Automated Hematology Analyzer MEK-6510 OPERATOR’S MANUAL Automated Hematology Analyzer MEK-6510 MEK-6510J MEK-6510K First Edition: 22 Oct 2012 0614-906135 Printed: 2012/11/01 Automated Hematology Analyzer MEK-6510 MEK-6510J MEK-6510K If you have any comments or suggestions on this manual, please contact us at: www.nihonkohden.com 0614-906135 In order to use this product safely and fully understand all its functions, make sure to read this manual before using the product. Keep this manual near the instrument or in the reach of the operator and refer to it whenever the operation is unclear. The contents of this manual are subject to change without notice. Copyright Notice The entire contents of this manual are copyrighted by Nihon Kohden. All rights are reserved. No part of this document may be reproduced, stored, or transmitted in any form or by any means (electronic, mechanical, photocopied, recorded, or otherwise) without the prior written permission of Nihon Kohden. Trademark The mark printed on the SD card that is used in this instrument is a trademark. The company name and model name are trademarks and registered trademarks of each company. Contents 1 2 GENERAL HANDLING PRECAUTIONS.............................................................................. i WARRANTY POLICY.......................................................................................................... ii RESPONSIBILITIES – PROFESSIONAL USERS............................................................... ii EMC RELATED CAUTION...................................................................................................iii Conventions Used in this Manual and Instrument.............................................................. iv Warnings, Cautions and Notes................................................................................. iv Explanations of the Symbols in this Manual and Instrument..................................... v Text Conventions in this Manual............................................................................... vi 3 4 5 6 7 Section 1 General.................................................................................... 1.1 Introduction....................................................................................................................... 1.2 Measured Parameters............................................................................................ 1.2 Features............................................................................................................................ 1.3 Panel Description.............................................................................................................. 1.5 Front Panel............................................................................................................. 1.5 Right Side Panel..................................................................................................... 1.6 Rear Panel.............................................................................................................. 1.7 Caution Labels on the Analyzer........................................................................................ 1.8 Flowchart of Screens........................................................................................................ 1.9 Basic Operations............................................................................................................ 1.11 Screen Information............................................................................................... 1.11 Shortcut Function................................................................................................. 1.11 Using Touch Screen Keys..................................................................................... 1.12 General Safety Information............................................................................................. 1.13 General................................................................................................................. 1.13 Installation............................................................................................................ 1.13 Measurement........................................................................................................ 1.14 Reagents and Consumable.................................................................................. 1.14 Maintenance......................................................................................................... 1.15 Disposal................................................................................................................ 1.15 Section 2 Preparation............................................................................. 2.1 Environmental Requirements............................................................................................ 2.2 Initial Preparation.............................................................................................................. 2.3 Inventory................................................................................................................. 2.3 Standard Accessories............................................................................................. 2.3 Unpacking............................................................................................................... 2.4 Installation Flowchart........................................................................................................ 2.5 Connecting an External Instrument to the Analyzer......................................................... 2.6 Connecting a PC.................................................................................................... 2.7 Connecting a Printer............................................................................................... 2.8 Connecting a Card Printer...................................................................................... 2.8 Connecting a Hand-held Bar Code Reader............................................................ 2.9 Connecting the Power Cord and Grounding the Analyzer.............................................. 2.10 Operator’s Manual MEK-6510 C.1 8 9 10 CONTENTS Connecting the Power Cord.................................................................................. 2.10 Equipotential Grounding....................................................................................... 2.10 Connecting Tubes and Installing Reagents..................................................................... 2.11 Materials Required............................................................................................... 2.11 Connecting Tubes................................................................................................. 2.13 Diluent Tube................................................................................................ 2.14 Detergent Tube........................................................................................... 2.14 Lysing Reagent Tube.................................................................................. 2.15 Waste Fluid Tube........................................................................................ 2.15 Loading Recording Paper in the WA-650VK Printer Unit (Option).................................. 2.16 Preparing an SD Memory Card...................................................................................... 2.17 Safety Information about the SD Memory Card.................................................... 2.17 Handling and Storage................................................................................. 2.17 Data Processing......................................................................................... 2.17 Inserting and Removing the SD Memory Card..................................................... 2.18 Turning Power On/Off..................................................................................................... 2.19 Check Before Turning Power On........................................................................... 2.19 Turning On the Power........................................................................................... 2.19 Checking the Date and Time Settings.................................................................. 2.20 Cleaning the Fluid Path After Turning the Power On (PRIME ON INSTALL)........ 2.21 Check After Turning On the Power........................................................................ 2.22 Daily Shutdown..................................................................................................... 2.23 Checking List Before Turning the Power Off............................................... 2.23 Turning the Power Off................................................................................. 2.23 Check List After Turning Power Off............................................................. 2.24 Check List Before Long Term Storage........................................................ 2.24 Checking Daily Accuracy................................................................................................ 2.25 Measuring Background Noise.............................................................................. 2.25 Measuring by Pressing the [ Count] Switch or Key................................. 2.25 Measuring on the BACKGROUND Screen................................................. 2.26 Results....................................................................................................... 2.27 Measuring Hematology Control............................................................................ 2.28 Section 3 Changing Settings................................................................. 3.1 General............................................................................................................................. 3.3 Assigning Users and Passwords....................................................................................... 3.4 General................................................................................................................... 3.4 Displaying the USERS Screen............................................................................... 3.5 Adding a User......................................................................................................... 3.6 Changing a User..................................................................................................... 3.9 Deleting a User..................................................................................................... 3.10 Assigning an ID to a Sample.......................................................................................... 3.11 Displaying the ID Screen...................................................................................... 3.12 Entering a 4 Digit Numeric ID............................................................................... 3.12 Entering a 13 Character Alphanumeric ID............................................................ 3.13 Using Bar Codes.................................................................................................. 3.14 Labeling and Selecting Sample Types............................................................................ 3.15 Labeling Sample Types......................................................................................... 3.15 C.2 Operator’s Manual MEK-6510 CONTENTS Selecting Sample Types for the Sample Type Selection List................................ 3.17 Setting Normal Range Upper and Lower Limits............................................................. 3.18 Default Settings of Upper and Lower Limits......................................................... 3.18 Changing the Limits.............................................................................................. 3.18 Changing Sensitivity and Threshold............................................................................... 3.21 General................................................................................................................. 3.21 Factory Default Settings and Setting Range.............................................. 3.21 RBC Automatic Threshold.......................................................................... 3.21 Changing Sensitivity and Threshold..................................................................... 3.21 Displaying the Sensitivity and Threshold Setting History...................................... 3.23 Determining Optimum Sensitivity......................................................................... 3.24 Determining Optimum Threshold.......................................................................... 3.24 Changing Measurement Settings................................................................................... 3.25 Setting Date and Time.................................................................................................... 3.28 Changing Display Format............................................................................................... 3.30 Changing Output Format................................................................................................ 3.35 Changing Print Format for Internal Printer............................................................ 3.37 Changing Print Format for External Printer.......................................................... 3.39 Changing Settings for Card Printer....................................................................... 3.44 Changing Format for PC....................................................................................... 3.46 Changing the USB Settings.................................................................................. 3.48 Changing the SD Memory Card Settings............................................................. 3.49 Formatting the SD Memory Card............................................................... 3.50 Selecting Language........................................................................................................ 3.51 Selecting Units................................................................................................................ 3.52 Selecting Unit Type............................................................................................... 3.52 Counting Unit Table.................................................................................... 3.53 Customizing Units................................................................................................. 3.53 Changing Sound and Screen Brightness Settings.......................................................... 3.54 Changing Various Settings for Analyzer Power On......................................................... 3.55 Setting Auto Priming/Cleaning........................................................................................ 3.57 Using Reagent Management.......................................................................................... 3.59 Setting the Warning Level..................................................................................... 3.59 When the Reagent Management Warning is Displayed....................................... 3.61 Initializing Settings.......................................................................................................... 3.64 Factory Default Settings....................................................................................... 3.66 Section 4 Measurement.......................................................................... 4.1 General............................................................................................................................. 4.2 Dilution Mode.......................................................................................................... 4.2 Sample Type........................................................................................................... 4.2 Single and Double Counting................................................................................... 4.2 ID Numbers............................................................................................................ 4.3 Alarm Display......................................................................................................... 4.3 Data Storage.......................................................................................................... 4.4 Printing and Sending Data...................................................................................... 4.4 PLT Recount........................................................................................................... 4.4 Recount when Out of Panic Range........................................................................ 4.4 Operator’s Manual MEK-6510 C.3 1 2 3 4 5 6 7 8 9 10 CONTENTS Counting Special Case Samples............................................................................ 4.5 Measuring a Venous Sample in Normal Dilution Mode..................................................... 4.6 Preparing a Venous Sample................................................................................... 4.6 Measuring a Venous Sample.................................................................................. 4.7 Measuring a Pre-Dilution Sample..................................................................................... 4.9 Preparing a Pre-Dilution Sample............................................................................ 4.9 Measuring a Pre-Dilution Sample......................................................................... 4.10 Measuring a Venous Sample in Low/High Dilution Mode............................................... 4.12 Performing Auto Recount................................................................................................ 4.14 Recount on Alarm................................................................................................. 4.14 Recount on PLT Count......................................................................................... 4.14 Recounting the Sample when Out of Panic Range......................................................... 4.15 Description of the RESULTS Screen.............................................................................. 4.17 Numeric Data........................................................................................................ 4.18 Measuring Units......................................................................................... 4.18 Displaying H and L Out of Range Marks.................................................... 4.18 Over Message............................................................................................ 4.18 Histograms............................................................................................................ 4.19 Vertical Axis Type for the Histogram........................................................... 4.19 Adjusting Axes Scale.................................................................................. 4.19 RBC (Red Blood Cell) Distribution Histogram............................................ 4.19 PLT (Platelet) Distribution Histogram.......................................................... 4.20 WBC (White Blood Cell) Distribution Histogram......................................... 4.20 Flags..................................................................................................................... 4.21 Flag Codes................................................................................................. 4.22 Flag Names................................................................................................ 4.23 Alarm Display....................................................................................................... 4.24 Printing and Sending Results......................................................................................... 4.25 Auto Printing/Sending after Measurement............................................................ 4.25 Printing by Pressing [Print] Key............................................................................ 4.25 Sending Data to PC.............................................................................................. 4.25 Section 5 Handling Data......................................................................... 5.1 General............................................................................................................................. 5.2 Displaying Numerical Data and Histograms..................................................................... 5.3 Displaying the Latest Measured Data..................................................................... 5.3 Displaying Saved Data............................................................................................ 5.4 Editing ID and Sample Type of Saved Data...................................................................... 5.6 Searching for Data............................................................................................................ 5.8 Printing and Sending Data.............................................................................................. 5.12 Automatic Printing and Sending Data after Measurement.................................... 5.12 Printing and Sending Stored Data........................................................................ 5.12 Printing or Sending Single Data................................................................. 5.12 Printing or Sending Multiple Data............................................................... 5.13 Printing or Sending Data for All Samples of a Single Day.......................... 5.15 Deleting Data.................................................................................................................. 5.18 Deleting Single Data............................................................................................. 5.18 Deleting Multiple Data.......................................................................................... 5.19 Deleting All Stored Data....................................................................................... 5.20 C.4 Operator’s Manual MEK-6510 CONTENTS Section 6 Quality Control....................................................................... 6.1 General............................................................................................................................. 6.3 When to Run QC.................................................................................................... 6.3 QC Methods........................................................................................................... 6.3 Control Material...................................................................................................... 6.3 Quality Control Procedures............................................................................................... 6.4 Guidelines for Running Controls............................................................................. 6.4 Control Material Guidelines.................................................................................... 6.4 X-R Program..................................................................................................................... 6.5 General................................................................................................................... 6.5 Overview of X-R Program and Quality Control Procedure........................... 6.5 Calculation of X and R.................................................................................. 6.5 Calculation of Upper and Lower Limits of X and R....................................... 6.6 X-R Graph Example..................................................................................... 6.7 How to Read the X-R Graph......................................................................... 6.9 Data Outside the Limits................................................................................ 6.9 Changing the Quality Control Settings................................................................. 6.10 Counting the Hematology Control........................................................................ 6.12 Handling X-R Data . ............................................................................................. 6.15 Displaying the X-R Data List (HISTORY)................................................... 6.15 Displaying the Detailed X-R Measurement Data........................................ 6.16 Printing, Sending or Deleting X-R Data................................................................ 6.18 Printing, Sending or Deleting X-R Data Individually................................... 6.18 Printing, Sending or Deleting X-R Data Consecutively.............................. 6.19 Deleting All Stored X-R Data...................................................................... 6.20 Displaying CV Values of the Stored X-R Data............................................ 6.21 Handling X-R Graphs........................................................................................... 6.22 Changing the X-R Limits....................................................................................... 6.23 L & J Program (Levey and Jennings).............................................................................. 6.25 General................................................................................................................. 6.25 Overview of L & J Program and Quality Control Procedure....................... 6.25 Calculation of Upper and Lower Limits....................................................... 6.26 How to Read the L & J Graph..................................................................... 6.26 Data Outside the Limits.............................................................................. 6.26 Changing the Quality Control Settings................................................................. 6.27 Counting the Hematology Control........................................................................ 6.27 Handling L & J Data . ........................................................................................... 6.30 Displaying the L & J Data List (HISTORY)................................................. 6.30 Displaying the Detailed L & J Measurement Data...................................... 6.31 Printing, Sending or Deleting L & J Data.............................................................. 6.32 Printing, Sending or Deleting L & J Data Individually................................. 6.32 Printing, Sending or Deleting L & J Data Consecutively............................ 6.33 Deleting All Stored L & J Data.................................................................... 6.35 Displaying CV Values of the Stored L & J Data.......................................... 6.36 Handling L & J Graphs......................................................................................... 6.37 XB (X Batch) Program.................................................................................................... 6.39 General................................................................................................................. 6.39 Overview of XB . ........................................................................................ 6.39 Calculation of XB . ..................................................................................... 6.39 Operator’s Manual MEK-6510 C.5 1 2 3 4 5 6 7 8 9 10 CONTENTS Handling XB Data................................................................................................. 6.41 Handling XB Graph............................................................................................... 6.43 Setting XB Initial Values and Limits...................................................................... 6.44 XD•CV Program.............................................................................................................. 6.46 General................................................................................................................. 6.46 Uses of the XD•CV Program...................................................................... 6.46 Handling XD•CV Data........................................................................................... 6.47 Displaying the Total Mean and CV of All Stored Data........................................... 6.48 Section 7 Calibration.............................................................................. 7.1 General............................................................................................................................. 7.2 When to Calibrate................................................................................................... 7.2 Note on the Calibration Procedure......................................................................... 7.2 Calibration in Open (Venus Blood) Mode.......................................................................... 7.4 Calibration in Pre-Dilution Blood Mode............................................................................. 7.8 Displaying and Printing Calibration Data History............................................................ 7.13 HGB/HCT Calibration with Human Blood....................................................................... 7.15 Measurement with the Analyzer........................................................................... 7.15 HGB Measurement with a Spectrophotometer..................................................... 7.15 HCT Measurement with a Microhematocrit Centrifuge......................................... 7.16 Determining the HGB and HCT Calibration Coefficient........................................ 7.17 Section 8 Messages and Troubleshooting............................................ 8.1 General............................................................................................................................. 8.2 Alarm Messages............................................................................................................... 8.5 Invalid Data Identifier.............................................................................................. 8.5 Flag Indication........................................................................................................ 8.6 Alarm Messages with Alarm Codes....................................................................... 8.6 Other Alarm Messages........................................................................................... 8.8 System Error Messages................................................................................................... 8.9 Inaccurate Counting and Other Problems....................................................................... 8.10 Section 9 Maintenance........................................................................... 9.1 General............................................................................................................................. 9.3 Disposing of Waste and the Analyzer..................................................................... 9.4 Repair Parts Availability Policy............................................................................... 9.4 Preventive Maintenance Schedule.................................................................................... 9.5 Maintenance Schedule........................................................................................... 9.5 Displaying Operation History Screen...................................................................... 9.6 Maintenance Check Sheet................................................................................................ 9.9 Inside Panel Components............................................................................................... 9.11 Before Maintenance Procedure...................................................................................... 9.12 Strong Cleaning.................................................................................................... 9.12 Draining Measurement Baths and Sub Baths...................................................... 9.13 Turning Power Off................................................................................................. 9.14 Daily Maintenance Procedures....................................................................................... 9.15 C.6 Operator’s Manual MEK-6510 CONTENTS Checking Reagents and Other Consumables...................................................... 9.15 Checking the Appearance of the Analyzer........................................................... 9.15 Cleaning the Surface of the Analyzer......................................................... 9.16 Disinfecting the Surface of the Analyzer..................................................... 9.16 Checking the Reagent Connection Tubes............................................................. 9.16 Checking the Power Cord and Grounding Lead................................................... 9.16 Checking the External Instrument Connection..................................................... 9.16 Checking the Power On........................................................................................ 9.17 Calibrating the Touch Screen..................................................................... 9.17 Checking the Date and Time................................................................................ 9.18 Clock Accuracy........................................................................................... 9.18 Checking Daily Accuracy...................................................................................... 9.18 Checking Measurement Baths and Sub Baths..................................................... 9.18 Checking Pump Tube............................................................................................ 9.18 Every 200 Counts Maintenance Procedures.................................................................. 9.19 Performing Strong Cleaning................................................................................. 9.19 Weekly/Every 300 Counts Maintenance Procedures...................................................... 9.19 Checking/Cleaning Filters..................................................................................... 9.19 Monthly/Every 1,000 Counts Maintenance Procedures.................................................. 9.20 Replacing Filters................................................................................................... 9.20 Materials Required..................................................................................... 9.20 Procedure................................................................................................... 9.20 Checking and Cleaning Measurement Baths and Sub Baths............................... 9.22 Materials Required..................................................................................... 9.22 Procedure................................................................................................... 9.22 Checking and Cleaning the Rinse Unit................................................................. 9.25 Materials Required..................................................................................... 9.25 Procedure................................................................................................... 9.25 Every Four Months/Every 3,000 Counts Maintenance Procedures................................ 9.27 Checking, Cleaning and Replacing the Sampling Nozzles................................... 9.27 Materials Required..................................................................................... 9.27 Procedure................................................................................................... 9.27 Replacing Pump Tube........................................................................................... 9.30 Materials Required..................................................................................... 9.30 Procedure................................................................................................... 9.30 As-Required Maintenance Procedures........................................................................... 9.33 Removing a Clog from the Aperture..................................................................... 9.33 Cleaning Aperture Caps....................................................................................... 9.34 Materials Required..................................................................................... 9.34 Procedures................................................................................................. 9.34 Checking the Prime Function............................................................................... 9.38 Checking the Drain Function................................................................................ 9.38 Checking the Cleaning Function........................................................................... 9.38 Checking the Circuit.............................................................................................. 9.38 Checking the Sensor Monitor Screen................................................................... 9.40 Checking the External Instruments Function........................................................ 9.41 Printers....................................................................................................... 9.41 Hand-held Bar Code Reader...................................................................... 9.41 PC.............................................................................................................. 9.41 Operator’s Manual MEK-6510 C.7 1 2 3 4 5 6 7 8 9 10 CONTENTS Decontamination Protocol.................................................................................... 9.42 Procedure................................................................................................... 9.43 Storing and Transporting the Analyzer.................................................................. 9.45 Preparing the Analyzer for Long Term Storage or Transport...................... 9.45 Using the Analyzer after Storage................................................................ 9.47 Preparing the Analyzer for Short Term Transport....................................... 9.48 Section 10 Reference.............................................................................. 10.1 Operation Theory............................................................................................................ 10.2 Electric Cell Counting........................................................................................... 10.2 Counting Method........................................................................................ 10.2 Red Blood Cell and Platelet Counting........................................................ 10.3 Principle of Hydraulic Operation........................................................................... 10.3 Hemoglobin Measurement................................................................................... 10.4 Chemical Processing.................................................................................. 10.4 Spectrophotometric Measurement Method................................................ 10.4 Hemoglobin Conversion Table (g/dL ↔ %SAHLI)........................................................... 10.5 RS-232C Data Transfer................................................................................................... 10.6 General................................................................................................................. 10.6 Connecting PC..................................................................................................... 10.6 Socket Pin Assignment................................................................................................... 10.9 ZK-820V Bar Code Reader Socket....................................................................... 10.9 Serial Port 1/Serial Port 2..................................................................................... 10.9 Printer Socket....................................................................................................... 10.9 USB Socket........................................................................................................ 10.10 Bar Codes for Using Hand-held Bar Code Reader....................................................... 10.11 Using Bar Codes................................................................................................ 10.11 Changing the Settings........................................................................................ 10.12 Bar Code Setup Menu........................................................................................ 10.13 Interference Substances............................................................................................... 10.24 Data and Symbol Display.............................................................................................. 10.27 Specifications................................................................................................................ 10.29 Measured Parameters, Ranges and Reproducibility to Specimen from Venous Blood...................................................................................................... 10.29 Standardization Analysis Method....................................................................... 10.29 Counting Time.................................................................................................... 10.30 Dilution Ratio...................................................................................................... 10.30 Safety.................................................................................................................. 10.30 Electromagnetic Compatibility............................................................................ 10.30 Environmental Conditions................................................................................... 10.31 Power Requirements.......................................................................................... 10.31 Dimensions and Weight...................................................................................... 10.31 Standard Accessories................................................................................................... 10.32 Options......................................................................................................................... 10.34 Consumables................................................................................................................ 10.36 C.8 Operator’s Manual MEK-6510 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 combined 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-6510 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-6510 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 representative for additional suggestions. This equipment complies with International Standard EN 55011: 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. Products with the CE mark comply with the requirements of In vitro Diagnostic Medical Device Directive 98/79/EC. NOTE about Waste Electrical and Electronic Equipment (WEEE) Directive 2002/96/EC For the member states of the European Union only: The purpose of WEEE directive 2002/96/EC is, as a first priority, the prevention of waste electrical and electronic equipment (WEEE), and in addition, the reuse, recycling and other forms of recovery of such wastes so as to reduce the disposal of waste. Contact your Nihon Kohden representative for disposal. Operator’s Manual MEK-6510 iii 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 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. iv Operator’s Manual MEK-6510 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 AC power off (Disconnection from the mains) Attention, consult operator’s manual AC power on (Connection to the mains) Inlet Main power lamp Outlet “Off” only for part of the equipment Biohazard “On” only for part of the equipment ZK-820V Bar code reader socket Auto print 1 Serial port 1 Feed 2 Serial port 2 Print Printer socket Reset USB socket Clean SD card socket (Read data from store) Count/dispense SD card slot Dispense key (in pre-dilution mode) Alternating current ISOTONAC•3 (diluent) Equipotential terminal CLEANAC (detergent) Fuse (time lag) CLEANAC•3 (detergent) Date of manufacture HEMOLYNAC•3N (hemolysing reagent) Serial number WASTE The CE mark is a protected conformity mark of the European Community. Products marked with this symbol comply with the requirements of the In vitro Diagnostic Medical Device Directive 98/79/EC. Operator’s Manual MEK-6510 IVD IN VITRO DIAGNOSTIC MEDICAL DEVICE Products marked with this symbol comply with the European WEEE directive 2002/96/EC and require separate waste collection. For Nihon Kohden products marked with this symbol, contact your Nihon Kohden representative for disposal. v On screen and recorded data Symbol Description When displayed beside WBC or RBC measured value: Sample error When displayed beside HGB measured value: HGB low voltage When displayed beside WBC measured value: Poor hemolyzation When displayed beside HGB measured value: HGB high voltage When displayed beside MCHC measured value: Abnormal RBC When displayed beside PLT measured value: High background noise When displayed beside HGB measured value: HGB abnormal circuit/WBC measured value is OVER When displayed beside PLT measured value: PLT low value (below 50,000/μL) C When displayed beside WBC or PLT measured value: Platelet coagulation H When displayed beside any measured value: Above than the normal range L When displayed beside any measured value: Below than the normal range F1, F2, F3, F4 When displayed beside LY%, MO% or GR% measured values: Flags (refer to “Description of the RESULTS Screen” in Section 4) Reagent level graph Text Conventions in this Manual In this manual, procedural instructions are explained in logical groups, using numbered steps. Illustrations and drawings appear where they are useful to the explanation. Text conventions are as follows: Screen Name The screen name is printed in uppercase, regular letters; for example, READY screen. Touch Screen Keys The screen has some touch screen keys which are pressure-sensitive. Pressing one of these touch screen keys initiates the action specified by a screen label. Screen labels are shown in uppercase, regular letters; for example, QUALITY CONTROL key. Data Entry Field Names Fields that accept data entered by the Operator have their names shown in regular, mixed-case font enclosed within carats < >. Hard Keys (Keys on the Panels) The keys on the panels are shown in regular, mixed-case font enclosed in brackets; for example, [Clean]. Screen Messages Screen messages or other screen displays will appear in regular, mixed-case font enclosed in quotation marks, for example, “Priming”. Information Screen name Touch screen keys Field names Hard keys (Panel keys) Screen message vi Presentation Regular, UPPERCASE Regular, UPPERCASE Regular, Mixed-Case, enclosed within carats < > Regular, Mixed-Case, enclosed within brackets Regular, Mixed-Case, enclosed within quotation marks Examples MENU screen QUALITY CONTROL <Dilute mode> [Clean] “Priming” Operator’s Manual MEK-6510 Section 1 General Introduction........................................................................................................................................................... 1.2 Measured Parameters................................................................................................................................ 1.2 Features............................................................................................................................................................... 1.3 Panel Description................................................................................................................................................. 1.5 Front Panel................................................................................................................................................. 1.5 Right Side Panel......................................................................................................................................... 1.6 Rear Panel................................................................................................................................................. 1.7 Caution Labels on the Analyzer............................................................................................................................ 1.8 Flowchart of Screens............................................................................................................................................ 1.9 Basic Operations................................................................................................................................................ 1.11 Screen Information................................................................................................................................... 1.11 Shortcut Function..................................................................................................................................... 1.11 Using Touch Screen Keys......................................................................................................................... 1.12 General Safety Information................................................................................................................................. 1.13 General..................................................................................................................................................... 1.13 Installation................................................................................................................................................ 1.13 Measurement........................................................................................................................................... 1.14 Reagents and Consumable...................................................................................................................... 1.14 Maintenance............................................................................................................................................. 1.15 Disposal.................................................................................................................................................... 1.15 Operator’s Manual MEK-6510 1.1 1 1. GENERAL Introduction The MEK-6510J/MEK-6510K Automated Hematology Analyzer is designed for simultaneous 19-parameter 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 a color LCD screen. An optional printer allows full reports. The analyzer automatically cleans the remaining blood on the sampling nozzle, so it is safe and there is no risk of touching the blood. The analyzer has selfcheck, quality control and other programs to provide reliable data management system. To achieve full performance, thoroughly read this operator’s manual before operating the analyzer. To use the analyzer safely and effectively and keep it in optimum condition, follow the operating and maintenance instructions in this manual. NOTE • Use only Nihon Kohden parts and accessories to assure maximum performance from your instrument. • For simplicity, the suffixes J/K are omitted in this manual. There is no difference in operation among models with different suffixes unless otherwise specified. Measured Parameters WBC: RBC: HGB: HCT: MCV: MCH: MCHC: PLT: LY%: MO%: GR%: LY: MO: GR: RDW-CV: RDW-SD: PCT: MPV: PDW: 1.2 White Blood Cell Count Red Blood Cell Count Hemoglobin Concentration Hematocrit (%) Mean Corpuscular Volume (fL) Mean Corpuscular Hemoglobin (pg) Mean Corpuscular Hemoglobin Concentration (g/dL) Platelet Count Lymphocyte Percent Monocyte Percent Granulocyte Percent Lymphocyte Count Monocyte Count Granulocyte Count Coefficient of Variation of the Red Blood Cell Distribution Width Standard Deviation of the Red Blood Cell Distribution Width Platelet Crit Mean Platelet Volume Platelet Distribution Width Operator’s Manual MEK-6510 1. GENERAL 1 Features Simultaneous 19 parameter measurement The analyzer simultaneously measures 19 parameters. WBC is differentiated into 3 parameters, lymphocyte, monocyte and granulocyte. WBC, RBC and PLT are measured by electrical resistance detection method. Automatic sampling Once the sample is aspirated through the sampling nozzle, all other operations are performed automatically. The sample is automatically diluted and measured. After measurement, the analyzer is cleaned and the waste fluid is automatically treated. Automatic sampling nozzle cleaning The analyzer automatically cleans the remaining blood on the sampling nozzle. There is no risk of touching blood during measurement. Automatic clog removal The analyzer removes blood protein or dust particles from around the aperture caps to prevent clogging after each counting. Even if a clog occurs, the analyzer automatically removes the clog and recounts the sample. High accuracy and reproducibility The analyzer reduces counting error by automatically diluting samples and wiping the sampling nozzle. The analyzer 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 and clogging is prevented. Color LCD screen with touch screen keys The analyzer has a color TFT LCD with 240 × 320 pixel resolution which clearly displays the results and various messages. The touch screen allows easy and intuitive operation of the analyzer. The screen messages prompt the operator through the procedure. Pre-diluted blood counting Pre-diluted blood (10 or 20 µL) can be measured. The sample needs to be diluted before measurement. 30 µL of the venous blood can also be measured. This sample does not need to be diluted before measurement. Automatic self-check When the analyzer is turned on, the analyzer automatically starts priming and checks itself with a calibration signal. If a problem is detected, the LCD displays an alarm message, e.g. BUBBLE, NO DILUENT or CLOG, so you can quickly identify and fix the problem. Operator’s Manual MEK-6510 1.3 1. GENERAL Variety of quality control programs The analyzer contains various programs for quality control for WBC, RBC, PLT, HGB, HCT (MCV), RDW and MPV calibration, mean and CV value calculation and X-R, L & J, XB and XD•CV quality control. Data management The analyzer can store measurement data of up to 400 samples and histograms of up to 50 samples. Stored measurement data can be called up to be printed, deleted or transferred to an external devices. Automatic priming and cleaning The analyzer automatically primes the fluid path when the power is turned on. The analyzer automatically cleans the fluid path when the power is turned off. Access restriction with password Measurement conditions, such as calibration coefficient, normal range and quality control, are managed by the operator who has the password to access these setting screens. Miscalculation caused by inappropriate measurement condition settings can be avoided. 1.4 Operator’s Manual MEK-6510 1. GENERAL 1 Panel Description Front Panel 1 5 6 2 7 8 9 3 10 4 11 12 13 14 15 No. Name 1 LCD display 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Description Displays various messages, measured data and touch screen keys. Aspirates the sample and starts counting when <[Eject] key operation> is set to “Count” Count key on the OPERATION screen of the SETTINGS screen. Dispenses the diluent in pre-dilution blood mode when <[Eject] key operation> is set to Dispense key “Dispense” on the OPERATION screen of the SETTINGS screen. Sampling nozzle Aspirates the sample. Dispenses the diluent when in the pre-dilution blood mode. Count switch Aspirates the sample and starts counting. Main power lamp Lights when the [Main power] switch on the rear panel is tuned on. Lights when the [Main power] switch on the rear panel and the [Power] key on the front Power lamp panel are turned on. Turns the analyzer power on or off when the [Main power] switch on the rear panel Power key is turned on. When the power is turned on, priming and self-check are automatically performed, and the READY screen appears. Stops operation when pressed during operation. Returns to the READY screen when Reset key pressed while changing settings. Use this key only when an error occurs. Cleans the fluid path, aperture and manometer with detergent. Automatically primes after Clean key cleaning the fluid path. Press this key when clogging occurs, the manometer becomes dirty or bubbles occur in the manometer. Auto print mode lamp Lights when automatic printing mode is selected. Auto print key Switches the printing mode between automatic and manual for the printer. Feed key Feeds paper of the printer while held down. Print key Prints displayed data on the printer. Printer unit (WA-650VK) Thermal array printer. Prints out measured data and sample ID number (optional). For the recording paper of the WA-650VK printer unit. To open, pull the upper left Printer door corner (optional). Operator’s Manual MEK-6510 1.5 1. GENERAL Right Side Panel 1 No. 1 2 3 4 5 1.6 Name ISO3 Diluent inlet CLN Detergent inlet CLN3 Deteregent inlet HEMO3N Lysing reagent inlet WASTE Waste outlet 2 3 4 5 Description Inlet for ISOTONAC•3 diluent Inlet for CLEANAC detergent Inlet for CLEANAC•3 detergent Inlet for Hemolynac•3N lysing reagent Outlet for waste such as used lyse, detergent and aspirated samples Operator’s Manual MEK-6510 1. GENERAL Rear Panel 1 CAUTION Connect only the specified instrument to the analyzer and follow the specified procedure. Failure to follow this instruction may result in electrical shock or injury to the operator, and cause fire or instrument malfunction. 1 2 3 8 4 9 5 6 10 No. Name 1 ZK-820V Bar code reader socket 2 3 4 Serial port 1 Serial port 2 Printer socket 5 USB socket 6 SD memory card slot Equipotential ground terminal 7 8 Main power switch 9 Fuse holder 10 AC SOURCE AC source socket Operator’s Manual MEK-6510 7 Description Connects to the optional hand-held bar code reader. Supplies the power to the bar code reader when connected. Power supply voltage: 5 V DC (pin 9: 5 V, pin 5: GND) Rated current: 200 mA Connects to the optional WA-460V/461V card printer or PC. Connects to the optional WA-460V/461V card printer or PC. Connects to an external printer (WA-710V/712V or other). Connects to a PC. The optional Data Management Software (DMS) needs to be installed on the PC to receive data from the analyzer. For details on the DMS, contact your Nihon Kohden representative. Insert an SD memory card. Connects the ground lead to the equipotential ground terminal on the wall for earth grounding. Supplies the power to the analyzer when it is turned on. Under normal conditions keep this switch turned on. Contains the time lag fuse. To replace the fuse, contact your Nihon Kohden representative. Connects the AC power cord to supply AC power to the analyzer. 1.7 1. GENERAL Caution Labels on the Analyzer Refer to “Connecting Tubes” in Section 2. Refer to “Inside Panel Components” in Section 9. Refer to “Inside Panel Components” in Section 9. Refer to “Replacing Filters” in Section 9. Refer to warnings and cautions in “Connecting the Power Cord and Grounding the Analyzer” in Section 2. Refer to warnings and cautions in “Connecting an External Instrument to the Analyzer” in Section 2. 1.8 Operator’s Manual MEK-6510 1. GENERAL 1 Flowchart of Screens Power ON READY CHECKING Measuring background noise (When “Background measurement at power on” is set to YES on the SETTINGS screen) READY Measurement RESULTS READY (OK key) SEND ID ID (SET key) MENU RESULTS ID CALIBRATION CAL OPEN Same as CAL CLOSED CAL Pre-dil (PREDILUTION) Same as CAL CLOSED DATA DETAILS EDIT EDI ID SEARCH SD DATA SEARCH RESULTS DETAILS DETAILS SEARCH SEARCH RESULTS DETAILS QC (QUALITY CONTROL) X-R or L & J Measurement X-R or L & J (NORMAL) X-R or L & J (NORMAL) measurement results HISTORY DETAILS CV GRAPH Set initial and limit values (Only for X-R) Auto set initial and limit values Results X-R or L & J (HIGH) Same as X-R or L & J (NORMAL) X-R or L & J (LOW) Same as X-R or L & J (NORMAL) DELETE X-R or L & J XB GRAPH Set initial and limit values Auto set initial and limit values XD CV TOTAL QC SETTINGS Operator’s Manual MEK-6510 1.9 1. GENERAL SETTINGS SAMPLE TYPE EDIT NORMAL RANGE SENS/THRESHOLD HISTORY MEASUREMENT DATE & TIME DISPLAY OUTPUT INTERNAL PRINTER EXTERNAL PRINTER EPSON VP page length Header SERIAL PORT 1 SERIAL PORT 2 USB SD CARD Format LANGUAGE UNITS SOUND/LCD OPERATION AUTO CLEANING USERS PASSWORD ADD USER INITIALIZE OPERATIONS PRIME PRIME ON INSTALL REMOVE CLOG DRAIN BATHS DRAIN ALL STRONG CLEAN OTHER OPERATION HISTORY CIRCUIT CHECK SENSOR MONITOR BACKGROUND DAILY OUTPUT MAINTENANCE REPLACE DILUENT REPLACE DETERGENT REPLACE LYSING REAGENT RESET ALL REAGENT MANAGE REAGENT Change level SERVICE (This screen is for service personnel when performing maintenance.) 1.10 Operator’s Manual MEK-6510 1. GENERAL 1 Basic Operations Screen Information Shortcut key Screen name Status bar When the type of operator is service, the status bar is orange. When the type of operator is lab technician, the status bar is blue. When the type of operator is other user, the status bar is green. For details, refer to “Assigning Users and Passwords” in Section 3. Date and time Check box Page status bar This example indicates that there are two pages. The displayed page is indicated by light blue. Shortcut Function Press the shortcut key on the status bar to display the Shortcut window. You can go to the READY, RESULTS or DATA screen from any other screen by using the Shortcut window. Shortcut key Shortcut window Operator’s Manual MEK-6510 1.11 1. GENERAL Using Touch Screen Keys NOTE Do not use a sharp object to press the touch screen key. Use your finger. Displays the selection list. Selection list Cursor (blue) Use arrow keys to move cursor. Page status bar Go to the previous or next page. Use the numeric keys to enter a value and press the Enter key to register the setting. Press the keys with triangle to display a selection list to select an item. Press bottom keys to display another screen. 1.12 Select a setting by pressing a check box. Operator’s Manual MEK-6510 1. GENERAL 1 General Safety Information General WARNING WARNING Never use the analyzer in the presence of any flammable anesthetic gas or high concentration oxygen atmosphere. Failure to follow this warning may cause explosion or fire. Never use the analyzer in a hyperbaric oxygen chamber. Failure to follow this warning may cause explosion or fire. WARNING WARNING Do not diagnose a patient based only on data acquired by the analyzer. Overall judgement must be performed by a physician who understands the features, limitations and characteristics of the analyzer and by reading the biomedical signals acquired by other instruments. Do not use the analyzer near an ESU. Noise from the ESU may cause the analyzer to malfunction. Installation WARNING Install the analyzer outside the patient environment (IEC 60601-1-1). If it is installed inside the patient environment, the patient or operator may receive electrical shock or injury. For installation, contact your Nihon Kohden representative. CAUTION Only use the provided power cord. Using other power cords may result in electrical shock or injury to the operator. CAUTION Connect only the specified instrument to the analyzer and follow the specified procedure. Failure to follow this instruction may result in electrical shock or injury to the operator, and cause fire or instrument malfunction. Operator’s Manual MEK-6510 CAUTION When several medical instruments are used together, ground all instruments to the same one-point ground. Any potential difference between instruments may cause electrical shock to the operator. CAUTION Before connecting or disconnecting instruments, make sure that each instrument is turned off and the power cord is disconnected from the AC socket. Otherwise, the operator may receive electrical shock or injury. 1.13 1. GENERAL Measurement WARNING Always wear rubber gloves to protect yourself from infection. CAUTION When an alarm occurs, the acquired data might not be correct, especially when “!” or “sample error” message appears. Do not use the data for diagnosis. Recount the sample. CAUTION Set the ID correctly. Otherwise, the examination data may be mixed up with data of another examination. Reagents and Consumable CAUTION CAUTION Only use Nihon Kohden specified reagents and consumables. Otherwise the measurement result cannot be guaranteed and incorrect reagent concentration can cause equipment damaged. Do not reuse disposable parts and accessories. Hemolynac•3N CLEANAC CAUTION • Do not swallow Hemolynac•3N lysing reagent. If swallowed, see a physician immediately. • If lysing reagent contacts the skin, eyes or mouth, wash thoroughly and immediately with water and see a physician. WARNING Do not swallow CLEANAC detergent. If swallowed, see a physician immediately. CLEANAC•3 WARNING WARNING If CLEANAC•3 detergent contacts the eyes, wash immediately with plenty of water for at least 15 minutes and see a physician. The detergent can cause blindness. • Do not allow CLEANAC•3 detergent to come into contact with acid. Contact with acid can release poisonous chlorine gas. • Do not inhale the detergent. If inhaled, move to fresh air, rest in a posture which allows easy breathing and see a physician. • Do not swallow the detergent. If swallowed, rinse the mouth immediately. See a physician. • If the detergent contacts the skin, wash thoroughly and immediately with water and see a physician. • Wear rubber gloves or goggles to protect yourself when handling the detergent. 1.14 Operator’s Manual MEK-6510 1. GENERAL Maintenance 1 WARNING WARNING • Be careful not to directly touch any place where blood sample is or may have contacted. • Always wear rubber gloves to protect yourself from infection. The sampling nozzle is sharp and potentially contaminated with infectious materials. Be careful when handling the sampling nozzle. CAUTION CAUTION Turn off the analyzer main power before maintenance. Otherwise, the operator may receive electrical shock and the analyzer may malfunction. Do not remove any parts that are not specified in this manual. CAUTION Before moving the analyzer, turn off the analyzer main power and remove the AC power cord from the outlet. Otherwise, the operator may receive electrical shock. Disposal WARNING • Dispose of the analyzer, replaced parts (such as sampling nozzle), waste fluid and parts used for collecting sample blood (such as needles, syringes and vials) by following your local laws for disposing of infectious medical waste (for incineration, melt treatment, sterilization and disinfection). • Before disposing of the analyzer, perform strong cleaning and remove the sampling nozzle from the analyzer. If the above warning is not followed, it causes infection or environmental contamination. WARNING Always wear rubber gloves to protect yourself from infection. CAUTION If blood sample or reagent contacts the skin, eyes or mouth, wash thoroughly and immediately with water and see a physician. Operator’s Manual MEK-6510 1.15 Section 2 Preparation Environmental Requirements............................................................................................................................... 2.2 Initial Preparation.................................................................................................................................................. 2.3 Inventory..................................................................................................................................................... 2.3 Standard Accessories................................................................................................................................ 2.3 Unpacking.................................................................................................................................................. 2.4 Installation Flowchart............................................................................................................................................ 2.5 Connecting an External Instrument to the Analyzer............................................................................................. 2.6 Connecting a PC........................................................................................................................................ 2.7 Connecting a Printer.................................................................................................................................. 2.8 Connecting a Card Printer.......................................................................................................................... 2.8 Connecting a Hand-held Bar Code Reader................................................................................................ 2.9 Connecting the Power Cord and Grounding the Analyzer.................................................................................. 2.10 Connecting the Power Cord..................................................................................................................... 2.10 Equipotential Grounding........................................................................................................................... 2.10 Connecting Tubes and Installing Reagents........................................................................................................ 2.11 Materials Required................................................................................................................................... 2.11 Connecting Tubes..................................................................................................................................... 2.13 Diluent Tube................................................................................................................................... 2.14 Detergent Tube............................................................................................................................... 2.14 Lysing Reagent Tube...................................................................................................................... 2.15 Waste Fluid Tube............................................................................................................................ 2.15 Loading Recording Paper in the WA-650VK Printer Unit (Option)...................................................................... 2.16 Preparing an SD Memory Card.......................................................................................................................... 2.17 Safety Information about the SD Memory Card....................................................................................... 2.17 Handling and Storage.................................................................................................................... 2.17 Data Processing............................................................................................................................. 2.17 Inserting and Removing the SD Memory Card........................................................................................ 2.18 Turning Power On/Off......................................................................................................................................... 2.19 Check Before Turning Power On.............................................................................................................. 2.19 Turning On the Power............................................................................................................................... 2.19 Checking the Date and Time Settings...................................................................................................... 2.20 Cleaning the Fluid Path After Turning the Power On (PRIME ON INSTALL)............................................ 2.21 Check After Turning On the Power........................................................................................................... 2.22 Daily Shutdown........................................................................................................................................ 2.23 Checking List Before Turning the Power Off................................................................................... 2.23 Turning the Power Off..................................................................................................................... 2.23 Check List After Turning Power Off................................................................................................ 2.24 Check List Before Long Term Storage........................................................................................... 2.24 Checking Daily Accuracy.................................................................................................................................... 2.25 Measuring Background Noise.................................................................................................................. 2.25 Measuring by Pressing the [ Count] Switch or Key..................................................................... 2.25 Measuring on the BACKGROUND Screen.................................................................................... 2.26 Results........................................................................................................................................... 2.27 Measuring Hematology Control................................................................................................................ 2.28 Operator’s Manual MEK-6510 2.1 2 2. PREPARATION Environmental Requirements WARNING Install the analyzer outside the patient environment (IEC 60601-1-1). If it is installed inside the patient environment, the patient or operator may receive electrical shock or injury. For installation, contact your Nihon Kohden representative. • Operate the analyzer in the following conditions. Keep the temperature of diluent and lysing reagent within the temperature in order to obtain reliable data. Temperature: 15 to 30°C (59 to 86°F) Humidity: 30 to 85% (noncondensing) Air pressure: 700 to 1060 hPa • No measurement can be done in dusty areas because the aperture for specimen aspiration is very fine and can get clogged. Therefore, install the analyzer in a dust-free area. • Do not install the analyzer in direct sunlight. • Do not place containers of reagent or fluid on the analyzer. To prevent electrical problems or electric shock, avoid spillage in or around the analyzer because the fluid is highly conductive. • Select a stable, flat buffering stand to set the analyzer on. •If possible, use an independent AC outlet only for this analyzer. The analyzer must not share an AC outlet with noise generating equipment such as a centrifuge, constant temperature bath (thermostat), refrigerator, air conditioner or ultrasonic cleaner. 5 cm Rear • Make sure that there is more than 5 cm of space between the rear panel and the wall and 15 cm of space between the left panel and the wall for adequate ventilation. 15 cm Side Top view 2.2 • When there is any problem in the analyzer, turn off the main power immediately and disconnect the power cord from the AC outlet. Take the analyzer out of service and check for damage. Operator’s Manual MEK-6510 2. PREPARATION Initial Preparation 2 Inventory Confirm that the analyzer shipment contains the following: • MEK-6510J or MEK-6510K Hematology Analyzer • Standard accessories • Reagents • Controls and Calibrator • Operator’s Manual • Printer (optional) • Hand-held Bar Code Reader (optional) Standard Accessories • Power cord • Ground lead • Fuse, 2.0 A time-lag amps 110 to 127 V for MEK-6510J or 1.0 A time-lag amps 220 to 240 V for MEK-6510K (2) • Filter assy (3) • Pump tube (N) assy • Sampling nozzle • Diluent tube, marked blue, 1.5 m • Waste tube, marked red, 0.4 m • Detergent tube for CLEANAC, marked green, 1.5 m • Cleanac tube 8 for CLEANAC•3, marked white, 1.5 m • 18 L container cap (3) • 18 L waste tube assy 2 • 5 L tube assy (2) • 2 L waste container • Hemolynac•3 cap • Hemolynac•3 tube assy, marked yellow • 2 L waste tube assy • MEK cap Visually inspect these items for damage. If there is any damage, contact your Nihon Kohden representative. Operator’s Manual MEK-6510 2.3 2. PREPARATION Unpacking Remove the analyzer from the shipping container and visually inspect for damage. If there is any damage, contact your Nihon Kohden representative. NOTE Use two people when lifting or moving the analyzer. Otherwise, you may injure your back or be injured from dropping the analyzer. Hold the bottom corners with two people to move the analyzer. 2.4 Operator’s Manual MEK-6510 2. PREPARATION Installation Flowchart 2 1. Place the analyzer in the appropriate place. 2. Connect external instruments such as printer, hand-held bar code reader and PC, if necessary. 3. Connect the power cord and if necessary, perform grounding. Do not turn on the power of any instrument at this stage. 4. Connect diluent, detergent, lysing reagent and waste container to the analyzer. 5. Check that pump tubes are not disconnected or damaged. 6. Turn on the power of the analyzer and connected external instruments. 7. Perform PRIME ON INSTALL on the OPERATIONS screen. 8. Check the settings on the SETTINGS screen. Make sure that the date and time settings are correct. Refer to Section 3. 9. Calibrate the analyzer. Refer to Section 7. 10. Check the daily accuracy. Operator’s Manual MEK-6510 2.5 2. PREPARATION Connecting an External Instrument to the Analyzer A personal computer and a card printer (WA-460V/461V or equivalent) can be connected to the serial port and a hand-held bar code reader can be connected to the bar code reader socket on the rear panel. An external printer can be connected to the printer socket. A PC can also be connected to the USB socket, but the optional Data Management Software must be installed on the PC to receive data from the analyzer. For details on the Data Management Software, contact your Nihon Kohden representative. Before connecting the external instrument to the analyzer, make sure that the power on the instruments are turned off. For changing the printing and communication format, refer to “Changing Output Format” in Section 3. CAUTION When several medical instruments are used together, ground all instruments to the same one-point ground. Any potential difference between instruments may cause electrical shock to the operator. 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. 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 instrument to the analyzer and follow the specified procedure. Failure to follow this instruction may result in electrical shock or injury to the operator, and cause fire or instrument malfunction. CAUTION Before connecting or disconnecting instruments, make sure that each instrument is turned off and the power cord is disconnected from the AC socket. Otherwise, the operator may receive electrical shock or injury. 2.6 Operator’s Manual MEK-6510 2. PREPARATION Connecting a PC A locally purchased PC can be connected to the serial port or USB port on the rear panel. The measured data can be automatically transferred to the PC after measurement. 2 When the PC is connected to the USB port, the optional Data Management Software must be installed on the PC to receive data from the analyzer. For details on the Data Management Software, contact your Nihon Kohden representative. Serial ports USB port Connect the serial cable to the PC and the serial port or USB port on the analyzer. For changing the transfer and communication format, refer to “Changing Output Format” in Section 3. For details on the RS-232C data transfer format, refer to “RS-232C Data Transfer” in Section 10. NOTE • Only connect a PC which complies with IEC 60950. • Only use a 3-prong power cord for the PC. Operator’s Manual MEK-6510 2.7 2. PREPARATION Connecting a Printer The following printers can be connected to the printer socket on the analyzer. For details on the type of printer that can be used with the analyzer, contact your Nihon Kohden representative. Printer socket • • • • WA-710V/712V printer SEIKO EPSON VP type SEIKO EPSON PM type CANON PIXUS type NOTE Printer cannot be connected to the USB port on the analyzer. Connect the printer cable to the printer and the printer socket on the analyzer. For changing the printing and communication format, refer to “Changing Output Format” in Section 3. NOTE Connect an external printer via bidirectional parallel interface complying with IEEE1284 standard. When the printer is connected to the analyzer and changing settings on the analyzer is complete, run self-test printouts before using the printer for the first time to verify proper printer operation. NOTE The analyzer software automatically adjusts most print conditions for the printer, including page width. Occasionally, a few settings may need to be changed in the printer’s software for correct operation. If printing is not what you expect, refer to the printer manual for guidance in making adjustments. Connecting a Card Printer The WA-460V/461V card printer can be connected to the serial port on the analyzer. On the WA-460V/461V card printer, only the numeric data is printed. Histograms cannot be printed. Serial ports 2.8 Connect the card printer cable to the card printer and the serial port on the analyzer. For changing the printing and communication format, refer to “Changing Output Format” in Section 3. Operator’s Manual MEK-6510 2. PREPARATION Connecting a Hand-held Bar Code Reader The optional BL-N60NK hand-held bar code reader can be used for reading the bar code label (up to 13 characters) on the sample tube. For details about the hand-held 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 • CODABAR (NW-7) • CODE 39 • CODE 93 • CODE 128 Bar code socket Before turning on the analyzer power by pressing the [Power] key on the front panel, connect the bar code reader cable to the bar code socket on the rear panel. When the bar code reader is connected, the power is supplied through pin 9 of the bar code reader socket. NOTE Do not connect instruments other than hand-held bar code reader to the bar code reader socket. To set the various settings for the hand-held bar code reader, read the bar code attached to the bar code reader manual with the hand-held bar code reader within 15 seconds after turning the bar code reader power on. After changing the settings, turn the bar code reader power off. You can also use the bar codes in “Bar Codes for Using Hand-held Bar Code Reader” in Section 10. Operator’s Manual MEK-6510 2.9 2 2. PREPARATION Connecting the Power Cord and Grounding the Analyzer Connecting the Power Cord CAUTION Only use the provided power cord. Using other power cords may result in electrical shock or injury to the operator. Connect the provided power cord to the AC SOURCE socket on the rear panel and plug the cord into a 3-prong AC outlet. Equipotential Grounding CAUTION When several medical instruments are used together, ground all instruments to the same one-point ground. Any potential difference between instruments may cause electrical shock to the operator. 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. 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 analyzer to the equipotential ground terminal on the wall (equipotential grounding system) with the equipotential grounding lead (potential equalization conductor). 2.10 Operator’s Manual MEK-6510 2. PREPARATION Connecting Tubes and Installing Reagents 2 In order for the analyzer to operate correctly, you must install all reagent and waste tube before the power is turned on. Materials Required • • • • • • • • • Powder-free gloves, lab coat, safety goggles ISOTONAC•3 diluent CLEANAC detergent CLEANAC•3 detergent Hemolynac•3N lysing reagent Reagent inlet tubes and waste outlet tube Waste container (or appropriate drain) 2 L container Lint-free cloth CAUTION Only use Nihon Kohden specified reagents and consumables. Otherwise the measurement result cannot be guaranteed and incorrect reagent concentration can cause equipment damaged. • • • • NOTE When setting and using a reagent, do not let dust enter the reagent container. If dust gets in the analyzer, correct measurement data may not be acquired or the analyzer may get damaged. If dust gets in a reagent container, wash the inside of the container with reagent. The usage environment of the reagents is between 15 and 30°C. Especially when using the diluent, temperatures outside the normal range may cause unstable measurement data. Do not use reagent which is past the expiration date. Diluent (ISOTONAC•3) NOTE • Do not swallow diluent. • If diluent contacts the skin or eyes or is swallowed, wash immediately and thoroughly with water. • Use diluent at room temperature (15 to 30ºC). • If the diluent is frozen, warm it at room temperature (15 to 30ºC) and stir it sufficiently. • Handle the diluent as follows. Otherwise the measurement data may be inaccurate due to background noise. - Do not leave the diluent container with the diluent tube inserted and the cap opened. Do not put the diluent tube on a desk. - When changing the diluent, do not let dust or germs get inside the diluent container. Operator’s Manual MEK-6510 2.11 2. PREPARATION - Do not mix fresh diluent and old diluent in the container. - Use the diluent within 60 days after opening. Detergent CLEANAC WARNING Do not swallow CLEANAC detergent. If swallowed, see a physician immediately. • • • • NOTE If CLEANAC detergent contacts the skin or eyes or is swallowed, wash immediately and thoroughly with water. Store CLEANAC detergent at room temperature (15 to 30ºC). If CLEANAC detergent is frozen, warm it at room temperature (15 to 30ºC) and stir it sufficiently. Do not mix fresh detergent and old detergent in the container. CLEANAC•3 WARNING If CLEANAC•3 detergent contacts the eyes, wash immediately with plenty of water for at least 15 minutes and see a physician. The detergent can cause blindness. WARNING • Do not allow CLEANAC•3 detergent to come into contact with acid. Contact with acid can release poisonous chlorine gas. • Do not inhale the detergent. If inhaled, move to fresh air, rest in a posture which allows easy breathing and see a physician. • Do not swallow the detergent. If swallowed, rinse the mouth immediately. See a physician. • If the detergent contacts the skin, wash thoroughly and immediately with water and see a physician. • Wear rubber gloves or goggles to protect yourself when handling the detergent. • • • • 2.12 NOTE Store CLEANAC•3 detergent at room temperature (15 to 30ºC). If CLEANAC•3 detergent is frozen, warm it at room temperature (15 to 30ºC) and stir it sufficiently. Do not leave the CLEANAC•3 detergent container with the detergent tube inserted and the cap opened. This weakens the detergent and the analyzer may not be cleaned adequately. Do not mix fresh detergent and old detergent in the container. Operator’s Manual MEK-6510 2. PREPARATION Lysing Reagent Hemolynac•3N 2 CAUTION • Do not swallow Hemolynac•3N lysing reagent. If swallowed, see a physician immediately. • If lysing reagent contacts the skin, eyes or mouth, wash thoroughly and immediately with water and see a physician. NOTE • If Hemolynac•3N lysing reagent is frozen during shipment or low temperature storage, background noise may increase. In this case, leave the lysing reagent at 25 to 30ºC for 2 days and shake well. Before use, make sure there are no bubbles in the lysing reagent. • Do not mix fresh lysing reagent and old lysing reagent in the container. • Use the lysing reagent within 90 days after opening. Connecting Tubes • • • • • • NOTE Do not squeeze or bend the tubes. Otherwise the tube is accidentally removed or the analyzer may be damaged. Try to keep the diluent and detergent containers at the same level as the analyzer. If necessary, cut the diluent tube and reagent tube to an appropriate length when the length of the tube does not fit. For the detergent, use only the specified tubes. Follow the instructions on each package for handling the reagent. Be careful not to let dust enter lysing reagent, diluent and detergent. After connecting the tubes, take care not to block the air holes on the caps. Waste container Diluent (ISOTONAC•3) Lysing reagent (Hemolynac•3N) Detergent (CLEANAC) Operator’s Manual MEK-6510 Detergent (CLEANAC•3) 2.13 2. PREPARATION Diluent Tube Connect ISOTONAC•3 (18 or 20 L) to the analyzer. NOTE • Place the diluent container at the same level as the analyzer. • Do not let dust or germs get inside the diluent container. Correct measurement data cannot be obtained. 18 L container cap 18 L tube assy 2 Diluent tube (marked blue) 1. Connect the diluent tube (marked blue) to the ISO3 inlet on the right side panel. 2. Pass the diluent tube through the 18 L container cap. 3. Connect the end of the diluent tube to the 18 L tube assy 2. ISOTONAC•3 diluent (18 L) 4. Put the 18 L tube assy 2 into the diluent container and tighten the 18 L container cap. Detergent Tube NOTE • Place the detergent containers at the same level as the analyzer. • Only use the specified detergent tubes for the detergent. For performing STRONG CLEAN, use CLEANAC•3 detergent (1 or 5 L). For other purposes, use CLEANAC detergent. CLEANAC Detergent 1. Connect the detergent tube (marked green) to the CLN inlet on the right side panel. 18 L container cap Detergent tube (marked green) CLEANAC detergent (5 L) 2.14 2. Pass the detergent tube through the 18 L container cap. 5 L tube assy 3. Connect the end of the detergent tube to the 5 L tube assy. 4. Put the 5 L tube assy into the CLEANAC detergent container and tighten the 18 L container cap. Operator’s Manual MEK-6510 2. PREPARATION CLEANAC•3 Detergent NOTE When using 1 L of CLEANAC•3, the 1 L tube assy (YZ-001B7) is required. Contact your Nihon Kohden representative. 2 1. Connect the cleanac tube 8 (marked white) to the CLN3 inlet on the right side panel. 18 L container cap 2. Pass the cleanac tube 8 through the 18 L container cap. 5 L tube assy 3. Connect the end of the cleanac tube 8 to the 5 L tube assy. Cleanac tube 8 (marked white) 4. Put the 5 L tube assy into the CLEANAC•3 container and tighten the 18 L container cap. CLEANAC•3 detergent (5 L) Lysing Reagent Tube Hemolynac•3N 1. Replace the lysing reagent cap with the Hemolynac•3 cap and tighten the cap. 2. Connect the Hemolynac•3 tube assy (marked yellow) to the HEMO3N inlet on the right side panel. Hemolynac•3 tube assy (marked yellow) 3. Put the other end of the tube into the lysing reagent container through the Hemolynac•3 cap. Hemolynac•3 cap Hemolynac•3N lysing reagent Waste Fluid Tube 1. Connect the waste tube (marked red) to the WASTE outlet on the right side panel. 2. Pass the waste tube through the MEK cap. MEK cap Waste tube (marked red) 2 L waste tube assy Waste container (2 L) Operator’s Manual MEK-6510 3. Connect the waste tube to the 2 L waste tube assy. 4. Insert the 2 L waste tube assy into the waste container and tighten the MEK cap. NOTE • Place the waste container at the same level as the analyzer. • The waste is under pressure. Be sure that the waste tube is securely placed in the waste container, flow of waste is unobstructed, and all analyzer components are located away from possible waste overflow. 2.15 2. PREPARATION Loading Recording Paper in the WA-650VK Printer Unit (Option) NOTE • The WA-650VK printer unit is optional (built-in type). • Only use the specified recording paper. 1. Open the printer door. 2. Set the recording paper in the paper tray in the direction as shown. 3. Insert the recording paper into the slot. 4. Press the [ Feed] key on the front panel until the recording paper comes out from the printer unit. 5. Put the paper through the opening of the door and close the door. 6. Cut the extra paper. 2.16 Operator’s Manual MEK-6510 2. PREPARATION Preparing an SD Memory Card 2 Use an SD memory card to save measurement data. NOTE • Operation with a mini or micro SD card with conversion adapter cannot be guaranteed. • An SDHC or SDXC memory card cannot be used. Safety Information about the SD Memory Card Handling and Storage • Keep the SD memory card slot clean. If dust gets into the slot, the SD memory card will not function. • Do not handle the SD memory card while eating or drinking. • Do not get the SD memory card wet. • Do not give impact to the SD memory card by dropping or bending. • Do not expose the SD memory card to direct sunlight or leave it in a high temperature place. Environmental Conditions • Storage environment Temperature: –20 to +65°C (–4 to +149°F) Humidity: less than 95% (noncondensing) • Operating environment: same as the analyzer Data Processing • Initialize the SD memory card on this analyzer. An SD memory card that was initialized on another instrument cannot be used. Refer to “Formatting the SD Memory Card” in Section 3. • Do not use an unspecified instrument to save data to the SD memory card. The card may become unusable for this analyzer. • Do not remove the SD memory card, turn off the power, or press the [Reset] key during data processing. This may damage the card. Operator’s Manual MEK-6510 2.17 2. PREPARATION Inserting and Removing the SD Memory Card NOTE • When inserting or removing the SD memory card, turn off the power of the analyzer. The data in the card may get damaged or the analyzer might not operate correctly. • Do not bend the SD card or insert it at an angle. It may cause malfunction on the analyzer. Insert the SD memory card into the SD memory card slot so that the label on the card is toward the front. When removing the SD memory card, push the card once. The card pops out. Insert Remove 2.18 Operator’s Manual MEK-6510 2. PREPARATION Turning Power On/Off 2 Check Before Turning Power On Check the following items before turning on the power. Item Check Accessories and Sufficient diluent, detergent and lysing reagent. consumables Connection and settings Power cord is connected properly. Grounding lead is connected properly when equipotential grounding is required. Tubes are connected properly. Diluent, detergent and lysing reagent containers are connected and have no dust in them. Waste container is in place and empty. Enough recording paper in the optional printer. External instruments (e.g. PC and printer) are properly connected. Appearance 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. Analyzer is not wet. Use after long term Aperture caps are clean. storage Pump tube is not broken and not disconnected. Turning On the Power 1. Confirm that the analyzer, printer (optional), and hand-held bar code reader (optional) power cords are connected to grounded power outlets. 2. Set the printer power switch ON. 3. Press the [Main power] switch on the rear panel to ON. The green [Main power lamp] on the front panel lights. Always leave the main power ON except for storage and transportation of the analyzer. 4. Press the [Power] key on the front panel ON. The green [Power lamp] lights and the screen illuminates within 15 to 30 seconds. Cleaning of the fluid path, priming and circuit self-check are automatically performed. Operator’s Manual MEK-6510 2.19 2. PREPARATION When there is an error, “Fail” appears. After priming operation is completed, the READY screen appears. The analyzer is ready for counting. NOTE If an error message appears, refer to “Alarm Messages” in Section 8. Checking the Date and Time Settings Date and time 2.20 After turning the analyzer ON, date and time must be checked. To correct the date and time on the upper right corner of the screen, refer to “Setting Date and Time” in Section 3. Operator’s Manual MEK-6510 2. PREPARATION Cleaning the Fluid Path After Turning the Power On (PRIME ON INSTALL) The fluid path inside the analyzer must be cleaned after installation or longterm storage. Perform PRIME ON INSTALL on the OPERATIONS screen. For details, refer to “Using the Analyzer after Storage” in Section 9. 1. Press the MENU key on the READY screen. 2. Press the OPERATIONS key on the MENU screen. Operator’s Manual MEK-6510 2.21 2 2. PREPARATION 3. Press the PRIME ON INSTALL key on the OPERATIONS screen. A confirmation message appears on the screen. 4. Press the YES key to prime the analyzer. Press the NO key to cancel the procedure and the screen returns to the OPERATIONS screen. After priming, the READY screen appears. 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 “Messages and Troubleshooting”. Item Check Turning on the There is no fire, smoke or smell. power The analyzer 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 lamps and LED indication are correct. The measured background noise values are proper. The measured hematology control values are proper. The printer works properly. The date and time are correct. No alarm message is displayed on the screen during operation. After long term Perform PRIME ON INSTALL on the OPERATIONS screen. storage NOTE At the start of the day, check that the date and time settings are correct. 2.22 Operator’s Manual MEK-6510 2. PREPARATION Daily Shutdown To keep the analyzer 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 the Power Off • There is enough lysing reagent, diluent 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 analyzer automatically performs cleaning and the “After cleaning, the power will automatically shut off.” message appears. After the cleaning is completed, the power is automatically turned off. When the sample counts is over 200 when the power is turned off, a message prompts you to perform strong cleaning. Operator’s Manual MEK-6510 2.23 2 2. PREPARATION Press the YES key to perform strong cleaning. After strong cleaning is complete, the power turns off. Press the NO key to not perform strong cleaning. The analyzer automatically performs cleaning and 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 analyzer. Check List After Turning Power Off • • • • There was no leakage during use. The outside enclosure of the analyzer is wiped off and clean. The fluid path is automatically cleaned when the power is turned off. There are no blood clots in the measurement bath or sub bath. Check List Before Long Term Storage • The inside of the analyzer has been cleaned with distilled water. For details, refer to “Storing and Transporting Analyzer” in Section 9. • There is no fluid left inside the analyzer. • The power is turned off. • No chemicals or water are placed around the analyzer. • The analyzer, diluent and detergent are stored properly. • There is enough lysing reagent, diluent and detergent left in the containers. 2.24 Operator’s Manual MEK-6510 2. PREPARATION Checking Daily Accuracy 2 Check the analyzer daily before measurement to assure measurement reliability. For details on the measurement reliability, refer to Section 6 “Quality Control”. • Count the diluent to measure background noise. • Count the MEK-3D hematology control to check accuracy. Measuring Background Noise Count the diluent to measure background noise. Background noise increases in the following cases. Problem Old diluent. Germs begin to breed in the diluent 60 days 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. Countermeasure Replace diluent. Replace diluent. Adjust diluent temperature to 15 to 30°C. Replace the sampling nozzle with a new one. There are two ways to measure background noise. One is by pressing the [ Count] switch or key. The other is using the BACKGROUND screen of the OTHER screen. When measured on the BACKGROUND screen, “Fail” appears beside the parameter which is over the acceptable value on the result screen. Measuring by Pressing the [ Count] Switch or Key Press the [ Count] switch or key to count the diluent. There is no need to aspirate the diluent from the sampling nozzle. The result is displayed after the measurement is complete. Count key The [Count] key becomes the [Dispense] key in pre-dilution blood mode when <[Eject] key operation> is set to “Dispense” on the OPERATION screen of the SETTINGS screen. In this case, the key only functions as the dispense key and does not function in any other way in any other mode. Count switch Operator’s Manual MEK-6510 2.25 2. PREPARATION Measuring on the BACKGROUND Screen 1. Press the MENU key on the READY screen. 2. Press the OTHER key on the MENU screen. 3. Press the BACKGROUND key on the OTHER screen. The “Measure background noise?” message appears on the screen. 2.26 Operator’s Manual MEK-6510 2. PREPARATION 4. Press the YES key to measure background noise. The result is displayed after the measurement is complete. 2 Results The result is displayed on the screen after measurement. When the measurement is performed on the BACKGROUND screen When the measurement is performed by the [ Count] switch Make sure that the values are less than or equal to the following values. WBC: 0.2 (×103/µL) RBC: 0.05 (×106/µL) HGB: 0.1 (g/dL) PLT: 10 (×103/µL) When measured on the BACKGROUND screen, “Fail” appears beside the parameter which is over the acceptable value. Disregard the other parameter values because noise does not affect the other parameters. If the values are greater than the values listed above, check the following items, press the [ Clean] key on the front panel to clean the fluid path and recount the diluent. • • • • • Operator’s Manual MEK-6510 The diluent is clean. No bubbles in the diluent. The aperture caps are clean. The aperture caps are firmly attached. The measurement baths and sub baths are clean. 2.27 2. PREPARATION Measuring Hematology Control For checking accuracy, use a MEK-3D 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 CAUTION Use hematology control before the expiration date. Do not freeze the hematology control because this hemolyses it. CAUTION CAUTION 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 hematology control are hemolyzed. 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. Count key Sampling nozzle Count switch Put the sampling nozzle to this level. 5. Press the [ Count] switch or key on the front panel. The hematology control is aspirated and counting is performed. 2.28 Operator’s Manual MEK-6510 2. PREPARATION After counting, the result appears on the screen. 2 6. Check the data with the assay sheet. NOTE • Calibrate the analyzer 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 representative if the calibration coefficient is over the limit. Operator’s Manual MEK-6510 2.29 Section 3 Changing Settings 3 General................................................................................................................................................................. 3.3 Assigning Users and Passwords.......................................................................................................................... 3.4 General....................................................................................................................................................... 3.4 Displaying the USERS Screen................................................................................................................... 3.5 Adding a User............................................................................................................................................. 3.6 Changing a User........................................................................................................................................ 3.9 Deleting a User......................................................................................................................................... 3.10 Assigning an ID to a Sample.............................................................................................................................. 3.11 Displaying the ID Screen.......................................................................................................................... 3.12 Entering a 4 Digit Numeric ID................................................................................................................... 3.12 Entering a 13 Character Alphanumeric ID............................................................................................... 3.13 Using Bar Codes...................................................................................................................................... 3.14 Labeling and Selecting Sample Types................................................................................................................ 3.15 Labeling Sample Types............................................................................................................................ 3.15 Selecting Sample Types for the Sample Type Selection List.................................................................... 3.17 Setting Normal Range Upper and Lower Limits................................................................................................. 3.18 Default Settings of Upper and Lower Limits............................................................................................. 3.18 Changing the Limits.................................................................................................................................. 3.18 Changing Sensitivity and Threshold................................................................................................................... 3.21 General..................................................................................................................................................... 3.21 Factory Default Settings and Setting Range.................................................................................. 3.21 RBC Automatic Threshold.............................................................................................................. 3.21 Changing Sensitivity and Threshold......................................................................................................... 3.21 Displaying the Sensitivity and Threshold Setting History......................................................................... 3.23 Determining Optimum Sensitivity............................................................................................................. 3.24 Determining Optimum Threshold............................................................................................................. 3.24 Changing Measurement Settings....................................................................................................................... 3.25 Setting Date and Time........................................................................................................................................ 3.28 Changing Display Format................................................................................................................................... 3.30 Changing Output Format.................................................................................................................................... 3.35 Changing Print Format for Internal Printer............................................................................................... 3.37 Changing Print Format for External Printer.............................................................................................. 3.39 Changing Settings for Card Printer.......................................................................................................... 3.44 Changing Format for PC.......................................................................................................................... 3.46 Changing the USB Settings...................................................................................................................... 3.48 Changing the SD Memory Card Settings................................................................................................. 3.49 Formatting the SD Memory Card................................................................................................... 3.50 Selecting Language............................................................................................................................................ 3.51 Selecting Units.................................................................................................................................................... 3.52 Selecting Unit Type................................................................................................................................... 3.52 Counting Unit Table........................................................................................................................ 3.53 Customizing Units.................................................................................................................................... 3.53 Changing Sound and Screen Brightness Settings............................................................................................. 3.54 Operator’s Manual MEK-6510 3.1 Changing Various Settings for Analyzer Power On............................................................................................. 3.55 Setting Auto Priming/Cleaning............................................................................................................................ 3.57 Using Reagent Management.............................................................................................................................. 3.59 Setting the Warning Level......................................................................................................................... 3.59 When the Reagent Management Warning is Displayed........................................................................... 3.61 Initializing Settings.............................................................................................................................................. 3.64 Factory Default Settings........................................................................................................................... 3.66 3.2 Operator’s Manual MEK-6510 3. CHANGING SETTINGS General Before starting measurement, assign an ID to the sample and change any necessary settings such as measurement mode, upper and lower limits, date and time. You can also set a warning window to display when reagent or waste reaches the warning level. Assign an ID on the ID screen which can be displayed from the READY, MENU or RESULTS screen. Set the following items on the SETTINGS screen. You can also initialize settings on the SETTINGS screen. Item SAMPLE TYPE Description Label each sample type. Set the upper and lower limits for each parameter. These NORMAL RANGE limits are used as criteria to decide abnormal values (H and L marks). Set the sensitivity and threshold for WBC, RBC and PLT SENS/THRESH when measuring non-human blood. Set the settings related to measurement, including single MEASUREMENT or double sample counting, pre-dilution blood volume and continuing dilution mode. Select the display format of the date and time and set the DATE & TIME date and time. DISPLAY Select the display format and histograms. Set the printing settings for using printer and OUTPUT communication settings for using PC. LANGUAGE Select the language from English or your local language. UNITS Select the units for parameters. Adjust the volume of alarms or buzzer and adjust the SOUND/LCD screen brightness. Set the functions to be operated at analyzer power on and OPERATION select the number of digits and display position for the ID. AUTO CLEANING Set the auto prime/clean time. USERS Set the users and passwords for operating the analyzer. INITIALIZE Initialize the settings to the factory default settings. Set reagent management on the OTHER screen. There are setting screens which can only be entered when the type of user is “Lab technician” or “Service”. For details, refer to the next “Assigning Users and Passwords” section. Operator’s Manual MEK-6510 3.3 3 3. CHANGING SETTINGS Assigning Users and Passwords General To prevent measuring with wrong measurement conditions, some screens and functions can only be entered or changed by a user with authority and a password. There are three levels of authority. NOTE Set the Users settings according to your facility’s conditions. Service: Status bar For servicing the analyzer. Can enter any screen and change any settings. The status bar on the screen is orange. Lab technician: For changing settings. Can enter any screen and change any settings except for the SERVICE screen. The status bar on the screen is blue. Other user: Can only perform measurement and view data and settings. The status bar on the screen is green. The following screens cannot be entered by an Other user. • INITIALIZE • MAINTENANCE • SERVICE On the USERS screen, an Other user can only select a user. Only a lab technician or service user can add or delete a user. On the USERS screen, the first three users are preset and cannot be changed. “FACTORY” is for engineers servicing the analyzer. “Celltac” is for changing settings for the first time after installing the analyzer. “USER” can only perform measurement and check measurement data. The passwords for “Celltac” and “USER” are as follows and these passwords cannot be changed. Celltac: 6500 USER: 0000 “Celltac” is the default setting. 3.4 Operator’s Manual MEK-6510 3. CHANGING SETTINGS Displaying the USERS Screen 1. Press the SETTINGS key on the MENU screen. 3 2. Press the USERS key on the SETTINGS screen. The USERS screen is displayed. Current user Registers a new user. Changes users. Deletes selected user. To print the data on the USERS screen, press the [ panel. Print] key on the front NOTE When printing on a WA-710V/712V or EPSON VP printer, <EPSON VP paper width> must be set to “Wide” on the EXTERNAL PRINTER screen of the SETTINGS screen and wide type paper must be set on the printer. Refer to “Changing Print Format for External Printer” in Section 3. 3. Press the OK key to return to the SETTINGS screen. 4. Press the OK key on the SETTINGS screen to return to the MENU screen. Operator’s Manual MEK-6510 3.5 3. CHANGING SETTINGS Adding a User Up to 8 users can be registered (including the factory default users). NOTE A new user can only be added by a lab technician or service user. 1. Press the ADD USER key on the USERS screen to display the ADD USER screen. 2. Use the displayed keyboard to enter the user name in <Name> (up to 8 alphanumerics). Select “123 …” or “ABC …” to select numbers or letters. The keys change to reflect your selection. Keys for entering numbers Keys for entering letters Cursor Switches between numbers and letters. Clears all entered characters. Move cursor. Clears the character at the cursor position. 3.6 Operator’s Manual MEK-6510 3. CHANGING SETTINGS On the alphabet and symbol keypad, the letters change in the following order every time a key is pressed. Key ABC DEF GHI JKL MNO PQRS TUV WXYZ .@,/ Symbols Corresponding Characters A →B → C → A… D → E → F → D… G→H→I→G… J → K → L → J… M → N → O → M… P → Q → R → S → P… T → U → V → T… W → X → Y → Z → W… .→@→,→/→.… !→?→‘→-→;→:→(→)→!… 3 3. Select “Other user” or “Lab technician” for the type of user from the selection list in <Type of user>. Selection list 4. Press the NEXT key. The password entry screen opens. 5. Enter the 4-digit password using the displayed numeric keys. The entered password appears as “****” in the <Password> box. Clears all entered numbers. Returns to the USERS screen. 6. Press the Enter key. The cursor moves to the <Re-enter pass> box. Operator’s Manual MEK-6510 3.7 3. CHANGING SETTINGS 7. Re-enter the password and press the Enter key to confirm the password. The screen returns to the USERS screen and the new user is added to the user list. Added user 3.8 Operator’s Manual MEK-6510 3. CHANGING SETTINGS Changing a User 1. Select the desired user on the USERS screen. 3 Current user 2. Press the CHANGE key. The PASSWORD window is displayed. 3. Enter the password for this user using the numeric keys on the window and press the Enter key. When the correct password is entered, the current user (indicated by the arrow on the screen) changes to the selected user. Clears all entered numbers. Returns to the USERS screen. When the wrong password is entered, the “Incorrect password” message appears. Enter the correct password. Operator’s Manual MEK-6510 3.9 3. CHANGING SETTINGS Deleting a User NOTE • A user can only be deleted by a lab technician or service user. • FACTORY, Celltac and USER are the default settings and cannot be deleted. 1. Select the user to be deleted on the USERS screen. 2. Press the DELETE key. The “Delete user?” message is displayed. 3. Press the YES key to delete the selected user. The password entry screen appears. Press the NO key to cancel deleting. The screen returns to the USERS screen. 4. Enter the password of the user to delete. When the correct password is entered, the user is deleted and “The user is deleted.” message is displayed. 3.10 Operator’s Manual MEK-6510 3. CHANGING SETTINGS Assigning an ID to a Sample All samples must have an ID. Otherwise, you cannot identify which samples correspond to the displayed or saved data. All saved and displayed data is identified by an ID number. 3 When you set an ID, the analyzer automatically assigns it to the next counted sample and increments the ID for each sample after that. Only the last 4 digits are incremented. When the last 4 digits are “9999”, the ID is incremented to “0000” for the next sample. It is possible to enter an ID manually for each sample. The ID can have up to 13 characters and the last 4 digits must be numbers. It is also possible to not assign an ID to a sample, such as in background noise measurement. When using an optional hand-held bar code reader (Keyence BL-N60NK or equivalent), the bar code label of the sample can be read by the bar code reader and this code is entered as the sample ID. The position of the displayed ID can be selected from Auto, Right or Left. For details, refer to “Changing Various Settings for Analyzer Power On” in this section. ID display position <Use ID> setting 4 digits 13 digits Auto Right Left No Right aligned Left aligned Right aligned Left aligned ID not displayed ID No. After pressing the Reset key 0001 After measurement Increments automatically. No ID assigned, assign an ID manually. To edit an ID of already saved data, refer to “Editing ID and Sample Type of Saved Data” in Section 5. Operator’s Manual MEK-6510 3.11 3. CHANGING SETTINGS Displaying the ID Screen 1. Press the ID key on the MENU or RESULTS screen, or the SET key or ID box on the READY screen to display the ID screen. ID box The cursor moves as you touch a number. Resets the ID to “0001”. 2. Press the OK key to return to the previous screen. (i.e. If the ID screen is displayed from the READY screen, the screen returns to the READY screen.) Entering a 4 Digit Numeric ID 1. Select “4 DIGITS” for <ID digits> and an ID alignment position for <Use ID> on the OPERATION screen. Refer to “Changing Various Settings for Analyzer Power On” in this section. 2. Open the ID screen. Refer to “Displaying the ID Screen” in this section. 3. Enter a 4 digit-ID with the numeric keys on the screen. When the Reset key is pressed, the number is reset to “0001”. 3.12 Operator’s Manual MEK-6510 3. CHANGING SETTINGS Entering a 13 Character Alphanumeric ID 1. Select “13 DIGITS” for <ID digits> and an ID alignment position for <Use ID> on the OPERATION screen. Refer to “Changing Various Settings for Analyzer Power On” in this section. 2. Open the ID screen. Refer to “Displaying the ID Screen” in this section. 3. Enter numbers with the numeric keys. Press the “ABC …” key when entering letters. The entered number or letter appears in ID box. In the last 4 digits, only the numbers can be entered. Cursor The cursor moves as you touch a number. The entered ID appears here. Cursor Switches between numbers and letters. Resets the ID to “0001”. Move cursor. Clears the character at the cursor position. Keys for entering numbers Keys for entering letters On the alphabet and symbol keypad, the letters change in the following order every time a key is pressed. Key ABC DEF GHI JKL MNO PQRS TUV WXYZ .@,/ Symbols Operator’s Manual MEK-6510 Corresponding Characters A →B → C → A… D → E → F → D… G→H→I→G… J → K → L → J… M → N → O → M… P → Q → R → S → P… T → U → V → T… W → X → Y → Z → W… .→@→,→/→.… !→?→‘→-→;→:→(→)→!… 3.13 3 3. CHANGING SETTINGS Using Bar Codes The optional hand-held bar code reader (Keyence BL-N60RK or equivalent) can be used to read the sample bar code label to establish the Sample ID. To enter the ID by using the hand-held bar code reader, display the READY, ID, RESULTS or ID EDIT screen and read the bar code of the sample. • • • • 3.14 NOTE Up to 13 digits can be entered for an ID. When the bar code has more than 13 digits, the digits after the 13th digit are deleted. A bar code ID might not be read properly due to poor printing quality of the label or the label is torn or detached. For such a sample, edit the ID on the ID EDIT screen of the DATA screen after measurement (refer to “Editing ID” in Section 5). Be careful not to mix up such samples. For details about bar code labels, refer to the “Bar Codes for Using Handheld Bar Code Reader” in Section 10. When CODABAR (NW-7) is used for the bar code type, a letter from “a” to “d” is assigned to the beginning and end of the ID. When there are more than 13 digits in the ID because of these start/stop characters or when you do not want these letters to be included in the sample ID, read “Do not send” bar code. Refer to “Bar Codes for Using Hand-held Bar Code Reader” in Section 10. When using the ITF bar code type, IDs may be frequently misread by the bar code reader when compared to the other types of bar codes, especially when the printing quality of the label is poor. Be careful not to mix up samples when using ITF bar codes. Operator’s Manual MEK-6510 3. CHANGING SETTINGS Labeling and Selecting Sample Types You can select the sample type before each measurement on the READY screen. You can label and select sample types to be displayed in the selection list on the READY screen and other setting screens. Labeling Sample Types You can label different sample types. Up to 10 sample types can be set, but one of them is fixed to “Control” and cannot be changed. These sample labels appear on the READY screen so you can select sample type before measurement. To label sample types, the type of user must be either lab technician or service. When the labels are changed, the new labels are also applied to the stored data. For example, when the “Male” label is changed to “Internal”, the sample type of all sample data with the “Male” sample type are changed to “Internal”. NOTE It is recommended to delete stored data before changing the sample type labels. Otherwise, it becomes difficult to distinguish the stored data. 1. Press the SETTINGS key on the MENU screen. 2. Press the SAMPLE TYPE key on the SETTINGS screen to display the SAMPLE TYPE screen. Operator’s Manual MEK-6510 3.15 3 3. CHANGING SETTINGS 3. Select the sample type for the label to be changed. “Control” cannot be changed. 4. Press the EDIT key to display keypads for entering the sample label. 5. Edit the sample label using numeric and alphabet keys. Select “123 …” or “ABC …” key to select numbers or letters. The keys change to reflect your selection. You can edit the sample labels using numeric and alphabet keys. Each label can have up to 8 characters. Cursor Entered label appears in the box. Cursor Switches between numbers and letters. Clears all entered characters. Move cursor. Clears the character at the cursor position. Returns to the SAMPLE TYPE list screen. Keys for entering numbers 3.16 Keys for entering letters Operator’s Manual MEK-6510 3. CHANGING SETTINGS 6. Press the OK key to register the sample label and return to the SAMPLE TYPE list screen. When the CANCEL key is pressed, the entered label is cancelled and the screen returns to the SAMPLE TYPE list screen. 3 The entered sample label is registered to the label position you have chosen in step 3. When a sample type is selected and the RESET key is pressed on the SAMPLE TYPE screen, the selected sample type label is reset to the factory default setting. 7. Press the OK key to return to the SETTINGS screen. Selecting Sample Types for the Sample Type Selection List You can set the sample types to be displayed in the sample type selection list. The sample type selection list appears on the READY, NORMAL RANGE, SENS/THRESH, DETAILS (EDIT) screen of the DATA screen and SEARCH screens. Press the check box beside the sample type you want to enter for the sample type selection list. To cancel, press the check box again. Check box Sample type selection list Resets the selected sample type label to the default setting. Operator’s Manual MEK-6510 3.17 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 (beyond the upper limit) or L (below the lower limit) mark. The upper and lower limits can be set individually for each parameter. You can set the upper and lower limits individually for different sample types. Default Settings of Upper and Lower Limits Parameter WBC (103/µL) RBC (106/µL) HGB (g/dL) HCT (%) MCV (fL) MCH (pg) MCHC (g/dL) PLT (103/µL) LY% MO% GR% LY (103/µL) MO (103/µL) GR (103/µL) RDW-CV (%) RDW-SD (fL) PCT (%) MPV (fL) PDW (%) Default Setting Lower Limit Upper Limit 4.0 9.0 3.76 5.70 12.0 18.0 33.5 52.0 80.0 100.0 28.0 32.0 31.0 35.0 150 350 17.0 57.0 0.0 10.0 42.0 85.0 0.7 5.1 0 0.9 1.7 7.7 11.6 14.0 39.0 46.0 0.16 0.33 7.0 11.0 15.0 17.0 Variable Range 0 to 99.9 0 to 14.99 0 to 29.9 0 to 99.9 20.0 to 199 10.0 to 50.0 10.0 to 50.0 0 to 1490 0 to 99.9 0 to 99.9 0 to 99.9 0 to 99.9 0 to 99.9 0 to 99.9 0 to 50.0 0 to 199 0 to 2.90 0 to 20.0 0 to 50.0 Changing the Limits To change the limits, the type of user must be either lab technician or service. 1. Press the SETTINGS key on the MENU screen. 3.18 Operator’s Manual MEK-6510 3. CHANGING SETTINGS 2. Press the NORMAL RANGE key on the SETTINGS screen to display the NORMAL RANGE screen. 3 3. Select the sample type in <Sample type>. Sample type selection list 4. Touch the setting value or use the arrow keys to move the cursor to the setting value you want to change. Press the PREV or NEXT key to display other parameters. Sample type key Cursor Move cursor. Numeric keys Change pages to display other parameters. Operator’s Manual MEK-6510 3.19 3. CHANGING SETTINGS 5. Enter the desired value using the numeric keys. 6. Press the Enter key to register the value. The cursor moves to the next parameter. 7. Repeat steps 3 to 6 to change the normal range limits for other sample types. 8. When you finish changing the settings, press the OK key to return to the SETTINGS screen. 3.20 Operator’s Manual MEK-6510 3. CHANGING SETTINGS Changing Sensitivity and Threshold General 3 For measuring nonhuman blood, the sensitivity and threshold should be changed to match the characteristics of the blood. You can set the sensitivity and threshold individually for different sample types. CAUTION Use only the initial sensitivity or threshold settings for measuring human blood. Do not change these settings. Factory Default Settings and Setting Range Parameter WBC RBC PLT Sensitivity Default Range 5 1 to 15 5 1 to 15 — — Threshold Default Range 4 1 to 15 AUTO 1 to 15, AUTO 5 1 to 15 RBC Automatic Threshold When AUTO is selected, the borderline between PLT and RBC is automatically detected to set the threshold. When measuring nonhuman blood that has small RBC particles (such as MCV less than 70 fL), set the threshold to AUTO. Changing Sensitivity and Threshold To change the settings, the type of user must be either lab technician or service. 1. Press the SETTINGS key on the MENU screen. Operator’s Manual MEK-6510 3.21 3. CHANGING SETTINGS 2. Press the SENS/THRESH key on the SETTINGS screen to display the SENS/THRESH screen. 3. Select the sample type in <Sample type>. Sample type selection list 4. Touch the setting value or use the arrow keys to move the cursor to the setting value you want to change. Sample type key Cursor Move cursor. Numeric keys 3.22 Operator’s Manual MEK-6510 3. CHANGING SETTINGS 5. To set the desired value: i) Enter the value using the numeric keys on the screen. ii) Press the Enter key to register the value at the cursor position. To set the RBC auto threshold: Select “On” for <Auto threshold>. When setting the value for RBC threshold, select “Off” for <Auto threshold> and enter the value for RBC Threshold. 6. Press the OK key to return to the SETTINGS screen. Displaying the Sensitivity and Threshold Setting History The sensitivity and threshold setting history is stored for up to 6 history for each sample type and can be displayed on the HISTORY screen. 1. Press the HISTORY key on the SENS/THRESH screen to display the HISTORY screen. Sample type key The user who changed the sensitivity and threshold settings. Displays older data. Displays newer data. Use the arrow keys to display other data. To see the history of other sample type, change the sample type in <Sample type>. 2. Press the OK key to return to the SENS/THRESH screen. Operator’s Manual MEK-6510 3.23 3 3. CHANGING SETTINGS Determining Optimum Sensitivity This analyzer is set for human blood cells. Nonhuman cells which have a different particle size from human blood cells require adjustment for the settings. For counting nonhuman 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. Mean Particle Volume (fL) 400 200 130 100 80 70 60 50 45 Particle Volume Range (fL) 200 to 600 100 to 300 70 to 200 50 to 150 40 to 120 35 to 100 30 to 90 25 to 80 20 to 70 Optimum Sensitivity 1 2 3 4 5 6 7 8 9 After setting the sensitivity, adjust the threshold to determine the optimum threshold. Determining Optimum Threshold 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 3.24 No plateau Threshold Counted value 0 Plateau is too short Threshold Operator’s Manual MEK-6510 3. CHANGING SETTINGS Changing Measurement Settings The following items can be set for measurement. Item Measurement count Display alarm on recount PLT recount threshold Pre-dilution volume Measure twice with pre-dilution Continue dilute mode Recount if panic value High dilute mode for panic value recount Description Select to count a sample either once or twice. Select whether or not to display an alarm when recounting a sample. Select the threshold under which a sample is recounted for the PLT parameter. When “None” is selected, a sample is not recounted. Refer to “PLT Recount” in Section 4. Select the pre-dilution blood measuring volume. Select whether or not to dilute the sample for two measurements in pre-dilution mode. Select whether or not to continue measurement in the same dilution mode. Select whether or not recount the sample when the measured value is out of the panic value range. Select dilution mode for panic value recount with high dilution. Refer to “Recount when Out of Panic Range” in Section 4. 3 Setting Single or Double Default Single Yes or No No 10 × 104/μL, 5 × 104/μL or None 10 μL or 20 μL 10 × 104/μL 20 μL Yes or No No Yes or No No Yes or No Yes High or Higher Higher To change the settings, the type of user must be either lab technician or service. 1. Press the SETTINGS key on the MENU screen. 2. Press the MEASUREMENT key on the SETTINGS screen to display the MEASUREMENT screen. Operator’s Manual MEK-6510 3.25 3. CHANGING SETTINGS First page Second page 3. Select the setting for each item by touching the check box. For details on the setting items, refer to the below description. To change displayed items, press the NEXT or PREV key. 4. Press the OK key to return to the SETTINGS screen. Measurement count In single counting mode, each sample is counted once. In double counting mode, the sample is counted twice and the mean value is displayed. Only the mean values are printed, displayed and stored in memory. If there is a significant deviation (more than 10%) between the two counts, a third count is automatically performed and the mean of the two closest counts is used. When displaying or printing histograms for a sample measured in the double counting mode, the WBC histogram from the first count is used and the RBC and PLT histograms from the second count are used. Display alarm on recount When an alarm occurs during measurement, the sample is automatically recounted up to three times. You can set the alarm to display upon auto recount to help find the problem. Alarm message is displayed when <Display alarm on recount> is set to “Yes”. 3.26 Operator’s Manual MEK-6510 3. CHANGING SETTINGS PLT recount threshold The analyzer automatically recounts a sample when PLT is extremely low regardless of the <Measurement count> setting. You can set the threshold under which a sample is recounted. For normal operation, select 10 × 104/µL. When “None” is selected, a sample is not recounted. Pre-dilution volume Select the pre-dilution blood measuring volume. Measure twice with pre-dilution When set to “Yes”, the sample is diluted to measure twice in pre-dilution mode. Continue dilute mode To continue measurement with the same dilution mode (Normal, Pre-dilution, Low, High or Higher), select “Yes”, When “No” is selected, the dilution mode returns to Normal. Recount if panic value When set to “Yes”, a message asks whether or not to remeasure the sample when the measurement result is out of panic value range, “ ! ” is displayed beside the parameter, or an A031 or A032 (WBC noise) alarm occurs. If you choose to remeasure, the sample is recounted with a different dilution mode. When the measurement result was lower than the panic value, the sample is recounted in low dilution mode. When the measurement result was higher than the panic value, the sample is recounted in the dilution mode which is set in <High dilute mode for panic value recount>. High dilute mode for panic value recount When “Yes” is set for <Recount if panic value> and the measurement result is higher than the panic value, the sample can be recounted in the high dilution mode which is set in <High dilute mode for panic value recount>. High: The sample is measured with dilution three times the usual dilution ratio. Higher: The sample is measured with dilution six times the usual dilution ratio. Operator’s Manual MEK-6510 3.27 3 3. CHANGING SETTINGS Setting Date and Time The date and time of the built-in clock can be set. The built-in backup circuit maintains the date and time when the analyzer is turned off. You can also select the date format. NOTE At the start of the day, check that the date and time settings are correct. Ranges you can set for the date and time are as follows: Date format: YY/MM/DD, YY-MM-DD, YY.MM.DD, ’YY MM DD, DD/MM/YY, DD-MM-YY, DD.MM.YY, DD MM ’YY, DD MMM ’YY, DD/MMM/YY, MM/DD/YY, MM-DD-YY, MM DD ’YY, MMM DD, ’YY Year: 0 to 99 Month: 1 to 12 Day: Hour: Minute: 1 to 31 0 to 23 0 to 59 To change the settings, the type of user must be either lab technician or service. 1. Press the SETTINGS key on the MENU screen. 2. Press the DATE & TIME key on the SETTINGS screen to display the DATE & TIME screen. 3.28 Operator’s Manual MEK-6510 3. CHANGING SETTINGS 3. Select the date format in <Date format>. NOTE The selected date format is also used in stored data, printing, sending and history. Date format selection list 4. Touch the setting value or use the arrow keys to move the cursor to the setting value you want to change. Date format key Cursor Move cursor. Numeric keys 5. Enter the value using the numeric keys. When setting <Hour>, use the 24 hour format. e.g. 17:00 6. Press the Enter key to register the value. The cursor moves to the next item. 7. Repeat steps 4 to 6 to enter other items. 8. Press the OK key to return to the SETTINGS screen. The clock starts immediately from the new date and time. Operator’s Manual MEK-6510 3.29 3 3. CHANGING SETTINGS Changing Display Format You can select the following display format settings for RESULTS and DATA screens. Item Display parameters Histogram Histogram Y-axis Display WBC histogram lines Adjust histogram scale DATA screen items DATA screen display items Select flags to display in red Description Select the number of parameters to be displayed on the RESULTS and DATA DETAILS screen. Select whether or not to display histograms and the display size on the RESULTS and DATA DETAILS screen. Select the vertical axis on the histogram on the RESULTS and DATA DETAILS screen. Select whether or not to display the borderline of differential parameters on the WBC histogram on the RESULTS and DATA DETAILS screen. Adjust RBC histogram horizontal axis scale, WBC, RBC and PLT histogram vertical axis scale on the RESULTS and DATA DETAILS screen. Select sequence number or sample type to be displayed on the DATA screen. Setting Default 8 or 19 19 Normal, Wide or None Normal Count or Percentage Count Yes or No No 50 to 200% 100 SEQ# or Sample type SEQ# LY%, MO%, GR%, LY, Select the display parameters for the DATA screen. MO, GR, RDW-CV, PCT, LY%, MO%, GR% Up to three parameters can be selected. MPV, PDW Poor hemolysis, Select flags to be highlighted in red. All flags PLT clumps, Abnormal MCHC To change the settings, the type of user must be either lab technician or service. 1. Press the SETTINGS key on the MENU screen. 3.30 Operator’s Manual MEK-6510 3. CHANGING SETTINGS 2. Press the DISPLAY key on the SETTINGS screen to display the DISPLAY screen. 3 3. Select the setting for each item by touching the check box. For details on the setting items, refer to the next pages. To change displayed items, press the NEXT or PREV key. Change pages to display other settings. 4. Press the OK key to return to the SETTINGS screen. Operator’s Manual MEK-6510 3.31 3. CHANGING SETTINGS Display parameters and Histogram The RESULTS screen and DETAILS screen of the DATA screen display format differ according to the <Display parameters> and <Histogram> settings. Display Parameters: 19 Histogram: Normal Display Parameters: 19 Histogram: Wide Display Parameters: 19 Histogram: None Display Parameters: 8 Histogram: Normal Display Parameters: 8 Histogram: Wide Display Parameters: 8 Histogram: None Histogram Y-axis You can select the type of the vertical axis on the histograms. Count: 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. <Counted Value> [%] 100% [Count] <Percentage> [fL] [fL] The horizontal axis represents the blood cell volume. (fL = 1 × 10-15 L) 3.32 Operator’s Manual MEK-6510 3. CHANGING SETTINGS Display WBC Histogram Lines You can set to display vertical lines to separate WBC histogram into the 3 differential parameters. 3 Lymphocyte distribution Second page of the DISPLAY screen Monocyte Granulocyte distribution distribution Adjust Histogram Scale You can adjust the horizontal and vertical axes for the RBC histogram and the vertical axis for the WBC and PLT histogram between 50 and 200%. To adjust the axes, <Histogram Y-axis> must be set to “Count”. RBC histogram horizontal axis 100% 50% 200% RBC histogram vertical axis 100% 50% 200% PLT histogram vertical axis 100% 50% 200% Operator’s Manual MEK-6510 3.33 3. CHANGING SETTINGS DATA Screen Items You can select either SEQ# or sample type to be displayed for the sample information and up to three parameters to be displayed on the DATA screen. Third page of the DISPLAY screen Select flags to display in red When the result has flags which were selected for this setting, the ID number of the result appears in red on the DATA screen. Fourth page of the DISPLAY screen ID is displayed in red. 3.34 Operator’s Manual MEK-6510 3. CHANGING SETTINGS Changing Output Format You can select the printers or external devices to which the data will be output. Also, you can automatically send the data to an assigned device after each measurement. To change the settings, the type of user must be either lab technician or service. 1. Press the SETTINGS key on the MENU screen. 2. Press the OUTPUT key on the SETTINGS screen to display the OUTPUT screen. Operator’s Manual MEK-6510 3.35 3 3. CHANGING SETTINGS 3. Select the printer or socket on the analyzer to which the device is connected to display the setting screen for the printer or socket. Serial port 1 Serial port 2 Printer socket USB port SD memory card slot INT PRINTER: EXT PRINTER: SERIAL PORT 1: SERIAL PORT 2: USB: SD CARD: WA-650VK thermal printer Printer connected to the printer socket External device connected to the serial port 1 External device connected to the serial port 2 External device connected to the USB port SD memory card 4. Change the settings by referring to the following sections. 5. Press the OK key to return to the OUTPUT screen. 6. Press the OK key to return to the SETTINGS screen. 3.36 Operator’s Manual MEK-6510 3. CHANGING SETTINGS Changing Print Format for Internal Printer You can set the following items for the optional internal thermal array printer. Item Auto output after measurement Print with [Print] key Print external data Print parameters Print measure mode Print WBC histogram Print RBC histogram Print PLT histogram Print radar graph Print flags Select parameters to print normal range graph Auto prints number Select parameter to print Description Select whether or not to automatically print data after measurement. Select whether or not to print data when you press the [Print] key on the front panel or PRINT key on the screen. Select whether or not to print received data from an external device. Select number of parameters for printing numeric data. When selecting “Select”, choose the parameter to print in the <Select parameter to print> setting. Select whether or not to print measuring mode. Select whether or not to print WBC histogram. Select whether or not to print RBC histogram. Select whether or not to print PLT histogram. Select whether or not to print numeric result with normal range in a radar graph. Select whether or not to print the flags when they appear. Select whether or not to print a normal range graph for each parameter. Select number of copies for printing data. Available only when “Yes” is selected for <Auto output after measurement>. Select whether or not to print the data for each parameter. Available only when “Select” is selected for <Print parameters>. Setting Default 3 Yes or No Yes Yes or No Yes Yes or No Yes Select, 8 or 19 19 Yes or No Yes or No Yes or No Yes or No Yes Yes Yes Yes Yes or No No Yes or No On or Off for each parameter No Off for all parameters 1 to 9 1 On or Off for each parameter Off for all parameters 1. Press the INT PRINTER key on the OUTPUT screen. Operator’s Manual MEK-6510 3.37 3. CHANGING SETTINGS 2. Select the settings by touching the check box. Change the setting pages by pressing the PREV or NEXT key. Internal printer setting page 1 Internal printer setting page 2 Internal printer setting page 4 Internal printer setting page 5 Internal printer setting page 3 To change settings on page 3 and 5, select on or off by touching the check box for each parameter. 3. Press the OK key to return to the OUTPUT screen. 3.38 Operator’s Manual MEK-6510 3. CHANGING SETTINGS Changing Print Format for External Printer You can connect the following printers to the printer socket on the analyzer. For details on the type of printer that can be used with the analyzer, contact your Nihon Kohden representative. • WA-710V/WA-712V printer • SEIKO EPSON VP type • SEIKO EPSON PM type • CANON PIXUS type The setting items differ for each printer type. WA-710V/712V printer or EPSON VP printer Item Auto output after measurement Description Setting Select whether or not to automatically print data after Yes or No measurement. Select whether or not to print data when you press Print with [Print] the [Print] key on the front panel or PRINT key on Yes or No key the screen. EPSON VP, EPSON PM or Printer type Select EPSON VP for printer type. CANON BJ Wide (10 inches) EPSON VP paper Select the width of the recording paper. Narrow (normal recording width paper) The following items are available only when “Narrow” is selected for the paper width. Print histograms Select whether or not to print histograms. Yes or No The following items are available only when “Wide” is selected for the paper width. EPSON VP page Select the length of the recording paper. 1 to 255 lines/page length (lines/page) Select to print numerical data only, numerical data Numeric, Num + hist or Radar Print format and histogram or radar graph. graph Select number of parameters for printing numeric Print parameters data. Available only when “Numeric” is selected for 8 or 15 <Print format>. Select whether or not to print measurement date & Print measurement Date & time, Date only, time. Available only when “Numeric” is selected for date & time Time only or None <Print format>. Select whether or not to print normal range settings Print normal range for all parameters. Available only when “Num + hist” Numeric, Graphic or None is selected for <Print format>. Select to print header or not. Available only when No or up to 46 characters can Print header “Num + Hist” or “Radar graph” is selected for <Print be entered. format>. Select whether or not to print flags when they appear. Print flags Available only when “Num + hist” is selected for Yes or No <Print format>. Select one or two data to be printed per page. Samples/page Available only when “Num + hist” is selected for 1 or 2 <Print format>. Select whether or not print auto analysis findings. Print auto analysis Available only when “Radar graph” is selected for Yes or No findings <Print format>. Operator’s Manual MEK-6510 Default Yes Yes EPSON VP Wide Yes 66 Numeric 15 Date & time None No Yes 1 Yes 3.39 3 3. CHANGING SETTINGS NOTE When printing on the WA-710V/712V or EPSON VP printer, <EPSON VP paper width> must be set to “Wide” and wide type paper must be set on the printer to print data other than measurement result, such as multiple data on the DATA screen or X-R data on the QUALITY CONTROL screen. EPSON PM or CANON BJ printer Item Auto output after measurement Description Select whether or not to automatically print data after measurement. Select whether or not to print data when you press Print with [Print] the [Print] key on the front panel or PRINT key on key the screen. Select EPSON PM when using EPSON PM printer Printer type or select CANON BJ when using CANON PIXUS printer. Select to print numerical data only, numerical data Print format and histogram or radar graph. Select number of parameters for printing numeric Print parameters data. Available only when “Numeric” is selected for <Print format>. Select whether or not to print measurement date & Print measurement time. Available only when “Numeric” is selected for date & time <Print format>. Select whether or not to print normal range settings Print normal range for all parameters. Available only when “Num + hist” is selected for <Print format>. Select to print header or not. Available only when Print header “Num + hist” or “Radar graph” is selected for <Print format>. Select whether or not to print flags when they Print flags appear. Available only when “Num + hist” is selected for <Print format>. Select one or two data to be printed per page. Samples/page Available only when “Num + hist” is selected for <Print format>. Select whether or not print auto analysis findings. Print auto analysis Available only when “Radar graph” is selected for findings <Print format>. 3.40 Setting Default Yes or No Yes Yes or No Yes EPSON VP, EPSON PM or CANON BJ EPSON VP Numeric, Num + hist or Radar graph Numeric 8 or 15 15 Date & time, Date only, Time only or None Date & time Numeric, Graphic or None None No or up to 46 characters can be entered. No Yes or No Yes 1 or 2 1 Yes or No Yes Operator’s Manual MEK-6510 3. CHANGING SETTINGS 1. Press the EXT PRINTER key on the OUTPUT screen. 3 2. Select the connected printer type in <Printer type>. 3. Select the settings by touching the check box. Change the setting pages by pressing the PREV or NEXT key. WA-710V/712V or EPSON VP with paper width “Narrow” First page Operator’s Manual MEK-6510 Second page 3.41 3. CHANGING SETTINGS WA-710V/712V or EPSON VP with paper width “Wide” or EPSON PM or CANON BJ First page for WA-710V/712V or EPSON VP type with paper width “Wide” First page for EPSON PM or CANON BJ type Press this key to display the screen for setting the page length. Refer to the following page. Second page When “Numeric” is selected for <Print format> When “Num + hist” is selected for <Print format> When “Radar graph” is selected for <Print format> Press this key to display the screen for setting the header. Refer to the following page. Third page when “Num + hist” is selected for <Print format> 3.42 Operator’s Manual MEK-6510 3. CHANGING SETTINGS To change the <Paper length> setting when using a WA-710V/712V or EPSON VP type printer and the paper width is “Wide”, enter the value using the numeric keys and press the Enter key to register the value. 3 Press the OK key to return to the previous screen. Numeric keys To set the header when “Num + hist” or “Radar graph” is selected for <Print format>, press the SET key in <Print header> to display the screen for entering the header. Cursor Entered characters appear in this box. Switches to the numerical keys. Clears all entered characters. Move cursor. Clears the character at the cursor position. Select “123 …” or “ABC …” key to select numbers or letters. The keys change to reflect your selection. Header can have up to 46 characters. Press the OK key to register the header setting and return to the previous screen. When the CANCEL key is pressed, the entered header is cancelled and the screen returns to the previous screen. 4. Press the OK key to return to the OUTPUT screen. Operator’s Manual MEK-6510 3.43 3. CHANGING SETTINGS Changing Settings for Card Printer You can set the following items for an optional WA-450V/460V/461V card printer. Item Description Format Select WA-450V or WA-460V. Auto output after measurement Select whether or not to automatically print data on the card printer after measurement. Date format Select whether or not to print data on the card printer when you press the [Print] key on the front panel or PRINT key on the screen. Select whether or not to send data to the card printer to print when you press the SEND key on the screen. Select the number of parameters for printing numeric data. Select the date format for printing. Baud rate Select the data transmission speed in bps. Print with [Print] key Output with SEND key Parameters Data bits Select data bits. Parity Select parity bit. Stop bits Select stop bits. The following items are available only for WA-460V card printer. ID digits Select the number of digits for printing ID. Select to print all parameter names, WBC Print parameter differential parameter names only, or no parameter names names. Select the number of blank lines at the top of the Top space recording paper. Select the amount of blank space at the left side of Left space the recording paper in characters. Select the width of the row in fifths of an inch. (X/5 Row size inches) Setting WA-450V, WA-460V, PC or Other Default PC Yes or No Yes Yes or No No Yes or No Yes 8, 18 or 19 18 YY/MM/DD or DD/MMM/YY 1200, 2400, 4800, 9600 or 19200 7 or 8 Even, Odd, or None 1 or 2 DD/MMM/YY 4 or 13 13 All, Diff only or None None 1 to 50 5 0 to 26 0 5 to 60 10 9600 8 Even 1 1. On the OUTPUT screen, press the SERIAL PORT 1 or SERIAL PORT 2 key to select the port which the card printer is connected to. Serial port 1 Serial port 2 3.44 Operator’s Manual MEK-6510 3. CHANGING SETTINGS 2. Select “WA-460V” or “WA-450V” in <Format> according to the card printer type. When using the WA-461V card printer, select “WA-460V”. When the card printer is connected to the serial port 2, select “Other” in <External device> and select the card printer type in <Format>. 3 3. Select the settings by pressing the item option box. Change the setting pages by pressing the PREV or NEXT key. Second page for WA-460V Operator’s Manual MEK-6510 Second page for WA-450V Third page for WA-450V or fourth page for WA-460V 3.45 3. CHANGING SETTINGS To change top or left margin or line spacing for using the WA-460V/461V card printer, touch the setting value or use the arrow keys to move the cursor to the setting value you want to change, enter the size using the numeric keys and press the Enter key to register the setting. Third page for WA-460V Move cursor. Cursor Numeric keys 4. Press the OK key to return to the OUTPUT screen. Changing Format for PC Set the following items for using a PC through RS-232C with the analyzer. Item Description Format Select PC. Auto output after measurement Output histograms Select whether or not to automatically output data after measurement. Select whether or not to print data when you press the [Print] key on the front panel or PRINT key on the screen. Select whether or not to send data when you press the SEND key on the screen. Select the format version for PC. The format version is specified in the Data Communication Protocol of the analyzer. For details, contact your Nihon Kohden representative. Select whether or not to output histograms to PC. Baud rate Select the data transmission speed in bps. Data bits Parity Stop bits Select data bits. Select parity bit. Select stop bits. Print with [Print] key Output with SEND key Version 3.46 Setting WA-450V, WA-460V, PC or Other Default PC Yes or No Yes Yes or No No Yes or No Yes V02-02, V04-01 or V04-02 V04-02 Yes or No 1200, 2400, 4800, 9600 or 19200 7 or 8 Even, Odd or None 1 or 2 No 9600 8 Even 1 Operator’s Manual MEK-6510 3. CHANGING SETTINGS 1. Check the communication settings of the external device. 2. Press the SERIAL PORT 1 or SERIAL PORT 2 key to which the PC is connected on the OUTPUT screen. 3 Serial port 1 Serial port 2 3. Select “PC” in <Format>. When the PC is connected to the serial port 2, select “Other” in <External device> and select the “PC” in <Format>. 4. Select the settings by touching the check box. Second page Third page 5. Press the OK key to return to the OUTPUT screen. Operator’s Manual MEK-6510 3.47 3. CHANGING SETTINGS Changing the USB Settings Set the following items for using a PC through USB with the analyzer. The Data Management Software must be installed on the PC to connect to the USB port on the analyzer. For details on the Data Management Software, contact your Nihon Kohden representative. Item Analyzer name Auto output after measurement Output with SEND key Description Setting When two analyzers are connected to the DMS on a PC, it is necessary to set a device name for the analyzer when sending Unit 1 or Unit 2 data in USB. Select whether or not to automatically output data after Yes or No measurement. Select whether or not to send data when you press the SEND Yes or No key on the screen. Default Unit 1 Yes Yes 1. Press the USB key on the OUTPUT screen to display the USB screen. 2. Select the settings by touching the check box. 3. Press the OK key to return to the OUTPUT screen. 3.48 Operator’s Manual MEK-6510 3. CHANGING SETTINGS Changing the SD Memory Card Settings Item Format card Auto output after measurement Output with SEND key Description Setting Default Initializes the SD memory card. Refer to “Formatting the SD Memory Card” section for details. Select if outputting data to the SD memory card after Yes or No No measurement. Select if outputting data to the SD memory card when Yes or No Yes pressing the SEND key on the screen. 3 1. Press the SD CARD key on the OUTPUT screen to display the SD CARD screen. 2. Select the settings by touching the check box. 3. Press the OK key to return to the OUTPUT screen. Operator’s Manual MEK-6510 3.49 3. CHANGING SETTINGS Formatting the SD Memory Card Format the SD memory card to save the measurement data. NOTE When the SD memory card is formatted, all the data in the card is deleted and the folder composition becomes as follows. It is recommended to back up the data before formatting the SD memory card. Volume label: MEK-6510 File system: FAT Folder composition of the SD memory card: MEK-6510 └ DATA folder to save the measurement data 1. Press the SD CARD key on the OUTPUT screen to display the SD CARD screen. 2. Press the Format key in <Format card>. A confirmation message appears. 3. Press the Yes key. The SD memory card is formatted and the confirmation window closes. Precautions for Backing Up Data The measurement data is saved in hierarchical year/month/day folders in the DATA folder. • When backing up the data with the external instrument, copy the data or folder to other media. • When backing up the data, do not change the folder composition or delete the folder. If the folder composition is changed or the folder is deleted, the analyzer cannot read and display the data correctly. Format the SD card again. • The analyzer displays the data when the backup data is transferred to the appropriate folder in the internal memory. Do not write any other files into the folder with the external instrument. The analyzer cannot display the data correctly if there are files from an external instrument. 3.50 Operator’s Manual MEK-6510 3. CHANGING SETTINGS Selecting Language You can select English or Japanese display. To change the settings, the type of user must be either lab technician or service. 1. Press the SETTINGS key on the MENU screen. 2. Press the LANGUAGE key on the SETTINGS screen to display the LANGUAGE screen. 3. Select JAPANESE or ENGLISH. 4. Press the OK key to return to the SETTINGS screen. Operator’s Manual MEK-6510 3.51 3 3. CHANGING SETTINGS Selecting Units You can select the counting units from JAPAN, USA, SI, SI MOD and MIXED (refer to the table in the “Counting Unit Table” section). You can select different units for different parameters (customize units). These units apply not only to data display but also to printing and sending data. To change the settings, the type of user must be either lab technician or service. Selecting Unit Type 1. Press the SETTINGS key on the MENU screen. 2. Press the UNITS key on the SETTINGS screen to display the UNITS screen. 3. Select the unit type from the <Units> box. The unit for each parameter changes according to the selected unit type. To set your own unit settings, refer to the “Customizing Units” section. 4. Press the OK key to return to the SETTINGS screen. 3.52 Operator’s Manual MEK-6510 3. CHANGING SETTINGS Counting Unit Table Parameter WBC JAPAN 102/µL USA 103/µL SI 109/L SIMOD 109/L MIXED 109/L RBC 104/µL 106/µL 1012/L 1012/L 1012/L HGB HCT MCV MCH MCHC PLT LY% MO% GR% LY MO GR RDW-CV RDW-SD g/dL % fL pg g/dL 104/µL % % % 102/µL 102/µL 102/µL % fL g/dL % fL pg g/dL 103/µL % % % 103/µL 103/µL 103/µL % fL g/L % fL pg g/L 103/µL % % % 109/L 109/L 109/L %CV fL mmol/L* % fL fmol mmol/L* 109/L % % % 109/L 109/L 109/L %CV fL g/L % fL pg g/L 109/L % % % 109/L 109/L 109/L %CV fL % fL % % fL % % fL % % fL %CV % fL % PCT MPV PDW * 1 mmol/L = 1.611 g/dL Customizing Units You can select unit for each parameter as shown in the table below. Item WBC RBC HGB HCT PLT RDW-CV PDW Setting 102/μL, 103/μL, 109/L 104/μL, 106/μL, 1012/L g/dL, g/L, mmol/L %, L/L 103/μL, 104/μL, 109/L %, %CV %, %CV Default 103/μL 106/μL g/dL % 103/μL % % 1. On the UNITS screen, select “User” in <Units>. 2. Select desired units for each parameter from the selection list. 3. Press the OK key to return to the SETTINGS screen. Press to display the selection list. Operator’s Manual MEK-6510 3.53 3 3. CHANGING SETTINGS Changing Sound and Screen Brightness Settings You can adjust the volume of the buzzer or click sound, or select whether or not to output count sound when counting blood cells. You can also select the screen brightness. To change the settings, the type of user must be either lab technician or service. 1. Press the SETTINGS key on the MENU screen. 2. Press the SOUND/LCD key on the SETTINGS screen to display the SOUND/LCD screen. 3. Select “On” or “Off” in <Measurement count sound> to turn on or off the count sound during counting sample. 4. Adjust the volume using the arrow keys in <Volume>. 5. Select “Light” or “Dark” for the screen brightness. 6. Press the OK key to return to the SETTINGS screen. 3.54 Operator’s Manual MEK-6510 3. CHANGING SETTINGS Changing Various Settings for Analyzer Power On You can change the following settings. To change the settings, the type of user must be either lab technician or service. Items Description Background noise check at Select whether or not to perform background power on measurement during checking after power on. Select the function of the key indicated below. [Eject] key operation Reset auto ID at power on When “Count” is selected, the key functions as the [Count] key and aspirates the sample and starts counting. When “Dispense” is selected, the key functions as the [Dispense] key and dispenses the diluent in predilution blood mode. The key does not function in any other mode. Select whether or not to reset ID to 0001 when the power is turned off. ID digits Select which digits to use for an ID. Use ID Select a position to align the numbers and letters for the ID display. Setting Default Yes or No No Count or Dispense Count Yes or No Yes 13 DIGITS or 4 DIGITS Auto, No, Right, Left 4 DIGITS Auto When using the key as [Dispense] key, attach the dispense symbol label. 1. Press the SETTINGS key on the MENU screen. Operator’s Manual MEK-6510 3.55 3 3. CHANGING SETTINGS 2. Press the OPERATION key on the SETTINGS screen to display the OPERATION screen. 3. Select the settings by touching the check box of the desired setting. When selecting an item for <Use ID>, refer to the following table. To not assign an ID, select “No”. ID display position <Use ID> setting 4 digits 13 digits Auto Right Left No Right aligned Left aligned Right aligned Left aligned ID not displayed ID No. After pressing the Reset key 0001 After measurement Increments automatically. No ID assigned, assign an ID manually. 4. Press the OK key to return to the SETTINGS screen. 3.56 Operator’s Manual MEK-6510 3. CHANGING SETTINGS Setting Auto Priming/Cleaning To maintain the optimum condition, you can set the analyzer to automatically perform priming or cleaning at a certain time of the day. You can schedule auto priming/cleaning for up to 4 times a day. To change the settings, the type of user must be either lab technician or service. 1. Press the SETTINGS key on the MENU screen. 2. Press the AUTO CLEANING key on the SETTINGS screen to display the AUTO CLEANING screen. Operator’s Manual MEK-6510 3.57 3 3. CHANGING SETTINGS 3. Set the time for the schedule. i) Touch the setting value or use the arrow keys to move the cursor to the setting value you want to change. ii) Enter the desired time with the numeric keys. Use the 24 hour format. (e.g. 17:00) iii) Press the Enter key to register the time. Cursor Move cursor. Numeric keys 4. Select “Clean”, “Prime” or “No” from the selection list for each schedule. Selection list 5. Press the OK key to return to the SETTINGS screen. If the analyzer is performing other operations at a scheduled time, priming/ cleaning is not performed. During priming/cleaning, the screen shows the “Priming” or “Cleaning” message. When priming/cleaning is completed, the screen returns to the READY screen. 3.58 Operator’s Manual MEK-6510 3. CHANGING SETTINGS Using Reagent Management You can set the analyzer to display a warning when the reagent or waste reaches the warning level. To change the settings, the type of user must be either lab technician or service. When <Use reagent management> is set to “On”, the reagent level bar graph is displayed on the READY screen so that you can easily see the current level. Reagent level bar graph Blue: Diluent Green: Detergent Yellow: Lysing reagent Red: Waste Setting the Warning Level 1. Press the OTHER key on the MENU screen to display the OTHER screen. 2. Press the MANAGE REAGENT key on the OTHER screen. Operator’s Manual MEK-6510 3.59 3 3. CHANGING SETTINGS 3. Select “On” in <Use reagent management> to use the reagent management function. Reagent keys Decreases the current volume. (Now) Increases the current volume. (Now) Resets the current volume (Now) to the bottle size (Bottle). Returns to the SETTINGS screen. Displays the screen for setting the reagent current level, warning level and bottle volume. 4. To set the current reagent or waste level (Now): i) Select the reagent or waste by pressing the reagent key. ii) Change the current level using the + and − keys. When the RESET key is pressed, the current level (Now) of a reagent is reset to the bottle size (Bottle). When the RESET key for WASTE is pressed, the current volume is reset to 0. As the reagent is used, the current level decreases. As the waste increases in the waste container, the current volume increases. To change current level, warning level and bottle size of a reagent: i) Select the reagent or waste by pressing the reagent key. ii) Press the SET key to display the setting screen for the selected reagent. Cursor Move cursor. Numeric keys 3.60 Operator’s Manual MEK-6510 3. CHANGING SETTINGS iii) Touch the setting value or use the arrow keys to move the cursor to the setting value you want to change. iv) Enter the value with the numeric keys and press the Enter key to register the value. v) Press the OK key to return to the previous screen. 5. Press the OK key to return to the OTHER screen. When the Reagent Management Warning is Displayed When a reagent reaches the warning level, the warning (ALARM window) is displayed. Replace the reagent(s) indicated on the screen or drain the waste from the waste container and press the RESET key on the screen. The current level of the reagent or waste displayed on the MANAGE REAGENT screen is reset to the bottle size and priming is performed. After priming, the READY screen is displayed. When all reagent and waste need replacement/draining, replace reagents and drain waste, then press the RESET ALL key to reset the current level of all reagent and waste to the bottle size. When the OK key on the warning screen is pressed, no volume setting is changed and the READY screen is displayed. If the RESET key on the screen is pressed before replacing reagent or draining the waste, replace the reagent or drain the waste and reset the current level to bottle size and then prime the analyzer by doing the following procedure. Operator’s Manual MEK-6510 3.61 3 3. CHANGING SETTINGS 1. Press the OTHER key on the MENU screen. 2. Press the MAINTENANCE key on the OTHER screen. 3. Press the REPLACE DIL key when replacing diluent, press the REPLACE DET key when replacing detergent, or press the REPLACE LYS when replacing lysing reagent. Press the RESET ALL key when replacing all reagents. The confirmation window appears. 3.62 Operator’s Manual MEK-6510 3. CHANGING SETTINGS 4. Check that the reagent tubes are connected properly and press the YES key. The “Priming diluent” message appears. The current level on the MANAGE REAGENT screen is automatically reset to the bottle size when the YES key is pressed. 3 When priming is complete, the screen returns to the MAINTENANCE screen. 5. Press the OK key to return to the OTHER screen. 6. Press the OK key to return to the MENU screen. Operator’s Manual MEK-6510 3.63 3. CHANGING SETTINGS Initializing Settings You can initialize the settings to the factory default settings. The factory default settings are shown in the “Factory Default Settings” section. To initialize the settings, the type of user must be either lab technician or service. 1. Press the SETTINGS key on the MENU screen. 2. Press the INITIALIZE key to display the INITIALIZE screen. All settings which will be initialized is listed on the screen and a confirmation message appears. 3.64 Operator’s Manual MEK-6510 3. CHANGING SETTINGS 3. Press YES to start initializing. If you press NO, initializing is canceled and the screen returns to the SETTINGS screen. 3 Operator’s Manual MEK-6510 3.65 3. CHANGING SETTINGS Factory Default Settings Setting Screen SAMPLE TYPE Setting Item Sample type labels Parameter WBC (10 /μL) RBC (106/μL) HGB (g/dL) HCT (%) MCV (fL) MCH (pg) MCHC (g/dL) PLT (103/μL) LY% MO% GR% LY (103/μL) MO (103/μL) GR (103/μL) RDW-CV (%) RDW-SD (fL) PCT (%) MPV (fL) PDW (%) Parameter WBC RBC PLT Auto threshold (RBC) Measurement count Display alarm on recount PLT recount threshold Pre-dilution volume Measure twice with pre-dilution Continue dilute mode Recount if panic value High dilute mode for panic value recount Date format Display parameters Histogram Histogram Y-axis Display WBC histogram lines Adjust histogram scale RBC horizontal axis WBC vertical axis RBC vertical axis PLT vertical axis DATA screen items DATA screen display items Select flags to display in red 3 NORMAL RANGE SENS/THRESH MEASUREMENT DATE & TIME DISPLAY 3.66 Default Setting Normal, Male, Female, Child, Infant, Other 1, Other 2, Other 3, Other 4, Control (Normal and Control are selected for the sample type selection list) Lower Limit Upper Limit 4.0 9.0 3.76 5.70 12.0 18.0 33.5 52.0 80.0 100.0 28.0 32.0 31.0 35.0 150 350 17.0 57.0 0.0 10.0 42.0 85.0 0.7 5.1 0 0.9 1.7 7.7 11.6 14.0 39.0 46.0 0.16 0.33 7.0 11.0 15.0 17.0 Sensitivity Threshold 5 4 5 AUTO — 5 — On Single No 10 × 104/μL 20 μL No No Yes Higher DD/MMM/YY 19 Normal Count No 100 100 100 100 SEQ# LY%, MO%, GR% Poor hemolysis, PLT clumps, Abnormal MCHC Operator’s Manual MEK-6510 3. CHANGING SETTINGS Setting Screen OUTPUT Setting Item Internal Printer Auto output after measurement Print with [Print] key Print external data Print parameters Print measure mode Print WBC histogram Print RBC histogram Print PLT histogram Print radar graph Print flags Select parameters to print normal range graph Auto prints number Select parameter to print External Printer Auto output after measurement Print with [Print] key Printer type EPSON VP paper width Print histogram EPSON VP page length (lines/page) Print format Print parameters Print measurement date & time Print normal range Print header Print flags Samples/page Print auto analysis findings Port 1, Port 2 External device (Port 2 only) Format Auto output after measurement Print with [Print] key Output with SEND key Version Output histograms Baud rate Data bits Parity Stop bits Parameters Date format ID digits Print parameter names Top space Left space Row size USB Analyzer name Auto output after measurement Output with SEND key SD card Auto output after measurement Output with OUTPUT key Operator’s Manual MEK-6510 Default Setting Yes Yes Yes 19 Yes Yes Yes Yes No No Off for all parameters 1 Off for all parameters Yes Yes EPSON VP Wide Yes 66 Numeric 15 Date & time None Off Yes 1 Yes Other PC Yes No Yes V04-02 No 9600 8 Even 1 18 DD/MMM/YY 13 None 5 0 10 Unit 1 Yes Yes No Yes 3.67 3 3. CHANGING SETTINGS Setting Screen LANGUAGE UNITS SOUND/LCD OPERATION AUTO CLEANING USERS MANAGE REAGENT QC SETTINGS 3.68 Setting Item Language Units Measurement count sound Volume Screen brightness Background noise check at power on [Eject] key operation Reset auto ID at power on ID digits Use ID 1st 2nd 3rd 4th Name Type of user Password Use reagent management Waste Diluent Reagent Detergent Lysing reagent QC method Save QC meas data on DATA screen Send data after QC measurement X limit calculation Default Setting English USA On 3 Dark No Count Yes 4 DIGITS Auto 0:00 0:00 0:00 0:00 Factory Service — Clean No No No User Other user 0000 Celltac Lab technician 6500 Off Warning: 9.5 L Bottle size: 10.0 L Warning: 0.5 L Bottle size: 18.0 L Warning: 0.15 L Bottle size: 5.0 L Warning: 15 mL Bottle size: 500 mL X-R Yes Yes ±2 SD Operator’s Manual MEK-6510 3. CHANGING SETTINGS Setting Screen X-R Normal X-R Low X-R High XB Setting Item Parameter WBC (103/μL) RBC (106/μL) HGB (g/dL) HCT (%) MCV (fL) MCH (pg) MCHC (g/dL) PLT (103/μL) LY% MO% GR% RDW (%) PCT (%) MPV (fL) PDW (%) Parameter WBC (103/μL) RBC (106/μL) HGB (g/dL) HCT (%) MCV (fL) MCH (pg) MCHC (g/dL) PLT (103/μL) LY% MO% GR% RDW (%) PCT (%) MPV (fL) PDW (%) Parameter WBC (103/μL) RBC (106/μL) HGB (g/dL) HCT (%) MCV (fL) MCH (pg) MCHC (g/dL) PLT (103/μL) LY% MO% GR% RDW (%) PCT (%) MPV (fL) PDW (%) Parameter MCV (fL) MCH (pg) MCHC (g/dL) Operator’s Manual MEK-6510 X INITIAL VALUE 7.9 4.81 14.0 42.3 88.0 29.1 33.1 251 35.3 4.8 59.9 13.9 0.14 5.4 17.1 X INITIAL VALUE 2.1 2.32 6.1 18.6 80.0 26.3 32.8 67 64.3 8.2 27.5 15.0 0.04 6.6 17.7 X INITIAL VALUE 21.2 5.57 18.6 55.5 94.0 31.5 33.5 485 21.1 1.5 77.4 13.3 0.20 4.1 16.3 X INITIAL VALUE 89.5 30.5 33.8 Default Setting X LIMIT R INITIAL VALUE ±0.8 0.8 ±0.18 0.18 ±0.4 0.4 ±2.5 2.5 ±3.0 3.0 ±1.5 1.5 ±2.0 2.0 ±40 40 ±5.0 5.0 ±3.0 3.0 ±5.0 5.0 ±2.0 2.0 ±0.05 0.05 ±2.0 2.0 ±2.0 2.0 X LIMIT R INITIAL VALUE ±0.6 0.6 ±0.14 0.14 ±0.3 0.3 ±2.0 2.0 ±3.0 3.0 ±1.5 1.5 ±2.0 2.0 ±20 20 ±6.0 6.0 ±2.0 2.0 ±6.0 6.0 ±2.0 2.0 ±0.02 0.02 ±2.0 2.0 ±2.0 2.0 X LIMIT R INITIAL VALUE ±1.6 1.6 ±0.23 0.23 ±0.5 0.5 ±3.0 3.0 ±3.0 3.0 ±1.5 1.5 ±2.0 2.0 ±70 70 ±5.0 5.0 ±2.0 2.0 ±5.0 5.0 ±2.0 2.0 ±0.07 0.07 ±2.0 2.0 ±2.0 2.0 X LIMIT ±2.7 ±0.9 ±1.0 R LIMIT 1.6 0.36 0.8 5.0 6.0 3.0 4.0 80 10.0 6.0 10.0 4.0 0.10 4.0 4.0 R LIMIT 1.2 0.28 0.6 4.0 6.0 3.0 4.0 40 12.0 4.0 12.0 4.0 0.04 4.0 4.0 R LIMIT 3.2 0.46 1.0 6.0 6.0 3.0 4.0 140 10.0 4.0 10.0 4.0 0.14 4.0 4.0 3.69 3 Section 4 Measurement General................................................................................................................................................................. 4.2 Dilution Mode............................................................................................................................................. 4.2 Sample Type............................................................................................................................................... 4.2 Single and Double Counting....................................................................................................................... 4.2 ID Numbers................................................................................................................................................ 4.3 Alarm Display............................................................................................................................................. 4.3 Data Storage.............................................................................................................................................. 4.4 Printing and Sending Data......................................................................................................................... 4.4 PLT Recount............................................................................................................................................... 4.4 Recount when Out of Panic Range............................................................................................................ 4.4 Counting Special Case Samples................................................................................................................ 4.5 Measuring a Venous Sample in Normal Dilution Mode........................................................................................ 4.6 Preparing a Venous Sample....................................................................................................................... 4.6 Measuring a Venous Sample...................................................................................................................... 4.7 Measuring a Pre-Dilution Sample......................................................................................................................... 4.9 Preparing a Pre-Dilution Sample................................................................................................................ 4.9 Measuring a Pre-Dilution Sample............................................................................................................ 4.10 Measuring a Venous Sample in Low/High Dilution Mode................................................................................... 4.12 Performing Auto Recount................................................................................................................................... 4.14 Recount on Alarm.................................................................................................................................... 4.14 Recount on PLT Count............................................................................................................................. 4.14 Recounting the Sample when Out of Panic Range............................................................................................ 4.15 Description of the RESULTS Screen.................................................................................................................. 4.17 Numeric Data........................................................................................................................................... 4.18 Measuring Units............................................................................................................................. 4.18 Displaying H and L Out of Range Marks........................................................................................ 4.18 Over Message................................................................................................................................ 4.18 Histograms............................................................................................................................................... 4.19 Vertical Axis Type for the Histogram............................................................................................... 4.19 Adjusting Axes Scale..................................................................................................................... 4.19 RBC (Red Blood Cell) Distribution Histogram................................................................................ 4.19 PLT (Platelet) Distribution Histogram............................................................................................. 4.20 WBC (White Blood Cell) Distribution Histogram............................................................................ 4.20 Flags......................................................................................................................................................... 4.21 Flag Codes..................................................................................................................................... 4.22 Flag Names.................................................................................................................................... 4.23 Alarm Display........................................................................................................................................... 4.24 Printing and Sending Results............................................................................................................................. 4.25 Auto Printing/Sending after Measurement............................................................................................... 4.25 Printing by Pressing [Print] Key................................................................................................................ 4.25 Sending Data to PC.................................................................................................................................. 4.25 Operator’s Manual MEK-6510 4.1 4 4. MEASUREMENT General Dilution Mode There are five dilution modes: normal, pre-dilution, low dilution, high dilution and higher dilution modes. • Normal mode In normal dilution mode, 30 µL sample volume is measured. • Pre-dilution mode For pre-dilution blood measurements, you can specify the pre-dilution blood measuring volume (10 µL or 20 µL) on the MEASUREMENT screen of the SETTINGS screen. Refer to “Changing Measurement Settings” in Section 3. • High or higher dilution mode When a blood sample’s WBC seems to be high, the sample can be measured in high or higher dilution mode. In high dilution mode, 10 µL of blood sample is aspirated and diluted three times the usual dilution ratio. In higher dilution mode, 5 µL of blood sample is aspirated and diluted six times the usual dilution ratio. • Low dilution mode When a blood sample’s WBC or PLT seems to be low, the sample can be measured in low dilution mode. The low dilution mode reduces the recount and measurement data is stable. Sample Type With this analyzer, you can specify the sample type before each measurement. This allows you to assign a different normal range to different samples or to retrieve specific data. Single and Double Counting In single counting mode, each sample is counted once. In double counting mode, the analyzer 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 (more than 10%) between the two counts, a third counting is automatically performed and the mean of the two closest counts is used. When displaying or 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 double count, refer to “Changing Measurement Settings” in Section 3. 4.2 Operator’s Manual MEK-6510 4. MEASUREMENT Single Counting Press the count switch Counting Display sample data Double Counting Press the count switch First counting 4 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. Alarm Display The analyzer automatically recounts a sample up to 3 times when an alarm occurs during measurement. If measurement is still unusable after 3 counts, the analyzer displays an alarm with the measurement results. Refer to “Alarm Display” in “Description of the RESULTS Screen” later in this section. You can also set the analyzer to display an alarm while recounting the sample. This helps you find where the trouble is when there are frequent recounts. Refer to “Changing Measurement Settings” in Section 3. In normal operation, set this to “Off”. CAUTION When an alarm occurs, the acquired data might not be correct, especially when “!” or “sample error” message appears. Do not use the data for diagnosis. Recount the sample. Operator’s Manual MEK-6510 4.3 4. MEASUREMENT Data Storage The analyzer stores all measured and calculated data for the latest 400 samples and histograms of up to 50 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) and calibration data is also stored. For details, refer to Section 6 and Section 7, respectively. Printing and Sending Data The acquired data can be printed and sent when a printer or personal computer is connected to the analyzer. When the auto printing or data transfer function is set to on, the data can be automatically printed on the printer or sent to personal computer. Refer to “Printing and Sending Results” in this section and “Changing Output Format” in Section 3. PLT Recount The analyzer automatically recounts a sample when PLT is extremely low. RBC, HCT, PLT, MCV, PCT, MCH, MCHC and RDW are recounted. You can set the threshold under which a sample is recounted. Refer to “Changing Measurement Settings” in Section 3. In normal operation, select 100,000/µL. Recount when Out of Panic Range The analyzer can be set to display a message to recount a sample when any parameter count is outside the measurable range of the analyzer (which is called panic range). When <Recount if panic value> is set to “Yes” on the MEASUREMENT screen of the SETTINGS screen and the measurement result is outside the panic range, a message asks whether or not to remeasure the sample in a different dilution mode. If you choose to remeasure and when the measurement result was below the panic range (“L” appears beside the parameter), the sample is recounted in low dilution mode. When the measurement result was “OVER”, “ ! ” appeared beside the parameter, or an A031, A032 (WBC noise) alarm code message appeared, the sample is recounted in high dilution mode. When “High” is selected for <High dilute mode for panic value recount> on the MEASUREMENT screen of the SETTINGS screen, the sample is diluted three times the usual dilution ratio. When “Higher” is selected, the sample is diluted six times the usual dilution ratio. When “High” is selected, the recount is performed at the “High” setting. If the WBC result is still high, another recount is performed at the “Higher” setting. To change recount settings, refer to “Changing Measurement Settings” in Section 3. 4.4 Operator’s Manual MEK-6510 4. MEASUREMENT The recount with high/low dilution is not available for pre-dilution mode samples. Counting Special Case Samples • WBC Count To measure a blood sample from 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 lysing 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-6510 4.5 4 4. MEASUREMENT Measuring a Venous Sample in Normal Dilution Mode WARNING Always wear rubber gloves to protect yourself from infection. NOTE The sampling nozzle comes down before the analyzer is ready to measure. Be careful not to stick your hands with the nozzle. Sample in any type of container can be measured. In the following procedure, a sample container listed in “Consumables” in Section 10 is used as an example. The sampling nozzle position can be adjusted according to the type of container. When using the sample container listed in “Consumables” in Section 10, set <Sampling nozzle position> to “Low” on the OPERATION screen of the SETTINGS screen. When using a sample tube, set <Sampling nozzle position> to “High” To change the setting, refer to “Changing Various Settings for Analyzer Power On” in Section 3. Preparing a Venous Sample 1. Put 2 mL of collected whole blood in a sample container which contains anticoagulant. CAUTION Use only EDTA (ethylenediamine tetra-acetic acid) as an anticoagulant. Do not use heparin as an anticoagulant. It affects white blood cell and platelet measurement. 2. Gently shake the covered sample container up and down more than 30 times. NOTE • Do not stir the sample excessively because it generates unwanted bubbles and cause hemolyzation. • For reliable data, measure the blood sample within 8 hours. If the blood sample is stored at room temperature for more than 8 hours, the white blood cell membrane resistance against lysing reagent decreases and the white blood cell will contract more (decrease of cell volume) just after the lysing reagent is added to the diluted sample. This causes the total WBC count to decrease. 4.6 Operator’s Manual MEK-6510 4. MEASUREMENT Measuring a Venous Sample CAUTION Do not use aggregated or coagulated blood. Otherwise the instrument may be damaged. • • • • • 4 NOTE When measurement cannot be performed properly due to poor hemolyzation, measure the blood sample at least 30 minutes after collection. If the blood sample is measured within 30 minutes after collection, false-positive flags may increase. Measure blood samples within 8 hours after collection. Keep the blood samples in room temperature. Do not keep them in a refrigerator. Gently and thoroughly shake the blood sample again before measurement. 1. On the READY screen, check the <ID> and <Sample type> setting and check that “Normal” is selected for <Dilute mode>. Displays ID screen for setting sample ID. Displays sample type selection list. Displays dilution mode selection list. The [Count] key becomes the [Dispense] key in pre-dilution blood mode when <[Eject] key operation> is set to “Dispense“ on the OPERATION screen of the SETTINGS screen. In this case, the key only functions as the dispense key and does not function in any other way in any other mode. Count key 2. Put the sampling nozzle into the sample container of the sample blood so that the tip of the sampling nozzle comes near but does not touch the bottom of the sample container. NOTE Do not let the sampling nozzle touch the bottom of the sample container. This may prevent aspiration of the sample. Sampling nozzle Count switch Put the sampling nozzle to this level. Operator’s Manual MEK-6510 4.7 4. MEASUREMENT 3. Press the [ Count] switch or key. The sample is aspirated and measurement starts. The “Measuring” message appears on the screen. NOTE Keep the sampling nozzle in the sample blood while the sample blood is aspirated. When measurement is completed, the measurement data is stored in memory and the numeric result and histogram appear on the screen. For details on the RESULTS screen, refer to “Description of the RESULTS Screen” section. (Display format differ according to the settings. For details on the setting, refer to “Changing Display Format” in Section 3.) To continue measuring samples, repeat the procedure. The ID is automatically incremented when the [ Count] switch or key is pressed. When measuring the same sample again, set the same ID on the ID screen and count the sample. When a PC or optional printer is connected to the analyzer and auto output or auto print is set to “On” on the OUTPUT screen, the measurement data is sent to the PC or printed on the printer. The sample can be recounted when any parameter count is outside the panic range of the analyzer when <Recount if panic value> is set to “Yes” on the MEASUREMENT screen of the SETTINGS screen. For details, refer to “Recounting the Sample when Out of Panic Range” later in this section. 4.8 Operator’s Manual MEK-6510 4. MEASUREMENT Measuring a Pre-Dilution Sample Preparing a Pre-Dilution Sample • • • • NOTE Carefully perform the following procedures to collect and dilute predilution blood from an earlobe or a finger tip. When pre-dilution 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 pre-dilution blood from a finger tip or heel. Measuring an earlobe pre-dilution blood may not be accurate. For each parameter, the values for earlobe pre-dilution 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. WBC distribution is not available for some pre-dilution samples. You can select pre-dilution blood measuring volume (10 or 20 µL) on the MEASUREMENT screen of the SETTINGS screen. For details, refer to “Changing Measurement Settings” in Section 3. 1. On the READY screen, check the <ID> and <Sample type> setting. 2. Select “Pre-dil” for <Dilute mode>. The DISPENSE key appears on the screen. The [Count] key becomes the [Dispense] key in pre-dilution blood mode when <[Eject] key operation> is set to “Dispense” on the OPERATION screen of the SETTINGS screen. In this case, the key only functions as the dispense key and does not function in any other way in any other mode. Dispense key Sampling nozzle Put the sampling nozzle at this point. Operator’s Manual MEK-6510 3. Put the sampling nozzle into an empty sample cup so that the tip of the sampling nozzle touches near the rim of the sample cup as shown in the figure. 4. Press the DISPENSE key on the READY screen or the [ Dispense] key on the front panel. A 2 mL of the diluent is dispensed into the sample cup. 4.9 4 4. MEASUREMENT 5. Collect 10 or 20 µL of whole blood with a capillary tube. Capillary tube NOTE When wiping the blood off the surface of the capillary tube, take extreme care not to wipe the blood inside the capillary tube. 6. Put the pre-dilution blood into the sample cup with the dispensed diluent. Be careful not to create any bubbles. Put the cap on the sample cup. 7. 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. To continue preparing more pre-dilution samples, repeat the procedure from step 3. Measuring a Pre-Dilution Sample Count key Sampling nozzle Count switch 4.10 Put the sampling nozzle to this level. 1. Put the sampling nozzle into the sample cup containing the pre-dilution sample so that the tip of the sampling nozzle comes near but does not touch the bottom of the sample cup. NOTE • Do not press the sampling nozzle too hard against the bottom of the sample cup. This decreases the aspirating volume. • In pre-dilution mode, about 1 mL of sample is aspirated. Make sure that the sampling nozzle is near the bottom of the sample cup so that the correct volume of the sample can be aspirated. Operator’s Manual MEK-6510 4. MEASUREMENT 2. Press the [ starts. Count] switch or key. The sample is aspirated and measurement NOTE Keep the sampling nozzle in the sample while the sample is aspirated. 4 When measurement is completed, the measurement data is stored in memory and the numeric result and histograms appear on the screen. For details on the RESULTS screen, refer to “Description of the RESULTS Screen” section. (Display format differ according to the settings. For details on the setting, refer to “Changing Display Format” in Section 3.) The dilution mode returns to “Normal” after pre-dilution mode measurement. When <Continue dilute mode> is set to “Yes” on the MEASUREMENT screen of the SETTINGS screen, the dilution mode does not return to “Normal” and you can continue to measure in your selected dilution mode. For details, refer to “Changing Measurement Settings” in Section 3. To continue measuring pre-dilution samples when <Continue dilute mode> is set to “No”, select “Pre-dilute” for <Dilute mode> on the READY screen. The instructions for making pre-dilution blood sample appears on the screen. When you have already prepared the pre-dilution blood samples, press the [ Count] switch or key and measure the sample. The ID is automatically incremented when the [ Count] switch or key is pressed. When measuring the same sample again, set the same ID on the ID screen and count the sample. When a PC or optional printer is connected to the analyzer and auto output or auto print is set to “On” on the OUTPUT screen, the measurement data is sent to the PC or printed on the printer. Operator’s Manual MEK-6510 4.11 4. MEASUREMENT Measuring a Venous Sample in Low/High Dilution Mode NOTE WBC distribution is not available for some low/high dilution samples. When a blood sample’s WBC seems to be high, the sample can be measured in high dilution mode. In high dilution mode, 10 µL of blood sample is aspirated and diluted three times the usual dilution ratio. In higher dilution mode, 5 µL of blood sample is aspirated and diluted six times the usual dilution ratio. When a blood sample’s WBC or PLT seems to be low, the sample can be measured in low dilution mode. Low/high dilution mode measurement is not available for pre-dilution samples. 1. Agitate the sample and anticoagulant thoroughly by turning the sample container upside down more than 30 times so that the blood sample and anticoagulant are mixed. 2. On the READY screen, check the <ID> and <Sample type> setting. 3. Select “High”, “Higher” or “Low” for <Dilute mode>. Displays dilution mode selection list. The [Count] key becomes the [Dispense] key in pre-dilution blood mode when <[Eject] key operation> is set to “Dispense“ on the OPERATION screen of the SETTINGS screen. In this case, the key only functions as the dispense key and does not function in any other way in any other mode. Count key NOTE Do not let the sampling nozzle touch the bottom of the sample container. This may prevent aspiration of the sample. Sampling nozzle Count switch 4.12 4. Put the sampling nozzle into the sample container of the sample blood so that the tip of the sampling nozzle comes near but does not touch the bottom of the sample container. Put the sampling nozzle to this level. Operator’s Manual MEK-6510 4. MEASUREMENT 5. Press the [ Count] switch or key. The sample is aspirated and measurement starts. The “Measuring” message appears on the screen. NOTE Keep the sampling nozzle in the sample while the sample is aspirated. 4 When measurement is completed, the measurement data is stored in memory and the numeric result and histogram appear on the screen. For details on the RESULTS screen, refer to “Description of the RESULTS Screen” section. (Display format differ according to the settings. For details on the setting, refer to “Changing Display Format” in Section 3.) The dilution mode returns to “Normal” after low/high mode measurement. When <Continue dilute mode> is set to “Yes” on the MEASUREMENT screen of the SETTINGS screen, the dilution mode does not return to “Normal” and you can continue to measure in your selected dilution mode. The ID is automatically incremented when the [ Count] switch or key is pressed. When measuring the same sample again, set the same ID on the ID screen and count the sample. When a PC or optional printer is connected to the analyzer and auto output or auto print is set to “On” on the OUTPUT screen, the measurement data is sent to the PC or printed on the printer. When the measurement is performed in high dilution mode and the result is outside the panic range of the analyzer, a message asks whether or not to recount the sample in higher dilution mode when <Recount if panic value> is set to “Yes” on the MEASUREMENT screen of the SETTINGS screen. Refer to the “Recounting the Sample when Out of Panic Range” later in this section. Operator’s Manual MEK-6510 4.13 4. MEASUREMENT Performing Auto Recount There are two types of auto recount. • Recount on alarm • Recount on PLT count Recount on Alarm When an alarm occurs during measurement, the sample is automatically recounted up to three times. The same aspirated portion of the sample is recounted. You can set to display alarm upon auto recount to distinguish the problem when <Display alarm on recount> is set to “Yes” on the MEASUREMENT screen of the SETTINGS screen. To change the setting, refer to “Changing Measurement Settings” in Section 3. For details on the alarm display, refer to the “Alarm Display” later in this section. Recount on PLT Count The analyzer automatically recounts a sample when PLT is extremely low. RBC, HCT, PLT, MCV, PCT, MCH, MCHC and RDW are recounted. The same aspirated portion of the sample is recounted. You can select 5 × 104/µL or 10 × 104/µL as the threshold under which a sample is recounted. When “None” is selected, a sample is not recounted. For normal operation, select 10 × 104/µL. To change the setting, refer to “Changing Measurement Settings” in Section 3. 4.14 Operator’s Manual MEK-6510 4. MEASUREMENT Recounting the Sample when Out of Panic Range The analyzer can be set to display a message to recount a sample when any parameter count is outside the measurable range of the analyzer (which is called panic range). When <Recount if panic value> is set to “Yes” on the MEASUREMENT screen of the SETTINGS screen and the measurement result is outside the panic range, a message asks whether or not to remeasure the sample in a different dilution mode. If you choose to remeasure and when the measurement result was below the panic range (“L” appears beside the parameter), the sample is recounted in low dilution mode. When the measurement result was “OVER”, “ ! ” appeared beside the parameter, or an A031, A032 (WBC noise) alarm code message appeared, the sample is recounted in either high or higher dilution mode, according to the setting of the <High dilute mode for panic value recount>. For details on the settings on the MEASUREMENT screen, refer to “Changing Measurement Settings” in Section 3. In high dilution mode, the sample is diluted three times the usual dilution ratio. In higher dilution mode, the sample is diluted six times the usual dilution ratio. When high dilution mode is selected, the recount is performed with high dilution mode setting. If the WBC result is still high, another recount is performed with higher dilution mode setting. In low dilution mode, the sample is diluted half the usual dilution ratio. When recounting with different dilution mode is required, the confirmation message appears on the screen. In the following procedure, the example is given when WBC is higher than the measurable range and <High dilute mode for panic value recount> is set to “High”. 1. Press the “YES” key to recount the sample with high dilution. The instruction appears on the screen. Press the “NO” key to not perform recount. The first measurement data is stored in memory. Instruction for recount appears. Cancels recount and the first measurement data is stored in memory. Operator’s Manual MEK-6510 4.15 4 4. MEASUREMENT The [Count] key becomes the [Dispense] key in pre-dilution blood mode when <[Eject] key operation> is set to “Dispense“ on the OPERATION screen of the SETTINGS screen. In this case, the key only functions as the dispense key and does not function in any other way in any other mode. Count key 3. Press the [ Count] switch or key or key. The sample is aspirated and measurement with high dilution starts. The “Measuring” message appears on the screen. NOTE Keep the sampling nozzle in the sample while the sample is aspirated. Sampling nozzle Count switch 2. Put the sampling nozzle into the sample container so that the tip of the sampling nozzle comes near but does not touch the bottom of the sample container. Put the sampling nozzle to this level. When measurement is completed, the numeric result and histogram appear on the screen. When the measured result is still “OVER”, the recount with higher dilution confirm message appears again on the screen. 4. Press the “YES” key to recount the sample with higher dilution mode again. Press the “NO” key to not perform recount. The second measurement data is stored in memory. 5. Repeat steps 2 and 3. The “Measuring” message appears on the screen. When measurement is completed, the measurement data is stored in memory and the numeric result and histogram appear on the screen. When a PC or optional printer is connected to the analyzer and auto output or auto print is set to “On” on the OUTPUT screen, the final measurement data is sent to the PC or printed on the printer. 4.16 Operator’s Manual MEK-6510 4. MEASUREMENT Description of the RESULTS Screen When the measurement is completed, the measured data is displayed on the RESULTS screen. On the RESULTS screen, WBC, RBC and PLT histograms and numeric data are displayed. The display format differ according to the setting on the DISPLAY screen of the SETTINGS screen. For details on the settings, refer to “Changing Display Format” in Section 3. ID number Measurement date and time Sample type Change sample information. 2nd page: Dilution mode WBC histogram 3rd page: Sampling mode Numeric result Alarmed parameters are displayed in red. RBC histogram PLT histogram 4th page: Sequence number 5th page: User Displays the READY screen. Displays the ID screen to change ID for the next sample. Outputs the data to the device selected on the OUTPUT screen. This key appears when the data has flags. Press to display the flag window. Operator’s Manual MEK-6510 This key appears when the data has alarm messages. Press to display the ALARM screen. 4.17 4 4. MEASUREMENT Numeric Data RESULTS screen with 19 parameter numeric data RESULTS screen with 8 parameter numeric data Measuring Units You can select the measuring units or edit them on the UNITS screen of the SETTINGS screen. For details, refer to “Selecting Units” in Section 3. The factory default settings are shown in the following table. Parameter WBC LY% MO% GR% LY MO GR RBC HGB Units 103/µL % % % 103/µL 103/µL 103/µL 106/µL g/dL Parameter HCT MCV MCH MCHC PLT RDW-CV PCT MPV PDW RDW-SD Units % fL pg g/dL 103/µL % % fL % fL 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. These values are displayed in red. 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. In this case, check background noise and decrease the noise. Refer to “Measuring Background Noise” in Section 2. Also refer to “Specifications” in Section 10 for measurable range. 4.18 Operator’s Manual MEK-6510 4. MEASUREMENT Histograms Vertical Axis Type for the Histogram You can select the type for the vertical axis on the histogram. 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. For selecting the vertical axis type, refer to “Changing Display Format” in Section 3. RESULTS screen with wide histogram display <Counted Value> [%] 100% [Count] <Percentage> [fL] [fL] The horizontal axis represents the blood cell volume. (fL = 1 × 10-15 L) Adjusting Axes Scale When the histogram vertical axis is set to “Count”, the WBC vertical axis, RBC vertical and horizontal axes and PLT vertical axis scale can be adjusted. For details, refer to “Changing Display Format” in Section 3. RBC (Red Blood Cell) Distribution Histogram RDW-CV (coefficient of variation of red blood cell distribution width) is automatically calculated from the RBC distribution histogram. RDW-CV (%) = Standard deviation of red blood cell volumes (SD) Mean cell volume (MCV) The RDW indicates the deviation ratio of the red blood cell volumes on the histogram. MCV Operator’s Manual MEK-6510 SD SD 100 200 4.19 4 4. MEASUREMENT RDW-SD (fL) The RDW-SD is the distribution width of the 20% frequency level when the peak of the RBC particle size distribution width is 100%. 100% 20% (fL) RDW-SD 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. SD SD MPV 10 20 WBC (White Blood Cell) Distribution Histogram The analyzer 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. You can set the analyzer to display lines showing the separation of the 3-part differential. Refer to “Changing Display Format” in Section 3. LY%: MO%: GR%: LY: 4.20 Lymphocyte percent Monocyte percent Granulocyte percent Lymphocyte count Operator’s Manual MEK-6510 4. MEASUREMENT MO: GR: Monocyte count Granulocyte count Lymphocyte distribution Monocyte Granulocyte distribution distribution 4 Flags 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 or F4) is displayed on the right side of the numeric data and the FLAGS key is displayed on the RESULTS screen. Press the FLAGS key to open the flag display box to display the type of flags. Flag display box You can set certain flags to be displayed in red on the DISPLAY screen of the SETTINGS screen. Refer to “Changing Display Format” in Section 3. 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. Operator’s Manual MEK-6510 4.21 4. MEASUREMENT Flag Codes 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: Poor Lymphocyte discrimination Granulocyte distribution Possible causes: Small number of lymphocytes F3: Poor Granulocyte discrimination Lymphocyte distribution Possible causes: • The blood sample was left more than 8 hours after collecting. • The blood sample was not stored in ideal conditions. • Poor blood cell membranes. • Small number of granulocytes. • Reagents other than ISOTONAC•3 and Hemolynac•3N were used. F4: Poor Lymphocyte, Monocyte and Granulocyte discriminations Possible causes: Reagents other than ISOTONAC•3 and Hemolynac•3N were used. 4.22 Operator’s Manual MEK-6510 4. MEASUREMENT Flag Names The following flags are displayed when the measurement result is below or above the normal range for each item. The following list is the factory default settings. You can change the normal range setting on the NORMAL RANGE screen of the SETTINGS screen. Refer to “Setting Normal Range Upper and Lower Limits” in Section 3. Flag Name WBC • Leukocytosis • Leukopenia • Poor hemolysis • RBC ghost • Can’t analyze LY • Can’t analyze GR • Can’t diff WBC • Eosinophilia Appears when Display on the RESULTS Screen WBC is above normal rangeH WBC is below normal rangeL Too many RBC ghosts! Too many RBC ghosts F1 Lymphocyte cannot be analyzed F2 Granulocyte cannot be analyzed F3 WBC cannot be differentiated F4 Too many eosinophil RBC • Erythrocytosis • Anemia • Anisocytosis • Microcytosis • Macrocytosis • Hypochromia • Abnormal MCHC RBC is above normal range HGB is below normal range RDW is above 20.0% MCV is below normal range MCV is above normal range MCHC is below normal range MCHC is below 26.0 g/dL or above 38.0 g/dL H L L H L PLT • Thrombocytosis PLT is above normal range H • Thrombocytopenia PLT is below normal range L • PLT clumps Presence of PLT clumps is suspected • PLT-RBC Interfere PLT-RBC is above 0.10 • If “C” appears on the right side of the WBC or PLT data, the PLT may be coagulated. Operator’s Manual MEK-6510 4.23 4 4. MEASUREMENT Alarm Display When trouble occurs during counting, alarms such as “clogged”, “bubble”, “fluid level”, “sample error”, or “ ! ” are displayed and sounded. The MESSAGES key is displayed on the RESULTS screen when alarm occurs. Press the MESSAGES key to display the ALARM screen to see the messages. If an alarm occurs, remove the cause by referring to Section 8 “Messages and Troubleshooting”. CAUTION When an alarm occurs, the acquired data might not be correct, especially when “!” or “sample error” message appears. Do not use the data for diagnosis. Recount the sample. Alarms appear in red. 4.24 Operator’s Manual MEK-6510 4. MEASUREMENT Printing and Sending Results When an optional printer or PC is connected to the analyzer, the measurement result can be printed on the printer or sent to the PC. 4 Auto Printing/Sending after Measurement When an optional printer or PC is connected to the analyzer and auto print or auto output is set to “On” on the OUTPUT screen of the SETTINGS screen, the measurement data is printed on the printer or sent to the PC when the measurement is complete. The data selected on the OUTPUT screen are printed or sent. For details on printing/sending settings, refer to “Changing Output Format” in Section 3. Auto print mode lamp Auto print key To perform auto print on the internal printer, set <Auto output after measurement> on the INT PRINTER screen of the OUTPUT screen to “Yes” or press the [ lights. Internal printer Auto print] key on the front panel to on. The auto print mode lamp To perform auto print on the external printer, set <Auto output after measurement> on the EXT PRINTER screen of the OUTPUT screen to “Yes” or press the [ Auto print] key on the front panel to on. The auto print mode lamp lights To perform auto print on the card printer or auto send to the PC, set <Auto output after measurement> to “Yes” on the SERIAL PORT 1 or SERIAL PORT 2 screen to which the card printer or PC is connected. Printing by Pressing [Print] Key Print key When the [ Print] key on the front panel is pressed, the displayed data is printed on the printer for which <Print with [Print] key> is set to “Yes” on the OUTPUT screen. The data selected on the OUTPUT screen are printed. Press the [ Feed] key to make some blank on the recording paper. Feed key Sending Data to PC When the SEND key on the RESULTS screen is pressed, the displayed data is sent to the PC for which <Output with SEND key> is set to “Yes” on the OUTPUT screen. The data selected on the OUTPUT screen are sent. Operator’s Manual MEK-6510 4.25 4. MEASUREMENT Printing Example WA-650VK internal printer Settings on the INTERNAL PRINTER screen of the SETTINGS screen Print parameters: 19 Print measure mode: Yes Print WBC histogram: Yes Print RBC histogram: Yes Print PLT histogram: Yes Print radar graph: Yes Select parameters to print normal range graph: On for all parameters Measurement mode Numeric measured values WBC histogram RBC histogram PLT histogram Normal range upper limit Measured value Radar graph Normal range lower limit Normal range lower limit Normal range upper limit Normal range graph 4.26 Measured value Operator’s Manual MEK-6510 4. MEASUREMENT External printer (WA-712V) Settings on the EXTERNAL PRINTER screen of the SETTINGS screen Printer type: EPSON VP Epson VP paper width: Narrow Print histograms: No Print flags: No 4 Only the measured numeric values are printed Settings on the EXTERNAL PRINTER screen of the SETTINGS screen Printer type: EPSON VP Epson VP paper width: Wide Print format: Num + hist Print normal range: Numeric WBC histogram RBC histogram PLT histogram Measured values Operator’s Manual MEK-6510 Normal range limits 4.27 4. MEASUREMENT Settings on the EXTERNAL PRINTER screen of the SETTINGS screen Printer type: EPSON VP Epson VP paper width: Wide Print format: Num + hist Print normal range: Graphic Measured values WBC histogram RBC histogram PLT histogram Normal range graph Normal range upper limit Normal range lower limit Measured value 4.28 Operator’s Manual MEK-6510 4. MEASUREMENT Settings on the EXTERNAL PRINTER screen of the SETTINGS screen Printer type: EPSON VP Epson VP paper width: Wide Print format: Radar graph Print auto analysis findings: Yes Normal range lower limit Measured value Normal range upper limit 4 Auto analysis findings Radar graph Normal range lower limit Operator’s Manual MEK-6510 Normal range upper limit Measured value 4.29 Section 5 Handling Data General................................................................................................................................................................. 5.2 Displaying Numerical Data and Histograms......................................................................................................... 5.3 Displaying the Latest Measured Data........................................................................................................ 5.3 Displaying Saved Data............................................................................................................................... 5.4 Editing ID and Sample Type of Saved Data.......................................................................................................... 5.6 Searching for Data................................................................................................................................................ 5.8 Printing and Sending Data................................................................................................................................. 5.12 Automatic Printing and Sending Data after Measurement....................................................................... 5.12 Printing and Sending Stored Data............................................................................................................ 5.12 Printing or Sending Single Data..................................................................................................... 5.12 Printing or Sending Multiple Data.................................................................................................. 5.13 Printing or Sending Data for All Samples of a Single Day.............................................................. 5.15 Deleting Data...................................................................................................................................................... 5.18 Deleting Single Data................................................................................................................................. 5.18 Deleting Multiple Data.............................................................................................................................. 5.19 Deleting All Stored Data........................................................................................................................... 5.20 Operator’s Manual MEK-6510 5.1 5 5. HANDLING DATA General The analyzer stores all measured and calculated data for the latest 400 samples and histograms of up to 50 samples in the internal memory or an SD memory card. The stored data can be printed, transferred to a personal computer, and deleted*. Sample IDs can be edited. * Deletion is available only on the DATA screen. When the sample has histograms, these can be displayed and printed. When the type of user is other user, the user cannot delete data. The data is saved in backup memory after the power is turned off. 5.2 Operator’s Manual MEK-6510 5. HANDLING DATA Displaying Numerical Data and Histograms Displaying the Latest Measured Data You can retrieve the latest measurement result from the READY screen. Press the RESULTS key on the READY screen. 5 The RESULTS screen appears showing the numeric data and histograms of the latest measurement. For details about the RESULTS screen, refer to “Description of the RESULTS Screen” in Section 4. Display format differ according to the settings. For details on the setting, refer to “Changing Display Format” in Section 3. Operator’s Manual MEK-6510 5.3 5. HANDLING DATA Displaying Saved Data You can display any saved numeric data. Numeric data for up to 400 samples can be stored in the internal memory or SD memory card. You can also display histograms. Up to 50 samples can be stored in memory. An asterisk (*) mark in front of the ID means that the histograms are stored. To print data, refer to the “Printing and Sending Data” later in this section. 1. Press the DATA or SD DATA key on the MENU screen to display the DATA or SD DATA screen. The numeric data for the latest 4 samples is listed. Asterisk (*) indicates that the data has histograms. ID number in red indicates that the data has flags which are selected for <Select flags to display in red> on the DISPLAY screen of the SETTINGS screen. Refer to “Changing Display Format” in Section 3. ID keys Either sequence number or sample type can be selected to be displayed. Alarmed parameter is displayed in red. These three parameters can be changed to other parameters. Data can only be deleted on the DATA screen. Displays older data. Displays newer data. Up to 100 pages can be created. 100/100 is the latest data page and 1/100 is the oldest data page. You can select either SEQ# or sample type and the last three parameters to be displayed on the DATA screen on the DISPLAY screen of the SETTINGS screen. Refer to “Changing Display Format” in Section 3. 5.4 Operator’s Manual MEK-6510 5. HANDLING DATA 2. Use the arrow keys to display the desired data. Press the ← key to display the previous page. Press the → key to display the next page. 3. To view the detailed data, press the ID key of the desired data and press the DETAILS key. If an ID has the asterisk (*) mark, the histograms appear with the numeric data. 5 The data displayed on the DETAILS screen is the same as the RESULTS screen. For details about the RESULTS screen, refer to “Description of the RESULTS Screen” in Section 4. Press the [ Print] key on the front panel to print the displayed data. Press the SEND key to send the displayed data to the connected PC. Press the OK key to return to the DATA or SD DATA screen. 4. Press the OK key to return to the MENU screen. Operator’s Manual MEK-6510 5.5 5. HANDLING DATA Editing ID and Sample Type of Saved Data You can change the ID and sample type of any saved data only on the DATA screen. The saved data cannot be changed on the SD DATA screen. 1. On the DATA screen, press the ID key of the data you want to edit and press the DETAILS key. 2. Press the EDIT key to display the DETAILS screen. 5.6 Operator’s Manual MEK-6510 5. HANDLING DATA 3. To edit ID: i) Press the EDIT key in <ID> to display the EDIT ID screen. ii) Edit the ID using the alphanumeric keys. This screen functions the same as the ID screen. For details, refer to “Assigning an ID to a Sample” in Section 3. When editing ID, letters can be used for the last 4 digits. 5 To change the sample type of the selected data: Select the sample type from the sample type selection list in <Sample type>. Sample type selection list 4. Press the OK key to return to the DETAILS screen. 5. Press the OK key to return to the DATA screen. Operator’s Manual MEK-6510 5.7 5. HANDLING DATA Searching for Data You can search for a data by ID, measurement date, sample type and flags. The searched result can be printed, sent or deleted. You can also edit the ID or view the detailed data of the searched samples. 1. On the DATA or SD DATA screen, press the SEARCH key to display the SEARCH screen. Displays screen for specifying sample ID. Displays screen for specifying dates. Displays sample type selection list. Displays screen for specifying flags. 2. Enter the search criteria. To specify ID: i) Press the SET key in <ID> to display the screen for entering ID. ii) Enter the ID by using the alphanumeric keys. This screen functions the same as the ID screen. For details, refer to “Assigning an ID to a Sample” in Section 3. When the ID is entered, the setting changes to “Yes” in <Search by ID>. When “No” is selected in <Search by ID>, the entered ID is deleted. iii) Press the OK key to return to the SEARCH screen. 5.8 Operator’s Manual MEK-6510 5. HANDLING DATA To specify measurement date: i) Press the SET key in <Dates> to display the screen for setting dates. Cursor 5 Move cursor. Numeric keys ii) Specify the date range in the <From> and <To> sections. Touch the setting value or use the arrow keys to move the cursor to the setting value you want to set. Enter the number using the numeric keys and press the Enter key to register the number. If you omit the <From> section, the search starts from the oldest stored data. If you omit the <To> section, the search ends with the latest stored data. When the RESET key is pressed, both dates are deleted. iii) Press the OK key to return to the SEARCH screen. To specify the sample type: Select the sample type from the sample type selection list in <Sample type>. You can select one sample type as a criterion. If you do not specify the sample type, all the sample types are searched. Sample type selection list Operator’s Manual MEK-6510 5.9 5. HANDLING DATA To specify flags: i) Press the SET key in <Flags> to display the screen for specifying flags. ii) Select the desired flags by pressing the check box. When the ALL key is pressed, all flags are selected. iii) Press the OK key to return to the SEARCH screen. 3. Press the SEARCH key on the SEARCH screen. 5.10 Operator’s Manual MEK-6510 5. HANDLING DATA The search starts and the search results appear on the screen. The SEARCH RESULTS screen provides the same functions as the DATA or SD DATA screen. 5 Operator’s Manual MEK-6510 5.11 5. HANDLING DATA Printing and Sending Data You can print one or more stored data on the following optional printers. Printer Card Printer Internal Printer External Printer Printing Data Numeric data Numeric data and histograms Numeric data and histograms The numerical data and histograms can be sent to the personal computer. Change the necessary settings for printing and sending data on the OUTPUT screens of the SETTINGS screen. Refer to “Changing Output Format” in Section 3. Automatic Printing and Sending Data after Measurement When auto output is selected, the data is automatically printed on the printer or sent to the connected PC after every measurement. Refer to the “Changing Print Format for External Printer” in Section 3 and “Printing and Sending Results” in Section 4. Printing and Sending Stored Data NOTE Printing and sending data is performed according to the settings on the OUTPUT screens of the SETTINGS screen. For example, if histogram is set not to be output, then histogram is not output to printer or PC. Printing or Sending Single Data You can print or send one data individually. NOTE Histograms cannot be printed on the card printer. 1. On the DATA or SD DATA screen, press the ID key of a desired data to print or send. 5.12 Operator’s Manual MEK-6510 5. HANDLING DATA 2. To print, press the PRINT key. The selected data is printed. To send, press the SEND key. The selected data is sent to the PC. 5 Printing or Sending Multiple Data On the DATA or SD DATA screen, you can select multiple data to print or send. NOTE When printing on the WA-710V/712V or EPSON VP printer, <EPSON VP paper width> must be set to “Wide” on the EXTERNAL PRINTER screen of the SETTINGS screen and wide type paper must be set on the printer. Refer to “Changing Print Format for External Printer” in Section 3. 1. On the DATA or SD DATA screen, press the PRINT key to print or press the SEND key to send the data. The “Select first data” message appears. Display other data. Operator’s Manual MEK-6510 5.13 5. HANDLING DATA 2. Find a desired data using the arrow keys and press the ID key of the data. The “Select last data” message appears. 3. Find the last data using the arrow keys and press the ID key of the data. All data between the first and last ID will be output. The “Print selected data?” message appears when printing or the “Send selected data?” message appears when sending data. 4. Press the YES key. The selected data is printed on the printer or sent to the PC. If you press NO, the process is canceled and the screen returns to the DATA or SD DATA screen. Total number of selected data The number of data currently printed/sent 5.14 Operator’s Manual MEK-6510 5. HANDLING DATA Printing or Sending Data for All Samples of a Single Day All numerical and histogram data for one day can be printed on the optional printers or sent to the connected PC. This function is not available for the card printer. When printing, make sure there is enough recording paper in the printer. NOTE When printing on the WA-710V/712V or EPSON VP printer, <EPSON VP paper width> must be set to “Wide” on the EXTERNAL PRINTER screen of the SETTINGS screen and wide type paper must be set on the printer. Refer to “Changing Print Format for External Printer” in Section 3. 1. Press the OTHER key on the MENU screen. 2. Press the DAILY OUTPUT key on the OTHER screen. Operator’s Manual MEK-6510 5.15 5 5. HANDLING DATA The screen shows the dates of the stored data and the number of data of each day. Date keys Display other dates. 3. Find a desired date using the arrow keys. 4. Press the desired date key to print or send the data. 5. To print, press the PRINT key. To send, press the SEND key. The confirmation message appears. When printing 5.16 When sending Operator’s Manual MEK-6510 5. HANDLING DATA 6. Press the YES key to print or send all data for the selected date. If you press NO, the process is canceled and the screen returns to the DAILY OUTPUT screen. 5 Total number of data for the selected date The number of data currently printed/sent When printing or sending is complete, the screen returns to the DAILY OUTPUT screen. Operator’s Manual MEK-6510 5.17 5. HANDLING DATA Deleting Data This analyzer can store numeric data for up to 400 samples and histograms for up to 50 samples. When the memory is full and a new data is acquired, the oldest data is automatically deleted to save the new data. You can delete one data or a block of data together from the DATA screen only. To delete data, the type of user must be either lab technician or service. Deleting Single Data 1. On the DATA screen, press the ID key of the data to be deleted. 2. Press the DELETE key. The confirmation message appears on the screen. 3. Press the YES key to delete the selected data. If you press NO, the process is cancelled and the screen returns to the DATA screen. 5.18 Operator’s Manual MEK-6510 5. HANDLING DATA Deleting Multiple Data 1. On the DATA screen, press the DELETE key. The “Select first data” message appears. 5 Display other data. 2. Find the first desired data using the arrow keys and press the ID key of the data. The “Select last data” message appears. 3. Find the last data using the arrow keys and press the ID key of the data. All data between the first and last ID will be deleted. When ID(s) are selected, the “Delete selected data?” message appears. 4. Press the YES key. The selected data (numeric and histogram) is deleted and the screen returns to the DATA screen. If you press NO, the process is canceled and the screen returns to the DATA screen. Operator’s Manual MEK-6510 5.19 5. HANDLING DATA Deleting All Stored Data To delete all stored data: 1. Press the DELETE key on the DATA screen. 2. Select the latest data. 3. Select the oldest stored data. Use the arrow key to display the oldest data. 4. Press the YES key to delete all data. 5.20 Operator’s Manual MEK-6510 Section 6 Quality Control General................................................................................................................................................................. 6.3 When to Run QC........................................................................................................................................ 6.3 QC Methods............................................................................................................................................... 6.3 Control Material.......................................................................................................................................... 6.3 Quality Control Procedures.................................................................................................................................. 6.4 Guidelines for Running Controls................................................................................................................ 6.4 Control Material Guidelines........................................................................................................................ 6.4 X-R Program......................................................................................................................................................... 6.5 General....................................................................................................................................................... 6.5 Overview of X-R Program and Quality Control Procedure............................................................... 6.5 Calculation of X and R..................................................................................................................... 6.5 Calculation of Upper and Lower Limits of X and R.......................................................................... 6.6 X-R Graph Example......................................................................................................................... 6.7 How to Read the X-R Graph............................................................................................................ 6.9 Data Outside the Limits.................................................................................................................... 6.9 Changing the Quality Control Settings..................................................................................................... 6.10 Counting the Hematology Control............................................................................................................ 6.12 Handling X-R Data .................................................................................................................................. 6.15 Displaying the X-R Data List (HISTORY)....................................................................................... 6.15 Displaying the Detailed X-R Measurement Data............................................................................ 6.16 Printing, Sending or Deleting X-R Data.................................................................................................... 6.18 Printing, Sending or Deleting X-R Data Individually....................................................................... 6.18 Printing, Sending or Deleting X-R Data Consecutively.................................................................. 6.19 Deleting All Stored X-R Data.......................................................................................................... 6.20 Displaying CV Values of the Stored X-R Data................................................................................ 6.21 Handling X-R Graphs............................................................................................................................... 6.22 Changing the X-R Limits.......................................................................................................................... 6.23 L & J Program (Levey and Jennings)................................................................................................................. 6.25 General..................................................................................................................................................... 6.25 Overview of L & J Program and Quality Control Procedure........................................................... 6.25 Calculation of Upper and Lower Limits.......................................................................................... 6.26 How to Read the L & J Graph........................................................................................................ 6.26 Data Outside the Limits.................................................................................................................. 6.26 Changing the Quality Control Settings..................................................................................................... 6.27 Counting the Hematology Control............................................................................................................ 6.27 Handling L & J Data ................................................................................................................................ 6.30 Displaying the L & J Data List (HISTORY)..................................................................................... 6.30 Displaying the Detailed L & J Measurement Data.......................................................................... 6.31 Printing, Sending or Deleting L & J Data.................................................................................................. 6.32 Printing, Sending or Deleting L & J Data Individually..................................................................... 6.32 Printing, Sending or Deleting L & J Data Consecutively................................................................ 6.33 Deleting All Stored L & J Data........................................................................................................ 6.35 Displaying CV Values of the Stored L & J Data.............................................................................. 6.36 Operator’s Manual MEK-6510 6.1 6 Handling L & J Graphs............................................................................................................................. 6.37 XB (X Batch) Program........................................................................................................................................ 6.39 General..................................................................................................................................................... 6.39 Overview of XB ............................................................................................................................. 6.39 Calculation of XB .......................................................................................................................... 6.39 Handling XB Data..................................................................................................................................... 6.41 Handling XB Graph.................................................................................................................................. 6.43 Setting XB Initial Values and Limits.......................................................................................................... 6.44 XD•CV Program.................................................................................................................................................. 6.46 General..................................................................................................................................................... 6.46 Uses of the XD•CV Program.......................................................................................................... 6.46 Handling XD•CV Data.............................................................................................................................. 6.47 Displaying the Total Mean and CV of All Stored Data.............................................................................. 6.48 6.2 Operator’s Manual MEK-6510 6. QUALITY CONTROL General Quality Control (QC) procedures are used to determine the accuracy and precision of the analyzer. These procedures allow the user to consistently and accurately evaluate instrument performance, interpret laboratory data, and ascertain acceptability of analysis results. We suggest that this information be incorporated into your laboratory’s protocol or procedures manual. Refer to your laboratory’s standard operating procedures and/or a quality assurance plan to check for and ensure proper instrument performance and analysis accuracy. When to Run QC QC testing must be conducted according to established regulations and procedures in your particular state or country. At a minimum, however, it is suggested that QC be conducted as follows: • After startup procedures are completed • To confirm calibration • When a reagent lot number has been changed • After maintenance or component replacement • When a new software version has been installed • When there is an unusual shift or trend in sample results • When there is a reason to suspect data or results QC Methods The analyzer offers the following Quality Control (QC) programs for monitoring and validating instrument performance. • X-R • L & J (Levey and Jennings) • XB • XD•CV These programs automatically calculate the plotting data from the sample data. The data can be displayed and printed as a table and graphs are plotted from the obtained data for each parameter for quality control. X-R and L & J programs cannot be used at the same time. Select either of them on the QC SETTINGS screen. Refer to the “Changing the Quality Control Settings” in this section. Control Material Controls usually consist of fixed blood cells with assayed ranges for each measured parameter. There are three levels of hematology controls for each measured parameter —Low, Normal, and High. Operator’s Manual MEK-6510 6.3 6 6. QUALITY CONTROL Quality Control Procedures Guidelines for Running Controls Quality Control (QC) procedures must be carried out in accordance with your laboratory’s QC protocol and according to regulatory requirements, using the following general guidelines: • Prior to running patient specimens, run a minimum of two levels of control on each day a test is run. • Run controls for each measured parameter in the same manner as patient specimens. • Verify that control results are within the laboratory’s acceptable limits and review the data for shifts or trends. • If the control results fall within acceptable limits, record the results and begin to process patient specimens. • If QC results fall outside the laboratory’s acceptable limits, try another vial from the same lot of control material. If the problem persists, contact your Nihon Kohden representative. • Do not report patient results if QC results fall outside the laboratory’s acceptable limits. • Verify that the control file being used is the correct file in which means and limits are updated. Control Material Guidelines Use the following guidelines for proper handling of control material: • Check the condition of incoming control material. Be sure the vials are at the proper temperature and are not leaking. Check for gross hemolysis. • Check the shelf life and open-tube stability dating. Do not use products longer than recommended by the manufacturer, or the results may be compromised. • Always mix and handle control materials according to the directions given on the package insert. Proper mixing is essential for accurate results. • Carefully prepare the control product according to the directions on the package insert. • Never subject controls to excessive cold, heat, or agitation. Store controls at recommended temperatures; if storing controls inside a refrigerator, place in a central location. Do not store control or calibrator material in the refrigerator door. 6.4 Operator’s Manual MEK-6510 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 control sample) and R (difference between the values of the first and second counting of the same 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 120 days is stored in memory. Every day the analyzer is used, count the control “n” times per day (n ≥ 2). Continue the counting for k days (more than 10 days). The analyzer automatically calculates the daily mean and difference and the averaged mean and difference for k days. The average of X (X), ±2 SD and ±3 SD of X, CV of X , the average of R (R), upper limit of R (RURL) and CV of R of the stored X-R data can be displayed. CAUTION CAUTION Perform the quality control measurement at a fixed time every day. CAUTION Do not use control after the expiration date. If you use control after the expiration date, the obtained X and R graphs are not reliable. Store control in optimum conditions. If the storage conditions of the 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. NOTE Only use the MEK-3D Hematology Control for the X-R program. Calculation of X and R X= X k X: Mean for one day X: Mean for k days Operator’s Manual MEK-6510 R= R k R: Difference for one day R: Difference for k days 6.5 6 6. QUALITY CONTROL 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 control is counted n (≥2) times every day, the upper and lower limits of X are as follows. Upper limit of X (UCL) = u + 3 δ R =X+3 √n √ n d2 Lower limit of X (LCL) = u – 3 δ R =X–3 √n √ n d2 δ = Standard deviation estimate u = Truth estimate The upper limit of R is as follows. Upper limit of R (UCL) = d2 δ + 3 d3 δ = (1 + 3 d3 )R d2 Relation between n and d2 (for X) or d2 and d3 (for R) n 2 3 4 5 6 7 8 9 10 6.6 d2 1.128 1.693 2.059 2.326 2.534 2.704 2.847 2.970 3.078 1/d2 0.8862 0.5908 0.4857 0.4299 0.3946 0.3698 0.3512 0.3367 0.3249 d3 0.853 0.888 0.880 0.864 0.848 0.833 0.820 0.808 0.797 Operator’s Manual MEK-6510 6. QUALITY CONTROL X-R Graph Example Following are example data and plotted graphs for RBC. Obtained Data First Second 4.82 4.76 4.79 4.80 4.80 4.85 4.71 4.77 4.80 4.89 4.82 4.83 4.77 4.74 4.77 4.80 4.68 4.74 4.91 4.92 4.73 4.77 4.79 4.80 4.77 4.73 4.77 4.82 Day 1 2 3 4 5 6 7 8 9 10 11 12 13 14 X R 4.79 4.80 4.83 4.74 4.85 4.83 4.76 4.79 4.71 4.92 4.75 4.80 4.75 4.80 0.06 0.01 0.05 0.06 0.09 0.01 0.03 0.03 0.06 0.01 0.04 0.01 0.04 0.05 X = 4.794 R = 0.0393 6 n = 2, d2 = 1.128, d3 = 0.853 X graph: 1 R √ n d2 = 4.794 + 1.88 × 0.0393 Upper limit of X = X + 3 = 4.868 1 R √ n d2 = 4.794 – 1.88 × 0.0393 Lower limit of X = X – 3 = 4.720 R graph: d3 )R d2 = 3.27 × 0.0393 Upper limit of R = (1 + 3 = 0.129 Operator’s Manual MEK-6510 6.7 6. QUALITY CONTROL X Graph for WBC 9.9 Upper limit of X 7.9 X: Mean of all X values Lower limit of X 5.9 R Graph for WBC 2.0 0.8 Upper limit of R R: Mean of all R values 0 6.8 Operator’s Manual MEK-6510 6. QUALITY CONTROL How to Read the X-R Graph Refer to the “Data Outside the Limits” section below when these plots appear. • The plot is outside the upper or lower limit. • The X plot goes to the plus side or minus side. 6 • 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, lysing 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 control. • Analyzer trouble. Operator’s Manual MEK-6510 6.9 6. QUALITY CONTROL R graph: • Insufficient control stirring. • Temperature variation of diluent. • Dirty fluid path such as aperture, manometer, measurement baths or sub baths. • Analyzer trouble such as dilution ratio error or circuit error. Changing the Quality Control Settings You can set the following items for X-R and L & J quality control programs. Item QC method Save QC meas data on DATA screen Send data after QC measurement X limit calculation Description Select either X-R or L & J for the quality control method. Select whether or not to save the hematology control measurement data on the DATA screen. Select whether or not to automatically send the hematology control measured data to the connected instrument after each measurement. Select either ±2 SD or ±3 SD for X limit calculation. Setting X-R or L & J Default X-R Yes or No Yes Yes or No Yes ±2 SD or ±3 SD ±2 SD When the X-R keys do not appear on the QC screen, change the quality control method as follows. 1. Press the QC key on the MENU screen to display the QC screen. 2. Press the QC SETTING key. L & J keys 6.10 Operator’s Manual MEK-6510 6. QUALITY CONTROL 3. Change necessary settings. Select “X-R” in <QC method>. 6 4. Press the OK key to return to the QC screen. Check that X-R keys are displayed on the screen. X-R keys Operator’s Manual MEK-6510 6.11 6. QUALITY CONTROL Counting the Hematology Control To ensure accuracy, observe the following cautions. CAUTION CAUTION Perform the quality control measurement at a fixed time every day. CAUTION Do not use control after the expiration date. If you use control after the expiration date, the obtained X and R graphs are not reliable. Store control in optimum conditions. If the storage conditions of the 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. You can use three types of control: MEK-3DN (Normal), MEK-3DH (High) and MEK-3DL (Low). The analyzer stores data for 120 measurements of each type of control. 1. Press the QC key on the MENU screen to display the QC screen. 2. Press the X-R (NORMAL) key when using the MEK-3DN control, the X-R (LOW) key when using the MEK-3DL control or the X-R (HIGH) key when using the MEK-3DH control. 6.12 Operator’s Manual MEK-6510 6. QUALITY CONTROL The X-R screen appears. When counting the control for the first time of the day, the “Measure hematology control” message appears. When the control is already counted, the measurement result of the previous measurement is displayed. When performing another control measurement is necessary, delete the previous measurement data on the HISTORY screen of the X-R screen. To delete data, refer to the “Deleting X-R Data” section. When the X-R keys do not appear on the QC screen, change the quality control method. Refer to the “Changing the Quality Control Settings” earlier in this section. Displays X-R graph screen. Refer to the “Handling X-R Graphs” section. Returns to the QC screen. Displays X-R history screen. Refer to the “Handling X-R Data” section. 3. Put the sampling nozzle into the sample container containing the hematology control and press the [ Count] switch or key. The [Count] key becomes [Dispense] key for pre-dilution blood mode when <[Eject] key operation> is set to “Dispense” on the OPERATION screen of the SETTINGS screen. Count key Sampling nozzle Count switch Operator’s Manual MEK-6510 Put the sampling nozzle to this level. 6.13 6 6. QUALITY CONTROL 4. After the first count, the measurement data appears on the screen. Measure the control again. Press to send the displayed data to PC. After the second count, the X-R data appears on the screen. The data is automatically saved (for up to 120 samples for each control type). Pressing the 1st key displays the detailed measured data of the first hematology control measurement. Pressing the 2nd key displays the detailed measured data of the second hematology control measurement. 6.14 Operator’s Manual MEK-6510 6. QUALITY CONTROL To print the displayed X-R data on the optional printer, press the [ key on the front panel. Print] NOTE When printing on the WA-710V/712V or EPSON VP printer, <EPSON VP paper width> must be set to “Wide” on the EXTERNAL PRINTER screen of the SETTINGS screen and wide type paper must be set on the printer. Refer to “Changing Print Format for External Printer” in Section 3. When a PC or optional printer is connected to the analyzer and <Send data after QC measurement> is set to “Yes” on the QC SETTINGS screen, the measurement data is sent to the PC or printed on the printer. Refer to the “Changing the Quality Control Settings” section. To display or print the X-R graph, press the GRAPH key. Refer to the “Handling X-R Graphs” section. To display stored data, press the HISTORY key. Refer to the next section. 5. Press the OK key to return to the QC screen. Handling X-R Data Displaying the X-R Data List (HISTORY) You can display stored X-R data on the HISTORY screen. 1. On the X-R screen, press the HISTORY key to display the latest 3 data. Displays CV values of X-R data. Operator’s Manual MEK-6510 Displays older data. Displays newer data. 6.15 6 6. QUALITY CONTROL 2. To display other data, use the arrow keys. To display the detailed measured data for a certain day, refer to the “Displaying the Detailed X-R Measurement Data” section. To print, send or delete the X-R data, refer to the “Printing, Sending or Deleting X-R Data” section. NOTE When printing on the WA-710V/712V or EPSON VP printer, <EPSON VP paper width> must be set to “Wide” on the EXTERNAL PRINTER screen of the SETTINGS screen and wide type paper must be set on the printer. Refer to “Changing Print Format for External Printer” in Section 3. 3. Press OK to return to the X-R screen. Displaying the Detailed X-R Measurement Data You can display detailed X-R data for one day. On this screen, you can view the measured data of the first and second measurement as well as X and R data. 1. On the HISTORY screen, press the desired date key. Use the arrow keys to find the desired data. 2. Press the DETAILS key to display the detailed X-R data. To print the data on the connected printer, press the [ front panel. 6.16 Print] key on the NOTE When printing on the WA-710V/712V or EPSON VP printer, <EPSON VP paper width> must be set to “Wide” on the EXTERNAL PRINTER screen of the SETTINGS screen and wide type paper must be set on the printer. Refer to “Changing Print Format for External Printer” in Section 3. Operator’s Manual MEK-6510 6. QUALITY CONTROL To send the data to the PC, press the SEND key on the screen. To delete the displayed data, press the DELETE key. A confirmation message appears. 6 Press YES to delete data. The screen returns to the HISTORY screen after deleting data. If you press NO, the process is canceled and the screen returns to the HISTORY screen. Operator’s Manual MEK-6510 6.17 6. QUALITY CONTROL Printing, Sending or Deleting X-R Data Printing, Sending or Deleting X-R Data Individually NOTE When printing on the WA-710V/712V or EPSON VP printer, <EPSON VP paper width> must be set to “Wide” on the EXTERNAL PRINTER screen of the SETTINGS screen and wide type paper must be set on the printer. Refer to “Changing Print Format for External Printer” in Section 3. 1. On the HISTORY screen, select one data to be printed, sent or deleted by pressing the desired date key. Use the arrow keys to find the desired data. 2. To print, press the PRINT key. To send, press the SEND key. To delete, press the DELETE key. The confirmation message appears. “Delete this data?” when deleting. “Print this data?” when printing. “Send this data?” when sending. 3. Press YES to print, send or delete selected data. Press NO to cancel the procedure. 6.18 Operator’s Manual MEK-6510 6. QUALITY CONTROL Printing, Sending or Deleting X-R Data Consecutively NOTE When printing on the WA-710V/712V or EPSON VP printer, <EPSON VP paper width> must be set to “Wide” on the EXTERNAL PRINTER screen of the SETTINGS screen and wide type paper must be set on the printer. Refer to “Changing Print Format for External Printer” in Section 3. 1. On the HISTORY screen; To print, press the PRINT key. To send, press the SEND key. To delete, press the DELETE key. 6 The “Select first data” message appears on the screen. 2. Press the date key of the first data. The “Select last data” message appears on the screen. 3. Find the last data using the arrow keys and press the date key of that data. The confirmation message appears on the screen. Operator’s Manual MEK-6510 6.19 6. QUALITY CONTROL 4. Press the YES key. All data between the first and last date will be printed, sent or deleted. Press the NO key to cancel the procedure. Deleting All Stored X-R Data You can delete all stored X-R data. This prevents mixing of the new and old data especially when a hematology control with a new lot number is used. 1. Press the DELETE X-R key on the QC screen. The “Delete all above data?” message appears. 2. Press YES to delete all stored X-R data. A confirmation message appears and the screen returns to the QC screen. If you press NO, the process is canceled and the screen returns to the QC screen. Only the X and R data is deleted. Measured data and the X-R limits are saved. 6.20 Operator’s Manual MEK-6510 6. QUALITY CONTROL Displaying CV Values of the Stored X-R Data The average of X (X), ±2 SD or ±3 SD of X, CV of X, the average of R (R), upper limit of R (RURL) and CV of R of the stored X-R data can be displayed. 1. On the HISTORY screen, press the CV key. 6 To print the data on the connected printer, press the [ front panel. Print] key on the NOTE When printing on the WA-710V/712V or EPSON VP printer, <EPSON VP paper width> must be set to “Wide” on the EXTERNAL PRINTER screen of the SETTINGS screen and wide type paper must be set on the printer. Refer to “Changing Print Format for External Printer” in Section 3. 2. Press the OK key to return to the HISTORY screen. Operator’s Manual MEK-6510 6.21 6. QUALITY CONTROL Handling X-R Graphs You can display the graph of the X and R for each parameter. 1. Press the GRAPH key on the X-R screen. The “Select parameter” message and the parameter keys appear. Displays the limit setting screen. 2. Press the desired parameter key. The graph for that parameter is displayed on the screen. Displays graph for RBC. Upper limit Displays graph for PDW. Initial value Lower limit Upper limit Initial value Displays the limit setting screen. Displays graph of other dates. (31 data/page, maximum of 4 pages) You can change parameters by pressing the parameter keys at the upper part of the screen. The “Out of range” message appears when the graph goes outside the limits. 6.22 Operator’s Manual MEK-6510 6. QUALITY CONTROL To print the displayed graph data on the connected printer, press the [ Print] key on the front panel. NOTE When printing on the WA-710V/712V or EPSON VP printer, <EPSON VP paper width> must be set to “Wide” on the EXTERNAL PRINTER screen of the SETTINGS screen and wide type paper must be set on the printer. Refer to “Changing Print Format for External Printer” in Section 3. To change the initial and the upper and lower limits of X and R values for the X-R graph, press the SET key. For details, refer to the next procedure. 3. Press the OK key to return to the previous screen. Changing the X-R Limits When necessary, you can change the initial and the upper and lower limits of X and R values for the X-R graph. 1. Press the SET key on the X-R graph screen to display the X-R limits setting screen. 2. Select “Set X” to change limits for X. Cursor Move cursor. Numeric keys Displays another parameters. Operator’s Manual MEK-6510 6.23 6 6. QUALITY CONTROL 3. Find the desired parameter using the NEXT or PREV key. 4. To change the limits individually: i) Touch the setting value or use the arrow keys to move the cursor to the setting value you want to change. ii) Enter the desired value using the numeric keys. Press the Enter key to register the value. The cursor moves to the next field. iii) Repeat steps i) and ii) to change other values. To automatically calculate the ideal values for all limits: i) Press the AUTO key. The confirmation message appears. ii) Press YES to set the ideal values which are automatically calculated based on the stored data. If you press NO, the process is canceled and the screen returns to the X-R limit screen. 5. Repeat steps 2 to 4 to change limits for R. Select “Set R” in step 2. 6. Press the OK key to return to the X-R graph screen. 6.24 Operator’s Manual MEK-6510 6. QUALITY CONTROL L & J Program (Levey and Jennings) General Overview of L & J Program and Quality Control Procedure The L & J (Levey and Jennings) program* counts one control sample every day and the mean and standard deviation (SD) are automatically calculated to plot L-J chart for quality control. The data for the last 120 days is stored in memory. * Westgard® Rules are applied to the L & J program. Westgard is a registered trademark of Westgard Quality Corporation. L-J graph 4.90 Upper limit (+3 SD) +2 SD +1 SD Mean 4.80 1 SD 2 SD Lower limit ( 3 SD) 4.70 Every day when the analyzer is stable, count the control once. The analyzer automatically calculates the mean and the upper and lower limits. The mean, ±2 SD, ±3 SD and CV of the stored data can be displayed. CAUTION CAUTION Perform the quality control measurement at a fixed time every day. CAUTION Do not use the control after the expiration date. If you use control after the expiration date, the obtained L & J graphs are not reliable. Store control in optimum conditions. If the storage conditions of the control are not optimum, hemolyzation or expansion of the blood cells will occur and abnormal data will be frequently obtained on the L & J graphs. NOTE Only use the MEK-3D hematology control for the L & J program. Operator’s Manual MEK-6510 6.25 6 6. QUALITY CONTROL Calculation of Upper and Lower Limits The upper and lower limits for L & J program is automatically calculated according to the following equations. Upper limit (+3S) = X + 3σ Lower limit (−3S) = X − 3σ X = mean σ = standard deviation How to Read the L & J Graph Refer to the “Data Outside the Limits” section when these plots appear. • The plot is outside ±3 SD limit. • The plot goes outside ±2 SD limit twice in a row. • Two consecutive plots go from outside +2 SD (or −2 SD) to −2 SD (or +2 SD). • The plot goes to the plus side or minus side. Data Outside the Limits Normally, each data are plotted within the range between the upper and lower limits. If the data exceeds an upper/lower limit, the “Out of range” message is displayed. It may be caused by the following. • Diluent, lysing 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 control. • Insufficient control stirring. • Temperature variation of diluent. • Dirty fluid path such as aperture, manometer, measurement baths or sub baths. • Analyzer trouble such as dilution ratio error or circuit error. 6.26 Operator’s Manual MEK-6510 6. QUALITY CONTROL Changing the Quality Control Settings When the L & J keys do not appear on the QC screen, change the quality control method. Select “L & J” in <QC method> on the QC SETTINGS screen. Refer to the “Changing the Quality Control Settings” in “X-R Program” section. Counting the Hematology Control To ensure accuracy, observe the following cautions. 6 CAUTION CAUTION Perform the quality control measurement at a fixed time every day. CAUTION Do not use the control after the expiration date. If you use control after the expiration date, the obtained L & J graphs are not reliable. Store control in optimum conditions. If the storage conditions of the control are not optimum, hemolyzation or expansion of the blood cells will occur and abnormal data will be frequently obtained on the L & J graphs. You can use three types of control: MEK-3DN (Normal), MEK-3DH (High) and MEK-3DL (Low). The analyzer stores data for 120 measurements of each type of control. 1. Press the QC key on the MENU screen to display the QC screen. Operator’s Manual MEK-6510 6.27 6. QUALITY CONTROL 2. Press the L & J (NORMAL) key when using the MEK-3DN control, the L & J (LOW) key when using the MEK-3DL control or the L & J (HIGH) key when using the MEK-3DH control. The L & J screen appears. When counting the control for the first time of the day, the “Measure hematology control” message appears. When the control is already counted, the measurement result of the previous measurement is displayed. When performing another control measurement is necessary, delete the previous measurement data on the HISTORY screen of the L & J screen. To delete data, refer to the “Deleting L & J Data” section. When the L & J keys do not appear on the QC screen, change the quality control method. Refer to the “Changing the Quality Control Settings” earlier in this section. Displays L & J graph screen. Refer to the “Handling L & J Graphs” section. Returns to the QC screen. Displays L & J history screen. Refer to the “Handling L & J Data” section. 6.28 Operator’s Manual MEK-6510 6. QUALITY CONTROL Count key 3. Put the sampling nozzle into the sample container containing the hematology control and press the [ Count] switch or key. Sampling nozzle Count switch Put the sampling nozzle to this level. 4. After the measurement, the measurement data appears on the screen. The data is automatically saved (for up to 120 samples for each control type). Pressing the DETAILS key displays the detailed measured data of the hematology control measurement. Operator’s Manual MEK-6510 6.29 6 6. QUALITY CONTROL To print the displayed L & J data on the optional printer, press the [ key on the front panel. Print] NOTE When printing on the WA-710V/712V or EPSON VP printer, <EPSON VP paper width> must be set to “Wide” on the EXTERNAL PRINTER screen of the SETTINGS screen and wide type paper must be set on the printer. Refer to “Changing Print Format for External Printer” in Section 3. When a PC or optional printer is connected to the analyzer and <Send data after QC measurement> is set to “Yes” on the QC SETTINGS screen, the measurement data is sent to the PC or printed on the printer. Refer to the “Changing the Quality Control Settings” section. To display or print the L & J graph, press the GRAPH key. Refer to the “Handling L & J Graphs” section. To display stored data, press the HISTORY key. Refer to the next section. 5. Press the OK key to return to the QC screen. Handling L & J Data Displaying the L & J Data List (HISTORY) You can display stored L & J data on the HISTORY screen. 1. On the L & J screen, press the HISTORY key to display the latest 4 data. Displays CV values of L & J data. 6.30 Displays older data. Displays newer data. Operator’s Manual MEK-6510 6. QUALITY CONTROL 2. To display other data, use the arrow keys. To display the detailed measured data for a certain day, refer to the “Displaying the Detailed L & J Measurement Data” section. To print, send or delete the L & J data, refer to the “Printing, Sending or Deleting L & J Data” section. NOTE When printing on the WA-710V/712V or EPSON VP printer, <EPSON VP paper width> must be set to “Wide” on the EXTERNAL PRINTER screen of the SETTINGS screen and wide type paper must be set on the printer. Refer to “Changing Print Format for External Printer” in Section 3. 3. Press OK to return to the L & J screen. Displaying the Detailed L & J Measurement Data You can display all L & J measured data for one day. 1. On the HISTORY screen, press the desired date key. Use the arrow keys to find the desired data. 2. Press the DETAILS key to display the detailed L & J data. To print the data on the connected printer, press the [ front panel. Print] key on the NOTE When printing on the WA-710V/712V or EPSON VP printer, <EPSON VP paper width> must be set to “Wide” on the EXTERNAL PRINTER screen of the SETTINGS screen and wide type paper must be set on the printer. Refer to “Changing Print Format for External Printer” in Section 3. Operator’s Manual MEK-6510 6.31 6 6. QUALITY CONTROL To send the data to the PC, press the SEND key on the screen. To delete the displayed data, press the DELETE key. A confirmation message appears. Press YES to delete data. The screen returns to the HISTORY screen after deleting data. If you press NO, the process is canceled and the screen returns to the HISTORY screen. Printing, Sending or Deleting L & J Data Printing, Sending or Deleting L & J Data Individually 1. On the HISTORY screen, select one data to be printed, sent or deleted by pressing the desired date key. Use the arrow keys to find the desired data. 6.32 Operator’s Manual MEK-6510 6. QUALITY CONTROL 2. To print, press the PRINT key. To send, press the SEND key. To delete, press the DELETE key. NOTE When printing on the WA-710V/712V or EPSON VP printer, <EPSON VP paper width> must be set to “Wide” on the EXTERNAL PRINTER screen of the SETTINGS screen and wide type paper must be set on the printer. Refer to “Changing Print Format for External Printer” in Section 3. The confirmation message appears. “Delete this data?” when deleting. “Print this data?” when printing. “Send this data?” when sending. 3. Press YES to print, send or delete selected data. Press NO to cancel the procedure. Printing, Sending or Deleting L & J Data Consecutively NOTE When printing on the WA-710V/712V or EPSON VP printer, <EPSON VP paper width> must be set to “Wide” on the EXTERNAL PRINTER screen of the SETTINGS screen and wide type paper must be set on the printer. Refer to “Changing Print Format for External Printer” in Section 3. Operator’s Manual MEK-6510 6.33 6 6. QUALITY CONTROL 1. On the HISTORY screen; To print, press the PRINT key. To send, press the SEND key. To delete data, press the DELETE key. The “Select first data” message appears on the screen. 2. Press the date key of the first data. The “Select last data” message appears on the screen. 3. Find the last data using the arrow keys and press the date key of that data. The confirmation message appears on the screen. 4. Press the YES key. All data between the first and last date will be printed, sent or deleted. Press the NO key to cancel the procedure. 6.34 Operator’s Manual MEK-6510 6. QUALITY CONTROL Deleting All Stored L & J Data You can delete all stored L & J data. This prevents mixing of the new and old data especially when a hematology control with a new lot number is used. 1. Press the DELETE L & J key on the QC screen. 6 The “Delete all above data?” message appears. 2. Press YES to delete all stored L & J data. A confirmation message appears and the screen returns to the QC screen. If you press NO, the process is canceled and the screen returns to the QC screen. Only the L & J data is deleted. Measured data is saved. Operator’s Manual MEK-6510 6.35 6. QUALITY CONTROL Displaying CV Values of the Stored L & J Data The mean of the stored L & J data, ±2 SD and ±3 SD of the mean and CV of the mean can be displayed. 1. On the HISTORY screen, press the CV key. To print the data on the connected printer, press the [ front panel. Print] key on the NOTE When printing on the WA-710V/712V or EPSON VP printer, <EPSON VP paper width> must be set to “Wide” on the EXTERNAL PRINTER screen of the SETTINGS screen and wide type paper must be set on the printer. Refer to “Changing Print Format for External Printer” in Section 3. 2. Press the OK key to return to the HISTORY screen. 6.36 Operator’s Manual MEK-6510 6. QUALITY CONTROL Handling L & J Graphs You can display the graph of the L & J for each parameter. 1. Press the GRAPH key on the L & J screen. The “Select parameter” message and the parameter keys appear. 6 2. Press the desired parameter key. The graph for that parameter is displayed on the screen. Displays graph for WBC. Displays graph for HGB. Displays graph of other dates. (31 data/page, maximum of 4 pages) You can change parameters by pressing the parameter keys at the upper part of the screen. The “Out of range” message appears when the graph goes outside the limits. Operator’s Manual MEK-6510 6.37 6. QUALITY CONTROL To print the displayed graph data on the connected printer, press the [ Print] key on the front panel. NOTE When printing on the WA-710V/712V or EPSON VP printer, <EPSON VP paper width> must be set to “Wide” on the EXTERNAL PRINTER screen of the SETTINGS screen and wide type paper must be set on the printer. Refer to “Changing Print Format for External Printer” in Section 3. 3. Press the OK key to return to the previous screen. 6.38 Operator’s Manual MEK-6510 6. QUALITY CONTROL XB (X Batch) Program General Overview of XB The daily samples data are divided into batches of 20 samples. The data within each batch is 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 The analyzer 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. • Use the past obtained value for the same facility. • 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 Operator’s Manual MEK-6510 6.39 6 6. QUALITY CONTROL The XB values are plotted on the screen. Management limit value Initial 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.) The analyzer 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 following 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 stored data to prevent data interference between the new and previous graphs. Refer to “Deleting Data” in Section 5. CAUTION Each XB is calculated from all the samples that have RBC count 500,000/μL or more. Therefore, data of MEK-3D Hematology Control should be deleted from the DATA screen beforehand. Any measured data with “Control” as the sample type is excluded from the calculation. 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. 6.40 Operator’s Manual MEK-6510 6. QUALITY CONTROL Handling XB Data 1. Press the QC key on the MENU screen to display the QC screen. 6 2. Press the XB key on the QC screen to display the XB screen. Operator’s Manual MEK-6510 6.41 6. QUALITY CONTROL The XB screen of the stored measured data is displayed on the screen. N: Number of samples in each batch MEAN: Averaged XB for parameter (MCV/MCH/MCHC) and total number of samples Use the arrow keys to display other batch data. To print the displayed data on an optional printer, press the [ the front panel. Print] key on NOTE When printing on the WA-710V/712V or EPSON VP printer, <EPSON VP paper width> must be set to “Wide” on the EXTERNAL PRINTER screen of the SETTINGS screen and wide type paper must be set on the printer. Refer to “Changing Print Format for External Printer” in Section 3. To display XB graph, press the GRAPH key. Refer to the “Handling XB Graph” section. 3. Press the OK key to return to the QC screen. 6.42 Operator’s Manual MEK-6510 6. QUALITY CONTROL Handling XB Graph 1. Press the GRAPH key on the XB screen to display the XB graph screen. Upper limit Initial value Lower limit 6 Displays the limit setting screen. The MCV, MCH and MCHC graphs are plotted on the screen. To print the graphs on an optional printer, press the [ front panel. Print] key on the NOTE When printing on the WA-710V/712V or EPSON VP printer, <EPSON VP paper width> must be set to “Wide” on the EXTERNAL PRINTER screen of the SETTINGS screen and wide type paper must be set on the printer. Refer to “Changing Print Format for External Printer” in Section 3. 2. Press the OK key to return to the XB screen. Operator’s Manual MEK-6510 6.43 6. QUALITY CONTROL Setting XB Initial Values and Limits When the XB program is used for the first time or the table on the XB screen becomes full, set the XB initial values. 1. Press the GRAPH key on the XB screen to display the XB graph screen. 2. Press the SET key on the XB screen to display the XB limit setting screen. Cursor Move cursor. Numeric keys 6.44 Operator’s Manual MEK-6510 6. QUALITY CONTROL 3. To change the limits individually: i) Touch the setting value or use the arrow keys to move the cursor to the setting value you want to change. ii) Enter the desired value using the numeric keys. Press the Enter key to register the value. The cursor moves to the next field. iii) Repeat steps i) and ii) to change other values. To automatically calculate the ideal values for all values: i) Press the AUTO key. The confirmation message appears. 6 ii) Press YES to set the ideal values which are automatically calculated based on the stored data. If you press NO, the process is canceled and the screen returns to the XB limit screen. 4. Press the OK key to return to the QC screen. Operator’s Manual MEK-6510 6.45 6. QUALITY CONTROL XD•CV Program General This program automatically calculates the following values from the daily sample data within the normal range for each parameter. Any sample with a parameter count that is out of the normal range is excluded from the calculation. XD: CV: X Daily mean value of daily sample data Coefficient of Variation (%) CV = Standard deviation XD Standard deviation = 100 (%) (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. 6.46 Operator’s Manual MEK-6510 6. QUALITY CONTROL Handling XD•CV Data 1. Press the QC key on the MENU screen to display the QC screen. 6 2. Press the XD•CV key on the QC screen to display the XD•CV screen. Data for up to 400 samples can be displayed. Total of up to 400 Displays total mean and CV. Displays older data. Displays newer data. N: Number of samples which have all the parameters within the normal range. Use the arrow keys to display other data. Press the TOTAL key to display the total mean and CV of all stored data. Refer to the next procedure. Operator’s Manual MEK-6510 6.47 6. QUALITY CONTROL To print the displayed data on the printer, press the [ front panel. Print] key on the NOTE • The data cannot be output to a personal computer or an external printer connected to the serial ports. • When printing on the WA-710V/712V or EPSON VP printer, <EPSON VP paper width> must be set to “Wide” on the EXTERNAL PRINTER screen of the SETTINGS screen and wide type paper must be set on the printer. Refer to “Changing Print Format for External Printer” in Section 3. 3. Press the OK key to return to the QC screen. Displaying the Total Mean and CV of All Stored Data You can display the total mean and CV of all stored data. 1. Press the TOTAL key on the XD•CV screen. 2. Press the OK key to return to the previous XD•CV screen. 6.48 Operator’s Manual MEK-6510 Section 7 Calibration General................................................................................................................................................................. 7.2 When to Calibrate....................................................................................................................................... 7.2 Note on the Calibration Procedure............................................................................................................. 7.2 Calibration in Open (Venus Blood) Mode............................................................................................................. 7.4 Calibration in Pre-Dilution Blood Mode................................................................................................................. 7.8 Displaying and Printing Calibration Data History................................................................................................ 7.13 HGB/HCT Calibration with Human Blood........................................................................................................... 7.15 Measurement with the Analyzer............................................................................................................... 7.15 HGB Measurement with a Spectrophotometer......................................................................................... 7.15 HCT Measurement with a Microhematocrit Centrifuge............................................................................ 7.16 Determining the HGB and HCT Calibration Coefficient........................................................................... 7.17 Operator’s Manual MEK-6510 7.1 7 7. CALIBRATION General Calibration is a procedure that confirms the accuracy of the analyzer and must conform to guidelines established by the regulatory agencies in your locality. The analyzer is initially calibrated at the factory prior to shipment. Calibration must be confirmed during installation by the user. The analyzer is electronically stable and should not require frequent recalibration when it is operated and maintained according to recommendations in this manual. Calibration can be performed for WBC, RBC, HGB, HCT, PLT, RDW and MPV using the MEK-CAL calibrator. This calibrator must be used within 7 days after opening, stored at 35 to 46˚F (2 to 8˚C) and handled appropriately according to its manual. For higher accuracy, use the calibrator soon after its opening. The parameters can be calibrated automatically at the same time using the assay values, or individually by selecting the desired parameter. HCT is calibrated from RBC and MCV. Therefore, it is calibrated by calibrating RBC and MCV. When to Calibrate Scheduled calibration of the analyzer must conform to the guidelines established by regulatory agencies. Calibration must be confirmed on a regular basis according to your laboratory’s standards and protocols, and should include daily confirmation on each shift and following a reagent lot number change. Built-in Quality Control programs on the analyzer are designed to provide continual monitoring and confirmation of instrument calibration. The laboratory should make the decision to recalibrate based on the performance of the analyzer in these Quality Control programs. Calibration is indicated following service adjustments (e.g., major component changes). Calibration is necessary when indicated by the results of Quality Control procedures. Calibration is also required following component replacement, software upgrade, preventive maintenance, or reagent changes. Calibration must be considered the last step in a troubleshooting sequence. Frequent unnecessary recalibrations can mask an underlying problem with the instrument’s performance. Note on the Calibration Procedure Calibration can be performed in venous blood mode (open mode) and predilution blood mode. Only calibrating in venous blood mode is necessary. When calibration is performed in venous blood mode, the new calibration coefficient is also applied to pre-dilution blood mode. However, because the pre-dilution blood samples are diluted manually, the obtained data may differ between the 7.2 Operator’s Manual MEK-6510 7. CALIBRATION different sampling and dilution modes. If the data differs, perform calibration in pre-dilution blood mode. Calibration in venous blood mode must be performed before calibration in predilution blood mode. Calibration can only be performed by a lab technician or service user. A user of the other user type can open the CALIBRATION screen but cannot change any settings. Refer to “Assigning Users and Passwords” in Section 3. NOTE You must calibrate in open mode even if you measure samples in predilution mode. 7 Flowchart of Calibration (i) When measuring samples in open mode Calibrate in open mode. ↓ (ii) When measuring samples in pre-dilution mode Calibrate in open mode. ↓ Do quality control with the hematology control (MEK-3DN) (check that the value is within the control range). ↓ Do quality control with the hematology control (MEK-3DN) (check that the value is within the control range). ↓ Calibration is finished. Calibrate in pre-dilution mode.* ↓ Do quality control with the hematology control (MEK-3DN) (check that the value is within the control range). ↓ Calibration is finished. * Perform calibration as needed when the measurement data does not match the calibration value of open mode. • • • • • • Operator’s Manual MEK-6510 NOTE MEK-3DN hematology control cannot be used as the calibrator. MEK3DN is only for quality control. Do not use calibrator which is past the following date or period. Unopened: Expiration date on the label or package Opened: 7 days after opening Store the calibrator between 2 and 8°C (35.6 to 46.4°F) and do not freeze it. Use the calibrator after it returns to room temperature. Mix the calibrator by gently turning it upside down several times before measurement. Read the manual of the calibrator thoroughly and follow the precautions. 7.3 7. CALIBRATION Calibration in Open (Venus Blood) Mode Calibration in open mode (venous blood mode) must be performed before calibration in pre-dilution blood mode. If the calibrator is taken from a refrigerator, wait at least 10 minutes after the calibrator temperature reaches room temperature. 1. On the MENU screen, press the CALIBRATION key to display the CALIBRATION screen. 2. Press the OPEN key to display the CAL OPEN screen. Count key NOTE Do not let the sampling nozzle touch the bottom of the vial. This may prevent aspiration of the sample. Sampling nozzle Count switch 7.4 3. Put the sampling nozzle into the calibrator vial so that the tip of the sampling nozzle comes near but does not touch the bottom of the vial. Put the sampling nozzle to this level. Operator’s Manual MEK-6510 7. CALIBRATION 4. Press the [ Count] switch or key. The calibrator is aspirated and measurement starts. NOTE Keep the sampling nozzle in the calibrator while the calibrator is aspirated. 7 After measurement, the measured data and the “Use this data for calibration?” message appear on the screen. 5. Check that there is no alarm or flag for the measured data and press the YES key to save the data. If there is an alarm, press the NO key and measure the calibrator again. Operator’s Manual MEK-6510 7.5 7. CALIBRATION 6. Measure the calibrator until you obtain at least 10 optimum data (up to 15 measurement data can be saved). The mean value of all the measurements is displayed on the screen. Calibration coefficient Mean value of the calibrator measurement Cursor Move cursor. Numeric keys Displays other parameters. 7. Press the CAL DATA key to check the calibrated data. Up to 15 calibrator measured data and the mean of all measured data are saved and displayed on the CAL DATA LIST screen. The mean of all stored calibration measurement data Sampling mode Deletes selected data. Returns to the CALIBRATION screen. Displays CV values of calibration measurement data. Displays older data. Displays newer data. To delete a measured data, select the data by pressing the time of the data and press the DELETE key. 7.6 Operator’s Manual MEK-6510 7. CALIBRATION To display the CV of a data, select the data by pressing the time of the data and press the CV key. 7 Returns to the previous CAL DATA LIST screen. 8. In the <Data> field, enter the median of the assay value listed in the assay sheet which is attached to the calibrator. i) Touch the setting value or use the arrow keys to move the cursor to the setting value you want to change. To display other parameters, use the NEXT or PREV keys. ii) Enter the median of the assay value listed in the assay sheet using the number keys. iii) Press the Enter key to register the value. When you register the median of the assay value, the calibration coefficient also changes. iv) Change all necessary parameter values. 9. Press the OK key to display the CALIBRATION screen. 10. Perform the quality control on the QC screen with the MEK-3DN hematology control and check that the value is within the control range. Refer to Section 6 “Quality Control”. Reference The new calibration coefficient is calculated from the equation below. New calibration coefficient = Previous calibration coefficient × Operator’s Manual MEK-6510 Calibrator assay value Mean measured value 7.7 7. CALIBRATION Calibration in Pre-Dilution Blood Mode When calibration is performed in open (venous blood) mode, the new calibration coefficient is also applied to pre-dilution blood mode. However, because the pre-dilution blood samples are diluted manually, the obtained data may differ between the different sampling and dilution modes. In such a case, perform calibration in pre-dilution blood mode. Calibration in venous blood mode must be performed before calibration in predilution blood mode. The relationship between the calibration coefficient in pre-dilution blood mode and the measured value is shown in the equation below. Measured value after Measured value in calibration in pre-dilution blood = pre-dilution blood × mode mode Calibration coefficient in open mode 1000 Calibration coefficient in pre-dilution blood mode × 1000 1. Prepare the calibrator sample for pre-dilution mode. Refer to “Preparing a Pre-Dilution Sample” in Section 4. 2. Select “Yes” for <Continue dilute mode> on the MEASUREMENT screen. Refer to “Changing Measurement Settings” in Section 3 for details. 3. Select “Pre-dil” for <Dilute mode> on the READY screen and press the MENU key to display the MENU screen. 7.8 Operator’s Manual MEK-6510 7. CALIBRATION 4. On the MENU screen, press the CALIBRATION key to display the CALIBRATION screen. 7 5. Press the PREDILUTION key to display the CAL Pre-dil screen. Count key Sampling nozzle Count switch Put the sampling nozzle to this level. 6. Put the sampling nozzle into the sample you have prepared in step 1 so that the tip of the sampling nozzle comes near but does not touch the bottom of the container. NOTE Do not let the sampling nozzle touch the bottom of the container. This may prevent aspiration of the sample. The [Count] key becomes the [Dispense] key in pre-dilution blood mode when <[Eject] key operation> is set to “Dispense” on the OPERATION screen of the SETTINGS screen. In this case, the key only functions as the dispense key and does not function in any other way in any other mode. Operator’s Manual MEK-6510 7.9 7. CALIBRATION 7. Press the [ Count] switch or key. The calibrator sample is aspirated and measurement starts. NOTE Keep the sampling nozzle in the calibrator sample while the sample is aspirated. After measurement, the measured data and the “Use this data for calibration?” message appear on the screen. 8. Check that there is no alarm or flag for the measured data and press the YES key to save the data. If there is an alarm, press the NO key and measure the calibrator sample again. 7.10 Operator’s Manual MEK-6510 7. CALIBRATION 9. Measure the calibrator until you obtain at least 10 optimum data (up to 15 measurement data can be saved). The mean value of all the measurements is displayed on the screen. Calibration coefficient Mean value of the calibrator measurement Cursor Move cursor. 7 Numeric keys Display other parameters. 10. Press the CAL DATA key to check the calibrated data. Up to 15 calibrator measured data and the mean of all measured data are saved and displayed on the CAL DATA LIST screen. The mean of all stored calibration measurement data Sampling mode Deletes selected data. Returns to the CALIBRATION screen. Displays CV values of calibration measurement data. Displays older data. Displays newer data. To delete a measured data, select the data by pressing the time of the data and press the DELETE key. Operator’s Manual MEK-6510 7.11 7. CALIBRATION To display the CV of a data, select the data by pressing the time of the data and press the CV key. Returns to the previous CAL DATA LIST screen. 11. In the <Data> field, enter the median of the assay value listed in the assay sheet which is attached to the calibrator. i) Touch the setting value or use the arrow keys to move the cursor to the setting value you want to change. To display other parameters, use the NEXT or PREV keys. ii) Enter the median of the assay value listed in the assay sheet using the number keys. iii) Press the Enter key to register the value. When you register the median of the assay value, the calibration coefficient also changes. iv) Change all necessary parameter values. 12. Press the OK key to display the CALIBRATION screen. 13. Perform the quality control on the QC screen with the MEK-3DN hematology control and check that the value is within the control range. Refer to Section 6 “Quality Control”. 7.12 Operator’s Manual MEK-6510 7. CALIBRATION Displaying and Printing Calibration Data History The analyzer automatically saves the calibration coefficient every time you perform calibration to create the calibration history record. This allows you to examine the trend of the precision variation of the analyzer or to find a faulty part in the instrument. The data is stored for up to 15 calibrations. 1. Press the CALIBRATION key on the MENU screen. 7 2. Select the sampling mode. Operator’s Manual MEK-6510 7.13 7. CALIBRATION 3. Press the HISTORY key on the CALIBRATION screen. The calibration data history for up to 3 calibrations appears on the screen. Sampling mode Displays older data. Use the arrow keys to view other data. To print the data on the printer, press the [ Displays newer data. Print] key on the front panel. NOTE When printing on the WA-710V/712V or EPSON VP printer, <EPSON VP paper width> must be set to “Wide” on the EXTERNAL PRINTER screen of the SETTINGS screen and wide type paper must be set on the printer. Refer to “Changing Print Format for External Printer” in Section 3. 4. Press the OK key to return to the CALIBRATION screen. 7.14 Operator’s Manual MEK-6510 7. CALIBRATION HGB/HCT Calibration with Human Blood When calibrating with human blood, use both of the following measurement methods. • Measurement with the MEK-6510 hematology analyzer • Measurement with a spectrophotometer and microhematocrit centrifuge Calculate the HGB/HCT value with these methods and then calculate the calibration coefficient. 7 NOTE Measurement accuracy with the spectrophotometer and microhematocrit centrifuge depends on the processes, i.e. sampling, diluting and stirring. Perform the processes carefully. Measurement with the Analyzer 1. Prepare 10 venous blood samples from a healthy person. 2. Count the samples in double counting mode. Refer to Section 4 “Measurement”. HGB Measurement with a Spectrophotometer 1. Prepare the diluent with lysing 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 above procedure (“Measurement with the Analyzer” section). 3. Set up the spectrophotometer as follows. Wavelength: Approx. 540 nm Mode: ABS (absorbance) mode 4. Measure the optical density (OD) value of each pair of 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. 29.3 = Operator’s Manual MEK-6510 64458 200 44 1000 1 10 64458: Molecular weight of HGB 200: Dilution ratio 44: Optical density coefficient in mm mol 1000: from mg to g 1: Cell thickness (cm) 10: from g/L to g/dL 7.15 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 WBC RBC B 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. 7.16 Operator’s Manual MEK-6510 7. CALIBRATION 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 analyzer. Sample No. Manual Measurement (M) Manual Measurement (I) Data = I − M × 100 (%) M 1 7 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 (M): (I): Spectrophotometer and microhematocrit centrifuge MEK-6510 Hematology Analyzer 2. Calibrate the hematology analyzer by changing the calibration coefficient setting to the revised calibration coefficient (C) in the previous table. i) Press the CALIBRATION key on the MENU screen to display the CALIBRATION screen. ii) Press the OPEN key on the CALIBRATION screen to display the CAL OPEN screen. NOTE Write down the current settings before changing them. iii) In the <Cal> field of the desired parameter, enter the new calibration coefficient. iv) Press the OK key to return to the CALIBRATION screen. Operator’s Manual MEK-6510 7.17 Section 8 Messages and Troubleshooting General................................................................................................................................................................. 8.2 Alarm Messages................................................................................................................................................... 8.5 Invalid Data Identifier.................................................................................................................................. 8.5 Flag Indication............................................................................................................................................ 8.6 Alarm Messages with Alarm Codes........................................................................................................... 8.6 Other Alarm Messages.............................................................................................................................. 8.8 System Error Messages....................................................................................................................................... 8.9 Inaccurate Counting and Other Problems.......................................................................................................... 8.10 Operator’s Manual MEK-6510 8.1 8 8. MESSAGES AND TROUBLESHOOTING General If the analyzer detects a problem, it displays an alarm message with an alarm sound. Use the tables in this section for more information, cause of alarm and countermeasures. Types of alarm messages • After self-check at power on • After cleaning or priming • When reagent reaches the warning level when using reagent management • System error • During measurement • Alarm on measurement result Alarm message display after self-check The analyzer performs self-check after power is turned on. If an error is detected, the following screen appears. If several errors are detected, the next ALARM or MESSAGE screen appears when the OK key is pressed. When errors concerning reagent are detected When errors concerning operation are detected 8.2 When errors concerning background noise are detected When errors concerning maintenance are detected Operator’s Manual MEK-6510 8. MESSAGES AND TROUBLESHOOTING Alarm message display after priming/cleaning When an error is detected during priming or cleaning, the following ALARM screen appears. Follow the instruction on the screen and remove the cause. 8 Alarm message display when reagent reaches the warning level when using reagent management When using reagent management and the reagent reaches the warning level, a warning message appears. If the reagent is not reset (or waste is not disposed of), the ALARM message appears. For details on the warning screen, refer to “Using Reagent Management” in Section 3. Warning message Operator’s Manual MEK-6510 Alarm message 8.3 8. MESSAGES AND TROUBLESHOOTING System error message display When a system error is detected, the SYSTEM ERROR screen appears. Follow the instruction on the screen. Alarm message display during measurement When an alarm occurs during measurement, the sample is automatically recounted up to three times. When <Display alarm on recount> is set to “Yes” on the MEASUREMENT screen of the SETTINGS screen, the alarm message is displayed when an alarm occurs during measurement. Alarm on measurement result When there is an alarm on the measured data, the alarmed parameter is displayed in red. For details, refer to the “Alarm Messages” in this section and “Description of the RESULTS Screen” in Section 4. Alarmed parameter displayed in red. 8.4 Operator’s Manual MEK-6510 8. MESSAGES AND TROUBLESHOOTING Alarm Messages CAUTION When an alarm occurs, the acquired data might not be correct, especially when “!” or “sample error” message appears. Do not use the data for diagnosis. Recount the sample. NOTE When performing the strong cleaning as the countermeasure, after the strong cleaning is completed, press the [ Count] switch in open mode without aspirating the diluent from the sampling nozzle. Perform this procedure two or more times so that the diluent replaces CLEANAC•3 detergent inside the analyzer. Invalid Data Identifier Identifier Possible Cause/Criteria ? is displayed to the right of WBC Abnormal sample or RBC measured value ? is displayed to the right of HGB measured value ! is displayed to the right of WBC measured value ! is displayed to the right of HGB measured value ! is displayed to the right of MCHC measured value ! is displayed to the right of PLT measured value The WBC measurement bath is dirty. WBC counting error. Poor hemolyzation. HGB voltage adjustment error. Abnormal RBC. Error occurred when diluting the sample. Background noise is increased. Other noises are detected during counting. * is displayed to the right of HGB Error in the circuit. measured value * is displayed to the right of PLT measured value PLT low value (below 50,000/μL) WBC and PLT counting error. C is displayed to the right of WBC Platelet coagulated. (Poor and PLT measured values hemolyzation and low PLT) Operator’s Manual MEK-6510 Countermeasure Check that the temperature of the diluent is between 15 and 30˚C. Then recount the sample. Water and alcohol cannot be measured. Clean the measurement bath. Check the analyzer by counting the hematology control. Then recount the sample. Replace the diluent and press the [Clean] key to perform cleaning. Then measure the background noise again. Check the internal circuit by referring to “Checking the Circuit” in Section 9. If an error is detected, refer to the Service Manual. Prepare a stained blood film and examine it under a microscope. Check the analyzer by counting the hematology control. Then recount the sample. 8.5 8 8. MESSAGES AND TROUBLESHOOTING Flag Indication Identifier F1 is displayed to the right of LY% measured value F2 is displayed to the right of LY% or MO% measured value F3 is displayed to the right of GR% measured value F4 is displayed to the right of LY%, MO% or GR% measured value H is displayed to the right of measured value L is displayed to the right of measured value Possible Cause/Criteria Countermeasure RBC ghost Poor Lymphocyte or Monocyte discrimination Poor Granulocyte discrimination Poor Lymphocyte, Monocyte or Granulocyte discrimination The measured value is above the normal range. The measured value is below the normal range. Check the analyzer by counting the hematology control. Then recount the sample. Refer to “Flags” in “Description of the RESULTS Screen” in Section 4. — — Alarm Messages with Alarm Codes Messages A001: No diluent A005: No detergent A007: No lysing reagent Possible Cause/Criteria Out of diluent, detergent or lysing reagent. A009: WBC priming error A010: RBC priming error Insufficient diluent in the manometer or the connection tube is out of position. A021: WBC level 1 A022: WBC level 2 Erroneous operation during WBC counting. A023: WBC level 3 The WBC aperture cap is clogged. A024: WBC bubble 1 A025: WBC bubble 2 A026: WBC bubble 3 A027: WBC bubble 4 Air bubbles in WBC manometer. A029: WBC clog The WBC aperture cap is clogged. A030: WBC sample error Abnormal sample A031: WBC noise 2 A032: WBC noise 1 Noise is detected during counting. A036: WBC upper manometer dirty A037: WBC lower manometer dirty The upper part of the manometer is dirty. WBC manometer sensor output is low. The lower part of the manometer is dirty. WBC manometer sensor output is low. A041: RBC level 1 A042: RBC level 2 Erroneous operation during RBC counting. A043: RBC level 3 The RBC aperture cap is clogged. 8.6 Countermeasure Replace the diluent, detergent or lysing reagent. Then press the PRIME key on the OPERATIONS screen. Add the diluent or check that the connection tube is connected properly. Perform counting again after priming or cleaning the analyzer. Press the [Clean] key to perform cleaning. Then recount the sample. If the alarm still occurs, perform strong cleaning, clean the aperture cap 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. If the alarm still occurs, perform strong cleaning, clean the aperture cap and replace the pump tube. Prepare the sample and measure again. Check that the temperature of the diluent is between 15 and 30˚C. Check the grounding, and separate the analyzer from other equipment and their power sources. Then recount the sample. Press the [Clean] key to perform the cleaning. Then press STRONG CLEAN on the OPERATIONS screen to perform the strong cleaning. Press the [Clean] key to perform cleaning. Then recount the sample. If the alarm still occurs, perform strong cleaning, clean the aperture cap and replace the pump tube. Operator’s Manual MEK-6510 8. MESSAGES AND TROUBLESHOOTING Messages A044: RBC bubble 1 A045: RBC bubble 2 A046: RBC bubble 3 A047: RBC bubble 4 Possible Cause/Criteria Air bubbles in RBC manometer. A049: RBC clog The RBC aperture cap is clogged. A050: RBC sample error Abnormal sample A051: RBC noise 2 A052: PLT noise 1 A053: PLT noise 3 Noise is detected during counting. A061: HGB voltage low The upper part of the manometer is dirty. RBC manometer sensor output is low. The lower part of the manometer is dirty. RBC manometer sensor output is low. The WBC measurement bath is dirty. A062: HGB voltage high HGB voltage adjustment error. A063: HGB circuit error Error in the HGB circuit. A056: RBC upper manometer dirty A057: RBC lower manometer dirty A091: Room temperature high A092: Room temperature low Press the [Clean] key to perform cleaning. Then recount the sample. If the alarm still occurs, perform strong cleaning, clean the aperture cap and replace the pump tube. Prepare the sample and measure again. Check that the temperature of the diluent is between 15 and 30˚C. Check the grounding, and separate the analyzer from other equipment and their power sources. Then recount the sample. Press the [Clean] key to perform the cleaning. Then press STRONG CLEAN on the OPERATIONS screen to perform the strong cleaning. Clean the measurement bath. Turn the power off. Wait for about 10 minutes and then turn the power on to start counting. If the alarm still occurs, contact your Nihon Kohden representative. Perform measurement at temperatures between 15 and 30˚C. Internal temperature is abnormal. Turn the power off. Wait for about 10 minutes and then turn the power on. Display the SENSOR MONITOR screen on the OTHER screen and check that alarm is not displayed for <Temperature>. If there is an alarm for <Temperature> or the same alarm still occurs, contact your Nihon Kohden representative. A095: Power supply temp high A101: Internal printer error Internal printer error. A102: No paper (Internal printer) No paper in the internal printer. A103: External printer error External printer error. A104: No paper (External printer) No paper in the external printer. Operator’s Manual MEK-6510 Press the [Clean] key to perform cleaning. Then recount the sample. Measurement is performed at temperatures over 30˚C. Measurement is performed at temperatures below 15˚C. A093: Internal temperature high A094: Internal temperature low Countermeasure Contact your Nihon Kohden representative. Set the new roll of recording paper. Refer to the printer manual. Set the new set of recording paper. Refer to the printer manual. 8.7 8 8. MESSAGES AND TROUBLESHOOTING Other Alarm Messages Messages Background noise check failed Check filters, baths and sub baths Check rinse unit Check sampling nozzle Possible Cause/Criteria Error occurred during background noise measurement. Measurement is performed more than 1,000 times. Measurement is performed more than 1,000 times. Measurement is performed more than 3,000 times. Check settings The backup data is inappropriately changed. Replace pump tube Measurement is performed more than 3,000 times. 8.8 Countermeasure Press the [Count] switch and measure background noise again. Check filters, baths and sub baths and reset the operation history. Replace filters if necessary. Check rinse unit and reset the operation history. Check sampling nozzle and reset the operation history. Re-enter the calibration coefficient and all other settings. Then sample counting can be performed. If the error still occurs, contact your Nihon Kohden representative for battery replacement. Replace the pump tube and reset the operation history. Operator’s Manual MEK-6510 8. MESSAGES AND TROUBLESHOOTING System Error Messages Messages E001: DILUTER INITIALIZE ERROR E021: SAMPLER INITIALIZE ERROR E041: SUB BATH INITIALIZE ERROR E101: BATH DRAIN ERROR E123: MEMORY ERROR E124: CIRCUIT ERROR E126: TOUCH PANEL ERROR Operator’s Manual MEK-6510 Possible Cause/Criteria The MD-640V combination syringe pump unit cannot be initialized. The MS-650V sampler unit cannot be initialized. The sub bath of the MC-640V measuring unit cannot be initialized. The MP-640V pump unit does not drain the measurement baths. The backup data is inappropriately changed. Countermeasure Turn the power off then on. If the alarm still occurs, write down the error code and contact your Nihon Kohden representative. Delete the stored data. 8 Circuit error. Turn the power off then on. If the alarm still occurs, write down the error code and contact your Nihon Kohden representative. The pressed position and operating position do not match. Calibrate the touch screen. Refer to Section 9. Circuit error. Press the [Reset] key. If the problem still occurs, turn off the analyzer, wait about 10 seconds, then turn it on again. 8.9 8. MESSAGES AND TROUBLESHOOTING Inaccurate Counting and Other Problems If operation is not accurate after attempting the countermeasure in the previous sections, check the causes according to the following table. Problem Noise interference during counting High background noise Poor reproducibility of blood cell count Water leaks from inside the analyzer Poor reproducibility of HGB value Incorrect LCD display Analyzer repeats same operation No printing The touch screen keys do not function Priming starts suddenly (When noise interferes with the analyzer program, priming automatically starts and the READY screen appears.) Possible Cause/Criteria Insufficient grounding. Equipment near the analyzer is generating noise. Noise in the power line. Dirty diluent. Dirty sub bath, measurement bath and filters. Dirty aperture caps. Poor contact of external electrode to the socket of the analyzer. The fluid path and diluent tube are dirty. Countermeasure Make sure the ground is sufficient. Separate the analyzer from other equipment and their power sources. Use a different power line. Replace the diluent. Clean the sub bath, measurement bath and filters. Refer to Section 9. Clean the aperture caps. Refer to Section 9. Firmly tighten the measurement bath. Circuit error. Press the [Reset] key. If the problem still occurs, turn off the analyzer, wait about 10 seconds, then turn it on again. Paper jammed. Remove the jammed paper. Refer to the printer manual. Press the [Reset] key. If the problem still occurs, turn off the analyzer, wait about 10 seconds, then turn it on again. Calibrate the touch screen. Refer to Section 9. Press the [Clean] key to clean the fluid path using the CLEANAC detergent. Perform the strong cleaning with CLEANAC3 detergent by selecting STRONG CLEAN on the OPERATION screen. Insufficient stirring of sample. Stir the sample sufficiently without creating bubbles. Dirty sub bath and/or measurement Clean the sub bath and/or measurement bath. Refer to bath. Section 9. Dirty aperture caps. Clean the aperture caps. Refer to Section 9. High background noise. Reduce the background noise. Refer to the problem “High background noise”. Pump tube is broken. Replace the pump tube. Refer to Section 9. Filter is clogged. Replace the filter. Refer to Section 9. The WBC measurement bath is dirty. Clean the measurement bath. Refer to Section 9. Circuit error. The pressed position and operating position do not match. Circuit error. Press the [Reset] key. If the problem still occurs, turn off the analyzer, wait about 10 seconds, then turn it on again. Power cord is not connected properly. Connect the power cord properly. Equipment near the analyzer is generating noise. Separate the analyzer from other equipment and their power sources. Noise in the power line. Use a different power line. The date and time setting is not correct. Set the correct date and time setting on the DATE & TIME screen. Refer to Section 3. The time displayed on the Check the date and time setting on the DATE & TIME upper right corner of the The backup battery is old. screen and turn off and on the power of the analyzer. If screen is not correct. (The backup battery lifetime is about the time is incorrect, replace the backup battery with a 6 years.) new one. Contact your Nihon Kohden representative. 8.10 Operator’s Manual MEK-6510 Section 9 Maintenance General................................................................................................................................................................. 9.3 Disposing of Waste and the Analyzer......................................................................................................... 9.4 Repair Parts Availability Policy................................................................................................................... 9.4 Preventive Maintenance Schedule....................................................................................................................... 9.5 Maintenance Schedule............................................................................................................................... 9.5 Displaying Operation History Screen......................................................................................................... 9.6 Maintenance Check Sheet................................................................................................................................... 9.9 Inside Panel Components.................................................................................................................................. 9.11 Before Maintenance Procedure.......................................................................................................................... 9.12 Strong Cleaning........................................................................................................................................ 9.12 Draining Measurement Baths and Sub Baths.......................................................................................... 9.13 Turning Power Off..................................................................................................................................... 9.14 Daily Maintenance Procedures........................................................................................................................... 9.15 Checking Reagents and Other Consumables.......................................................................................... 9.15 Checking the Appearance of the Analyzer............................................................................................... 9.15 Cleaning the Surface of the Analyzer............................................................................................. 9.16 Disinfecting the Surface of the Analyzer........................................................................................ 9.16 Checking the Reagent Connection Tubes................................................................................................ 9.16 Checking the Power Cord and Grounding Lead....................................................................................... 9.16 Checking the External Instrument Connection......................................................................................... 9.16 Checking the Power On............................................................................................................................ 9.17 Calibrating the Touch Screen......................................................................................................... 9.17 Checking the Date and Time.................................................................................................................... 9.18 Clock Accuracy.............................................................................................................................. 9.18 Checking Daily Accuracy.......................................................................................................................... 9.18 Checking Measurement Baths and Sub Baths......................................................................................... 9.18 Checking Pump Tube............................................................................................................................... 9.18 Every 200 Counts Maintenance Procedures...................................................................................................... 9.19 Performing Strong Cleaning..................................................................................................................... 9.19 Weekly/Every 300 Counts Maintenance Procedures......................................................................................... 9.19 Checking/Cleaning Filters........................................................................................................................ 9.19 Monthly/Every 1,000 Counts Maintenance Procedures..................................................................................... 9.20 Replacing Filters....................................................................................................................................... 9.20 Materials Required......................................................................................................................... 9.20 Procedure....................................................................................................................................... 9.20 Checking and Cleaning Measurement Baths and Sub Baths.................................................................. 9.22 Materials Required......................................................................................................................... 9.22 Procedure....................................................................................................................................... 9.22 Checking and Cleaning the Rinse Unit..................................................................................................... 9.25 Materials Required......................................................................................................................... 9.25 Procedure....................................................................................................................................... 9.25 Every Four Months/Every 3,000 Counts Maintenance Procedures.................................................................... 9.27 Checking, Cleaning and Replacing the Sampling Nozzles...................................................................... 9.27 Operator’s Manual MEK-6510 9.1 9 Materials Required......................................................................................................................... 9.27 Procedure....................................................................................................................................... 9.27 Replacing Pump Tube.............................................................................................................................. 9.30 Materials Required......................................................................................................................... 9.30 Procedure....................................................................................................................................... 9.30 As-Required Maintenance Procedures............................................................................................................... 9.33 Removing a Clog from the Aperture......................................................................................................... 9.33 Cleaning Aperture Caps........................................................................................................................... 9.34 Materials Required......................................................................................................................... 9.34 Procedures..................................................................................................................................... 9.34 Checking the Prime Function................................................................................................................... 9.38 Checking the Drain Function.................................................................................................................... 9.38 Checking the Cleaning Function.............................................................................................................. 9.38 Checking the Circuit................................................................................................................................. 9.38 Checking the Sensor Monitor Screen....................................................................................................... 9.40 Checking the External Instruments Function........................................................................................... 9.41 Printers........................................................................................................................................... 9.41 Hand-held Bar Code Reader.......................................................................................................... 9.41 PC.................................................................................................................................................. 9.41 Decontamination Protocol........................................................................................................................ 9.42 Procedure....................................................................................................................................... 9.43 Storing and Transporting the Analyzer..................................................................................................... 9.45 Preparing the Analyzer for Long Term Storage or Transport.......................................................... 9.45 Using the Analyzer after Storage................................................................................................... 9.47 Preparing the Analyzer for Short Term Transport........................................................................... 9.48 9.2 Operator’s Manual MEK-6510 9. MAINTENANCE General This analyzer has been designed to require minimal routine maintenance. The operator must routinely perform the scheduled maintenance procedures described in this section in order to ensure optimum performance. Failure to perform the scheduled maintenance procedures may result in inaccurate or imprecise analysis of whole blood samples. This section describes recommended preventive maintenance procedures and provides instructions for preparing the analyzer for extended periods of inactivity. NOTE Upon performing any maintenance procedure, perform strong cleaning and drain baths prior to turning the power off, document the activity, measure background noise (run without a specimen) until results are within specifications, followed by running quality control material. Refer to “Measuring Background Noise” in Section 2. The maintenance schedule outlined on the following page will minimize operational problems with the analyzer. The recommended intervals are based on analyzers operating in laboratories that process samples from a general patient population. These intervals are affected by several factors, including the following: • Number of samples processed • Work load schedule • Operating environment • Patient population being analyzed Each laboratory must assess its own situation and modify these recommended intervals as necessary. A diagram of the inside panel is included in this section to assist in component identification and location. To order any parts, accessories, or consumables, refer to “Standard Accessories” and “Consumables” in Section 10. WARNING • Be careful not to directly touch any place where blood sample is or may have contacted. • Always wear rubber gloves to protect yourself from infection. Operator’s Manual MEK-6510 9.3 9 9. MAINTENANCE NOTE Overdue maintenance is usually indicated by an increase in imprecision of one or more of the directly-measured parameters. This imprecision is due to carryover or dilution/sampling inconsistencies. If this occurs on more than a random basis, perform the appropriate maintenance more frequently than indicated. Disposing of Waste and the Analyzer Follow your local laws for disposing of medical waste. When disposing of the analyzer, contact your Nihon Kohden representative. WARNING • Dispose of the analyzer, replaced parts (such as sampling nozzle), waste fluid and parts used for collecting sample blood (such as needles, syringes and vials) by following your local laws for disposing of infectious medical waste (for incineration, melt treatment, sterilization and disinfection). • Before disposing of the analyzer, perform strong cleaning and remove the sampling nozzle from the analyzer. If the above warning is not followed, it causes infection or environmental contamination. WARNING Always wear rubber gloves to protect yourself from infection. 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 after delivery of the instrument. In that period, NKC or its representatives will repair the instrument. This period may be shorter than 7 years if the necessary board or part is not available. For discontinuation announcements, contact your Nihon Kohden representative. 9.4 Operator’s Manual MEK-6510 9. MAINTENANCE Preventive Maintenance Schedule Maintenance Schedule Perform the following procedures at the scheduled intervals: Daily • Check reagent volume, recording paper and other consumables • Check sampling nozzle, switches, keys and outside surface of the analyzer • Check reagent tube connection • Check power cord and grounding lead connection • Check external instrument connection (printer, PC, bar code reader) • Check screen display and touch screen key function (Calibrate touch screen) • Check date and time settings • Check daily accuracy (background noise, measure hematology control) • Check measurement baths and sub baths • Check pump tube Every 200 counts • Do strong cleaning Weekly or every 300 counts • Check filters and filter packings Monthly or every 1,000 counts, whichever comes first • Replace filters • Clean measurement baths and sub baths • Clean rinse unit Every Four Months or every 3,000 counts, whichever comes first • Check sampling nozzles • Replace pump tube As Required • Clean aperture caps • Check priming function • Check draining function • Check cleaning function • Check circuit • Check sensor monitor • Check external instrument function (printer, PC, bar code reader) • Decontamination protocol • Storing and transporting the analyzer Operator’s Manual MEK-6510 To keep the analyzer in optimum condition, periodically check, clean and maintain it according to the above schedule. If an error is found during a periodic check, clean or replace the item. If the error persists, contact your Nihon Kohden representative. You can use the OPER HISTORY screen to keep track of maintenance. 9.5 9 9. MAINTENANCE The fluid needs to be drained from the analyzer for some of the above maintenance. For the aperture caps, the fluid must be completely drained from the analyzer (DRAIN ALL). After draining, the analyzer power must be turned off. Follow the instructions in this section. Displaying Operation History Screen You can display the total operating time (hours), total number of counts, and number of counts used to determine the maintenance schedule for filters, measurement baths, sub baths, pump tube, rinse unit, sampling nozzles, and strong cleaning. When the filters, measurement baths, sub baths, pump tube, rinse unit and sampling nozzle are used more than the following number of sample counts, the MESSAGE screen appears to prompt you to check and/or replace them. Filters, measurement baths and sub baths: Pump tube: Rinse unit: Sampling nozzles: 1,000 counts 3,000 counts 1,000 counts 3,000 counts After 200 sample counts, the MESSAGE screen prompts you to do strong cleaning. 1. Press the OTHER key on the MENU screen to display the OTHER screen. 2. Press the OPER HISTORY key to display the OPER HISTORY screen. 9.6 Operator’s Manual MEK-6510 9. MAINTENANCE The first page displays the software version, installed language, hardware version, total operating time (hours) and total number of counts. 9 The second page displays the number of counts for filters, measurement baths, sub baths, pump tube, rinse unit and sampling nozzle. After checking and replacing the filters, measurement baths, sub baths, pump tube, rinse unit and sampling nozzle, and doing strong cleaning, reset the counts to zero by pressing the RESET key. Operator’s Manual MEK-6510 9.7 9. MAINTENANCE The third page displays the number of counts to do strong cleaning. After doing the strong cleaning, reset the counts to zero by pressing the RESET key. 3. Press the OK key to return to the OTHER screen. 9.8 Operator’s Manual MEK-6510 9. MAINTENANCE Maintenance Check Sheet It is recommended that operators keep a record of scheduled and unscheduled maintenance procedures using this maintenance check sheet. Hospital/Organization: Checking Date: Analyzer Model: Analyzer Serial Number: Hardware Revision Number: Software Revision Number: Service Personnel: Check Item Daily Check There are enough Nihon Kohden specified reagent, recording paper and other consumables. The reagents are not expired. There are no damaged or dirty parts on the outside of the analyzer. There is no leakage from the analyzer. The sampling nozzle, switches and keys are not damaged. The labels are not torn or removed. The reagents are properly connected to the analyzer. The tubes are not damaged, bent or clogged. The power cord is connected properly. The power cord is not damaged. Grounding lead is connected properly. The external instruments are properly connected to the analyzer. The connection cables are not damaged. No alarms appear when the analyzer is turned on and the READY screen appears. The messages are displayed properly. The touch screen keys function properly. Calibrate the touch screen when necessary. Date and time are correct. Enter the value WBC: 0.2 (×103/µL) Measure background noise RBC: 0.05 (×106/µL) HGB: 0.1 (g/dL) PLT: 10 (×103/µL) Measure hematology control and check that the obtained data is within the acceptable range on the assay sheet of the hematology control. Check that the measurement baths and sub baths are not dirty or damaged. Check that the pump tube is not collapsed or damaged. Every 200 counts Do strong cleaning. Weekly or every 300 counts Check that filters and filter packings are not damaged. Monthly or every 1,000 counts, whichever comes first Replace filters Clean sub baths and measurement baths Clean rinse unit Every four months or 3,000 counts, whichever comes first Check sampling nozzles Replace pump tube Operator’s Manual MEK-6510 OK No 9 9.9 9. MAINTENANCE Check Item As required Clean aperture caps Remove clog from aperture Check prime function Check draining function Check cleaning function OK No Enter the value Check circuit WBC: 7.6 to 8.4 (×103/µL) RBC: 1.52 to 1.68 (×106/µL) MCV: 85 to 115 (fL) PLT: 152 to 168 (×103/µL) HGB ON: 1.5 to 4.5 V HGB OFF: <0.5 V WBC sensitivity WBC threshold RBC sensitivity RBC threshold PLT threshold Enter the value HGB LED On: 1.5 to 4.5 V HGB LED Off: <0.5 V WBC: 17.8 to 18.8 V RBC: 17.8 to 18.8 V WBC manometer Upper: >3.5 V WBC manometer Lower: >3.5 V Without RBC manometer Upper: >3.5 V reagent RBC manometer Lower: >3.5 V Diluent: >3.5 V Check sensor monitor Lysing reagent: >3.5 V WBC manometer Upper: <1.5 V WBC manometer Lower: <1.5 V RBC manometer Upper: <1.5 V With reagent RBC manometer Lower: <1.5 V Diluent: <1.5 V Lysing reagent: <1.5 V HGB unit (°C) MC unit (°C) Power board (°C) Check printer function Check bar code reader function Check communication function between analyzer and PC. Decontamination protocol Storing and transporting analyzer 9.10 Operator’s Manual MEK-6510 9. MAINTENANCE Inside Panel Components WBC measurement bath Sub bath Sampling nozzles RBC measurement bath Rinse unit 9 Aperture caps Filters Pump tube WARNING WARNING • Dispose of the analyzer, replaced parts (such as sampling nozzle), waste fluid and parts used for collecting sample blood (such as needles, syringes and vials) by following your local laws for disposing of infectious medical waste (for incineration, melt treatment, sterilization and disinfection). • Before disposing of the analyzer, perform strong cleaning and remove the sampling nozzle from the analyzer. If the above warning is not followed, it causes infection or environmental contamination. • Be careful not to directly touch any place where blood sample is or may have contacted. • Always wear rubber gloves to protect yourself from infection. CAUTION Turn off the analyzer main power before maintenance. Otherwise, the operator may receive electrical shock and the analyzer may malfunction. Operator’s Manual MEK-6510 WARNING The sampling nozzle is sharp and potentially contaminated with infectious materials. Be careful when handling the sampling nozzle. CAUTION Do not remove any parts that are not specified in this manual. 9.11 9. MAINTENANCE Before Maintenance Procedure Before turning the analyzer power off and removing the right side cover for maintenance, perform strong cleaning and drain fluid from the measurement baths and sub baths. Strong Cleaning Strong cleaning cleans the analyzer more thoroughly with CLEANAC•3 detergent containing sodium hypochlorite. Perform strong cleaning when the analyzer indicates that the strong cleaning is needed, background counts are out of specification, or the clogging message frequently appears or before disposing of the analyzer. Do not perform strong cleaning every day because it deteriorates the analyzer. 1. Press the OPERATIONS key on the MENU screen to display the OPERATIONS screen. 2. Press the STRONG CLEAN key on the OPERATIONS screen. 9.12 Operator’s Manual MEK-6510 9. MAINTENANCE 3. Press the YES key to perform strong cleaning. The analyzer starts cleaning and the “Strong cleaning” message appears on the screen. Press the NO key to cancel the procedure. After cleaning, the screen returns to the READY screen. 4. After maintenance is complete and the analyzer is turned on again, measure background noise at least twice. Draining Measurement Baths and Sub Baths This function drains the measurement and sub baths to avoid spillage of the diluent. 1. Press the OPERATIONS key on the MENU screen to display the OPERATIONS screen. 9 2. Press the DRAIN BATHS key on the OPERATIONS screen. The “Drain baths?” message appears. Operator’s Manual MEK-6510 9.13 9. MAINTENANCE 3. Press the YES key to drain fluids from the measurement baths and sub baths. The analyzer starts draining the baths and the “Draining” message appears on the screen. Press the NO key to cancel the procedure. After draining, the screen returns to the READY screen. Turning Power Off CAUTION Turn off the analyzer main power before maintenance. Otherwise, the operator may receive electrical shock and the analyzer may malfunction. Press the [Power] key while holding down the [Reset] key. The power turns off without cleaning. Check that the power lamp is off. 9.14 Operator’s Manual MEK-6510 9. MAINTENANCE Daily Maintenance Procedures Checking Reagents and Other Consumables CAUTION Only use Nihon Kohden specified reagents and consumables. Otherwise the measurement result cannot be guaranteed and incorrect reagent concentration can cause equipment damaged. Check that the following Nihon Kohden specified reagents are used. • ISOTONAC•3 diluent • CLEANAC detergent • CLEANAC•3 detergent (For STRONG CLEAN only) • Hemolynac•3N hemolysing reagent 9 Check that these reagents are not expired and are not run out. Check that there are enough consumables, such as hematology control, sample containers, sample tubes and sample cups. When using a printer, check that there is enough recording paper. Checking the Appearance of the Analyzer Check the following points. • There are no damaged or dirty parts on the outside of the analyzer. • The sampling nozzle, switches and keys are not damaged. • There is no leakage from the analyzer. • The labels are not torn or removed. WARNING • Be careful not to directly touch any place where blood sample is or may have contacted. • Always wear rubber gloves to protect yourself from infection. CAUTION Turn off the analyzer main power before maintenance. Otherwise, the operator may receive electrical shock and the analyzer may malfunction. NOTE When using flammable solvent such as ethanol for cleaning and disinfecting, ventilate the room adequately. Operator’s Manual MEK-6510 9.15 9. MAINTENANCE Cleaning the Surface of the Analyzer Clean the surface of the analyzer with a soft cloth moistened with water, mild detergent or disinfecting ethanol (15°C (59°F), 76.9 to 81.4% by vol) and wipe with a dry cloth. NOTE • Never use organic solvents such as thinner or acetone because they damage the enclosure of the analyzer. • When cleaning the analyzer with a cloth moistened with water, wring out the cloth to prevent water from entering the analyzer. Disinfecting the Surface of the Analyzer Wipe the analyzer with a cloth moistened with disinfecting ethanol (15°C (59°F), 76.9 to 81.4% by vol). Disinfect the sampling nozzle (open mode) thoroughly because it touches blood. NOTE Disinfect the sampling nozzle before every maintenance because infectious blood may be adhered to it. Checking the Reagent Connection Tubes Check that the reagent tubes are not damaged, bent or clogged. For correct tube connection, refer to “Connecting Tubes and Installing Reagents” in Section 2. Checking the Power Cord and Grounding Lead Check that the power cord and grounding lead are properly connected and not damaged. Checking the External Instrument Connection When using an optional printer, PC and hand-held bar code reader, check that they are properly connected to the analyzer. Check that the connection cables are not damaged. 9.16 Operator’s Manual MEK-6510 9. MAINTENANCE Checking the Power On When the analyzer is turned on, check that the self-check is performed and the READY screen appears. Check that no alarms appear and the touch screen keys function properly. Also check that there is no smell, heat or noise and that there is no leakage from the analyzer. Calibrating the Touch Screen Calibrate the touch screen when the pressed position and operating position do not match. 1. Press the [ Count] key (or [Dispense] key when <[Eject] key operation> is set to “Dispense” on the OPERATION screen of the SETTINGS screen) while holding down the [ Reset] key. The TOUCH SCREEN CALIBRATION screen appears. 9 2. Follow the instructions on the screen to calibrate the screen. NOTE Do not use a sharp object to press the mark. Use your finger. After calibration is completed, the screen returns to the READY screen. Operator’s Manual MEK-6510 9.17 9. MAINTENANCE Checking the Date and Time Check that the date and time on the screen are correct. To change the date and time, refer to “Setting Date and Time” in Section 3. Date Time Clock Accuracy At an operating temperature of 25ºC (77ºF), the accuracy of the clock IC of the analyzer is about ±52 seconds per month. At storage temperatures between –20 and +60ºC (–4 and 140ºF), the accuracy of the clock IC of the analyzer is about –7 minutes to +52 seconds per month. Checking Daily Accuracy Check the daily accuracy. Refer to “Checking Daily Accuracy” in Section 2. Checking Measurement Baths and Sub Baths Refer to the “Checking and Cleaning Measurement Baths and Sub Baths” in the “Monthly/Every 1,000 Counts Maintenance Procedures” later in this section. Checking Pump Tube Refer to the “Replacing Pump Tube” in the “Every Four Months/Every 3,000 Counts Maintenance Procedures” later in this section. 9.18 Operator’s Manual MEK-6510 9. MAINTENANCE Every 200 Counts Maintenance Procedures Performing Strong Cleaning Perform strong cleaning every 200 sample counts. Refer to “Strong Cleaning” in the “Before Maintenance Procedure” in this section. Strong cleaning cleans the analyzer more thoroughly with CLEANAC•3 detergent containing sodium hypochlorite. Perform strong cleaning when the analyzer indicates that the strong cleaning is needed, background counts are out of specification, or the clogging message frequently appears or before disposing of the analyzer. Do not perform strong cleaning every day because it deteriorates the analyzer. 9 Weekly/Every 300 Counts Maintenance Procedures Checking/Cleaning Filters Check and clean the filters once a week or every 300 sample counts. Refer to the “Replacing Filters” in the “Monthly/Every 1,000 Counts Maintenance Procedures” later in this section. Operator’s Manual MEK-6510 9.19 9. MAINTENANCE Monthly/Every 1,000 Counts Maintenance Procedures Replacing Filters Materials Required • Powder-free gloves, lab coat, safety goggles • Phillips screwdriver • Tweezers Procedure Replace the filters when they are clogged, dirty and/or after every 1,000 sample counts. 1. Press the STRONG CLEAN key on the OPERATIONS screen to perform strong cleaning. Refer to “Before Maintenance Procedure” earlier in this section. 2. Press the DRAIN BATHS key on the OPERATIONS screen to drain the measurement baths and sub baths. Refer to “Before Maintenance Procedure” earlier in this section. 3. Press the [Power] key while holding down the [Reset] key to turn the power off. Check that the power lamp is off. NOTE Make sure that the power is turned off. If the power is on, the analyzer may start up when a key is accidentally pressed during maintenance. 4. Remove the three screws on the right side panel. 5. Pull the right side panel toward you to remove it. RBC measurement bath 6. Remove the 2 filter joint assemblies by turning the tube connectors. Air trap Filter joints 9.20 Operator’s Manual MEK-6510 9. MAINTENANCE 7. Remove the filter from each assembly. Use tweezers to remove any dust from the filter. If it is still dirty, replace it with a new one. Filter 8. Reattach the filter joint assemblies to the bottom of the RBC measurement bath and air trap. Make sure that the tube with the same number as the number label on the attaching part is connected back to the original position. Only finger tighten the filter joint. Filter packing NOTE • When attaching the filter joint assembly, be careful not to bend or damage the filter packing at the bottom of the measurement bath. • If there is leakage noted after installment of the filter, check that there are no scratches or damage around the filter. Damage may occur if a component is overtightened. 9. Reattach the right side cover and fasten it with the three screws on the rear panel and one screw on the right side panel. 10. Press the [Power] key to turn on the power. The analyzer starts priming the fluid pathway. 11. If filters were replaced, reset the filter counter. When the filter counter is reset, the measurement baths and sub baths counter is also reset. Before resetting the counter, the measurement baths and sub baths should be cleaned. Refer to the “Checking and Cleaning Measurement Baths and Sub Baths” section. To reset the counter, press the RESET key for <Filters, baths & sub baths> on the OPER HISTORY screen to reset the counts to zero. 12. Fill in the Maintenance Check Sheet. 13. Measure background noise at least twice. 14. Run quality controls before running patient samples. Operator’s Manual MEK-6510 9.21 9 9. MAINTENANCE Checking and Cleaning Measurement Baths and Sub Baths Check the measurement baths and sub baths every day. Clean the measurement baths and sub baths when there is any blood or dust on them. (Once a month or every 1,000 sample counts) Materials Required • • • • Powder-free gloves, lab coat, safety goggles Phillips and flat-blade screwdrivers CLEANAC•3 detergent Dry lint-free cloth Procedure NOTE Be careful not to damage the measurement baths and sub baths. 1. Press the STRONG CLEAN key on the OPERATIONS screen to perform strong cleaning. Refer to “Before Maintenance Procedure” earlier in this section. 2. Press the DRAIN BATHS key on the OPERATIONS screen to drain the measurement baths and sub baths. Refer to “Before Maintenance Procedure” earlier in this section. 3. Press the [Power] key while holding down the [Reset] key to turn the power off. Check that the power lamp is off. NOTE Make sure that the power is turned off. If the power is on, the analyzer may start up when a key is accidentally pressed during maintenance. 4. Remove the three screws on the right side panel. 5. Pull the right side panel toward you to remove it. 6. Remove the screw on the HGB cover and remove the HGB cover. HGB cover 7. Check the WBC and RBC measurement baths and sub baths. If there is any blood or dust on them, remove and clean them taking the following steps. 9.22 Operator’s Manual MEK-6510 9. MAINTENANCE Cap WBC meas bath Tube joint Sub baths 8. Remove the tube joint connected to the WBC measurement bath by turning the knurl joint. 9. Remove filter joints on the RBC and WBC measurement bath assemblies by turning the tube connectors. 10. Loosen the screws fastening the measurement baths. (The screws cannot be removed from the measurement baths.) 11. Remove the measurement baths by pulling them toward you to remove them from the aperture and then pulling them downward. 12. Remove the cap from the left side of the WBC sub bath. 13. Remove the sub baths by pushing them to the left, then pulling them toward you. 14. Soak the measurement baths and sub baths in CLEANAC•3 detergent for about 10 minutes. 15. Rinse the measurement baths and sub baths with water and wipe them with a dry lint-free cloth. Filter joints Meas baths Screws 16. Reattach the sub baths to their original positions. Reattach the cap (which was removed in step 12) to the left side of the WBC sub bath to fasten the sub baths. Shaft Aperture Tab Round indent 17. Reattach the measurement baths so that the sub bath is in the measurement bath, the shaft of the sub bath is in the tab of the measurement bath, and the round indent of the measurement bath fits the aperture. 18. Tighten the screws which were loosened in step 10 to fasten the measurement baths. NOTE Before tightening the screws, check and remove any dirt or rust on and around the screws. If dirt or rust is present, noise alarm may occur during measurement. 19. Reconnect the filter joints to the RBC and WBC measurement bath assemblies by turning the tube connectors. Operator’s Manual MEK-6510 9.23 9 9. MAINTENANCE 20. Reattach the tube joint to the WBC measurement bath by turning the knurl joint. 21. Reattach the HGB cover and fasten it with the screw. 22. Reattach the right side cover and fasten it with the three screws on the rear panel and one screw on the right side panel. 23. Press the [Power] key to turn on the power. The analyzer starts priming the fluid pathway. 24. If the measurement baths and sub baths are cleaned, the bath counter must be reset. When the bath counter is reset, the filter counter is also reset. Before resetting the counter, the filters should be replaced. Refer to “Replacing Filters” earlier in this section. To reset the counter, press the RESET key for <Filters, baths & sub baths> on the OPER HISTORY screen to reset the counts to zero. 25. Fill in the Maintenance Check Sheet. 26. Measure background noise at least twice. 27. Run quality controls before running patient samples. 9.24 Operator’s Manual MEK-6510 9. MAINTENANCE Checking and Cleaning the Rinse Unit Check and clean the rinse unit once a month or every 1,000 sample counts whichever comes first. Materials Required • • • • • Powder-free gloves, lab coat, safety goggles Phillips and flat-blade screwdrivers Cotton swabs CLEANAC•3 detergent Lint-free pad Procedure 1. Press the STRONG CLEAN key on the OPERATIONS screen to perform strong cleaning. Refer to “Before Maintenance Procedure” earlier in this section. 2. Press the DRAIN BATHS key on the OPERATIONS screen to drain the measurement baths and sub baths. Refer to “Before Maintenance Procedure” earlier in this section. 3. Press the [Power] key while holding down the [Reset] key to turn the power off. Check that the power lamp is off. NOTE Make sure that the power is turned off. If the power is on, the analyzer may start up when a key is accidentally pressed during maintenance. 4. Remove the three screws on the right side panel. 5. Pull the right side panel toward you to remove it. 6. Slide the sampling nozzle plate to the right. Sampling nozzle plate Operator’s Manual MEK-6510 9.25 9 9. MAINTENANCE 7. Check the following parts for dirt or blood clot. Remove blood or salt crystals on the rinse unit and sampling nozzles with a cotton swab or lintfree pad moistened with water or CLEANAC•3 detergent. NOTE Do not use alcohol for cleaning the rinse unit. When the inside of the rinse unit is dirty, contact your Nihon Kohden representative. The rinse unit needs to be disassembled for cleaning or replaced with a new one. Rinse unit (top view) Sampling nozzles Rinse unit (bottom view seen from the front panel side) 8. Reattach the right side cover and fasten it with the three screws on the rear panel and one screw on the right side panel. 9. Press the [Power] key to turn on the power. The analyzer starts priming the fluid pathway. 10. When the rinse unit is checked and cleaned, the rinse unit counter must be reset. To reset the counter, press the RESET key for <Rinse unit> on the OPER HISTORY screen to reset the counts to zero. 11. Fill in the Maintenance Check Sheet. 12. Measure background noise at least twice. 13. Run quality controls before running patient samples. 9.26 Operator’s Manual MEK-6510 9. MAINTENANCE Every Four Months/Every 3,000 Counts Maintenance Procedures Checking, Cleaning and Replacing the Sampling Nozzles Check and clean the sampling nozzles once every four months or every 3,000 sample counts whichever comes first. When PLT background count increases or the sampling nozzle is bent, replace the sampling nozzles with a new one. WARNING The sampling nozzles are sharp and potentially contaminated with infectious materials. Be careful when handling the sampling nozzles and performing this procedure. Materials Required • • • • • • Powder-free gloves, lab coat, safety goggles Phillips and flat-blade screwdrivers Cotton swabs CLEANAC•3 detergent Lint-free pad New sampling nozzle(s) (when required) Procedure 1. Press the STRONG CLEAN key on the OPERATIONS screen to perform strong cleaning. Refer to “Before Maintenance Procedure” earlier in this section. 2. Press the DRAIN BATHS key on the OPERATIONS screen to drain the measurement baths and sub baths. Refer to “Before Maintenance Procedure” earlier in this section. 3. Press the [Power] key while holding down the [Reset] key to turn the power off. Check that the power lamp is off. NOTE Make sure that the power is turned off. If the power is on, the analyzer may start up when a key is accidentally pressed during maintenance. 4. Remove the three screws on the right side panel. 5. Pull the right side panel toward you to remove it. Operator’s Manual MEK-6510 9.27 9 9. MAINTENANCE 6. Slide the sampling nozzle plate to the right. Sampling nozzle plate 7. Check the following parts for dirt or blood clot. Remove blood or salt crystals on the tip of the sampling nozzles with a cotton swab or lint-free pad moistened with CLEANAC•3 detergent. Sampling nozzles If the sampling nozzle is damaged or dirt/blood cannot be removed, replace the sampling nozzle with a new one. The sampling nozzle plate should be about here. 9.28 To replace sampling nozzles: i) Push down the sampling nozzle plate as far as it goes. The sampling nozzle plate must be at the position indicated at left. Otherwise, the measurement baths and sub baths get in the way and the sampling nozzles may be damaged. Operator’s Manual MEK-6510 9. MAINTENANCE ii) Loosen the sampling nozzle screw from each of the sampling nozzle. Tube guide Sampling nozzle screw NOTE Be careful not to drop the screws into the analyzer. iii) Unfasten the tube from the tube guide. iv) Turn the sampling nozzle 90º clockwise. Sampling nozzle 9 v) Remove the joint from each sampling nozzle. White joint NOTE Diluent may flow out from the sampling nozzle when the joint is removed. Black joint vi) Pull the sampling nozzle up to remove it. vii) Insert each new sampling nozzle into the sampling nozzle guide, attach the joint and turn the sampling nozzle 90º counterclockwise to lock it into place. Make sure that the white joint is attached to the left sampling nozzle (front panel side) and the black joint to the right sampling nozzle. Fasten the sampling nozzles with the sampling nozzle screws. Sampling nozzle guide viii) Raise the sampling nozzle plate to the original position. 8. Reattach the right side cover and fasten it with the three screws on the rear panel and one screw on the right side panel. 9. Press the [Power] key to turn on the power. The analyzer starts priming the fluid pathway. Operator’s Manual MEK-6510 9.29 9. MAINTENANCE 10. If the sampling nozzle is checked and cleaned, the sampling nozzle counter must be reset. To reset the counter, press the RESET key for <Sampling nozzle> on the OPER HISTORY screen to reset the counts to zero. 11. Fill in the Maintenance Check Sheet. 12. Measure background noise at least twice. 13. Run quality controls before running patient samples. Replacing Pump Tube Check the pump tube for water droplets and leaks every day. Replace the pump tube when there are water droplets or leaks. (Once every 4 months or every 3,000 sample counts whichever comes first.) NOTE • Do not leave the pump tube with water droplets or leaks on it. Make sure to replace the pump tube with a new one. Otherwise, the analyzer may be damaged. • If the pump tube leaks frequently, the pump unit may need to be replaced. Contact your Nihon Kohden representative. Materials Required • Powder-free gloves, lab coat, safety goggles • Phillips screwdriver Procedure 1. Press the STRONG CLEAN key on the OPERATIONS screen to perform strong cleaning. Refer to “Before Maintenance Procedure” earlier in this section. 2. Press the DRAIN BATHS key on the OPERATIONS screen to drain the measurement baths and sub baths. Refer to “Before Maintenance Procedure” earlier in this section. 3. Press the [Power] key while holding down the [Reset] key to turn the power off. Check that the power lamp is off. NOTE Make sure that the power is turned off. If the power is on, the analyzer may start up when a key is accidentally pressed during maintenance. 9.30 Operator’s Manual MEK-6510 9. MAINTENANCE 4. Remove the three screws on the right side panel. 5. Pull the right side panel toward you to remove it. Pump tube 6. Check the pump tube for water droplets and leaks. If any droplet or leak is found, replace the tube with a new one by doing the following procedure. 7. Flip the pump cover and pull it towards you to expose the pump unit. 9 Pump cover Tube holder White Black 8. Pull out the white tube joint from the tube holder and pull out the pump tube by turning the pump rotator counterclockwise. Then pull the black tube joint out of the tube holder. Pump rotator 9. Remove the white and black tube joints and replace the pump tube. White Tube holder 10. Return the white tube joint to the original position and push the pump tube into the tube guide by turning the rotator counterclockwise. Pump rotator Tube guide Pump tube Operator’s Manual MEK-6510 9.31 9. MAINTENANCE 11. Return the black tube joint to the original position. Tube holder Black White Pump rotator NOTE • Be careful not to pinch the new pump tube between the tube guide and housing. This may damage the pump tube. • Do not attach the black tube joint to the tube holder before the white tube joint because internal compressed air may disconnect the tube. • Put back the pump tube properly. If the pump tube has slack, remove the slack by turning the rotator clockwise. If the pump tube has slack, it will be damaged by the tube guide. 12. Check that the pump tube is not twisted and return the pump cover to the original position. NOTE If the pump tube is twisted, release the twist by turning the tube joint. Otherwise the tube may break in a short time. Cutout of the tube joint The tube joint has two or six cutouts. The cutout can face in any direction. Tube 13. Reattach the right side cover and fasten it with the three screws on the rear panel and one screw on the right side panel. 14. Press the [Power] key to turn on the power. The analyzer starts priming the fluid pathway. 15. If the pump tube is replaced, the pump tube counter must be reset. To reset the counter, press the RESET key for <Pump tube> on the OPER HISTORY screen to reset the counts to zero. 16. Fill in the Maintenance Check Sheet. 17. Measure background noise at least twice. 18. Run quality controls before running patient samples. 9.32 Operator’s Manual MEK-6510 9. MAINTENANCE As-Required Maintenance Procedures Removing a Clog from the Aperture When the “CLOG” alarm occurs, remove the clog by the following procedure. 1. Press the OPERATIONS key on the MENU screen to display the OPERATIONS screen. 9 2. Press the REMOVE CLOG key on the OPERATIONS screen. The confirmation message appears. 3. Press the YES key to remove the clog from the aperture. The analyzer starts removing the clog and the “Removing clog” message appears on the screen. Press the NO key to cancel the procedure. After removing the clog, the screen returns to the OPERATIONS screen. Operator’s Manual MEK-6510 9.33 9. MAINTENANCE Cleaning Aperture Caps Materials Required • • • • • Powder-free gloves, lab coat, safety goggles Phillips and flat-blade screwdrivers Dry cloth or tissue paper CLEANAC•3 detergent Microscope Procedures For daily cleaning of the aperture caps, press the [ panel. Clean] key on the front However, if the “CLOG” message frequently appears or the background count is high, clean the aperture caps as directed in the following procedure. NOTE The aperture caps are behind the measurement baths. 1. Press the STRONG CLEAN key on the OPERATIONS screen to perform strong cleaning. Refer to “Before Maintenance Procedure” earlier in this section. 2. Remove the diluent tube from the ISO3 diluent inlet, cleanac tube 8 from the CLN3 inlet and the hemolysing reagent tube from the HEMO3N inlet on the right side panel. 3. Remove the detergent tube from the CLEANAC detergent container and put it into the waste container. Do not disconnect the waste fluid tube from the WASTE outlet. NOTE Waste comes out from the CLN inlet when DRAIN ALL is performed. Wate container 4. Press the DRAIN ALL key on the OPERATIONS screen. 9.34 Operator’s Manual MEK-6510 9. MAINTENANCE A confirmation message appears on the screen. 9 5. Press YES to start draining the analyzer. NOTE Be sure all reagent has drained into the container. Failure to do so may result in a liquid spill. 6. After draining, press the [Power] key while holding down the [Reset] key to turn the power off. Check that the power lamp is off. NOTE Make sure that the power is turned off. If the power is on, the analyzer may start up when a key is accidentally pressed during maintenance. 7. Remove the three screws on the right side panel. 8. Pull the right side panel toward you to remove it. 9. Remove the screw on the HGB cover and remove the HGB cover. HGB cover Operator’s Manual MEK-6510 9.35 9. MAINTENANCE 10. Remove the tube joint connected to the WBC measurement bath by turning the knurl joint. 11. Loosen the screws fastening the measurement baths. (The screws cannot be removed from the measurement baths.) 12. Remove the measurement baths by pulling them toward you to remove them from the aperture and then pulling them downward. If necessary, remove filter joints on the RBC and WBC measurement bath assemblies by turning the tube connectors. WBC meas bath Tube joint Screws 13. Place a cloth or tissue paper under your hand and remove the aperture cap by pulling it toward you. If it is not easy to pull the aperture cap, move it slowly left and right to remove it. Aperture cap Detection hole 14. Carefully rinse the aperture cap. Remove all protein build-up in the detection hole of the aperture cap. If a clog or dust still remains in the detection hole, soak the aperture cap in CLEANAC•3 detergent for about an hour. Aperture cap Red O-ring Black O-ring Concave Analyzer Do not push the center to attach the aperture caps. NOTE Handle the aperture cap with care. The detection hole can be damaged easily if a sharp object such as a needle is used to clean the inside of the hole. 15. Rinse the aperture caps with water and replace them in the original positions. Make sure that the concave part is facing the hole (analyzer side). NOTE When replacing the aperture cap, do not push the center of it with your fingers. The aperture cap may break. 9.36 Operator’s Manual MEK-6510 9. MAINTENANCE 16. Reattach the measurement baths so that the sub bath is in the measurement bath, the shaft of the sub bath is in the tab of the measurement bath, and the round indent of the measurement bath fits the aperture. Shaft Aperture Tab Round indent 17. Tighten the screws which were loosened in step 11 to fasten the measurement baths. NOTE Before tightening the screws, check and remove any dirt or rust on and around the screws. If dirt or rust is present, noise alarm may occur during measurement. Reconnect the filter joints to the RBC and WBC measurement bath assemblies by turning the tube connectors if they were removed in step 12. 18. Reattach the tube joint to the WBC measurement bath by turning the knurl joint. 19. Reattach the HGB cover and fasten it with the screw. WBC meas bath Tube Tube joint 20. Reattach the right side cover and fasten it with the three screws on the rear panel and one screw on the right side panel. 21. Press the [Power] key to turn on the power. The analyzer starts priming the fluid pathway. 22. Fill in the Maintenance Check Sheet. 23. Measure background noise at least twice. 24. Run quality controls before running patient samples. Operator’s Manual MEK-6510 9.37 9 9. MAINTENANCE Checking the Prime Function This function fills the fluid path inside the analyzer with diluent. 1. Press the OPERATIONS key on the MENU screen to display the OPERATIONS screen. 2. Press the PRIME key. The “Prime?” confirmation message appears. 3. Press the YES key to prime. The analyzer automatically checks the reagent and starts priming. Press the NO key to cancel the procedure. The screen returns to the OPERATIONS screen. During priming, the screen shows the “Priming” message. After priming is completed, the screen returns to the READY screen. Checking the Drain Function Refer to “Before Maintenance Procedure” earlier in this section. Checking the Cleaning Function Press the [ Clean] key on the front panel to check the cleaning function. After cleaning, the screen returns to the READY screen. For checking the strong cleaning function, refer to “Before Maintenance Procedure” earlier in this section. Checking the Circuit You can check the analyzer’s electrical circuit. 1. Press the OTHER key on the MENU screen. 9.38 Operator’s Manual MEK-6510 9. MAINTENANCE 2. Press the CIRCUIT CHECK key on the OTHER screen. The analyzer starts checking the circuit and the screen shows the “Checking circuit” message. When the check is completed, the result appears. 9 3. Check that the results are in the following ranges. Normal range WBC: 7.6 to 8.4 (103/µL) RBC: 1.52 to 1.68 (106/µL) MCV: 85 to 115 (fL) PLT: 152 to 168 (103/µL) HGB ON: 1.5 V to 4.5 V HGB OFF: less than 0.5 V • If the HGB value is outside the normal range, clean the WBC measurement bath and recheck the circuit. • If a check result is outside the normal range, contact your Nihon Kohden representative. • Also check the sensitivity and threshold setting and write down the settings in the maintenance check sheet. 4. Press the OK key to return to the OTHER screen. 5. Press the OK key to return to the MENU screen. Operator’s Manual MEK-6510 9.39 9. MAINTENANCE Checking the Sensor Monitor Screen You can view the power voltage for the sensors in real-time on the SENSOR MONITOR screen. Use this function when an error is found in the analyzer. 1. Press the OTHER key on the MENU screen to display the OTHER screen. 2. Press the SENSOR MONITOR key on the OTHER screen. The SENSOR MONITOR screen appears listing the output voltage of each sensor. 1 2 3 4 5, 11 6, 12 7, 13 8, 14 9, 15 10, 16 17 18 19 9.40 Operator’s Manual MEK-6510 9. MAINTENANCE 3. Check that the results are in the following ranges. Normal range <Electrode> 1. HGB LED On: 1.5 to 4.5 V 2. HGB LED Off: <0.5 V 3. WBC: 17.8 to 18.8 V 4. RBC: 17.8 to 18.8 V <Mano/Reagent> Without reagent (when reagents are not connected) 5. WBC manometer upper: >3.5 V 6. WBC manometer lower: >3.5 V 7. RBC manometer upper: >3.5 V 8. RBC manometer lower: >3.5 V 9. Diluent: >3.5 V 10. Lysing reagent: >3.5 V With reagent (when reagents are connected) 11. WBC manometer upper: <1.5 V 12. WBC manometer lower: <1.5 V 13. RBC manometer upper: <1.5 V 14. RBC manometer lower: <1.5 V 15. Diluent: <1.5 V 16. Lysing reagent: <1.5 V <Temperature> 17. HGB unit: (any value is OK as long as no alarm is displayed) 18. MC unit: (any value is OK as long as no alarm is displayed) 19. Power board: (any value is OK as long as no alarm is displayed) 9 If a check result is outside the normal range, contact your Nihon Kohden representative. 4. Press the OK key to return to the OTHER screen. Checking the External Instruments Function Printers Check the printer function. Check that data is printed properly and that the print is not faint and no dots missing. Hand-held Bar Code Reader Read a sample ID bar code label with the hand-held bar code reader and check that the correct ID appears on the READY screen. PC Send a sample data to PC and check that the data is properly received by the PC. Operator’s Manual MEK-6510 9.41 9. MAINTENANCE Decontamination Protocol Decontaminate the analyzer by rinsing the fluid path with a 0.5% sodium hypochlorite solution. The surfaces of the analyzer should be wiped with a non-abrasive detergent solution to remove any soiling, then wiped with a tuberculocidal disinfectant, such as 0.5% sodium hypochlorite solution. To calculate the percent (%) sodium hypochlorite concentration desired see the following formula: A = Percent (%) of sodium hypochlorite solution desired B = Percent (%) of sodium hypochlorite stock solution (as purchased) X = Parts of water to be mixed with one part of the sodium hypochlorite stock solution X= B–A A Example: If you need a 0.5% sodium hypochlorite solution for a cleaning procedure, and the label on the bottle of bleach states that it is 5.25% sodium hypochlorite, then: X= 5.25–0.5 0.5 X = 9.5 Add 9.5 parts deionized water to 1 part bleach to obtain a 0.5% sodium hypochlorite solution, or 9.5 mL of deionized water to 1.0 mL of bleach (5.25% sodium hypochlorite) to obtain 10.5 mL of a 0.5% solution of sodium hypochlorite. Before servicing by Nihon Kohden representative, the following Decontamination Protocol must be performed by the relevant qualified laboratory personnel. Failure to perform this protocol may result in the analyzer not being serviced. CAUTION During this procedure, normal precautions regarding the handling of biologically hazardous material must be observed. 9.42 Operator’s Manual MEK-6510 9. MAINTENANCE Procedure 1. Press the OPERATIONS key on the MENU screen to display the OPERATIONS screen. 2. Press the STRONG CLEAN key on the OPERATIONS screen. The confirmation message appears. 9 3. Press the YES key to perform strong cleaning. The analyzer starts cleaning and the “Strong cleaning” message appears on the screen. When cleaning is complete, the screen returns to the READY screen. 4. Wipe down all analyzer surfaces with 0.5% sodium hypochlorite solution. 5. Wipe the analyzer surface with a soft cloth moistened with tap water. Wring out the cloth thoroughly. When transporting or shipping the analyzer, follow the procedure in “Storing and Transporting the Analyzer” later in this section. Operator’s Manual MEK-6510 9.43 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: 9.44 Operator’s Manual MEK-6510 9. MAINTENANCE Storing and Transporting the Analyzer CAUTION Before moving the analyzer, turn off the analyzer main power and remove the AC power cord from the outlet. Otherwise, the operator may receive electrical shock. Preparing the Analyzer for Long Term Storage or Transport NOTE If the analyzer is not cleaned before a long period of inactivity, the inside of the analyzer may be tainted by germs or crystallized diluent and this increases background noise. Before transporting or storing the analyzer for a long period of time, clean it by the following procedure. 1. Press the OPERATIONS key on the MENU screen to display the OPERATIONS screen. 2. Press the STRONG CLEAN key on the OPERATIONS screen. The confirmation message appears. 3. Press the YES key to perform strong cleaning. The analyzer starts cleaning and the “Strong cleaning” message appears on the screen. When cleaning is completed, the screen returns to the READY screen. Operator’s Manual MEK-6510 9.45 9 9. MAINTENANCE 4. Press the MENU key on the READY screen and then press the OPERATIONS key on the MENU screen. 5. Press the DRAIN ALL key on the OPERATIONS screen. A confirmation message appears on the screen. 6. Press YES to start draining. If you press NO, the process is canceled and the screen returns to the OPERATIONS screen. During draining, the screen shows the “Draining” message. 7. After draining is complete, connect the spare tubes to the ISO3, CLN, CLN3 and HEMO3N inlets and put the other ends of the tubes into a container filled with 500 mL of distilled water. (The optional YZ-0252 cleaning bottle kit is available for easy setup.) NOTE Make sure that all tubes are fully submerged in the distilled water. Cleaning bottle kit (YZ-0252) Waste container 8. Press the [ Clean] key on the front panel to clean with the distilled water. 9. Repeat steps 5 to 6. 10. Press the [Main power] switch on the rear panel to turn the main power off. 11. Wipe down the analyzer surfaces with a non-abrasive detergent solution then with a 0.5% sodium hypochlorite solution. 12. Wipe the analyzer surface with a soft cloth moistened with tap water. Wring out the cloth thoroughly. 9.46 Operator’s Manual MEK-6510 9. MAINTENANCE Using the Analyzer after Storage NOTE After long term storage (more than 2 weeks), the pump tube may need to be replaced or the fluid path may be dirty. Perform the following procedures before using the analyzer. 1. Clean the aperture caps by following the procedure in the “Cleaning Aperture Caps” earlier in this section. 2. Set up the analyzer and turn the power on. Refer to Section 2 “Preparation”. After automatic draining and priming, the READY screen appears. 3. Clean the inside of the analyzer by pressing the PRIME ON INSTALL key on the OPERATIONS screen. 9 4. Press the YES key to prime. The analyzer automatically checks the reagent and starts priming. Press the NO key to cancel the procedure. The screen returns to the OPERATIONS screen. During priming, the screen shows the “Priming” message. After priming is completed, the screen returns to the READY screen. 5. Check the daily accuracy. Refer to “Checking Daily Accuracy” in Section 2. Operator’s Manual MEK-6510 9.47 9. MAINTENANCE Preparing the Analyzer for Short Term Transport 1. Press the DRAIN BATHS key on the OPERATIONS screen to drain the measurement baths and sub baths. Refer to “Before Maintenance Procedure” earlier in this section. 2. Press the [Main power] switch on the rear panel to turn off the analyzer. 9.48 Operator’s Manual MEK-6510 Section 10 Reference Operation Theory................................................................................................................................................ 10.2 Electric Cell Counting............................................................................................................................... 10.2 Counting Method............................................................................................................................ 10.2 Red Blood Cell and Platelet Counting............................................................................................ 10.3 Principle of Hydraulic Operation............................................................................................................... 10.3 Hemoglobin Measurement....................................................................................................................... 10.4 Chemical Processing..................................................................................................................... 10.4 Spectrophotometric Measurement Method.................................................................................... 10.4 Hemoglobin Conversion Table (g/dL ↔ %SAHLI).............................................................................................. 10.5 RS-232C Data Transfer...................................................................................................................................... 10.6 General..................................................................................................................................................... 10.6 Connecting PC......................................................................................................................................... 10.6 Socket Pin Assignment....................................................................................................................................... 10.9 ZK-820V Bar Code Reader Socket.......................................................................................................... 10.9 Serial Port 1/Serial Port 2......................................................................................................................... 10.9 Printer Socket........................................................................................................................................... 10.9 USB Socket............................................................................................................................................ 10.10 Bar Codes for Using Hand-held Bar Code Reader........................................................................................... 10.11 Using Bar Codes.................................................................................................................................... 10.11 Changing the Settings............................................................................................................................ 10.12 Bar Code Setup Menu............................................................................................................................ 10.13 Interference Substances................................................................................................................................... 10.24 Data and Symbol Display................................................................................................................................. 10.27 Specifications................................................................................................................................................... 10.29 Measured Parameters, Ranges and Reproducibility to Specimen from Venous Blood.......................... 10.29 Standardization Analysis Method........................................................................................................... 10.29 Counting Time........................................................................................................................................ 10.30 Dilution Ratio.......................................................................................................................................... 10.30 Safety..................................................................................................................................................... 10.30 Electromagnetic Compatibility................................................................................................................ 10.30 Environmental Conditions...................................................................................................................... 10.31 Power Requirements.............................................................................................................................. 10.31 Dimensions and Weight.......................................................................................................................... 10.31 Standard Accessories...................................................................................................................................... 10.32 Options............................................................................................................................................................. 10.34 Consumables.................................................................................................................................................... 10.36 Operator’s Manual MEK-6510 10.1 10 10. REFERENCE Operation Theory Electric Cell Counting Counting Method The hematology analyzer 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 screen. 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. 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. 10.2 Operator’s Manual MEK-6510 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 10 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 hematology analyzer 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 screen. Operator’s Manual MEK-6510 10.3 10. REFERENCE 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. 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. In this hematology analyzer, 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 measurement, the sample and diluent are drained from the hematology analyzer. 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. Hemoglobin absorption characteristics Absorbance (0.D) 0.5 Cyanmethemoglobin Non-cyan surfactant Oxidized hemoglobin 500 10.4 520 540 560 580 Wavelength (nm) Operator’s Manual MEK-6510 10. REFERENCE Hemoglobin Conversion Table (g/dL ↔ %SAHLI) The analyzer 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 5.1 5.2 5.3 5.4 5.5 5.6 5.7 5.8 5.9 6.0 6.1 6.2 6.3 6.4 6.5 6.6 6.7 6.8 6.9 31.3 31.9 32.5 33.1 33.8 34.4 35.0 35.6 36.3 36.9 37.5 38.1 38.8 39.4 40.0 40.6 41.3 41.9 42.5 43.1 7.0 7.1 7.2 7.3 7.4 7.5 7.6 7.7 7.8 7.9 8.0 8.1 8.2 8.3 8.4 8.5 8.6 8.7 8.8 8.9 43.8 44.4 45.0 45.6 46.3 46.9 47.5 48.1 48.8 49.4 50.0 50.6 51.3 51.9 52.5 53.1 53.8 54.4 55.0 55.6 9.0 9.1 9.2 9.3 9.4 9.5 9.6 9.7 9.8 9.9 10.0 10.1 10.2 10.3 10.4 10.5 10.6 10.7 10.8 10.9 56.3 56.9 57.5 58.1 58.8 59.4 60.0 60.6 61.3 61.9 62.5 63.1 63.8 64.4 65.0 65.6 66.3 66.9 67.5 68.1 11.0 11.1 11.2 11.3 11.4 11.5 11.6 11.7 11.8 11.9 12.0 12.1 12.2 12.3 12.4 12.5 12.6 12.7 12.8 12.9 68.8 69.4 70.0 70.6 71.3 71.9 72.5 73.1 73.8 74.4 75.0 75.6 76.3 76.9 77.5 78.1 78.8 79.4 80.0 80.6 13.0 13.1 13.2 13.3 13.4 13.5 13.6 13.7 13.8 13.9 14.0 14.1 14.2 14.3 14.4 14.5 14.6 14.7 14.8 14.9 81.3 81.9 82.5 83.1 83.8 84.4 85.0 85.6 86.3 86.9 87.5 88.1 88.8 89.4 90.0 90.6 91.3 91.9 92.5 93.1 15.0 15.1 15.2 15.3 15.4 15.5 15.6 15.7 15.8 15.9 16.0 16.1 16.2 16.3 16.4 16.5 16.6 16.7 16.8 16.9 93.8 94.4 95.0 95.6 96.3 96.9 97.5 98.1 98.8 99.4 100.0 100.6 101.3 101.9 102.5 103.1 103.8 104.4 105.0 105.6 17.0 17.1 17.2 17.3 17.4 17.5 17.6 17.7 17.8 17.9 18.0 18.1 18.2 18.3 18.4 18.5 18.6 18.7 18.8 18.9 106.3 106.9 107.5 108.1 108.8 109.4 110.0 110.6 111.3 111.9 112.5 113.1 113.8 114.4 115.0 115.6 116.3 116.9 117.5 118.1 19.0 19.1 19.2 19.3 19.4 19.5 19.6 19.7 19.8 19.9 20.0 20.1 20.2 20.3 20.4 20.5 20.6 20.7 20.8 20.9 118.8 119.4 120.0 120.6 121.3 121.9 122.5 123.1 123.8 124.4 125.0 125.6 126.3 126.9 127.5 128.1 128.8 129.4 130.0 130.6 Operator’s Manual MEK-6510 10.5 10 10. REFERENCE RS-232C Data Transfer General Sample data can be transferred to the optional printer or a personal computer via the serial ports on the rear panel of the analyzer. This allows you to print or search specific data or perform the statistical work. Sample data can be automatically transferred after each counting. CAUTION Connect only the specified instruments to the connectors or sockets on the analyzer by following the specified procedure. Otherwise electrical leakage current may harm the operator. NOTE • Only connect a PC which complies with IEC 60950. • Only use a 3-prong power cord for the PC. Use the following cables or similar for connecting PC to the serial port on the analyzer. • YZ-0318 D9-D25 cable • YZ-0323 D9-D9 cable Connecting PC Use the serial port 1 on the analyzer to connect a PC. Wiring MEK-6510J/K Serial port D-sub connector 9 pins (female) NC 1 RxD 2 TxD 3 DTR 4 GND 5 DSR 6 RTS 7 CTS 8 NC 9 10.6 PC D-sub 9 pins (female) 1 2 3 4 5 6 7 8 9 NC RxD TxD DTR GND DSR RTS CTS NC Operator’s Manual MEK-6510 10. REFERENCE Settings on MEK-6510J/K Change the following settings for the serial port 1. Refer to “Changing Output Format” in Section 3. • • • • • • • • • Format: Other Parameters: 18 Date format: YY/MMM/DD ID digits: 13 Output histograms: No Baud rate: 9600 Data bits: 8 Parity: Even Stop bits: 1 Data Transfer Format • Data transfer starts from 02 (STX: Start of text) and ends with 03 (ETX: End of text) • Transferring order 1. Date (year, month, day) 2. ID number 3. Parameter data WBC, LY%, MO%, GR%, LY, MO, GR, RBC, HGB, HCT, MCV, MCH, MCHC, RDW-CV, PLT, PCT, MPV, PDW • Each data is separated by 0D (CR) • ASCII code Format Example • Measured value is composed by 4 bytes of value (including decimal), 2 bytes of abnormal information and 1 byte of line break. For example, when MCV: 90.1 Value 39 30 2E 31 Abnormal information 20 20 Line break 0D • When the measured value is outside the normal range (H: above upper limit, L: below lower limit) MCV: 102H Value 20 31 30 32 Abnormal information 48 20 Line break 0D (For MCV, decimals are indicated when MCV is below 100, omitted when over 100) • When a flag appears WBC: 100F1 Value 20 Operator’s Manual MEK-6510 31 30 30 Abnormal information 46 31 Line break 0D 10.7 10 10. REFERENCE • When outside measuring range WBC: OVER Value 4F 56 45 52 Abnormal information 20 20 Line break 0D • Transfer format example Measured Data Transferred Data <Start> 02 06/01/31 0001 (Date) 30 36 2F 20 31 2F 33 31 0D 0A 20 20 20 20 20 20 20 20 20 30 30 30 31 0D 7.5 (ID) (WBC) 30.5 (LY%) 33 30 2E 35 20 20 0D 5.0 64.5 (MO%) 20 35 2E 30 20 20 0D 36 34 2E 35 20 20 0D 2.3 0.4 20 37 2E 35 20 20 0D (GR%) (LY) 20 32 2E 33 20 20 0D 20 20 2E 34 20 20 0D 4.8 (MO) (GR) 4.45 (RBC) 20 34 2E 34 35 20 0D 13.6 40.2 (HGB) 31 33 2E 36 20 20 0D 34 30 2E 32 20 20 0D 90.1 30.6 33.8 27.3 0.21 7.6 17.9 20 34 2E 38 20 20 0D (HCT) (MCV) 39 30 2E 31 20 20 0D (MCH) 33 30 2E 36 20 20 0D 33 33 2E 38 20 20 0D 32 37 2E 33 20 20 0D (MCHC) (PLT) (PCT) 20 20 2E 32 31 20 0D 20 37 2E 36 20 20 0D 31 37 2E 39 20 20 0D (MPV) (PDW) <End> 03 Abnormal mark Abnormal mark shows following error. Item Mark H All L ? ! WBC F1 C RBC ? ! HGB ? * MCHC ! ? C PLT * ! F1 LY% F2 F2 MO% F3 F3 GR% F4 10.8 Description Above normal range Below normal range WBC sample error Poor hemolyzation F1 flag (Too many RBC ghosts) PLT clumps RBC sample error HGB voltage high HGB voltage low HGB circuit error, WBC over RBC sample error, abnormal MCHC RBC sample error PLT clumps PLT low value (below 50,000/μL) Background noise is increased. Too many RBC ghosts Poor lymphocyte discrimination Poor lymphocyte discrimination Poor granulocyte discrimination Poor granulocyte discrimination Poor lymphocyte, monocyte and granulocyte discriminations Operator’s Manual MEK-6510 10. REFERENCE Socket Pin Assignment CAUTION Connect only the specified instrument to the analyzer and follow the specified procedure. Failure to follow this instruction may result in electrical shock or injury to the operator, and cause fire or instrument malfunction. ZK-820V Bar Code Reader Socket D-sub 9 pins (male) 1 6 9 5 Pin No. 1 2 3 Signal FG TxD RxD Pin No. 4 5 6 Signal DSR GND (SG) DTR Pin No. 7 8 9 Signal CTS RTS VCC* * VCC: DC 5 V Serial Port 1/Serial Port 2 1 6 9 5 D-sub 9 pins (male) Pin No. 1 2 3 Signal FG TxD RxD Pin No. 4 5 6 Signal DSR GND (SG) DTR Pin No. 7 8 9 Signal CTS RTS NC Pin No. 10 11 12 13 14 15 16 17 18 Signal NC NC NC NC NC NC NC NC NC Pin No. 19 20 21 22 23 24 25 Signal NC DTR NC NC NC NC NC 1 6 9 5 Printer Socket 13 25 14 1 Operator’s Manual MEK-6510 D-sub 25 pins (female) Pin No. 1 2 3 4 5 6 7 8 9 Signal NC TxD RxD RTS CTS DSR GND (SG) NC NC 10.9 10 10. REFERENCE USB Socket D-sub 9 pins (male) 1 2 10.10 4 3 Pin No. 1 2 3 4 Signal NG USB-D+ USB-D– ED Operator’s Manual MEK-6510 10. REFERENCE Bar Codes for Using Hand-held Bar Code Reader Using Bar Codes WB NB WS NS A bar code consists of narrow bars (NB), wide bars (WB), narrow spaces (NS) and wide spaces (WS). The width of the WB and WS depends on the width of the NB. The ratio between NB and WB is NB:WB = NS:WS = 1:2 to 1.3. Usually, it is 1:2.5. When using the optional hand-held bar code reader (Keyence BL-N60RK or equivalent), the bar code label of the sample can be read by the bar code reader and this code is entered as the sample ID. NOTE • ID can only be entered up to 13 digits. When the bar code has more than 13 digits, the ID cannot be entered. • When CODABAR (NW-7) is used for the bar code type, a letter from “a”, “b”, “c” and “d” is assigned to the beginning and end of the ID. When there are more than 13 digits in the ID because of these start/ stop characters or when you do not want these letters to be included in the sample ID, read “Do not send” bar code. Refer to the “Changing Settings” section. • When using the ITF bar code type, IDs may be frequently misread by the bar code reader when compared to the other types of bar codes, especially when the printing quality of the label is poor. Be careful not to mix up samples when using ITF bar codes. For the bar code to be read properly by the bar code reader, attach the bar code label to the sample tube checking the following points. (Refer to the illustration below.) • The bar code label length must be within 60 mm. • NB must be wider than 0.125 mm. • The bar code width must be 35 mm. • The left and right margins must be the same size and 10 times larger than NB. bar code label length bar code width margin start character Operator’s Manual MEK-6510 data check digit margin stop character 10.11 10 10. REFERENCE If the bar code cannot be read properly by the bar code reader, check the following points. • Bar code is dirty or damaged • Margin on the bar code is too small • Bar code print is faint • Bar code is printed in silver or is covered by laminate film • The printing quality of the bar code is poor (The printing quality is poor especially when printed on a dot printer or ink jet printer. When printing on such a printer, NB must be as wide as possible. If the bar code type is JAN or CODE128, code may not be read properly.) • The appropriate bar code type or check digit type is not set on the bar code reader. Changing the Settings To change the setting of the BL-N60RK bar code reader, use the following procedure. The setting are saved in an EEPROM. 1. With the bar code reader, read the three bar codes of “Start setting” from top to bottom within 15 seconds of turning the bar code reader power on. The beeper sounds five times to indicate that the bar code reader has entered the setup mode. 2. Read all necessary parameter bar codes of the items to be set (see p. 10.13 or later). NOTE The factory setting is indicated with < >. 3. When setting is complete, read the “Complete setting” bar code. The settings are saved in an EEPROM to exit the setup mode (The beeper sounds five times, indicating completion of this procedure.). 4. After the settings are completed, turn off the bar code reader. 5. Reading the “Initialize” bar code (on p. 10.13) in the setup mode will reset the bar code reader to the factory settings. 6. Reading “Cancel setting” bar code (on p. 10.13) cancels any changes and resets to the settings prior to entering the setup mode. Example To change the settings to not read ITF code: 1. Within 15 seconds of turning on the bar code reader, read the three bar codes in the “Start setting” (on p. 10.13) from top to bottom. Beepers sounds five times. 2. Read the “OFF” of ITF on p. 10.13. 3. Read the “Complete setting” bar code. 4. Turn off the bar code reader to complete the settings. 10.12 Operator’s Manual MEK-6510 10. REFERENCE Bar Code Setup Menu Start Setting and Complete Setting Codes 1 Initialize 2 Complete setting 3 Start setting Cancel Settings for bar codes Bar code type setting 10 Operator’s Manual MEK-6510 10.13 10. REFERENCE UPC Setting details CODABAR Setting details Setting procedure 1. Read the “Minimum/Maximum code length setting” bar code. 2. Set the desired code length ranging from 01 to 99 in 2 decimal digits using “Hexadecimal digit setting bar code” (See p. 10.23). (The code length does not include the start/stop characters.) Example • To set 8 digits, read bar codes in the order of “0” and “8”. • To set 12 digits, read bar codes in the order of “1” and “2”. 3. Read the “SET” bar code to save the settings. If the “CANCEL” bar code is read, the settings are canceled. Go back to step 1 and do this procedure again to set the code length. 10.14 Operator’s Manual MEK-6510 10. REFERENCE CODE39 Setting details 10 Setting procedure Refer to the “CODABAR Setting details” for the setting procedure. ITF Setting details Setting procedure Refer to the “CODABAR Setting details” for the setting procedure. Operator’s Manual MEK-6510 10.15 10. REFERENCE Industrial 2 of 5/IATA Setting details Setting procedure Refer to the “CODABAR Setting details” for the setting procedure. CODE93/CODE128 Setting details Setting procedure Refer to the “CODABAR Setting details” for the setting procedure. 10.16 Operator’s Manual MEK-6510 10. REFERENCE Function setting Selection of trigger switch operation mode 10 Beeper and LED setting Operator’s Manual MEK-6510 10.17 10. REFERENCE Data format setting Header setting You can select a header from [STX] and [ESC]. You do not have to use a header. When you want to set other character than above, use the following procedure (You can also set the desired header with one character.). Setting procedure 1. Read the “Header settings” bar code. 2. Set one ASCII code (2 digits in hexadecimal) corresponding to the desired character, by referring to the “Hexadecimal digits setting bar code” (See p. 10.23). Example • To set “3” (ASCII code “33”), read bar codes in the order of “3” and “3”. • To set “E” (ASCII code “45”), read bar codes in the order of “4” and “5”. 3. Read the “SET” bar code to save the settings. If the “CANCEL” bar code is read, the settings are canceled. Go back to step 1 and do this procedure again to set the header. 10.18 Operator’s Manual MEK-6510 10. REFERENCE Terminator settings Read the two desired terminator codes from top to bottom. You can select a terminator from [ETX], [CR], [LF], [EOT] and [CR][LF]. You do not have to use a terminator. 10 You can also set the desired terminator with one or two characters. To do this, use the following procedure. Setting procedure 1. Read the “First character setting for terminator” bar code. 2. Set one ASCII code (2 digits in hexadecimal) corresponding to the desired character, by referring to the “Hexadecimal digits setting bar code” (See p. 10.23). Example • To set “3” (ASCII code “33”), read bar codes in the order of “3” and “3”. • To set “E” (ASCII code “45”), read bar codes in the order of “4” and “5”. Reading “0” and “0” sets the terminator to nothing. 3. Read the “SET” bar code to save the settings. If the “CANCEL” bar code is read, the settings are canceled. Go back to step 1 and do the procedure again to set the first character for terminator. 4. Read the “Second character setting for terminator” bar code. 5. Set one ASCII code (2 digits in hexadecimal) corresponding to the desired character, using the “Hexadecimal digits setting bar code” (See p. 10.23). When setting only one character as a terminator, read “0” and “0”. 6. Read the “SET” code. If the “CANCEL” bar code is read, the settings are canceled. Do steps from 4 to 6 again to set the second character for terminator. Operator’s Manual MEK-6510 10.19 10. REFERENCE Adding the number of digits The number of readout bar code digits is added. When using the JAN/EAN/UPC type, this number is not added. Adding the identification code indicating the code type An identification code can be added to indicate the reading bar code type. Bar code type JAN/EAN-13 JAN/EAN-8 UPC-A UPC-E CODABAR CODE39 ITF Industrial 2 of 5, IATA CODE93 CODE128 10.20 Identification code A F FF A E N M I H L K Identification code B 4 4 4 4 3 0 1 2 8 5 Identification code C E E E E F A I S G C Operator’s Manual MEK-6510 10. REFERENCE When setting the desired identification code type, use the following procedure. 10 Setting procedure 1. Read the desired “Identification code” type. 2. Set one ASCII code (2 digits in hexadecimal) corresponding to the desired character, by referring to the “Hexadecimal digits setting bar code” (See p. 10.23). Example • To set “3” (ASCII code “33”), read the bar codes in the order of “3” and “3”. • To set “E” (ASCII code “45”), read the bar codes in the order of “4” and “5”. Reading “0” and “0” deletes the identification code. Reading “0” and “1” adds the two characters “FF”. 3. Read the “SET” bar code to save the settings. If the “CANCEL” bar code is read, the settings are canceled. Go back to step 1 and do this procedure again to set the identification code. Operator’s Manual MEK-6510 10.21 10. REFERENCE Setting for RS-232C Baud rates Data length Stop bit Communication protocol 10.22 Operator’s Manual MEK-6510 10. REFERENCE Status RTS signal Hexadecimal digits setting bar code (For entering values from 0 to F) Use the hexadecimal digits setting bar code to directly enter numerical values or characters. 10 Operator’s Manual MEK-6510 10.23 10. REFERENCE Interference Substances WBC: RBC: HGB: 10.24 High WBC When WBC count is outside the measurable range, measure the sample in high dilution mode. If the WBC count is still outside the range, dilute the sample further. Nucleated erythrocyte Nucleated erythrocyte is detected as WBC and causes increase in WBC count. 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 patients 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 pregnant or have myeloma, cancer, leukemia, macroglobulinemia, lymphoproliferative disorders, metastatic tumors, autoimmune disorders, infections, aneurysm, 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 cold agglutinin disease may decrease RBC and PLT counts and increase MCV. Hemolysis When RBC is hemolyzed, RBC is decreased. 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 causes 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 lipids. 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. Operator’s Manual MEK-6510 10. REFERENCE 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 levels also become high. HCT: 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. MCV: 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: MCH is determined from HGB and RBC values. Therefore, the limitations for HGB and RBC also affect MCH value. MCHC: MCHC is determined from HGB and HCT values. Therefore, the limitations for HGB and HCT also affect MCHC value. RDW-CV: RDW is determined from RBC value. Therefore, the limitations for RBC also affect RDW-CV value. Agglutinated RBC Agglutinated RBC may decrease RBC count and erroneous RDW-CV. 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-CV. PLT: 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 might 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. MPV: 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 in erroneous MPV. This can be checked by abnormal MCH and MCHC values and examination of the stained blood film. Operator’s Manual MEK-6510 10.25 10 10. REFERENCE Chemotherapy Cytotoxic and immunosuppressive drugs may affect MPV. In such a case, measure manually. NOTE Blood samples collected in EDTA do not maintain stable MPV because platelets swell depending on the interval after collection and storage temperature. WBC differential parameters are derived from the WBC count, therefore, the limitations for WBC also affect these parameters. LY and LY%: Erythroblasts, certain parasites and RBC that are resistant to lysis may interfere with an accurate 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%. EO: Abnormal granules may interfere with an accurate EO count. 10.26 Operator’s Manual MEK-6510 10. REFERENCE Data and Symbol Display The following table shows the relationship between the data classification and display. Classification Data cannot be analyzed Data Display Symbol Display Description None None Data cannot be analyzed. Measurement alarm Abbreviated alarm message (see the table below) None Error found during measurement. Measurement alarm Data displayed “?” beside numeric data Measurement error due to surrounding temperature out of specified range. Measured data is displayed but measurement accuracy is not reliable. None Out of measuring range. Out of measuring “OVER” message range displayed Abnormal flag detected in the sample. Measurement accuracy is not reliable due to abnormal cell. • When WBC flag appears, all WBC parameters are Data with low reliability Data displayed “ * ”, “ ! ” or “C” beside numeric data Out of normal range Data displayed “H” or “L” beside numeric data affected by the abnormal cell. “ * ” is displayed beside the parameter which is greatly affected. • When there is possibility of PLT coagulation, “C” is displayed beside the parameter. • When there is possibility of poor hemolyzation, “ ! ” is displayed beside the parameter. Out of normal range setting. Abbreviated alarm messages Abbreviation Displayed beside Displayed beside WBC data RBC data LEVEL1 LEVEL2 LEVEL3 BBL1 BBL2 BBL3 BBL4 CLOG NOISE2 NOISE1 LEVEL1 LEVEL2 LEVEL3 BBL1 BBL2 BBL3 BBL4 CLOG NOISE2 NOISE1 Operator’s Manual MEK-6510 Code Alarm Message A021 A022 A023 A024 A025 A026 A027 A029 A031 A032 A041 A042 A043 A044 A045 A046 A047 A049 A051 A052 WBC fluid level 1 WBC fluid level 2 WBC fluid level 3 WBC bubble 1 WBC bubble 2 WBC bubble 3 WBC bubble 4 WBC clogged WBC hardware noise WBC software noise RBC fluid level 1 RBC fluid level 2 RBC fluid level 3 RBC bubble 1 RBC bubble 2 RBC bubble 3 RBC bubble 4 RBC clogged RBC hardware noise RBC software noise 10.27 10 10. REFERENCE The following table shows the relationship between the flags and symbols. Flag PLT-RBC Interference PLT Clumps WBC OVER Abnormal MCHC Poor hemolyzation Flag Class. LY% LY# RBC/PLT Other Parameters MO% GR% WBC RBC HGB MO# GR# * C * HCT MCHC PLT * C ! Specimen ! The following table shows the relationship between the alarm messages and symbols. 10.28 Alarm message Code WBC SAMPLE ERROR RBC SAMPLE ERROR HGB VOLTAGE LOW HGB VOLTAGE HIGH HGB CIRCUIT ERROR A030 A050 A061 A062 A063 LY% LY# Parameters MO% GR% WBC RBC HGB HCT MCHC PLT MO# GR# ? ? ? ? ! * Operator’s Manual MEK-6510 10. REFERENCE Specifications Measured Parameters, Ranges and Reproducibility to Specimen from Venous Blood Specifications except WBC population were determined using hematology control blood (MEK-3DN), counted 10 times consecutively. Measured Parameters Blood cell count Hemoglobin concentration Hematocrit Erythrocyte indices WBC RBC PLT Electrical resistance detection HGB Colorimetric method HCT MCV MCH MCHC Calculated from RBC histogram Calculated from RBC, HGB, HCT Measuring Range 0 to 59.9 × 103/µL 0 to 599.9 × 103/µL* 0 to 14.9 × 106/µL 0 to 1490 × 103/µL 0 to 29.9 g/dL 0 to 99.9% 20.0 to 199.0 fL 10 to 50 pg 10 to 50 g/dL LY% Leucocyte hemocyte classification Platelet clit Mean platelet value Red blood cell distribution width Platelet distribution width MO% GR% LY MO Calculated from WBC histogram MPV Calculated from PLT, PCT PDW within 1.5%CV within 4.0%CV within 1.5%CV within 1.0%CV (MCV) within 1.0%CV 10 — within 12.0%CV within 5.0%CV 0 to 59.9 × 103/µL 0 to 599.9 × 103/µL* Calculated from PLT histogram RDW-SD within 2.0%CV within 5.0%CV 0 to 100% GR PCT RDW-CV Reproducibility to Specimen from Venous Blood (CV: Coefficient of Variation) Calculated from RBC histogram Calculated from PLT histogram 0 to 2.9% 0 to 20.0 fL 0 to 50.0% — 0 to 199.0 fL 0 to 50.0% * In panic value recount: 0 to 599 × 103/µL Standardization Analysis Method WBC: ICSH1988 RBC: ICSH1988 HGB: NCCLS H15-A2 HCT: NCCLS H7-A2 PLT: Brecher & Cronkite Method: Operator’s Manual MEK-6510 ICSH: The assignment of values to fresh blood used for calibrating automated blood cell counters. Clin Lab Haematol, 10:203-212, 1988 ICSH: The assignment of values to fresh blood used for calibrating automated blood cell counters. Clin Lab Haematol, 10:203-212, 1988 H15-A2: Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood Second Edition; Approved Standard (1994) H7-A2: Procedure for Determining Packed Cell Volume by the Microhematocrit Method Second Edition; Approved Standard (1993) Morphology and enumeration of human blood platelets, J Appl Physiol 3 365 (Dec) 1950; Brecher G, Cronkite EP 10.29 10. REFERENCE Counting Time about 60 s/sample (from measurement start to data display) Dilution Ratio • Venous blood Sample volume: WBC/HGB: RBC/PLT: • Pre-dilution blood Sample volume: WBC/HGB: RBC/PLT: 30 µL in normal and low dilution modes, about 10 µL in high dilution mode, 5 µL in higher dilution mode 200:1 (in normal dilution mode) 40,000:1 (in normal dilution mode) 10 µL 1200:1 240,000:1 20 µL 600:1 120,000:1 Safety Safety standards: IEC 61010-1: 2001 EN 61010-1: 2001 IEC 61010-2-101: 2002 EN 61010-2-101: 2002 IEC 61010-2-081: 2001 IEC 61326-1: 2005 EN 61326-1: 2005 IEC 61326-2-6: 2005 CISPR11: 2003, Group 1, Class B EN 55011: 2002, Group 1, Class B Type of protection against electrical shock: CLASS I EQUIPMENT Degree of protection against harmful ingress of water: IPX0 (non-protected) 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 Mode of operation: CONTINUOUS OPERATION EQUIPMENT types (classification): Indoor stationary EQUIPMENT Requirements for marking of IN VITRO DIAGNOSTIC instruments: EN 1658: 1996 Electromagnetic Compatibility IEC 61326-1: 2005 EN 61326-1: 2005 IEC 61326-2-6: 2005 EN 61326-2-6: 2006 CISPR11: 2003, Group 1, Class B 10.30 Operator’s Manual MEK-6510 10. REFERENCE Environmental Conditions Storage temperature: Storage humidity: Storage atmospheric pressure: Operating temperature: Operating humidity: Operating atmospheric pressure: −20 to +60˚C (−4 to +140˚F) 10 to 95% (noncondensing) 700 to 1060 hPa 15 to 30˚C (59 to 86˚F) 30 to 85% 700 to 1060 hPa Power Requirements Power requirements: MEK-6510J: MEK-6510K: Power consumption: Cooling system: 110 to 127 V ± 10% AC, 50/60 Hz 220 to 240 V ± 10% AC, 50/60 Hz less than 120 VA Natural cooling Dimensions and Weight Dimensions: 230 W × 450 D × 428 H (mm) Net weight: approx. 20 kg Operator’s Manual MEK-6510 10 10.31 10. REFERENCE Standard Accessories NOTE • Use only Nihon Kohden specified parts and accessories to assure maximum performance from your instrument. • When ordering the following accessories, specify the supply code. When the supply code is not provided with the accessory, specify the model or code number. 1 2 3 4 5 6 7, 9 8 10 11 12 13 14 15 16 17 10.32 Operator’s Manual MEK-6510 10. REFERENCE No. 1 Power cord 2 Ground lead Qty 1 1 Supply Code L912 Code No. Fuse 2.0 A time-lag (for MEK-6500J) 2 338867 2 3 1 1 T802 T462 274026 1 each T409 8 9 10 11 12 13 14 15 Fuse 1.0 A time-lag (for MEK-6500K) Filter assy Pump tube (N) assy, YS-001B1 Sampling nozzle Diluent tube, 1.5 m (marked blue) Detergent tube for CLEANAC, 1.5 m (marked green) Waste tube, 0.4 m (marked red) Cleanac tube 8 for CLEANAC•3, 1.5 m (marked white) 18 L container cap 18 L tube assy 2, YZ-0356 5 L tube assy, YZ-0358 Hemolynac•3 cap (marked yellow), YZ-003B7 Hemolynac•3 tube assy (marked yellow), YK-00004 Waste container (2 L) 1 1 3 1 2 1 1 1 T464A T723A 16 17 2 L waste tube assy MEK cap T469 3 4 5 6 7 Description/Model Operator’s Manual MEK-6510 1 1 T461A T464B T447B T473 10 10.33 10. REFERENCE Options NOTE Use only Nihon Kohden specified options to assure maximum performance from your instrument. WA-650VK Printer Unit Thermal printer. Installed in the analyzer. Prints numeric data and histograms on thermal roll paper. WA-712V Printer (Seiko Epson VP-700 or equivalent, PM-3700C or equivalent, or Canon PIXUS iP4100 or equivalent) Connected to the printer socket on the rear panel of the analyzer. Prints numeric data and histograms on normal paper or continuous paper. WA-461V Card Printer (Seiko Epson TM-U295 or equivalent) POWER RELEASE Connected to the serial port on the rear panel of the analyzer. Prints numerical data on a hematology data card. When using the TM-U295 printer, set the bit switch at the bottom of the printer as follows. PAPER OUT DIP SW 1 1 2 3 4 FORWARD REVERSE RELEASE Settings OFF OFF OFF OFF DIP SW 1 5 6 7 8 Settings ON ON OFF OFF WA-461V Card Printer Specifications Printing method: Shuttle impact dot matrix Power requirements: Operating temperature: Operating humidity: Dimensions: Net weight: +24 V DC 5 to 40°C 30 to 85% 180 W × 190 D × 101 H (mm) approx. 1.6 kg Setting Up the Card Printer 1. Connect the card printer to the serial port 1 or 2 on the analyzer with the YZ-0318 D9-D25 cable which is provided with the card printer. 2. Connect the output power cord of the power supply unit to the DC24V connector of the card printer. Connect the AC power cord to the power supply unit and to the AC outlet. 10.34 Operator’s Manual MEK-6510 10. REFERENCE Printing The card printer stores the data until it is printed. If the data is not printed soon after receiving data, the data displayed on the analyzer and the printed data do not correspond. To delete the stored data in the card printer, turn the card printer power off and then on again. 1. Turn on the card printer. 2. Press the RELEASE key to light the RELEASE LED on the card printer. 3. Insert the data card in the slot with the right side of the card against the guide. Recording starts automatically when the data is received from the analyzer. 4. Take the card from the card printer when printing is complete. Hand-held Bar Code Reader (Keyence BL-N60RK or equivalent) Connected to the bar code socket on the rear panel of the analyzer. Reads the bar code label (up to 13 characters) on the sample tube. The bar code reader can read the following codes: • Industrial 2 of 5 • CODE 39 • ITF • CODE 93 • JAN/EAN/UPC • CODE 128 • CODABAR (NW-7) The power is supplied through pin 9 of the bar code reader socket to the handheld bar code reader. Refer to the “Bar Codes for Using Hand-held Bar Code Reader” earlier in this section and the bar code reader manual for details. Data Management Software This software can be installed in a PC for data communication with the hematology analyzer. You can receive the measured data from a hematology analyzer and edit and print the data on the PC. YZ-0317 D25-amphenol36 Cable For connecting WA-712V printer to the analyzer. YZ-0318 D9-D25 Cable For connecting WA-460V/461V card printer or PC to the analyzer. (Provided with the card printer.) YZ-0320 USB Cable, 0.7 m YZ-0321 USB Cable, 2.0 m For connecting PC to the analyzer through USB. YZ-0323 D9-D9 Cable For connecting PC to the analyzer through RS-232C. Operator’s Manual MEK-6510 10.35 10 10. REFERENCE Consumables NOTE When ordering the following consumables, specify the supply code. When the supply code is not provided with the consumables, specify the model or code number. 1 6 11 2 7 3 4, 5 8 12 9 13 C975 10 14 C962 15 16 17 18 19 20, 21 22, 23 24 25 26 to 29 30 10.36 Operator’s Manual MEK-6510 10. REFERENCE No. 1 2 3 4 5 6 8 9 10 Description/Model Sample container set, MEK-435 Recording paper for WA-650VK, RQW58-2 Diluent ISOTONAC•3, MEK-640 Detergent CLEANAC, MEK-520 Detergent CLEANAC•3, MEK-620 Hemolysing reagent HEMOLYNAC•3N, MEK-680 Hematology control MEK-3DN MEK-3DL MEK-3DH Calibrator for hematology analyzer, MEK-CAL Hemoglobin filter assy set, YZ-0024 Pump tube (N) assy, YS-001B1 11 Hematology data card for WA-460V/461V card printer 12 Hematology data sheet for WA-710V/712V printer, narrow type 2 mL × 3 2 mL × 3 2 mL × 3 1 10 pcs 1 pcs 100 cards × 4 copies 1000 sheets 13 Hematology data sheet for WA-710V/712V printer, wide type 2000 sheets C962 14 Hemolynac3 tube assy, YK-00004 1 T473 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 Cleanac tube 8 (1.5 m) Connection tube (5.0 m) Cleaning bottle kit, YZ-0252 Sampling nozzle (6510) 500 mL tube assy, YZ-0399 5 L CLEANAC tube assy, YZ-0358 18 L tube assy 2, YZ-0356 SD memory card (2GB) SD memory card (1GB) 1 L tube assy, YZ-001B7 Sample cup (5.0 mL), YZ-001B6 Micro cap, DRUMMOND (20 μL) Micro cap, DRUMMOND (10 μL) Mini caps, HIRSCHMANN (20 μL) Mini caps, HIRSCHMANN (10 μL) Cotton swabs 1 1 1 1 1 1 1 1 1 1 500 pcs 100 pcs 100 pcs 100 pcs 100 pcs 100 pcs T464A T463 T414 — T464L T464B T461A Y154E Y154D T464D T857A — — — — — 7 Operator’s Manual MEK-6510 Packing Unit 200 pcs × 5 10 rolls 18 L 5L 5L 500 mL × 3 Supply Code T435 A819B T436D T438 T438D T498 T455 T455L T455H T457 T802 T462 C976 C975 10 10.37