MEK6318 OM

HEMATOLOGY ANALYZER MEK-6318J/K 0614-004583G Model: MEK-6318J/K Manual code no.: 0614-004583G Reader Comment Card We welcome your comments about this manual Your comments and suggestions help us improve our manuals Please circle the number for each of the following statements corresponding to your evaluation and add comments in the space provided Fax or send your completed comment card to: Fax: +81 (3) 5996-8100 International Div., Sales Promotion Section, Nihon Kohden Corp., 1-31-4, Nishiochiai Shinjuku-ku, Tokyo 161-8560, Japan Strongly Agree This manual is organized I can find the information I want The information is accurate I can understand the instructions The illustrations are appropriate and helpful The manual length is appropriate Agree 2 2 2 cutting line Comments: Thank you for your cooperation We appreciate it very much Name: Occupation/Position: Hospital/Company: Address: Phone: Neutral Disagree 3 3 3 4 4 4 Strongly Disagree 5 5 5 CONTENTS Contents GENERAL HANDLING PRECAUTIONS i WARRANTY POLICY ii EMC Related Caution iii Conventions Used in this Manual and Instrument v Warnings, Cautions and Notes v Explanations of the Symbols in this Manual and Instrument vi Section General 1.C1 Introduction 1.1 Measured Parameters 1.2 Features 1.3 Panel Description 1.5 Front Panel and Keys 1.5 Side Panel 1.7 Rear Panel 1.8 Flowchart of Screens 1.9 General Safety Information 1.10 Installation 1.10 Reagents 1.10 Measurement 1.12 Maintenance 1.12 Waste Fluid Treatment (Applies Only when Using Hemolynac•3 Hemolysing Reagent) 1.12 Section Preparation 2.C1 Environmental Requirements 2.1 Caution for Moving the Hematology Analyzer 2.2 Connecting an External Instrument to the Hematology Analyzer 2.3 Connecting a PC 2.4 Connecting a Printer 2.4 Connecting a Card Printer 2.5 Connecting a Handy Bar Code Reader 2.5 Connecting the Power Cord and Grounding the Instrument 2.6 Connecting the Power Cord 2.6 Grounding the Instrument 2.6 Equipotential Grounding 2.6 Connecting Tubes 2.7 Diluent, Detergent and Hemolysing Reagent 2.7 Connecting Tubes 2.9 Diluent Tube 2.10 Detergent Tube 2.10 Hemolysing Reagent Tube 2.11 Waste Fluid Tube 2.11 Operator's Manual MEK-6318J/K C.1 CONTENTS Turning On the Power 2.12 Check Before Turning On the Power 2.12 Turning On the Power 2.12 Check After Turning On the Power 2.13 Loading Recording Paper in the WA-630VK Printer Unit (Option) 2.14 Daily Accuracy Check 2.15 Measuring Background Noise 2.15 Counting the Hematology Control 2.17 Section Changing Settings 3.C1 General 3.1 Assigning an ID to a Sample 3.2 Displaying the ENTER ID Screen 3.2 Entering a 4-digit Numeric ID 3.3 Entering a 13-character Alphanumeric ID 3.3 Setting Normal Range Upper and Lower Limits 3.4 Default Settings of Upper and Lower Limits 3.4 Selecting Single or Double Sample Counting 3.6 Selecting the Capillary Blood Volume 3.7 Setting High Altitude Mode On/Off 3.8 Setting the Date and Time 3.9 Selecting Units 3.10 Counting Unit Table 3.11 Setting the User Units 3.11 Selecting the Histogram Display Format 3.12 Selecting Vertical Axis Type for the Histogram 3.12 Differentiating the Kinds of WBC Histogram 3.12 Changing Sensitivity and Threshold 3.13 General 3.13 Factory Default Settings and Setting Range 3.13 RBC Automatic Threshold 3.13 Using 1/10 Sensitivity 3.13 Changing Sensitivity and Threshold 3.14 Determining Optimum Sensitivity 3.15 Determining Optimum Threshold 3.15 Changing Printing Settings 3.16 Setting Items 3.16 Changing Settings 3.17 Settings for the WA-630VK Printer Unit (Internal Printer) 3.17 Settings for the WA-460V Card Printer 3.18 Settings for the Other External Printers (WA-710V, FUJITSU, EPSON or CANON) 3.19 Changing Communication Settings 3.20 Using the Optional Handy Bar Code Reader 3.22 General 3.22 Changing Settings 3.23 Initializing Settings 3.24 Factory Default Settings 3.25 C.2 Operator's Manual MEK-6318J/K CONTENTS Section Measurement 4.C1 General 4.1 Single and Double Counting 4.1 ID Numbers 4.1 Alarms 4.2 Displaying H and L Out of Range Marks 4.2 OVER Message 4.2 Data Storage 4.2 Printing and Transferring Data 4.2 Counting Special Case Samples 4.3 Explanation of Histograms and Each Measured Blood Parameter 4.4 WBC (White Blood Cell) Distribution Histogram 4.4 WBC Histogram and Screen Code Messages 4.4 RBC (Red Blood Cell) Distribution Histogram 4.6 PLT (Platelet) Distribution Histogram 4.6 Measuring a Venous Sample 4.7 Preparing a Venous Sample 4.7 Measuring a Venous Sample 4.7 Measuring a 10 µL Blood Sample 4.9 Measuring a Capillary Sample 4.10 Preparing a Capillary Sample 4.10 Measuring a Capillary Sample 4.12 Continuous Capillary Blood Measurement 4.13 Automatic Waste Fluid Treatment 4.14 Waste Fluid Treatment Trouble 4.15 Daily Shutdown 4.16 Checking List Before Turning Power Off 4.16 Turning the Power Off 4.16 Checking List After Turning Power Off 4.16 Checking List Before Long Term Storage 4.16 Section Handling Data 5.C1 General 5.1 Displaying Numerical Data and Histograms 5.2 Displaying Numerical Data 5.2 Displaying Histograms for Individual Samples 5.2 Deleting Data 5.4 Deleting Data for Individual Samples 5.4 Deleting All Data 5.5 Editing IDs of Data 5.6 Printing and Transferring Data 5.7 Automatic Printing and Transferring Data after Measurement 5.7 Printing on the WA-630VK Printer Unit 5.8 Automatic Printing after Measurement 5.8 Manual Printing 5.8 Printing Stored Data 5.8 Printing Numerical Data 5.8 Printing Histograms of a Sample 5.9 Operator's Manual MEK-6318J/K C.3 CONTENTS Printing Numerical Data for All Samples of a Single Day 5.9 Transferring Data to a PC or Card Printer 5.10 Transferring Data During Counting 5.11 Transferring Stored Data for Individual Samples 5.11 Transferring Stored Data for All Samples of a Single Day 5.12 Section Quality Control 6.C1 General 6.1 _ X-R Program 6.2 General 6.2 _ Overview of X-R Program and Quality Control Procedure 6.2 _ _ Calculation of X and R 6.2 _ Calculation of Upper and Lower Limits of X and R 6.2 _ X-R Graph Example 6.4 _ How to Read the X-R Graph 6.6 Data Outside the Limits 6.6 Counting the Hematology Control 6.7 _ Displaying and Printing Stored X-R Data 6.8 _ Deleting the Stored X-R Data 6.9 _ _ XB (X Batch) Program 6.10 General 6.10 _ Overview of XB 6.10 _ Calculation of XB 6.10 _ Displaying and Printing XB Data 6.12 _ Setting XB Initial Values 6.13 _ XD„CV Program 6.14 General 6.14 _ Uses of the XD„CV Program 6.14 _ Displaying and Printing XD„CV Data 6.15 Section Calibration 7.C1 General 7.1 Calibration Methods Using Calibrator 7.1 Calibration ID 7.2 Calibration with Hematology Control 7.3 Calibration in Venous Mode 7.3 Precise Method 7.3 Simple Method 7.4 Calibration in Capillary Blood Mode 7.5 HGB/HCT Calibration with Human Blood 7.7 General 7.7 Measurement with the Instrument 7.7 HGB Measurement with a Spectrophotometer 7.7 HCT Measurement with a Microhematocrit Centrifuge 7.8 Determining the HGB and HCT Calibration Coefficient 7.8 Hemoglobin Conversion Table (g/dL ↔ %SAHLI) 7.10 Displaying and Printing Calibration Data History 7.11 C.4 Operator's Manual MEK-6318J/K CONTENTS Displaying Calibration Data History 7.11 Printing Calibration Data History 7.12 Deleting Calibration Data History 7.12 Section Error Messages and Troubleshooting 8.C1 General 8.1 Error Messages at Power On or Before or After Counting 8.2 Error Messages during Counting 8.3 System Error Messages 8.4 Inaccurate Counting and Other Problems 8.5 Section Maintenance 9.C1 Periodic Check 9.1 Checking the Circuit 9.2 Disposing of Waste 9.3 Battery Lifetime 9.3 When the Battery Loses its Charge 9.3 How to Replace the Battery 9.3 Disposing of Used Batteries 9.3 Disinfecting and Cleaning the Outside of the Instrument 9.4 Disinfecting 9.4 Cleaning 9.4 Checking, Cleaning and Maintenance Schedule 9.5 Periodic Check and Maintenance 9.5 Maintenance when Problem Occurs 9.5 Maintenance Cleaning 9.6 Displaying Operation History Screen 9.7 General 9.7 Displaying the OPER HISTORY Screen 9.7 Resetting the Counts 9.8 Before Maintenance 9.9 Checking, Cleaning or Replacing Filters 9.10 Checking and Cleaning the Sub Baths and Measurement Baths 9.12 Checking and Cleaning the Rinse Unit and Sampling Nozzles 9.14 Checking and Replacing the Pump Tube 9.16 Cleaning the Aperture Caps 9.19 Replacing the Sampling Nozzles 9.23 Calibrating Touch Screen 9.26 Removing the Jammed Paper from the WA-630VK Printer Unit 9.27 Priming 9.28 Draining the Measurement and Sub Baths 9.29 Draining the Instrument 9.30 Storing and Transporting the Instrument 9.31 Preparing the Instrument for Long Term Storage and Transport 9.31 Using the Instrument after Storage 9.32 Preparing the Instrument for Short Term Transport 9.33 Decontamination Protocol 9.34 Operator's Manual MEK-6318J/K C.5 CONTENTS Clock Accuracy 9.36 Repair Parts Availability Policy 9.36 Section 10 Reference 10.C1 Operation Theory 10.1 Electric Cell Counting 10.1 Counting Method 10.1 Red Blood Cell and Platelet Counting 10.2 Principle of Hydraulic Operation 10.2 Hemoglobin Measurement 10.3 Chemical Processing 10.3 Spectrophotometric Measurement Method 10.3 RS-232C Data Transfer 10.5 Special Key Operations for Servicing 10.5 Interference Substances 10.6 Specifications 10.9 Measured Parameters, Ranges and Reproducibility to Specimen from Venous Blood 10.9 Detection Method 10.9 Standardization Analysis Method 10.9 Dilution Ratio 10.10 Counting Time 10.10 Display 10.10 Data Storage 10.10 Environmental Conditions 10.10 Power Requirements 10.10 Dimensions and Weight 10.10 Electromagnetic Compatibility 10.10 Safety 10.11 WA-630VK Printer Unit 10.11 WA-460V Card Printer 10.11 WA-710V Printer 10.11 Standard Accessories 10.12 Consumables 10.14 Options 10.15 C.6 Operator's Manual MEK-6318J/K GENERAL HANDLING PRECAUTIONS This device is intended for use only by qualified medical personnel Use only Nihon Kohden approved products with this device Use of non-approved products or in a non-approved manner may affect the performance specifications of the device This includes, but is not limited to, batteries, recording paper, pens, extension cables, electrode leads, input boxes and AC power Please read these precautions thoroughly before attempting to operate the instrument To safely and effectively use the instrument, its operation must be fully understood 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 Before Operation (1) Check that the instrument is in perfect operating order (2) Check that the instrument is grounded properly (3) Check that all cords are connected properly (4) Pay extra attention when the instrument is in combination with other instruments to avoid misdiagnosis or other problems (5) All circuitry used for direct patient connection must be doubly checked (6) Check that battery level is acceptable and battery condition is good when using battery-operated models 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 To Shutdown After Use (1) Turn power off with all controls returned to their original positions (2) Remove the cords gently; not use force to remove them (3) Clean the instrument together with all accessories for their next use 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 The instrument must not be altered or modified in any way Maintenance and Inspection: (1) The instrument and parts must undergo regular maintenance inspection at least every months (2) If stored for extended periods without being used, make sure prior to operation that the instrument is in perfect operating condition Operator's Manual MEK-6318J/K i When the instrument is used with an electrosurgical instrument, pay careful attention to the application and/ or location of electrodes and/or transducers to avoid possible burn to the patient 10 When the instrument is used with a defibrillator, make sure that the instrument is protected against defibrillator discharge If not, remove patient cables and/or transducers from the instrument to avoid possible damage WARRANTY POLICY Nihon Kohden Corporation (NKC) shall warrant its products against all defects in materials and workmanship for one year from the date of delivery However, consumable materials such as recording paper, ink, stylus and battery are excluded from the warranty NKC or its authorized agents will repair or replace any products which prove to be defective during the warranty period, provided these products are used as prescribed by the operating instructions given in the operator’s and service manuals No other party is authorized to make any warranty or assume liability for NKC’s products NKC will not recognize any other warranty, either implied or in writing In addition, service, technical modification or any other product change performed by someone other than NKC or its authorized agents without prior consent of NKC may be cause for voiding this warranty Defective products or parts must be returned to NKC or its authorized agents, along with an explanation of the failure Shipping costs must be pre-paid This warranty does not apply to products that have been modified, disassembled, reinstalled or repaired without Nihon Kohden approval or which have been subjected to neglect or accident, damage due to accident, fire, lightning, vandalism, water or other casualty, improper installation or application, or on which the original identification marks have been removed In the USA and Canada other warranty policies may apply RESPONSIBILITIES - PROFESSIONAL USERS This instrument must be used by a professional user with a full knowledge of operating this instrument, only for his/ her intended use and according to the instructions for use Instructions in the operator’s manual must be followed, especially the following points • Storage and stability of reagents • Handling of reagents • Instrument installation • Connection of all tubes to inlets and outlets • Connection of all tubes to reagents and waste container • Checking the amount of reagents and waste fluid • Calibration • Quality control • Maintaining and servicing If deviating from the instructions, the professional user does it at the risk and liability of the laboratory and only after validation by the laboratory Nihon Kohden has no responsibility over such deviations ii Operator's Manual MEK-6318J/K ... and manometer with detergent Priming is performed automatically after cleaning the fluid path Press this key when clogging occurs, the manometer becomes dirty or bubbles occur in the manometer... corresponding to your evaluation and add comments in the space provided Fax or send your completed comment card to: Fax: +81 (3) 5996-8100 International Div., Sales Promotion Section, Nihon Kohden Corp.,... 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