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MEK 6510 OM

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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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.
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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
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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”.
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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.
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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.
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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)
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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.
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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.
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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.
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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>
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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.
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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.
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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.
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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
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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
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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
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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
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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
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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
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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.
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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
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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.
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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.
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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.
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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
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