition (2001) Laser: IEC 60825-1 (1993) Amendment 1 (1997) EN 60825-1 (1994) Amendment 11 (1996) According to the type of protection against electrical shock: CLASS I EQUIPMENT According to the degree of protection against harmful ingress of water: IPX0 (Ordinary EQUIPMENT) According to the degree of safety of application in the presence of a FLAMMABLE ANAESTHETIC MIXTURE WITH AIR, OR WITH OXYGEN OR NITROUS OXIDE: EQUIPMENT not suitable for use in the presence of FLAMMABLE ANAESTHETIC MIXTURE WITH AIR, OR WITH OXYGEN OR NITROUS OXIDE According to the mode of operation: CONTINUOUS OPERATION EQUIPMENT types (classification): Indoor stationary EQUIPMENT Pollution Degree: 2 EQUIPMENT Requirements for marking of in vitro diagnostic instruments: EN 1658 (1996) WA-630VK Printer Unit Printing method: Thermal array Printing speed: 1 to 1.5 lines/s Printing data: Numerical data and histograms Recording paper: RQW58-2 WA-460V Card Printer Printing method: Impact dot matrix Printing speed: 1 to 1.5 lines/s Printing data: Numerical data Recording paper: Hematology data card, C976 WA-710V Printer Printing method: Impact dot matrix Printing speed: 1 to 1.5 lines/s Printing data: Numerical data and histograms Recording paper: Hematology data sheet, C975 and C962 Operator's Manual MEK-6318J/K 10.11 10. REFERENCE Standard Accessories 1 2 3 4 5 6 7, 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 10.12 Operator's Manual MEK-6318J/K 10. REFERENCE No. Description Qty Code no. Supply code no. 1 Power cord (200 to 240 V) 1 2 Ground lead D 1 098029 L912 3 Fuse 1.6 A time-lag (200 to 240 V AC) 2 274017 4 Connection tube for detergent (0.4 m) 2 2114-082383B Y999T 5 Connection tube (0.4 m) 2 2114-050872C 6 Hemoglobin filter assy set (2 pcs/set) 1 6144-001907A T802 7 1 1 9 Diluent ISOTONAC•3 (2 L) MEK-640 Detergent CLEANAC•3 (2L) MEK-620 Detergent CLEANAC (2L) MEK-520 Waste container (2 L) 1 YZ-0056 YZ-0061 YZ-0055 2113-023957E T436D T438D T438 10 18 L diluent container cock 2 299053 Y999T 11 Sampling nozzle 1 6114-096103A 12 Sample container set MEK-435 (10 beakers) 1 YZ-0070 T435 13 Connection tube, spare (5.0 m) 1 2114-080786D 14 Container cap for detergent and diluent 4 2114-074258 T469 15 Tube assembly (6100) 3 2144-012812C T470A 8 16 Pump tube (N) assy 2 YS-001B1 T462 17 Hemolysing reagent tube assembly 1 AAA-50125 T473 18 Hemolysing reagent container cap 1 2114-081963A T447A 19 18 L diluent container cap 1 6114-000047C T723A 20 18 L diluent tube assembly 1 YS-002B5 T461 21 Screwdriver 1 333515 22 Waste tube assembly (2 L) 1 6144-001961A Operator's Manual MEK-6318J/K 10.13 10. REFERENCE Consumables NOTE When ordering the following options/consumables, specify the supply code. When the supply code is not provided with the options or consumables, specify the model or code number. 1 2 3 4 5 6 7 8 9 10 HEM ATO LOG Y 11 C-975 C-962 No. 1 Sample container set, MEK-435 2 Recording paper for WA-630VK, RQW58-2 3 7 Diluent ISOTONAC•3, MEK-640 Detergent CLEANAC•3, MEK-620 Detergent CLEANAC, MEK-520 Hemolysing reagent HEMOLYNAC•3, MEK-660 Hemolysing reagent HEMOLYNAC•3N, MEK-680 Hematology control MEK-3DN MEK-3DL MEK-3DH Hemoglobin filter assy set (2 pcs/set), YZ-0024 8 Pump tube (N) assy, YS-001B1 4 5 6 9 18 L diluent container cock, 299053 10 Hematology data card for WA-450V/WA-460V Card Printer Hematology data sheet for WA-710V Printer, 2123-007002A Hematology data sheet for WA-710V Printer, 275506 11 10.14 Description Packing unit Supply code no. 200 pcs × 5 T435 10 A819B 18 L T436D T438D T438 T489 T498 5L 500 mL × 3 10 pcs T455 T455L T455H T802 1 pcs T462 1 pc Y999T 100 cards × 4 copies 1000 sheets 2000 sheets C976 C975 C962 2 mL × 3 Operator's Manual MEK-6318J/K 10. REFERENCE Consumables for Capillary Blood Measurement 1 3 2 No. Description Packing unit Supply code no. 1 Sample cup (5.0 mL), TA-8 500 pcs T857 2 Micro cap 100 pcs T812 3 Sahli pipette, (0.02 mL) 1 pc T421 Options • Printer Unit, WA-630VK Prints numerical data and histogram on roll paper. • Card Printer, WA-460V (SEIKO EPSON TM-U295 or equivalent) Prints numerical data on a hematology data card. • Printer, WA-710V (FUJITSU, SEIKO EPSON-VP, EPSON-PM or CANON BJ or equivalent) Epson printer. Prints numerical data and histogram on normal paper or continuous paper. • Cap Pierce Unit, MS-631V Measures samples in capped sample tubes. • Bar Code Reader Cable, YZ-0313 Connects the ZK-820V handy bar code reader to the hematology analyzer. • Handy Bar Code Reader, ZK-820V (Keyence BL-N60RK or equivalent) Reads the bar code label on the sample tube when connected to the hematology analyzer using the YZ-0313 bar code reader cable. Up to 13 characters can be entered as the sample ID. The following codes can be used. • Industrial 2 of 5 • CODE 39 • ITF • CODE 93 • JAN/EAN/UPC • CODE 128 • NW-7 Operator's Manual MEK-6318J/K 10.15